1st 28 sets

When granted expanded authorities, pre-award costs on a federal grant may be incurred by an institution within a maximum of

90 days prior to the official start date.

R15

- Academic Research Enhancement Award - For IHEs that have not received major NIH funding - Direct costs limited to $300K for entire period - Project period limited to 3 years

Must be identified to the subrecipient at the time of award and be put into the agreement

- FAIN - IDC rate - Requirements imposed by the pass-thru entity - Requirement to provide access to records for audit

Institutional Policy Requirement for Research Misconduct

- Investigation of allegations - Notification of sponsor - Protection of whistleblowers - Restoring reputations - Informing scientific & administrative staff

to terminate a contract for convenience.....

A specific statement defining the reason for termination notice must be included in the notification by a federal officer to the contractor

Def. of Trademarks

A symbol, word, or words legally registered or established by use as representing a company or product.

iEdison

A system administered by NIH; it enables institutions and federal agencies to manage inventions electronically.

Losses on other sponsored agreements or contracts

A-21: Unallowable A-122: Unallowable (losses on other awards or contracts)

Pre-agreement costs

A-21: Unallowable unless approved by the federal sponsoring agency A-122: allowable w/restrictions

Communication costs

A-21: allowable A-122: allowable

Rearrangement and alteration costs

A-21: allowable (ordinary and normal); allowable w/federal prior approval (special) A-122: allowable (ordinary and normal); allowable w/federal prior approval (special)

Training costs

A-21: allowable for employee development A-122: allowable w/limitations

Taxes

A-21: allowable w/restrictions A-122: allowable w/restrictions

Advertising and public relations

A-21: allowable w/restrictions A-122:allowable w/restrictions

Transportation costs

A-21: allowable w/restrictions A-122: allowable

Employee morale, health, and welfare costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Plant and homeland security costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

License

Practice of leasing a legally protected property to another party in conjunction with a product, service or promotion.

Micro-Purchase

Purchase of supplies or services using simplified acquisition procedures, the aggregate amount of which does not exceed the micro-purchase threshold. Currently set at $10K

Section III-F and Appendix C of the NIH Guidelines

Where can I find a list of experiments that are exempt from the NIH Guidelines?

Appendix III to Part 200 - Indirect (F&A) costs Identification and Assignment

Where is the DS-2 located?

Limited Submissions

Where the sponsor requires an institution limits the number of applications submitted by that institution. Submitting more than one application disqualifies all submissions from the institution.

grants.gov

Where to check statuses on proposals after submission

Cost Accounting Standards (CAS) must be applied to awards: a. without federal funding b. received from any funding source c. for federal contracts over $500,000 c. for all federal awards covered by 2 CFR 230 (OMB Circular A-122)

c. for federal contracts over $500,000

Fly American Act

designed to assure federal funds being expended to benefit American companies - applies to all contracts and grants

CFDA contains

detailed program descriptions for 2053 federal assistance programs; also contains non financial assistance programs

STTR Phase I

funding not to exceed $150,000 for a period of 1 year

SBIR Phase I

funding not to exceed $150,000 for a period of 6 months

STTR Phase II

funding not to exceed $1M for up to two years, which is the same as its counterpart mechanism.

Debarment and Suspension Requirements

presently debarred, suspended, proposed for debarment, declare ineligible or voluntarily excluded from covered transaction; within 3 yr period of proceeding application been convicted or criminal judgement

Declaration of Helsinki (1964)

the World Medical Association established recommendations guiding medical doctors in biomedical research involving human participants.

IRB: Minimal Risk Review

"The probability and magnitude of harm and discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily lifer or during the performance of routine physical or psychological examinations or tests." (45 CFR 46.102)

200.338 Remedies for noncompliance

- Withhold cash payments - Disallow activity - Suspend or terminate federal award - Withhold further federal awards - Initiate suspension or debarment

Federal definition of Research & Development (R&D) - (200.87)

"R&D means all research activities, both basic and applied, and all development activities that are performed by non-Federal entities. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function." The Federal agencies are required to include whether the award is R&D in the prime Notice of Award (NoA). PTEs need to flow this information through to subawardees.

NSF Data Management Plan

- required for awards over $750k - limited to 2 pages but can use part of the 15 pages allowed for project description - required for simultaneously submitted collaborative proposals and proposals including subawards

Characteristics of grants

- the PI retains flexibility within the awarded scope of work - names a PI or project director - made for a stated purpose and period of time - minimum limiting conditions - initiated by grantee

Characteristics of cooperative agreements

- very similar to grants - ALWAYS initiated by the sponsor - substantive programmatic involvement by and with the sponsor - terms and conditions underscore agency involvement

Items that cannot be copyrighted

- works not fixed in a tangible form of expression - titles, names, short phrases, and slogans; familiar symbols or designs - ideas, procedures, methods, discoveries (concept vs. scripted) - works of common property with no original authorship (calendar)

IRB Membership

-At least 5 members -Varying backgrounds -Qualified members -At least 1 scientific -At least 1 non-scientific -At least one not affiliated with institution

Name the 2 types of intellectual property protections that may apply to computer software:

1) Copyright 2) Patent

Name 3 key differences between an independent federal agency and an executive federal department?

1) Executive federal departments are lead by "secretaries," who are president-appointed cabinet members (independent agencies are usually lead by commissions of 5-7 people appointed by presidents but serving terms longer than 4 years); Executive federal depts serve as administrative arms of the president (independent agencies have more autonomy from the president); the secretaries of the federal executive departments are in the line of succession to the president and vice president (independent agency commissions are not).

What are the characteristics of discretionary federal grants?

A discretionary grant program awards funds on the basis of a competitive process. The award is made based on merit and eligibility.

Request for Proposal (RFP)

A document that solicits proposal, often made through a bidding process, by an agency or company interested in procurement of a commodity, service, or valuable asset, to potential suppliers to submit business proposals.

Office for Human Research Protections (DHHS)

A federal agency that requires an institution to: - File /obtain Federal-wide Assurance (this is what the entity agrees to follow) - Establish an institutional IRB, use an existing IRB, or use an approved commercial IRB for protocol review - Ensure regulatory compliance in the protection of Human Subjects Report to OHRP if adverse event occurs.

Effort Reporting

A-122 Monthly Percentage of hourly reporting First hand knowledge Partners has a waiver that allows for less frequent certification, but A-122 requires monthly.

F&A Administrative cap

A-122 None

Department Admin Cost Pool

A-122 Not defined

Costing

A-122 (2 CFR 230) Nonprofit

Use to determine how to audit compliance with circulars A-21 & A-110

A-133

Audit

A-133 College/university

Audit

A-133 Nonprofit

Use to determine what could be charged to sponsored awards as direct & indirect costs

A-21

F&A Administrative cap

A-21 "A" capped at 26% MTDC

Effort Reporting

A-21 Annual Reported in calendar months/percentage of overall activity Suitable means of verification

Cost Accounting Standards

A-21 CAS 501, 502, 505, 506, DS-2 Report (disclosure statement)

Applied F&A Rate

A-21 Existing rates at time of award ("fixed rate") Federal agencies use negotiated rates for F&A that are in effect at the time of the initial award throughout the life of the sponsored agreement. "Life" means each competitive segment of a project.

Idle facilities and idle capacity

A-21: idle facilities: Unallowable w/exceptions; idle capacity: allowable w/restrictions A-122: idle facilities: Unallowable w/exceptions; idle capacity: allowable w/restrictions

Organization costs

A-21: not specifically addressed A-122: Unallowable except w/ federal prior approval

Participant support costs

A-21: not specifically addressed A-122: allowable w/prior approval of the federal awarding agency

General government expenses

A-21: not specifically addressed A-122: not specifically addressed

Interest: substantial relocation

A-21: possible adjustment if relocated within 20 years A-122: possible adjustment if relocated within 20 years

Compensation for personal services

A-21: unique criteria for support A-122: unique criteria for support

Patent Clauses - FAR 52.227-1 Authorization & Consent

Allows a Contractor to use any invention covered by a U.S. patent to accomplish the research covered under the contract. - Universities should request Alt I which removes the patent indemnity provision

What is a "deemed export?" Can it only happen when something is transferred to a person on foreign soil?

An item is "deemed" to be exported when a foreign national is given access to it (whether on or off US soil).

Federal Register

An official document, published every weekday, except on Federal Holidays, which lists the new and proposed regulations of executive departments and regulatory agencies.

four years

Any non-Federal entity that has a federally negotiated indirect cost rate may apply for a one-time extension of a current negotiated indirect cost rates for a period of up to

2 months

As a general policy, NSF limits the salary compensation requested in the proposal budget for senior personnel to no more than ___________ of their regular salary in any one year

Short-term travel visas

As opposed to longer-term immigration visas - are allowable as directs

Federal Demonstration Partnership (FDP)

Association of federal agencies, academic research institutions and research policy organizations that streamline the administration of federally sponsored research. Originally Florida Demonstration Project.

How often do faculty need to certify effort on grants, according to Uniform Guidance?

At least annually.

How often do IACUCs need to review each animal use protocol?

At minimum every 3 years

200.310 Property Standards - Insurance Coverage

At minimum, provide insurance coverage for real property and equipment acquired or improved with Federal funds

CFDA # and applicable FAIN

Audit Findings 200.516 requires that questioned costs be identified by:

OMB Circular A-50

Audit Follow-Up

2 CFR 200 - Subpart F

Audit Requirements. Formerly A-133. Section 200.5xx.

OMB A-50

Audit follow up; replaced by UG

A-133

Audits State & local gov'ts & nonprofits (single audit)...includes educational institutions

OMB Circular A-133

Audits of States, Local Governments & Non-Profit Organizations

OMB Circular A-133

Audits of states, local governments and nonprofit organizations

Contracting Officer (CO):

Authorized by a government warrant to issue awards and modifications; May legally bind the government

National Research Act of 1974

Authorized the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged with developing an ethical code and guidelines for researchers

When do copyright rights vest with an author?

Automatically, from the moment of inception of the work (copyright rights cover unpublished as well as published works).

What is the F&A Simplified Method and when is it used?

Available to universities with direct funding under $10M; used when major functions benefit approximately to same degree (same rate used regardless of activity).

Unilateral Award

Award made by sponsor to an organization without considering competitive proposals

Bequests and gifts

Awards that are given with few or no conditions

Nuclear Regulatory Commission

Developed and administers the standards for handling radioactive materials

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): COMPUTERS/COMPUTING DEVICES

Devices under $5,000 may be direct charged if essential to the performance of the award.

400.413

Direct Costs

Publishing costs

Direct and are still allowable costs after award end date but before closeout

Computing Devices

Direct charged if essential to the performance of the Federal Award and under $5,000

Fly American Act

Designed to assure federal funds being expended to benefit American companies - applies to all federal contracts and grants. Must use American flag carriers for travel (very limited exemption circumstances).

Show Cause Notice

Directs contractor to show why the contract should not be terminated for default. It ensures that contractor understands it's predicament and it's answers can be used in evaluating whether circumstances justify default action.

True or False: The Small Business Administration (SBA) administers all SBIR and STTR programs.

False: the participating agencies (ex: DoD, NASA, NSF, etc) each administer their own individual program, within the guidelines established by Congress.

True or False: Copyright rights are automatically defensible from infringement from the moment a work is created by the author.

False: while copyright rights are protected from inception, an author must file a copyright with the Library of Congress if they wish to have the ability to sue for infringement.

What is falsification of research?

Falsification in research is manipulating research materials, equipment or processes; changing or omitting data or results

Buckley Amendment

Family Educational Rights and Privacy Act of 1974 Grades of a college student cannot be released to parents without the student's permission (records management aspect of research administration)

What is FAR Part 13?

Far Part 13 is the "Simplified Acquisition Threshold (SAT) Procedures." It is the governing regulation for acquisitions BELOW the SAT. The FAR Part 13 menu of terms and conditions is shorter, especially in the areas of reporting requirements and subcontracting. The terms are also tailored to a small business environment (e.g. FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors).

200.211 Public access to Fed award info

Fed award agency must announce all fed award publicly

200.201 Use of grant agmts, cooperative agmts, and contracts - When can Fixed Amount Awards be used?

Fed award must be negotiated using cost principles. May use fixed if project scope is specific and if adequate cost, historical, or unit pricing data is available to establish a fixed amount award based on a reasonable estimate of actual cost. Accountability based on performance and results

Sources of Federal Contract Opportunities

FedBiz Opps, grants.gov, Catalog of Federal Domestic Assistance

CFR Title 48

Federal Acquisition Requisition Systems

§200.414(c)((1)

Federal Agency Acceptance of Negotiated Indirect Cost Rates

Cognizant Agency

Federal Agency responsible for negotiating and approving F&A rate

FAIN

Federal Award Identification Number - An OMB memorandum (not numbered) dated June 12, 2013, titled "Improving Data Quality for USAspending. gov," emphasized the requirement for a unique FAIN. It stated that beginning in October 2013, each federal agency must assign a FAIN, unique within the federal agency, to each financial assistance award, and cannot modify the FAIN during the life of the award. The award identifier is included on all reported subcontracts and subawards.; used to implement FFATA

FDP

Federal Demonstration Partnership

Examples of reports submitted at closeout

Federal Financial Report (SF 425 or SF 269), Final technical reports (RPPR-Research Performance Progress Report), Invention Report, and Tangible Property Report

Where you will find the regulations issued by executive branch agencies that affect the management of grants

Federal Register

OMB A-89

Mandated the creation of the CFDA

What are the characteristics of mandatory federal grants?

Mandatory grants are a type of grant that must be awarded to each eligible applicant (generally a government entity) based on the conditions defined in the authorizing statute. The are authorized when bills are passed by Congress.They are non-competitive. They can be either Formula or Block grants.

90 Calendar days

Number of days after period of performance end date that the non-federal entity has to submit their final report. NIH is 120.

5 Committee members

Number of members required on the Institutional Biosafety Committee

What is the OHRP and what federal agency is it a part of?

OHRP is the Office for Human Research Protections, and is within DHHS.

Property management

OMB Circular A-110 prescribe standards around management and disposition of property purchased with federal funds; "exempt property" provision allows any Federal agency which has statutory authority (such as NSF) to vest title in an institution of higher education, hospital or other non-profit organization without further obligation to the Federal Government and under conditions the agency considers appropriate.

State and local government are subjects to

OMB Circulars A-102 (45 CFR Pt92) for administrative requirements.

SF 425

OMB Federal Financial Report

ONR F&A rate negotiation

ONR administers indirect cost rates for nonprofits for which the largest dollar value of direct federal awards is from the Department of Defense (DoD) or NASA (upon delegation). If the the largest dollar value of direct federal awards is from the DoD and your primary business with the DoD is research and development, ONR will be your cognizant agency for administration of your indirect cost rates. OMB Circular A-122 requires submission of an indirect cost rate proposal to your cognizant agency no later than three months after receipt of your first direct federal award

Cognizant agencies

ONR and DHHS

Blood-borne Pathogens

OSHA promulgated this standard to eliminate and minimize occupational exposure to Hepatits B, HIV and other blood-borne Pathogens

What is the aim of the Blood-borne Pathogens standard?

OSHA promulgated this standard to eliminate and minimize occupational exposure to Hepatits B, HIV and other blood-borne Pathogens

Internal Controls

Objectives are the Efficient and effective operations and reliable financial reporting (COSO Report)

OSHA

Occupational Safety and Health

What does OSHA stand for? and at what procurement threshold are OSHA regs applicable?

Occupational Safety and Health Administration. OSHA Act of 1970 established these standards and they apply to all agreements over $2,500

Federal Fiscal Year

October 1 to September 30

OBA

Office of Biotechnology Activities - NIH

Types of proposals

New Continuation Renewal of competing continuation Supplemental Contract Proposal (solicited and unsolicited)

NDA

New Drug Application (for approval)

Program income (under UG)

New default treatment is deduction (reduce the amount of the federal award and use program income to replace that funding) unless specified otherwise. Def. now includes license fees and royalty income earned on patents and copyrights during award POP.

Can slogans be copyrighted?

No

Under Uniform Guidance Subpart A, does the definition of "State" (200.90) include Indian tribe?

No - this is a change under UG. Indian Tribe is defined under 200.54

OBA

Office of Biotechnology Activities - NIH. OBA promotes science, safety and ethics in the development of public policies in three areas: Biomedical Technology Assessment, Biosafety, and Biosecurity.

Treasury

Office of Foreign Assets Control (OFAC) is part of what Department?

Specially Designated Nationals and Blocked Persons

Office of Foreign Assets and Controls' list is

IRB Registrations and assurances

Office of Human Research Protections (OHRP), FDA for clinical trials, Federal-wide Assurance (FWA)

Reasons to minimize cost sharing

Increased administrative burden -- ALL cost sharing on ALL sponsored projects must be documented Increase in cost sharing causes decrease in indirect cost rate Depreciation on cost shared equipment may NOT contribute to indirect rate

Office of Human Research Protections (OHRP)

Office that oversees all IRBs and requires the filing of Federalwide Assurance

US Code

Official codification of congressional laws; bill becomes a law and is then codified as part of US Code.

Federal Register (FR)

Official daily publication of rules, proposed rules and notices by federal agencies, as well as executive orders and presidential documents

Payments for Clinical Trial Agreement funds are typically made how?

On a per subject basis and may include start up funds that cover IRB fees and equipment

How often is each volume of the CFR updated?

Once each calendar year.

FAR Contract Types: Basic Principles & Selection

One size does not fit all situations Differing contract mechanisms are available to: allocate the performance benefits and risks fairly; and provide adequate payment/financing arrangements to support successful execution of the project Align the interests of the government and the contractor

§200.414(g)

One-Time Extension of Rate - Up to 4 years; subject to review and approval

Who can approve exceptions to the rules of Uniform Guidance?

Only OMB can approve exceptions to rules for broad classes of federal awards or non-federal entities. Exceptions on an individual/ case-by-case basis may be made by federal awarding agencies. The Federal awarding agencies may also apply more restrictive rules when approved by OMB or required by federal statute or regulation.

Walsh-Healy Public Contracts Act

Passed in 1936 Applies to contracts over $10k Prohibits child labor Establishes minimum wages and overtime pay. Maximum hours Safe and sanitary working conditions Convict labor

Administrative Procedures Act (APA) 5 USC 551-559

Passed in 1946. Established the rule making process for all government institutions.

Bayh-Dole Act AKA

Patent and Trademark Law Amendment Act of 1980. Codified in 37 CFR 401

Reasonable Cost

Prudent person Necessary expense Restraints of arms-length bargaining Consistent with institutional policy and procedure

CFR Title 42

Public Health

CFR Title 45

Public Welfare

CFR Title 45

Public Welfare regulations

OMB Uniform Guidance (2 CFR 200)

Published in the December 26, 2013, Federal Register; became effective on December 26, 2014

Circular A-133 (Audits of States, Local Governments, and Non-Profit Organizations)

Pursuant to the Single Audit Act of 1984, P.L. 98-502, and the Single Audit Act Amendments of 1996, P.L. 104-156. Sets standards for consistency and uniformity among Federal agencies for the audit of States, local governments, and non-profit organizations expending Federal awards (non-fed entities)

OMB A-133 reporting guidelines

Quarterly and semi-annual interim reports - 30 days; annual reports - 90 days; final reports - 90 days.

C20: purpose

Sets standards for financial management systems Methods for making payments Satisfying cost sharing and matching requirements Accounting for program income Budget revision approvals Audits Determining Allowability of cost Establishing fund availability

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): VISA COSTS

Short term travel visas are allowable.

$5,000

Significant Financial Interest De minimis threshold of the NIH

PI or any project team member who can affect the project's outcome plus immediate family

Significant Financial Interests include

Two methods for developing F&A rates for Colleges & Universities

Simplified Method (S&W) and F&A Cost Base Principle Method (MTDC)

FedBizOpps.gov

Single point-of-entry for federal procurement opportunities >$25K (Government buyers can post their information here, vendors can search, monitor and retrieve contract solicitations); Site lists justification and approval for limiting competition on specific contracts/orders; no direct application through website.

National Science Foundation indicates that decisions on the funding of grant proposals should normally take

Six to nine months

SBIR

Small Business Innovation Research. Gives Small Business Administration grants to businesses.

SBIR

Small Business Innovative Research - supported by ear marked, federal funds

What is the SBIR program? What does SBIR stand for?

Small Business Innovative Research - supported by ear marked, federal funds (a % of agency budgets from participating agencies must go to fund these programs). The purpose was to invest in innovations coming out of American small businesses.

STTR

Small Business Technology Transfer Program

What does STTR stand for?

Small Business Technology Transfer Program

STTR

Small Business Technology Transfer. SBA grant where a business must partner with a non-profit.

FAR 52.219-9

Small Business and Subcontracting Plan

FAR Part 52

Solicitation Provisions and Contract Clauses

FAR at 48 CFR Part 52

Solicitation provisions and contract clauses

Cost Clause - FAR 52.230-5, Cost Accounting Standards—Educational Institutions

Specifically tailored to universities; Incorporates OMB Uniform Guidance, (formerly A-21).

Contract

Sponsor procures research from an institution and acts as the technical overseer

SPIN

Sponsored Programs Info Network - developed by InfoEd - available by subscription

Fulbright Program

Sponsored by US government. International education exchange to increase mutual understanding between US Citizens and citizens of other countries. Focus is on teaching.

A Notice of Award typically includes which of the following? a. Approval of facilities and administrative costs (Indirect Costs) rate b. Award terms and conditions c. Congressional approval d. Guarantees for continuation

b. Award terms and conditions

Debarment and Suspension

The actions taken by an official in accordance with OMB guidance at 2 CFR part 180, to exclude a person or organization from participating in grants and other non-procurement awards government-wide.

Which of the following was enacted as a uniform patent policy among the many federal agencies that fund research? a. Patriot Act b. Bayh-Dole Act c. Solomon Act d. Davis-Bacon Act

b. Bayh-Dole Act

A project has a total cost limit of $200,000. The project requires $20,000 for supplies, with the remainder of the budget allocated to the PI's salary. If an institution has an F&A rate of 40% (MTDC), and a fringe benefit rate of 25%, how much will be budgeted for fringe benefits? a. $48,714 b. $36,325 c. $24,571 d. $12,854

The answer is $24,571 $200,000 / 1.40 = $142,857 (Direct Cost) $142,857 - $20,000 (Supplies) = $122,857 $122,847 / 1.25 = $98,286 = salaries $122,857 - $98,286 = $24,571

The Federal Financial Assistance Management Improvement Act of 1999 (Public Law 106-107)

The impetus to change the ways in which federal agencies accept grant applications and manage grant awards has been mandated by:

Which of the following is included in 2 CFR 215 (OMB Circular A-110)? a. Audit requirements b. Debarment and suspension rules c. Federal contact requirements d. Cost principles for nonprofits

b. Debarment and suspension rules

Form 990-PF

The public record information return that all private foundations are required by law to submit annually to the Internal Revenue Service (IRS).

Tuskegee Experiment (1932-1972)

The purpose of this study was to observe the natural history of untreated syphilis; the African-American men in the study were told they were receiving free health care from the United States government.

On an STTR grant, what % of the work must be done by the small business? What % must be done by the research institution?

The small business must do 40% of the work, and the research institution must do at least 30%

Fixed-price (fixed amount) agreements

These agreements specify a fixed price for project performance or completion of certain project milestones. Requires sponsor approval if the grant is from a federal sponsor and subject to UG.

Comprehensive Financial Statements

These are always the sole responsibility of the Auditee

Post-award audits

These are audits that take place after the conclusion of contracts, grants, or other assistance agreements, and before the end of the required record retention period.

When does the Drug Free Workplace term apply?

This term must be on all federal contracts $25k or more.

Standards established by GAGAS

Those standards require an independent auditor — whether federal or non-federal — to have an affirmative obligation to report, as part of the current audit report, the status of known but uncorrected findings from prior audits that affect the scope of the current audit.

What can happen if you are found guilty of making false claims, under the False Claims Act?

Those who knowingly submit or cause another person/entity to submit false claims for payment of government funds are liable for 3x govt damages plus civil penalties ($5500-$11k/false claim)

Belmont Report (1979): What are the three primary areas of application when considering the core principles?

Three primary areas of application are: 1) informed consent 2) assessment of risks vs benefits 3) selection of subjects. MNEMONIC: Ice Cream, Roast Beef and Salsa (IC, RvsB, Sel-s)

What is the minimum length of time a recipient of federal grant funds must maintain records?

Three years from the submission of final report of expenditure

Certificate of Current Costs and Pricing

Threshold for obtaining the data is $550,000

Cost Sharing - In-kind

Time Invested

General Proposal Elements (7)

Title Abstract Table of Contents Project Description/Scope of Work Vitae/Biosketch Budget and Justification Appendices

Federal Regulation: the Common Rule

Title 45 CFR PART 46: all encompassing Subpart A: HHS policy for protection of human research subjects (IRB membership, functions and operations, requirements, IRB review of research) Subpart B: protections for pregnant women, human fetuses, and neonates in research Subpart C: protections for research involving prisoners as subjects Subpart D: protections for children as subject in research Subpart E: registration of institutional review board (IRB)

C34: equipment

Title and use Property management standards Description Serial number Source and award number Title Acquisition date Percent of federal participation in cost Location and condition Cost Disposition data Physical inventory at least once every two years

CFDA program Title

Title of the program under which the federal award was funded

C35: supplies and other expendable property

Title shall vest in recipient upon acquisition Requirements for residual inventory exceeding $5k

200.313 Equipment

Title to equipment acquired under award will vest with non fed entity - use equipment for project during performance period - when no longer needed for project, may be used for other activities - non fed entity must keep records of property. physical inventory must be taken once every 2 years

Cost Sharing and Cost Accounting Standards

Treat a cost consistently as direct or indirect Accumulate all costs consistently and only once

Under Uniform Guidance, closeout is now ____ days from the end of the period of performance: A) 45 days B) 60 days C) 90 days D) 120 days

Trick question! Under Uniform Guidance, the standard remains 90 days, with the option to request an extension up to 120 days. Certain agencies like NIH and NSF automatically grant the extension to 120 days.

200.312 Federally owned and exempt property

Title to property remains with Fed govt unless marked as exempt in award, then title can vest with non fed entity

200.311 Property Standards - Real Property

Title to real property acquired or improved under Fed award will vest upon acquisition in non Fed entity

C32: real property

Title to real property shall vest in the recipient provided the recipient use the real property for the authorized purpose of the project Shall not encumber the property without approval Must obtain written permission to use the property in other federally-sponsored projects Recipient shall request disposition instructions when no longer needed

200.314 Supplies

Title to supplies will vest in non Fed entity. If residual inventory exceeds $5K, must compensate the Fed Govt for its share

Direct charging of administrative and clerical salaries to federal awards

To comply with OMB Circular A-21, section F6b(2), "The salaries of administrative and clerical staff should normally be treated as F&A costs. Circular does allow for "unlike circumstances" where direct charging could be justified, but university must also comply with the requirements in Appendix A (CAS 990.502) that universities classify costs consistently as direct or indirect.

Description of a cost transfer journal entry

To correct prior date entry/transfer lab supplies, a Fisher scientific, Po#, appropriate date

Mission of VA

To fulfill President Lincoln's promise "To care for him who shall have borne the battle, and for his widow, and his orphan" by serving and honoring the men and women who are America's Veterans.

What was the goal of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

To improve US ability to prepare for and respond to bioterrorism and prevent public health emergencies

What was the goal of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002?

To improve US ability to prepare for and respond to bioterrorism and prevent public health emergencies

NSF- The National Science Foundation Act of 1950 (Public Law 81-507) set forth NSF's mission and purpose:

To promote the progress of science; to advance the national health, prosperity, and welfare; to secure the national defense....

What are some of the goals of IACUCs?

To provide for the humane care and use of live vertebrate animals in research; this can mean taking measures to reduce the number of animals used, reduce the pain the animals experience, and to increase the health of the animals used. IACUCs enforce stricter standards than IRBs because animals cannot consent to the research.

IRB Expedited Review

To qualify for _______________, study must be of minimal risk to subjects and cannot include pregnant women, prisoners, or the mentally impaired. Must meet requirements of 9 categories.

IRB Exempt Review

To qualify for ________________, study subjects cannot be pregnant women, prisoners, or the mentally impaired. There can be no audio/visual recording and no minors unless it is a standard educational test. No minors in public observation. Does not have to complete annual review.

The Cognizant Agency for indirect costs with a copy to the IHE's cognizant agency for audit

To who should the DS-2 be submitted?

Objectives of Internal Control

Transactions executed in compliance with regulations, Funds safeguarded against loss from unauthorized use, processes and procedures promote efficiency

Drug-Free Workplace Act 48 CFR 23

U.S. law that requires federal contractors with contracts of $100,000 or more as well as recipients of grants from federal government to certify they are maintaining a drug-free workplace. Does not require drug testing.

PHS Tuskegee Syphilis Study 1932-1972

US Public Health Service study on syphilis in 600 poor African-American men in rural Tuskegee, Alabama. 1947 when penicillin became the drug of choice, researchers withheld treatment.

CAS 502

Which one of the 4 basic requirements for Cost Accounting Standards is defined by: consistency in allocating costs incurred for the same purpose?

Which of the following are two critical termination clauses of General Provisions of a federal contract: a. Dispute and changes b. Default and convenience c. Default and stop work order d. Stop work order and failure to confirm

b. Default and convenience

EAR99

a classification for an item. It indicates that a particular item is subject to the Export Administration Regulations (EAR), but not specifically described by an Export Control Classification Number (ECCN) on the Commerce Control List (CCL).

Which of the following agencies is responsible for administering the Animals Welfare Act? a. Public Health Service b. Department of Agriculture c. Environmental Protection Agency d. American Society for Prevention of Cruelty to Animals

b. Department of Agriculture

Who should administer progressive discipline to an employee? a. Director of human resources b. Direct Supervisor c. Legal counsel d. Chair of grievance committee

b. Direct Supervisor

Which of the following populations has special protection as research participates under federal guidelines? a. Elderly b. Prisoners c. College Students d. Persons diagnosed as HIV positive

b. Prisoners

Expanded Authority

carry forward of unobligated balances to subsequent funding period

Procurement Integrity

certification required for $100k/year level - applies to all recipients of federal contract funds

Code of Federal Regulations (CFR)

codification of general and permanent rules of agencies; updated once a year; published in federal register by executive departments and agencies of the federal government; FAR info are codified in title 48 of CFR

Soloman Act

colleges that accept federal money must allow military recruiters on campus

Animal Welfare Assurance

commitment that institutions will comply with PHS policy, with the Guide for Care and Use of Lab Animal; description of institutions program; designation of IO responsible for compliance

Institutional Review Board (IRB)

committee of administrators, scientists, and community members that reviews proposals for research involving human participants

The Tuskegee Syphilis Study

conducted from 1932 to 1972 around Tuskegee, Alabama. Six hundred poor — and mostly illiterate — African-American males, 400 of whom were infected with syphilis, were monitored for 40 years. Free medical examinations were given; however, subjects were not told about their diagnosis. Even though a cure (penicillin) became available in the 1950s, the study continued until 1972 with participants being denied proper treatment or given fake treatments and placebos, instead

National Research Act of 1974

created a commission for the protection of human subjects of Biomedical and Behavioral research.

NIH Peer review process

dual review system - initial review and National Advisory Council/Board review

Federal Demonstration Partnership (FDP)

an association of federal agencies, academic research institutions with administrative, faculty and technical representation, and research policy organizations that work to streamline the administration of federally sponsored research.

2 CRF 215 (OMB Circular A-110) provides regulations governing which of the following for educational institutions? a. Administrative requirements for contracts b. Administrative requirements for grants and cooperate agreements c. Cost principles for grants and cooperative agreements only d. Administrative requirements and cost principles for grants and cooperative agreements

b. Administrative requirements for grants and cooperate agreements

If an agency requires 20% of the total project cost as cost sharing and the proposal is requesting $200,000 from the agency, what is the additional amount that the institution much cost share? a. $40,000 b. $50,000 c. $100,000 d. $220,000

b. $40,000 200,000 x 20% = $40,000

The National Science Foundation indicates decisions on the funding of grant proposals should normally takea a. 2-4 months b. 6-9 months c. 10-12 months d. 18-24 months

b. 6-9 months

Patents

licenses that give an inventor the exclusive right to make, use, or sell an invention for 20 years from the date on which the application for the patent was filed in the US.

When must ADA terms be flowed down?

must be flowed down to recipients with 25 or more employees - applies to all agreements

Test of allowability: def. of conformance

must conform to award document (special terms and conditions) and type of award.

Patent

must disclose new invention to agency within two months of discovery

Independent Agencies (must go to Congress to request / defend funding)

must have board who control power over agency (vs. head appointed by Pres. as in Executive branches); Funding agencies examples: NASA, NSF, NEH, NEA, USAID

Bayh-Dohl

must make disclosure to govt within 2 months of disclosure by PI to university

IACUC members

must meet 2x a year and inspect their animal facilities 2x a year (at 6 month intervals or semiannually)

IRB register

must register with OHRP

FFATA compensation reporting requirements

names and total compensation of the five most highly compensated officers of the entity if the entity in the preceding fiscal year received 80 percent or more of its annual gross revenues in Federal awards; and $25,000,000 or more in annual gross revenues from Federal awards; and the public does not have access to this information about the compensation of the senior executives

Common identifiers

names, SS#, address, birth date

Americans with disabilities act (1990)

protects individuals who possess, or are thought to possess, a wide range of disabilities; does not force employer to employ someone if a disability would create "undue hardship" onto business.

Copyright

protects the ownership rights of creative works, including books, articles and lyrics for the life of the author plus 70 years.

First amendment law materials

protects the right to freedom of religion and freedom of expression from government interference. Freedom of expression consists of the rights to freedom of speech, press, assembly and to petition the government for a redress of grievances, and the implied rights of association and belief.

Walsh-Healey Public Contracts Act

provide conditions for the purchase of supplies and making of contrast by US (any amount exceeding $10K)

Service Contract Act of 1965

provide labor standards for certain persons employed by federal contractors to furnish services to federal agencies (contracts over $2500)

The Code of Federal Regulations

provides information on patent rights and responsibilities currently applicable to universities and federally sponsored projects

The Fullbright Program

provides opportunity for teaching abroad

Privacy Act of 1974

provides protection to individuals by ensuring that personal information collected by Federal agencies is limited to that which is legally authorized and necessary and is maintained in a manner which precludes unwarranted intrusions upon individual privacy.

2 CFR 215 (OMB Circular A-110)

provides regulations governing Administrative requirements for grants and cooperative agreements for educational institutions, inventory control, Admin Requirements for Institutions of higher education, hospitals, & other nonprofits

Non-delinquency on Federal Debt

provides that an organization or individual that is indebted to the United States, and has a judgment lien filed against it, is ineligible to receive a Federal grant. Does not include student loan debt.

Test of allowability: def. of reasonableness (includes necessity)

prudent person test; consider whether the cost is of a type generally necessary for the organization's operations or the grant's performance

Byrd Anti-Lobbying Amendment common rule (1989)

published by Social Security Administration (SSA); prohibits the recipient of a Federal contract, grant, loan or cooperative agreement from using appropriated funds to pay any person to influence or attempt to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions: The awarding of any Federal contract, The making of any Federal grant, The making of any Federal loan, The entering into of any cooperative agreement, and The extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement; imposes requirements for disclosure and certification related to lobbying by recipients of any of the covered Federal actions; term must be flown down to subs;

Committed Voluntary Cost sharing

quantified contributions reflected in the proposal that are binding and must be accounted for

Fixed indirect cost rate

rate established for a period; under-over recovery adjusted during next negotiation. Often used by tribal governments.

International Traffic in Arms Regulations (ITAR) is administered by

the Department of State

The Buckley Amendment

the Family Educational Rights and Privacy Act of 1974 (FERPA) is also known as:

The right of the General Public to access records in the possession of federal agency is contained in

the Freedom of Information Act

Researchers must make available data produced under a federal award through:

the Freedom of Information Act (FOIA)

Approved animal protocols need to be reviewed by

the IACUC every 3 years

National Library of Medicine is located within

the NIH

Standards for handling radioactive materials are developed and monitored by

the Nuclear Regulatory Commission

Access to federal funded research data is required under

the Shelby Amendment

The federal agency responsible for prosecuting institutional violations of effort reporting is

the U.S. Department of Justice, under the False Claims Act

Administrative Procedure Act (APA), Pub.L. 79-404, 60 Stat. 237 (1946)

the United States federal statute that governs the way in which administrative agencies of the federal government of the United States may propose and establish regulations

Declaration of Helsinki 1964

the World Medical Association established recommendations guiding medical doctors in biomedical research involving human participants.

Under Uniform Guidance, Federal awarding agencies determine:

the appropriate award instrument (mode of support)

Equal Employment Opportunity

the condition in which all individuals have an equal chance for employment, regardless of their race, color, religion, sex, age, disability, or national origin

Walsh-Healey Public Contracts Act stipulation

the contractor will comply with govt minimum wage and hour requirements, child and convict labor restrictions and work safety provisions

Termination for Default

the exercise of the Government's right to completely or partially terminate a contract because of the contractor's actual or anticipated failure to perform its contractual obligations

Termination for Convenience

the exercise of the Government's right to completely or partially terminate performance of work under a contract when it is in the Government's interest

Under federal grant conditions, the title to equipment must remain with

the institution

Public Law

the law of relationships between individuals and the government.

Deemed Export

the release of technology or source code that is subject to the Export Administration Regulations, to a foreign national located in the United States.

Equitable selection of subjects

Belmont Report: Justice underlying principle is:

Trailing charges

Late posting charges from internal utilities like recharge centers, shops and animal care

1965 Sports Illustrated

"The Lost Pets that Stray to the Labs" Describes the disappearance of the infamous Dalmatian, Pepper

UG Retention reqs. for records

3 yrs (all records pertinent to a Federal award) from submission of the final expenditure report.

Informed Consent: Elements, continued

13. Consequences for withdrawing 14. Disclose new findings affecting willingness to participate.

Design Patent

14 years from the date of issue

Bad debts

A-21: Unallowable A-122: Unallowable

Goods or services for personal use

A-21: Unallowable A-122: Unallowable

Fundamental Research Exemption:

"research in science, engineering or mathematics, the results of which ordinarily are published and shared broadly within the research community, and for which the researchers have no accepted restrictions for proprietary or national security reasons." EAR is 15 CFR § 734.8.

F&A cost may be a direct cost if

"unlike circumstances" are present

An anti lobbying certificate is required on federal grants, cooperative agreements, and contracts exceeding a minimum of

$100,000

TINA threshold

$700k

National Research Act 1974

(est. requirement for IRB)

45 CFR Part 74.26

(not covered by OMB Cirular) For profit orgs

A well-designed grant budget outlines costs that are

- Allocable, allowable, reasonable - Complete, adequate, accurate - Justified clearly and consistently with budget and project narratives - follow sponsor guidelines

200.466 Scholarships and student aid costs

- Allowable only when purpose of fed award to provide training to selected participants - Must be consistently provided - Student should be enrolled in advanced degree - Charges subject to temporary reporting requirements

Items released in Freedom of Information Act Inquiries

- Application information only after the initial Award - Notice of Grant Award Information - Interim and terminal progress reports - Reports of expenditures - Final report of performance conducted by grantor. Private agencies don't have to reveal salaries. PI can redact and send back to the Feds.

Shared characteristics of grants, cooperative agreements, and contracts

- Award is made to the grantee Institution - the scope of work defines the project - Award is made for a stated period of time (project period, budget period) - names a principle investigator or project director - Terms and conditions dictate latitude

200.403 Factors affecting allowability of costs

- Be necessary and reasonable - Be consistent and applied uniformly - Be consistent in treatment - In accordance with GAAP

Safety and Health compliance requirements

- Community notification - Containment - emergency preparedness

Institutional system requirements for contracts and purchasing

- Cost principles & procurement procedures described by federal regulations - Personnel trained in institution's policies and requirements - Vendor relationships reviewed to prevent conflict of interest - Procedures in place to detect, prevent, & report kickbacks

Copyrightable works

- Literary works, musical and dramatic works, including software - pantomimes and choreographic works - pictorial, graphic, and sculptural works - motion pictures and other audiovisual works - sound recordings - architectural works

Mandatory Cost Sharing requirements

- May be a fixed percent or specific level of participation negotiated between the institution and sponsor - Must be included in the proposal and provided by someone other than the sponsor - Is binding and must be accounted for - Reportable to the sponsor

200.454 Memberships, Subscriptions, and professional activity costs

- Membership of prof. org allowable - Subscriptions to business and prof. periodicals allowable - Country club costs unallowable - Costs of membership for lobbying unallowable

Conditions for Cost Sharing

- Must be verifiable and included in proposal budget - May be used for only one award - Must be an otherwise allowable cost - A federal award cannot be used as cost sharing on another federal award - Equipment donated to a project is calculated at Fair Market Value at the time of the award - Unrecovered F&A may be allowed as cost sharing

200.343 Closeout

- Must submit no later than 90 days after the project end date all financial and performance reports - All obligations must be liquidated no later than 90 calendar days after the project end date

200.331 Requirements for pass through entitites

- PTE must provide best info available about award - Evaluate subrecipients risk of noncompliance - Monitor activities - Verify every subrecipient audited

Funding Opportunity Announcements require

- Standard 60-day lead time (minimum of 30 days) - Statute requirements or exigent circumstances may allow shorter lead times - Must be announced on OMB-designed websites - Must contain six specific data elements

Alcoholic beverages

A-21: Unallowable A-122: Unallowable (There is some Allowability for some research studies)

IRB 5 members

1 primary concern in scientific areas, 1 primary concern is not scientific, 1 not affiliated with institution

IACUCs are subject to 2 sets of regulations. Name the regulations, and the federal agency/unit in charge of oversight and compliance for each.

1) Animal Welfare Act (federal law); compliance and monitoring from USDA APHIS AC unit. 2) PHS policy; compliance and monitoring from OLAW (DHHS).

Name 14 essential clauses/elements of a contract

1) Consideration; 2) Key Personnel/Contacts; 3) Invoicing terms; 4) Term (Period of Performance); 5) Scope of Work/Deliverables; 6) Intellectual Property; 7) Publication Rights; 8) Confidential Information; 9) Indemnification; 10) Insurance; 11) Technical Reports; 12) Termination; 13) Governing Law/Disputes; 14) Change clause.

Order of precedence

1). Laws (general & less restrictive) 2). Program Regs 3). Admin Regs 4). Special Terms & Conditions (NGA)

3 eligibility requirements for small business applying to an SBIR or STTR

1)US-based, 2) less than 500 employees, 3) not publicly-owned.

Describe 3 outcomes the Tuskegee Syphilis Experiment had on modern Human Subjects Research regulations.

1. Belmont Report (1979), which outlined ethical principles for Human Subjects Research. 2. Establishment of the Office for Human Research Protections (OHRP) under DHHS. 3. Federal laws and regulations requiring Institutional Review Boards for the protection of human subjects in studies involving them.

PTE oversight and monitoring

1. Federal award information 2. Subrecipient compliance with federal award requirements 3. Subrecipient audit and prompt corrective action 4. Alleviate subrecipient noncompliance impact on PTE compliance with federal requirements

Informed Consent: Process

1. Obtained from subjects prior to participation 2. information, understanding, willful volunteering 3. Written between a sixth and eighth-grade levels. 4. The subject has to have the opportunity to read the entire document before signing 5. Written consent document must be signed by the subject (or legally authorized representative) 6. A copy of the informed consent document must be given to the subject

SBIR # of participating federal departments

11

OSHA Act

1970 - applies to all agreements over $2500

$25,000 (formerly $10,000)

2 CFR 200 Subpart F (formerly OMB Circular A-133) Questioned Cost Threshold

Debarment and suspension rules is included in

2 CFR 215 (OMB Circular A-110).

Biosafety Recombinant DNA

2 members not affiliated with institution who represent interest of community

Three criteria for Patentability: two

2. Non-obvious An invention is considered obvious if teachings from the prior art appear to suggest the invention to a person of ordinary skills in the art. (Subjective standard)

A 9 month faculty member wants to commit 25% FTE to a grant. How many person-months does this represent?

2.25 Academic Year person months. To convert percent effort to person months, multiply the percentage of effort associated with the project times the number of months of the appointment.

What percentage of Federal Agency budget is set aside for SBIR/STTR funding (when budget exceeds 100 million).

2.5% of budget

If the regular pay schedule of an institution is a 9 month academic year and the PI will devote 9 months at 30% time/effort and 3 months summer term at 30% time/effort to the project, then how many person months will she devote to the project?

2.7 academic months and .9 summer months. (9 x 30% = 2.7 person months; 3 x 30%= .9)

Three criteria for Patentability: three

3. Utility In order to be patentable an invention must also be useful. (Credible use) Diagnostic methods: study disease (elevated protein in blood) is not patentable because it is naturally occurring. Tying a diagnostic to a therapeutic treatment method becomes valuable.

Patent Regulations

37 CFR 401 Requires written agreements with PI and staff Must disclose new invention to agency within 2 months of discovery (iEdison) Decision to retain title within two years after disclosure under the Bayh-Dole Act Must file within one year of electing to retain title

Vulnerable populations are outlined in

45 CFR 46.111(b)

What (one) type of intellectual property protection could be applicable to: artistic work, musical work, unpublished literary work, computer software.

A copyright could be filed for these types of works.

Allocable cost

A cost that can be assigned to a project or activity based on relative benefits received.

Internal control

A process designed to achieve its objectives through efficient reliable operations

Defense and prosecution of criminal and civil proceedings and claims

A-21: allowable w/restrictions (defense and prosecution of criminal and civil proceedings, claims, appeals and patent infringement) A-122: allowable w/restrictions (defense and prosecution of criminal and civil proceedings, claims, appeals and patent infringement)

Accounting

A-21: not addressed A-122: not addressed

31 USC 3729

False Claims Act. Violators liable for treble damages and penalties ranging from $5,500 to $11,000

Expanded Authorities

Allowed at the option of the agency, allow for 90 day pre-award costs, one-time no cost extensions up to 12 months, carry forward of unobligated balances to subsequent funding periods, waiver of some cost-related prior approvals. Noted in award notice.

EDGAR Parts 74 and 80

now part of Uniform Guidance

NIH Page limits

Abstract - 30 lines of text Aims - 1 page Biosketch - 5 pages Research Strategy - 12 pages (R01), 6 pages (R03, R21) Intro to resubmission/revision applications - 1 page

Technology commercialization

Academic institutions do not make products Must partner with a company that can take a technology and invest additional resources to create a product Relative timeline to a product depends on the nature of the product: Therapeutic device (longest) 10 - 15 years Device is intermediate 5 - 10 years Diagnostic (quickest) 1 - 5 years (depending on the form of the diagnostic)

A procurement contract is used for the purpose of

Acquisition of property and services

Independent Agencies

Agencies outside of the Executive Branch that depend on Congress for funding. - NSF - National Endowment for Humanities - National Endowment for the Arts - USAID - NASA

Micro-Purchase

An acquisition of authorized supplies or services that do not exceed the current competitive threshold of $10,000

Assurance

An institution is eligible for PHS funding when it has ____________ on file with the ORI (Office of Research Integrity)

AAALACI

Association for Assessment and Accreditation of Lab Animal Care International; reaccreditation every 5 yrs

AAALAC

Association for Assessment and Accreditation of Laboratory Animal Care International; voluntary accreditation body; inspects every 3 years

SF424-B

Assurances for Non Construction Programs

Under FOIA, what info will NOT be released?

Pending or disapproved applications; individual financial info like salaries; proprietary info; etc.

essential laboratory levels in medical research

Basic and containment procedures designed to protect personnel and the environment

________ is a law that requires institutions to file "inventions reports" for inventions created using federal grant funds, and allows institutions to retain the title.

Bayh-Dole (1980)

Risk Vs. Benefits

Belmont Report: Beneficence underlying principles are:

Animals Excluded from Animal Welfare Act

Birds, rats of the genus Rattus and mice of the genus Mus bred for use in research, and horses not used for research purposes and other farm animals, such as, but not limited to livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency,or for improving the quality of food or fiber.

NSF Summary form must include

Broader Impacts Statement

SF424-A

Budget Information for Non Construction Programs

1. The acronym GAGAS as related to sponsored projects stands for: a. Generally Accepted Government Accounting Standards b. Government Accepted Grant Accounting Standards c. Generally Accepted Government Auditing Standards d. Government Accepted Grant Auditing Standards

C- Generally Accepted Government Auditing Standards

NSPIRES

Electronic Research Administration of NASA awards. NASA Solicitation and Proposal Integrated Review and Evaluation System

Contract Clauses & Case Law

Christian Doctrine FAR clauses required by statute or regulation will be incorporated into the contract by operation of the law, even if those clauses have been (intentionally or unintentionally) omitted mandatory clauses which express a significant or deeply-ingrained strand of public procurement policy" and not every clause GL CHRISTIAN AND ASSOCIATES VS. US 375 US 954 (1963)

IACUC Composition

Chair Veterinarian (with program responsibility and authority; also known as attending veterinarian) Practicing Scientist (experience in animal research) Non-scientist Unaffiliated member (community member)

Despite expanded authorities, prior approval from a granting agency is required for

Change of principal investigator or project scope

Select Agents and Toxins

CDC's list of highly dangerous items

Allocable

Charged in relation to the benefit You cannot shift the cost around

Program Fraud Civil Remedies Act 3 USC 381-3812

Civil Penalties

Violation of Program Fraud Civil Liberties Act

Civil penalty -- money

Security compliance requirements

Classified research and clearances

Contract Clauses & Case Law, continued

Clauses included in the contract in violation of statutory or regulatory criteria will be read out of the contract (where the Contracting Officer acts beyond the scope of statutory authority, government will not be bound by the acts) A clause incorporated erroneously will be replaced by the correct clause Contracts tainted by fraud in the inducement, will be void, cannot be ratified and contractors may not recover costs.

45 CFR Part 94

Codifies responsibilities of institutions regarding investigator financial conflicts of interest

Cost Allocations Services within HHS

Cognizant agency

400.432

Conferences - allowable

2 CFR 200 Appendix II

Contract provisions for non-federal entities

Procurement Awards are

Contracts

OMB Circular A-21

Cost Principles for Educational Institutions

OMB Circular A-122

Cost Principles for Non-Profit Organizations

200.309

Period of Performance

Shelby Amendment AKA

Data Access Act/1999 Omnibus Appropriations Act

§200.414(f)

De Minimis Indirect Cost Rate - 10%

Flow down clauses

Debarment and suspension, standards for financial systems, cost principles, administrative requirements are examples of:

What date did Uniform Guidance go into effect?

December 26, 2014

A-133 def. of Audit findings

Deficiencies the the auditor must report in schedule of findings and questioned costs.

What agency is responsible for EAR (Export Administration Regulations)?

Department of Commerce -- Bureau of Industry and Security

claim

Depending on the context, either 1) the pay L

What is the definition of 'Beneficence' in the context of human subjects research?

Do no harm; maximize possible benefits; minimize risks

B13: Debarment and suspension

EOs 12549 and 12689 Restricts Subawards and contracts with certain parties that are debarred, suspended or otherwise excluded from participating in or receiving federal assistance

200.438

Entertainment Costs - Unallowable

Approved IACUC protocols must be resubmitted for full review every _______ years

Every 3 years under PHS/Guide; Every 1 year under USDA/AWA.

How often are public laws codified

Every six years

Commerce

Export Administration Regulations (EAR) is part of what Department?

ITAR Educational Information

Export control laws do not apply to info that is "general scientific, mathematical, or engineering principles commonly taught in schools, colleges, or universities" (state department)

What does Subpart F of the Uniform Guidance address?

F = Audit requirements

3.6% allowance for administrative efforts of faculty

F&A Administrative component rate includes

True or false: the FDA is part of the USDA

False. The FDA is part of DHHS

The Guide for Care and Use of Laboratory Animals

Followed by the Office of Laboratory Animal Welfare.

CFR Title 21

Food & Drugs

48 CFR Sub 31.2 (FAR)

For profit organtizations

USA PATRIOT Act (2001)

Full title / acronym: Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001; An Act to deter and punish terrorist acts in the United States and around the world, to enhance law enforcement investigatory tools, and for other purposes.Title I authorizes measures to enhance the ability of domestic security services to prevent terrorism. Title II is titled "Enhanced Surveillance Procedures", and covers all aspects of the surveillance of suspected terrorists, those suspected of engaging in computer fraud or abuse, and agents of a foreign power who are engaged in clandestine activities. Title III of the Act, titled "International Money Laundering Abatement and Financial Anti-Terrorism Act of 2001," is intended to facilitate the prevention, detection and prosecution of international money laundering and the financing of terrorism. Title IV amends the Immigration and Nationality Act of 1952 to give more law enforcement and investigative power to the United States Attorney General and to the Immigration and Naturalization Service (INS).

Discretionary Funding

Funds allocated by Congress through the appropriations process in the yearly budget.

Mandatory Funding

Funds earmarked in the Federal budget for State governments and other entities. Allocated via Formula or Block.

Plant patents example

GMOs

USDA-Covered Species

Hamsters, guinea pigs, sheep, canines, pigs, rabbits, ferrets, non-human primates

Public Health Service Policy on Humane Care and Use of Laboratory Animals

Health Research Extension Act of 1985 instructed PHS to establish guidelines for animal research. Requires institutions receiving funds PHS provide acceptable standards of care for animals used in research. Incorporates the US Government Principles and requires institutions base their program of animal care and use on the guide. Animals are defined to include all live, vertebrate animals used in research, teaching, or testing.

45 CFR 74 Appendix E

Hospitals

Institutional Review Boards

IRB: Title 21 CFR Part 56 Office of Human Research Protections (HHS) Federal Wide Assurance (FWA) numbers Five Members of varying background: 1 member must be from the community (not associated w/IRB or institution) Must meet at least once a year (continuing reviews at intervals appropriate to the degree of risk) Quorum: count of the number of IRB members present Decision notifications: in writing (adequate documentation of activities)

Salary Cap info (NIH specific)

In 1990 Congress legislatively mandated limiting the direct salary that an individual may receive under an NIH grant; FY 2012 the Consolidated Appropriations Act, 2012 (Public Law 112-74) signed into law on December 23, 2011, restricted the amount of direct salary to Executive Level II of Federal Executive Pay scale (179,700 at time).

Align with the mission of the current presidential administration.

Independent Agency missions do not have to...

400.414

Indirect Costs

postpone the submission of Certifications and representations items until a decision to make award is reached

Just-in-time' initiatives

STTR Phase III

Like it's counterpart mechanism, no funds are provided by STTR

What are the characteristics of mandatory federal grants?

Mandatory grants are a type of grant that must be awarded to each eligible applicant (generally a government entity) based on the conditions defined in the authorizing statute. They are authorized when bills are passed by Congress. They are non-competitive. They can be either Formula or Block grants.

What is Fabrication of research?

Making up data or results and recording or reporting them

Types of Federal Funding

Mandatory or Discretionary

Real Property

Means land, including land improvements, structures, and appurtenances thereto but excludes moveable machinery and equipment.

OMB-21 Time and effort reporting

Minimum annual reporting

200.328 Monitoring and reporting program performance

Non Fed entity must submit performance reports at least 1x per year but not more frequently than quarterly. Annual reports due 90 days after the reporting period

A-122 2CFR 230

Non profit organizations

Payments methods

Non-Federal entities other than states must use ____________ _____________ that minimize the time elapsing between the transfer of funds from the US Treasury or Pass-thru entity and disbursement by the non-Federal Entity

A-133 audit requirement (FY after 2003)

Non-Federal entities that expend $500,000 (300k previous to 2003) or more/year in Federal awards must have single or program specific audit.

A-133 single audit exemption (after FY 2003)

Non-Federal entities that expend less than $500k/year in Federal awards are exempt from Federal audit requirements. Records must be available for review or audit by Federal agencies, pass-through entities, and General Accounting Office (GAO).

OMB A-122

Non-profit cost principles; replaced by UG

Bayh-Dole Act allows:

Non-profit organizations and small businesses to pursue ownership of intellectual property generated by Federal funds.

200.460 Proposal Costs

Normally treated as indirect (F&A)

Student activity costs (intramurals, clubs, student publications)

Not allowable under A-21 Unallowable unless superficially provided for in the sponsored agreement

Commencement & Convocation Costs

Not allowable under A-21 Unallowable with some exceptions. See a-21 section F9

General Purpose Equipment

Not limited to research, medical, scientific, or other technical activities. EX: Office equipment, furnishings, etc.

Catalog of Federal Domestic Assistance (CFDA)

Number assigned to a Federal program in the CFDA

Catalog of Federal Domestic Assistance (CFDA) number

Number assigned to a federal program in the CFDA

27 and 24

Number of NIH Centers/Institutes, and number that can award funds.

7

Number of NSF Directorates

The Guide for the Care and Use of Laboratory Animals (8th edition)

PHS Policy --animal care and use program must be based on Guide standards Chapters of The Guide: Animal care and use program Environment, housing and management Veterinary care Physical plant

Animal

PHS policy defines this as any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.

Office of Laboratory Animal Welfare (OLAW)

PL 99-158, November 20, 1985, "Animals in Research"

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): PUBLICATION COSTS.

Page charges are now allowable if charged after the period of performance but before the end of closeout/termination. (Adopted from the NSF model).

What is a Parent Announcement? (NIH)

Parent announcements are broad funding opportunity announcements allowing applicants to submit investigator-initiated applications for specific activity codes. They are open for up to 3 years and use standard due dates.

2 CFR 220 (OMB Circular A-21)

Purpose is to establish principles for determining costs applicable to grants, contracts, & other agreements with educational institutions. Deals with cost determination but does not identify the circumstances or dictate the participation in financing of a project.

"Without excluding other scientific and classical studies and including military tactic, to teach such branches of learning as are related to agriculture and the mechanic arts, in such manner as the legislatures of the States may respectively prescribe, in order to promote the liberal and practical education of the industrial classes in the several pursuits and professions in life."

Purpose of land-grant universities and colleges.

Predetermined (F&A Rate)

Rate established for period; no carry forward provisions

A-21 Allowable Cost

Reasonable Allocable Consistently treated Conform to limits in a-21 or specific award

RCR

Responsible Conduct of Research

Export Administration Regulations (EAR)

Responsible for "Dual-use" items

SBIR Phase III

SBIR does not provide funding

NSF administers

SBIR program

SF424 Short Form

SF424 Cover Page

Title IX

Sex Discrimination - prohibits exclusion of an individual on the basis of sex from any educational program or activity receiving federal support/assistance

Simplified Method

Salary and Wage F&A is also called

$10,000

Significant Financial Interest De minimis threshold of NSF

Expanded authorities delegate

The modification of the budget

Uniform Guidance Subpart A addresses ____________?

Subpart A addresses acronyms and definitions

Salary & Wage Facilities & Administrative Costs

The audited base specified by the Federal Government in F&A agreements with small institutions. Usually a higher percentage.

Administrative Law

The body of law created by administrative agencies (in the form of rules, regulations, orders, and decisions) in order to carry out their duties and responsibilities.

Acquisition Cost

The cost of the asset including the cost to ready the asset for intended use.

National Science Foundation

The first federal agency to sponsor scientific research

When do approved IRB protocols expire?

They expire after 1 year, and require renewal or they lapse.

Letter of Intent (LOI)

Treated as an RSVP to the sponsor and is used to determine the number of review panels needed for Federal sponsors

True or false: the PTE must verify their subrecipient's audit?

True (per Uniform Guidance)

IACUC Review

Types of Review 1. Initial protocol review 2. Annual review 3. Triennial review (de novo) 4. amendments--modifications to original protocol

Put these items in the correct order of hierarchy: Federal regulations, Statutory requirements, US Constitution, Executive Order, Federal Agency terms and conditions.

US Constitution Statutory requirements (US Code) Executive Order Federal regulations Federal agency terms and conditions

USPTO

US Patent and Trademark Office (Filing agency for patents, inventions, and trademarks)

USPTO

US Patent and Trademark Office (Patents and inventions)

US Persons

US citizens, green card holders, asylees

Cuba, Iran, Sudan, Syria, North Korea

US embargoed countries

Modular Budget

Up to $250,000 direct costs annually, direct costs requested in modules of $25,000, flat funding (no future year escalation), extra modules for justified purpose

Only licensed use of radiation sources, radioisotopes, and radio-labeled compounds

What can be used according to Radiation Safety Rules

Def of Intellectual Property (IP)

a work or invention that is the result of creativity, such as a manuscript or a design, to which one has rights and for which one may apply for a patent, copyright, trademark, etc. Intellectual property includes: Patents, Copyrights, Trademarks, and Related proprietary matters

Final rate

applicable to specific past period with no adjustments

McNamara-O'Hara Service Contract Act (1965)

applies to federal contracts (not grants) requires contractors and subcontractors performing services on prime contracts in excess of $2,500 to pay service employees in various classes no less than the wage rates and fringe benefits found prevailing in the locality, or the rates (including prospective increases) contained in a predecessor contractor's collective bargaining agreement

Which of the following best describes federal regulations governing the use of humans in research? a. Allow the researcher full discretion as to what to include in informed consent materials b. Always require full informed consent on the subject or the subject's guardian c. Allow the Institutional Review Board discretion in limited situations to approve protocols providing less than full informed consent d. Waive full informed consent of the subject when the protocol is too complicated for an individual subject to understand the risks

b. Always require full informed consent on the subject or the subject's guardian

For copyrighted works which result from federally sponsored activities the federal government usually requires a. disclosure of the copyright only b. one copy of the official archives c. a royalty-bearing , exclusive, and irrevocable license d. a royalty-free, nonexclusive, and irrevocable license

b. one copy of the official archives

Under which of the following conditions is a Certificate of Current Cost and Pricing required? a. For a federal contract over $1,000,000 b. For any federal subcontractor c. From any institution that received more than $500,000 in federal funding d. As a standard of certification submitted by institutions applying for federal grants

c. from an institution that received more than $500,000 in federal funding

Members of an Institutional Animal Care and Use Committee (IACUC) must be appointed a. funding agency program officer b. Office of Human Research Protection c. responsible administrative official of the organization d. research administrator responsible for the committee

c. responsible administrative official of the organization

FedBizOpps.gov

contracts

1. For works created on or after Jan 1, 1978, copyright protection is for the following term: a. 95 years from creation b. 120 years from creation c. Author's life plus 90 years d. Author's life plus 70 years

d. Author's life plus 70 years

APHIS (Animal and Plant Health Inspection Service)

division of USDA that does the physical annual inspections on lab animals, zoos, circuses

1966 Life Magazine

expose on "concentration camps for dogs"

SBIR Phase 1

feasibility study to evaluate technical and scientific merit up to 6 months $150k.

GAGAS

generally accepted government auditing standards

ADA

must be flowed down to recipients with 25 or more employees - applies to all agreements

COI Policy 13010

must disclose 3rd party travel

Federal Registrar

official daily publication of agency rules, notices from federal agencies, and executive orders; Final rules of registrar are codified in CFR

USA.gov

official web portal of US federal govt. designed to improve public's interaction with the US govt and links to state, local and tribal govts

Expanded authority delegates to grantees authorization of

one-year-no-cost extension

Def. of clinical trials (also called interventional studies)

participants receive specific interventions according to the research plan or protocol; interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet.

Rehabilitation Act

prohibits employers from discriminating against the handicapped

basic research

pure science that aims to increase the scientific knowledge base

Small Business Act 1953

requires money allocated for small businesses...2 ½ %.

OSHA

responsible for the Chemical Hygiene Plan

NIH RFA

should submit copies of applications concurrently to CSR and the soliciting IC

PA

subject to common receipt dates, competitive and standard peer review

Justice

treated fairly and selection

Data Use and Security (for unclassified info) - FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (June 2016)

when government contract information is stored on a non-governmental system, that system must meet 15 specific requirements. - Applies to ALL federal agency contracts - These requirements are in addition to any specific agency requirements.

the simplified method should be used

when: -direct federal funding is under $10,000,000 -all major organizational functions benefit from F&A costs to approximately the same degree

False Claims Act 31 USC 3729

within 6 years of end of award claim can be made....usually results in criminal action.

Assurance

written guarantee or pledge that one will operate in a certain way or comply with certain terms and conditions of an award

Statutes

written laws enacted by legislatures

Affirmative Action Plan

written statement of how the organization intends to actively recruit, hire, and develop members of relevant protected classes

Cost Accounting Standards (CAS) Disclosure Statement: DS-2

• Required when federal $ > $50million as of UG • Disclose cost accounting practices

Definition of Intellectual Property

•Legal rights that result from intellectual activities in the industrial, scientific, literary, and artistic fields. •The legal rights confer on the creators the ability to control to the use of result of the intellectual activities for a certain amount of time

beneficence

do not harm; maximize possible benefits; minimize risks

Copyrights and trademarks

protect the form in which ideas are fixed

Patents and trade secrets

protect the substance of ideas

Expression of the idea

protected under copyright

Cost Transfer

use to correct a clerical or bookkeeping error

Catalog of Federal Domestic Assistance

A database which helps the federal government track all programs it has domestically funded.

Page charges in professional journals

A-21: allowable w/restrictions (addressed under publication and printing costs) A-122: allowable w/restrictions

Audit costs and related services

A-21: allowable w/restrictions and as addressed in OMB Circular A-133 A-122: allowable w/restrictions and as addressed in OMB Circular A-133

What does Subpart E of the Uniform Guidance address?

E = Cost Principles.

Informed Consent, Privacy and confidentiality

Belmont Report: Respect for persons underlying principles are:

History on clinical trials

James Lind (1716-1794) from Royal Navy is first person to conduct a clinical trial: developed the theory that citrus fruits cured scurvy.

Uniform Guidance

This provides many of the rules and regulations for institutions that receive federal funds

Mission and structure of NSF

"To promote the progress of science; to advance the national health, prosperity, and welfare; and to secure the national defense." - does not fund medical sciences; 7 discipline based directorates - BIO, CISE, EHR, ENG, GEO MPS, SBE

Temporary export (tools of the trade)

"Tools of Trade" license exception apply when the laptop, PDA, cell phone, data storage devices and encrypted software are: - Hand carried with you while you travel - Carried in your luggage or baggage that travels with you - Shipped no more than thirty days prior to your departure, or may be shipped to you at any time while you are outside the country Generally, no export license is required so long as you - Retain these items under your personal custody and effective control for the duration of your travel - Effective Control - means retaining physical possession of an item or maintaining it in a secure environment - Do not intend to keep these items in these countries for longer than 1 year and - Not traveling to Cuba, Iran, North Korea, Sudan, or Syria

HIPAA def. of health information

"any information, whether oral or recorded in any form or medium, that- (A) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (B) relates to the past, present, or future physical or mental health or condition of any individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual."

What is the threshold for using small purchase procedures?

$150,000 (SAT)

An investigator on an NSF grant has permission to rebudget $150,000 in renovation monies into equipment. If the institution's F&A (indirect cost) rate (based on MTDC) is 54%, how much money will be available for the equipment? a. $69,000 b. $81,000 c. $97,403 d. $150,000

$150,000 (we do not take IDC on equipment)

Executive Level II

$185,100 effective 1/10/16

Executive Level II salary (current)

$185,100 effective 1/10/16

Simplified Acquisition Threshold

$250,000 - Dollar amount below which a non-Federal entity may purchase property or services using small purchase methods.

What is the current (2017) micro-purchase threshold?

$3,500

If an agency is requires 20% cost sharing of the total project for a particular program and a proposal is requesting $200,000 from the agency, the additional amount that the institution must cost share is

$40,000 (200,000*.20).

What is the amount of F&A that should be requested by an institution with a 50% F&A rate (MTDC) on a one-year project that requires $40,000 in salaries and benefits, $2,000 in travel and $2,000 in tuition costs? The project also includes $75,000 for a subcontract. a. $17,500 b. $65,000 c. $33,500 d. $55,450 The correct answer is $33,500

$40,000 (Salaries & Benefits) $2,000 (Travel) $25,000 (1st $25K of the subcontract) $67,000 (Indirect Cost Base) X .50 (Indirect Cost Rate) $33,500 (Total Indirect Cost) Tuition is excluded from F&A in MTDC

NIH significant financial interest threshold

$5,000. Disclosure must be filed annually or when anything changes.

If an agency requires 20% cost sharing of the total project for a particular program and a proposal is requesting $200,000 from the agency, what is the additional amount that the institution must cost share? a. $40,000 b. $50,000 c. $100,000 d. $220,000

$50,000 $200000 / .8 = $250,000 $250,000-$200,000 = $50,000

An investigator on an NIH grant has permission to rebudget $50,000 in supply monies into equipment. If the institution's F&A cost rate (based on MTDC) is 50%, how much money will be available for the equipment

$50,000 equipment is exempt from F&A.

How much interest income may a grantee retain from advanced drawdown of federal funds from the Treasury?

$500 per year - the rest must be returned to the Treasury. Earning too much interest income is also a sign that the grantee has poor cash management practices.

Cost Accounting Standard (CAS) must be applied to awards for federal contracts over

$500,000

Single Audit threshold

$750,000 in federal spending in the audit period (usually 1 year).

UG required info to include in award (15 data elements)

(1) Recipient name; (2) Recipient's unique entity identifier; (3) Unique FAIN; (4) Federal Award Date; (5) Period of Performance Start and End Date; (6) Amt of Federal Funds Obligated by this action; (7) Total Amount of Federal Funds Obligated; (8) Total Amount of the Federal Award; (9) Budget Approved by the Awarding Agency; (10) Total Approved CS or Matching, if applicable; (11) Federal award project description, (to comply with statutory requirements (e.g., FFATA)); (12) Name of Federal awarding agency and contact information for awarding official, (13) CFDA Number and Name; (14) Identification of whether the award is R&D; (15) Indirect cost rate for the Federal award (including if the de minimis rate is charged per § 200.414 Indirect (F&A) costs).

Criteria for IRB approval (all must be satisfied)

(1) Risks are minimized; (2) Risks are reasonable in relation to anticipated benefits and the importance of the knowledge to be gained; (3) Selection of subjects is equitable; (4) Informed consent is sought; (5) Informed consent is documented; (6) research plan monitors the data collected to ensure subject safety; (7) protect the privacy of subjects and maintain confidentiality of data; Additional safeguards if vulnerable HS pop (e.g. pregnant women, convicts, and children).

community of science

(COS) web server containing info about scientific expertise, funded scientific research and funding opportunities

Office of Research Integrity

(ORI) The Office of Research Integrity Oversees and directs Public Health Service (PHS) research integrity activities Within DHHS

Falsification

manipulating research materials, equipment or processes; changing or omitting data or results

200.463 Recruiting Costs

- Costs for "help wanted", advertising, travel costs while engaged in recruiting, and relocation costs incurred for recruitment allowable pursuant to non Fed entity's standard recruitment program

Short Term Visa Costs

- Covered under 200.463 - Generally allowable; for a specific period of time and purpose - Must be clearly identified as directly connected to the work performed

Executive Branch Agencies

- Department of Defense - Department of Education - Department of Energy - Department of Transportation - Department of Agriculture - Department of Veterans Affairs - Health and Human Services

Relocation costs for current employee - Unallowable

- Fees and costs associated with acquiring a new home - Loss of sale of former home - Continuing mortgage principal and interest payments - Income taxes paid by employee related to reimbursement relocation costs

Six specific data elements required in Funding Opportunity Announcement

- Full programmatic description - Eligibility - Guidance on how to submit - Federal award administration information - Federal award information - Application review information

Items not released in Freedom of Information Act Inquiries

- Pending or disapproved applications - financial information pertaining to a specific individual such as salaries - Information subject to the Privacy Act of 1974 - Confidential personal or medical information - Summaries of discussion of application by advisory bodies (anything from a Review Panel) - Proprietary Information

Characteristics of Contracts

- Procurement of goods and services - Terms are usually detailed and specific - deliverables are dictated by the sponsor - little latitude to modify work or budget - NO authority to change the scope of work

Unacceptable reasons for cost transfer

- Reduce overruns if the transfer is from one federal project to another - Reasons of accessibility - Use unspent funds in a project - PI was on a sabbatical or insufficient oversight of the project

Allowable conference costs

- Rental of facilities - Speakers' fees - Costs of meals and refreshments - Local transportation - Other incidentals related to the conference, unless restricted by federal award

Data use and security - DFARS 252.204-7-12, Safeguarding Covered Defense Information and Cyber Incident Reporting (Dec. 2015).

- Required in all DoD contracts and subcontracts - Requires safeguarding all controlled government information (any technical information with a Distribution Statement B-F limitation, critical system operations security information, export controlled information, etc.) - Requires compliance with all National Institute of Standards and Technology (NIST) Special Publication 800-171.

R01

- Research Grant - No specific dollar limit - Typically 3-5 years - Utilized by all ICs

Differences b/w SBIR and STTR

- SBIR: 11 agencies (5 from STTR + USDA, DOE (NIST, NOAA), USDE, DHS, DOT, EPA) ; mission is to stimulate tech. innovation and increase SBC commercialization with fed funds; PI primary employment must be with SBC; - STTR: 5 agencies (DOD, DOE, NASA, NSF, DHHS (NIH)); missions is to stimulate tech innovation and foster tech transfer b/w SBC and Univ. and increase commercialization with ed. funds; requires IP agreement

Elements of a Subaward Agreement

- Scope of work - Terms of payment - Copyright, Data Rights, Patent Rights - Publication - Indemnity - Termination - Special Sponsor Restrictions - Jurisdiction (for State/Public does not apply or says "to the extent allowed by the law"

R03

- Small grant program - For pilot, feasibility studies, data collection - Limited to up to 2 years of funding - $50K per year direct costs

Unallowable Recruitment Costs

- Special salary allowances to attract personnel that do not meet reasonableness or do not conform to established practices of non-fed entity unallowable - If newly hired employee resigns within 12 mths, non fed entity must refund Federal share of reallocation

What is not patentable?

- Substitution of one material for another - Mere change in size or shape - Merely making something portable - Mere reversal of parts: substitution of an equivalent element for another element

R13

- Support for conferences and scientific meetings - Requires advance permission from funding IC - Award amount set by IC

Acceptable reasons for cost transfer

- To correct a clerical or bookkeeping error - when work on a project has started, but the official notification of the award is delayed - to move payroll off suspense

200.475 Travel Costs

- Travel costs for transportation, lodging, subsistence, and related items may be charged on actual basis, per diem, or mileage basis provided that a method is applied to the whole trip. - Charges must be consistent with what's normally allowed under entity's written travel reimbursement policies. Dependent care costs directly as a result of travel provided that - costs are direct result of individual's travel - consistent with non Fed entity's travel policy - temporary during the travel period - cannot last more than 6 months Airfare in excess of least expensive accommodations unallowable except - Travel during unreasonable hours - Excessively prolong travel - Result in additional costs - Accommodations not reasonable for traveler's medical needs

Cost Sharing Criteria

- Verifiable - Not included as contributions for any other federal award - Not paid by the fed govt under another federal award - Program income may be used with prior approval

Exceptions to fly america act

- When the use of U.S. carrier service would extend travel time (including delay at origin) by 24 hours or more - When the costs of transportation are reimbursed in full by a third party, such as a foreign government or an international agency - When U.S. carriers do not offer nonstop or direct service between origin and destination. However, a U.S. carrier must be used on every portion of the route where it provides service unless, when compared to using a foreign air carrier, such use would: --Increase the number of aircraft changes outside the United States by two or more --Extend travel time by at least six hours or more --Require a connecting time of four hours or more at an overseas interchange point.

Human Subjects (IRB) protocol review: 3 categories of review

1) Exempt - Fits within one the the exempt categories as defined by federal regs (examples include use of educational tests; use of publicly-available, deidentified data sets, etc) 2) Expedited - Non-invasive, low risk of harm. 3) Full - more than "minimal risk" to subjects, requires full review because the procedures may involve physical or emotional discomfort or sensitive data collection from subjects.

Common certifications for federal grant applications (name 5)

1) Federal Drugfree Workplace; 2) Federal Debt Delinquency; 3)Debarment/suspension; 4) Lobbying; 5) Conflict of Interest (required by specific agencies including NSF and DHHS).

Name the 7 out of 15 Executive Branch Departments that provide grant funding. Mnemonic: HEATED-V

1) Health 2) Defense 3) Energy 4) Education 5) Agriculture 6) Transportation 7) (Veteran Affairs) - sort of Mnemonic: HEATED-V Note VA doesn't do grants but will do a buy out of faculty time (IPA). DHHS, DoD, DoE, USDE, USDA, USDOT, VA

What three characteristics determine if something is patentable?

1) It must be novel. 2) It must be useful. 3) It must not be obvious.

Name 5 Independent Federal Funding Agencies

1) NSF 2) NASA 3) USAID 4) NEA 5) NEH

What are two characteristics of a Small Business as defined by the government?

1) No more than 500 employees 2) independently owned

Put these in the correct order of precedence from most to least binding: Special Terms and Conditions, Statutes, Federal Regulations, Institutional policies.

1) Statutes, 2)Federal Regs, 3)Special Terms and Conditions, 4) Institutional Policies.

Grants Regulatory Requirements

1) Statutory 2) Program, and 3) Administrative

In terms of intellectual property ownership, name 2 circumstances where a "work for hire" scenario would likely apply.

1) The work is created by an employee within the scope of their job description. 2) Work that is specifically ordered or commissioned for use.

3 Characteristics of NIH Modular budgets: R01, R03, R15, R21, R34

1) Up to $250,000 direct costs per year; 2) Direct costs in modules of $25,000; 3) Flat funding -- no future year escalations without justified purpose.

UG coverage on fixed amount awards (5 Characteristics)

1) payments are based on meeting specific requirements of the Federal award 2) Accountability is based on performance and results 3) Award amount is negotiated using cost principles as a guide 4) No governmental review of the actual costs incurred 5) Significant changes must receive prior awarding agency written approval

What 4 categories of people have additional protections when it comes to human subjects research?

1) pregnant women; 2) human fetuses, and neonates; 3) prisoners; 4) children.

Subcontract--- Responsibilities

1) to perform project's technical objectives, 2) for programmatic decisions, and 3) receives flow down terms and conditions.

MTDC Inclusions

Salaries and wages, fringe benefits, materials and supplies, services, travel, and subcontracts up to the first $25,000 of expenditures.

Types of Intellectual Property

1. Copyrights: surveys & software (life: author's life plus 70-125 years after s/he passes) 2. Trademarks: logos, names, etc... 3. Trade Secrets: "know how" (employer owns) 4. Patents: protect inventions, devices, compositions, methods (good for 20 years from the date of filing) (employer owns)

PHS Policy Requirements of Program of Animal Care and Use

1. Designation of an institutional official 2. Appointment of an Institutional Animal Care and Use Committee (IACUC) 3. Administrative support for the IACUC 4. Standard IACUC procedures 5. Arrangements for a veterinarian with authority and responsibility for animals 6. Adequate veterinary care 7. Formal or on-the-job training for personnel that care for or use animals 8. An occupational health and safety program for those who have animal contact 9. Maintenance of animal facilities 10. Provisions for animal care

IACUC Review Questions

1. How proposed use of animals benefit human or animal health 2. Experimental design and details of procedures proposed justification of species and numbers (stats) 3. Description of humane endpoints 4. Surgery details, anesthesia and analgesia (survival v. Non-survival; major v. minor surgery; multiple survival surgeries) 5. Use and handling of hazardous or toxic agents 6. Euthanasia methods 7. Housing, restraint, etc

AWR Requirements

1. Investigators to consider alternatives and document this for IACUC to review 2. Investigators to assure the IACUC that proposed use of animals is not unnecessarily duplicative

IACUC Semi-Annual Review

1. Monitor animal facilities and program of animal care and use to determine if they comply with AWA, AWR, and PHS Policy 2. Identify deficiencies, create a plan to correct deficiencies, ensure they are corrected 3. Communicate results to IO, with suggestions for improvements to program or facilities

Three Criteria for Patentability: one

1. Novelty: (objective standard) Public disclosures of inventions, either by the inventor or by others, can defeat Patentability if they occur prior to filing for patent protection Examples of Prior Art: Publications available to the public Public uses or sales Conference presentations Internet communications Posters presented at conferences Meeting abstracts Awarded grant applications Non-confidential oral disclosures PhD thesis ( defense) File patent application first and then publish Conduct prior art search to make sure others have not published invention

PHS def. of Clinical Trials

1. Patient-oriented research: Research conducted with human subjects (or on material of human origin) for which an investigator (or colleague) directly interacts with human subjects. Excluded: in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. 2. Epidemiologic and behavioral studies. 3. Outcomes research and health services research.

Exemption of research to common rule (IRB reqs)

1. Research in educational settings, under normal educational practices; 2. research using educational tests, survey procedures, interview procedures or observation of public behavior, 4. collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if publicly available or de-identifiable (5) ordered by Fed. department head and examines public benefit or service programs; (6) Taste and food quality evaluation studies, (i) if wholesome foods without additives are consumed or (ii) food consumed contains a food ingredient... to be found safe by USDA.

Ethical principles coming out of Belmont Report

1. Respect - respect autonomy of subject to make informed decisions; protect those who cannot. 2. Beneficence - do no harm; maximize benefits, minimize harm 3. Justice - justly distribute benefits and burdens Led to: Informed consent; Assess risks / benefits; determine best / just selection of subjects

3 Core ethical principles of Belmont Report

1. Respect for persons (informed consent is requirement. Individual must be capable of freely authorizing his/her participation) 2. Beneficence: harm must be minimizing and benefits must be maximizing for study participants. 3. Justice: even distribution of benefits and burdens; impartial study selection.

Primary Roles of the IACUC

1. Review and approve animal use protocols 2. Monitor the animal care and use program by thoroughly reviewing the program and inspecting animal housing and use areas twice a year (semi-annual) 3. Review any animal welfare concerns 4. Suspend animal activities when warranted 5. Report to an institutional official IACUC functions as self-regulating body for animal research

Documenting Cost Sharing

1. Separate ledger/ cost sharing account 2. Faculty effort system 3. Cost sharing certification report form

Applied F&A Rate

A-122 Current rate

Informed Consent: Elements

1. Statement: study involves research 2. Purpose of research 3. Cost of participation; description of procedures (experimental noted) 4. Expected duration of the subject's participation; total number of subjects 5. Foreseeable risks/discomfort; there may be unforeseeable risks 6. Any benefits to the subjects. Or others 7. Disclose alternative procedures/treatments that might be advantageous 8. Extent to which confidentiality of records will be maintained (PHI) 9. More than minimal risk: if injury occurs, what compensation and medical treatments are available. What do they consist of and where to get more information. 10. Contact for answers to questions about the research and subjects' rights, or for research-related injury to the subject. 11. Participation is voluntary, no penalty or loss of benefit for refusal to participate, and the subject may discontinue participation at any time. 12. Circumstances that investigator can terminate participation.

Subaward (or subcontract)

1. The mechanism used to facilitate research collaborations between a pass-through entity (PTE) and a subrecipient 2. A binding legal agreement that sets forth the expectations of the parties with regard to the scope of work and budget 3. Incorporates compliance requirements such IRB, ACUC, COI, allowable costs, audit, closeout, and other terms/conditions as may be flowed down from the prime sponsor

UG procurement standards (general)

1. create policies that reflect state/fed laws 2. oversee contractors, ensure following terms/contract 3. maintain policy on COI with contractors 4. avoid duplicative / unnecessary purchases 5. only give contracts to responsible contractors / able to perform successfully - look at integrity, past performance, financial and tech resources. 6. full and open competition 7. use acceptable methods of procurement 8. use small/minority business when possible 9. perform cost / price analysis if over SAT

A-110 procurement standards

1. must have written procurement policies 2. ensure purchasing of necessary items 3. cost or price analysis shall be made and documented in the procurement files in connection with every procurement action - compare price quotes, market prices; should review and evaluate each element of cost to determine reasonableness, allocability and allowability.

Federal Acquisition Regulation (FAR)

1. rules (i.e. process/procedures) governing the federal government's purchasing process; ensures purchasing procedures are standard and consistent, and conducted in a fair and impartial manner; SAT is 150k according to FAR 2. Applies to all agencies in the executive branch 3. issued and maintained jointly by Secretary of Defense, Administrator of General Services and the Administrator, NASA. Title 48 of CFR

Export control info - Nuclear Regulatory Commission (NRC)

10 CFR sec 110: Export and Import of Nuclear Equipment and Materials Regulations - General Authorization: Furnishing public information , Furnishing assistance/aid in emergency situations or to improve safety, Participation in open meetings sponsored by educational, scientific or technical organizations 10 CFR sec 810: Assistance to Foreign Atomic Energy Activities - Specific Authorization: List based controls, covers providing sensitive nuclear technology, providing training or assistance for certain nuclear and reactor related activities, design, construction, fabrication of components, etc.

US Patriot Act

10/26/01 Uniting and Strengthening America by Providing Appropriate Tools Required to Interpret and Obstruct Terrorism Act Criminalizes possession of Select Agents not reasonably justified for bona fide research

US Patriot Act PL 107-56

10/26/01 Uniting and Strengthening America by Providing Appropriate Tools Required to Interpret and Obstruct Terrorism Act Criminalizes possession of Select Agents not reasonably justified for bona fide research

Dept. of Health and Human Services (DHHS)

11 public health service agencies (PHS) (NIH, AHRQ, CDC, HRSA, FDA, SAMHSA, Centers for Medicare and Medicaid Services (CMS), Indian Health Service (IHS), Agency for Toxic Substances and Disease Registry (ATSDR), Office of the Assistant Secretary for Health (ASH), Office of Secretary, Program Support Center (PSC), and Office of the Assistant Secretary for Preparedness and Response (ASPR)). Mission: to protect, promote, and advance the health and safety of our Nation.

NSF and NIH final reporting under UG

120 days after end date for FFR, final project reports, project outcomes report (NSF)

Executive Branches (many are fed. funding agencies)

15 Executive Departments under the Executive Branch of Gov: USDA (e.g. NIFA); DOC (NIST, NOAA); DOD (ONR, AFOSR, ARO, DARPA); DoED; DOE (national labs); DHHS (NIH, AHRQ, HRSA, FDA); DHS (FEMA); Dept. Housing and Urban Dev; DOI (Nat. Parks service; USFWS); DOJ, DOL; DOS, DOT; Dept. of Treasury Dept. Veterans Affairs;

CFDA categories

15 total, including formula grants and project grants

UG Simplified Acquisition Threshold (SAT)

150k or under; allows purchase of property or services using small purchase methods. set by the FAR at 48 CFR Subpart 2.1 (Definitions) and in accordance with 41 U.S.C. 1908.

Federal Budget Process timeline

18 months out - President proposes budget, agencies submit budget requests, Congress takes action

NIH unilateral closeout (UG)

180 days after award end if without the receipt of required final reports

Cost Accounting Standards

19 standards and rules designed to achieve uniformity and consistency in cost accounting principles.

Nuremberg Code

1948 stating that "The voluntary consent of the human participant is absolutely essential," making it clear that participants should give consent and that the benefits of research must outweigh the risks.

Small Business Act

1958. Enacted to assure that a fair portion of Fed contracts are placed with small businesses. Recipients of a contract over the simplified acquisition threshold ($100K) must agree to this act. Recipients of a contract over $500K with Subcontracting possibilities must submit a Subcontracting Plan. Good faith effort.

Three Rs

1959 William Russell and Rex Burch Replacement: with non-animal models (or less sentiment) Reduction: of animal numbers Refinement: of technique to reduce pain / distress

Contract Work Hours and Safety Standards Act

1962 - all contracts that exceed simplified threshold ($100k); 40 hour workweek with OT no less than 1.5 pay

Equal Pay Act

1963 law that required both men and women to receive equal pay for equal work

Employment of Handicapped Rehabilitate Act

1973 - must execute with award or have on file with agency assurance

Belmont Report 1979

1974: national research act authorized the creation of the national commission for the protection of human subjects of biomedical and behavioral research. The commission created the Belmont report.

Belmont Report 1979

1974: national research act authorized the creation of the national commission for the protection of human subjects of biomedical and behavioral research. The commission created the Belmont report. 1. Respects for persons (informed consent is requirement. Individual must be capable of freely authorizing his/her participation) 2. Beneficence: harms must be minimizing and benefits must be maximizing for study participants. 3. Justice: even distribution of benefits and burdens; impartial study selection.

Age Discrimination Act

1975 - prohibits unreasonable discrimination of basis of age

Anti-Kickback Act

1986; prohibits persons from soliciting, accepting or attempting to accept any kickback

Solomon Amendment 1996 10 USC 983

1996 US federal law that allows the secretary of Defense to deny federal grants to institutions of higher education if they prohibit or prevent ROTC or military recruitment on campus

Utility Patent and Plant Patent

20 years from date of effective filing

Depreciation of Equip (under UG)

200.436. Depreciation is the method for allocating the cost of fixed assets to periods benefiting from asset use; UG shifts from GASBA #51 to GAAP; Donated assets are valued at the time of donation - donated asset may be depreciated or claimed as matching, but not both (consider this info for CS)

Program Fraud Civil Remedies Act of 1986 (PFCRA)

2009 fianl rule to authorizes NSF to impose, through administrative adjudication, civil penalties and assessments against any person who makes, submits, or presents, or causes to be made, submitted, or presented, a false, fictitious, or fraudulent claim or written statement to the agency. The regulations establish the procedures that NSF will follow in implementing PFCRA, and specify the hearing and appeal rights of persons subject to penalties and assessments under PFCRA. previous rule included federal agencies, but not NSF.

Research regulated by the FDA

21 CFR 50 and 56

A-110 small purchase threshold

25k; purchase above this need to include the following: (a) basis for contractor selection, (b) justification for lack of competition when competitive bids or offers are not obtained, and (c) basis for award cost or price.

Administrative Component of F&A is capped at

26%

General info on NIH

27 Institutes & Centers + OD; 24 fund extramural research + OD; lower score = better application - scale 1 to 10; Types of application; 1 = new; 2 = renewal (competing); 3 = supplement; 4 = funded extension awards (i.e. R21 to R33); 5 = non-competing continuation; 7 = transfer; 8 = change of IC with non competing; 9 = change of IC with competing app.

Institutional Animal Care and Use Committee (IACUC) - general

3 ppl minimum (5 PHS); one is the attending veterinarian of the research facility; one is not affiliated in any way with the facility other than as a member of the committee; the research facility shall establish the Committee to evaluate the care, treatment, housing, and use of animals, and to certifying compliance with OLWA

Federal law generally requires grant financial records to be kept a minimum of how many years?

3 years (but varies)

Data use and security - Controlled Unclassified Information (Nov. 2016)

32 CFR Part 2002; - Will apply to all federal grants and contracts - Creates a uniform "CUI Program" to establish policies for designating, handling, safeguarding and disseminating CUI. - Two types: Basic CUI and CUI Specified - National Archives and Records Administration will oversee. - CUI Executive Agent, CUI Program Managers, CUI Registry, etc. - Agencies are free to add supplemental requirements.

How much work must the lead (small business) organization do in a STTR?

40% of the total project work (and budget must correspond).

Federal Policy for the Protection of Human Subjects or the "Common Rule" (1991)

45 CFR part 46 - subpart A; outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency; applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department/ entity that follows rule.

Example: Basic FAR

48 CFAR 52.227-11 52 (part).2 (Subpart)27 (section)-11 (subsection) (Omitting chapter 1 for Basic FAR)

Example: DFAR Citation

48 CFR 252.227-7039 2 (chapter)-52 (part).2 (Subpart)27 (section)-7039 (subsection)

Contract Termination

48 CFR 49.502 Termination for the Convenience of the Government (D) research and development contracts. The contracting officer shall insert the clause at 52.249-5 Termination for the Convenience of the Government (educational and other nonprofit institutions) in solicitations and contracts when either is fixed price or cost reimbursement contract is complemented for research and development work with an educational and nonprofit institution on a no profit or no fee basis.

E-Verify

48 CFR 52.222-54, which requires that federal contractors or subcontractors verify the employment eligibility of all new hires on a contract through an electronic screening database. This clause is usually found in contracts that also have export controls. May restrict ability of foreign nationals to work on a research project. Flows down to subcontractors.

STTR # of participating federal departments

5

IRB membership

5 members; one whose primary concerns in scientific areas, one whose primary concerns are nonscientific areas; at least one not affiliated with the institution and not immediate family to a person affiliated with the institution; no member with COI; IRB may invite specialists if additional expertise is required (no vote)

What is the minimum number of people for an IACUC committee? Name the 5 qualifications/roles must they have represented among them?

5 people minimum (can hold multiple roles from the following required list of roles: one vet; one scientist experienced in research with animals; one nonscientific member; one member who is not affiliated with the institution.

FAR Matrix

52.301 Solicitation Provisions and Contract Clauses (matrix) Provides a key containing Types of contract Contract purpose The matrix lists Each provision of clause It's prescription Indicates whether the clause is required, required when applicable, or optional in the specific contract.

Selected Items of Cost

55 items outlined in 2 CFR 200.420-475 (Subpart E) and their allowability based on cost circumstances

2011 FCOI changes

5k for SFIs; ALL SFIs related to Investigator responsibilities at inst. (previously ONLY if related to research); Inst. must incorporate in sub agreement language requiring either the establishment of FCOI policy or that sub will adhere to Inst. policy (previously just reasonable steps taken to ensure that PIs work with subs to comply with policy); FCOI training is required to complete training prior to engaging in PHS funded research ever 4 years or immediately if FCOI policy changes to affect investigator responsibilities or if new PI; or if PI is noncompliant with FCOI policy / management plan (previously no requirement)

The National Science Foundation indicates decisions on the funding of grants proposals should normally take

6-9 months

NSF

7 directorates and 3 offices awarding basic and applied research in social, behavioral, biological, physical, math, computer, geological science, engineering and science education

Cost transfers must happen within ______ days of an error

90 days

1. Under the Single Audit Act, a grantee may choose to elect the following type of audit if all of their R&D awards are from the same sponsor: a. Program Specific Audit b. Single Program Audit c. Internal only audit d. Sponsor-specific audit only

A - program specific audit

1. When determining whether overtime should be paid to a non-exempt employee under the Fair Labor Standards Act, which of the following scenarios would not automatically require overtime pay: a. Working on holidays b. Working over 40 hours a week c. Working an additional 10 hours on saturday after working 32 hours monday thru Friday d. None of the above - all scenarios will automatically require overtime pay (regardless of previous hours worked in the workweek).

A -working on holidays is not covered under FLSA.

What is a DS-2? Who must file a DS-2? Who does it get submitted to?

A DS-2 is a formal description, prepared and certified by the institution, of the educational institution's cost accounting practices. The DS-2 explains the methodology for distinguishing "direct" from "facilities and administrative" (F&A) costs and identifies the methodology for accumulating and basis for allocating the F&A costs. The DS-2 is intended to establish a clear understanding of the practices under generally accepted accounting principles that the educational institution follows or proposes to follow. Educational institutions that receive aggregate sponsored agreements of $50 Million or more must submit to the report to their cognizant agency.

What does a U01 grant support?

A U01 is a Research Project Cooperative Agreement. Supports discrete, specified, circumscribed projects to be performed by investigator(s) in an area representing their specific interests and competencies Used when substantial programmatic involvement is anticipated between the awarding Institute and Center One of many types of cooperative agreements

Modified Total Direct Costs (MTDC)

A base consisting of the following direct costs; Salaries, Fringe Benefits, Supplies and Materials, Travel, and the first $25,000 of each Subaward on which the negotiated indirect cost rates are applied. This form of F&A calculation is required for organizations receiving more than $10 million in Federal Funding.

What is a block grant?

A block grant is a type of mandatory grant (noncompetitive). The term "block grant" refers to grant programs that provide federal assistance for broadly defined functions, such as community development or social services. Block grants allow the grant recipient more discretion and flexibility than other grants in determining how to use the funds to meet a broader program goal.

What is a block grant? Is it mandatory or discretionary?

A block grant is a type of mandatory grant (noncompetitive). The term "block grant" refers to grant programs that provide federal assistance for broadly defined functions, such as community development or social services. Block grants allow the grant recipient more discretion and flexibility than other grants in determining how to use the funds to meet a broader program goal.

Indemnification Clause

A clause in which one party agrees to compensate another for a loss or damage that is sustained. Public institutions cannot accept.

Def. of contract/contractor (consultant or vendor)

A contract obtains goods and services for the entity's own use, creates a procurement relationship. Determination of contract (depends on substance of relation, not form of agreement): (1) the goods and services are normally provided; (2) Provides similar services to other purchasers; (3) operates in a competitive environment; (4) Provides goods or services that are ancillary to the operation of the Federal program; and (5) Is not subject to compliance requirements of the Federal program as a result of the agreement

A-133 def. of questioned cost

A cost questioned by the auditor because of an audit finding - resulted from a violation of a law, regulation, or award doc.; when costs are not supported by adequate documentation; or when costs incurred appear unreasonable and do not reflect the actions a prudent person; reportable if over 10k (25k under UG)

disallowed cost

A cost which management, in a management decision, has determined should not be charged to the federal government.

FAR & Legal Tenets

A federal contractor is expected to know: What is required and the limitations of the authority of government contracting personnel Government regulations have the force and effect of law Government officials may not deviate from law without proper authorization

F&A rate def. of fixed dollar amount (NSF info)

A fixed dollar amount limits organizations to that "amount" of indirect costs specified in the approved budget. It is not subject to adjustment

What is a formula grant?

A formula grant is a type of mandatory (noncompetitive) grant that is awarded based on statistical criteria for specific types of work. The authorizing legislation and regulations define these statistical criteria and the amount of funds to be distributed. So, the term "formula" refers to the way the grant funding is allocated to recipients.

What is a formula grant?

A formula grant is a type of mandatory grant (noncompetitive) that is awarded based on statistical criteria for specific types of work. The authorizing legislation and regulations define these statistical criteria and the amount of funds to be distributed. So, the term "formula" refers to the way the grant funding is allocated to recipients. Medicaid is an example of a formula grant. Per legislation, there is an open-ended matching formula in which the federal government provides matching funds to state governments for all activities that fall within Medicaid coverage. So long as regulations are followed and the services are provided in compliance, the states receive the output of the formula (i.e., the matching grant funds).

Types of federal assistance - Formula grants (mandatory spending)

A formula grant is a type of mandatory grant that is awarded based on statistical criteria for specific types of work. The authorizing legislation and regulations define these statistical criteria and the amount of funds to be distributed. So, the term "formula" refers to the way the grant funding is allocated to recipients. Non-competitive grant - examples include: Medicaid,

Small Business Administration

A government agency that helps small business owners develop business plans and obtain financing and other support for their companies.

Def. of Patent

A government authority or license conferring a right or title for a set period, especially the sole right to exclude others from making, using, or selling an invention. Patents are any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof. To be patented it must be novel, useful, and not be obvious. Patent applications are filed with USPTO.

What is the cap on GRA compensation under an NIH award?

A graduate student supported by an NIH research grant or cooperative agreement (non-NRSA) cannot be paid more than the zero level of the National Research Service Award (NRSA) stipend for postdoctoral fellows in effect at the time the grant award is issued.

A-133 def of cluster of programs

A grouping of closely related programs that share common compliance requirements. Types include research and development (R&D), student financial aid (SFA), and other clusters.

Commerce Control List (CCL)

A list of products that cannot be exported from the United States without an export license. (EAR)

Cost Accounting Standards

A-122 If federal contracts exceeds $25 million

Leahy-Smith America Invents Act (AIA) (2011)

A major overhaul of the US Patent System; biggest change: changed the system from "first to invent" to "first inventor to file." Inventors have a 1 year grace period to disclose an invention before filing a patent. Also increased universities' share of profit from inventions.

UG Audit requirements

A non-Federal entity that expends $750,000 or more during the non-Federal entity's fiscal year in Federal awards must have a single or program-specific audit conducted for that year. Exempt if less than 750k

advance payment

A payment that a federal awarding agency or pass-through entity makes by any appropriate payment mechanism, including a predetermined payment schedule before non-federal entity disburses the funds for program purpose

A-133 def of internal control (general)

A process that provides reasonable assurance of achieving effectiveness and efficiency of operations; reliability of financial reporting; and compliance with applicable laws and regulations

Proposal costs

A-21: allowable w/restrictions A-122: not specifically addressed

A-133 def. of internal control (specific to fed awards)

A process that provides reasonable assurance that transactions are properly recorded and accounted for (to prepare reliable reports, maintain accountability over assets; and demonstrate compliance with laws, regulations, and other compliance requirements); transactions are executed in compliance with laws, regulations, and the provisions of contracts or grant agreements; funds, property, and other assets are safeguarded from unauthorized use or fraud.

A-133 definition of auditor

A public accountant or a Federal, State or local government audit organization, which meets the general standards specified in generally accepted government auditing standards (GAGAS). Does not include internal auditors of non-profit organizations.

Auditor

A public accountant or federal, state, local government, or Indian tribe audit organization, which meets the general standards specified for external auditors in generally accepted auditing standards (GAGAS). Term does not include auditors of non profit organizations. [79 FR 75880, Dec 19, 2014.]

Executive Order

A regulation authorized by the POTUS

NIH Def. of clinical trail (for NIH applications)

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

For copyrighted works which result from federally sponsored activities, the federal government usually requires

A royalty-free, non exclusive, and irrevocable license

Executive Order

A rule issued by the president that has the force of law. Congress can counter with a 2/3 majority. Next president can rescind.

Scholarship and student aid costs

A-21: allowable w/restrictions A-122: not specifically addressed

Research as defined by 45 CFR 46.102d

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

NIH def. of audit (general)

A systematic review or appraisal made to determine whether internal accounting and other control systems provide reasonable assurance of the following: 1. Financial operations are properly conducted. 2. Financial reports are timely, fair, and accurately. 3. The entity has complied with applicable laws, regulations, and other grant terms. 4. Resources- managed/used economically/efficiently. 5. Desired results/objectives are achieved effectively.

Continuing Resolution

A temporary funding law that Congress passes when an appropriations bill has not been decided by the beginning of the new fiscal year on October 1.

Cooperative agreement

A type of agreement used when sponsor involvement is reuired

Investigational new drug application

A type of application that must be submitted to the FDA before a drug can be studied in humans under 21 CFR 312.

Fixed amount awards

A type of grant agreement under which the Federal awarding agency or pass-through entity provides a specific level of support without regard to actual costs incurred under the Federal award.

Formula Funding

A type of mandatory funding in the Federal budget where the Federal government dictates how funds are allocated and spent via a specified formula such as census data.

Block Funding

A type of mandatory funding that allows the state government or entity to determine how Federal funds are allocated and spent.

FAR Citation in a Contract

A valid reference would contain the Number, Title, Date (month/year) 48 CFR 52.249-5 Termination for Convenience of the Government (educational and other nonprofit institutions) (September 1996) FAR clauses are continually being updated and it is important to ensure that the most recent version of the clause is included in the contract If the clause is updated after the contract start date, the version of the clause included in the contract remains controlling

Guide for the Care and Use of Laboratory Animals

A widely accepted primary reference on animal care and use. The 8th and latest edition of the Guide, published in 2011, was written under the auspices of the Institute for Laboratory Animal Research of the NationalAcademy of Sciences.

Animal Welfare Assurance - implementation of PHS Health Research Extension Act

A written assurance statement must be submitted and approved before animal work supported by PHS can be conducted (Assurance # eg A3208-01). The Assurance must: - be submitted to the NIH Office for Laboratory Animal Welfare (OLAW) and approved - fully describe the institution's program for the care and use of animals in research - list the IO, IACUC chair, Veterinarian and provide qualifications of theIACUC members. - describe the procedures that the IACUC will follow to fulfill the requirements of the Policy - renewed every 5 years or earlier dependent on expiration from OLAW - describe the occupational health program for personnel who work with or have frequent contact with animals or their tissues - indicate that an IACUC has been appointed by the CEO (or designee(IO)), and that the members possess the requisite qualifications and experience, along with the name and title of the IACUC Chair, IO and Veterinarian

State and local governments are subject to which OMB Circular

A-102

Use to determine how to charge sponsored agreements .. ie, purchasing system, cost share, asset/inventory management, time, etc.

A-110

Administrative

A-110 (2 CFR 215) College/university

Administrative

A-110 (2 CFR 215) Nonprofit

A5: Subawards

A-110 should be flowed down to subrecipents which fall under the circular State and local government recipients OMB circular a-102 Also known as the "common rule"

Department Admin Cost Pool

A-21 Specifically defined 3.6% faculty allowance (Eliminates the need for faculty members to report their administrative activity in effect, faculty administrative effort recovered through the institution's facilities and administrative rate is set at a 3.6% faculty administrative allowance (cap), with no need for further documentation.

Costing

A-21 (2CFR 220) College/university

Does A-21 serve as the cost principle guidance for grants or contracts?

A-21 provides cost principles for Grants (assistance funding).

Equipment and other capital expenditures

A-21: Allowability based on specific requirements A-122: Allowability based on specific requirements

Housing and personal living expenses

A-21: Unallowable A-122: Unallowable as overhead costs

Lobbying: executive lobbying costs

A-21: Unallowable A-122: Unallowable w/exceptions

Alumni activities

A-21: Unallowable A-122: not specifically addressed

Entertainment costs

A-21: Unallowable A-122: Unallowable

Donations and contributions

A-21: Unallowable (made by recipient) not reimbursable but value may be used as cost sharing or matching (made to recipient) A-122: Unallowable (made by recipient) not reimbursable but value may be used as cost sharing or matching (made to recipient)

Memberships, subscriptions, and professional activity costs

A-21: Unallowable for civic, community, or social organizations A-122: allowable for civic and community organizations w/ federal approval; Unallowable for social organizations

Compensation for personal services: organization furnished automobile

A-21: Unallowable for that portion of costs attributed to personal use A-122: Unallowable for that portion of costs attributed to personal use

Student activity costs

A-21: Unallowable unless specifically provided for in the sponsored agreement A-122: not specifically addressed

Lobbying

A-21: Unallowable w/ exceptions A-122: Unallowable w/exceptions

Contingency provisions

A-21: Unallowable w/exceptions A-122: Unallowable w/exceptions

Fines and penalties

A-21: Unallowable w/exceptions A-122: Unallowable w/exceptions

Commencement & convocation costs

A-21: Unallowable w/exceptions A-122: not specifically addressed

Selling and marketing costs

A-21: Unallowable w/exceptions A-122: Unallowable w/exceptions

Fundraising and investment management costs

A-21: Unallowable w/exceptions (fundraising) A-122: Unallowable w/exceptions

Deans of faculty and grad schools

A-21: allowable A-122: not addressed

Labor relations costs

A-21: allowable A-122: allowable

Specialized service facilities

A-21: allowable w/Restrictions A-122: allowable w/restrictions

Depreciation and use allowances

A-21: allowable w/qualifications A-122: allowable w/qualifications

Insurance and indemnification

A-21: allowable w/restrictions A-122: allowable w/ restrictions

Bonding cost

A-21: allowable w/restrictions A-122: allowable w/restrictions

Compensation for personal services: severance pay

A-21: allowable w/restrictions A-122: allowable w/restrictions

Gains and losses on depreciable assets

A-21: allowable w/restrictions A-122: allowable w/restrictions

Interest

A-21: allowable w/restrictions A-122: allowable w/restrictions

Maintenance and repair costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Materials and supplies costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Professional service costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Publication and printing costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Reconversion costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Relocation costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Rental costs of building and equipment

A-21: allowable w/restrictions A-122: allowable w/restrictions

Termination costs applicable to sponsored agreements

A-21: allowable w/restrictions A-122: allowable w/restrictions

Travel costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Trustees

A-21: allowable w/restrictions A-122: allowable w/restrictions

Compensation for personal services: sabbatical leave costs

A-21: allowable w/restrictions A-122: not specifically addressed

Royalties and other costs for use of patents

A-21: allowable w/restrictions A-122: allowable w/ restrictions

Advisory councils

A-21: allowable w/restrictions A-122: allowable w/restrictions

Meetings and conferences

A-21: allowable w/restrictions A-122: allowable w/restrictions

Patent costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Recruiting costs

A-21: allowable w/restrictions A-122: allowable w/restrictions

Process to test single audit controls

A. Identify the control objectives or "what can go wrong" B. Understand the mitigating controls C. Walk through the control process D. Assess the design effectiveness E. Test Controls F. Assess Operating Effectiveness G. Report Findings

How often are animal research facilities inspected? Who inspects them? What standard are they inspected against?

APHIS AC (Animal Care) unit inspects at least 1 time per year, and inspects for compliance with Animal Welfare Act standards. IACUCs must inspect their own animal use facilities every 6 months. PHS may inspect facilities with activities funded by PHS grants at any time. The look for compliance with PHS policy.

UG access to records

Access to all award docs (and ppl to discuss docs): Awarding agency, IG, the Comptroller General of US, and the pass-through entity, or any of their authorized representatives, Expiration of access: the rights of access in this section are not limited to the required retention period but last as long as the records are retained. Federal awarding agencies and pass-through entities must not impose any other access requirements upon non-Federal entities.

Cost Accounting Standard 505

Accounting for Unallowable Costs

CAS 505

Accounting for Unallowable costs Unallowable costs must be identified and excluded from any billing, claim, application or proposal

Intellectual Property Policy Requirements

Acknowledgement: I acknowledge that as a condition of my appointment to the professional staff or of employment by the hospital or my opportunity to otherwise participate in any hospital activities, I am subject to the following obligations: 1. General compliance with policies 2. My disclosure obligations 3. My obligations to assign intellectual property 4. My additional obligations to disclose and obtain approval of consulting arrangements 5. My obligations under hospital grants and agreements 6. My agreement not to sign documents

2 CFR 200 - Subpart A

Acronyms and Definitions

USA Patriot Act

Act that gives federal officials greater authority to take measures to combat terrorism. Required the CDC to begin publishing the Select Agents Regulations.

Pregnancy Discrimination Act

Act that prohibits discrimination on the basis of pregnancy, childbirth, or related conditions.

Copeland "Anti-Kickback" Act

Act that prohibits federal contractors from receiving kickbacks from employees or subcontractors for wages earned on federal projects.

A-133 def. of corrective action

Action taken by the auditee that corrects identified deficiencies; produces recommended improvements; or demonstrates that audit findings are either invalid or do not warrant auditee action.

A-102

Admin Requirements for State & Local gov'ts...Common Rule

Office of Foreign Assets Control (OFAC)

Administers economic sanctions and embargo programs that require assets and transactions involving the interest of targeted parties be blocked or frozen. Trade or Financial.

OMB A-110

Administrative Requirements for Higher Ed, Hospitals and Non-Profits; replaced by UG

OMB Circular A-110

Administrative Requirements for Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations

1994

Administrative cap has been 26% since:

Describe the difference between Administrative Requirements and Cost Principles?

Administrative requirements are to create standards for consistent grant administration by recipients. Cost principles define allowable costs for different types of recipients.

A-110

Administrative requirements for IHE's, non-profits, hospitals

A-102

Administrative requirements for state, local, and tribal government

Declaration of Helsinki 1964

Adopted by World Medical Assembly: international living document. Summary: 1. Subjects' well-being precedes the interests of science and society 2. Some populations are vulnerable and require special protections. 3. Experimental procedures must be detailed in a protocol, which is submitted to an IRB 4. Assessment of risks and benefits to subjects is required prior to research. 5. Subjects must be informed volunteers. If they cannot consent for themselves, legally authorized representatives must consent on their behalf. 6. Informed consent must be documented

FAR Part 200 and up

Agency-specific supplements

Primary sources of funding (i.e. places to find FOAs)

Agency; Policy Manuals and Websites; CFDA; FedBizOpps; Fedconnect; Federal Register; Foundation Reports; Grants.gov; Program Announcements

400.423

Alcoholic beverages - unallowable

Appendix A: contract provisions

All contracts awarded by a recipient shall contain the following provisions, as applicable: Equal employment opportunity Copeland Anti-kickback act Davis-Bacon act Contract work hours and safety standard acts Rights to inventions made under a contract or agreement Clean air act and federal water pollution control act Byrd Anti Lobbying Amendment Debarment and suspension

A3: Effect on Other Issuances & A4: Deviations

All other administrative requirements codified in program regulations, manuals, handbooks inconsistent with this circular are superseded, unless required by statute or authorized by the deviations provision of this circular

C43: competition

All procurement transactions shall be conducted to provide open and free competition

Drug Free Schools and Communities Act

All programs administered by any federal agency - must annually distribute in writing to each employee and student except for students in continuing education units

Research and Development (R&D)

All research activities, both basic and applied, and all development activities that are performed by non-Fed entities. Research includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other R&D

A-21 and A-122 require that costs are:

Allocable Allowable Reasonable Consistently treated

200.459 Professional Services (consultants)

Allowable

200.448 Intellectual Property - Allowable

Allowable Costs - Costs of preparing disclosures, reports required by fed govt - Costs of preparing documents and other patent costs - Gen. counseling services relating to patent and copyright matters Unallowable Costs - Costs in connection with foreign patent applications - Royalties and other costs for use of patents and copyrights

Relocation costs for current employee - Allowable

Allowable items - Costs of transportation of employee, members of immediate family - Costs of finding new home, locate living quarters, temporary lodging for up to 30 days - Closing costs; limited to 8% of sale's price of employee's former home - Continuing costs of ownership of vacant home for up to 6 months - Other necessary and reasonable expenses, such as costs of canceling unexpired lease; limited to 3 times the monthly rent

Deans of faculty and graduate schools

Allowable under A-21

Scholarship and student aid costs

Allowable under A-21 with restrictions on training grants if sponsor approved; tuition paid in lieu of wages

200.464 Relocation costs of employees

Allowable under the following conditions for new employee - For benefit of employer - Reimbursement does not exceed actual expenses - If employee resigns within 12 mths, non fed entity must refund govt its share

200.456 Participant Support Costs

Allowable with prior approval

Direct costs should be...

Allowable, Allocable, Reasonable, and Consistent

200.453 Materials and Supplies

Allowable. Computing devices allowable if essential and allocable.

Time and Materials Agreement

Allows a Sponsor to acquire supplies or services based upon specific labor hours and actual material costs. Because Universities do not track time using an hourly time-keeping system, it is impossible for us to report and certify hours on an invoice. A T&M agreement is not appropriate for a University.

Fixed price incentive contract

Allows for adjustment of the profit built into the contract, final contract price is based on a formula applied to the final negotiated cost and target cost, efficient performance will lead to higher fee (incentive)

Bayh-Dole Act (1980) - 35 U.S.C. § 200 et seq.,

Allows institutions to retain title and file for patent on inventions they elect to own and made with federal funding. The purpose of the Bayh-Dole Act was to make sure that inventions funded with federal money were being commercialized and released to the larger public to ensure wider benefit from research investment by the federal government; must disclose invention to Government within 2 months and Government retains "government purpose rights."

Patent Clauses - FAR 52.227-11 Patent Rights-Retention by the Contractor

Allows the University the right to elect ownership of patents it develops under the contract. - Implements the Bayh-Dole Act

Patent Clauses - FAR 52.227-3 Patent Indemnity

Allows the government to be indemnified for a patent infringement if the contractor is delivering services in the open market - Public Universities cannot accept indemnification provisions - even to the US Government - Request deletion of this clause in favor of 52.227- 1, Alt I, Authorization and Consent - Can be a deal breaker

3 divisions under DAB that implement Alternative Dispute Resolution ("ADR")

Alternative Dispute Resolution Division (ADR): Alternate plans to legal dispute filed under the 3 boards - usually involves mediation or ombudsman Appellate Division (staff support to the DAB); Appellate review of admin law decisions; board's decision is usually final decision of HHS Civil Remedies Division (CRD) (Support staff to Admin. Law judges (ALJs)) "ALJs are qualified under the Federal Administrative Procedure Act to conduct hearings on the record"

400.424

Alumni/ae activities - unallowable

NSF Resp. Conduct of Research (RCR) info

America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act requires that ''each institution that applies for financial assistance from the Foundation for science and engineering research or education describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project."

America Competes Act PL 110-69

America creating opportunities to meaningfully promote excellence in technology, education and science act of 2007 Section 7009 requires that each institution receiving NSF funds for STEM research or education have a plan to provide training on the responsible conduct of research to undergraduates, graduate students, and postdoctoral researchers

Eligibility for Small Business Concern (SBC)

American-owned (at least 51%) and independently operated; For-profit; Company size limited to 500 employees

Doctor of Veterinary Medicine, practicing scientist experienced in research involving animals, public member to represent community interest.

An IACUC committee must have at least one of each of these:

Disclosure Statement (DS-2) - (from UG)

An IHE that receives aggregate Federal awards totaling $50 million or more subject to this part during its most recently completed fiscal year must disclose their cost accounting practices by filing a Disclosure Statement (DS-2). An IHE is responsible for maintaining an accurate DS-2 and complying with disclosed cost accounting practices. An IHE must file amendments to the DS-2 to the cognizant agency for indirect costs six months in advance of a disclosed practices being changed to comply with a new or modified standard, or when practices are changed for other reasons.

Name a required assurance and a required registration each IRB must have.

An IRB must be registered with the OHRP under DHHS. An IRB must also have a federal-wide assurance number (FWA), also obtained from OHRP. If doing food or drug testing controlled by the FDA, then need to register with FDA as well.

How many people must serve on an Institutional Review Board, and what are the required roles/affiliations of the members?

An IRB must have at least 5 members. Of the members, 1 must be a scientist, 1 must be a non-scientist, and 1 must have no affiliation with the institution.

Describe how you would prepare a proposal narrative differently for an in house merit review versus peer merit review

An In House review should assume general knowledge but not technical knowledge-- write for the informed general public. Peer review -- assume expertise and technical writing is okay.

Merit review; describe how you would prepare a proposal narrative differently for an In House review versus Peer Review

An In House review should assume general knowledge but not technical knowledge-- write for the informed general public. Peer review -- assume expertise and technical writing is okay.

What is an RSC?

An RSC is an institutional Radiation Safety Committee that implements and oversees radiation safety in research at an institution. (As required by the NRC, the Nuclear Regulatory Commission).

What is the difference between an absolute priority, an invitational priority, and a competitive priority in an RFP?

An absolute priority is a priority that an applicant must address in order to receive an award. An invitational priority is a priority that reflects a particular interest of the Department; however, an applicant choosing to address an invitational priority will not receive any competitive preference over other applications. A competitive priority may be handled in one of two ways: 1. An application may be awarded additional points depending on how effectively it addresses the competitive priority; or 2. An application that meets a competitive priority may be selected over an application of comparable merit that does not address the competitive priority. The type of competitive priority for a particular competition is always included in the Federal Register announcement.

Supplemental Appropriations

An act appropriating funds in addition to those provided for in an annual appropriations bill. Supplemental appropriations are often provided when the cost of a program exceeds initial estimates, or in times of national disaster or crisis. Disaster/Emergency funding

appropriations bill

An act of Congress that actually funds programs within limits established by authorization bills. Appropriations usually cover one year.

authorization bill

An act of Congress that establishes, continues, or changes a discretionary government program or an entitlement. Prerequisite for Congress to appropriate budget authority for programs.

Civil Rights Act of 1964 (Pub.L. 88-352, 78 Stat. 241, enacted July 2, 1964)

An act to enforce the constitutional right to vote, to confer jurisdiction upon the district courts of the United States of America to provide injunctive relief against discrimination in public accommodations, to authorize the Attorney General to institute suits to protect constitutional rights in public facilities and public education, to extend the Commission on Civil Rights, to prevent discrimination in federally assisted programs, to establish a Commission on Equal Employment Opportunity, and for other purposes; a landmark civil rights and US labor law in the United States that outlaws discrimination based on race, color, religion, sex, or national origin. It ended unequal application of voter registration requirements and racial segregation in schools, at the workplace and by facilities that served the general public.

Def. of Export

An actual shipment or transmission out of the United States, including the sending or taking of an item out of the United States, including the sending or taking of an item out of the united States in any manner

Broad Agency Announcement (BAA)

An announcement of a federal agency's general research interests. Invites proposals, and specifies general terms and conditions for award. Eg: ARO, ONR, AFOSR BAA's.

Request for Application (RFA)

An announcement that indicates the availability of funds in a more "specific," or "targeted" area of interest to the sponsor. Eg: NIH DP2, New Innovator.

Request for Proposal (RFP)

An announcement that specifies a topic of research, methods, product delivery, and category of applicants. (Proposals in response to an RFP generally result in a contract.) Eg: DoD SBIR/STTR with Corporation

Code of Federal Regulations (CFR)

An annually revised codification of the general and permanent rules published in the Federal Register by executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each title is divided into chapters, subchapters, parts, subparts, sections and paragraphs.

Public Law 89-544

Animal Welfare Act passed in 1966 Established standards for handling, housing, transporting, and feeding animals used in research.

APHIS

Animal and Plant Health Inspection Service

APHIS

Animal and Plant Health Inspection Service (part of USDA). Responsible for monitoring compliance with the Animal Welfare Act (among other things).

Institutional Animal Care and Use Committee (IACUC)

Animal protocols are reviewed by:

CFR Title 9

Animals & Animal Products

Program Announcement/Program Solicitation (PA/PS)

Announcement of sponsor's intent to support a general area of research, or some other activity, that furthers the goals and mission of the sponsor. Eg: NIH Parent Announcements, NSF Program Solicitations.

Entities that receive over $25 M in federally sponsored agreements annually, must submit an

Annual Disclosure Statement

B17: Certifications and Representations

Annual basis encouraged

USDA Pain Categories

Annual report to the USDA of species / number used in each pain category B: no pain distress (breeders, ordered but not used) C: procedures may cause no more than discomfort or mild and transient pain (behavior observation, injection) D: relieved pain / distress (surgery w/analgesia) E: unrelieved pain / distress (strong justification--intense scrutiny) US Principle IV: procedures that cause pain / distress in humans should be considered to cause pain / distress in animals

An institution has an award of $200,000 -- there are no excluded cost categories. The institution's F&A rate is 40% MTDC. What are the total direct costs (TDC) for the project?

Answer: $142,857. 200,000/1.40 = $142,857

An institution has an award of $200,000. The institution's F&A rate is 40% MTDC. The institution's fringe rate is 25%. The project budget includes $20,000 for supplies. How much of the remaining award can be used for salaries and fringe benefits?

Answer: $98,286. 200,000/1.40 = $142,857(TDC)... $142,857-$20,000 supplies = $122,857... $122,857/1.25 = $98,285, the remainder available for salaries and benefits.

An institution has an award of $200,000. The institution's F&A rate is 40% MTDC. The institution's fringe rate is 25%. The project budget includes $20,000 for supplies. How much of the remaining award can be used for salaries?

Answer: $98,286. 200,000/1.40 = $142,857(TDC)... $142,857-$20,000 supplies = $122,857... $122,857/1.25 = $98,285, the remainder available for salaries.

Which of the following best describes essential laboratory biosafety levels in medical research? A) Special microbiological practices used to conduct procedures with high aerosol potential B) Basic containment procedures designed to protect personnel and the environment. C) Degrees of protection provided to personnel, environment, and community. D)Biological safety cabinets class I, II, or III

Answer: Basic containment procedures designed to protect personnel and the environment.

Which of the following currently provides information on patent rights and responsibilities currently applicable to universities and federally sponsored projects? A) Federal Register B) CFR C) USA.gov D) USPTO

Answer: CFR

In which of the following areas is work for hire most suitable? A) Patents B) Trademarks C) Copyrights D) None are suitable

Answer: Copyrights

Exports

Any oral, written, electronic or visual disclosure, shipment, transfer or transmission of commodities, technology, information, technical data, assistance or software codes to: Anyone outside the US (including a US citizen) A non-US individual (wherever they are) A foreign embassy or affiliate Licenses may be required to export

Research Facility

Any school (except an elementary or secondary school), institution, organization, or person that uses or intends to use live animals in research, tests, or experiments, and that (1) purchases or transports live animals in commerce, or (2) receives funds under a grant, award, loan, or contract from a department, agency, or instrumentality of the United States or the purpose of carrying out research, tests, or experiments.

Trade secrets

Any secret information used by a business to obtain a competitive advantage over those who do not know it

B12: Forms for applying for federal assistance

Applicants shall use the sf-424 series or the forms prescribed by the awarding agency

Under FOIA, what parts of a grant are publicly requestable information?

Application (only if the grant was funded); notice of award; progress reports; financial reports; final report of grantee performance conducted by grantor.

PHS-398

Application for PHS grant

What are the two types of Organized Research as described in A-21? Define both.

Applied research: Applied research is the application of scientific knowledge to the solution of a specific, defined problem. Basic research: Basic Research: Basic research is research that contributes to the more complete understanding of a subject area and is not necessarily directly applicable to the solution of a specific problem.

Select Agent compliance

Applies to all use of identified agents/toxins and is applicable to both individuals and entities

Walsh-Healy Public Contracts Act

Applies to contracts over $10k Prohibits child labor Establishes minimum wages and overtime pay

Animal Welfare Act (AWA)

Applies to institutions that: 1. Purchases or transports live animals in commerce 2. Receives funds under a grant, award, loan, or contract from a department, agency, or instrumentality of the United States for the purpose of carrying out research, tests, or experiments.

PHS Policy

Applies to those receiving PHS funds and covers all live vertebrates; overseen by the Office of Laboratory Welfare (OLAW)

Contracting Officer's TechnicalRepresentative (COTR):

Appointed by the CO to monitor technical performance and progress. - Reviews and approves deliverables - Reviews and approves invoices - Limited authority—can not legally bind the government

Procedures: Awarded account

Approved indirect items budgeted in specific object codes Monthly report of federal funds with indirect object codes not approved Remove Correct object code Justify as special purpose

HIPAA Privacy Rule

April 14, 2003 Restrictions on the use and disclosure of protected health information (PHI) A covered entity can use or disclose PHI for research under the following circumstances: 1. De-identified PHI 2. Subject of the PHI has granted specific written authorization 3. Authorization waiver from IRB or a Privacy Board

UG Auditee responsiblities

Arrange for the audit and ensure it is properly performed and submitted; Prepare appropriate financial statements, including the schedule of expenditures of Federal awards; take corrective action on audit findings; provide the auditor with access to personnel, accounts, books, records, supporting documentation, and other information as needed.

Examples of Direct Costs

Salaries of PI, technician, research assistant Scientific equipment Animal care Duplicating Lab supplies Subcontracts travel

What is background intellectual property (BIP)?

Background Intellectual Property is any intellectual property that a party owns or controls prior to, or outside of, a contractual agreement and that may be necessary to its related efforts.

Genesis of FAR

Based on two statutes The Armed Services Procurement Act of 1947 The Federal Property and Administrative Services Act of 1949 FAR System is issued pursuant to the Office of Federal Procurement Policy Act of 1974 (public law 93-400) Statutory authority to issue and revise the FAR is delegated to the Agency Executives: DOD, GSA, & NASA

What is the fundamental research exemption to export control regulations?

Basic and applied research that is ordinarily shared broadly within the scientific community is exempt from some export control restrictions.

IDC rate for land grants

Basic rule found in USC Chapter 64 Part 7 - IDC capped at 19% TDC; some state rules indicate no IDC

Belmont Report 1979

Basic underlying principles: Respect for persons- informed consent; privacy & confidentiality; Beneficence---Risks vs Benefits (benefits outweigh the risks) Justice-Equitable selection of subjects.

UG possible method of procurement - sealed bids

Bids are publicly solicited and a firm fixed price contract (lump sum or unit price) is awarded to the responsible bidder whose bid, conforming with all the material terms and conditions of the invitation for bids, is the lowest in price. The sealed bid method is the preferred method for procuring construction

1. The sharing of technical data or information with a foreign national inside the U.S. as part of a class, laboratory, or conference or seminar, if the same technical data or information has already been widely published is which of the following export controls exemption: a. Education Exemption b. Bona Fide employee c. Public Domain Exemption d. Tools of the Trade Exemption

C - Public Domain Exemption

1. Under the uniform guidance, how long do federal agencies have access to grantee records: a. 3 years b. 7 years c. As long as the records are retained d. As long as required in the notice of award

C) As long as the records are retained (but most organizations keep them at least 7 years because the false claims act statute of limitations expires after 6.

Who is responsible for determining the applicable administrative requirements for a federal grant? A) Congress; B) the OMB; C) the awarding agency; D) the authorizing statute.

C) The awarding agency determines the applicable administrative requirements for managing a federal grant, and states them in the federal award.

4 Cost Accounting Standards (CAS)

CAS 501: consistency in estimating, accumulating, and reporting costs CAS 502: consistency in allocating costs for the same purpose CAS 505: accounting for Unallowable costs CAS 506: cost accounting period

What is COGR?

COGR is the Council on Governmental Relations - an association of research universities, affiliated medical centers, and independent research institutes. Their mission is to keep their membership informed of any and all issues facing research institutions today. They are also an advocacy group that gives feedback to the government on how regulations affect their members. They define themselves as "the national authorities on the financial and regulatory infrastructure, and the corresponding compliance requirements associated with managing federal research grants and contracts within research institutions. We provide information, analyses, advice, policy perspective, and historical context to our members in the areas of research administration and compliance, financial oversight, and intellectual property. COGR communicates the viewpoint and concerns of its members and fosters productive relationships between the research community and federal policymakers, advocating for innovation and change that avoid unnecessary regulatory burden."

COMPETES

COMPETES is an authorization bill that sets policy and funding targets for the National Science Foundation (NSF), the Department of Energy's research programs, and the National Institute of Standards and Technology (NIST). First enacted in 2007 and reauthorized in 2010, 2013, and 2015.

Current embargoed countries

CUBA, IRAN, NORTH KOREA, SUDAN, and SYRIA; ITAR - a) Prohibited countries: Belarus, Cuba, Eritrea, Iran, North Korea, Syria, Venezuela. (b) U.N. Arms Embargoed countries (ITAR): Burma, Code d'Ivoire, Congo, Eritrea, Iraq, Iran, Lebanon, Liberia, Libya, North Korea, People's Republic of China, Somalia, The Republic of the Sudan.

Direct Costs

Can be identified and charged to a specific project with relative ease and accuracy.

Define: dual-use technology

Can be used for both peaceful and military aims. In the US, export of dual use technology is regulated by BIS under the Dept of Commerce (EAR).

US patent prosecution process

Can take up to seven-plus years

Fixed Amount Subawards

Cannot exceed Simplified Acquisition Threshold ($150,000) and require prior written approval from the Federal Agency

MTDC Exclusions

Capital equipment, capital expenditures, patient care costs, tuition remission, rental charges, scholarships and fellowships, and subcontracts exceeding $25,000 in expenditures.

OMB Circular A-89

Catalog of Federal Domestic Assistance (CFDA)

Sources for information about funding opportunities

Catalog of Federal Domestic Assistance (CFDA); mandated by OMB Circular A-89 Fed Biz Opps (aka Commerce Business Daily) for contracts Federal Register: some Department of Education grants are announced here PAs, FOAs, BAAs (broad agency announcement), RFAs, RFPs,RFQs (quotations)

OMB A-89

Catalog of Federal Domestic Assistance CFDA; circular replaced by UG

Fixed price ceiling price contract with retroactive price determination

Ceiling price with ability to retroactively adjust price within the ceiling after completion of the work, exclusively for R&D contracts under $100k

FAR Citation: 48 CFR 1 (part)

Chapters are further organized into Parts Parts 1-51 include general information, solicitation clauses and prescriptions Part 52 contains the Contract Clauses and Matrix Part 53 contains Forms (parts 54-99 are reserved) When citing basic FAR, the chapter number 1 is omitted

Value Added Tax (VAT) Foreign Taxes

Charged for purchase of goods or services that non-Fed entity is legally required to pay in country is an allowable expense

IRB: special populations

Children, inmates, pregnant women

Clinical Trials

Clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome

C72: subsequent adjustments and continuing responsibilities

Closeout of an award does not affect the following: Right of the federal awarding agency to disallow costs and recover funds on the basis of a later audit or other review Obligation of recipient to return any funds as a result of later refunds, corrections, or other transactions

2 CFR 200.315

Code of Federal Regulations addressing government rights in intellectual property.

FAR Citation

Codified: Title 48 CFR United States Code (USC): Statutes of the US US Code of Federal Regulations (CFR) Policies and procedures that implement the USC Divides into Titles, Chapters, Parts, Subparts, Sections, and Subsections Title 48 of the CFR is the Federal Acquisition Regulation System (FAR) The legal citation looks like: 48 CFR (number)

Soloman Act

Colleges that accept federal money must allow military recruiters on campus

Secondary sources of funding (i.e. places that list FOAs)

Commercial Subscription Companies: COS (PIVOT), SPIN, IRIS; Foundation Directory; GrantsNet.org; Newsletters

SBIR Phase 3

Commercialization of results of Phase requires private sector use of non-SBIR funding

400.431

Compensation - fringe benefits - allowable

400.430

Compensation - personal services/salary - generally allowable

Info on research misconduct process (PHS)

Complaint resolved (reported to ORI) within 180 days unless extension is granted; handle in 3 ways: 1. Inst. Investigation (conducted by a panel of 3 individuals: may be from outside the institution, have no personal or professional relationship or other COI with the whistleblower or the alleged individual retaliator(s)); 2. Arbitration: Whistleblower and inst sign agreement to id an arbitrator, who has no personal or professional relationship or COI with whistleblower, inst., the alleged retaliator(s); arbitration should be facilitated by non-profit arbitration association; 3. Settlement: institution and whistleblower may enter into settlement and sign a statement indicating that the retaliation complaint has been resolved (send to ORI w/in 30 days)

Pass-through entity must

Complete a risk assessment, ensure that proper financial monitoring including segregate accounts and invoice review is occurring, technical monitoring, and review subrecipient's Single Audit Report

Space Survey

Completed to equitably distribute facilities costs

Clinical Trial Agreements negotiations are

Complex and must cover: - confidentiality - indemnification and subject injury - ownership of study data - intellectual property - publications with respect to multi-center trials

CRISP

Computer Retrieval of Info on Scientific Projects - biomedical database system containing information on research projects/programs supported by DHHS

Information Technology Systems

Computing devices, software, firmware, similar support services

Bayh-Dohl Act

Concerns inventions/IP developed with federal assistance funding. Grantees must make invention disclosure to govt within 2 months of disclosure by PI to university. Purpose is to encourage dissemination of advancements developed using federal funds.

Government Contracting Objective

Conduct business with transparency, integrity, and fairness. Minimize administrative operating costs. Satisfy customers by ensuring the best cost, highest quality, and timely delivery. Fulfill public policy objectives through implementation of socioeconomic policies.

What is the difference between confidential information, proprietary information, and proprietary data?

Confidential Information is information exchanged between two parties; the receiving party must keep the information confidential and may not disclose it to any third party. Proprietary Information constitutes a trade secret and/or information that is commercial or financial and confidential or privileged. Proprietary Data is defined as technical data submitted to the sponsor under a contract and subject to protection by the contractor.

Certifications required at time of submission

Conflict of Interest; Drug-Free Workplace; Debarment and Suspension; Lobbying; Nondiscrimination; Flood Hazard Insurance; Responsible Conduct of Research (RCR); Organizational Support; Federal Tax Obligations; Unpaid Federal Tax Liability; Criminal Convictions; Dual Use Research of Concern

Who approves an item to be listed in the CFDA?

Congress approves CFDA listings, but not all listings are funded.

Small Business Act of July 30, 1953

Congress created the Small Business Administration, whose function was to "aid, counsel, assist and protect, insofar as is possible, the interests of small business concerns."; The charter also stipulated that SBA would ensure small businesses a "fair proportion"; of government contracts and sales of surplus property.

CAS 501

Consistency in Estimating, accumulating and reporting costs Practices used to estimate costs in a proposal should be the same as the way we charge and report Level of detail can be different, but should be able to make "sufficient and meaningful comparison." Classifying as direct v indirect Placing an item in an indirect pool Methods of allocating indirect to sponsored agreements

CAS 502

Consistency in allocating costs incurred for the same purpose Each type of cost may be allocated only once However, all costs incurred for the same purpose, in like circumstances, are either direct only or indirect costs only

De minimus rate (UG)

Consistent with 45 CFR 75.414(f), any institution of higher education (IHE) or nonprofit organization that has never received a negotiated indirect cost rate, may elect to charge a de minimis rate of 10% of modified total direct costs (MTDC) which may be used indefinitely."; "If chosen, this methodology once elected must be used consistently for all Federal awards until such time as a non-Federal entity chooses to negotiate for a rate, which the non-Federal entity may apply to do at any time.

2 CFR 200

Contains Cost Principles for Educational institutions State governments Local governments Indian Tribal Governments Nonprofit organizations 45 CFR 74 Appendix E (aka OASC 3) contains cost principles for hospitals

Prudent Person Test

Contemplating any business act, an employee should ask himself whether he would be willing to see it immediately described by an informed and critical reporter on the front page of his local newspaper, there to be read by his spouse, children, and friends." Warren E. Buffet

§200.22 Contract definition

Contract means a legal instrument by which a non-Federal entity (NFE) purchases property or services needed to carry out the project or program under a Federal award. The term as used in this part does not include a legal instrument, even if the non-Federal entity considers it a contract, when the substance of the transaction meets the definition of a Federal award or subaward (see §200.92 Subaward).

Cure Notice

Contracting Officer will give written notice. The notice allows 10 days to cure any defect. Unless failure to perform is cured within 10 days, contracting officer will issue a termination for default.

Uniform Contract format (per Far 15.404-1; Standard Form 33)

Contracting Officers must prepare solicitations and contracts using the uniform contracting format as follows: Part I--The Schedule A Solicitation/contract form B Supplies or services and prices/costs C Description/specifications/work statement D Packaging and marking E Inspection and acceptance F Deliveries or performance G Contract administration data H Special contract requirements Part II--Contract Clauses I Contract clauses Part III--List of Documents, Exhibits, and Other Attachments J List of attachments Part IV--Representations and Instructions K Representations, certifications, and other statements of offerors L Instructions, conditions, and notices to offerors M Evaluation factors for award

Firm fixed price, level of effort term contract

Contractor commits to a specific level of effort to perform R&D, deliverable is usually a report, contract is paid on effort expended rather than results achieved

Contract Termination: Stop Work Order Issued

Contractor must: Stop the work immediately Freeze any future related contracts or subcontracts and terminate all current subcontracts Reassign personnel commitments beyond the termination date Submit a termination proposal within the time allotted by the Contracting Officer. [sites should ask for termination costs in the termination proposal, allowable costs after the termination date.]

Cost sharing contract

Contractor shares the costs of conducting the work, contractor will only be reimbursed for government's portion of the costs

20.434

Contributions and donations

Voluntary Cost sharing

Contributions to a sponsored project or program not required by the sponsor as an award condition.

International Traffic in Arms Regulations (ITAR)

Controlled by US State Department. Dept of State is responsible for the export and temporary import of defense articles and services

EO 12372

Coordinated Review Process

EO 12372

Coordinated Review Process: Establishes that states may establish their own practices and review processes before allowing submission of proposals for federal grants (Oregon does not participate).

Small Business Administration (SBA)

Coordinates the SBIR and STTR programs; indep. agency created in 1953 to advise, assist, and protect the interests of small business concerns. The SBA guarantees loans to small businesses, aids victims of floods and other natural disasters, promotes the growth of minority-owned firms, and helps secure contracts for small businesses to supply goods and services to the federal government.

File your ______ with the Library of Congress

Copyright

A law that protects the exclusive rights, given to an originator or an assignee of the "original work of authorship," to reproduce, print, publish, perform, film, or display or and to authorize others to do the same."

Copyright Act (1976)

Copyright rights automatically vest with the ______.

Copyright rights automatically vest with the author of the work, without the author filing for rights.

DARPA

Defense Advanced Research Projects Agency - funded computer networking, first hypertext system NLS

Selecting contract type

Cost Analysis Is the proposed price competitive? Is the price realistic? Is the cost estimate provided accurate? Are there uncertainties that would support use of a contract type that puts the burden of cost responsibility on the contractor? Type and Complexity of SOW Does the likelihood of changes make it difficult to accurately estimate costs in advance? Urgency of the Work Is there an urgent need for the government to have the work done so that the government would be willing to take some risk?

OMB Circular A-87

Cost Principles for State, Local and Indian Tribal Governments

2 CFR 200 - Subpart E

Cost Principles. Section 200.4xx.

be made with the sole intent of using unexpended balance in a federal account

Cost Transfer may not

Justification, documentation, and authorization

Cost Transfers need and require

Types of cost reimbursable contracts

Cost contract Cost sharing contract Cost plus incentive fee contract Cost plus awarded fee contract Cost plus fixed fee contract

Acquisition Cost

Cost of the asset including cost to ready the asset for its intended use. Acquisition cost for equipment means net invoice price of equipment, including cost of modifications, attachments, accessories, etc.

Uniform Guidance Subpart E

Cost principles

OMB Circular A-21

Cost principles for education institutions

A-122

Cost principles for non-profits (including non-profit hospitals)

OMB Circular A-122

Cost principles for nonprofit organizations

2 CFR 230 (A-122)

Cost principles; Nonprofit orgs

2 CFR 225 (A-87)

Cost principles; State, local, & Indian Tribal gov'ts

Cost plus award fee contract

Cost reimbursement contract that allows for a fee to be paid, fee consists of a base amount fixed at the beginning of the contract and an award amount at the discretion of the government

200.404 Reasonable Costs

Cost should be ordinary and necessary

200.405 Allocable Costs

Cost specifically chargable or assignable to a federal award

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): PROTOCOL AND DATA COSTS

Costs associated with developing and maintaining animal/human subjects protocols, coordinating research subjects, and securing project-specific data is ALLOWABLE to direct charged to federal awards.

200.452 Maintenance and repair

Costs for utilities, insurance, security, maintenance, which neither add to the improvement or permanent value of property are allowable. Anything that adds value or extends life of equipment must be treated as capital expenditures

either direct or indirect

Costs incurred by a non-federal entity to recover improper payments are allowable as

Indirect costs

Costs incurred for common or joint objectives and, therefore, cannot be identified readily and specifically with a particular sponsored project, an instructional activity or any other institutional activity.

200.473 Transportation Costs

Costs incurred for freight, express, postage, and other transportation services related to goods purchased in the process or delivered are allowable.. Items must be readily identifiable with items involved.

Cost Accounting Standards (CAS) 502 : Consistency in Allocating Costs Incurred for the Same Purpose

Costs incurred for the same purpose, in like circumstances, must be treated consistently as direct or indirect costs.

200.458 Pre-award costs

Costs incurred prior to the effective date of the award are allowable so long as necessary for performance of SOW. Need written approval of sponsor.

200.468 Specialized service facilities

Costs of services provided by highly complex or specialized facilities

Facilities and Administrative (F&A) Costs

Costs that are incurred for common or joint objectives and, therefore, cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity. They are synonymous with Indirect Costs.

Direct costs

Costs that can be identified specifically with a particular sponsored project, an instructional activity or any other institutional activity or that can be directly assigned to such activities relatively easily with a high degree of accuracy.

Direct Costs

Costs that can be specifically identified with a particular project or activity.

Biosafety Level 2 (BSL-2)

Covers agents associated with human diseases that pose a moderate health hazard. Must wear appropriate personal protective equipment, procedures that can cause infection from splashes must take place within a biosafety cabinet, an autoclave must be available, lab must have self-closing, lockable doors, biohazard signs.

Animal Welfare Act

Covers all warm blooded animals used for, or is intended for use for research, teaching, testing, experimentation, or exhibition purposes, or as a pet.

Material transfer agreement (MTA)

Covers the transfer of incoming and outgoing research materials with industry or academic colleagues outside of the home institution. Usually specifies that there is no warranty.

Laboratory Animal Welfare Act (7 USC Chapter 54) (1966; updated 1970 to include all animals not just cats and dogs) - also called Animal Welfare Act

Created to: (1) to insure that animals intended for use in research facilities or for exhibition purposes or for use as pets are provided humane care and treatment;(2) to assure the humane treatment of animals during transportation in commerce; and (3) to protect the owners of animals from the theft of their animals by preventing the sale or use of animals which have been stolen; Regulates "the transportation, purchase, sale, housing, care, handling, and treatment of animals by carriers or by persons or organizations engaged in using them for research or experimental purposes or for exhibition purposes or holding them for sale as pets or for any such purpose or use." USDA-APHIS implements regs.

NSF -COMPETES Act

Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science.

Who owns inventions?

Creator/Inventor owns unless the existing agreement says otherwise Work for hire agreement Intellectual Property Acknowledgement

Violation of False Claims Act

Criminal penalty -- jail

OFAC Country Sanctions

Cuba (new license exception -- support for the Cuban people) (SCP) Democratic Republic of the Congo Iran Iraq North Korea Sudan Syria Former Liberian Regime of Charles Taylor For complete list go to: http://www.treasury.gov/resource-center/sanctions/programs/pages/programs.aspx

DCAA

Defense Contract Audit Agency - operates under the authority, direction and control of the Under Secretary of Defense Comptroller

HHS appeals under Departmental Appeals Board (DAB)

DAB provides impartial, independent review of disputed decisions from HHS DAB includes the Board itself (appellate div. supports), Admin. Law judges (CRD supports), Medicare appeals council (Medicare div. supports); Board members are "career civil servants appointed by the Secretary"; Board provides outside (additional) review of final HHS decisions such as: "Determinations in discretionary, project grant programs, including disallowances, terminations and denials of refunding, cost allocation plan disapprovals, and rate determinations; and" "Determinations in mandatory grant programs, including disallowances of state claims under titles I, IV-A (Temporary Assistance for Needy Families), IV-D (Child Support Enforcement), IV-E (Foster Care and Adoption Assistance), X, XIV, XVI, XIX (Medicaid), and XXI (State Children's Health Insurance Program) of the Social Security Act."; Provides appellate review of ALJ

What are the DFARs?

DFARS is an agency supplement of the FAR, Federal Acquisition Regulations. DFARS is used by the Department of Defense.

Air Force Office of Scientific Research

DOD - chemistry and life sciences, aerospace and material sciences, physical and electronics, math and space sciences

STTR Contributing Agencies

DOD, Department of Energy, Health and Human Servies, NASA, NSF. Contribute 3% of budget because their annual R&D budgets exceed 1 billion.

Def. and Characteristics of Cooperative Agreement

Def: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement (i.e. the sponsor's scientific or program staff will guide, coordinate or participate in the project activities). Characteristics: - Used when a grant is determined inappropriate. - Substantial Government involvement is anticipated. - Government receives paid-up license and march-in rights to IP. - There is no fee or profit. - Cost share may be encouraged or required. - DoD Grant and Agreement Regulations (DoDGARS) apply. - Not subject to the FAR.

Def. and Characteristics of Contract

Def: A mutually binding legal relationship obligating the seller to furnish the supplies or services and the buyer to pay for them. (FAR 2.101) Characteristics: - Primary purpose is the delivery of goods and services for the benefit of the Government. - Not an assistance award. - Paid with federal appropriated funds. - Subject to the Federal Acquisition Regulation.

Def. and Characteristics of Grant

Def: Financial assistance mechanism providing money, property or both, to an eligible entity to carry out an approved project or activity; no substantial sponsor programmatic involvement; recipient conducts the work independently and reports the results to the sponsor. Characteristics: - The objective is to advance science for the benefit of the public; Primarily for basic and applied research. - Publication is encouraged. - More flexible, less restrictive and easier to administer than procurement contracts. - usually, there is no a fee or profit. - DoD Grant and Agreement Regulations (DoDGARS) apply. - Not subject to the terms of a procurement contract (not subject to the FAR). - Must provide Government with , at a minimum, a paid-up, royalty-free license to any IP created under the grant. - Government reserves "march in" rights to patents.

DARPA

Defense Advanced Research Projects Agency

What is the DCAA and what does it do?

Defense Contract Audit Agency - performs all contract audits for the Department of Defense. Previously, the various branches of military service were responsible for their own contract audits. It also occasionally performs audits on request of other agencies, through its cognizant authority. It does not have true audit independence (see 2015 NEON whistleblower case with J. Kirk McGill).

DFARS

Defense Federal Acquisition Regulation Supplement (DFARS). The DFARS provides DoD implementation and supplementation of the Federal Acquisition Regulation (FAR). The DFARS contains requirements of law, DoD-wide policies, delegations of FAR authorities, deviations from FAR requirements, and policies/procedures that have a significant effect on the public. Relevant procedures, guidance, and information that do not meet the criteria for inclusion in the DFARS are issued in the DFARS companion resource, PGI. Unclassified, non-confidential memoranda, guidance, and other DPAP procurement-related policy documents can be found in the appropriate PGI subpart.

Audit finding

Deficiencies which the auditor is required by 200.516 audit findings paragraph (a) to report in the schedule of findings and questionable cost

Modified Total Direct Costs (MTDC)

Defined in 2 CFR 200. Used by universities that are required to complete the long form F&A rate proposal due to research volume.

§200.56

Definition

"The exclusive legal right, given to an originator or an assignee to print, publish, perform, film, or record literary, artistic, or musical material, and to authorize others to do the same."

Definition of "Copyright"

"A work or invention that is the result of creativity, such as a manuscript or a design, to which one has rights and for which one may apply for a patent, copyright, trademark, etc."

Definition of "Intellectual Property"

"A government authority or license conferring a right or title for a set period, especially the sole right to exclude others from making, using, or selling an invention. Any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof."

Definition of "Patent"

"A symbol, word, or words legally registered or established by use as representing a company or product."

Definition of "Trademark."

''Basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons."

Definition of fundamental research from NSDD-189

SBIR Participating agencies

Department of Agriculture Department of Commerce (NIST & NOAA) Department of Defense Department of Education Department of Energy Health and Human Services Department of Homeland Security Department of Transportation Environmental Protection Agency NASA National Science Foundation

What agency is responsible for enforcing ITAR (International Traffic in Arms Regulations)?

Department of State --Directorate of Defense Trade Controls (DDTC) (Mnemonic: ITAR = InTernational AffaiRs)

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): DEPENDENT CARE FOR CONFERENCES

Dependent care for personnel traveling to conferences can be direct charged to a grant if the grantee institution has that policy.

Indirect Rate Calculation

Depreciation & Interest, Operations & Maintenance, Library, Administration DIVIDED BY Sponsored agreements, Cost sharing or matching

What is Depreciation? What methodology does Uniform Guidance say should be used in calculating depreciation?

Depreciation is an allocation method used to allocate the cost of a fixed asset over the period of its useful life. Uniform Guidance refers to GAAP (Generally Accepted Accounting Principles) in calculating depreciation.

Program Announcement/Funding Opportunity Announcements

Describes existence of a research opportunity. Contains policy manuals and application guidelines as well as reporting requirements. It may describe new or expanded interest in a particular extramural program or be a reminder of a continuing interest in an extramural program.

Equipment records must include:

Description of the property, Serial number or other identification number, Source of funding for the property (including the FAIN), Who holds title, , Acquisition date, Cost of the property, Percentage of Federal participation in the project costs for the Federal award under which the property was acquired, Location, use and condition of the property, Any ultimate disposition data including the date of disposal and sale price of the property.

Federal Audit Clearinghouse

Designated by OMB as the repository of record where non-Fed entities are required to transmit the reporting packages required by Subpart F - Audit Requirements

DS-2

Disclosure Statement (DS-2) Requires Institutes of Higher Education (IHE) that receive aggregate Federal awards totaling $50M or more to disclose their cost accounting practices.

DS-2

Disclosure Statement (DS-2) Requires universities to confirm their compliance with standards and complete a formal disclosure statement if the university receives more than $25 million in federal funding. Report on file @ DHHS.

A PI discloses to her university research administrator an invention created under a federal grant. How long does the university have to disclose the invention to the federal government? How long does the university have to file a patent?

Disclosure: 60 days/2 months; patent filing: 1 year.

Types of federal assistance - discretionary spending

Discretionary spending requires an annual appropriation bill, which is a piece of legislation. Discretionary spending is typically set by the House and Senate Appropriations Committees and their various subcommittees. Since the spending is typically for a fixed period (usually a year), it is said to be under the discretion of the Congress. Some appropriations last for more than one year (see Appropriation bill for details). In particular, multi-year appropriations are often used for housing programs and military procurement programs. Funding for science research and development is mainly funded through discretionary funding through agencies such as the National Institutes of Health, Department of Energy Office of Science, National Aeronautics and Space Administration, and National Science Foundation. Slightly more than half of federal research and development funds go to the Department of Defense and thus overlaps with military spending. Discretionary grants permit the agency to exercise judgment in selecting recipients through a competitive grant process.

Name 5 federal agencies that participate in the STTR program

DoD DoE DHHS NASA NSF

Central service cost allocation plan

Documentation identifying, accumulating, and allocating or developing billing rates based on allowable costs of services provided by a state, local govt, or Indian tribe on a centralized basis to its departments and agencies.

False Claims Act 31 USC 3729

Does not require proof of a specific intent to defraud the US GOVERNMENT. Imposes liability on persons and companies (federal contractors) who defraud governmental programs. Federal government primary tool in combating fraud against government. AKA the Lincoln Law Liability for up to 3x the amount falsely claimed, plus any civil or criminal penalties ($5,500 - $11,000 for each fraudulent claim) Other possible consequences include disqualification from future federal/state government contracts. Includes a qui tam provision that allows people who are not affiliated with the government, called realtors under the law, to file actions on behalf of the government -- WHISTLE BLOWING Healthcare providers can be prosecuted for conduct that leads to the submission of fraudulent claims to the government, such as: Knowingly making false statements Falsifying records Double billing for items or services Submitting bills for services never performed Submitting bills got items never furnished Otherwise causing a false claim to be submitted Referral from a governmental audit or review Inaccurate effort reporting Abusive cost transfers Not meeting effort commitments Direct charging of overhead costs Graduate student compensation/increasing salary in response to an award Service center billing Financial status reports (now known as final financial reports)

False Claims Act 31 USC 3729 1863

Does not require proof of a specific intent to defraud the US GOVERNMENT. Imposes liability on persons and companies (federal contractors) who defraud governmental programs. Federal government primary tool in combating fraud against government. AKA the Lincoln Law Liability for up to 3x the amount falsely claimed, plus any civil or criminal penalties ($5,500 - $11,000 for each fraudulent claim) Other possible consequences include disqualification from future federal/state government contracts. Includes a qui tam provision that allows people who are not affiliated with the government, called realtors under the law, to file actions on behalf of the government -- WHISTLE BLOWING Healthcare providers can be prosecuted for conduct that leads to the submission of fraudulent claims to the government, such as: Knowingly making false statements Falsifying records Double billing for items or services Submitting bills for services never performed Submitting bills got items never furnished Otherwise causing a false claim to be submitted Referral from a governmental audit or review Inaccurate effort reporting Abusive cost transfers Not meeting effort commitments Direct charging of overhead costs Graduate student compensation/increasing salary in response to an award Service center billing Financial status reports (now known as final financial reports)

Simplified Acquisition Threshold

Dollar amount below which a non-Fed entity may purchase property or services using small purchase methods. Threshold set by Federal Acquisition Regulations (FAR) 48 CFR Subpart 2.1. Threshold currently set at $250,000

Cost Sharing - matching

Dollars invested

NIH Peer review info

Dual peer review system for the National Institutes of Health is mandated by statute in accordance with section 492 of the Public Health Service Act and federal regulations governing "Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects" (42 CFR Part 52h). 1st review by Scientific Review Group (SRG), a committee of scientists who have expertise in relevant scientific disciplines and current research areas, and who make recommendations concerning the scientific and technical merit of the applications 2nd review by IC Councils, composed of both scientific and lay members chosen for their expertise, interest, or activity in matters related to health and disease. The official outcome of review is in summary statement

Dual-Use items

Dual-use as defined in the EAR (2016) means "items that have both commercial and military or proliferation applications." While this term is used informally to describe items that are subject to the EAR, purely commercial items are also subject to the EAR (see 15 CFR 734.2-5). Subject to the EAR is a term used in the EAR to describe those items and activities over which BIS exercises regulatory jurisdiction under the EAR. Examples of dual-use items include satellites, gas turbine engines, and drones (unmanned aerial vehicles [UAVs]).

FAR 52.222-54 Employment Eligibility Verification (E-verify) (2009)

E-verify required for federal contracts with this FAR clause; must be flown down to subs; for contracts over 120k and over SAT (100k); for IHEs (and state gov) only those working on contract are required to e-verify; For each employee assigned to the contract, the Contractor shall initiate verification within 90 calendar days after date of contract award or within 30 days after assignment to the contract, whichever date is later (but see paragraph (b)(4) of this section).

What agency is responsible for EAR?

EAR = Department of Commerce BIS. (MNEMONIC: Ear of Corn)

Bureau of Industry and Security (BIS)

EAR is contained in what Commerce Department area?

EAR99

EAR99 is a classification for an item. It indicates that a particular item is subject to the Export Administration Regulations (EAR), but not specifically described by an Export Control Classification Number (ECCN) on the Commerce Control List (CCL).

Mission of USDE

ED's mission is to promote student achievement and preparation for global competitiveness by fostering educational excellence and ensuring equal access. Congress established the U.S. Department of Education (ED) on May 4, 1980, in the Department of Education Organization Act (Public Law 96-88 of October 1979); manages student aide through FASFA such as Pell grants, direct loans, perkins loans, fulbrights, etc.

What are earmarks?

Earmarks circumvent Executive Branch merit-based or competitive allocation processes, and name a specific location or recipient.

CFR Title 34

Education

EDGAR

Education Department General Administrative Regulations

DS-2 filing

Educational institutions that receive aggregate sponsored agreements of $25M+ must submit to cognizant agency

Anti-kickback Statute Copeland Anti-Kickback Act Law 73-324, 48 stat. 948, 18 USC 874

Effective June 13, 1934 What's prohibited? Offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate federal health care program business Applies to: All federal health care programs; any items or services Penalties: Criminal: up to $25k per violation/5 years in prison Civil/administrative: false claims act liability Monetary penalties (potentially $50k per violation) Program exclusion Civil assessment up to 3x kickback amount Prohibits federal contractors or subcontractors engaged in building construction or repair from inducing an employee to give up any part of the compensation to which he or she is entitled under his or her employment contract. Requires contractors and subcontractors to submit weekly statements of compliance.

Cost Principles

Effort Reporting is required by:

OSHA for chemical safety

Employers are required to identify and evaluate the respiratory hazard(s) in their workplaces. Various types of Occupational Exposure Limits (OELs) have been established by a number of organizations, and are listed on many of OSHA's Safety and Health webpages on chemical hazards and toxic substances. OSHA sets enforceable permissible exposure limits (PELs) to protect workers against the health effects of exposure to hazardous substances, including limits on the airborne concentrations of hazardous chemicals in the air. NIOSH RELs are Federal agency recommendations established according to the legislative mandate for NIOSH to recommend standards to OSHA. RELs are recommended exposure limits for hazardous substances in the workplace to protect worker health. NIOSH evaluates all available medical, biological, engineering, chemical, and trade information relevant to the hazard. NIOSH transmits its recommendations to OSHA for use in developing legally enforceable standards.

Shelby Amendment 1999 Public Law 105-277

Ensures that all data produced under an award will be made available to the public through the procedures established under the Freedom of Information Act. NIH public access policy.

Unallowable Costs

Entertainment, travel on Non-US carriers, memberships or subscriptions, costs to write proposals, alcohol.

safety plan and lab compliance program, emergency response plan, security risk assessment, record management system, theft/loss/release notification procedure

Entities using select agents must develop these five things:

A2: Definition

Equipment Prior approval Program income

Special Purpose Equipment

Equipment used only for research, medical, sci., or other technical activities. Examples: microscopes, x-rays, machines, surgical instruments, and etc.

Capital Assets

Equipment, buildings and land

C31: insurance coverage

Equivalent insurance coverage for real property and equipment acquired with federal funds as provided to property owned by recipient

Material Safety Data Sheet (MSDS)

Essential to a Chemical Hygiene Plan

Subpart A: general A1: Purpose

Establish uniform administrative requirements for federal grants and cooperative agreements awarded to institutions of higher education, hospitals, other nonprofits Sets forth standards for obtaining consistency and uniformity among federal agencies Establishes MINIMUM standards for institutional systems

42 CFR Part 50, Subpart A

Established Office of Scientific Integrity (OSI) Research misconduct

Predetermined Indirect Cost Rate

Established for a specific period of time with no adjustments and no carry-forward provision. Used when financial data demonstrate a reasonable assurance that a reimbursement rate is likely to remain stable.

Public Health Service Act Section 493

Established the Office of Research Integrity (ORI) Research misconduct

Public Health Service Act Section 493 Title 42 USC chapter 6a 1944

Established the Office of Research Integrity (ORI) Research misconduct

Office of Laboratory Animal Welfare (OLAW)

Established to administer the PHS Policy Prior to accepting any PHS awarded funds the institution must have an Animal Welfare Assurance on file with OLAW: 1. Comply with PHS Policy, the Guide, and the Animal Welfare Act 2. Describe the animal program 3. Appoint an institutional official

"Privacy Rule"

Establishes conditions for use and disclosure of individually identifiable health information.

Cost contract

Establishes estimates of the costs for performance, with no added fee, and a ceiling that the contractor may not exceed without contracting officer's approval. Used when uncertainties in performance preclude accurately estimating future costs for successful performance Standard of performance: contractor's best efforts -- government bears the risks Cost principles apply (reasonable, allowable, allocable) Exceeding the cost ceiling is at the contractors own risk

A-21

Establishes principles for determining costs applicable to federal grants,contracts, and other sponsored agreements with educational institutions Defines often used terms Defines methods of F&A cost calculations Defines allowable and Unallowable costs (section j) Includes cost accounting standards Examples of major project for clerical/administrative salary charging

Administrative Procedures Act (APA) 5 USC 551-559

Establishes procedures for program management

For all federal awards covered by 2 CFR 230 (OMB Circular A-122) 72

Establishes the F&A cost rates for a subcontract at the subcontractor's normal rate.

Cost Clause - FAR 52.215-2: Audit & Records-Negotiation

Establishes the Government's rights to access and audit a Contractor's records - Per the prescription at 15.209(b)(3), request Alt II which implements OMB Uniform Guidance and provides for audit of OMB Uniform Guidance Cost Principles (allowable, allocable, reasonable).

Cost Clause - FAR 52.216-7: Allowable Cost & Payment

Establishes which cost principles apply to the Contractor - Default clause applies commercial cost principles of FAR Part 31.2 to the contract - Per the prescription at 16.307, request the substitution of the university cost principles of FAR Part 31.3, Contracts with Educational Institutions (OMB UG)

Provisional Indirect Rate

Estimated Indirect Cost rate used until actual rate is determined. Often sought by new institutions or institutions with no prior federal grants or contracts.

HIPAA non covered entities

Examples of organizations that do not have to follow the Privacy and Security Rules include: Life insurers Employers Workers compensation carriers Most schools and school districts Many state agencies like child protective service agencies Most law enforcement agencies Many municipal offices

200.440

Exchange rates - allowable subject to availability of funding

Fundamental Research exemption

Excludes from Export Control Laws most basic research at a research university•EAR definition: (Part 734.8) •"basic and applied research in science and engineering, where the resulting information is ordinarily published and shared broadly within the scientific community. Such research can be distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary reasons or specific national security reasons" •ITAR definition: (Part 120.11) •Fundamental research in science and engineering performed at an accredited institution of higher learning in the US

An investigator is using deidentified data that has been previously published. What kind of IRB review does she need for her research?

Exempt.

IRB Expedited Review info

Expedited review is when IRB chairperson (or designee) reviews IRB outside of regular review/ meeting; not appropriate on continuing review if original review was with full IRB; All regular IRB review criteria apply, including informed consent; Certain procedure categories are eligible for expedited review if involves minimal risk

Facilities and administrative (F&A) costs

Expenditures colleges and universities incur in support of major functions: organized research, instruction, other sponsored activities, and other institutional activities.

Capital Expenditures

Expenditures to acquire capital assets or expenditures to make additions, improvements, mods, replacements, reinstallations, etc. to materially increase their value or useful life

capital expenditures

Expenditures to acquire capital assist or expenditures to make additions, improvements, modifications, or alterations to capital asses that materially increase their value of use life

Phase 2 Trial

Experimental drug/treatment is administered to 100-300 people w/disease for effectiveness and further safety evaluation.

In F&A, what is the 'F' and what is the 'A?' List three examples of F&A costs.

F = facilities. A = administrative. Three costs that should be recovered through F&A: Campus library, accounting staff, campus-wide Internet service.

UG Subpart E F&A statement

F&A costs are incurred for common or joint objectives and therefore not identified readily and specifically with a particular sponsored project.

2 CFR 200 Appendix III

F&A identification and assignment for higher education

F&A rates (general about negotiation, includes info on NIH negotiation)

F&A rates are negotiated by DCA, DFAS in the Office of Acquisition Management and Policy, NIH (responsible for negotiating F&A cost rates for for-profit entities receiving awards from HHS), or other agency with cognizance for F&A/indirect cost rate (and other special rate) negotiation

A Federal Request for Proposal (RFP) would include reference to...

FAR

48 CFR part 31

FAR - Contract Cost Principles and Procedures

Who are the principal customers for the products and services procured under the Federal Acquisition System?

FAR 1.102-2 provides that the principal customers are "the users and line managers acting on behalf of the American tax payer."

What three government officials are personally responsible for compliance with the FAR?

FAR 1.202 provides that "Agency compliance with the FAR is the responsibility of the Secretary of Defense (for the military departments and defense agencies), the Administrator of General Services (for civilian agencies other than NASA), and the Administrator of NASA (for NASA activities).

When an acquisition is above the SAT, what part of FAR governs the applicable regulations?

FAR Part 52.

Name the 3 types of research misconduct.

Fabrication, Falsification, Plagiarism.

FFP

Fabrication, Falsification, and Plagiarism

Depreciation on buildings, equipment and capitol improvement, interest on debt associated with certain buildings, operations and maintenance expenses

Facilities costs are defined as

Justice - (HSR definition)

Fair and equitable selection and treatment of subjects.

True or False? A contracting officer may unilaterally incorporate a new or modified FAR clause into an awarded contract without consideration?

False. FAR 1.108(d)(3) provides that "Contracting officers may, at their discretion, include the changes in any existing contract with appropriate consideration."

True or false: Patent applications protect a patent in perpetuity.

False. Patents provide protection for a set period of time.

True or False: all federal procurements, including competitive bids, are subject to the Truth and Negotiations Act (TINA)

False: TINA applies to sole source providers; does not apply where the contract is obtained through a competitive open bid.

True or false: Uniform Guidance requirements are statutory law.

False: Uniform Guidance contains rules, and is administered by the OMB, an executive branch agency. Congress creates statutory laws (which are signed into being by the president).

True or false: copyrights are relatively expensive and time-consuming to file.

False: copyrights are simple to file, and only cost a nominal fee.

True or False: for purchases over $150,000, the institution does not need to used a sealed bid or competitive bid procedure.

False: for purchases over $150,000, the institution must use methods that ensure fair and quality vendor selection, including the sealed bid or competitive bid procedures.

Cognizant agency for audit

Federal agency responsible auditing. May not be the same agency for indirect costs

Cognizant agency for indirect costs

Federal agency responsible for reviewing, negotiating, and approving costs allocation plans or indirect cost proposals.

Pass thru entity required info in subaward (UG is same as A-133 info)

Federal award identification, e.g., DUNS #; FAIN #; F&A rate for the Federal Award, including if the de minimus rate is charged per 200.414; Requirements imposed by the pass-through entity; Requirement to provide access to records for audit; info on FCOI policy, reporting requirements;

a 10% de minimis rate

Federal award recipient who has never received a federally negotiated indirect cost rate may elect to use:

B14: Special award conditions

Federal awarding agencies may impose additional requirements if applicant or recipient History of poor performance Not financially stable Management system that does not meet standards prescribed in this circular Non conformance to terms and conditions of a previous award Not otherwise responsible

C36: Intangible property

Federal awarding agency reserves a royalty free, non exclusive and irrevocable right to reproduce, publish, or otherwise use the work for federal purposes Incorporates 37 CFR 401 (Bayh-Dole act)

What is FEDBIZOPPs?

Federal business opportunities for contractors are listed at FedBizOpps: Federal Business Opportunities. Federal agencies are required to use this site to communicate available procurement opportunities and their vendor requirements to the public and interested potential vendors for all contracts valued over $25,000.

lobbying disclosure act of 1995 (FAR 52.230-11)

Federal funds cannot be used to influence a member of congress on awarded contract; Use OMB Standard Form LLL, Disclosure of Lobbying Activities if need to disclose any lobbying (with non-federal funds as well) on behalf of contract.

What does the Stevens Amendment require from federal grant recipients?

Federal grant recipients must acknowledge federal funding when issuing statements, press releases, requests for proposals, bid solicitations and other documents - clearly state total cost of the program and the $ amount of federal funds

Animal Welfare Act

Federal law overseen by the US Dept. Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) [excluding birds, rats, and mice bred for research]

Fair Labor Standards Act (FLSA)

Federal law that establishes a minimum wage and requirements for overtime pay and child labor. Protects time.

Family Education Rights and Privacy Act (FERPA)

Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education. FERPA gives parents certain rights with respect to their children's education records. These rights transfer to the student when he or she reaches the age of 18 or attends a school beyond the high school level. Students to whom the rights have transferred are "eligible students."

Export Controls

Federal laws that prohibit the unlicensed export of information, technology or commodities and their corresponding regulations, which direct how information and technology are transferred.

Land-Grant College Act of 1862 - known as Morrill Act

Federal legislation from Rep. Justin Smith Morrill of Vermont; allowed states to sell federal land, invest proceeds, and use income to support colleges whose mission will be "to reach agriculture and the mechanic arts [engineering]...in order to promote the liberal and practical education of the industrial classes in all the pursuits and professions of life."; Focused on agriculture / considered blue collar colleges, leads to research projects that are agriculture based and work closely with industry

Health Research Extension Act of 1985

Federal legislation that established guidelines for the proper care of animals used in biomedical and behavioral research in HHS funded research (Public Law 99-158 1985). Defines establishment of IACUC.

Fly America Act

Federal travelers are required by 49 U.S.C. 40118, commonly referred to as the "Fly America Act," to use United States air carrier service for all air travel and cargo transportation services funded by the United States Government.

Fly America Act (FAR Section 47)

Federal travelers are required to use U.S. air carrier service for all air travel and cargo transportation services funded by the U.S. government. One exception to this requirement is transportation provided under a bilateral or multilateral air transport agreement, to which the U.S. government and the government of a foreign country are parties, and which the Department of Transportation has determined meets the requirements of the Fly America Act. The U.S. government has entered into several air transport agreements that allow federal funded transportation services for travel and cargo movements to use foreign air carriers under certain circumstances. There are currently four bilateral/multilateral "Open Skies Agreements" (U.S. Government Procured Transportation) in effect: U.S. Government and the European Union (EU) effective April 30, 2007 U.S. - EU Amendment effective June 24, 2010 U.S. - EU Amendment effective June 21, 2011 U.S. - Australia Open Skies Agreement [PDF - 4.27 MB] effective October 1, 2008 U.S. - Switzerland Transport Agreement [PDF - 3.55 MB] effective October 1, 2008 U. S. and Japan effective October 1, 2011

Types of Sponsors

Federal, State/Local, Private Foundations, Professional Associations, Commercial, International

Cost Accounting Standards - CAS

Federally mandated accounting standards intended to ensure uniformity in budgeting and spending funds. 48 CFR 9905

C33: federally owned and exempt property

Federally owned property Title remains vested in the federal government Submit annual inventory listing Final report for further federal agency utilization Exempt property When statutory authority exists, awarding agency has option to vest title to property acquired in the recipient without further obligation

Cost plus incentive fee contract

Final contract price will include a fee that is determined by a formula applied to the allowable costs in relation to the target costs, efficient performance will lead to a higher fee (incentive)

Phase 3 Trial

Final phase prior to market approval. Experimental drug/treatment is administered to a large number of people to confirm effectiveness, safety, monitor side effects, compare standard treatments.

Subpart C: Post-award requirements

Financial and program management

Common federal reporting requirements (name 4 reports)

Financial reports; progress reports; invention reports; equipment/property reports.

Grants.gov

Find and submit applications for over 900 grant programs offered by 26 Federal Agencies. Can search across agencies. Managed by Health and Human Services under OMB. Made possible by the Federal Assistance Improvement Act of 1999 (PL 106-107)

Types of Fixed Price Contracts

Firm fixed price Fixed price contract with economic price adjustment Fixed price incentive contract Fixed price incentive contract with prospective price redetermination Fixed ceiling price contract with retroactive price determination Firm fixed price, level of effort term contract

Each CFDA number has 5 digits. What do the first 2 digits signify? What do the last 3 digits signify?

First 2 digits represent federal agency, second 3 digits represent the program

FAR Types of Contracts

Fixed Price Cost Reimbursement Definite Quantity Infinite delivery Time and Materials Labor hours Letter contracts Basic Ordering Agreements (Part 16 of the FAR)

200.201 Use of grant agmts, cooperative agmts, and contracts - When you cannot use fixed price?

Fixed amount award cannot be used in programs which require mandatory cost sharing or match.

Fixed price contract with prospective price redetermination

Fixed price for initial work and opportunity to review pricing at stated times during future performance and adjust pricing

Copyright - work for hire info

For "works for hire," the duration of copyright is 95 years from publication, or 120 years from creation, whichever is shorter. "Work for Hire" - Work for Hire does not automatically vest with the author. Work for Hire applies when: the work is created by an employee within the scope of their job description; work that is specifically ordered or commissioned for use. Both parties must agree in writing before something should be considered "Work for Hire."

FAR Citation: 48 CFR (chapter) (part)

For each federal agency supplement, the parts represent the same subject matter as the part in the basic FAR Basic FAR 45 Property Management DFAR 245 Basic FAR 49 Termination DFAR 249 Basic FAR 52 Contract Clauses DFAR 252 (Omitting Chapter 1 for Basic FAR; adding chapter 2 for DOD FAR)

202.202 Info to submit to GSA

For each program, Fed agency must submit the following info to the GSA - Program description, purpose, goals - Id of whether program makes award on discretionary basis or formula grant - Projected total amount of funds available for programs - Anticipated source of available funds - General eligibility requirements - Applicability of single audit requirements

Program Fraud Civil Remedies Act 3 USC 3801-3812, 10 CFR Part 13

For smaller claims, like a mini false claims act Civil penalties of not more than $7,000 for each false claim or statement Civil penalties of up to 2x the amount of any payments made by the agency

Clinical Trial Agreement

For testing human (or sometimes animal) subjects; for investigating new drugs, devices, diagnostics, or treatments; includes clauses on confidentiality, indemnification, ownership of study data, intellectual property, and publications with respect to multi-center trials. Payment is usually made on a per-subject basis.

C52: financial reporting

Forms approved by OMB for obtaining financial information from recipients SF-269 and SF-272, which were replaced by the SF-425

Cost Accounting Standards

Four basic requirements 1. CAS 501 Consistency in Estimating, Accumulating, and Reporting Costs 2. CAS 502 Consistency in Allocating Costs Incurred for the Same Purpose 3. CAS 505 Accounting for Unallowable Costs 4. CAS 506 Accounting Period DS-2 sent annually to cognizant agency for F&A Rate negotiations

Contract Termination

Fourteen different termination clauses in FAR beginning with 52.249-1. 52.249-5 Termination for Convenience of the Government is the most appropriate for contracts with nonprofit, educational institutions. Rights belong to the government only Subcontracting institution may request this be inserted in the prime contract when the prime recipient is not a nonprofit or educational institution

Federal Freedom of Information Act 1967 PL 89-487

Full or partial disclosure of previously unreleased information and documents controlled by US Government (exemptions for national security, trade secrets, invasion of personal privacy,etc..) Government transparency What will be released Application after awarded Progress reports Expenditure reports What will not be released Applications that are pending or not awarded Proprietary information Salaries of named personnel

Federal Freedom of Information Act 1967

Full or partial disclosure of previously unreleased information and documents controlled by US Government (exemptions for national security, trade secrets, invasion of personal privacy,etc..) Government transparency What will be released Application after awarding Progress reports Expenditure reports What will not be released Applications that are pending or not awarded Proprietary information Salaries of named personnel

2 CFR 200 Appendix I

Full text of the Funding Opportunity Notice

FedConnect.net

Gateway to Government Opportunities, Acquisition and Grants Portal. Mainly used for contracts. Used in conjunction with FedBizOpps.gov.

Uniform Guidance Subpart B

General Provisions

Default and convenience are two critical termination clauses of the

General Provisions of a federal contract.

2 CFR 200 - Subpart B

General Provisions. Section 200.1xx.

200.210 Info contained in a Fed award

General award info, general terms and conditions. If non-fed entity requests copy of award, must be provided.

GAGAS

Generally Accepted Government Auditing Standards

200.461 Publication and printing costs

Generally allowable if can be allocated to a specific fed award

Rebudgeting b/w F&A and DC (NIH specific)

Generally, recipients may rebudget between direct and F&A costs (in either direction) without NIH prior approval, provided there is no change in the scope of the approved project. F&A cost reimbursement on grants formerly subject to OMB Circular A-21 (IHEs) is based on the rates used in the award, which are not subject to adjustment in reimbursement except for the establishment of permanent rates when a provisional rate was used for funding. Therefore, per 45 CFR 75 Appendix III C.7., recipients formerly subject to OMB Circular A-21 (IHEs) may not rebudget from direct costs to accommodate a rate increase if the F&A costs provided for a period were based on negotiated (final, fixed or predetermined) rates rather than provisional rates (defined as not "negotiated" for the application of the OMB Circular A-21 requirement).

Property Clause - FAR 52.245-1: Government Property

Gives the Contractor: - Title to property and tangible assets purchased with federal funds - When acquired property is less than $5,000 - And Government Contracting Officer has approved the purchase - Requires property to be labeled, tracked and reported (DD 1662) - Reports must be submitted annually and are required for close-out

Reasonable

Goods or services acquired or applied in an amount that must be able to withstand scrutiny

Termination for Deafult

Government may terminate all of part of a contract for anything that was done that was not in the interest of the government, including: Attempted fraud Failure to meet the quality requirements Failure to deliver the supplies or perform services within the time specified in the contract Failure to make progress and that failure endangers performance of the contract Failure to provide any provisions of the contract

- Semi-annual review of programs - Semi-annual review of facilities - Review of each protocol for approval (approved protocols must be resubmitted for review every 3 years) - Suspend animal activities if there is a violation of policies

IACUC major responsibilities

Bayh-Dole Act (Patent and Trademark Law Amendment act; 37 CFR 401)

Government patent policy act of 1980 Intellectual property arising from federal government funded research. Ownership of inventions. Permits university, small business, or nonprofit institution to pursue ownership of an invention in preference to the government. Retain title as primary awardee to any IP developed by subawardee on a federally sponsored project. Applies to grants, cooperative agreements, and contracts. Requires written agreements with PIs, students and staff Requires disclosure of new inventions to funding agency within 60 days Requires decision about whether or not to retain title to invention within two years--if retain title, requires patent filing within one year Requires granting of a royalty free non exclusive license to the government

Bayh-Dole Act (Patent and Trademark Law Amendment act; 37 CFR 401) PL 95-517

Government patent policy act of 1980 Intellectual property arising from federal government funded research. Ownership of inventions. Permits university, small business, or nonprofit institution to pursue ownership of an invention in preference to the government. Retain title as primary awardee to any IP developed by subawardee on a federally sponsored project. Applies to grants, cooperative agreements, and contracts. Requires written agreements with PIs, students and staff Requires disclosure of new inventions to funding agency within 60 days Requires decision about whether or not to retain title to invention within two years--if retain title, requires patent filing within one year Requires granting of a royalty free non exclusive license to the government

Uniform Guidance §200.315 (b)

Government retains right to obtain, reproduce, publish, or use data

CFR Title 2

Grants & Agreements

Assistance Awards are

Grants and Cooperative Agreements

OMB 102

Grants and Cooperative Agreements with State and Local Government; replaced by UG

OMB Circular A-102

Grants and Cooperative Agreements with State and Local Governments

OMB Circular A-102

Grants and cooperative agreements with state and local governments

Electronic Research Administration Tools

Grants.gov NSF Fastlane Research.gov ERA Commons NIH Reporter FedConnect (vendors) IEdison (inventions) G-5 (department of education) USAspending.gov (FFATA) NSPIRES (NASA)

Program Income

Gross income earned by the non-fed entity that is directly generated by a supported activity or earned as a result of the Fed award during the period of performance

Cluster of programs

Grouping of closely related programs that share common compliance requirements. EX: research and development (R&D), student financial aid (SFA)

FAR at 48 CFR Parts 1-51

Guidelines for use of clause

FAR Part 1-51

Guidelines for use of clauses (Chapter 1)

Health Insurance Portability and Accountability Act

HIPAA 1996 Protected Health Information (PHI): information created/received by healthcare entity or that can be linked to a specific individual.

Health Insurance Portability and Accountability Act

HIPAA stands for

HIPAA covered entities

Health Plans, including health insurance companies, HMOs, company health plans, and certain government programs that pay for health care, such as Medicare and Medicaid. Most Health Care Providers Health Care Clearinghouses—entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa. Business associates of covered entities must follow parts of the HIPAA regulations - i.e. contractors, subcontractors, and other outside persons and companies that are not employees of a covered entity will need to have access to your health information when providing services to the covered entity.

12 appropriation bills

House and Senate Appropriation Committees is responsible for what during the Congressional Enactment Process?

Every 3 years

How often must Federalwide Assurance be renewed?

Every three years

How often must approved IACUC protocols be resubmitted for full review?

At least once every six months

How often must the Institutional Animal Care and Use Committee meet?

Divide award amount by 1 + F&A rate

How to calculate total direct costs

# of animals used and pain category, AWA deviations, Justification for category E pain protocols

IACUC annual reports should include

international traffic in arms regulations

ITAR Covers articles, services, and related technical data designated as defense articles and services contained in the USML - U.S. Munitions List

Public Domain/Fundamental Research ITAR:

ITAR definition: (Part 120.11)Public Domain: means information which is published and which is generally accessible or available to the public ...(8) through fundamental research in science and engineering at accredited institutions of higher learning in the U.S. where the resulting information is ordinarily published and shared broadly in the scientific community... The ITAR citation is 22 CFR § 120.11

Directorate of Defense Trade Controls (DDTC)

ITAR is contained in what State Department area?

Request for Application (RFA)

Identifies a more narrowly defined area for which one or more NIH institutes have set aside funds for awarding grants. Usually has a single receipt (received on or before) date specified in the RFA announcement. Usually reviewed by a Scientific Review Group convened by the issuing awarding component.

C61: termination

Identifies circumstances in which awards may be terminated in whole or in part

Office of Inspector General

Identifying, auditing, and investigating fraud waste abuse and mismanagement within the parent agency

Acquire IBC review and approval under NIH Guidelines

If an experiment is not exempt according to NIH Guidelines you must:

A-133 Program-specific audit election

If funds are expended under one Federal program (excluding R&D), the auditee may elect a program-specific audit. Can only have program specific audit for R&D if all awards were received from the same Federal agency, or special approval in advance.

On an SBIR project, what % of the project can be subcontracted to another organization: In Phase 1? In Phase 2?

In Phase 1, up to 33%; in Phase 2, up to 50%

Describe the federal budget process, starting in September of the year prior to the budget year.

In September, federal agencies submit their budget requests for the following FY to the OMB. The President with OMB formulates a proposed budget and submits it to Congress (usually in early February). Congress considers the budget and makes any revisions as they wish, and passes budget resolution setting the total budget amount for the year. Then the funding process moves to the appropriations committees in each chamber, who determine funding levels for individual federal agencies or groupings of agencies (subcommittees are convened for each of the 12 appropriations bills). The final version of both the House and Senate bills are reconciled between them, and the omnibus bill then go before the president for signature in September. The FY begins October 1.

Management Fees: What's their deal?

In accordance with the Uniform Guidance, profit is typically unallowable; however, the guidance does maintain flexibility for Federal awarding agencies to allow award recipients to earn profit when expressly authorized by the terms and conditions of the Federal award. Furthermore, in practice, Federal awarding agencies treat "management fees" earned under grants and cooperative agreements as profit. Typically, Federal awarding agencies permit management fees or profit in grants and cooperative agreements only in circumstances when the viability of the project may be at risk because therecipient organization has limited or no financial resources to cover certain ordinary and necessary business expenses that may not be reimbursable under the governing cost principles. For Small Business Innovative Research (SBIR) and (STTR) awards, management fees or profit are required in accordance with the Small Business Administration (SBA) policy directives. HOWEVER, historically, management fees have been used to create a slush fund on which to charge unallowable costs like luxury travel, alcohol, entertainment, etc. In response to the 2015 NEON scandal, a comptroller alert was issued to federal agencies urging greater oversight of management fees. See: https://cfo.gov/wp-content/uploads/2015/04/CONTROLLER-ALERT-Management-Fees-or-Profit-under-Federal-Assistance-Awards.pdf

Most Popular Types of Contracts

In educational institutions, fixed price or cost reimbursement are the best fit given the nature of the work and the organizational structure and culture

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): CONFERENCE COSTS

In order to be considered a conference, it must mean dissemination of info to an external audience --excludes meeting within the institution unless there are external participants.

Def. of Idemnification

In service level agreements (SLAs) and other legal contracts such as end-user license agreements (EULAs), indemnification is the part of an agreement that provides for one party to bear the monetary costs, either directly or by reimbursement, for losses incurred by a second party. To indemnify another party is to compensate that party for loss or damage that has already occurred, or to guarantee through a contractual agreement to repay another party for loss or damage that occurs in the future.

HIPAA - info on Protected Health Information (PHI)

Includes: Info health care providers put in your medical record; conversations about care or treatment with nurses and others; info in health insurer's computer system; billing information; Covered entities must: put in place safeguards to PHI and ensure they do not use or disclose it improperly; limit uses and disclosures to the minimum necessary; have procedures in place to limit view and access of PHI as well as implement training programs for employees about how to protect PHI

C24: Program income

Income generated by a supported activity or earned as a result of the award Recipients must account for program income related to projects financed in whole or in part with federal funds Recipients shall have no further obligation to the federal government regarding program income: Earned after the end of the project period Earned from license fees and royalties for copyrighted material, patents, patent applications, trademarks, and inventions produced under an award Program income earned during the project period shall be retained by the recipient and shall be used in one or more of the following ways: Additional Method (increase in the available budget) Matching Method (offset to cost sharing) Deduction Method (offset to sponsor's costs) If agency regulations do not specify: Deduction method shall apply to all non-research projects Addition method shall apply to research projects

Drug free workforce: (DOD DFAR as of Sept. 1988)

Indicates that contractor agrees to institute and maintain program for drug free work force - requires drug testing for those in sensitive positions

General & Administrative, Sponsored Projects Administration, Departmental Administration, Student Administration and Services

Indirect Cost Categories: Administrative

Depreciation & Interest, Operation & Maintenance, Library

Indirect cost categories: Facilities

HIPAA Privacy Rule: Authorization

Individual's signed permission that allows a covered entity to use or disclose the individual's PHI for the purpose(s) and to the recipient(s) stated in the Authorization. 1. A description of the PHI to be used or disclosed 2. Who is authorized to make the requested use or disclosure 3. To whom the covered entity may make the requested use or disclosure 4. The purpose of the requested use or disclosure 5. authorization expiration date ("end of the research study" or "none") 6. Signature of the individual and date.

Phase 1 Trial

Initial testing in 20-100 healthy volunteers to evaluate safety.

Info on protecting whistle blowers

Inst. must establish policy / procedures to protect the reputation and positions of those who in good faith make allegations;

Requirements of the Bayh-Dole Act

Institution pursuing ownership of intellectual property rights must acknowledge government support. The government has march-in rights to grant additional licenses to reasonable applicants.

Federal Wide Assurance (FWA)

Institution's agreement that it will comply with the requirements of human subjects regulations

What are the responsibilities of the Institutional Biosafety Committee (IBC)?

Institutional Biosafety Committees (IBCs) are the cornerstone of institutional oversight of recombinant DNA research. The IBC must develop safety plans, emergency response plans, and have a process for community notification and containment. Required to report any serious adverse events that are unexpected and are possibly associated with human gene transfer intervention to OBA and IBC within 15 calendar days or 7 days if life threatening or fatal.

First Research Integrity Official (RIO), then Deciding Official (DO)

Institutional Officials for Research Misconduct

examples of deemed exports

Institutional lab tours to foreign nationals, involvement of foreign persons in research domestically, oral exchanges via email or visual inspection, hosting a foreign researcher in the US

Chemical Safety Committee

Institutional oversight of safe chemical use:

Identify debarred/suspended vendors

Institutional purchasing system must

Indefinite delivery indefinite quantity agreement

Issued when a set quantity of goods or services are needed, but not known or specified (although there can be minimums and maximums.) The Sponsor issues Task Orders for the delivery of the goods or performance of the services during the life of the contract.

B11: Pre-award policies

Instructions on appropriate award instrument Grant: principle purpose is to accomplish a public purpose Cooperative agreement: substantial involvement is expected between the executive agency and the recipient Contract: principle purpose is acquisition of property or services for direct benefit of federal government Public notice and priority setting Federal awarding agencies must notify the public of its intended funding priorities for discretionary grant programs

NSF review criteria

Intellectual Merit and Broader Impact sponsor?

Research Performance Progress Report (RPPR)

Intended to replace other interim performance reporting formats currently used by agencies but not change the reporting requirements of OMB Circular A-110 (2 CFR Part 215).

Small Business Technology Transfer (STTR) - NIH

Intended to stimulate scientific and technological innovation through cooperative research/research and development (R/R&D) carried out between small business concerns (SBCs) and research institutions (RIs); Fosters technology transfer between SBCs and RIs; Assists the small business and research communities in commercializing innovative technologies; 3 phases: phase I - Feasibility study to establish scientific/technical merit of the proposed R/R&D efforts (generally, 1 year; $150,000); phase II - Full R/R&D efforts initiated in Phase I (generally 2 years; $1,000,000); phase III- Commercialization stage (cannot use STTR funds); Eligibility limited to U.S. small business concerns; Project Director/Principal investigator (PD/PI) may be employed with the SBC or the participating non-profit research institution as long as he/she has a formal appointment with or commitment to the applicant SBC.

Small Business Innovation Research (SBIR) - NIH

Intended to stimulate technological innovation in the private sector by supporting R&D for for-profit institutions for ideas that have potential for commercialization; Assists the small business research community in commercializing innovative tech; 3 phases for NIH: phase I - Feasibility study to establish scientific/technical merit of the proposed R/R&D efforts (generally, 6 months; $150,000); phase II - Full research or R&D efforts initiated in Phase I (generally 2 years; $1,000,000); phase III- Commercialization stage (cannot use SBIR funds); Eligibility limited to U.S. small business concerns; The primary employment of PI must be with the small bus. concern. 2/3 budget allocation must be for small business; optional research inst. partner.

$500

Interest in the amount of ________ per year may be retained by the non-federal entity for administrative expenses.

E.O. 12372

Intergovernmental Review of Federal Programs

Internal controls definition from Uniform Guidance § 200.61

Internal controls means a process, implemented by a non-Federal entity, designed to provide reasonable assurance regarding the achievement of objectives in the following categories: (a) Effectiveness and efficiency of operations; (b) Reliability of reporting for internal and external use; and (c) Compliance with applicable laws and regulations.

State

International Traffic in Arms Regulations (ITAR) is part of what Department?

PHS Innovation Process

Invention [complete invention disclosure form (web) and provide all data on Invention] Evaluation of Invention (up to 12-weeks; Extent of data, prior art, commercial potential considered) Convey decision to Principal Investigator: No: no patent filing ever (free to publish) or possible interest later, but not now. Yes: Patent filing. Outside attorney's file. Collaborative (inventors, attorneys) (1-3 months) Notification of patent filing to inventors. Free to publish (or make other public disclosures) Inventors to complete Declaration of Assignment Documents ( most important to IP office because the inventor declares that the hospital is the owner).

Who must report their Conflict of interests according to PHS?

Investigator, PI, co-PI, any other person at institution responsible for design, conduct and reporting of research/educational activities funded by or proposed for funding by PHS

No

Is effort reporting based on a 40 hour work week?

OMB Circular A-21

Issued 1979 Defines allowable direct and indirect costs May 1996 revision incorporated four cost accounting standards Required disclosure statement (DS-2) (roadmap for our policies)

Fixed price agreement

Issued when the Sponsor determines that the price quoted is reasonable and does not want to give the Contractor an opportunity to adjust their price based upon actual expenses incurred during performance. The completion of a task/milestone usually renders a payment due.

What was the Morrill Act?

It created land-grant universities, using the proceeds of federal land sales.

What is the Animal Welfare Assurance? Where is the assurance filed (what office and what federal agency?)

It is a commitment that institutions will comply with PHS policy, with the Guide for Care and Use of Lab Animal; description of institutions program; designation of Institutional Official (IO) responsible for compliance. It is filed with OLAW, which is under DHHS and oversees all PHS-agency animal research protections.

What is the Copeland Act ("Anti-Kickback Act") of 1986?

It prohibits a federal building contractor or subcontractor from inducing an employee into giving up any part of the compensation that he or she is entitled to under the terms of his or her employment contract (paying a kickback in order to be hired to a federal building project).

What was the Tuskegee Syphilis Study?

It was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service. The purpose of this study was to observe the natural progression of untreated syphilis in rural African-American men in Alabama under the guise of receiving free health care from the United States government. It left subjects uninformed of the nature of their illness, and untreated, even after penicillin became widely available.

export control classification number (ECCN)

Items on the CCL are categorized with an alphanumeric sequence referred to as ECCN. The sequence has three primary parts: the category (the first digit), the product group (the second digit), and the level of restriction or type of control (the last 3 digits). The ECCN may also include subparts that identify detailed characteristics of the item. Examples of ECCNs are: 7A994, 0A980, 3D001.a. Items that appear on the CCL may require obtaining an export license prior to exporting or "releasing" the technology or software, depending upon the country of destination and reason for control. Releasing as defined in the EAR means visual or other inspection, oral or written exchanges, or other forms of access.

EAR99

Items that fall under U.S. Department of Commerce jurisdiction and are not listed on the CCL. These generally consist of low-technology consumer goods and do not require a license in many situations. The US does not want these shared with embargoed countries.

A law that did a major overhaul of the US Patent System. Biggest difference: it changed the system from "first to invent" to "first inventor to file." Inventors have a 1 year grace period to disclose an invention before filing a patent. Also increased universities' share of profit from inventions.

Leahy-Smith America Invents Act (AIA) (2011)

Public Law 106-107 (the federal financial assistance management improvement act of 1999)

Led to the creation of grants.gov. Provides a single website for all federal Grant opportunities. (Impetus to change the ways in which federal agencies accept grant applications and manage grants--paper to electronic submissions)

Contract

Legal instrument in which a non Fed entity purchases property or services needed to carry out the project or program under a Federal award

Cooperative Agreement

Legal instrument of financial assistance between a Federal awarding agency or pass through entity and a non-Federal entity

Dual Use Research of Concern (DURC)

Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. 15 agents/toxins; 7 experimental effects

Byrd Amendment (31 USC 1352; 32 CFR 28.100 and 34 CFR 82.100)

Limitation on use of appropriated funds to influence certain federal contracting and financial transactions. No federal funds used for lobbying. Requires disclosure of lobbying activities when receiving federal contracts, grants loans or cooperative agreements Requires certification and disclosure regarding lobbying with each submission for consideration of a federal contract, grant or cooperative agreement exceeding $100k

Byrd Amendment

Lobbying - disclosure forms must be filed prior to any award and thereafter at the end of each calendar quarter

IRB: exempt

Low risk to subjects; no vulnerable populations involvement, no recordings

Biosafety Level 1 (BSL-1)

Lowest biosafety level for work on benches without the use of special containment equipment. No food or drink, must wash hands, daily decontamination of work surfaces, biohazard signs, etc.

Types of federal assistance - mandatory spending

Mandatory spending pays for U.S. Federal programs that have already been established by Congress under authorization laws. These laws both establish the federal programs and mandate that Congress must appropriate whatever funds are needed to keep the programs running. In other words, Congress cannot reduce the funding for these programs without changing the authorization law itself. Funding can't be changed without an act of Congress (60-vote majority in the Senate to pass). Mandatory spending is usually to state / county gov and includes the major entitlement programs, such as Social Security, Medicare, and Medicaid. Mandatory programs are outside of the normal discretionary budgetary process that's negotiated between the President and Congress each year. Mandatory grants are required to be awarded if the recipients meet certain predetermined conditions (e.g. state / county).

What types of activities might be exempt from IRB review?

Many surveys, interviews, and public observation studies will fall in one of these categories, and will, as a result, undergo a process of certification by a member of the HSRRC, rather than review.

UG Methods for collection, transmission and storage of information.

May 2013 EO (Making Open and Machine Readable the New Default for Government Information) indicates should collect, transmit, and store Federal award-related information in open and machine readable formats rather than in closed formats or on paper. If original records are electronic and cannot be altered, no need to retain paper copies.

McNamara-O'Hara Service Contract Act

McNamara-O'Hara Service Contract Act, • Source: https://www.dol.gov/whd/govcontracts/sca.htm • When does it apply?: Federal procurement (not grants) • Who does it apply to?: o On contracts over $2,500, contractors and 1st tier subs must pay employees no less than the wage rates and fringe prevailing in the local area or in the collective bargaining agreement. o On contracts equal or less than $2,500, must pay employees federal minimum wage. o For prime contracts over $100,000 contractors and 1st tier subs must pay employees overtime pay (1.5x). • Mnemonic: McNamara and O'Hara must receive fair pay.

Fundamental Research

Means basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community Not proprietary research, or research from industrial development design production and productulization, the results of which ordinarily are restricted for proprietary or national security reasons. The fundamental research exclusion applies only to the dissemination of research data and information, not to the transmission of material goods.

What is the difference between a Public Law (PL) and a regulation?

Most laws passed by Congress are Public Laws. Every 6 years public laws are incorporated into the United States Code of Regulations.

UG criteria of low risk auditee

Meets all criteria for 2 preceding audit periods: 1. Single audits were performed on an annual basis and reports submitted on time. 2. no deficiencies in internal control which were identified as material weaknesses under the requirements of GAGAS. 3. no report of substantial doubt about the auditee's ability to continue as a going concern. 4. None of the Federal programs had audit findings on internal control deficiencies that were identified as material weaknesses; modified findings on major program; or questioned costs that exceeded five percent of the total Federal awards during audit period.

Characteristics of a successful proposal

Meets stated needs of sponsor Follows directions/guidelines Directed to reviewers Demonstrates the need for the work Documents achievable deliverables Clear and concise narrative Budget consistent with scope of work & well justified

Biosafety Level 3 (BSL-3)

Microbes are indigenous or exotic and are seriously hazardous or lethal through respiratory transmission. Lab Practices: Medical Surveillance Immunizations Access is restricted and controlled Safety Equipment: PPE as needed Respirators as needed All work is performed within a Biosafety Cabinet (BSC) Facility Design: Hands-free sink and eyewash Exhaust air is not recirculated Sustained directional airflow Entrance to lab is through two sets of self-closing and locking doors

Name some Biological Hazards (in the field of Biosafety)

Microorganisms, recombinant DNA, CDC list of select agents, genetically engineered organisms and products.

Laboratory Animal Welfare Act (1966)

Minimum standards during the transport, handling and sales of "animals" and licensing and records requirements for dog and cat dealers and laboratories. Amended to include: 1. Establishment of the IACUC 2. Exercise for dogs and physiological well-being of NHPs 3. Requirements to minimize pain/distress and search for alternatives

How big is a "module" in a modular budget? How many modules per year can be requested?

Modules are $25,000 in direct costs (excludes indirects and consortium F&A). Up to 10 modules can be requested per year (more would put the total funding over the modular budget threshold of $250,000 in direct costs, so a detailed budget would be required.

FAR Agency Supplements

Most federal agencies have their own supplemental acquisition regulations. Examples include Department of Defense Federal Agency Regulation Supplement (DFARS), NASA FAR Supplement (NFS), Department of Education Acquisition Regulation (EDAR)

What is the difference between a Public Law (PL) and a codified regulation?

Most laws passed by Congress are Public Laws - after congress votes and the president signs a bill into law, it is given a sequential number (ex: PL-123). Every 6 years public laws are codified -- meaning they are incorporated into the United States Code of Federal Regulations (CFR) wherein they are sorted by subjects and assigned an identifier based on their location within the CFR. Therefore same law may be PL 83-12 and Title 4 U.S. Code Section 308 paragraph 7. This made-up example refers to the same law -- One refers to the fact that the 83rd Congress passed it as the twelfth measure to be enacted into law by that Congress; the other refers to its regulation of the interstate transportation of raw rutabagas as part of our agricultural statutes in that Title.

DS-2 Amendments

Must be filed with the cognizant agency for indirect costs six months in advance of a disclosed practice being changed to comply with a new or modified standard, or when a practice is changed for other reasons.

Small Business eligibility for SBIR/STTR

Must be for profit, located in the United States, be greater than or equal to 51% controlled by a US Citizen or resident, and have no more than 500 employees

Audit report package

Must contain the following: 1. Financial statements and schedule of expenditures of Federal awards. 2. Independent auditor's report, including an opinion on the financial statements and the schedule of expenditures of Federal awards, a report on compliance and internal control over financial reporting, and a report on compliance with requirements applicable to each major program and on internal control over such compliance requirements. 3. A schedule of findings and questioned costs. 4. If applicable, a summary of prior audit findings and a corrective action plan.

Reporting period end dates for non-final reports

Must fall on end of calendar quarter (e.g. 3/31, 6/30, 9/30, 12/31)

C23: Cost sharing

Must meet all of the following: Verifiable from the recipient's records Not included as contributions for any other federally sponsored project Necessary and reasonable to accomplish project objectives Allowable under applicable cost principles Not paid by the federal government under another award, except where authorized by federal statute to be used for cost sharing Provided for in approved budget Unrecovered indirect may be included as cost sharing only with prior approval Requirements and determination of value for services and property Volunteer services Donated supplies Donated equipment, building and land

requirements for informed consent

Must provide "legally effective informed consent" from subject or rep.; No coercion in consent (voluntary); must educate about program and explain risk vs. benefits; Must use language understandable by HS; Must not (in written/oral) have language that waives HS legal rights or releases PI / sponsor / Inst from liability / negligence

Lobbying Discolsure Act (LDA) effective 2008

Must register and report on lobbying activities if over 20% of time is lobbying over 3-month period for a client. Also $3k minimum. Quarterly & other lobbying reports

What does an R34 grant support?

NIH Clinical Trial Planning Grant (R34) Program Designed to permit early peer review of the rationale for the proposed clinical trial and support development of essential elements of a clinical trial

Examples of Shelby Amendment implementation through policy guides:

NIH Data Sharing Policies/Guiding Principles NSF Data Management Plan

What is the K99/R00 grant?

NIH Pathway to Independence (PI) Award (K99/R00) Also see, New Investigators Program web page Provides up to five years of support consisting of two phases I - will provide 1-2 years of mentored support for highly promising, postdoctoral research scientists II - up to 3 years of independent support contingent on securing an independent research position Award recipients will be expected to compete successfully for independent R01 support from the NIH during the career transition award period Eligible Principal Investigators include outstanding postdoctoral candidates who have terminal clinical or research doctorates who have no more than 4 years of postdoctoral research training

NIH RePorter

NIH Research Portfolio Online Reporting Tools Expenditures and Results. Search repository of NIH-funded projects and access publications and patents resulting from NIH funding. Formerly CRISP

What does an R03 grant support?

NIH Small Grant Program (R03): Provides limited funding for a short period of time to support a variety of types of projects, including: pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, small, self-contained research projects, development of new research technology, etc. Limited to two years of funding Direct costs generally up to $50,000 per year Not renewable

Cost Principles/considerations (NIH)

NIH cost principles set out in "HHS regulations at in 45 CFR 75, Subpart E and Appendix IX (hospitals) to Part 75"; "Recipients may use their own accounting systems, policies, and procedures to implement the cost principle requirements as long as they meet the standards prescribed in 45 CFR 75.302 for financial management systems"; 4 tests of allowability - reasonableness, allocability, consistency, and conformance

"A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."

NIH definition of clinical research

NIH requirement of audit

NIH recipients (other than Federal institutions) are subject to the audit requirements in 45 CFR Subpart F and in the NIHGPS.

Executive Level II

NIH salary cap is called

eRA Commons

NIH's online interface where grant applicants, grantees, NIH Federal staff & grantor agencies can access and share administrative info relating to grants. RPPRs and financial reporting are done here.

iEdison

NIH; enables institutions and federal agencies to manage inventions electronically.

FFAR Contract Types: Basic Principles & Selection: Primary Objective

Negotiation of the appropriate contract type and price estimated cost and fees should result in a reasonable risk to the contractor and, at the same time, provide the contractor with the greatest incentive for efficient and economical performance.

What is NIST 800-53?

NIST Special Publication 800-53, "Security and Privacy Controls for Federal Information Systems and Organizations," provides a catalog of security controls for all U.S. federal information systems except those related to national security. NIST 800-53 covers the steps in the Risk Management Framework that address security control selection for federal information systems in accordance with the security requirements in Federal Information Processing Standard (FIPS) 200. A key part of the certification and accreditation process for federal information systems is selecting and implementing a subset of the controls (safeguards) from the Security Control Catalog (NIST 800-53, Appendix F) . These controls are the management, operational, and technical safeguards (or countermeasures) prescribed for an information system to protect the confidentiality, integrity, and availability of the system and its information.

What is NIST? What federal agency is it a part of? What do they do?

NIST is the National Institute of Standards and Technology -- is a measurement standards laboratory, and a non-regulatory agency of the United States Department of Commerce. Its mission is to promote innovation and industrial competitiveness. NIST sets standards in a variety of areas including in data security.

Independent Agencies

NSF NASA USAID ART WORKS NATIONAL ENDOWMENT FOR THE HUMANITIES

NSF rate negotiation

NSF can be the cognizant agency for org. "CAAR is responsible for negotiating and issuing ICRs for NSF's cognizant awardees. CAAR does not negotiate ICRs for organizations that are not direct recipients of NSF funding (e.g. subrecipients) or for foreign organizations;

NSF and Summer Salary

NSF grants proposal guide NSF 14-1 January 2014 As a general policy,NSF limits salary compensation for senior project personnel to no more than two months of their regular salary in an one year. The limit includes salary compensation received from all NSF-funded grants.

NEON scandal (2015)

NSF non-competitive project. Largest ever termination-for-cause of a federal grant in US history (440 million). Terminated due to lax internal controls (ran 80 million over budget) and use of extra-legal methods like using management fees to use federal funds to pay for alcohol, entertainment, luxury travel, etc. Resulted in NSF Major Research Facility Reform Act (H.R. 5049) in April 2016 to address misconduct. The cases brought by the auditor from DCAA that discovered the misconduct is inspiring likely changes in Whistleblower protections for federal workers (he made the case that if whistleblowing is part of his job, they should do it on the job rather than in private time).

Biological Sciences, Computer and Information Science and Engineering, Engineering, Geosciences, Mathematical and Physical Sciences, Social, Behavioral and Economic Sciences, and Education and Human Resources

Name the 7 NSF Directorates

Public Law 101-5101

Nation Defense Authorization Act of FY1991 Passed in November 1990 Requires that agencies keep any remaining budget authority for five years after the appropriation expires to use in paying unliquidated obligations and liabilities on the books at expiration

Public Law 101-5101c

Nation Defense Authorization Act of FY1991 Passed in November 1990 Requires that agencies keep any remaining budget authority for five years after the appropriation expires to use in paying unliquidated obligations and liabilities on the books at expiration

Executive Branch Agencies

National Institutes of Health Department of Defense DARPA Defense Threat Reduction Agency Air Force Office of Scientific Research Office of Naval Research Department of Energy ARPA Department of Transportation

NSDD-189

National Security Division Directive-189. Defines fundamental research and fundamental research exemption for export control. NSDD 189 established the national policy for controlling the flow of scientific, technical, and engineering information produced in federally funded fundamental research at colleges, universities, and laboratories. NSDD 189 makes clear that the products of fundamental research are to remain unrestricted to the maximum extent possible.

Cost plus fixed fee contract

Negotiated fee is fixed and paid at the beginning of the contract and then cost reimbursement for actual costs throughout the period of performance, the fixed fee does not change based on how funds are expended but may be adjusted if the changes are made to the SOW

What does ITAR regulate? What agency is ITAR under?

Only regulates the export of defense items (incl. technical data), not dual-use items. Under the US Dept of State.

Uniform Guidance Single Audit

Organization is subject to Single Audit if it expends more than $750,000 in Federal Funds in a fiscal year

Office of Research Integrity

Oversees and directs PHS research integrity activities to ensure that applicant and awardee institutions are complying with PHS regulations.

Federal Select Agents Program

Oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. Jointly managed by CDC and APHIS

The Bayh-dole act addresses

Ownership,of intellectual property resulting from federal sponsored research

Working w/PHS Innovation Office

Ownership: A clear title to the invention is an absolute requirement for commercialization. Institution's Intellectual Property Policy requires that all ideas be disclosed to the Licensing Office Licensing Office is obligated by NIH to notify NIH if an invention is disclosed, filed,licensed or abandoned that was supported with federal funds. Inventions are asked to give this information as part of the grant process. Patent applications and patents list the grant number and the government audits institutions for compliance.

What does the NIH P-series of grants support?

P = Program Project Center Grants. Program project/center grants are large, multi-project efforts that generally include a diverse array of research activities.

Procedures: Proposal Budget

PI/department prepares budget Draft budget to OSPA for review PI and OSPA discuss changes to budget Internal approval form completed and signed

What was the effect of Public Law 106-107 (1999)?

PL 106-107 created Grants.gov. The intent was to provide equal opportunity in proposal submission.

The Federal Grant & Cooperative Agreement Act of 1977

PL 95-224 Why: In the 1970s congress was concerned over the perceived misuse of assistance agreements--using them to circumvent competition and procurement rules. Law established to address these problems and to ensure uniform agency practices. Purpose: Government wide criteria for determining appropriate legal instrument for external activity. Distinguishes between acquisition and assistance based on the principal purpose of the legal relationship between the parties.

The Fernald School experiments

Parents gave their intellectually disabled children permission to participate in "science club." The children were fed radioisotopes of calcium and iron mixed with oatmeal at "science club breakfasts." The purpose of the study was to determine how cereal affects the digestion of calcium and iron.

Americans with Disabilities Act

Passed by Congress in 1991, this act banned discrimination against the disabled in employment and mandated easy access to all public and commercial buildings.

CAS 506

Which one of the 4 basic requirements for Cost Accounting Standards is defined by: Consistency in the Accounting Periods.

Why are patents important

Patents provide the legal right to exclude others from practicing an invention--provides a period of exclusivity which in turn provides an incentive for companies/investors to provide funding to develop a product. (20 years from the earliest effective filing date.) Without this period of exclusivity competitors could take advantage of a company's development and introduce competitive products. Exclusivity can justify investment To pressure Patentability: disclose to innovation office before public disclosure United States adopted First to File on March 16, 2013. Prior to to 2013, it was first to invent.

Name 3 classes of Intellectual Property

Patents, Copyrights, Trademarks

CFR Title 37

Patents, Trademarks, & Copyrights

Property Types / Intellectual Property

Patents, trade secrets, copyrights, trademarks

3 P's

Patron (Grant) Partner (Co-Op Agreement) Purchaser (Contract)

Grant v Cooperative Agreement v Contract

Patron v Partner v Purchaser

C22: Payment

Payment methods shall minimize the time elapsing between transfer of funds and disbursement by recipient Requirements for advance payment SF-270 and SF-271 Agencies shall not withhold payments unless: Noncompliance with project objectives, terms/conditions of the award, reporting requirements Delinquent in a debt

What are Pell Grants?

Pell Grants represent the largest student aid program, and combine both mandatory and discretionary funding streams. They are administered by US Dept of Education, and are need-based awards designated specifically for undergraduate students.

Selecting Contract Type, continued

Period of Performance Is the contract for a long period of time increasing the need for a contract type thar would allow for price adjustments? Contractor's Technical Capability and Financial Responsibility Is the contractor responsible? Contractor's Accounting System Does the contractor have the ability to report cost accurately and timely so that the government is aware of the progress? Concurrent Contracts Is the contractor performing similar work under another contract? What type and how goes the progress? Extent and Nature of Proposed Subcontracting Is much of the effort being subcontracted and does it present a risk to the sponsor? Acquisition History Have similar goods and services been procured from the contractor before? Can the contractor benefit from the resulting economies of scale?

NIH Clinical Trials Phase I

Phase I trials: Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time. The purpose is to evaluate its safety and identify side effects.

SBIR/STTR Phase 1 goals, funding limits, and periods of performance.

Phase I: Feasibility and Proof of Concept: The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R&D efforts. Phase I awards: SBIR ($150,000), up to 6 months; STTR: $150,000 and up to 1 year.

Describe the 4 standard phases of NIH clinical trials:

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II:The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III:The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NIH Clinical Trials Phase II

Phase II trials: The experimental drug or treatment is administered to a larger group of people (100-300) to determine its effectiveness and to further evaluate its safety.

SBIR/STTR Phase 2 goals, funding limits, and periods of performance.

Phase II: Research/Research and Development: The objective of Phase II is to continue R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II. Only Phase I awardees are eligible for a Phase II award. SBIR/STTR Phase II awards normally do not exceed 1 million total costs for 2 years.

SBIR/STTR Phase 3 goals, funding limits, and periods of performance.

Phase III: Commercialization: The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase 1&2 R&D activities. The NIH SBIR/STTR programs do not fund Phase III, and NIH does not generally provide any Phase III funding to small businesses.

iEdison

Place to report intellectual property that was created from govt funded research. Sponsored by NIH

45 CFR 46

Policies & Procedures for dealing with suspension or termination of an IRB approved research. adopted by 15 federal agencies, special protections for vulnerable populations. aka common rule

NSDD 189

Policy for controlling the flow of science, technology, and engineering information produced by federally-funded research at colleges, universities and laboratories

NSDD-189

Policy for controlling the flow of science, technology, and engineering information produced by federally-funded research at colleges, universities and laboratories

1. Names 3 outcomes of the COMPETES act of 2010:

Post Doc Mentoring Plan, Publicizing the project outcomes report Doubling NSF appropriations to support specific programs

Phase 4 Trial

Post FDA approval (post marketing phase) and available to the public. Safety tracking for risks, benefits, other possible uses and best use.

2 CFR 200 - Subpart D

Post-award Requirements. Section 200.3xx.

Unrelated Business Income Tax, loss of tax-exempt bond status

Potential consequence of contract/grant that limits or delays publication (2)

Electronic Research Administration Sites - NSF

Pre-award - NSF Fastlane Post-Award - Research.gov

2 CFR 200 - Subpart C

Pre-award Requirements. Section 200.2xx.

Describe the following types of F&A rates: Predetermined Fixed Provisional Final

Predetermined: rate established for a period; not subject to later adjustment. Fixed: A fixed rate is an indirect cost rate that applies to a specific current or future time period (usually the organization's fiscal year). It differs from the predetermined rate in that it is subject to later adjustment. Provisional: estimated rate used until actual rate is determined. Final:rate applicable to a specified PAST period with no adjustments.

B16: resource conservation and recovery act (RCRA)

Preference be given to the purchase of specific products containing recycled materials identified in EPA guidelines

B15: metric system of measurement

Preferred measurement for use in agency's procurements, grants, and other business-related activities

Subpart B: Pre-award requirements B10: Purpose

Prescribes form and instructions and other pre-award matters to be used in applying for federal awards

Reading FAR Termination Clause

Prescription Each contract clause references a prescription that will provide guidance as to when the term should be used. Example: 52.249-5 Termination for Convenience of the Government (Educational and Other Nonprofit Institutions)(September 1996) As prescribed I in 49-502(d), insert the following clause: (A) the government may terminate performance of work under this contract in whole or, from time to time, in part if the contracting officer determines.....

Codes of Federal Regulations (CFR)

Presents the official and complete text of agency regulations published in the Federal Register

Laboratory Animal Welfare Act (1966)

President Johnson. Momentum from the Life Magazine photo essay depicting stolen pets in poor condition sold to labs for research.

Public Law 89-544 Animal Welfare Act

President Johnson. Momentum from the Life Magazine photo essay depicting stolen pets in poor condition sold to labs for research. Animal Welfare Act passed in 1966 Established standards for handling, housing, transporting, and feeding animals used in research. Federal law overseen by the US Dept. Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) [excluding birds, rats, and mice bred for research] Minimum standards during the transport, handling and sales of "animals" and licensing and records requirements for dog and cat dealers and laboratories. Amended to include: 1. Establishment of the IACUC 2. Exercise for dogs and physiological well-being of Non human primates 3. Requirements to minimize pain/distress and search for alternatives

DFARS 252.204-7000 Disclosure of Information (publication clause - contracts)

Prevents the release of unclassified information without advance, specific contracting officer approval - Prescribing Clause at 204.404-70(a) specifies that this clause must be included when the contractor will generate unclassified information that may be sensitive and inappropriate for public release. - Serves as a waiver of the university fundamental research exclusion to export control laws - Update in August 2013 requires subrecipients to "scope out" fundamental research portion of their statement of work with Government CO (requires understanding and cooperation from the prime sponsor) - May be a deal breaker

FAR 52.227-17 Special Works (publication clause - contracts)

Prevents the release, distribution and publication of any data first produced in the performance of this award. All data and deliverables will belong to the Government. - Prescribing Clause at 27.409(e) sets forth the limited situations in which this clause is required. It should be removed unless it directly applies (i.e., when research is for internal government use).

Fixed Price contract

Price quoted by the contractor is reasonable, market is stable, no opportunity for price adjustment, full payment upon delivery of work. Most common type of contract Contractor bears full responsibility for the performance costs and resulting profit, or loss Provides maximum incentive for contractor to control its costs and perform efficiently Minimal administrative burden

Tools of the Trade

Primarily under EAR regulations and include cell phones, laptops, data storage devices, and encrypted software. Must be under your personal custody and effective control while traveling. Cannot be out of the US for longer than 1 year.

OMB A-21

Principles for Determining Costs Applicable to Grants, Contracts and Other Agreements with Educational Institutions - University cost principles; replaced by UG (part E)

NSF page limits

Prior NSF support - 5 pages Project Description (includes prior support) - 15 pages Biosketch for Senior Personnel - 2 pages Budget Justification - 5 pages (formerly 3)

C25: revision of budget and program plans

Prior approval: Change in scope Change in key personnel Absence for more than 3 months or a 25% reduction in time devoted to the project by the PI Need for additional funding Transfer between direct and indirect costs, if approval is required by the federal awarding agency Subawards, unless described in the application and funded in the approved awards Expanded Authorities Per award costs 90 days prior to award (or more than 90 days with prior approval of the federal awarding agency) Initiate a one-time extension of the expiration date of the award up to 12 months Carry forward in obligated balances to subsequent funding periods Must refer to the award document Re-budgeting Federal awarding agency may, at its option, restrict the transfer of funds among direct cost categories for awards in which the federal share of the project exceeds $100,000 and the cumulative amount of such transfers exceeds or is expected to exceed 10 percent of the total budget

200.317 - 200.326

Procurement Standards

Different FOAs (NIH)

Program Announcement (PA): IC request in a particular scientific area RFP/RFA:Official invitation for applications Parent announcement (usually under a PA): For "unsolicited" applications which do not fall within the scope of targeted announcements

Funding opportunities for grants are announced via

Program Announcement, Request for Application

200.307

Program Income

Additive Program Income

Program income that can be pulled into a project as additional funds. Default for non-profit sponsors.

Deductive Program Income

Program income where budget is reduced by amount of income (still whole). Default for for-profit sponsors.

Cost Accounting Standards (CAS) 505 : Accounting for Unallowable Costs

Provides guidance for accounting for unallowable costs for those in the institution responsible for preparation of the F&A proposal

Anti-kickback act of 1986

Prohibits a person from soliciting or accepting any kickback related to a federal subcontract. Institutions must have a compliance policy in accordance with ______________ . Clarifies its 1934 predecessor.

Age Discrimination Act of 1975

Prohibits discrimination on the basis of age in programs and activities receiving federal financial assistance

Copeland Anti-Kickback Act Public Law 73-324, 48 stat. 948, 18 USC 874

Prohibits federal contractors or subcontractors engaged in building construction or repair from inducing an employee to give up any part of the compensation to which he or she is entitled under his or her employment contract. Requires contractors and subcontractors to submit weekly statements of compliance.

Anti-lobbying

Prohibits recipients of federal funds from using those funds to obtain, modify, or extend a federal award. Applies to grants, contracts, and cooperative agreements. Penalties apply.

Smoke-Free Workplace 41 CFR 102

Prohibits smoking tobacco products in the Federal Workplace

Office of Foreign Asset Control (OFAC)

Prohibits transactions and/or interactions with countries, entities and individuals subject to trade sanctions; Regulates: Sanctions List, Restricted Parties

IRB Full Review

Projects for which the level of risk is determined by the IRB Chair to be greater than minimal require

Disclosure of Federal Participation. (Stevens Amendment)

Projects or programs funded in whole or in part with Federal grant money must credit the Federal government for the Federal government's portion of the financial support. It requires federal grant recipients to include funding information on all publications related to projects that use federal funds, including statements, press releases, signs at construction sites, requests for proposals, bid solicitations, and other documents that describe projects or programs funded in whole or in part with federal money. The information must state clearly: - total cost of the program - dollar amount of federal funds used This law applies to grants and cooperative agreements but not to contracts. It does not apply to subcontracts, but it may apply to subawards. Academic publications (peer-reviewed journals, presentations to professional groups) resulting from the project research are not required to include this information. Although no sanctions are specified for noncompliance, failure to comply could be considered a breach of responsibilities and may result in termination, suspension, or debarment.

Intangible Property

Property having no physical existence, such as trademarks, copyrights, patents, patent applications and property such as loans, notes, and other debt instruments, lease agreements, stock, and other instruments of property ownership

proposalCENTRAL

Proposal submission site used by several foundations. Mostly disease-centric awards and medical school research applicants.

What gets posted in the Federal Register? How often is it published?

Proposed and final administrative regulations of federal agencies, funding opportunities, executive orders, public notices, other executive branch documents. It is published daily.

Chemical Hygiene Plan

Protect lab workers from harm due to hazardous chemicals. Written program stating the policies, procedures and responsibilities that protect workers. Requires that Material Safety Data Sheets (MSDS) be on file. Now known as safety data sheets.

Utility Patent

Protects function of new machines/processes, manufactures, compositions of matter, and improvements thereon. They are more expensive and protect many variations of a product

Health Insurance Portability & Accountability Act

Protects personal health information (PHI)

Design Patents

Protects the appearance, not the function, of an item. They are faster and cheaper to obtain than utility patents.

Copyright Act (1976)

Protects the exclusive rights, given to an originator or an assignee of the "original work of authorship," to reproduce, print, publish, perform, film, or display or and to authorize others to do the same."

False Claims Act

Protects the government from being overcharged for services provided or sold, or substandard goods or services. Can result in criminal action. Requires grant records retained for 3 years.

Code of Federal Regulations

Provides information on patent rights and responsibilities currently applicable to universities and federally sponsored projects.

NIH reporting requirements

Quarterly cash Transaction report (CTR) required through PMS - due w/in30 days of financial quarter; within 90 days of end; Inventions - fully disclose within 2 months after inventor provides written disclosure to institution - reported on iedison; also disclose in annual / final reports; Annual RPPR report due - 45 days before anniversary date due date in eRA commons

R15 grant characteristics

R15 - The purpose of the Academic Research Enhancement Award (AREA) program is to stimulate research in educational institutions that provide baccalaureate or advanced degrees for a significant number of the nation's research scientists, but that have not been major recipients of NIH support. AREA grants are intended to support small-scale health-related research projects proposed by faculty members of eligible domestic institutions.

What does the R25 grant support?

R25 - Education Projects Used in a wide variety of ways to promote an appreciation for and interest in biomedical research, provide additional training in specific areas, and/or to develop ways to disseminate scientific discovery into public health and community applications

Institutional Biosafety Committees (IBCs) - NIH guidelines

RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC Nucleic Acid MOLECULES - guidelines on IBC created by NIH office of science policy; The purpose of the NIH Guidelines is to specify the practices for constructing and handling: (i) recombinant nucleic acid molecules, (ii) synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, and (iii) cells, organisms, and viruses containing such molecules; The institution shall establish IBC whose responsibilities need not be restricted to recombinant or synthetic nucleic acid molecule research; 5 members; at least 2 not affiliated with inst.; 1 expert in plant pathogens; 1 expert in animal contaminants; The institution shall file an annual report with NIH OSP which includes: (i) a roster of all IBC members clearly indicating the Chair, contact person, Biological Safety Officer (if applicable), plant expert (if applicable), animal expert (if applicable), human gene therapy expertise or ad hoc consultant (if applicable); and (ii) biographical sketches of all IBC members (including community members).

NIH appeal procedures (2011)

Read summary statement, discuss with PO, if still wish to appeal, then PI or Inst. should write appeal letter to PO, which shows concurrence from the AOR. Appeal letters needs the following: 1) describes the flaws in the review process for app. 2) explains the reasons for the appeal, and 3) is based on one of the following issues: Evidence of bias of reviewers; COI; Lack of expertise within the SRG; Factual error(s) made by reviewers that could have altered the outcome of review substantially. Appeal letters based solely on differences of scientific opinion will not be accepted. NIH Staff review: If both review staff and program staff support an appeal, then SRG (same or diff) will re-review then the original application, without additional materials or modifications. If review staff and program staff do not support the appeal, the PD/PI may withdraw the appeal letter. If appeal letter is not withdrawn, it will be made available to Council. Council makes final decision and either concurs with the appeal or with the SRG and deny the appeal. Council communicates decision within 30 calendar days; If the application is re-reviewed, then it is re-assigned to a subsequent review round. The outcome of the re-review is final and cannot be appealed again.

200.303 Internal Controls

Reasonable assurance non fed entity is managing Fed award in compliance with Fed statutes, regs, and terms/conditions of fed award.

This type of center provides a service and moves funding/expenses from one department to another, without increasing total funding for the campus.

Recharge center.

C28: Period of Availability of Funds

Recipient may charge to the grant only allowable costs resulting from obligations incurred during the funding period and any pre-award costs authorized by federal awarding agency

C48: contract provisions

Recipient shall include the provisions listed in this section to all contracts and subcontracts Provisions of Appendix A shall also be included, as applicable

C42: codes of conduct

Recipient shall maintain written standards of conduct governing performance of its employees engaged in the award and administration of contracts

Intellectual Property and Federal Support

Recipient shall: Provide an irrevocable, royalty-free non-exclusive license granted to the US government for the invention ("March in Rights"); and Adhere to the requirements that any patent-protected products that are used or sold in the United States be manufactured substantially in the US.

C26: non federal audits and C27: allowable costs

Recipient: State, local governments, Indian tribes Cost Principles: A-87 Admin Requirements: A-102 Audit Requirements: A-133 Recipient: Educational Institutions Cost Principles: A-21 Admin Requirements: A-110 Audit Requirements: A-133 Recipient: Nonprofit Organizations Cost Principles: A-122 Admin Requirements: A-110 Audit Requirements: A-133 Recipient: Hospitals Cost Principles: 45 CFR 74 Admin Requirements: depends Audit Requirements: A-133 (depends) Recipient: Commercial Organizations Cost Principles: 48 CFR 31 Admin Requirements: federal agencies may apply to A-110 Audit Requirements: federal awarding agency or prime

CAS 505

Which one of the 4 basic requirements for Cost Accounting Standards is defined by: Proper treatment of Unallowable Costs?

Subpart D: after the award requirements C71: closeout procedures

Recipients have 90 days after expiration date to submit all financial, performance, and other reports as required Liquidate all obligations incurred no later than 90 days after the funding period Recipient shall promptly refund any balances of unobligated cash Recipient shall account for any real and personal property acquired with federal funds or received from the federal government

lab notebooks

Record retention for a minimum of three years includes ____________

C46: procurement records

Records in excess of small purchase threshold ($25k) shall include at a minimum Basis for contractor selection Justification for lack of competition Basis for award cost or price

200.333 Retention requirements for records

Records must be retained for period of 3 years from date of submission of final expenditure report

F&A rate to be used in award (NIH specific)

Regardless of the type of recipient, the rate(s) in effect at the beginning of the competitive segment will be used to determine the amount budgeted for F&A costs for each year of the competitive segment. If the rate agreement does not extend to the end of the project period, the last rate in effect will be used to establish the total cost commitment for any remaining future years. NIH generally will not award additional F&A costs beyond those calculated in the approved budget.

3 types of appropriations

Regular Appropriations Bills Continuing Resolutions Supplemental Appropriations Bills

Safety in Animal and Lab Research

Regulated Waste: biohazards/infectious waste 1. Human and non-human primate blood, body fluid, tissues 2. Microbiological and pathological waste 3. Items contaminated with above 4. OPIM (Other potentially infectious materials) Lab/Institution responsibilities 1. Determine the existence of biohazard waste 2. Correct treatment and disposal of biohazard waste 3. Correct packaging and labeling to avoid exposure Special Considerations: Sharps (needles, scalpels, dissection pins) Regulated federally by Occupational Safety and Health Administration (OSHA)'s Bloodborne Pathogen Standards and by state regulations

Nuclear Regulatory Commission and States

Regulates radiation safety

What does the Nuclear Regulatory Commission do?

Regulates radiation safety and the nuclear power industry; committee reviews research protocols.

OMB Circulars

Regulatory circulars issued by the Office of Management & Budget.

C21: standards for financial management system

Relate financial data to performance data Accurate, current and complete financial results of each federally sponsored project Identification of source and application of funds Effective control over accountability for all funds, property and other assets Comparison of outlays with budget amounts for each award Procedures to minimize the time between payment and disbursement of funds Procedures for determining the reasonableness, allocability, and allowability of costs Accounting records supported by source documentation

Deemed Export

Releasing or otherwise transferring "technology" or source code (but not object code) to a foreign person in the United States. - Transferring by a person in the United States of registration, control, or ownership of: - A spacecraft subject to the EAR that is not eligible for export under License Exception STA(i.e., spacecraft that provide space-based logistics, assembly or servicing of any spacecraft) to a person in or a national of any other country; or - Any other spacecraft subject to the EAR to a person in or a national of a Country Group D:5 country.

C62: enforcement

Remedies for noncompliance Temporarily withhold cash payments Disallow funds Wholly or partly suspend or terminate current award Withhold further awards Other remedies legally available

Which of the following is considered program income? A) Petty cash reimbursements B) Tuition from training programs developed under the grant that is received after the grant ends C) Rental or usage fees from equipment purchased with grant funds during the project. D) Royalties earned after the period of performance ends

Rental or usage fees from equipment purchased with grant funds during the project.

How often are IACUC reports required? Who is the report submitted to?

Reports are due twice a year to the institutional official.

America COMPETES Act (2007, amended 2011)

Reports on on the state of innovation and competitiveness in the US and state of STEM education agenda. The Act added specific appropriations - i.e. doubling the annual appropriations for the National Science Foundation by the year 2011 to support specific programs: e.g. MRI, CAREER, REU, and the GRFP. The Act mandates new proposal requirements such as postdoc mentoring plan, RCR plan for undergraduates, graduate students, and postdoctoral researchers, and the sharing of final project reports.

Funding opportunities for contracts are announced via

Request for Proposal, Request for Bid, Request for Quotation

RFP

Request for application - targeted solicitation for grant apps in a well-defined scientific area, 1 one competitions, construction grant or cooperative grant

A faculty member has a five year NIH grant which will terminate August 31, with $14,000 remaining on July 15th of the same year. A competing continuation was recommended for approval but not funded. What is the most appropriate advice for the research administrator to give the faculty member:

Request no-cost extension of the grant while a revised application is under preparation

200.308 Revision of budget/program - Prior Approval

Require Prior Approval from agency - Change in scope - Change in key personnel - Reduction of 25% effort of PI - Transfer of funds to participant support - Initiate subawards - Changes in approved cost sharing Prior Approvals that may be waived - Incur project costs 90 calendar days before start of award - One time NCE - Carryforward unobligated balance

Stevens Act 1989 Department of Defense Appropriations

Required acknowledgement of sponsorship in publications. When issuing statements, press releases, requests for proposals, bids, solicitations and other documents describing projects or programs funded in whole or in part w/federal money, will state total cost of the program; total cost of the program dollar amount of federal funds for project or program. Tired of hearing state and local governments take credit for projects funded at least in part by the federal government. Give credit where credit is due

Anti-lobbying certification

Required for federal contracts, grants, or cooperative agreements in excess of $100,000

metric system

Required form of measurement on Federal Contracts

Debarment and Suspension certification on federal awards: What does a grantee certify to? What period is covered?

Required on all agreementents over $100,000. Grantee certifies that they are not presently debarred, suspended, proposed for debarment, declare ineligible or voluntarily excluded from covered transaction; within 3 yr period of proceeding application been convicted or criminal judgement

IACUC Meetings

Required to meet at least two times per year

Institutional Biosafety Committee

Required to oversee federal research involving recombinant DNA.

Davis-Bacon Act 1931

Requirement of paying a local prevailing wage on public works projects for laborers and mechanics. Applies to contractors and subcontractors performing on federally funded or assisted contracts in excess of $2,000 for the construction, alteration or repair of public buildings or public works (includes painting and decorating). Department of Labor sets wages. Required fair wages on federal contracts, established minimums Penalties: withholding contract funds to rectify wage underpayment; contract termination and debarment from future for up to 3 years

Davis-Bacon Act 1931 PL 71-798

Requirement of paying a local prevailing wage on public works projects for laborers and mechanics. Applies to contractors and subcontractors performing on federally funded or assisted contracts in excess of $2,000 for the construction, alteration or repair of public buildings or public works (includes painting and decorating). Department of Labor sets wages. Required fair wages on federal contracts, established minimums Penalties: withholding contract funds to rectify wage underpayment; contract termination and debarment from future for up to 3 years

200.202

Requirement to provide public notice of Federal financial assistance programs

OSHA Lab Standard

Requires Chemical Hygiene Officer and Chemical Hygiene Plan, Information and training, Medical exams for persons showing symptoms of chemical exposure. Affects all facilities using hazardous chemicals.

National Institutes of Health

Requires a written description of a program for providing instruction in the responsible conduct of research for Institutional National Research Service Awards

Stevens Amendment

Requires acknowledgement of Federal grant support when issuing statements, press releases, requests for proposals, bid solicitations, publications, and in other documents describing programs or projects funded in whole or in part; grantees should clearly state the total cost of the program and the Federal share of funding; applicable to all awards.

Department of Treasury (regulating US DEPT)

Responsible Office/section Office of Foreign Assets Control (OFAC) Regulations Foreign Assets Control Regulations (FACR) What do they Control Travel abroad Transactions with foreign individuals and entities Transactions in specific foreign countries Export and import of items

Examples of indirect costs

Salaries of secretary or dept administrators General purpose equipment Postage Basic telephone Office supplies OSP Expenses, purchasing

UG standard application requirements (200.206) and FOA requirements

Requires fed. agencies to use OMB-approved application standard info collections to solicit applications. FOA must include the following: review process; Agency Name; FOA title; Announcement Type (whether the funding opportunity is the initial announcement of this funding opportunity or a modification of a previously announced opportunity); FOA # (required, if applicable); Catalog of Federal Financial Assistance (CFDA) Number(s); Key Dates, include due dates for applications or Executive Order 12372 submissions, as well as for any letters of intent or pre-applications; - must publish FOA for at least 60 calendar days - may be less, but no less than 30 days before due date unless exigent circumstances require as determined by the Federal awarding agency head or delegate. - Full Text of Funding Opportunities - must include: (1) Full programmatic description of the funding opportunity. (2) Federal award information, including sufficient information to help an applicant make an informed decision about whether to submit an application. (3) Specific eligibility information, including any factors or priorities that affect an applicant's or its application's eligibility for selection. (4) Application Preparation and Submission Information, including the applicable submission dates and time. (5) Application Review Information including the criteria and process to be used to evaluate applications. (6) Federal Award Administration Information.

Federal Funding Accountability and Transparency Act (FFATA) 2006

Requires full disclosure to the public of all entities or organizations receiving federal funds. Created USASPENDING.gov. Maintained by the Office of Management and Budget (OMB)

NIH Responsible Conduct of Research

Requires in-person training and participation in face-to-face didactic and small group discussions for all staff who have direct involvement in proposing, performing, reviewing, or reporting research.

NSF Responsible Conduct of Research

Requires online training for undergraduate students, graduate students, and postdocs participating in a proposed research project.

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): PARTICIPANT SUPPORT

Requires prior approval to rebudget.

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): PARTICIPANT SUPPORT

Requires prior approval.

Shelby Amendment

Requires researchers to make available data produced under a federal award to the public

C45: cost and price analysis

Requires some form of cost or price analysis with every procurement action

Cost Accounting Standards (CAS) 501: Consistency in Estimating, Accumulating and Reporting Costs

Requires that costs must be proposed in the same way that they are treated in an institution's accounting system.

Cost Accounting Standards (CAS) 506 : Cost Accounting Period

Requires that the cost accounting period for costs accounting purposes be the same as an institution's fiscal year.

Cost Clause - FAR 52.232-22: Limitation of Funds

Requires the Contractor to notify the Government: - When expenditures reach a certain threshold (usually 75%) - If expenditures are more or less than the obligated total - Also establishes that the Contractor has a 60 day period to request supplemental funding or a no cost extension

FAR 52.227-14 Rights in Data (publication clause - contracts)

Requires the prior written consent of the Government to establish a claim in copyrightable data first produced or delivered under the contract - Prescription at FAR 27.409(e) allows the use of Alt. IV: A contractor may establish a claim to the copyrightable data first produced or delivered under the contract; Specifically for use in contracts to universities performing fundamental research

C44: procurement procedures

Requires written procurement procedures Positive efforts shall be made to utilize small businesses, minority owned firms, women's business enterprises Contractors shall be made only with responsible contractors

Benefits of licensing

Research - invention (IP) - research & development - Products Advance health care To allow our researchers to see real-world results of their research Development of new breakthrough products and medicines for improved patient care Encourage entrepreneurship for local and national development (create jobs) PHS IP Revenue Sharing Policy: financial return to inventors and hospital on licensed inventions: after deducting out of pocket costs, 25% to inventors, 25% to lab, 25% to department, 25% to hospital.

Fabrication, Falsification, Plagiarism 42 CFR Part 93

Research Misconduct - FFP (includes obstruction of an investigation)

What human subjects research activities might prompt an expedited review by the IRB?

Research activities involving no more than minimal risk and limited involvement of human subjects; for example, blood draws, use of medicine or medical devices already on the market, collection of data through non-invasive procedures, collection of data from existing records like recordings, transcripts, etc.

21 CFR 50 & 56

Research regulated by FDA

Issues addressed in the Declaration of Helsinki

Research with humans should be based on the results from laboratory and animal experimentation Research protocols should be reviewed by an independent committee prior to initiation Informed consent from research participants is necessary Research should be conducted by medically/scientifically qualified individuals Risks should not exceed benefits

Department of State (Regulating US DEPT)

Responsible Office/Section Directorate of Defense Trade Controls (DDTC) Regulations International Traffic in Arms Regulations (ITAR) What doe they control? Defense articles and technical data Goods software or information specifically designed developed or modified for military intelligence application Defense services

Department of Commerce ( Regulating US DEPT)

Responsible Office/section Bureau of Industry & Security (BIS) Regulations Export Administration Regulations (EAR) What do they control? Dual use goods, software and technology predominately civilian in nature but may include military applications Any boycott provisions

Clinical Trial Registration

Responsible parties: Sponsor of clinical trial: PI, if designated by the Sponsor, grantee, contractor, or awardee PI responsible for conducting the trial, has access to and control over the data from the trial, has the rights to publish the results, and has the ability to meet all FDA requirements to submit clinical trial information

Nuremberg Code 1947

Resulted from violence committed by Nazi Physicians; judges at Nuremberg had no legal basis to evaluate the Nazi physicians. Summary of Code: 1. Pre-clinical animal studies must precede human research 2. Investigator must be knowledgeable in condition 3. Societal benefit 4. Voluntary consent is essential 5. Risks minimized relative to benefits 6. Subjects have the right to end research participation

C53: retention and access requirements

Retained for three years from the date of submission of the final expenditure report, with exceptions Litigation requires retention until all matters have been resolved Real property and equipment records retained three years after final disposition Allows public access (FOIA)

What are some of the responsibilities of a cognizant agency?

Review and negotiate institution's F&A rate; receive DS-2 form IHEs; help resolve questioned costs during an audit.

IRB: expedited review

Reviewed by an IRB Chair or designee; minimal risk to subjects, no vulnerable populations involvement

Unsolicited applications to NIH are reviewed how many times per year?

Reviewed in 3 review cycles per year (dates vary by program)

Radiation Safety Committee

Reviews and approves the use of radiation

37 CFR 401

Rights to Inventions made by Non-Profit Organizations and Small Business Firms under Government Grants, Contracts, and Cooperative Agreements

UG 200.331

Risk-Based Analysis (subrecipient risk assessment): •PTE must conduct risk-based analysis of subrecipients in advance of making an award, and reassess throughout the award period •Oversight responsibilities tied to internal controls •PTE must demonstrate adequate internal controls of the management of its federal awards, including oversight of subrecipients

What is SAM?

SAM (used to be the CCR) is the primary database of vendors doing business with the federal government, and grant-seekers for federal assistance. Each entity must have a current SAM registration to receive federal funds. This registration is sometimes referred to as "self-certifying." SAM reps and certs include certification that the entity is not debarred or suspended, or otherwise ineligible to receive federal funding; conviction of fraud or civil judgment for malfeasance in obtaining a federal grant or contract; federal tax delinquency, etc.

Est. of Small Business programs

SBIR and STTR; Purpose - Government program established by E.O. 13329 to help small businesses receive federal funding; Federal departments and agencies required to reserve a portion of their annual Research and Development funds for small businesses

SMART

SPIN Matching and Research Transmittal System - automated alerts system

The sponsor has given approval to completely rebudget a technician's salary and all associated costs in order to purchase a piece of equipment. The amount budgeted for the technician's salary is $40,000. The institution has an F&A rate of 112% based on salaries and wages, and a fringe benefit rate of 31.2%. How much will be available for equipment? a. $40,000 b. $52,480 c. $84,800 d. $97,280

Salary $40,000 F&A $44,800 ($40,000 X 1.12) F/B $12,480 ($40,000 X .312) $40,000+$44,800+$12,480=$97,280

Mission of NIH

Science in pursuit of knowledge about the nature and behavior of living systems and applying that knowledge to improve human health and to reduce the burdens resulting from disease and disability. - Foster fundamental discoveries and innovative research and applications; - Develop, maintain, and renew the human and physical resources needed to accomplish this mission; - Expand the knowledge base in biomedical, behavioral, and associated sciences in order to enhance the nation's economic well-being and ensure a continued high return on the public investment in research; and - Exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.

America Competes Act

Section 7009 requires that each institution receiving NSF funds for STEM research or education have a plan to provide training on the responsible conduct of research to undergraduates, graduate students, and postdoctoral researchers

The Patriot Act of 2001 placed restrictions on who can possess ______ and provides criminal penalties for possession that cannot be justified for peaceful purposes

Select agents (biological agents or toxins). List maintained by CDC

International Traffic in Arms Regulations (ITAR)

Set of United States government regulations that control the export and import of defense-related articles and services on the United States Munitions List (USML). Its goal is to safeguard U.S. national security and further U.S. foreign policy objectives.

Export Administration Regulations (EAR)

Set of United States government regulations that control the export and reexport of "dual use" items, information and software that are primarily commercial in nature but also have potential military applications.

DS-2

Sets forth our accounting practices to distinguish direct v indirect and If a cost is sometimes direct and sometimes indirect, spell out specific criteria and circumstances Examples of projects which could be conspired special purpose or circumstance: Industry sponsored projects State sponsored projects Training grants Geographically inaccessible projects Large complex projects

Progressive discipline policies

Sets standard of conduct and a set of consequences if the standard is not met. Fairness in the workplace. Supervisor administers the policy and HR is required to provide assistance, guidance, and training to supervisors. Encourages teamwork.

Non-delinquency on fed. Debt

Standard assurance that confirms that applications are non-delinquent in their repayment of any federal debt. Examples of relevant debt include delinquent payroll and other taxes, audit disallowances, and benefit overpayments. See OMB Circular A-129.

The Uniform Biological Material Transfer Agreement (UBMTA)

Standardized terms and conditions in an agreement that facilitates the transfer of biological materials between academic institutions. Published by NIH on behalf of PHS. Not suitable for industry supported research.

C40: purpose of procurement standards

Standards for procurement of supplies and other expendable property, equipment, real property and other services with federal funds

A-87 2 CFR 225

State & local governments

OMB A-87

State, Local and Indian Tribal, and Gov. cost principles; replaced by UG

Federal Wide Assurance (FWA) for protection of HS

Statement of Principles (sent to OHRP) governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution. Must ensure that the Institution has written procedures for prompt reporting to the IRB, IO, sponsor, and OHRP of any: - unanticipated problems involving risks to subjects or others; - serious or continuing noncompliance with the applicable U.S. federal regulations or the requirements or determinations of the IRB(s); and - suspension or termination of IRB approval. Must ensure that the IRB(s) that reviews research has established written procedures for: - conducting IRB initial and continuing review (not less than once per year), of research, and reporting IRB findings to the PI and the Institution; - determining which projects require review more often than annually Porvide copy to OHRP or fed. sponsor as requested. Must renew every 5 years, even if no changes; any change must report /win 90 days; any changes submitted to OHRP begins a new 5-year effective period.

Property Standards (equipment disposal) for States

States must use, manage and dispose of equipment in accordance with state law and procedure.

What property standards for equipment disposal must States follow?

States must use, manage and dispose of equipment in accordance with their own state law and procedure.

Statutes vs. Regulations

Statutes passed by state or central government. Regulation is issued by a regulatory body appointed by the state or central government.

Order of importance

Statutes, Federal Regs, Special Terms and Conditions

USDA

Steward of Animal Welfare Act

Uniform Guidance

Streamlines and supersedes guidance that was previously contained in eight different OMB Circulars (Chapter 2 CFR, Part 200). Effective December 26, 2014.

IRB: Full Board Review

Studies with greater than minimal risk, continuing reviews, annual approval, protocol amendments, or vulnerable populations are involved (e.g., children or adolescents, inmates, pregnant women), majority of quorum vote needed

Standards of IRB Approval

Subjects' risks are minimized and reasonable relative to anticipated benefits (beneficence) Selection of subjects is equitable (justice) Informed consent required and documented from each prospective subject or legally authorized representative (respect for persons) Mindful of research with vulnerable populations: children, prisoners, pregnant women, mentally disabled persons, or economically/educationally disadvantaged persons Data monitoring to ensure the subjects' safety and privacy of are maintained (HIPAA)

Organization of:

Subpart A: general Subpart B: pre-award requirements Subpart C: post-award requirements Subpart D: after-the-award requirements Appendix A: contract provisions

In what section in UG might one find information about preaward requirements?

Subpart C - Section 200.2XX

In what part and section in UG might one find information about post-award requirements?

Subpart D - Section 200.3XX

In what section in UG might one find the cost principles for federal awards?

Subpart E - Section 200.4XX

In what section in UG might one find information about audit requirements?

Subpart F - Section 200.5XX

C51: monitoring and reporting program performance

Subrecipent monitoring Performance reports required no more frequently than quarterly or less frequently than annually Annual reports due 90 days after the grant year Quarterly or semiannual reports due 30 days after the reporting period end date Final report due 90 days after the expiration date

200.330 Subrecipient and contractor determinations

Subrecipient - carries out a portion of the fed award - performance measured - adherence to applicable fed requirements Contractor - Obtains goods and services for the non Fed entity's own use and creates a procurement relationship with contractor - Competitive environment - Provides goods and services - Not subject to compliance requirements

Uniform Guidance definition of Supplies

Supplies are all tangible personal property that falls below the threshold for equipment (200.94)

NSF EAGER

Supports exploratory work in its early stages on untested, but potentially transformative, research ideas or approaches - Can be high-risk high-payoff - Budget consistent with project scope and existing programmatic activities (up to $300K for 2 years) - Program Officer approval needed to submit

C47: contract administration

System for contract administration shall be maintained Recipients shall evaluate contractor performance

Capital Assets

Tangible or intangible assets used in operations having a useful life of more than one year which are capitalized in accordance with GAAP. EX: land, buildings (facilities), equipment, and intellectual property (software). EX: additions, improvements, modifications, renovations to capital assets that materially increase the value or useful life (not ordinary repairs and maintenance)

capital assets

Tangible or intangible assets used in operations having a useful life of more than one year which are capitalized in accordance with the GAAP.

Equipment

Tangible personal property (including information technology systems) having a useful life of more than one year and a per-unit acquisition cost which equals or exceeds the lesser of the capitalization level established by the non-Federal entity for financial statement purposes

Cost transfers, effort reporting, and direct charging of clerical and administrative salaries

Target areas for post-award audits

200.470 Taxes

Taxes from which exemptions are available for non Fed entity are unallowable

dual-use technology

Technology that can be used for civilian or military purposes

200.339

Termination

Clinical Trial Agreements are for

Testing in human subjects, specifically with investigational new drugs, devices, diagnostics, or treatments

What animals are covered under the Animal Welfare Act? What carve-out of this group of animals are specifically NOT covered under the Animal Welfare Act?

The AWA covers all warm-blooded vertebrate animals who are commonly experimented upon EXCEPT rats, mice, and birds (which make up 95% of all experimental animals). OLAW policy does provide regulations for rats, mice and birds, in addition to all vertebrate animals, including fish, wildlife, etc. But this only covers PHS-funded research.

Belmont Report (1979), what is it, and what are its core ethical principles?

The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: 1) respect for persons, 2) beneficence (do no harm), and 3) justice (equity). MNEMONIC: Ruth Bader ginsberg is my favorite JUSTICE (R-B-Justice)

The difference between research and medicine

The Belmont report clarifies

What is the Buy American Act?

The Buy American Act applies to all awards; it establishes a general preference for domestic articles, materials and supplies.

What is the CFDA? What organization maintains it?

The CFDA contains detailed program descriptions for 2053 federal assistance programs; also contains non financial assistance programs. The General Services Administration (GSA) maintains the catalog.

What is the CFR?

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the federal government of the United States.

Written records/meeting notes

The Common Rule dictates that IRB committees must keep

Declaration of Helsinki

The Declaration governs international research ethics and defines rules for "research combined with clinical care" and "non-therapeutic research."

Biomedical Research, Medical Research, Clinical Research

The Declaration of Helsinki only covers these three things:

Mission of USDA (includes programs)

The Department of Agriculture (USDA) provides leadership on food, agriculture, natural resources, rural development, nutrition and related issues based on sound public policy, the best available science, and efficient management. Largest part of budget to Food and Nutrition Service (FNS) program (houses SNAP), includes USFS, NIFA, Animal and Plant Health Inspection Service (APHIS)

educational information is released by instruction in catalog courses and associated teaching labs

The EAR applies the Educational Information Exclusion when

What does EAR regulate?

The EAR regulates "dual-use" commodities and certain military items

When are the Expanded Authorities applicable? Name some of them...

The Expanded Authorities are applicable when the granting agency allows them. They include, 90 day preaward spending without prior approval; a 1 time no cost extension for up to 12 months without prior approval; Carryforward without prior approval; waiver of some cost-related approvals (varies).

R21 grant characteristics

The Exploratory/Developmental Grant (R21) program is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

What is the FAR?

The FAR (Federal Acquisition Regulations) is system of uniform policies and procedures governing acquisition or contracting actions of all executive agencies

When is the Federal Register published/updated? When are the contents of the Federal Register codified?

The FR is updated daily by 6 am Mon-Fri, except federal holidays. The final rules published in the FR are codified annually and published in the CFR (Code of Federal Regulations).

This group helped develop the expanded authorities.

The Federal Demonstration Partnership, made up of academic research institutions, federal agencies, and research policy organizations.

PL 106-107 created what?

The Federal Financial Assistance Management Improvement Act - improve the effectiveness and performance of Federal grant programs; simplify grant application and reporting requirements; improve the delivery of services to the public; and facilitate greater coordination among those responsible for delivering such services. Gave us grants.gov

What is FISMA?

The Federal Information Security Management Act of 2002 ("FISMA") is a federal law. The act requires each federal agency to develop, document, and implement an agency-wide program to provide information security for the information and information systems that support the operations and assets of the agency, including those managed by contractors or grantees. FISMA has brought attention within the federal government to cybersecurity. FISMA requires agencies to conduct annual reviews of the agency's information security program and report the results to Office of Management and Budget (OMB).

What is The Common Rule?

The Federal Policy for the Protection of Human Subjects or the "Common Rule" was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below. The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the "Common Rule"; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.

Common Rule

The Federal Policy for the Protection of Human Subjects. Shared standards adopted by federal agencies for the protection of human research subjects. Adopted by 15 federal agencies. "Diminished capacity to ascent"

What is the Federal Register? Why might the general public think it is important?

The Federal Register is the official journal of the federal government of the United States that contains government agency rules, proposed rules, and public notices. It is important because is a way for the government to announce proposed changes to the public. The notice and comment process gives the people a chance to participate in agency rulemaking.

Cognizant Agency

The Federal agency which (on behalf of all Federal agencies) is responsible for: reviewing, negotiating, and approving cost allocation plans, indirect cost rate and similar rates; monitoring non-Federal audit reports; conducting Federal audits as necessary; and resolving cross-cutting audit findings.

What is the HUBZone Program?

The Historically Underutilized Business Zones (HUBZone) program was enacted into law as part of the Small Business Reauthorization Act of 1997. The program encourages economic development in historically underutilized business zones - "HUBZones" - through the establishment of preferences. SBA's HUBZone program is in line with the efforts of both the Administration and Congress to promote economic development and employment growth in distressed areas by providing access to more federal contracting opportunities.

What is the area of responsibility for the Institutional Biosafety Committee (IBC)? How many members? How often do investigators need review by the IBC? What federal organization oversees the IBCs?

The IBC is responsible for assessing the biosafety containment level for CDC select agents, including research involving recombinant DNA and synthetic nucleic acid molecules. The IBC must have 5 members, 2 of whom are public members. All must have a background in biosafety. OBA oversees IBCs (Office of Biotechnology Activities). Investigators must submit to OBA certain info about protocols annually.

Department of Health and Human Services (DHHS)

The National Institutes of Health (NIH) is part this organization.

What is a NAICs code?

The North American Industry Classification System (NAICS) classifies business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. economy. The NAICS industry codes define establishments based on the activities in which they are primarily engaged. NAICS codes are also used for administrative, contracting, and tax purposes. NAICS is production oriented (not product oriented) and categorizes businesses with others that have similar methods of production.

What is OFAC? What do they oversee?

The Office of Foreign Assets Control (OFAC) is a financial intelligence and enforcement agency of the U.S. Treasury Department charged with planning and execution of economic and trade sanctions in support of U.S. national security and foreign policy objectives. They maintain the list of sanctioned and embargoed countries, and publish the Specially Designated Nationals (SDN) List, which lists people, organizations and vessels with whom United States citizens and permanent residents are prohibited from doing business.

R01 characteristics and purpose

The Research Project Grant (R01) is an award made to support a discrete, specified, circumscribed project. The R01 is also called a project grant. It is the original and historically oldest grant mechanism used by NIH. The R01 provides support for health-related research and development based on the mission of the NIH. R01s can be investigator-initiated or can solicited via a Request for Applications.If the R01 is under 250,000 in direct costs per year, a modular budget should be used.

What is the Simplified Acquisition Threshold (SAT) $ amount for 2017? How often is the SAT recalculated?

The SAT is currently at $150,000 in 2016. The SAT is recalculated every 5 years.

Name the primary difference between SBIR and STTR in terms of partnership requirements.

The SBIR program does NOT require the business to sub-partner with an IHE. The STTR program does require an IHE partner-sub.

What is Sub-Net?

The SUB-Net database is a listing of subcontracting solicitations and opportunities posted by large prime contractors and other non-federal agencies. SUB-Net has been used by state and local governments, non-profit organizations, colleges and universities, and even foreign governments to post solicitations and identify small businesses.

What was the outcome of the Shelby Amendment?

The Shelby Amendment requires researchers to make data produced under a federal award available to the public. The Shelby Amendment resulted in NIH adopting Data Sharing policies, and NSF requiring a Data Management Plan with proposals.

HIPAA Privacy Rule

The Standards for Privacy of Individually Identifiable Health Information establishes a set of national standards for the protection of certain health information. HHS issued the Privacy Rule to implement HIPAA. The Rule standards address the use and disclosure of individuals' health information—called "protected health information" PHI, as well as standards for individuals' privacy rights to understand and control how their health information is used. Within HHS, the Office for Civil Rights ("OCR") has responsibility for implementing and enforcing the Privacy Rule.

What federal entity administers the False Claims Act?

The US Department of Justice

Walsh-Healey Public Contracts Act (1936)

The Walsh-Healey Act applies to U.S. government contracts exceeding $10,000 for the manufacture or furnishing of goods. Walsh-Healey establishes overtime pay for hours worked by contractor employees in excess of 40 hours per week, and sets the minimum wage equal to the prevailing wage as determined by the Secretary of Labor. The law prohibits the employment of youths less than 16 years of age and convicts. The Act sets job health and safety standards. The Walsh-Healey Act does not apply to commercial items. Commercial items are goods that are already marketed/sold to the public.

UG scope of audit

The audit/auditor must: 1. be conducted in accordance with GAGAS. 2. cover all operations of auditee in same audit period. 3. review financial statements and the schedule of expenditures of Federal awards 4. review internal control 5. obtain an understanding of internal control over Federal programs sufficient to assess level of control risk of noncompliance for major programs. 6. report a significant deficiency or material weakness, assess the related control risk at the maximum, and consider whether additional compliance tests are required because of ineffective internal control. 7. determine whether the auditee has complied with Fed statutes, regulations, and terms and conditions

audit resolution

The basis for federal audit resolution arises from the Supplemental Appropriations Act of 1980 (Pub. L. 96-304); and, in part, from the enactment of the Inspector General Act of 1978. A provision in that law established that the backlog of federal audit reports in existence on the effective date of the statute (July 8, 1980) was to be eliminated by September 30, 1981. All new audits arising after that date which contained questioned costs were required to be resolved within six months after their date of issuance. This six-month time frame has become a hallmark for subsequent resolution of both federal and non-federal audit reports. The time frame is also tied to periodic reporting that IGs make to Congress.

Allocation of work in an STTR

The business must contribute at least 40% of the work and the non-profit must contribute at least 30% of the work.

An institution has an indirect cost rate of 40%. A research project is budgeted at $125,000 in direct costs including an item of equipment at $25,000. The equipment is the only item excluded from the indirect cost base. What is the total cost for the project? a. $135,000 b. $150,000 c. $165,000 d. $175,000

The correct answer is $165,000 $125,000 - $25,000 (equipment) = $100,000 X .4= $40,000 $125,000 + $40,000 = $165,000

A particular RFP from the U.S. Department of Energy requires a 20% cost share on Total Project Costs (which include agency funds and the required cost share funds). If the agency funds total $1,500,000 then the required cost share amount is: a. $300,000 b. $375,000 c. $400,000 d. $425,000

The correct answer is b. $375,000 Take $1,500,000 / .80 = $1,875,000 $1,875,000 X .20 = $375,000

What is the Simplified Acquisition Threshold (SAT) and why does it matter to federal contractors?

The current SAT is $150,000. Expenditures under the SAT face fewer and less complex regulations and procedures -- which brings less administrative burden on the contractor. Expenditures over the SAT are subject to every applicable federal acquisition law under FAR Part 52.

Central service allocation plan

The documentation identifying, accumulating and allocating or developing billing rates based on the allowable cost of services provide by a state, local government, or Indian tribe on a centralized basis to its departments agencies.

Name some of the certifications made by an institution as part of SAM registration

The entity is not debarred or suspended or otherwise ineligible to receive federal funding; neither the entity nor any of its agents have been convicted of fraud or civil judgment for malfeasance in obtaining a federal grant or contract; no federal tax delinquency over $3,000 in the last 3 years.

Def. of Copyright

The exclusive legal right, given to an originator or an assignee to print, publish, perform, film, or record literary, artistic, or musical material, and to authorize others to do the same. Copyrights apply to: Literary work, Dramatic work, Musical work, Artistic work, Computer software, Applies to published or unpublished work. Copyright is the property of the author from the moment of inception of the work (does not require filing); However, if the owner wants to sue for copyright infringement, then they must file with Library of Congress (relatively cheap). For works created on or after Jan 1, 1978, copyright protection is for the term of the author's life plus 70 years.

Copyrighted Works and Federal Awards

The federal government typically requires one copy of the copyrighted works for the official archives

General IP considerations under Fed. grants

The federal government usually retains rights to IP developed using federal funds. Under Bayh-Dole, Institutions are required to file inventions reports for inventions created using federal grant funds. Ownership of the copyright vests with the author, the government retains the right to a royalty-free, nonexclusive, and irrevocable right to use the work for public purposes and to authorize others to do so. This includes the government's right to request research data ("rights in data.")

budget

The financial plan for the project or program that the federal awarding agency or pass-through entity approves during the Federal Award process or in subsequent amendments to the federal award it may include the federal and non-federal share or only the federal share, as determined by the federal awarding agency or pass-through entity.

Who owns the IP and why?

The hospital owns the IP (Unless unrelated, no hospital resources, or made under approved consulting arrangement) Why: Bayh-Dole Act of 1980 permitting universities/hospitals to elect ownership of inventions made under federal funding. Obligated to have a written policy with its employers requiring disclosure and assignment of inventions and in return must share with the inventor(s) a portion of any revenue received from licensing the invention. Institutional Policy: intellectual property policy

The Federal Financial Assistance Management Improvement Act of 1999 (Public Law 106-107)

The impetus to change the ways in which federal agencies accept grant applications and manage awards. (Grants.gov)

Fundamental Research: Exclusions is Destroyed if

The institution accepts any contractual clause that: Forbids the participation of foreign persons Gives the sponsor a right to approve publications resulting from the research Otherwise operates to restrict participation in research and/or access to and disclosure of research results. Note: side deals between PI and sponsor destroy the fundamental research exclusion and may also violate institutional policies on openness in research

Criteria for direct charging normally indirect costs to a project

The item of cost must be: Identified specifically with the project with a high degree of accuracy Incurred for a specific purpose as described in UK Costing Policy Explicitly budgeted, justified in proposal, and awarded Federal projects have an additional requirement: the budget justification must state that the costs is normally treated as indirect by the university; it is requested due to a different or special circumstance; and the circumstance is explained.

Mission of DOT

The mission of the Department is to: Serve the United States by ensuring a fast, safe, efficient, accessible and convenient transportation system that meets our vital national interests and enhances the quality of life of the American people, today and into the future.

Mission of DOD

The mission of the Department of Defense is to provide the military forces needed to deter war and to protect the security of our country. The department's headquarters is at the Pentagon.

Mission of DOE

The mission of the Energy Department is to ensure America's security and prosperity by addressing its energy, environmental and nuclear challenges through transformative science and technology solutions.

Reasons for Export Controls

The nature of the export has actual or potential military applications or economic protection issues; Government concerns about the destination country, organization, or individual; and Government concerns about the declared or suspected end use or the end user of the export

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): PROGRAM INCOME

The new "default" treatment is deductive -- to reduce the amount of the federal award and replace it with the earned program income -- unless otherwise specified in the award. Program income definition includes license fees and royalty income earned during the period of performance.

Federalwide Assurance

The only type of new assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS.

What is FAR

The principle set of rules (system) issued by the US federal government that governs the acquisition process utilizing contracts. FAR does not apply to grants or cooperative agreements Propose is to provide uniform policies and procedures for acquisition while minimizing administrative burdens The government is represented by the contracting officer

allocation

The process of assigning a cost or a group of cost to one or more cost objectives, in reasonable proportion to the benefit provided or other equitable relationship. Process may entail assigning a cost(s) directly to a final cost objective or through one or more intermediate cost objectives

Describe some features of the NSF MRI grant program:

The program provides organizations with opportunities to acquire major instrumentation that supports the research and research training goals of the organization and that may be used by other researchers regionally or nationally. It is a rare NSF program that requires costshare. Equipment vests with the grantee. The instrument acquired or developed is expected to be operational for regular research use by the end of the award period

Fly America Act

The recipient of federal funds agrees that US flag air carriers will be used to transport personnel and property when costs are charged to these funds; including any air transportation to, from, between or within a country other than the US when US flag air carriers are available; applicable to awards.

UG info on charging Admin salaries

The salaries of administrative or clerical staff should normally be treated as indirect (F&A) costs. Direct charging may be appropriate if all of the following conditions are met: - Administrative/clerical services are integral to the project or activity - Individuals involved can be specifically identified with the project or activity - Such costs are explicitly included in the budget or have the prior written approval of the Federal awarding agency - The costs are not also recovered as indirect costs

Tuskegee Syphilis Study (1939-1973)

The study initially involved 600 black men - 399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients' informed consent.

Types of Academic IP

Therapeutics: small molecules, biologics, cell-based vaccines Diagnostics: May overlap with therapeutics Devices: both therapeutics and devices Software: for the management of clinical information, workflow processing, image analysis (not always a good investment, but it's wise to obtain copyright protection) Research Tools: materials, software code, tissues

How many titles are there in the Code of Federal Regulations (CFR)?

There are 50 titles in the CFR.

UBMTA is used primarily when...

There is a need for standardized terms to transfer one class of transfer routine between 2 academic institutions. It is not suitable for industry supported research.

Consultant Agreements

These agreements are used for activities performed by a private individual who is not an employee of the PTE and are typically handled through university purchasing division and are not considered subrecipient agreements.

Institutional Animal Care and Use Committees (IACUCs)

These are local institutional committees with federally mandated oversight responsibilities, including: Reviewing animal‐use protocols; Reviewing significant changes to protocols; Evaluating institutional compliance with PHS Policy, U.S. Department of Agriculture (USDA) Animal Welfare Act an d Regulations, and institutional policies; Monitoring institutional animal care and use programs, including inspecting animal facilities; Reviewing concerns about animal care or use; and Reporting noncompliance and suspensions to the NIH Office of Laboratory Animal Welfare (OLAW).

Subaward Agreement

These are the documents generally included in this type of agreement: •Statement of work (SOW) •Dates (budget period and project period) •Amount of funding to subrecipient •General Terms & Conditions •Special Terms & Conditions •Contacts (for both the PTE and subrecipient) •Reporting Requirements •Certifications and Assurances •Copy of the Primary Award •Budget Justification •Budget and payment considerations

Copyrights

These provide the exclusive right to reproduce, prepare derivative works, distribute copies, publically perform, and display. Exists when original works of authorship fixed in a tangible medium of expression.

Patents - Rights conferred

These provide the right to exclude others from making, using, offering for sale, selling, and importing and lasts 20 years from filing date.

What are the NIH K-series grants?

They are research training and career development awards for individuals, including for undergrads, grads, and postdocs.

What do the Executive Branch Agencies do? How many of them are there?

They develop and execute policies, laws, and rules using Code of Federal Regulations (administrative law). There are 15 executive branch departments headed by members of the President's cabinet. There are also numerous independent executive agencies and quasi-federal agencies.

As defined by 45 CFR 46.102(f), a "human subject" has what characteristics?

They must be a living individual, about whom an investigator conducting research obtains either 1) data, or 2) identifiable private information, through intervention or interaction with the individual.

How often must IACUC members meet? How often must they inspect animal facilities?

They must meet 2x a year and inspect their animal facilities 2x a year (at 6 month intervals or semiannually)

Bayh-Dole Act of 1980

This Act addresses ownership of intellectual property resulting from federally sponsored research

Walsh-Healey Public Contracts Act (PCA)

This Act deals with issues on minimum wages, maximum hours, and health standards.

The Anti-Kickback Act

This Act deters contractors from accepting payments for the purpose of improperly obtaining or rewarding favorable treatment in connection with a prime contract.

The Freedom of Information Act (FOIA)

This Act provides the right of the general public to access records in the possession of a federal agency.

The Drug-Free Schools and Communities Act

This Act requires biennial review of the institution's drug prevention program.

Bayh-Dole (37 CFR Part 401)

This Act states that universities can elect and retain title and requires reporting and federal licensing.

The Animal Welfare Act (AWA)

This Act was initially enacted in 1966 and amended in 1970, 1976, 1985, 1990, 2002, 2007, and 2008 is the principal Federal statute governing the sale, handling, transport and use of animals.

Contract Work Hours and Safety Standards Act (CWHSSA)

This Act would require that certain contracts contain a clause specifying that no laborer doing any part of the work would be required or permitted to work more than a certain number of hours in any work week

Dual Use Research of Concern (DURC)

This Policy is to establish regular review of research (regardless of the source of funding) with certain high consequence pathogens and toxins for its potential to be Dual Use Research of Concern (DURC) as defined by the US Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern. The DURC review is designed to: - (a) mitigate risks where appropriate; and - (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. Requires the establishment of an Institutional Review Entity (IRE).

Department of Agriculture

This agency is responsible for administering the Animal Welfare Act

qui tam

This allows a private person, called a whistleblower, to bring suit on behalf of the government.

$300,000 and $500,000

This amount is the original threshold for an audit and this is the threshold today.

Nuclear Regulatory Commission

This group develops and monitors standards for handling radioactive materials

Institutional Biosafety Committee

This group is mandated for the oversight of research involving recombinant DNA.

National Library of Medicine

This institution is located within the National Institutes of Health

questioned cost

This is a cost that is questioned because it (a) is an alleged violation of an applicable policy; (b) lacks documentation at the time of the audit; or (c) is unreasonable and does not represent that which would be incurred by a prudent person in the circumstances surrounding the incurrence of cost.

Subrecipient

This is a nonfederal entity that receives a subaward from a PTE to carry out part of a federal program

Relator

This is a private person or whistleblower who brings suit on behalf of the government if he or she has information — which the government does not have — that the institution has knowingly submitted or caused the submission of false claims to the United States.

Fixed Amount Awards for PTE's

This is a type of grant agreement under which the Federal awarding agency or pass-through entity provides a specific level of support without regard to actual costs incurred under the Federal award. This type of Federal award reduces some of the administrative burden and record-keeping requirements....accountability is based primarily on performance and results." (2 CFR 200.45)

Subaward (or subcontract)

This is an award provided by a PTE to a subrecipient to carry out part of a federal award received by the PTE.

What does an R43/R44 grant support?

This is the NIH SBIR program, and it is intended to stimulate technological innovation in the private sector by supporting research or research and development (R/R&D) for for-profit institutions for ideas that have potential for commercialization

What does an R41/R42 grant support?

This is the NIH STTR program, and it is intended to stimulate scientific and technological innovation through cooperative research/research and development (R/R&D) carried out between small business concerns (SBCs) and research institutions (RIs)

September 30

This is the date in which the federal fiscal year ends

Government Accountability Office (GAO)

This is the legislative auditing arm of Congress, who request ongoing or ad hoc reports from this office.

Pass-through entity (PTE)

This is the prime recipient of federal award

What is the Multiple Allocation Base Method for Indirect Costs?

This is used when an organization has several major functions which benefits from indirect costs in varying amounts -- for example, PSU's indirect rates for research, instruction, and public service, on and off campus.

Drug-Free Schools and Campuses and Communities

This law requires institutions receiving federal financial assistance to establish drug and alcohol abuse prevention programs for students and employees. Students and employees must receive materials annually that contain standards of conduct, a description of the various laws that apply in that jurisdiction regarding alcohol and drugs, a description of the various health risks of drug and alcohol abuse, a description of counseling and treatment programs that are available, and a statement on the sanctions the university will impose for a violation of the standards of conduct. Does not require drug testing.

Davis-Bacon Act of 1931

This law requires the payment of "prevailing wages" to employees of contractors and subcontractors working on government construction projects.

Cost Reimbursable

This means that the subrecipient's costs will be reimbursed against actual expenditures up to a predetermined ceiling amount

iEdison

This online system provides the interface for reporting intellectual property.

Responsible Official (RO)

This person must be selected by the entity to act on behalf of the entity to ensure compliance with select agent regulations

NIH Single IRB

This policy affects multi-site studies involving non-exempt human subjects research funded by NIH, and applies to grant applications with due dates on or after January 25, 2018. in addition, the policy applies to the domestic sites of NIH-funded multi -site studies where each site will conduct the same protocol involving non-exempt human subjects research.

Closeout Process

This process is the final review of items such as incurred costs, cost transfers, and direct charging of clerical and administrative costs before submission of the final financial report. Unallowable costs not previously detected should be removed at this time and documentation not previously provided should be obtained for costs.

True or False?: For federal acquisitions below $150,000 vendors can provide quotes (including oral quotes) rather than bids and proposals.

True - If an acquisition is under SAT ($150k), it is therefore only subject to the regulations of FAR Part 13, under which quotes (including oral quotes) are acceptable. A an institution need not undergo a full blown proposal/bid process, but can utilize the small purchases process.

True or false: license fees and royalty income earned during the period of performance of an award must be reported as program income.

True -- under Uniform Guidance, this income is program income and must be reported as such if earned during the period of performance.

False

True or False: if an institution is approved for a one time extension of their current F&A rate, they can renegotiate before the term of 4 years ends

True

True or False: the required members of an IACUC committee can all be the same person.

True or false: the CFR contains statutes and regulations that are legally binding as statutory law.

True!

True or False: ITAR is responsible for governing export control for military and defense items and technology, while EAR governs dual-use technology.

True.

True or False: The US government is the world's largest single customer of goods and services

True.

True or false: Patent applications are relatively expensive and time-consuming to file.

True. Patent filing can be very costly and consume a lot of resources; this is why universities may be very selective in which patents they file.

True or false: the US government is required by law to provide opportunities for small businesses

True. This is to ensure that large businesses don't "muscle out" small businesses; To gain access to the new ideas small businesses are great at providing; To support small businesses as engines of economic development and job creation; To offer opportunities to disadvantaged socio-ethnic groups.

TINA

Truth and Negotiations Act

What is TINA? To what does it apply? What is the threshold?

Truth in Negotiations Act -- It applies to contracting, and requires offerors to submit certified cost or pricing data if a procurement exceeds the TINA threshold ($750,000) and none of the exceptions to certified cost or pricing data requirements applies.

What does TINA stand for? When is it applicable?

Truth in Negotiations Act. Applicable to federal procurement. It requires offerors to submit certified cost or pricing data if a procurement exceeds the TINA threshold -- the current TINA threshold is $750k.

IACUC Protocol Review

Two Methods of Review: 1. Full Committee Review (FCR) 2. Designated Member Review (DMR): All members receive the protocol and determine if it needs full committee review. If not, chairman assigns one or more reviewer. Three Actions of Full Committee Review 1. Approve 2. Require modifications to secure approval 3. Withhold approval

The Common Rule

Two references: 1. A102 Administrative Requirements for State and Local Governments 2. 45 CFR 46: this defines human subject and research; Applies to research funded in whole or in part by PHS (NIH)

Unrelated Business Income Tax (UBIT)

U.S. Internal Revenue Code is the tax on unrelated business income, which comes from an activity engaged in by a tax-exempt 26 USCA 501 organization that is not related to the tax-exempt purpose of that organization. Certain types of income are not considered unrelated business income, such as income from dividends; interest; royalties; rental of real property; research for a federal, state, or local government; and charitable contributions, gifts, and grants.

Deemed Exports

US export controls cover transfers of technology to a foreign national within the US (the transfer outside the US is deemed to apply when a foreign national receives information in the US) Applies to technology transfers under the EAR and provision of the ITAR technical data and defense services Includes source code (not encrypted source code) Unless fundamental research exclusion applies, a university's transfer of controlled technology to a non-permanent resident foreign national who is not a full time university employee in the US may be controlled and/or prohibited

Solomon Amendment 1996

US federal law that allows the secretary of Defense to deny federal grants to institutions of higher education if they prohibit or prevent ROTC or military recruitment on campus

Buy American Act (1933)

US government purchases and 3rd party purchases using federal funds must buy from US source if the US good is not more than a certain differential above the foreign good

What is USA.gov?

USA.gov is official web portal of US federal govt. designed to improve public's interaction with the US govt and links to state, local and tribal govts

Who enforces the Animal Welfare Act?

USDA's APHIS enforces the AWA. APHIS will make unannounced inspections at least annually; responsible for day to day compliance with the AWA.

Animal Welfare Act

USDA's APHIS will make unannounced inspections at least annually; responsible for day to day compliance

Patent applications are filed with _______

USPTO -- US Patent and Trademark Office.

200.445 Goods or services for personal use

Unallowable. Costs of housing allowable only as a direct cost

US Department of Agriculture

Unannounced annual inspections of animal care and use program: review any areas where animals are housed or used and all associated animal protocols and medical records. Annual reports of research facility and use submitted to the USDA. "USDA-covered species" refers to the "animals"as defined by AW

Fixed price contract with economic price adjustment

Uncertainty in labor market condition over period performance, allows for increase or decrease of price based on contingencies that were identified in the contract

OMB A-81

Uniform Guidance (!!!!)

OMB Circulars A-133, A-50 are contained where in Uniform Guidance?

Uniform Guidance Subpart F

Changes in direct costing rules from A-21 to Uniform Guidance (2 CFR 200): CONFERENCE COSTS

Uniform Guidance clarifies the definition of "conference." In order to be considered a conference, it must mean dissemination of info to an external audience --excludes meeting within the institution unless there are external participants.

OMB Circulars A-21, A-87, A-122 are contained where in Uniform Guidance?

Uniform Guidance subpart E

OMB Circulars A-89, A102, A110 are which parts of Uniform Guidance?

Uniform Guidance subparts B, C, and D

Circulars A-21, A-87, and A-122 are now...

Uniform Guidance, Subpart E

OMB A-110

Uniform administrative guidelines for grants and other agreements with institutions of higher education, hospitals, and other nonprofits Issued by the office of management and budget Relocated to 2 CFR 215

OMB Circular A-110

Uniform administrative guidelines for grants and other agreements with institutions of higher education, hospitals, and other nonprofits Issued by the office of management and budget Relocated to 2 CFR 215

OMB Circular A-81

Uniform guidance (2 CFR 200) Effective 12/26/14; eliminates OMB A-21, A-110, A-133, A-87, A-122, A-50, A-102, A-89; Uniform Administrative Requirements, Cost Principles, and Audit requirements for federal awards; purpose is to eliminate administrative burden and strengthen oversight of fed. funds to reduce fraud, waste, and abuse.; audits apply for FY16

C30: Property Standards

Uniform standards governing management and disposition of property acquired by a federal award

Sources of Cost Sharing

University funds Unfunded or waived indirect cost Another sponsored project (requires approval of both sponsors and is rare) Third parties (non-university sources)

Exemption for Disclosures to Bona Fide Full-time Employees (ITAR-regulated research only):

University release or disclosure of unclassified information to foreign nationals is exempt from export licensing if 1) the foreign national is the University's bona fide full-time regular employee, 2) the employee's permanent abode throughout the period of employment is in the U.S., 3) the employee is not a national of an embargoed country, and 4) the University informs the employee in writing that information disclosed may not be disclosed to other foreign nationals without governmental approval.

200.327 Financial Reporting

Unless otherwise approved by OMB, Fed awarding agency may solicit only the standard, OMB approved govt wide data elements for collection of financial info. Must be collected at least annually but no more than quarterly

PHS Innovation: bringing solutions to patients

Unmet medical need (suffer from medical conditions) Elucidate underlying problem (identifying problem) Innovation/solutions (develop solutions) PHS INNOVATION: Brings solutions to patents through commercialization partnership Develops commercialization strategy Identifies industry partners Creates start-up companies Creates patent protection strategy Provides venture funding Negotiates contracts Leverages hospital's infrastructure

Cost Sharing

Use of institutional funds to supplement project costs not borne by sponsoring agency. Either required by sponsor, to voluntarily reflect university financial support, or when award is less than proposals.

G5

Used for Electronic Research Administration of Department of Education awards

NSF RAPID

Used for proposals having a severe urgency with regard to availability of, or access to, data, facilities or specialized equipment, including quick-response research on natural or anthropogenic disasters and similar unanticipated events. - Budget consistent with project scope and existing programmatic activities (up to $200K for 1 year)

Risk Assessment Procedures

Used to obtain an understanding of the entity and its environment, including its internal control, financial stability, quality of management systems, history of performance, report findings from audits performed under Subpart F

iEdison

Used to report intellectual property arising out of Federally funded research as required by the Bayh-Dole Act

F&A cost rate proposal method (MTDC)

Used when grantee institution receives >$10,000,000 in federal funding in a fiscal year

Patentable items must be:

Useful Novel Non-obvious

CAS 501

Which one of the 4 basic requirements for Cost Accounting Standards is defined by: Consistency in estimating, accumulating and reporting costs?

200.434 Contributions and donations

Value of services and property may not be charged to the fed award either as a direct or indirect cost. Donated services and property may be used to meet cost sharing or matching requirements

Criteria for cost sharing expenses

Verifiable in accounting records Each expenditure used only once Necessary and reasonable expense Allowable as direct cost Itemized in budget (if required by sponsor) Incurred during effective dates of sponsored agreement

Biosafety Level 4 (BSL-4)

Very rare. Consists of work with highly dangerous and exotic microbes where infections caused are frequently fatal and come without treatment or vaccines. Personnel are required to change clothing before entering, shower upon exiting Decontamination of all materials before exiting Personnel must wear appropriate protective equipment as well as a full body, air-supplied, positive pressure suit. A Class III Biosafety Cabinet.

Equipment

Vests with non-federal entity upon acquisition. After the project is over, the expectation is that _________ is used to benefit other Federal awards, is cared for properly, and if the PI moves, the item moves with it if the government says so.

Veteran's preference (HR related)

Veterans and other eligible persons have special employment rights with the federal government. They are provided preference in initial hiring and protection in reductions in force.

200.306 Cost Sharing or Matching

Voluntary committed cost sharing not expected. It cannot be used as a factor during the merit review of proposals

Stark Law 42 USC 1395nn

What's prohibited? Physician referring Medicare patients for health services to an entity with which there is a financial relationship The entity cannot submit Medicare claims for services resulting from such a referral Applies to: Medicare/Medicaid; designated health services Penalties: Civil: Refund obligation false claims act liability Monetary penalties/program exclusion if knowing violation Potentially $15k civil monetary penalty per violation Civil assessment up to 3x amount claimed

Privacy Act of 1974

When an agency contracts for the design, development, or operation of a system of records on individuals on behalf of the agency to accomplish an agency function, the agency must apply the requirements of this Act.

Conflict of Interest Management Plan

When an individual has a significant financial interest they need:

Never

When can the Deciding Official be the same person as the Research Integrity Official?

200.335 Retention Requirements for records

When orig. records are electronic and cannot be altered, no need to create and retain paper copies, Methods for collection, transmission, and storage of info

Cost reimbursable agreement

When the Contractor is reimbursed for allowable costs incurred during contract performance. A total cost estimate is prepared and the award contains a ceiling that may not be exceeded without Sponsor approval. OMB Uniform Guidance cost principles apply.

Significant Financial Interest

When total income/assets that a researcher receives go above a certain level, the researcher may be asked to disclose, manage, or eliminate such financial interests.

Institutional Biosafety Committee

Which of the following is mandated for the oversight of research involving recombinant DNA

the Department of Commerce through Export Administration Regulations (EAR) and the Department of State through International Traffic in Arms Regulations (ITAR)

Who implements Export Control Laws?

Patents: section 101 of Title 35 USC

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. Patent allows it's owner to prevent others from making, using, selling and importing the protected invention (in the countries in which the patent is valid) "Discovers" is misleading because naturally occurring items are not patentable (example: bacterial species found in ice in Antarctica v Bacterial species that has been genetically engineered)

200.332 Fixed amount subawards

With prior written approval, PTE may provide fixed amounts up to the Simplified Acquisition Threshold ($150K)

DOE

Workplace Substance Abuse Programs - contractor required to conduct drug testing, provide training/ed, place disciplinary measures

documentation of informed consent

Written consent form/ signed by subject and provided w/copy; required format: 1. Written form that includes required information OR 2. Short form that indicates this was done orally - must be witnessed.

FAR Citation: 48 CFR (number)

XX (chapter) - XX (part).X (Subpart)XX (section)-XXX (subsections) XX-XX.XXX-XXX

Does the OLAW Guide cover mice, rats, birds, fish, and wildlife?

Yes - OLAW (PHS policy) addresses all live vertebrate animals, regardless of species and warm/cold-bloodedness. However, the Animal Welfare Act (USDA) only covers live warmblooded vertebrates excluding mice, rats, and birds.

Should a grant that includes service charges from a Recharge Center charge the same amount to the federal government as it would to a private customer?

Yes -- recharge centers should charge private and government indirect and direct costs, and the price should be the same for each customer

Adjustments

________________ to the Federal award amount based on an audit or other review after closeout must be made within the record retention period.

Solomon Amendment

a United States federal law that allows the Secretary of Defense to deny federal grants (including research grants) to institutions of higher education if they prohibit or prevent ROTC or military recruitment on campus. The exception is religious institutions with a history of passivism

Equal Pay Act of 1963 (29 USC 206)

a United States labor law amending the Fair Labor Standards Act, aimed at abolishing wage disparity based on sex (see Gender pay gap). It was signed into law on June 10, 1963, by John F. Kennedy as part of his New Frontier Program; No employer shall discriminate...between employees on the basis of sex by paying wages to employees at a rate less than the rate at which he pays wages to employees of the opposite sex for equal work on jobs[,] the performance of which requires equal skill, effort, and responsibility, and which are performed under similar working conditions, except where such payment is made pursuant to (i) a seniority system; (ii) a merit system; (iii) a system which measures earnings by quantity or quality of production; or (iv) a differential based on any other factor other than sex.

Material transfer agreement (MTA)

a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Biological materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds and even some types of software. Three types of MTAs are most common at academic institutions: transfer between academic or research institutions, transfer from academia to industry, and transfer from industry to academia. Each call for different terms and conditions.

Federal Demonstration Partnership (FDP) 1986

a cooperative initiative among federal agencies and institutional recipients of federal funds. It was established to increase research productivity by streamlining the administrative process and minimizing the administrative burden on principal investigators while maintaining effective stewardship of federal funds. NSF serves as the official host of participating agency documents relating to the FDP. Begun as an experiment in 1986 between five federal agencies (NSF, NIH, ONR, DOE, and USDA) and the Florida State University System and the University of Miami to test and evaluate a grant mechanism utilizing a standardized and simplified set of terms and conditions across all participating agencies. Effective July 1, 2008, FDP Federal agencies implemented use of Federal-wide Standard Terms and Conditions for Research Grants.

Institutions that have more than $25,000,000 in federal grants or contracts would be required to file

a disclosure statement (DS-2) with the federal government

Family Educational Rights and Privacy Act (FERPA)

a federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education.

Catalog of Federal Domestic Assistance - CFDA number

a government-wide compendium of Federal programs, projects, services, and activities that provide assistance or benefits to the American public. It contains financial and nonfinancial assistance programs administered gov. The primary purpose of the Catalog is to assist users in identifying programs that meet specific objectives of the potential applicant, and to obtain general information on Federal assistance programs. In addition, the intent of the Catalog is to improve coordination and communication between the Federal government and State and local governments.

Age Discrimination Act of 1975

a law which prohibits discrimination based on age in programs or activities that receive federal financial assistance; no person in the United States shall, on the basis of age, be excluded from participation, in be denied the benefits of, or be subjected to discrimination under, any program or activity receiving Federal financial assistance.

Human subject as defined by 45 CFR 46.102f

a living individual about whom an investigator (whether professional or student) conducting research obtains data, or identifiable private information through intervention or interaction with the individual

F&A def. of Predetermined Fixed Rate (NSF info)

a permanent rate established for a discrete period of time that corresponds to one or more of the organization's fiscal years. Organizations are permitted to charge NSF awards at the predetermined fixed rate(s) stipulated in the award document(s). However, if negotiations between the organization and NSF (or the cognizant Federal agency, if not NSF) result in changes to the organization's ICR during the award period, the organization may charge the award at the newly negotiated rate in effect when direct cost expenditures are made

The Nuremberg Code (1946)

a set of 10 research ethics principles for human experimentation set as a result of the subsequent Nuremberg trials at the end of the Second World War; trials centered on sterilization of millions in concentration camps without their knowledge. led to informed consent - basis of CFR 45 part 46 (common rule)

Declaration of Helsinki (1964 - Finland)

a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics; The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physicians' ethical duties. The Declaration more specifically addressed clinical research and a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available.

Nuremberg Code (1946)

a set of research ethics principles for human experimentation set as a result of the subsequent Nuremberg trials at the end of the Second World War.

In order for a foreign national student researcher to work on a federal grant in an American institution, it is necessary for the student to have: a. a visa b. United States citizenship c. evidence of English proficiency d. approval of student's embassy

a. a visa

FAR at 48 CFR Part 200

agency specific supplements

GOOD CLINICAL PRACTICE (GCP)

a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials and studies. - GCP is an international quality standard that is provided by the International Conference on Harmonisation (ICH). - ICH finalized guideline published May 1996 - 1997 the FDA endorsed the ICH GCP guidelines, published in the Federal Register May 9, 1997 - GCP compliance provides pubic assurance that the rights, safety, and well-being of human subjects involved in research are protected. The goals of GCP are: to protect the right, safety and welfare of humans participating in research; assure quality, reliability and integrity of data collected; provide standards and guidelines for the conduct of clinical research.

F&A def. of Maximum provisional rate (NSF info)

a temporary rate established to permit funding and reimbursement of indirect costs pending establishment of a final rate (that rate determined at the end of an accounting period using "actual" direct and indirect cost data.) This type of rate limits indirect cost recoveries to the LOWER of the maximum provisional rate established at the time of the award, or the final rate, established at the end of an accounting period

Def. of Continuing resolution

a type of appropriations legislation. When Congress and the president fail to agree on and pass one or more of the regular appropriations bills, a continuing resolution can be passed instead. A continuing resolution continues the pre-existing appropriations at the same levels as the previous fiscal year (or with minor modifications) for a set amount of time. Continuing resolutions typically provide funding at a rate or formula based on the previous year's funding. The funding extends until a specific date or regular appropriations bills are passed, whichever comes first. There can be some changes to some of the accounts in a continuing resolution. The continuing resolution takes the form of a joint resolution, and may provide bridging funding for existing federal programs at current, reduced, or expanded levels.

NIH Def. of Appeal

a written communication from a PD/PI and/or applicant institution that meets the following four criteria: 1) is received after issuance of the summary statement and up to 30 calendar days after the second level of peer review, 2) describes a flaw or perceived flaw in the review process for a particular application, 3) is based on one or more of four allowable issues and 4) displays concurrence from the AOR

NIH Def. of Greivance

a written communication from a PD/PI and/or applicant organization that presents concerns about the peer review process for a particular application and does not meet the criteria for an appeal

An anti-lobbying certification is required on federal grants, cooperative agreements and contracts exceeding a MINIMUM of: a. $100,000 b. $500,000 c. $1,000,000 d. 10,000,000

a. $100,000

What is the F&A that will be charged to the sponsor if you have direct costs of $100,000, a $25,000 piece of equipment, an F&A rate of 50% (MTDC), with the sponsor limiting your F&A to 10% of total direct cost? a. $7,500 b. $10,000 c. $37,500 d. $50,000

a. $7,500 $100,000 - $25,000 (equipment) = $75,000 $75,000 x 10% = $7,500

If an institution of higher education is subject to OMB Circular A-133, when must it have an independent audit? a. Annually b. Biennially c. Triennially d. At the discretion of its governing body

a. Annually

Which of the following is allowable as cost sharing? a. Equipment donated at fair market value b. Alcohol purchased for an allowable business dinner c. A portion of the salary of the department head's secretary d. Travel costs in excess of institutional per diem

a. Equipment donated at fair market value

Which of the following delegates to grantee authorization of one year, no-cost extensions? a. Expanded Authorities b. Cost Accounting Standards c. Public Law 106-107 d. Code of Federal Regulations

a. Expanded Authorities

Which of the following is essential to a Clinical Hygiene Plan? a. Material Safety Data Sheet (MSDS) file b. Monthly fire and safety drills c. Public information program d. Federal Food & Drug Administration inspection

a. Material Safety Data Sheet (MSDS) file

1. Which of the following defines fundamental research and indicates exception for restricting the flow of information: a. NSDD-189 b. USML c. CCL d. EAR99

a. NSDD-189

Which of the following is located within the National Institutes of Health? a. National Library of Medicine b. Centers for Disease Control and Prevention c. Food and Drug Administration d. National Institute for Occupational Safety and Health

a. National Library of Medicine

Standards for handling radioactive materials are developed and monitored by the: a. Nuclear Regulatory Commission b. Environmental Protection Agency c. Centers for Disease Control and Prevention d. Occupational Safety and Health Administration

a. Nuclear Regulatory Commission

Federal expanded authorities permit which of the following without additional sponsor approvals? a. Rebudgeting b. Change of the Institution c. Renovation of laboratory space d. Change of the principal investigator

a. Rebudgeting

Which of the following is responsible for clinical trail registration of Clinical Trials.gov? a. Sponsor b. Institution c. Sponsored research office d. Institutional Review Board (IRB)

a. Sponsor

In the event of cost overrun by a subcontractor, who would be held responsible by the funding sources? a. Subcontractor only b. Prime contractor only c. Project director and subcontractor d. Project directly and prime contractor

a. Subcontractor only

Which federal agency is responsible for prosecuting institutional violations of effort reporting? a. U.S. Department of Justice, under the False Claims Act b. Government Accountability Office, under the Code of Federal Regulations c. Office of Management and Budget, under OMB Circular A-133 Audit Requirements d. National Science Foundation Office of the Inspector General, under Congressional Oversight Authority

a. U.S. Dept of Justice, under the False Claims Act

Under a federal contract, which of the following is a reason for termination for default? a. Untimely performance b. Budget revision c. Cost overrun d. Inadequate performance on another contract

a. Untimely performance

Does A-21 apply to a. Subawards? b. Non-Federal awards? c. Fellowships?

a. Yes, FEDERAL subawards b. No c. No

Vertebrates animal info in PHS applications

a. identify the species and approximate number of animals to be used; b. rationale for involving animals, and for the appropriateness of the species and numbers used; c. a complete description of the proposed use of the animals; d. a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; e. a description of any euthanasia method to be used.

Efficient and effective operations and reliable financial reporting are the objectives of: a. internal controls b. research compliance c. cost transfer processes d. postaward administration

a. internal controls

The PHS policy governing the use and care of animals covers a. live, vertebrate animals only b. any animal use in research and training c. animals involved in research only d. animals that might otherwise be kept as pets only

a. live, vertebrate animals only

A facilities & administrative costs (indirect cots) rate is usually established based on: a. prior actual costs b. reimbursed costs c. capital expenses d. unaudited expenses

a. prior actual costs

Upon completion of a federal grant, excess funds remaining in the account should be : a. returned to the sponsoring agency b. transferred to another sponsored project c. assigned to institution's general funds d. included in proposal for an additional grant

a. returned to the sponsoring agency

The Fulbright Program provides opportunities for a. teaching abroad b. service abroad c. teaching n low income communities d. construction of low income housing

a. teaching abroad

Cost sharing must be: a. verifiable from records b. included with other federal awards c. paid from federal funds if it is a fellowship d. donated third party contributions

a. verifiable from records

Stevens Amendment

acknowledgement of federal funding when issuing statements, press releases, requests for proposals, bid solicitations and other documents - clearly state total cost of the program and the $ amount of federal funds

The Bayh-Dole Act

addresses ownership of intellectual property

Department of Justice

administers False Claims Act - any government dealing

Multiple Allocation Base Method

agency has several major functions which benefits from indirect costs in varying amounts - seldom used by nonprofit

Debarment and Suspension

all agreements in excess of $100k - aimed at delegating and punishing individuals and entities for fraudulent or improper use of govt funds

A-133 def. of research and dev.

all research activities, both basic and applied, and all development activities performed by a non-Fed entity. Research = a systematic study directed toward fuller scientific knowledge or understanding of the subject studied (includes activities training in research techniques when using same res. facilities and not instruction). Development = systematic use of knowledge directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes.

Expanded authorities

allow a grantee to adjust budgets as project needs change

Dependent Care Costs

allowable if the institution has a consistent policy of paying these costs

Solomon Amendment (1996)

allows the Secretary of Defense to deny federal grants (including research grants) to institutions of higher education if they prohibit or prevent ROTC or military recruitment on campus.

Representation

an account or statement of fact concerning an offeror and its capabilities and abilities to perform. It is viewed legally as an inducement to parties to enter into a contract. It may introduce terms into a contract and affect performance. May be a vital part of a contract, a "condition" of an award and an untruth may be the basis for an award being withdrawn. A "warranty" or an independent subsidiary promise, may allow the sponsor to claim damages, but normally will not provide grounds to invalidate the entire contract.

Impoundment Control Act

an act designed to reform the budgeting process by making Congress less dependent on the president's budget; established a fixed budget calendar and a budget committee in each house.

Def. of subaward (subrecipient)

an award provided by a pass-through entity to a subrecipient to carry out part of a Federal award; it does not include payments to a contractor. Determination of sub (depends on substance of relation, not form of agreement): (1) sub is eligible to receive Federal assistance; (2) its performance measured against whether objectives of Federal program were met; (3) resp. for programmatic decision making; (4) resp. for adhering to applicable Fed program requirements specified in award (5) uses the Fed. funds to carry out a program for a public purpose specified in authorizing statute, as opposed to providing goods or services for the benefit of the pass-through entity.

If an institution of higher education is subject to OMB A-133, it must have

an independent audit annually.

Def. of direct cost

any cost that can be specifically identified with a particular project, program, or activity or that can be directly assigned to such activities relatively easily and with a high degree of accuracy.

AWA def. of animal (and exclusions)

any live or dead dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warm-blooded animal; excludes (1) birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research, (2) horses not used for research purposes, and (3) other farm animals, such as, but not limited to livestock or poultry, used or intended for use as food

Auditee

any non-Federal entity that expends Federal awards which must be audited under subpart-F audit requirements of this part.

Significant Financial Interest

anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights) - must be 10k or higher (1995); 5k 2011

NIH Modular Budgets

applicable to R01, R03, R15 (Area), R21, R34 Up to $250,000 direct costs annually...Direct cost requested in modules of $25,000 (to determine how many modules follow—if less than $12-$15K over ask for the lower module....over $15K ask for the next module up. Flat funding ---no future year escalations, extra module(s) for justified purpose.

Walsh-Healey Act

applies to U.S. government contracts. It requires that a minimum wage, as well as overtime pay at 1.5 times regular pay rates, be paid to employees of manufacturers or suppliers entering into contracts with agencies of the federal government.

Ship American Act

applies to all awards - protects domestic industry by establishing a general preference for using domestic vessels

Buy American Act

applies to all awards, establishes a general preference for domestic articles, materials and supplies

Walsh Healy Public Contracts Act (PCA)

applies to contractors with contracts in excess of $10,000 for the manufacturing or furnishing materials, supplies, articles, or ship goods under these contracts....1936

Davis-Bacon Act (1931) - construction

applies to federal contracts over 2k for public works: requires payment of prevailing wages and benefits to employees of contractors (and subcontractors) engaged in federal government construction projects

Plagiarism

appropriation of another person's ideas, processes, results or words without giving appropriate credit

Authorized Organizational Representative (AOR)

assigned in grants.gov by e-biz point of contact (POC) who can delegate or revoke authority; AOR is the organization's authorized submitter of a Federal grant application

Cooperative Agreement

assistance involving the sponsor in the outcome of research results. Continual collaboration with the sponsor. May co-locate.

Grant

assistance without the expectation of tangible deliverables, other than a final report.

IRB—must have

at least 5 memebers....memberships should include at least one member; Whose primary concerns are scientific Whose primary concerns are non-scientific Who is not affiliated with the institution IRB must register with the Office of Human Research Protections (OHRP-HHS) Must register with FDA

The Belmont Report (general)

attempts to summarize the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in Feb. 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects

F&A Simplified Method

available to universities with direct funding under $10M; used when major functions benefit approximately to same degree

Standard of work

avoid and change the language to best efforts

A facilities and administrative cost (indirect cost) may be a direct cost if: a. it meets the definition of allocable b. "unlike circumstances" are present c. normally allowable on federal or federal flow-through awards d. the award activities are like those generally charged as facilities and administrative costs (indirect costs)

b. "unlike circumstances are present

Which of the following is most important in developing a program of available support within a grantee institution? a. Hiring of information specialist b. Regular dissemination of funding opportunities c. Development of subject-related database d. Establishment of potential investigator file

b. Regular dissemination of funding opportunities

Which of the following sources in NOT commonly used for FEDERAL funding opportunites: a. The Federal Register b. The Foundation Directory c. Commerce Business Daily d. The Catalog of Federal Domestic Assistance

b. The Foundation Directory

When a subaward is involved in a federal grant to a large university, on what portion of the subawardee's budget does the prime institution recover facilities and administrative costs (indirect costs)? a. None of it b. The first $25,000 c. The subawardee's modified total direct cost amount d. The amount is excess of $25,000

b. The first $25,000

International Traffic in Arms Regulations (ITAR) are controlled by the : a. United Nations b. U.S. Department of State c. U.S. Department of Homeland Security d. Bureau of Alcohol, Tobacco, and Firearms

b. U.S. Department of State

A federal agency responsible for negotiating and approving facilities and administrative cost (indirect costs) rates for an educational on behalf of all other federal agencies in referred to as the: a. lead agency b. cognizant agency c. sponsoring agency d. governmental agency

b. cognizant agency

Which of the following expenses would be include in the distribution base of modified total direct costs? a. travel b. equipment depreciation c. sponsored programs office expenses d. the portion of each subcontract in excess of $25,000

b. equipment depreciation

Prior approval from a federal agency is usually NOT needed when: a. the scope of work is changed b. personnel salaries are increased c. the principal investigator is changed d. additional alterations costing more than $10,000 are made

b. personnel salaries are increased

Under federal grant conditions, the title to equipment must a. remain with the agency b. remain with the institution c. be vested with the institution only under $5,000 d. be vested in the institution with the agency's right to transfer to itself or another entity

b. remain with the institution

If a principal investigator proposes to conduct research involving human subjects who will take a standardized educational test, but the test will not include any names or other identifying information, the proposal should be: a. reviewed by the full Institutional Review Board b. submitted for expedited review by the Institutional Review Board c. submitted for review to the Office of Human Research Protection d. treated under organization's policy as exempt from review

b. submitted for expedited review by the Institutional Review Board

The Institutional Animal Care and Use Committee (IACUC) is required to inspect animal facilities a MINIMUM a. one a month b. twice a year c. once a year d. once every three years

b. twice a year

Clinical Trial Agreements must

be conducted under an industry-authored protocol or investigator-authored protocol

. A federal agency issues a contract for an amount not-to-exceed $30,000. The contract specifies fixed hourly rates that include wages, overhead, general and administrative expenses, and profit for each category of labor. The contract also provides funding for the actual cost of materials. The contract type is: a) Firm Fixed Price b) Cost-reimburseable c) Time & Materials d) Fixed-price contract with economic price adjustment.

c) Time & Materials Contract -- An arrangement under which a contractor is paid on the basis of (1) actual cost of direct labor, usually at specified hourly rates, (2) actual cost of materials and equipment usage, and (3) agreed upon fixed add-on to cover the contractor's overheads and profit.

A particular RFP from the U.S. Department of Energy requires a 20% cost share on Total Project Costs (which include agency funds and the required cost share funds). The RFP also requires that 10% of the Total Project Costs be budgeted for technology transfer. If the 20% cost share funds total $100,000 then the amount to be budgeted for technology transfer is: a. $10,000 b. $40,000 c. $50,000 d. $80,000

c. $50,000 $100,000 / 0.20 = $500,000 (total project costs; agency funds + cost share) $500,000 * 0.10 = $50,000

How many days do recipients of federal grant funds have to submit final reports after completion of the project period? a. 30 b. 60 c. 90 d. 120

c. 90

When granted expanded authorities pre-award costs on a federal grant may be incurred by an institutional within a MAXIMUM of how many days prior to the official start date: a. 30 days b. 45 days c. 90 days d. 120 days

c. 90 days

Which of the following is mandated for the oversight of research involving recombinant DNA? a. rDNA Committee b. Biosafety Ethics Committee c. Institutional Biosafety Committee d. Institutional Biohazard Committee

c. Institutional Biosafety Committee

Which of the following is a frequently used base for facilities and administrative costs (indirect cost) computations a. Nonsalary costs b. Capitalized equipment c. Modified total direct cots d. Total direct costs less pre-award costs

c. Modified total direct cots

Which of the following is a base for facilities and administrative costs (indirect costs)? a. Subcontracts b. Capital Equipment c. Salaries and wages d. Professional and outside services

c. Salaries and wages

Access to federally funded research data is required under the: a. Solomon Act b. Davis-Bacon Act c. Shelby Amendment d. Stevens Amendment

c. Shelby Amendment

Which of the following establishes the actual facilities and administrative cost (indirect cost) rate for a subcontract? a. Prime recipient's rate b. Prime award agreement c. Subcontractor's normal rate d. Agreement between subcontractor and funding agency

c. Subcontractor's normal rate

Which of the following requires Institutional Animal Care and Use Committee (IACUC) review and approval governing the use of animals? a. When any animal is used b. Only when laboratory animals are used in instruction c. Whenever covered animals are involved in a protocol d. Only if a protocol involve sacrificing animals

c. Whenever covered animals are involved in a protocol

"Just in time" initiatives postpone the submission of which of the following items until a decision to make an award is reached? a. Full proposal b. Budget justification c. Certification and representations d. Research background of principal investigator

c. certification and representations

The federal government prefers to disburse funds under federal grants via: a. letters of credit b. reimbursement check c. electronic funds transfer d. advanced treasury checks

c. electronic funds transfer

agricultural experiment stations (AES) - first started 1875

came from land grant legislation, which required integration of research / teaching - practical teaching through creation of model farms called stations; Has a "project system" all research was to be related to a specific project at each station; E.g. at PA state, this means that all College of Ag. Sciences faculty must have a USDA-approved AES project or be part of one; All research in college must be conducted under specific USDA approved project (regardless of source).

InfoEd Proposal Development module

can generate a new electronic proposal template that is pre-loadd with relevant Sponsor and program details from SPIN

NSF Limited Submissions

can limit submissions to departments within an institution

Federal Drug Free Workplace (FAR 23.5)

can only get funds from federal government if certifies and publishes statement indicating that workplace is free of drugs, including manufacture, distribution, possession

Vulnerable populations include

children, wards of the state, prisoners, pregnant women and fetuses, persons who are mentally disabled or otherwise cognitively impaired, and economically or educationally disadvantaged persons.

Earmarks

circumvent Executive Branch merit-based or competitive allocation processes, specifies location/recipient

Program Fraud Civil Remedies Act 3 USC 381-3812

civil penalties

Uncommitted Voluntary Cost Sharing

contributions not quantified or reflected in the proposal. Not binding and do not require documentation or reporting.

Components of Internal Control

control environment, risk assessment, control activities, information and communication, monitoring

International Traffic in Arms Regulations (ITAR), CFR, 1993

control the export and import of defense-related articles and services on the United States Munitions List (USML). The Department of State Directorate of Defense Trade Controls (DDTC) interprets and enforces ITAR. Its goal is to safeguard U.S. national security and further U.S. foreign policy objectives. ITAR regulations dictate that information and material pertaining to defense and military related technologies (items listed on the U.S. Munitions List) may only be shared with U.S. Persons unless authorization from the Department of State is received or a special exemption is used.

development research

converts the results of applied research into useful commercial applications

Equipment donated at fair market value is an allowable

cost sharing

Def. of F&A

costs for common or joint objectives that cannot be readily identified with an individual project or program. Facilities operation and maintenance costs, depreciation, and administrative expenses are examples of costs that usually are treated as F&A costs

Test of allowability: def. of consistency

costs must be consistently DC or IDC regardless of source of funding

Small Business Administration (1953)

created as an independent agency of the federal government to aid, counsel, assist and protect the interests of small business concerns, to preserve free competitive enterprise and to maintain and strengthen the overall economy of our nation. Coordinates SBIR and STTR with federal agencies - e.g. USDA, DHHS, DOD, NIH, NSF, EPA, US Dept. of ED, DOE, NIST, NASA.

Office of Science and Technology Policy (OSTP) - 1976

created by Congress; provides the President and others... with advice on the scientific, engineering, and technological aspects of the economy, national security, homeland security, health, foreign relations, the environment, and the technological recovery and use of resources; OSTP also leads interagency science and technology efforts, assists OMB with an annual review and analysis of Federal research and development in budgets, and serves as a source of scientific and technological analysis and judgment for the President with respect to major policies, plans, and programs of the Fed. gov.

Council on Financial Assistance Reform (COFAR) - 2011

created by OMB to replace the GPC and the Grants Executive Board (GEB) (which was established in 2002); builds on the initiatives first outlined in The Federal Financial Assistance Management Improvement Act of 1999; comprised of an interagency group of Executive Branch officials to coordinate financial assistance; provides recommendations to OMB on policies and actions necessary to effectively deliver, oversee, and report on grants and cooperative agreements, as well as sharing with executive departments and agencies (agencies) best practices and innovative ideas for transforming the delivery of this assistance.

U.S. Nuclear Regulatory Commission (NRC) - 1974

created by congress as independent agency to ensure the safe use of radioactive materials for beneficial civilian purposes while protecting people and the environment. The NRC regulates commercial nuclear power plants and other uses of nuclear materials, such as in nuclear medicine, through licensing, inspection and enforcement of its requirements.

Federal budget process

created by the 1974 Budget Control Act; process starts 18 months before FY start (FY Oct thru Sept); federal agencies submit their budget requests to the OMB, which prepares and manages the budget for the President; OMB sends its budget review comments back to the agencies. They send final budget requests in December. OMB then assembles the final budget for the following fiscal year, and sends it to the President. President submits his budget to Congress, which addresses the following: - Funding levels for Federal agencies. - Changes to Mandatory programs already enacted by Congress. These include Medicare, Social Security, Medicaid,TARP and the Affordable Care Act. - Changes to the tax code. The budget must show the impact on Federal revenue. Congress uses the President's budget to prepare a Budget Resolution by April 15th. Each house of Congress develops their own budget proposals separately. The final Budget Resolution must approved by majority votes in the House and Senate. Congress creates spending Appropriation Bills by June 10th. The bills appropriate funds for each agency in the Discretionary budget. First, the House Appropriations Subcommittees prepare their bills and pass their bills internally. These bills go to the Senate, which revises and must approve them before they go to the President. The House must approve all the bills by June 30. However, often the President doesn't get them until September. Pres. approve these bills, veto them (starting the process all over again) or allow them to go forward without his approval within the next 10 days. All the bills must be signed into law before October 1st or CR happens to keep Federal agencies running at their current funding levels until a budget can be passed. If a CR isn't passed, then a government shutdown occurs. That means all non-essential Discretionary programs close, and workers are furloughed without pay.

National Research Act (Pub. L. 93-348) (July 12 1974)

created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles (commission created Belmont report)

Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191

created to improve the efficiency and effectiveness of the health care system; includes Administrative Simplification provisions that required HHS to adopt national standards for electronic health care transactions and code sets, unique health identifiers, and security.

1888 - office of exp. Stations (land grant info)

created under USDA; reviewed research portfolio, financial management, etc. of Hatch funds; Restricted Hatch funds to only support research of stations and not for education

A PI has permission to re-budget $50,000 in supplies funds to the equipment line item. In the institution's facilities and administrative cost rate based on MTDC is 50%, how much money will be available for the investigator to spend on equipment? a. $25,000 b. $33,333 c. $50,000 d. $75,000

d. $75,000 $50,000 X .5 IDC = $25,000 (F&A charged on Supplies) $25,000 + $50,000 = $75,000

An investigator on an NIH grant has permission to rebudget $50,000 in supply monies into equipment. If the institution's facilities and administrative cost (indirect costs) rate (based on MTD) is 50%, how much money will be available for the equipment? a. $25,000 b. $33,333 c. $50,000 d. $75,000

d. $75,000 $50,000 X 1.50 = $75,000

Recipients of federal grant funds must retain records for a MINIUMUM of: a. 180 days after closeout b. 18 month after the grant end date c. 2 years after each grant budget year d. 3 years from submission of final report of expenditure

d. 3 years from submission of final report of expenditure

Which of the following information must be included in the notification by a federal officer to the contractor to terminate a contract for convenience? a. Signature of program office b. The effective date of the contract c. A citation of the contract clause authorizing the termination d. A specific statement defining the reason for the termination notice

d. A specific statement defining the reason for the termination notice

How often do approved animal protocols need to be reviewed by the Institutional Animals Care and Use Committee (IACUC): a. Annually b. Semiannually c. Every 2 years d. Every 3 years

d. Every 3 years

Which of the following involves a conflict of interest? a. Faculty member owns and operates a business outside of university commitment b. Faculty member consults with outside business in area of expertise c. Faculty member supervises students employs them in university sponsored projects d. Faculty member is a major stockholder in a for-profit company receiving a university contract

d. Faculty member is a major stockholder in a for-profit company receiving a university contract

The National Institutes of Health requires a written description of a program for providing instruction in the responsible conduct of research for: a. program project grants b. competing research project grants c. noncompeting research project grants d. Institutional National Research Service Awards

d. Institutional National Research Service Awards

Which of the following would be required to file a disclosure statement (DS02) with the federal government? a. Institutions that have significant material findings from a government audit b. Institutions with more than $5,000,000 in capital expenditures c. Institutions with more than $10,000,000 in all sponsored projects d. Institutions that have more than $25,000,000 in federal grants or contracts

d. Institutions that have more than $25,000,000 in federal grants or contracts

According to federal regulations, which of the following must be included in an Institution Review Board? a. Ethicist b. Attorney c. Member of the clergy d. Member unaffiliated with the institution

d. Member unaffiliated with the institution

Which of the following agencies does NOT fund health science research? a. U.S. Army b. Department of Energy c. National Institute of Aging d. National Science Foundation

d. National Science Foundation

When applying for extramural support, in which of the following ways should the PI address prior related support? a. Prior intramural support should be ignored b. Prior intramural support can be considered as an item of cost sharing in the budget narrative c. Prior research related support should be considered unrelated in current grant request d. Prior intramural support should be addressed in the narrative

d. Prior intramural support should be addressed in the narrative

Which of the following is a primary purpose of a federal cooperative agreement? a. To allow for flexible budgeting b. To provide assistance with few restrictions c. To enable solicitation by a Request of Proposal d. To provide assistance with substantial involvement of federal agency

d. To provide assistance with substantial involvement of federal agency

The office for Human Research Protection is administered by: a. a private agency b. a nonprofit foundation c. an independent federal agency d. a cabinet-level department

d. a cabinet-level department

Upon receipt of awarded projects, educational institutions are required to establish? a. credit card account for the investigator b. combined accounts for easier investigator access c. noninstitutional savings account for the investigators d. individual accounts in an approved accounting system

d. individual accounts in an approved accounting system

A faculty member has a 5-yar federal NIH grant which will terminate 8/31, with $14,000 remaining on 7/15 of the same year. A competing continuation was recommended for approval but not funded. Which of the following is the most appropriate advise for the research administrator to give to the member a. buy as much equipment as possible before the grant year ends b. request a second review of the continuation application for the NIH c. transfer laboratory personnel salaries to the to use up the remaining funds d. request a 1-year, no-cost extension of the grant while revised continuation is under preparation

d. request a 1-year, no-cost extension of the grant while revised continuation is under preparation

Each organization using animals in Public Health Service projects must provide written assurance of its compliance with: a. regulations requiring full-time staff veterinarian b. provisions for an organizational program for the care and use of animals c. standard for accreditation with the American Association for Accreditation of Laboratory Animal Care d. requirements for organizational training and instruction program in the human practices of animal care and use

d. requirements for organizational training and d. requirements for organizational training and instruction program in the human practices of animal care and use

If a graduate student comes into a university sponsored research office charging that because of the federal Freedom on Information Act (FOIA) he has the right to obtain a copy of recently submitted proposal, the research administrator should a. provide student with a complete copy of the proposal b. provide student with a copy of the proposal with proprietary and salary information blacked out c. advise student to apply to the federal agency to request a proposal 90 days after the proposal was submitted d. tell the student to wait to apply to the federal agency until after the decision is made on the proposal

d. tell the student to wait to apply to the federal agency until after the decision is made on the proposal

The impetus to change the ways in which federal agencies accept grant applications and manage grant awards has been mandated by: a. e-Government strategies b. new audit policies at the Office of Management & Budget c. Office of Science & Technology Policy d. the Federal Financial Assistance Management Improvement Act of 1999 (Public Law 106-107).

d. the Federal Financial Assistance Management Improvement Act of 1999 (Public Law 106-107).

National Security Decision Directive 189 (NSDD-189)

defines fundamental research and indicates exception for restricting the flow of information (e.g. export controls); It says if federally funded basic scientific and technical information produced at colleges, universities and laboratories is to be controlled for national security reasons, it should be classified. But fundamental research findings generally are not to be restricted (are unclassified).

Drug-Free Work Place Act

denies federal funding from any institutions that do not have a drug-free workplace policy - for all contracts greater than $25, 000 or more; does not require testing

Syphilis Study at Tuskegee

developed National "Commission" for the protection of Human Subjects of Biomedical and Behavioral Research; commission developed Belmont Report

Text messaging while driving (EO 13513) (2009)

directs federal employees: not to engage in text messaging while driving government-owned vehicles; when using electronic equipment supplied by the government while driving; or while driving privately owned vehicles when they're on official government business; Each Federal agency, in procurement contracts, grants, and cooperative agreements, and other grants, entered into after the date of this order, shall encourage contractors, subcontractors, and recipients and subrecipients to adopt and enforce policies that ban text messaging while driving company-owned or -rented vehicles or GOV, or while driving POV when on official Government business or when performing any work for or on behalf of the Government.

The CFR (Code of Federal Regulations) is

divided into 50 titles that represents broad areas subject to regulation and is published by the Federal executive agencies/departments. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis

Small Business

employees don't exceed 500, independently owned, 51%

Animal Welfare Act

ensures that animals used in research, for exhibition, or as pets receive humane care & treatment; regulates transport, purchase, sale, housing, care, handling and treatment of such animals. Doesn't cover mice. 1966.

Contract Work Hours and Safety Standards Act

established 40 hpw -child labor laws....1962

Final Indirect Cost Rate

established after an organizations costs for a period are known. When established, based on financial statements, is often lower than provisional rate. No adjustments.

Equal Employment Opportunity Commission

established by Title VII of the Civil Rights Act of 1964 to assist in the protection of United States employees from discrimination - first federal law designed to protect most US employees from employment discrimination based upon that employee's (or applicant's) race, color, religion, sex, or national origin (Public Law 88-352, July 2, 1964, 78 Stat. 253, 42 U.S.C. Sec. 2000e et. seq.)

Predetermined Rate

established for period, no CF provision

Fixed rate

established for period, under-over recovery adjusted during next negotation

Provisional rate

established until actual rate is determined

Privacy Act of 1974 (Pub.L. 93-579, 88 Stat. 1896, enacted December 31, 1974, 5 U.S.C. § 552a)

establishes a Code of Fair Information Practice that governs the collection, maintenance, use, and dissemination of personally identifiable information about individuals that is maintained in systems of records by federal agencies. A system of records is a group of records under the control of an agency from which information is retrieved by the name of the individual or by some identifier assigned to the individual. The Privacy Act requires that agencies give the public notice of their systems of records by publication in the Federal Register. The Privacy Act prohibits the disclosure of information from a system of records absent the written consent of the subject individual, unless the disclosure is pursuant to one of twelve statutory exceptions. The Act also provides individuals with a means by which to seek access to and amendment of their records, and sets forth various agency record-keeping requirements. Additionally, with people granted the right to review what was documented on their name, they are also able to find out if the "records have been disclosed".. and are also given the rights to make corrections.

42 USC Chapter 6A

establishes discretionary funding

Walsh-Healey Public Contracts Act (PCA) - 1936 (part of new deal)

establishes minimum wage, max hours, and safety and health standards for work on contracts in excess of $10,000 for the manufacturing or furnishing of materials, supplies, articles, or equipment to the U.S. gov or DC (i.e. manufactured goods not for commercial items - those generally used by public / non gov items); no hiring of convicts or children under 16.

Types of human subject protection

exemption, expedited, full

SBIR Phase 2

expand on results and further development oh Phase I - up to 2 years and $1M

If a principal investigator proposes to conduct research involving human subjects who will take a standardized educational test, but the test will not include any names or other identifying information, the proposal should be submitted for what type of review by the Institutional Review Board?

expedited review

F&A Cost Categories

facilities, depreciation, interests, operation, maintenance, library, general and admin, sponsored program admin, departmental admin, student admin

Name some categories recovered through F&A.

facilities, depreciation, interests, operation, maintenance, library, general and admin, sponsored program admin, departmental admin, student admin

Traffic in Persons (2 CFR 175.15)

federal awarding agency is required to include term on prohibiting trafficking of humans in award document; includes IHEs as "private entity": the recipient, its employees, subrecipients under this award, and subrecipients' employees may not— i. Engage in severe forms of trafficking in persons during the period of time that the award is in effect; ii. Procure a commercial sex act during the period of time that the award is in effect; or iii. Use forced labor in the performance of the award or subawards under the award. Must flow down to subs

Administrative Procedures Act

federal law passed in 1946 establishing uniform procedures for federal agencies to propose and issue regulations, a process known as rulemaking.

41. US Code - (fed. procurement policy) public contracts

federal statutes (i.e. the laws governing) on public contracts (i.e. the procurement standards the government must follow when procuring supplies / services in support of that federal agency - federal contracts); can use simplified acquisition procedures listed in FAR for contracts under SAT (100k)

CFDA 5 digit number

first 2 digits represent federal agency, second 3 digits represent the program

Subaward

for the purpose of carrying out a portion of a Federal award and creates a Federal assistance relationship between the non-Federal entity and the subrecipient

Non-Federal Entity provided contract

for the purpose of obtaining goods and services for the non-Federal entity's own use and creates a procurement relationship between the non-Federal entity and the contractor

FAR at 48 CFR Part 53

forms

FAR Part 53

forms - which section?

Federal regulations governing the use of humans in research always require

full informed consent of the subject or the subject's guardian.

SBIR Phase II

funding not to exceed $1M total for a period of up to 2 years

STTR Phase1

funding threshold is $100k

STTR - NSF

funds for small businesses to conduct R&D on technology innovations that have the potential to be commercially successful and benefit society; STTR Phase I proposals establish technical feasibility of an innovation; funding up to $225,000 for 6 to 12 months; requires that the awardee small business undertake a portion of the R&D via a subaward to a non-profit research institution; Companies that receive a Phase I award can apply for a Phase II (award amount up to $750,000; duration 2 years); budget requires research inst. partner; min. of 40% to small bus; Min. of 30% to research partner.

NSF SBIR info

funds for small businesses to conduct research and development (R&D) on technology innovations that have the potential to be commercially successful and benefit society; Phase I proposals aim to establish technical feasibility of an innovation. Successful applicants will receive a grant of up to $225,000 for a period of 6 to 12 months; Companies that receive a Phase I award are eligible to apply for a Phase II award (award amount up to $750,000; duration 2 years). The primary employment of PI must be with the small bus. concern. 2/3 budget allocation must be for small business; optional research inst. partner.

1914 - Smith Lever Agricultural Extension Act (land grant info)

funds for vocational education for adults located in rural areas; This act led to first time use of "Matching funds", which required state to provide 1:1 match of amounts over 10k.

Freedom of Information Act (5 U.S.C. 552) (FOIA) - 1996

gives public right to request / access info from fed gov.; requires fed. gov agencies to publish info and rules on federal register for public comment; person may request record - gov shall produce record in format requested; 20 days to respond to request if will comply; defense, foreign policy, classified, trade secrets, medical files are excluded; may request fee; may request research data from non-fed entity with award.

Test of allowability: def. of allocability

goods/services are chargeable to cost objective in accordance with benefit received to that objective; allocable to grant if "it is incurred solely in order to advance work under the grant; it benefits both the grant and other work of the institution, including other grant-supported projects; or it is necessary to the overall operation of the organization and is deemed to be assignable, at least in part, to the grant. A cost is allocable as a direct cost to a grant if it is incurred solely in order to advance work under the grant or meets the criteria for closely related projects determination.

Trade secrets

governed by state laws, many states have adopted Uniform Trade Secrets Act - any secret information used by a business to obtain a competitive advantage over those who do not know it

Federal Funding Accountability and Transparency Act (FFATA) - 2006

government-wide reporting procedure for information about entities and organizations receiving federal funds - ensures that the public can access information on all entities and organizations receiving Federal funds. Central to the law was the development of www.USASpending.gov, a publically available website with searchable information on each Federal grant and contract over $25,000. sponsors responsible for reporting to usaspending.gov

Types of federal assistance - Block grants (mandatory spending)

grant programs that provide federal assistance for broadly defined functions, such as community development or social services. Block grants allow the grant recipient more discretion than other grants in determining how to use the funds to meet a broader program goal. Federal block grants are typically for U.S. state or territory governments and allow these government entities to determine specifically how to allocate and spend the funding. Of course, there are rules and guidelines for implementation that vary with each grant program as defined in the authorizing statute. Block grants are a type of mandatory grant. Examples: Community Dev. Block grant (HUB) and Social Services block grant (DHHS), TRIO (USDE).

Council on Governmental Relations (COGR) (1948)

group of medical centers, universities, research inst. that advocate for policies and practices that fairly reflect the mutual interests and separate obligations of federal agencies and research institutions as it relates to research and graduate education. COGR provides information, analyses, advice, policy perspective, and historical context to our members and by makes certain that federal agencies understand academic operations and the impact of proposed regulations on research institutions; COGR holds three meetings/year to keep its membership informed of any and all issues facing research institutions today

Radiation Safety Committee

group responsible for monitoring and maintaining a radiation-safe environment

Internal Controls

he organizational processes that institutions implement to ensure operational effectiveness and efficiency, reliability of internal and external reporting, and compliance with applicable laws and regulations.

an on-line system that provides the interface for reporting intellectual property

iEdison

Executive Branch Agencies

implement laws/rules using Code of Federal Regulations - 50 titles updated 1x each calendar year

Office of lab animals welfare (OLAW)

implements PHS policy; Inst. Animal welfare Assurance is filed and reviewed by OLAW - Assurance shall fully describe the institution's program for the care and use of animals in PHS-conducted or supported activities ; Inst. submits annual report to OLAW RE changes in accreditation, members, IO, & policy; program must be accredited by AAALAC

False Claims Act (31 U.S.C. §§ 3729-3733, also called the "Lincoln Law")

imposes liability on persons and companies (typically federal contractors) who defraud governmental programs. It is the federal Government's primary litigation tool in combating fraud against the Government. The law includes a qui tam provision that allows people who are not affiliated with the government, called "relators" under the law, to file actions on behalf of the government (informally called "whistleblowing" especially when the relator is employed by the organization accused in the suit). Persons filing under the Act stand to receive a portion (usually about 15-25 percent) of any recovered damages.

FCA examples

improper cost allocation, noncompliance with contract specification; no minimum threshold

Def. of Protected Health Info (inclusions and exclusions)

individually identifiable health information that is (i) Transmitted by electronic media; (ii) Maintained in electronic media; or (iii) Transmitted or maintained in any other form or medium. Excludes: (i) Education records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. 1232g; (iii) Employment records held by a covered entity in its role as employer.

HIPAA individually identifiable health information

information that is a subset of health information (see def of health info), including demographic information collected from an individual, and: (i) That identifies the individual; or (ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual.

A-133 Audit required for...

institutions that expend 500K (UG 750K) or more in federal funds annually...requirements for both prime and subawards

Efficient and effective operations and reliable financial reporting are the objective of

internal controls

Observational Studies

investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions or procedures as part of routine medical care, but are not assigned to specific interventions by the investigator (as in a clinical trial).

Institutional Biosafety Committee

investigators must submit to OBA certain info about protocols annually

General def. of clinical studies

involves research using human volunteers that is intended to add to medical knowledge; 2 types: clinical trials (also called interventional studies) and observational studies.

NIH-Defined Phase III Clinical Trial

is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.

Untimely Performance

is a reason for termination under a federal contract,.

Certification

is the submission of documents that serve as guarantees that the award applicant meets certain standards or will comply with certain governmental acts

Export Administration Regulations (EAR) - general

issued by the Department of Commerce, Bureau of Industry and Security (BIS) to control certain exports, reexports, and activities. The export control provisions of the EAR are intended to serve the national security, foreign policy, nonproliferation of weapons of mass destruction, and other interests of the United States; some controls are designed to restrict access to items subject to the EAR (commerce control list) by countries or persons that might apply such items to uses inimical to U.S. interests (dual-use items, sanctioned countries) Items that are under the jurisdiction of the EAR are categorized on the Commerce Control List (CCL). Items on the CCL are considered commercial or dual-use.

Select Agent Program (managed by CDC)

jointly comprised of the Centers for Disease Control and Prevention/Division of Select Agents and Toxins and the Animal and Plant Health Inspection Services/ Agriculture Select Agent Services; oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products. The Program greatly enhances the nation's oversight of the safety and security of select agents by: - Developing, implementing, and enforcing the Select Agent Regulations - Maintaining a national database - Inspecting entities that possess, use, or transfer select agents - Ensuring that all individuals who work with these agents undergo a security risk assessment performed by the Federal Bureau of Investigation/Criminal Justice Information Service - Providing guidance to regulated entities on achieving compliance to the regulations through the development of guidance documents, conducting workshops and webinars - Investigation of any incidents in which non-compliance may have occurred

Davis-Bacon Act 1931

laborers & mechanics...set wage rates on contract

NIH Clinical Trials Phase II

larger several hundred to determine efficacy and evaluate safety

Task Order Agreement

legally binding, authorizing work and appropriating funds as a supplement to a basic contract

Antideficiency Act (ADA), Pub.L. 97-258, 96 Stat. 923

legislation enacted by the United States Congress to prevent the incurring of obligations or the making of expenditures (outlays) in excess of amounts available in appropriations or funds.

National Historic Preservation Act

legislation intended to preserve historical & archaeological sites in the U.S. The act created the National Register of Historic Places, the list of National Historic Landmarks, & the State Historic Preservation Offices.The act requires Federal agencies to evaluate the impact of all Federally funded or permitted projects on historic properties (buildings, archaeological sites, etc.). Must comply with American s with Disabilities Act.

National Historic Preservation Act (NHPA) (Public Law 89-665; 54 U.S.C. 300101 et seq.)

legislation intended to preserve historical and archaeological sites in the United States of America. the act requires federal agencies to evaluate the impact of all federally funded or permitted projects on historic properties (buildings, archaeological sites, etc.) through a process known as Section 106 Review.

Shelby Act

legislation that requires research make available data produced under a federal award to the public

Animals covered by Animal Welfare Act

live or dead cat, dog, hamster, rabbit, nonhuman primate, guinea pig, and any other warm-blooded animal for research, pet use or exhibition

Animals covered by Animal Welfare Act

live warm-blooded vertebrates excluding mice, rats, and birds

The PHS policy governing the use and care of animals covers

live, vertebrate animals only

Fabrication

making up data or results and recording or reporting them

Institutional Biosafety Committee

mandated for the oversight of research involving recombinant DNA

Limitation of Costs

mandatory clause for CR-type contracts

Uniform Biological Material Transfer Agreement

master agreement that was developed by the NIH to simplify transfers of biological research materials. Institutions that have signed the UBMTA Master Agreement can transfer biological materials under the terms of the UBMTA by executing an Implementing Letter for each transfer (inst. to inst. transfer (not usually used with for-profit transfers)

Contracts ... publishing

may require prior review/approval for publications

Funding Opportunity Announcement (FOA)

mechanism by which a federal agency makes known its intentions to award discretionary grants or cooperative agreements

Biosafety: Biological Hazards

microorganisms, recombinant DNS, CDC list of select agents, genetically engineered organisms and products

1974 Congressional Budget and Impoundment Control Act

modified the role of Congress in the federal budgetary process. It created standing budget committees in both the House and the Senate, established the Congressional Budget Office, and moved the beginning of the fiscal year from July 1 to October 1

Cooperative Agreements

more reporting & more site visits....very similar to grants, always initiated by sponsor...substantive programmatic involvement by and with sponsor...terms and conditions underscore agency involvement.

Parent Announcements

new, continuing or expanded program interests of IC or to announce a new mechanism of support

NSF annual reports

no later than 90 days prior to the end of the current budget period

Title VI of the Civil Rights Act of 1964

no person b/c of race, color, or national origin shall be excluded from participation nor denied benefits, or otherwise subject to discrimination if program receives federal funds.

Supplies valued at $5,000 or more at the end of the project

non-Federal entity must retain the supplies for use on other activities or sell them, but must, in either case, compensate the Federal government for its share.

Office of Naval Research (ONR)

non-medical cognizant agency

Rights of the Federal government for copyrights produced under federal awards.

nonexclusive, irrevocable, royalty-free license to reproduce, translate, publish, and dispose of the material and to authorize others to use the work for government purposes

Truth and Negotiations Act

normally applies when an organization is sole source provider; does not apply where the contract is obtained through a competitive open big

PHS IACUC membership (5 members)

one veterinarian with training or experience in laboratory animal science and medicine, who has direct or delegated authority and responsibility for activities involving animals at the institution; one practicing scientist experienced in research with animals; one member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, member of the clergy); one member who is not affiliated with the institution other than as a member of the IACUC

Who is held responsible by the funding source in the event of a cost overrun by a subcontractor.

only the prime contractor

Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50 Subpart F, grants; and Responsible Prospective Contractors, 45 CFR Part 94, contracts) - 1995 reg.

original COI policy (NIH?) ensures that the design, conduct, or reporting of research funded under grants and cooperative agreements will not be biased by any conflicting financial interest of the Investigators responsible for the research

Drug free workplace exceptions

outside US, law enforcement with undercover agents, inconsistent with international obligations

Def. of Appropriations bills

part of US Fed. budget process - set by congress; An appropriations bill is a bill that appropriates (gives to, sets aside for) money to specific federal government departments, agencies, and programs. The money provides funding for operations, personnel, equipment, and activities. Traditionally, regular appropriations bills are passed annually, with the funding they provide covering one fiscal year; three types of appropriations bills: regular appropriations bills, continuing resolutions, and supplemental appropriations bills. Regular appropriations bills are the twelve standard bills that cover the funding for the federal government for one fiscal year and that are supposed to be enacted into law by October 1; supplemental appropriations bills, which add additional funding above and beyond what was originally appropriated at the beginning of the fiscal year. Supplemental appropriations bills can be used for things like disaster relief.

USAID- Mission

partner to end extreme poverty and to promote resilient, democratic societies while advancing our security and prosperity

Federal Financial Assistance Management Improvement Act of 1999 (P.L. 106-107)

passed by Congress to improve coordination among grant-making agencies AND to make the application and reporting process more consistent for people and organizations seeking Federal awards; Grants Policy Committee (GPC), carried out law (replaced by COFAR); expired in 2007;

Clinical Trial phases (drug development; defined by FDA)

phase 1: test based on preclinical results; healthy participants w/out disease; looks at Pharmacokinetic and pharmodynamic properties and side effects - small populations; short time period; phase 2 and 3: build on knowledge gained in phase 1; large populations; long time period; Investigate safety and efficacy of drug as a therapeutic response to disease; Phase 2 has restrictive inclusion criteria; Phase 3 participants may have other co-morbidity illnesses; phase 4: post market studies about the effectiveness and safety of the approved drug; can involve thousands of patients; simpler studies (b/c drug is already approved)

Patriot Act

places restriction on who can possess select agents and provides criminal penalties for possession that cannot be justified for peaceful purposes

Unsolicited applications

preponderance of applications submitted to NIH are investigator-initiated; reviewed in 3 review cycles per year

Fair Labor Standards Act (FLSA)

prescribes standards for wages and overtime pay; requires employers to pay at least fed. minimum wage and for non-exempt, overtime pay of one-and-one-half-times the regular rate of pay if work over 40 hours during workweek; does not require overtime pay for work on Saturdays, Sundays, holidays, or regular days of rest, unless overtime is worked on such days. The Act applies on a workweek basis. An employee's workweek is a fixed and regularly recurring period of 168 hours — seven consecutive 24-hour periods.

Anti-Deficiency Act

prevents involving the government in a contract for payment before appropriation is made. Budget confined to year-long period.

The Uniform Biological Material Transfer Agreement (UBMTA)

primarily for transfers between Academia and government labs or academic institutions

UG requirements of subreceipent risk assestment

prime entity must evaluate each subrecipients risk of non-compliance with Federal statutes, regulations, and the terms and conditions of the subaward for purposes of determining the appropriate monitoring. Factors include: Experience with the same or similar awards Results of previous audits New personnel, or new or substantially changed systems Extent and result of federal monitoring of the subrecipient Use Federal Audit Clearinghouse to verify audit reports (200.512) Depending on the risk assessment may need to: Provide subrecipients with training and technical assistance Perform on-site reviews Arrange for agreed-upon procedure engagements

Copeland Anti-Kickback Act

prohibits a federal contractor from convincing an employee to give up his compensation or work for less than the entitled federal law wage. procurement office not allowed to receive gifts from vendors..1934

Genetic Nondiscrimination Act of 2008

prohibits employers from making employment related decisions based upon genetic information

Federal Procurement Integrity Act

prohibits the release of source selection and contractor bid or proposal information. Also, a former employee who served in certain positions on a procurement action or contract in excess of $10 million is barred for one year from receiving compensation as an employee or consultant from that contractor.

Def. of Intangible property

property having no physical existence - trademarks, copyrights, patents/patent applications and property, loans, notes and other debt instruments, lease agreements, stock.

42 CFR 52

refers to NIH program establishment

System for Award Management (SAM)

registration system to submit applications, do business with government; requires annual registration / certifications; includes exclusion list;

Office of the Library of Congress

regulates copyrights

Nuclear Regulatory Commission

regulates radiation safety; committee reviews use and protocols

FFATA Subaward Reporting System (FSRS)

reporting tool Federal prime awardees (i.e. prime contractors and prime grants recipients) use to capture and report subaward and executive compensation data regarding their first-tier subawards to meet the FFATA reporting requirements.

Health Research Extension Act of 1985 (animal care)

required creation of proper care of animals in research with appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia; appropriate "pre-surgical and post-surgical veterinary medical and nursing care for animals in such research." Should not prescribe methods of research; creation of Animal care committees - each inst. Must have animal care committee to comply with guidelines, which is appointed by CEO, with no less than 3 members, and 1 without association with inst. And 1 is a vet.; Animal care committee should: Review care / treatment of animals at least semiannually and keep records; Files annual certification with NIH that review was done and report violation

1887 - Hatch Act (land grant info)

required these "ag. experiment stations" to be housed at inst. under Morrill act - provided funds to inst. (15k) from gov to conduct research / exp that related to agricultural industry of US - to connect research / teaching in a unified program to place practical knowledge in hands of public.

FAR clause 52.204-10 (Reporting Executive Compensation and First-Tier Subcontract Awards)

required to file a FFATA subaward report by the end of the month following the month in which the prime contractor awards any subcontract greater than $30,000 (2015), $25,000 before then

Institutional Animal Care and Use Committee (IACUC)

required to inspect animal facilities a minimum of twice a year

Davis-Bacon Act

required to pay wages not less than 1x/week at rate no less than minimum wage - laborers/mechanics

Effort Reporting

required when an individual is compensated by or agrees to contribute time to a federally sponsored project.

Effort Reporting

required when an individual is compensated by or agrees to contribute time to a federally sponsored project. Verifies payroll distribution AND cost-shared/contributed time.

Seat Belt Use (EO 13043) (1997)

requires Each Federal employee occupying any seating position of a motor vehicle on official business, whose seat is equipped with a seat belt, shall have the seat belt properly fastened at all times when the vehicle is in motion; Each Federal agency, in contracts, subcontracts, and grants entered into after the date of this order, shall seek to encourage contractors, sub-contractors, and grantees to adopt and enforce on-the-job seat belt policies and programs for their employees when operating company-owned, rented, or personally owned vehicles.

Family Medical Leave Act (FMLA)

requires employers of 50 or more employees to give up to 12 weeks of unpaid, job-protected leave to eligible employees for the birth or adoption of a child or for the serious illness of the employee or a spouse, child or parent.

Buy American Act (FAR Section 25.1) (1933)

requires grantees to prefer U.S.-made products in its purchases In certain government procurements, the requirement purchase may be waived by the Contracting Officer or the Head of the Contracting Activity (HCA) if the domestic product is 25% or more expensive than an identical foreign-sourced product, if the product is not available domestically in sufficient quantity or quality, or if doing so is in the public interest. Don't confuse with "buy America" act (RE: DOT mass transit purchases)

OMB A-110

requires record retention for Colleges and Universities

Drug Free School Act (1989)

requires schools to promote and establish drug-free school zones; allows plans for drug abuse prevention and education;

Drug-Free Workplace Act of 1988

requires some federal contractors and all federal grantees to agree that they will provide drug-free workplaces as a condition of receiving a contract or grant from a federal agency.

Drug-Free Workplace Act of 1988

requires that all organizations receiving grants from any Federal agency agree to maintain a drug-free workplace.

Public Health Service (PHS) Policies on Research Misconduct 42 CFR 93 (NIH specific)

research misconduct is defined as fabrication, falsification and plagiarism, and does not include honest error or differences of opinion; "Fabrication: Making up data or results and recording or reporting them" "Falsification: Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record." "Plagiarism: The appropriation of another person's ideas, processes, results, or words without giving appropriate credit." Requirements for allegation: 1. significant departure from accepted practices of the relevant research community; 2. was committed intentionally, knowingly, or recklessly; and 3. proven by a preponderance of the evidence; 6 year time limit for research misconduct to be brought to DHHS attention; ORI determines administrative actions (i.e. suspension, debarment, etc.); Inst. determines individual sanctions which can include loss of employment

Belmont Report

respect for persons, beneficence, justice

The Department of Agriculture

responsible for administering the Animal Welfare Act

Service and recharge centers

revenue neutral centers that have an established fee structure, dedicated staff, serve across departments, enhance funding opportunities, and are revenue neutral

IACUC review and responsibilities (PHS)

review must be done every 3 years; review, at least semiannually, the institution's program for the humane care and use of animals; inspect, at least semiannually, the institution's animal facilities (including satellite facilities); prepare reports to the Institutional Official (IO) of the IACUC evaluations; review animal welfare concerns; make recommendations to the IO on any aspect of the animal program, facilities, or personnel training; review and approve, those components of PHS conducted or supported activities related to the care and use of animals; review and approve, proposed significant changes to the use of animals in ongoing activities; and be authorized to suspend activity involving animals.

NSF Merit Review (criteria to review and types of review)

reviewers evaluate all proposals against 2 criteria: - Intellectual Merit: The Intellectual Merit criterion encompasses the potential to advance knowledge; and - Broader Impacts: The Broader Impacts criterion encompasses the potential to benefit society and contribute to the achievement of specific, desired societal outcomes. Ad Hoc review: Proposals sent out for review - reviewers usually have specific expertise in a field related to the proposal. - Some proposals may undergo ad hoc review only Panel review: face-to-face sessions conducted by reviewers mainly at NSF but also in other settings -Panel reviewers usually have a broader scientific knowledge. -Some proposals may undergo only a panel review. -Some proposals may undergo reviews by multiple panels (if across disciplines) Combination of Ad hoc / Panel Internal Review: Review by NSF PO only (e.g. RAPID, EAGER, Conferences/workshops)

Education Department Acquisition Regulation (EDAR)

revised 2011; The FAR System brings together, in title 48 of the Code of Federal Regulations, the acquisition regulations applicable to all executive agencies of the Federal government. This part establishes a system of Department of Education (Department) acquisition regulations, referred to as the EDAR, for the codification and publication of policies and procedures of the Department that implement and supplement the Federal Acquisition Regulation (FAR). Chapter 34 of CFR title 48

Federal Debarment / Suspension - Executive Order 12549--Debarment and suspension; from 1986;

rules around debarment and suspension, indicating that individual is debarred from all agencies; Section 9.4 in FAR outlines information regarding debarment; Information and list of excluded parties can be found in SAM; Includes exclusion from being a subaward; FAR contract clause = 52.209-6

Federal Acquisition Regulations - FAR

rules that provide a uniform set of policies and procedures for acquisition (contracts).

Name a few areas of exclusion faculty might consider when reporting significant financial interest (exempt from reporting these income sources):

salary royalties or remuneration from employing institutions; income from seminars/lectures/teaching engagements, service/advisory committees, review panels

Significant financial interest does not include

salary royalties or remuneration from employing institutions; income from seminars/lectures/teaching engagements, service/advisory committees, review panels

applied research

scientific study that aims to solve practical problems

IBC must report

serious adverse events that are unexpected and are possibly associated with human gene transfer intervention to OBA and IBC within 15 calendar days or 7 days if life threatening or fatal

F&A rate def. of fixed rate (NSF info)

set for the period covered under the funding action and is not subject to any adjustment or carry forward. Any funding action amendment to an award will be subject to the same rate(s) unless modified in writing by the NSF Grants Officer.

Occupational Safety and Health (OSH) Act

set in 1970; must provide safe / healthy workplace; general duties clause: employers must provide employees with work and a workplace free from serious hazards; OSHA =(OSH admin)

NIH Clinical Trials Phase III

several hundred to several thousand determine efficacy by comparing intervention to other standard or experimental intervention; monitor adverse effects and collect info to allow safe use

UG possible method of procurement - Small purchase procedures

simple and informal procurement methods for securing services, supplies, or other property that do not cost more than the Simplified Acquisition Threshold (150k). price or rate quotations must be obtained from an adequate number of qualified sources - requires bid; anything more than micro purchase amount, but less than 150k?

UG possible method of procurement - micropurchases

simplified acquisition procedures for supplies or services, the aggregate dollar amount of which does not exceed the micro-purchase threshold (org. $3,000, increased to 3500, then 10k effective 7/1/17); does not require competitive quotations if the price seems reasonable.

FedBizOpps

single government wide point of entry for federal govt procurement opportunities of $25k+

NIH Clinical Trials Phase I

small group 20-80 to determine efficacy and evaluate safety

UG possible method of procurement - noncompetitive proposals

solicitation of a proposal from only one source - single source applies (only available from one source); public exigency or emergency does not allow time for bidding; after solicitation of others, competition is inadequate

In-Kind

something that is already paid for as part of operation that will be allocated

Termination for default

sponsor is not obligated to any costs incurred

Termination for convenience

sponsor will pay for costs up to the termination notice

FFR (SF425)

standardized Federal Financial Report submitted to single location unless special system is used

FFATA change in 2010

start reporting on executive compensation and first-tier subawards through the development of the Federal Subaward Reporting System (FSRS). Grantees will be responsible for entering their executive compensation and subaward information into FSRS.gov.

Executive Order 12372 (E.O. 12372), "Intergovernmental Review of Federal Programs,"

structures the federal government's system of consultation with state and local governments on its decisions involving grants, other forms of financial assistance, and direct development. Under E.O. 12372, states, in consultation with their local governments, design their own review processes and select those federal financial assistance and direct development activities they wish to review. Since October 1, 1983, most states, have acted to establish a review and comment system in response to E.O. 12372. In such cases, applicants for grants will need to meet the requirements of the intergovernmental consultation process established by a particular state and its local governments before Federal agencies take action on the application. The CFDA lists the federal programs subject to review.

IACUC semi annual report

submits to institutional official and doesn't need to go to OLAW unless requested or submitting new/renewal

Belmont Report (1979)

summarizes the basic ethical principles and guidelines for the protection of human subjects of research. (Respect for persons, beneficence and justice)

Copeland "Anti-kickback" Act (1934)

supplemented the Davis-Bacon Act of 1931. It prohibits a federal building contractor or subcontractor from inducing an employee into giving up any part of the compensation that he or she is entitled to under the terms of his or her employment contract. The Copeland Act takes its name from U.S. Senator Royal S. Copeland, its primary sponsor. Copeland's Senate Subcommittee on Crime found that up to 25% of the federal money paid for labor under prevailing wage rates was actually returned by the wage-earner as a kickback to the employing contractor or subcontractor, or to government officials

National Endowment for Humanities

supports individuals institutions for research program and other activities in history, literature, philosophy, text preservation, museum exhibitions, TV and radio programs

Education Exemption (export controls)

the sharing of information commonly taught (ITAR) or educational information released by instruction in catalog courses and associated teaching laboratories (EAR). Therefore, in general, no license is required to share information as part of a course being taught. Note, however, that the education exclusion does not apply to proprietary information and certain information deemed classified or sensitive by the federal government.

Public Domain Exemption (export controls)

the sharing of technical data or information with a foreign national inside the U.S. as part of a class, laboratory, or conference or seminar, if the same technical data or information has already been widely published or is available in libraries or through newsstands, bookstores, subscriptions, or free web sites or is disclosed in published patent applications.

DHHS ORI def of plagiarism

the theft or misappropriation of intellectual property and the substantial unattributed textual copying of another's work. It does not include authorship or credit disputes

Liable

those who knowingly submit or cause another person/entity to submit false claims for payment of government funds are liable for 3x govt damages plus civil penalties ($5500-$11k/false claim)

UG guidance on intangible property

title vests to non-fed entity upon acquisition who may copyright work developed under fed. award - fed. reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so.

Funding threshold where A-133 applies to an institution (pre Uniform Guidance fact!)

to all institutions receiving more than $500k in sponsored support

Service Contract Act is not applicable

to any contract where the work is performed under the provisions of the Walsh-Healey Public Contracts Act

representations and certifications

to eliminate the administrative burden for contractors submitting the same information to various offices, this listing establishes a common source of compliance information. When submitting a proposal, the authorized organizational representative agrees to abide by these regulations and certifies that the institution is in compliance.

Cost-Sharing

typically requires actual cash contribution ... must have a source...must be from discretionary funds.

Buy American Act exceptions

unreasonable cost, quantity/quality, use outside of US, inconsistent with public interests, trade agreements

Federal Register

updated daily by 6 am Mon-Fri, except federal holidays

Types of Patents

utility, design, plant

Organizations receiving more than $10M in Federal funds must

utilize the Modified Total Direct Costs method of calculating F&A

Cost sharing must be

verifiable from records

IACUC 5 members

vet, practicing scientist experienced with animals, non-scientific; not affiliated with university

Name the 3 fundamentals of informed consent.

voluntariness, comprehension, disclosure (I know, I understand, I agree).

Fundamentals of informed consent

voluntariness, comprehension, purpose of study (disclosure, benefits)

If a graduate student comes into a university sponsored research office charging that because of the Federal Freedom of Information Act (FOIA) he has the right to obtain a copy of the recently submitted proposal, the research administrator should tell the student to

wait to apply to the federal agency until after a decision is made with the proposal.

Community of Science

web server containing info about scientific expertise, funded scientific research and funding opportunities

Intangible Property

§200.315

Davis-Bacon Act

• When does it apply?: Contracts for public works • Who does it apply to? o Contractors and subcontractors receiving federal contracts in excess of $2,000 for construction, alteration and repair of public works. • Intended purpose: o Avoid a "race-to-the-bottom" of employing unskilled or migrant workers. (Result of racialized prejudice against employment of black southern workers by northern white workers/unions) • Mnemonic: "Bringing home the bacon."

What are four types of small businesses that the government prioritizes working with?

• Women Owned Small Business - 5% • Small Disadvantaged Business - 5% • Service Disabled Veteran Owned Small Business - 3% • HUBZone - 3%

Trademarks

•Identifies source of the product or service - Distinctive sign or indicator •Protects company's goodwill •Protects consumers from confusion in the marketplace

Types of Intellectual Property

•Industrial: Patents, Trademarks, and Trade Secrets •Copyrights •Regulations and guidelines