2nd 28 sets
What is the micro-purchase threshold?
$3,500
TINA threshold
$700k
Each agency, in accordance with published rules, shall make WHAT available for public inspection and copying?
(A) final opinions, including concurring and dissenting opinions, as well as orders, made in the adjudication of cases; (B) those statements of policy and interpretations which have been adopted by the agency and are not published in the Federal Register; (C) administrative staff manuals and instructions to staff that affect a member of the public; (D) copies of all records, regardless of form or format, which have been released to any person under paragraph (3) and which, because of the nature of their subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records; and (E) a general index of the records referred to under subparagraph (D)
A-21
(Cost Principles for Educational Institutions): a circular published by the federal OMB that establishes the principles for determining the costs applicable to grants, contracts, and other gov't agreements with educational institutions (also known as Sponsored Projects)
Financial Conflict of Interest(FCOI)
- A situation that has the potential to undermine the impartiality of a person because of the possibility of a clash between the person's self-interest and professional interest or public interest. - A situation in which a party's responsibility to a second-party limits its ability to discharge its responsibility to a third-party.
NSF Responsible Conduct of Research (RCR) requirements
- AOR must certify that institution has RCR plan - Institutions responsible for content and frequency of training - Does not apply to conference, symposium, workshop or travel proposals
Cost Accounting Standards - CAS
- CAS are a set of 19 standards and rules promulgated by the United States Government for use in determining costs on negotiated procurements - CAS governing sponsored projects financial administrations are sections (501, 502, 505 and 506) and a disclosure statement (DS2) - The DS is a comprehensive description of an organization's cost accounting practices and includes Direct costs and F&A costs - Federally mandated accounting standards intended to ensure uniformity in budgeting and spending funds - Applies to contracts > $100,000 - CAS differs from the Federal Acquisition Regulation in that FAR applies to substantially all contractors, whereas CAS applies primarily to the larger ones - in UG 2 CFR 200, part 200.419
Grants.gov
- Grants.gov is your source to FIND and APPLY for Federal government grants - Workspace allows multiple collaborators to work on the same applications package. - Can download/upload documents or work via fillable online forms - Provides review of proposals after submission
Code of Federal Regulations (CFR)
- The 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. It is revised annually. - The CFR 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.
The main elements of a Review of Animal Use Protocol are?
- ensuring the procedures will minimize discomfort, distress & pain - ensuring that procedures with more than momentary or slight pain is preformed with appropriate sedation, analgesia or anesthesia unless properly justified - animals that would experience sever or chronic pain will be painlessly killed at the end of the procedure - living conditions will be appropriate to their species and contribute to their health and comfort - medical care will be provided as necessary by a qualified vet - personnel conducting procedures will be appropriately qualified and trained. - methods of euthanasia will be consistent with the AVMA Panel on Euthanasia unless properly justified - renewal reviews must be done every 3 years - modifications to the protocol must be reviewed - inspections by PHS or USDA APHIS may happen at any time (APHIS restricted to up to every 6 months)
Defense Acquisition Regulations - DAR
- is a supplement to the FAR that provides DoD-specific acquisition regulations that DoD government acquisition officials - and those contractors doing business with DoD - must follow in the procurement process for goods and services. - the source of regulations for research projects sponsored by the Department of Defense. - 48CFR, chapter 2
The Office of Laboratiory Animal Welfare (OLAW) does what?
- oversees the care and use of research animals in Public Health Service (PHS)-funded research - provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, - supports educational programs, and - monitors compliance with the Policy - relies on certification by institutions and - oversees all IACUC activities and ensures compliance - covers all Live Vertebrate animals
Code of Federal Regulations (CFR) p2
-45 CFR Part 46 is the part covering the protection of human subjects - 45CFR Part 74 - Uniform Administrative Requirements for awards and subs to HE institutions, Hospitals and Other NP orgs. Includes: - Pre award policies - Specials award conditions - Certifications and representations
Code of Federal Regulations (CFR) p3
-A publication of the U.S. government that prints executive orders, rules, and regulations. -Provides access to the official text of: Federal laws Presidential documents Administrative Regulations and Notices (proposed, Interim and final rules) -Descriptions of federal organizations, programs and activities.
Responsible Conduct of Research (RCR)
-Fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results. -Credible allegations of Research Misconduct trigger reporting requirements. -Notification to the Office of research integrity (ORI) and individual sponsors
Departments under Department of Defense (DoD)
-ONR -AFORS -ARO -DARPA
NIH Funding Mechanisms
-Research -Program -Training -Resource -Trans-NIH
Biological hazards include?
-micro organisms including infectious agents -Recombinant DNA (rDNA) -CDC list of special agents -Genetically Engineered Organisms & Products
IRB 5 members
1 primary concern in scientific areas, 1 primary concern is not scientific, 1 not affiliated with institution
Name the 2 types of intellectual property protections that may apply to computer software:
1) Copyright 2) Patent
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 5 Independent Federal Funding Agencies
1) NSF 2) NASA 3) USAID 4) NEA 5) NEH
Assessment of allowable cost
1.A cost may be expressly unallowable as direct and indirect costs 2.May be allowable but only as indirect cost 3.A cost allowable as a direct cost should not be included in the F&A rate 4.Generally it is not the type of cost that determines allowablity; it's the purpose and circumstance of the expenditure 5.Direct cost must be necessary for the performance of the project and consistent with policies
Allowability of costs:
1.The cost is reasonable 2.The cost is allocable-can be assigned to a specific sponsored project 3. Given consistent treatment (across institution) 4. Conform to any limitations or exclusions (eligible for reimbursement) set forth by federal government principles
SBIR # of participating federal departments
11
Design Patent
14 years from the date of issue
Animal Welfare History
1961 - Animal Care Panel was formed by a group of veterinarians 1963 - the Animal Care Panel published the "Guide for the Care and Use of Laboratory Animals" 1963 - an Accredidation committee is formed independent from the Animal Care Panel and named American Association for the Accreditation of Laboratory Animal Care (AAALAC) 1966 - Animal Welfare Act was created by the US Congress naming USDA APHIS as the agency responsible for inspecting animal use facilities 1971 - the Animal Welfare Act is revised to allow institutional compliance through an animal care committee or via AAALAC accreditation 1979 - PHS policy took over requiring an animal care committee for each animal-using grantee institution and expanding the species covered to include all vertebrates. The animal care committee was required to have five members with expertise to regulate animal welfare at that institution, including at least one veterinarian. 1985- NIH enacts the Health Research Extension Act via PHS policy and the Office of Laboratiory Animal Welfare (OLAW) 1986 - the term IACUC "Institutional Animal Care and Use Committee" was introduced to refer to the PHS required institutional committees in an amendment to the Animal Welfare Act an updates to the PHS policy - updates also included mandatory 2 year inspections of animal use facilities and the modern composition of the IACUCs
OSHA Act
1970 - applies to all agreements over $2500
Federal regulations require that any reduction in effort on a sponsored project of ________ of the committed effort be approved by the sponsor.
25% +
Activity Code
3-Character Code used to identify a specific catergory of extramural research activity, applied to various funding mechanisms ie R01, t32
How many days does the FDA have to approve an application?
30 days
Before any drug can make it to market how many phases must they go thru?
4 phases
How many types of visits are there?
4 visits
NSF
7 directorates and 3 offices awarding basic and applied research in social, behavioral, biological, physical, math, computer, geological science, engineering and science education
cognizant agency
A Federal agency responsible for negotiating and approving facilities and administrative cost rate for an education institution on behalf of all other federal agencies is referred to as the
Nondisclosure Agreement
A Local Business wants to meet with a PI to discuss a product that they might agree to begin work on. What should be done?
Award terms and conditions
A Notice of Award typically includes which of the following
Clinical Trial
A biomedical or behavioral research study of human subjects designed to answer specific quesions about biomedical or bahavioral interventions (durgs, treatments, devices)
Encumbrance Funds
A commitment to purchase something that has not yet been paid for.
The main ingredient in a drug is called?
A compound
Cost-Reimbursement Type
A contract / grant for which the sponsor pays for the full costs incurred in the conduct of the work up to an agreed upon amount.
fixed-price contract
A contract for which one party pay the other party a predetermined price, regardless of actual costs, for services rendered. Quite often this is a fee-for-service agreement.
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 an activity based on the relative benefits received
Critical Path Method (CPM)
A critical path describes the sequence of project network activities with the longest overall duration. With CPM you want to construct a model of your project that includes a list of all activities required to complete the project the time it takes for each activity to complete and the dependancies between all these activitis...can be used to ensure that the logic of the plan is accurate....possible to have mulitple papallel near critical paths
Catalog of Federal Domestic Assistance (CFDA)
A database which helps the federal government track all programs it has domestically funded (referred to as the CFDA number)
An investigator is usually?
A doctor or physician
Subcontract, Sub-grant, or Sub-agreement
A document written under the authority of, and consistent with the terms and conditions of an award (a grant, contract or cooperative agreement), that transfers a portion of the research or substantive effort of the prime award to another institution or organization.
Intellectual Property
A form of capital or wealth which refers to creations of the mind for which exclusive rights are recognized.
Cost Sharing
A general term, used as a noun or adjective, that can describe virtually any type of arrangement in one party supports research, equipment acquisition, demonstration projects, programs, institutions.
Task Order Agreement - TOA
A legally binding document authorizing work and appropriating funds as a supplement to a basic contract.
Limitation of Cost (LOC)
A mandatory clause for cost-reimbursement type contracts under which the sponsor is not obligated to reimburse the contractor for costs in excess of the stated amount. The contractor, however, is not obligated to continue performance once expenses reach the stated amount.
Contract
A mechanism for procurement of a product or service with specific obligations for both sponsor and recipient. Typically, a research topic and the methods for conducting the research are specified in detail by the sponsor, although some sponsors award these in response to unsolicited proposals.
Stipend
A payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training.
Can a private person bring civil action for violation of section 3729 of the
A person may bring a civil action for a violation of section 3729 for the person and for the United States Government. The action shall be brought in the name of the Government. The action may be dismissed only if the court and the Attorney General give written consent to the dismissal and their reasons for consenting. (2) A copy of the complaint and written
What's another name for a sugar pill?
A placebo
Funding Opportunity Announcements
A publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds.
Letter of support
A straight forward document stating that the institution is in support of the application to proceed and that it will host the proposed research should the application be successful.
Cooperative Agreement (U Series)
A support mechanism used when there will be substantial Federal scientific or programmatic involovement
iEdison
A system administered by NIH; it enables institutions and federal agencies to manage inventions electronically.
Bequests
A type of donation or gift with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs.
What is a grant?
A type of financial assistance awarded for the conduct of research and no substantial programmatic involvement with the recipient during the performance of the activities.
Community of Science - COS
A web server containing information about scientific expertise, funded scientific research, and funding opportunities for research.
Trademarks
A word, phrase, symbol or design, or combination of words, phrases, symbols or designs, which identifies and distinguishes the source of the goods or services of one party from those of others. It arises from actual use of the mark, or the filling of a proper application to register in the Patent and Trademark Office. Anyone who claims rights to a mark can use "TM" or "SM" with out registration, however, (R) can only be used if the symbol has been registered with PTO.
Change Order
A written order signed by the Contracting Officer, directing the contractor to make changes that the changes clause of the contract authorizes the CO to order without the consent of the contractor.
Change Order
A written order signed by the contracting officer, directing the contractor to make changes that the changes clause of the contract authorizes the contracting officer to order without the consent of the contractor.
Does A-21 serve as the cost principle guidance for grants or contracts?
A-21 provides cost principles for Grants (assistance funding).
What is AAALAC?
AAALAC International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. Established in 1971? More than 1,000 companies, universities, hospitals, government agencies and other research institutions in 47 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC's program, in addition to complying with the local, state and federal laws that regulate animal research. Some of the institutions that have earned AAALAC accreditation include the Sloan-Kettering Cancer Center, St. Jude Children's Research Hospital, The American Red Cross, and the National Institutes of Health.
Bayh-Dole Act (1980)
Accepting federal funding for research imposes certain responsibilities to bring discoveries made during the course of research to commercial development so that they can benefit the citizenry. This act sets forth these responsibilities.
Shelby Amendment
Access to federally funded research data is required under the
allowable only if approved by the sponsoring agency
According to OMB Circular A-21, costs incurred prior to the project start date are:
Member unaffiliated with the institution
According to federal regulations, which of the following must be included in an Institutional Review Board?
What are the basic purposes of the APA?
According to the Attorney General's Manual on the Administrative Procedure Act (1947), drafted after the 1946 enactment of the APA, the basic purposes of the APA are (1) to require agencies to keep the public informed of their organization, procedures and rules; (2) to provide for public participation in the rulemaking process; (3) to establish uniform standards for the conduct of formal rulemaking and adjudication; (4) to define the scope of judicial review
Subpart A
Acronyms and Definitions
International Traffic in Arms Regulations (ITAR)
Administered by the Department of State, regulates and restricts the transfer and export of technologies relating to military applications listed on the Munitions Control List (MCL).
2 CFR 215 OMB A-110
Administration Regulation for Education Institutes, Hospitals, and Non profits
What are Research Administrators?
Advocate, Facilitator, Gatekeeper, Reviewer, Enforcer, Motivator, Resource Locator, Interpreter,Team Builder,Compliance Manager
Small Business Innovative Research (SBIR)
Agency administered programs supported by ear-marked federal funds, making grants to small business entities.
NSF Data sharing plan policy
All NSF proposals must include a supplementary document that provides for a data management plan
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
Formula Grants
Allocations of money to States or their subdivisions in accordance with distribution formulas prescribed by law or administrative regulation, for activities of a continuing nature not confined to a specific project.
Allocable Costs
Allowable Costs that benefit the grant or contract to which they are being charged
Federal regulations governing the use of humans in research
Always require full informed consent of the subject or the subject's guardian
STTR Qualifications - Business
American-owned and independently operated ; For-profit; Principal researcher need not be employed by small business; Company size limited to 500 employees
Teaming Agreement
An agreement between two or more parties to participate in a research project or teaching activity
Cost contingency
An amount aded to an estimate to allor for items, conditions or events for which the state, occurrence or effect is uncertain and that experience shows will likely result in aggregrate in additional costs.
Broad Agency Announcement - BAA
An announcement of a federal agency's general research interests that invites proposals and specifies the general terms and conditions under which an award may be made.
Code of Federal Regulations (CFR)
An annually revised codification of the general and permanent rules published in the Federal Register
$100,000
An anti-lobbying certification is required on federal grants, cooperative agreements, and contracts exceeding a MINIMUM of
Council on Government Relations (COGR)
An association of Research Universities, founded in 1948, which has been continuously involved in the development of all major financial and administrative aspects of federally-funded research. Today, the group's primary function is to provide advice and information to its membership and to make certain the federal agencies understand academic operations and the impact of proposed regulations on colleges and universities. This group helps to develop policies and procedures that fairly reflect the mutual interests and separate obligations of federal agencies and universities in research and graduate education.
Cooperative Agreement
An award similar to a grant, but in which the sponsor's staff may be actively involved in proposal preparation, and anticipates having substantial involvement in research activities once the award has been made.
A career development program
An employee in a position which does not enable realization of full potential would benefit most from
No Cost Time Extension
An extension of the period of performances beyond the expiration date to allow the principal investigator to finish a project. Usually, no additional costs are provided.
What is a "deemed export"
An item is "deemed" to be exported when a foreign national is given access to it (whether on or off US soil).
SPIN Sponsored Programs Information Network
An on-line search system available by subscription for research opportunities developed by the InfoEd.
Before animals can be ordered or used, the PI must receive approval form IACUC by completing an...
Animal Use Protocol Application
APHIS
Animal and Plant Health Inspection Service
Pre-clinical trials are done on??
Animals, microorganisms, and tissue
Work for Hire
Any work prepared by an employee within the scope of his or her employment, or certain types of work specially ordered or commissioned for use, and parties expressly agree in writing that it shall be work made for hire.
Renewal
Applicable to grants and cooperative agreements only. A competitively reviewed proposal requesting additional funds extending the scope of work beyond the current project period.
Continuation Project (Non-Competing)
Applicable to grants and cooperative agreements only. A project approved for multiple-year funding, although funds are typically committed only one year at a time. At the end of the initial budget period, progress on the project is assessed. If satisfactory, an award is made for the next budget period, subject to the availability of funds. They do not compete with new project proposals and are not subjected to peer review beyond the initial project approval.
Goals/Objectives/SOW/Implementation
Applicant should explain the expected results and benefits of each objectives.
Data sharing plan/ Publish and Share
Applicant who are planning to share data may wish to describe briefly the expected scheduled for data sharing, the format of the final data set, the documentation to be provided, whether or not any analytic tools also will be provided and so on ...
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.
NIH Data sharing plan policy
Applies to proposals seeking direct costs of > $500,000.00 /yr
What are allowable costs
Are costs that can be legitimately charged to a grant. An award refers to those funds that have been obligated by a funding agency for a specific project.
Facilities and Administrative Costs-
Are synonymous with indirect costs incurred for a common or joint objective and therefore cannot be identified as a specific project activity.
AAALACI
Association for Assessment and Accreditation of Lab Animal Care International; reaccreditation every 5 yrs
Subpart F
Audit Requirements
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).
Appendix XII
Award Term and Condition for Recipient Integrity and Performance Matters
Bequests
Awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available. The unique flexibility, or lack of restrictions, makes gifts attractive sources of support. (Also see Gifts).
Civil Rights Act
Bars recipients of federal funds from excluding persons because of race, sex, color or national origin or religion from participation in receiving benefits or otherwise subjecting them to discrimination under federally supported programs or activities. (1964)
What is the Civil Rights Act?
Bars recipients of federal funds from excluding persons because of race, sex, color, or national origin from participation in receiving benefits or otherwise subjecting them to discrimination under federally supported programs or activities. Law also interpreted to cover discrimination against those persons with limited English. Sex includes pregnancy, childbirth or related medical conditions.
What is the fundamental research exemption to export control regulations?
Basic and applied research in science and engineering that is ordinarily shared broadly within the scientific community is exempt from some restrictions.
________ 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)
Why was the APA enacted?
Beginning in 1933, President Franklin D. Roosevelt and the Democratic Congress enacted several statutes that created new federal agencies as part of the New Deal legislative plan, designed to deliver the United States from the social and economic hardship of the Great Depression. However, following the Great Depression and World War II the Congress became concerned about the expanding powers that federal agencies possessed, resulting in the enactment of the APA to regulate and standardize federal agency procedures
Executive Branch
Branch of U.S. Government in which power is vested in the President of the United States. The President is responsible for implementing and enforcing the laws written by Congress and, to that end, appoints the heads of the federal agencies, including the Cabinet. The Cabinet and independent federal agencies are responsible for the day-to-day enforcement and administration of federal laws.
Indirect Cost examples;
Building, equipment, interest expense, operations and maintenance, general administration, general expenses, departmental administration, library, sponsored projects administration, student services
2 CFR 220
COST PRINCIPLES FOR EDUCATIONAL INSTITUTIONS (OMB CIRCULAR A-21)
2 CFR 230
COST PRINCIPLES FOR NON-PROFIT ORGANIZATIONS (OMB CIRCULAR A-122)
2 CFR 225
COST PRINCIPLES FOR STATE, LOCAL, AND INDIAN TRIBAL GOVERNMENTS (OMB CIRCULAR A-87)
Physician Payments (Sunshine Act)
Calls for increased transparency about the financial relationships between physicians and industry resulted in this act as part of the Patient Protection and Affordable Care Act.
STTR
Central program to expand the public/private sector partnership to include joint venture opportunities for small business and nonprofit research institutions. The program requires a small business be American-owned, for-profit, with no more than 500 employees. The business must also partner with a university and other non-profit research institution to have a formal collaborative relationship. The research institution must be located in the U.S. and be either a non-profit college or university, domestic non-profit research organization, or a federally funded R&D center. At least 40% of the STTR research project is to be conducted by the small business and at least 30% by the partnering research institution. Five federal agencies participate in this program.
What Transactions Fall Outside the FAR's Coverage?
Certain transactions, by their nature, are not subject to the FAR. Notable examples of such transactions are •any agency contract or agreement that is not a procurement contract(i.e., not a contract that uses appropriated funds to acquire property or services for the direct use of the United States), including "other transactions"(i.e., non-procurement contracts that authorized agencies may use for research and/or development of prototypes);21•grantsand cooperative agreements;22•contracts with third parties entered into by persons using federal funds from a grant, cooperative agreement, or other federal financial assistance;23•purchases or leases of real property;24 and •transactions where Congress has authorized a government entity to acquire goods or services "notwithstanding any other provision of law."25
Direct Costs
Clearly identifiable costs related to a specific project. General categories of directs costs include, but are not limited to, salaries and wages, fringe benefits, supplies, contractual services, travel and communications, equipment, and computer use.
What does CRA stand for?
Clinical research associate
What does CRO stand for?
Clinical research organization
2 CFR 200.315
Code of Federal Regulations addressing government rights in intellectual property.
SBIR Phase 3
Commercialization of results of Phase requires private sector use of non-SBIR funding
Institutional Base Salary (IBS)
Compensation paid to each employee for the duties required of the appointment, equal to the employee's contract salary plus any administrative supplement. IBS is used as the basis for salary distribution and for comparison to the DHHS salary cap.
PHS 2014-01
Competing SBIR Phase I and II contract solicitation.
SBIR
Competitive program which awards funds to small businesses as incentive for technological development resulting in profit from its commercialization. To qualify for the program you must be an American-owned, for-profit business with principal researchers employed primarily by the small business and no more than 500 employees. SBIR has three phases, but only the first two are funded; the start-up phase and the R&D phase. Eleven federal agencies participate in this program.
Appendix XI
Compliance Supplement
CRISP
Computer Retrieval of Info on Scientific Projects - biomedical database system containing information on research projects/programs supported by DHHS
Shelby Amendment
Concern has been expressed about the source data used by the gov't in making regulations, specifically, the EPA (Environmental Protection Agency) had issued regulations based on the outcome of a university research project. When the basis for the regulation was questioned, it was discovered that the source data could not be accessed under the Freedom of Information Act (FOIA). This amendment required OMB to amend Circular A-110 to allow access to such data. (DATA COLLECTION)
Electronic Research Administration - ERA
Conducting research administration by utilizing electronic resources such as the internet, the World Wide Web, form templates, databases, and other electronic tools. ( For more information link to NCURA or ERA Task Force).
Government Auditing Standards ("Yellow Book")
Contains standards for audits of government organizations, programs, activities, and functions, and of government assistance received by contractors, nonprofit organizations, and other nongovernment organizations. These standards, often referred to as generally accepted government auditing standards (GAGAS), are to be followed by auditors and audit organizations when required by law, regulation, agreement, contract, or policy. These standards pertain to auditors' professional qualifications, the quality of audit effort, and the characteristics of professional and meaningful audit reports.
Bilateral Modification
Contract modifcation that requires signatrues of both the contractor and the contracting officer.
EO 12372
Coordinated Review Process
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.
received from any funding source
Cost Accounting Standards (CAS) must be applied to awards
Subpart E
Cost Principles
2 CFR 225 OMB A-87
Cost Principles for State, Local, and Indian Tribal
COLA
Cost of Living Allowance granted to employees based in a foreign city, where cost of living is higher than in Washington D.C.
verifiable from records
Cost sharing must be
Voluntary Committed Cost Sharing
Cost sharing that is proposed and when accepted and included in the terms of the award by the sponsor becomes mandatory.
Direct Costs
Costs that can be specifically identified with a particular project or activity.
Judicial Branch
Courts decide arguments about the meaning of laws and how they are applied. They also decide if laws violate the Constitution—this is known as judicial review, and it is how federal courts provide checks and balances on the legislative and executive branches.
Small Business Administration (SBA)
Created in 1953 as a federal government agency to aid, counsel, assist and protect the interests of small businesses.
Government-University-Industry Research Roundtable (GUIRR)
Current sponsor of the FDP and a subgroup under the Policy and Global Affairs Division of the National Research Council at the National Academies. Mission: To convene senior-most representatives from government, universities, and industry to define and explore critical issues related to the national and global science and technology agenda that are of shared interest; to frame the next critical question stemming from current debate and analysis; and to incubate activities of on-going value to the stakeholders. This forum is designed to facilitate candid dialogue among participants, to foster self-implementing activities, and, where appropriate, to carry awareness of consequences to the wider public.
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
DUNS
Data Universal Numbering System that is a unique nine digit number assigned by Dun & Bradstreet. Universal standard for identifying more that 92 million businesses worldwide
2 CFR 220, OMB Circular A-21
Deals with cost determination but does not identify the circumstance or dictate the participation in the financing of a project
What date did Uniform Guidance go into effect?
December 26, 2014
DARPA
Defense Advanced Research Projects Agency - funded computer networking, first hypertext system NLS
DCAA
Defense Contract Audit Agency - operates under the authority, direction and control of the Under Secretary of Defense Comptroller
"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."
What agency is responsible for EAR (Export Administration Regulations)?
Department of Commerce -- Bureau of Industry and Security
What agency is responsible for enforcing ITAR (International Traffic in Arms Regulations)?
Department of State --Directorate of Defense Trade Controls (DDTC)
Department of Commerce Export Administration Regulations
Department under the Bureau of Industry ad Security which controls Commercial and Dual Use products and technical data, using ECCN for classifying items
Program Announcement
Describes existence of a research opportunity. It may describe new or expanded interest in a particular extramural program or be a reminder of a continuing interest in an extramural program.
Joint Inventors
Do not have to physically work together, each co-inventor does not have to make the same type or amount of contribution to the invention. Each does not have to contribute to each claim. Each joint inventor has the right to practice the patent without permission from the other joint inventors and no accounting of income is required to each co-inventor unless agreed to otherwise.
Animal Welfare Assurance
Document an institution and all performance sites involving animals in research must have on file with the office of laboratory Animal Welfare before a PHS agency may award a grant or contract.
DS-2 filing
Educational institutions that receive aggregate sponsored agreements of $25M+ must submit to cognizant agency
Disclosure Statement/ DS-2:
Educational institutions that received sponsored money over $25M must disclose their cost accounting practices by filing this statement
internal controls
Efficient and effective operations and reliable financial reporting are the objectives of
What is Effort Reporting
Effort reporting is the method used by an institution to confirm to federal sponsors that salary charges on their grants and contracts are a reasonable representation of the work performed thereon, and that effort commitments have been satisfied.
Voluntary Uncommitted Cost Sharing
Effort voluntarily expended on a sponsored project that is greater than the salary budget.
fringe benefits
Employee benefits paid by the employer. (e.g., FICA, Worker's Compensation, Withholding Tax, Insurance, etc.)
Direct Cost examples;
Employee compensation, employee fringe benefits, travel, lab supplies, consulting and other specialized services, subaward/subcontracts
OSHA
Enacted to ensure safe and healthful working conditions by requiring employers to comply with identified health and safety standards. (1970)
What is the Buy America Act?
Establish a general preference for domestic articles, materials/supplies to protect the American worker by saving and creating jobs.
Executive Orders 8248 and 11541
Establishing the divisions of the Executive Office of the President and defining their functions and duties Source and -Prescribing the duties of the Office of Management and Budget and the Domestic Council in the Executive Office of the President
What are the general responsibilities of IBCs?
Examination of a number of matters, including: Containment levels Facilities Institutional procedures and practices Training and expertise of personnel IBCs should also: Notify the PI of IBC review and approval. Set containment levels and modify containment levels for ongoing experiments as warranted; Implement contingency plans for handling accidental spills and personnel contamination resulting from research involving recombinant or synthetic nucleic acid molecules; and Report to OBA and institutional officials within 30 days any: o Substantial problems or violations of the NIH Guidelines; and o Significant research related accidents or illnesses.
Administrative Law-
Exists because of the U.S. Congress often grants broad authority to executive branch agencies to interpret the status in the United States Code which the agencies are entrusted with enforcing.
Post-Differential Allowance
Expenses authorized for employees based abroad to provide additional compensation for services as a recruitment and retention tool.
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, Internet service.
Effort distribution must be representative of the work performed, and should be manipulated to facilitate budget practices.
FALSE
When an acquisition is above the SAT, what part of FAR governs the applicable regulations?
FAR Part 52.
Request for Application (RFA)
FOA which 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 date, also usually reviewed by a Scientific Review Group convened by the awarding office. It is the official statement inviting grant or cooperative agreement applications to accomplish a specific program purpose. RFAs indicate the amount of funds set aside for the competition and generally identify a single application receipt date.
T-F 4 applications are required to be sent in for pre clinical trial?
False
T-F Preclinical trials involve humans?
False
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).
NSF Sites
Fastlane and Research.gov
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.
Varies with funding source
Federal regulations require that documentation of expenditures must be kept for how long?
Cost Accounting Standards - CAS
Federally mandated accounting standards intended to ensure uniformity in budgeting and spending funds.
a royalty-free, nonexclusive, and irrevocable license
For copyrighted works which result from federally sponsored activities, the federal government usually requires
When and why was the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research established?
Formed in the aftermath of the Tuskegee Experiment scandal, the Commission was created in 1974 as Title II of the National Research Act. It was part of the United States Department of Health, Education, and Welfare (DHEW) until 1978. The Commission had four goals that it needed to analyze: 1. the boundaries between biomedical and behavioral research and what the accepted and routine practices of medicine were, 2. assessing the risks and benefits of the appropriateness of research involving human subjects, 3. determining appropriate guidelines for how human subjects can be chosen for the participation in such research and 4. defining what informed consent is in each research setting
Publication Rights
Free, unrestricted right of researchers to publicly share research results. If compromised, lends appearance of control of research by third parties.
Appendix I
Full Text of Notice of Funding Opportunity
What determines if Financial Interest is Significant
Funds received for investigator and spouse/children meets both the following tests: 1) does not exceed $5000 in value as determined through reference to public prices or other reasonable measures of market value 2) does not represent more than a 5% ownership interest in any single entities.
Award
Funds that have been obligated by a funding agency for a particular project.
Christian Doctrine
GL Christian & Assoc VS US..1963 US FAR case which has become known as "christian doctorrine". Standard clauses established by regulation must be read into every federal contract.
Subpart B
General Provisions
Small Business Technology Transfer
Grant applications and / or programs to fund small business "teamed" with research institutions.
Design Patents
Granted for 14 years from the issue date; the emphasis is on the design of the invention, not on its functionality. The focus on the inventions unique ornamental and aesthetic properties.
FAR at 48 CFR Parts 1-51
Guidelines for use of clause
GrantSolutions
HHS and DOS post award
Departments under DHHS
HRSA - Health resources & services administration FDA NIH AHRQ - Agency for health care research & quality
Office of Regulatory Affairs (ORA)
Handles allegations of misconduct in regulated research, it is under FDA jurisdiction that focuses on testing and evaluating human and animal - drugs - food and feed - additives, and - human biological products and medical devices through its Division of Compliance Policy, Bioresearch Program Coordination
HSES
Head Start Enterprise System: Head Start Post award
Appendix IX
Hospital Cost Principles
Technology Transfer
How institutions performing federally-funded research share their knowledge for the betterment of society. Technology is transferred through educational programs, technical assistance, publications and licensing.
90 days
How many days do recipients of federal grants funds have to submits final reports after completion of the project?
Every 3 years
How often do approved animal protocols need to be reviewed by the Institutional Animal Care and Use Committee (IACUC)
IRB is administered by?
IRBs are administered on a federal level by the Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services. OHRP assists IRBs in their work and receives and investigates claims of inappropriate research practices
Contact legal, then contact program officer over concerns
If a PI received an award and his wife is using the lab and charging to the award. How would you handle it?
Make sure budget/rates are accurate.
If a PI submitted a proposal without going through the SRO office, what is our first concern?
FOA instructions always supersede these form instructions.
If you have a funding opportunity announcement (FOA), which instructions do you go by... the research form or the FOA
What is the False Claims Act?
Improper costing, product substitutions, failure to comply with contract specifications and filing false claims with government health care programs
The NIH produced it's first Federal Policy regarding human subjects in what year?
In 1953 the NIH establish the requirement for human subjects policy to contain a Medical Board responsible for developing policies governing standards of medical care in the Clinical Center.
control commodities and is governed by Department of Commerce
In Export Control, what does Export Administration Regulation control and who governs it
control money: Governed by Department of Treasury.
In Export Control, what does Office of Foreign Assets Control control and who governs it
Land acquisition
In a Construction Grant, which is allowable
PHS Offices that Handle Research Abuses
In addition to ORI, four other offices within PHS handle abuses of the research process: (1) OPRR - Office for Protection from Research Risks handles misuse of human and animal research subjects; (2) the Office of Management Assessment handles financial mismanagement; (3) OER - Office of Extramural Research handles conflicts-of-interest (COI); and (4) the Office of Regulatory Affairs handles misconduct in specifically-regulated research. The first three offices are located within NIH; the fourth office is located within FDA.
PHS Offices that Handle Research Abuse
In addition to ORI, four other offices within PHS handle abuses of the research process: (1) OPRR - Office for Protection from Research Risks handles misuse of human and animal research subjects; under NIH (2) OMA - Office of Management Assessment handles financial mismanagement; under NIH (3) OER - Office of Extramural Research handles conflicts-of-interest (COI); under NIH (4) ORA - Office of Regulatory Affairs handles misconduct in specifically-regulated research. under FDA
modular budget is applicable only to R01, R03, R15, R21, and R34 applications
In an NIH Research Project Grant Program, which budget couldn't be over $25,000 in direct cost per year?
FAR
In order for a contractor to be awarded a federal contract, he must comply with the provisions set forth by:
Subcontractor only
In the event of a cost overrun by a subcontractor, who would be held responsible by the funding source?
Copyright
In which of the following areas of intellectual property is the concept of work-for-hire germane
Public Health Service Grant Application PHS 398
Includes application guides and forms to be used with all competing applications for Cooperative Agreements and Complex Mechanisms with intended due dates on or After September 25, 2013 and that do not use the SF424 R&R application package.
Appendix IV
Indirect (F&A) Costs Identification and Assignment, and Rate Determination for Nonprofit Organizations
Appendix III
Indirect (F&A) Costs Identification and Assignment, and Rate Determination for nstitutions of Higher Education (IHEs)
What is the Byrd Amendment?
Institution must certify that no appropriated funds were or will be expended to pay any person for influencing or attempting to influence an officer or an employee of any agency, a member of Congress, an officer or employee of Congress in connection with a specific award.
Institutional Biosafety Committee (IBC) is what?
Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules. Over time, many institutions have chosen to assign their IBCs the responsibility of reviewing a variety of experimentation that involves biological materials (e.g., infectious agents) and other potentially hazardous agents (e.g., carcinogens). This additional responsibility is assigned entirely at the discretion of the institution.
What is the name of the Institutional committee that oversees human subjects
Institutional Review Board (IRB) Human Subjects
CREATE ACT
Intended to promote research among universities, by treating joint inventions as if they had a single owner with prior written agreement in place. (2004)
iEdison
Interagency Extramural Invention Information Management System helps government grantees and contractors comply with a federal law, the Bayh-Dole Act regulations require that government funded inventions be reported to the federal agency who made the award
U.S. Department of State
International Traffic in Arms Regulations (ITAR) are controlled by the
What's another name for a physician in the clinical field?
Investigator
Conflict of interests
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
Modified total direct cost
Is a frequently used base for facilities and administrative cost (F&A) computation?
Equipment donated at fair market value
Is allowable as cost sharing
Office of Extramural Research (OER)
Is responsible for the implementation of the objectivity in Research (conflict-of-interest) regulation.
Plant Patent
Issued for newly invented strains of asexually reproducing plants. Wild uncultivated plants may not be patented. Not all countries allow plant patents.
Evaluation Plan
It is important to define carefully and exactly how success will be determined.
Cost Accounting Standards
It is the ___________ that dictate the way in which a contractor must maintain its accounting system.
What is the Drug Free Workplace Act
It says you can't receive federal funding if you do not have a drug-free workplace policy in place
Needs/Problem statement
It should be a clear and concise statement of the problem you want to solve with grant funds.
Title
It should tell us in 25 words or less what you intend to research and should be relevant
What is use of name exception
It's an exception that agree that neither party will use directly or by implication names or trademarks of the other party in connection with any publicity, promotion or advertising without prior written approval.
Certifications and representations
Just-In-Time initiatives postpone the submission of which of the following items until a decision to make an award is reached?
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)
Commerce Business Daily (CBD)
Lists notices of proposed government procurement actions, contract awards, sales of government property, and other procurement information over $25,000 prior to December 2001. Each edition contains approximately 500-1,000 notices. Each notice appears only once. The databases online via GPO Access contain notices from December 2, 1996 to January 2, 2002. Replaced by FedBizOpps.
Byrd Amendment
Lobbying - disclosure forms must be filed prior to any award and thereafter at the end of each calendar quarter
Inventions
Made up of two parts; conception and reduction to practice.
Fabrication
Making up data or results and recording or reporting them
OMB A-89
Mandated the creation of the CFDA
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
UBMTA may NOT be use for?
Materials in projects supported by "industry."
responsible administrative official of the organization
Members of an Institutional Animal Care and Use Committee (IACUC) must be appointed by the
Unrestricted Funds
Monies with no requirements or restrictions as to use or disposition. They are different than grants, contracts, and cooperative agreements, which are considered to be restricted funds.
Research Performance Progress Report RPPR
Must be used for submitting Streamlined Non-competing Award Process (SNAP), Fellowship, and multi-year funded progress reports. The RPPR may be used for Non-SNAP progress reports submitted by Federal Demonstration Partnership (FDP) institutions.
Center for Scientific Review (CSR)
NIH Component responsible for the receipt and referral of applications to the PHS as well as the initial review for scientific merit of most applications submitted to the NIH
RePORTER
NIH Research Portfolio Online Reporting Tools Expenditures & Results—A public search engine where you can find information on NIH research programs. You can find award data for individual organizations.
Executive Level II $181,500
NIH Salary cap is at what percentage?
2
NIH limits how many resubmissions on proposals?
Which Federal agency is the lead agency for the UBMTA?
NIH, is the designated lead PHS agency for technology transfer activities. NIH issued the final version of the Uniform Biological Material Transfer Agreement ("UBMTA") in March 1995.
Easygrants
National Fish and Wildlife Foundation
Data Management Plan Requirement
No more than 2 pages and must describe how the proposal will conform to NSF policy on dissemination and sharing of research results.
Appendix VIII
Nonprofit Organizations Exempted From Subpart E—Cost Principles of Part 200
Each calendar year
OMB Circular A-21, time and effort reporting must be submitted to the institution a MINIMUM of once
OBA
Office of Biotechnology Activities - NIH
Which office at the NIH is responsible for administration and coordination of the PHS Policy?
Office of Laboratory Animal Welfare
Licensing
Official or legal permission to do or own a specific thing. It is a legal contract that spells out the conditions under which one party can make use of the property of another party. The owner agrees not to sue and the party using the property agrees to give some consideration, i.e. royalties, fees, etc. Grant of right may have limitations and can be exclusive or not.
What were the main principles of the Belmont Report established in 1979?
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission 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. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held 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. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees.
indemnity
One may use what kind of clause to require that one party indemnify the other when certain expenses are incurred
SBIR Program Eligibility
Only United States small businesses are eligible to participate in the SBIR program. Organized for profit, with a place of business located in the United States; More than 50 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or by another for-profit business concern that is more than 50% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and No more than 500 employees, including affiliates.
What does ITAR regulate?
Only regulates the export of defense items (incl. technical data), not dual-use items.
Possible items could NIH request through Just-in-time
Other support Current and Pending, Certificate of IRB approval of proposed use of human subjects , Evidence of compliance with education in the protection of human subjects ,Verification of IACUC approval of proposed use of live vertebrate animals
DOE sites (3)
PAMS (Portfolio Analysis and Management System); EERE Exchange ARPA-E
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 composition and responsibilities of IACUC are mandated by which public law?
PL 98-198, The Animal Welfare Act
Parent Announcements (For Unsolicited or Investigator-Initiated Applications)
Parent announcements are for use by applications who wish to submit what were formerly termed investigator-initiated or unsolicited applications. Applying to this omnibus announcement insures that the correct application package is used.
What are the Official parts of FAR at 48 Code of Federal Regulations (CFR)
Part 1-51: Guidelines for use of clauses (Chapter 1) Part 52: Solicitation provisions & contract clauses Part 53: Forms Part 200 & up: Agency specific supplements
iEdison
Patents
Name 3 classes of Intellectual Property
Patents, Copyrights, Trademarks
Property Types / Intellectual Property
Patents, trade secrets, copyrights, trademarks
PMS
Payment Management System
Salaries and Wages
Payments made to employees of the institutions for work performed.
STTR Phase III
Period during which Phase II innovation moves from the laboratory into the marketplace. No SBIR/STTR funds support this phase. Phase III. The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase I/II R/R&D activities. The STTR program does not fund Phase III. In some Federal agencies, Phase III may involve follow-on non-STTR funded R&D or production contracts for products, processes or services intended for use by the U.S. Government.
At what phase would you see healthy patients?
Phase 1
Which phase involves the 3+3 design?
Phase 1
Which phase is a continuous phase?
Phase 4
Defense Federal Acquisition Regulation Supplement - DFARS
Places further restrictions on DOD contractors as a supplement to the FAR. - A supplement to the FAR that provides DoD-specific acquisition regulations that DoD government acquisition officials - and those contractors doing business with DoD - must follow in the procurement process for goods and services.
Subpart D
Post-Federal Award Requirements
Conflicts of Interest
Potential for financial interest to bias the integrity of research.
Subpart C
Pre-Federal Award Requirements and Contents of Federal Awards
personnel salaries are increased
Prior approval from a federal agency is usually not needed when
Senior Personnel
Professional personnel who are responsible for the scientific or technical direction of project.
Age Discrimination Act
Prohibits unreasonable discrimination on the basis of age in any program or activity receiving federal assistance. (1975)
Roles and responsibilities of the Principal Investigator and other key personnel
Proper technical conduct of the research effort Compliance with the terms and conditions of the sponsored agreement, Managing project funds within the approved budget Timely completion and submission of required technical reports Complying with all university and sponsor policies and procedures pertinent to the award
unsolicited proposal
Proposals submitted to a sponsor that are not in response to an RFP, RFA, or program announcement.
New Proposal
Proposals that are submitted for the first time or ongoing projects that must re-compete for funding prior to expiration of the original award.
Competing Proposal
Proposals that are submitted for the first time or unfunded proposals that are resubmitted; either must compete for research funds. Ongoing projects must compete again if the term of the original award has expired (See New Proposal).
What is another name for a study?
Protocol and clinical trial
Welsh-Healy Public Contracts Act
Provides conditions for the purchase of supplies and the making of contracts by the United States in ruling regarding the applicability of the act, the Supreme Court has declared the act's purpose "was to impose obligations under those favored with government business and to obviate the possibility that any part of our tremendous national expenditures would go to depress wages and purchasing power and offending fair social standards of employment" (FAIR EMPLOYMENT)
Office of Federal Procurement Policy - OFPP
Provides overall direction for government-wide procurement policies.
Roles and responsibilities of the Sponsored Programs Office
Providing accounting, Purchasing Other administrative services to assist the principal investigators in: - managing the financial aspects of their projects obtaining the necessary goods, services, and personnel to conduct the research effort, meeting sponsor needs for fiscal reports, Provides financial accounting to sponsors for the activity funded and is subject to federal audit.
Appendix VI
Public Assistance Cost Allocation Plans
Cost Principles for Educational Institutions: A-21
Purpose. This Circular establishes principles for determining costs applicable to grants, contracts, and other agreements with educational institutions. The principles deal with the subject of cost determination, and make no attempt to identify the circumstances or dictate the extent of agency and institutional participation in the financing of a particular project. The principles are designed to provide that the Federal Government bear its fair share of total costs, determined in accordance with generally accepted accounting principles, except where restricted or prohibited by law. Agencies are not expected to place additional restrictions on individual items of cost. Provision for profit or other increment above cost is outside the scope of this Circular.
Proposal Solicitation
RFP and RFA are examples of
What is another name for "enrolled"in clinical trial?
Randomization
3 years from submission of final report of expenditures
Recipients of federal grant funds must retain records for a MINIMUM of
Technical Data
Recorded information, regardless of form or characteristic, of a scientific or technical nature. Often referred to as the "science" of a proposal.
What are the 3 important features of the Protocol Application Review? _____of the # of animals used _____of techniques to minimize pain or distress _____of using animals to using other models
Reduction, Refinement, Replacement
NIH: What is Just-in-Time
Refers to the information that NIH will ask you to send after your application goes through initial peer review and is within the range of possible funding. NIH will need this information but does not require it with your application.
Committed effort
Refers to the level of effort promised to be contributed to a project by the named, key personnel as included in the research proposal and, ultimately, in the award document.
The three R's of animal use in research are?
Refinement - to minimize pain and distress Reduction - find ways to use fewer animals Replacement - use other options (computer models) or other species
Cost Sharing
Represents costs associated with a sponsored project that are not funded by the sponsor. These costs must be funded by an institutional account (entity 02, 03, or 04), or in some cases, a career development or K-award.
Actual Effort Percentage
Represents the portion of an employee's appointment spent on a given activity.
Distributed Percentage
Represents the portion of an employee's salary that is charged to the specified Institutional or sponsored account for a given activity.
RFP
Request for application - targeted solicitation for grant apps in a well-defined scientific area, 1 one competitions, construction grant or cooperative grant
Rehabilitation Act
Requires affirmative action in the employment of individuals with disabilities - employment of the handicapped (1973)
What is the Davis/Bacon Act
Requires contractors to pay wages to laborers and mechanics at a rate of no less than a minimum wage specified in a wage determination made by the Secretary of Labor.
Where are the rules and regulations for the APA published?
Rules and regulations issued by federal administrative agencies are published chronologically (by date of issuance) in the Federal Register. Rules and regulations are then organized by topic (subject matter) in a separate publication called the Code of Federal Regulations. In comparing publication of regulations to publication of statutes, the Federal Register is analogous to the United States Statutes at Large and the Code of Federal Regulations is analogous to the United States Code.
NSF administers
SBIR program
SMART
SPIN Matching and Research Transmittal System - automated alerts system
Progress Report Periodic
Scheduled reports required by the sponsor summarizing research progress to date. Technical, fiscal, and invention reports may be required.
Health Insurance Portability and Accountability Act (HIPAA)
Set national standards for the protection of certain health information. For universities ______ does not generally or directly cover research but has an impact on research involving human subjects. The degree of the impact depends upon whether the researcher works for a covered entity and the degree of access the researcher requires. Noncompliance - Civil money penalties for institutions as well as criminal penalties for individuals. (1996)
Abstract
Should be 5,000 to 25,000 words in length. This summary should demonstrate to the reader the most important parts of each of the sections of the research proposal in around 200 words.
SBIR
Small Business Innovative Research - supported by ear marked, federal funds
STTR
Small Business Technology Transfer Program
InfoEd
Software company founded in 1991 to optimize administration and discovery for research. Provides eResearch portals used in over 600 research institutions. Works with SPIN to provide funding opportunity searches.
SPIN
Sponsored Programs Info Network - developed by InfoEd - available by subscription
Nuclear Regulatory Commission
Standards for handling radioactive materials are developed and monitored by the
A-102
State and local governments are subject to which of the following OMB Circulars?
Order of importance
Statutes, Federal Regs, Special Terms and Conditions
Buying-in
Submitting an offer below anticipated costs, expecting to increase the contract amount after or recieve follow-on contracts at artificially high prices to recover losses incurred on the buy-in contract
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
Effort is not based on a standard (e.g. 40-hour) work week, instead based on each employee's typical level of work performed (e.g. 25, 48, 60 hours/week)
TRUE
Mandatory Cost Sharing
That portion of an employee's salary that exceeds the sponsor-imposed salary restriction and must be cost shared to an institutional account as required by the agencies of the Department of Health and Human Services (DHHS) and certain other sponsors when specified in the award document.
Where Can I Find the FAR?
The FAR is available in print from the Government Printing Office as part of the Code of Federal Regulations, or from private publishers. However, it is arguably most conveniently accessed online, where it is available in either PDF or HTML format.
All vertebrate animals
The Federal Animal Welfare Act applies to which of the following animal species
teaching abroad
The Fulbright Program provides opportunities for
What is IACUC?
The Institutional Animal Care & Use Committee
U.S.C-.
The United States Code is a compilation and codification of the general and permanent federal law of the United States.
Re-budget
The act of amending the budget by moving funds from one category or line item to another.
OMB (Office of Management and Budget)
The cabinet-level office with the primary task of assisting the President in the development of the federal budget and managing the administration of Executive Level agencies.
Regulations
The contractural rules and procedures governing sponsored research projects.
Expiration Date
The date signifying the end of the performance period, as indicated on the Notice of Grant Award.
Scope of Work
The description of the work to be performed and completed on a research project.
Budget
The detailed statement outlining estimated projects costs to support work under a grant or contract.
The Institutional Official for a sponsored research project
The individual authorized by the Board of Trustees to sign on behalf of the institution
Internal controls-
The institution's financial management system shall ensure that no person has complete control over all aspects of a financial transaction.
Key Personnel
The personnel considered to be of primary importance to the successful conduct of a research project. The term usually applies to the senior members of the project staff.
Cost principles-
The recipient institution is responsible for ensuring that costs charged to project are allowable, allocable and reasonable
Executive Agencies
Those agencies that exist within the federal executive departments, headed by a Cabinet Secretary. These entities are among the oldest primary units of the executive branch. The heads of these departments serve at the disposal of the U.S. President and normally act as an advisory body to the presidency. These departments currently include: USDA, DOC, DOD, DoEd, DOE, HHS, DHS, HUD, DOI, DOJ, DOL, DOS, DOT, DoTreasury, DOVA
Allocable Costs
Those allowable costs that actually benefit the grant or contract to which they are being charged.
Allowable Costs
Those categories of costs that can be charged to a grant, such as salaries and equipment.
The Office of Management Assessment (OMA)
Through its Division of Program Integrity, handles allegations of financial waste, fraud, and abuse (F, W & A) of NIH research funding.
Primary purpose of a federal cooperative agreement
To provide assistance with substantial involvement of the federal agency
What's another name for side effects?
Toxicity and adverse events
True or False: The US government is the world's largest single customer of goods and services
True.
True or false: the US government is required by law to provide opportunities for small businesses
True. 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
Application Types
Type 1 - New 2-Competing Continuation 3 - supplement 4-competing extension for R37 5- non-competing continuation 7-change of grantee institution 9-change of NIH awarding institute
Cooperative Agreement
Type of award similar to a grant but in which the sponsors staff will be actively involved in proposal preparation, and anticipating involvement once the award is made. - Substantial federal scientific or programmatic involvement
Animal Welfare Act
USDA's APHIS will make unannounced inspections at least annually; responsible for day to day compliance
From any institution that receives more than $700,000 in federal funding
Under which of the following conditions is a Certificate of Current Cost and Pricing required
2 CFR 200
Uniform Administration Requirements, Cost, Principles, and Audit Requirements for Federal Awards
OMB A-81
Uniform Guidance (!!!!)
Which Office regulates the treatment of animals in research via the Animal Welfare Act?
United States Department of Agriculture (USDA)
Returned to the sponsoring agency
Upon completion of a federal grant, excess funds remaining in the account should be
Break refreshments at a project sponsored workshop
Using the criteria contained in 2 CFR 220, OMB Circular A-21, which of the following costs would most likely be allowable as a direct expenditure item on a federal grant?
Patients participating in a clinical trial are always?
Volunteers
Freedom of Information Act (FOI)
What act brought this on FFATA?
protects people from discrimination based on sex in education programs or activities which receive Federal financial assistance
What is Title IX of the Education Amendments: Sex Discrimination?
Federal commons
What is an Internet grants management portal which serves the grantee organization community?
cost sharing occurs when the sponsored program requires financial support for the project from the awarded institution as a condition of the award.
What is involuntary committed (mandatory) cost sharing?
Prior intramural support should be addressed in the narrative
When applying for extramural support, in which of the following ways should the principal investigator address prior related intramural support?
90 days
When granted expanded authorities, pre-award costs on a federal grant may be incurred by an institution within a MAXIMUM of how many days prior to the official start date?
In the credentials box
Where do you put the ERA Login?
Change in allocation within a single budget category
Which of the following changes does not require prior National Science Foundation approval?
Whenever covered animals are involved in a protocol
Which of the following requires Institutional Animal Care and Use Committee (IACUC) review and approval governing the use of animals?
Commons Business Daily
Which of the following sources is not commonly used for federal funding opportunities?
DOE
Workplace Substance Abuse Programs - contractor required to conduct drug testing, provide training/ed, place disciplinary measures
How does an institution find their DUNS number
You can contact your office of sponsored research or you can also log in to the eRA Commons.
Donation Transfer
_______ of equipment , money, goods, services, and property with our without specifications as to its use. Sometimes donation is used to designate contributions that are made with more specific intent than is usually the case with a gift, but the two terms are used interchangeably .
United States Department of Homeland Security
a cabinet department of the United States federal government, created in response to the September 11 attacks, and with the primary responsibilities of protecting the United States and its territories (including protectorates) from and responding to terrorist attacks, man-made accidents, and natural disasters.
Incremental Funding
a method of funding contracts that provides specific spending limits below the total estimated costs. These limits may be exceeded only at the contractors own risk. Eash increment is, in essence, a funding action.
Indirect Cost Rate
a percentage of a base amount (MTDC) established by negotiation with the cognizant federal agency on the basis of the institute's projected costs for the year and distributed as prescribed in OMB Circular A-21.
iEdison
a portal which helps government grantees and contractors comply with a federal law, the Bayh-Dole Act. Bayh-Dole regulations require that government funded inventions be reported to the federal agency who made the award.
Close Out
a procedure to officially conclude a grant
PAS
a program announcement that includes specific set-aside funds
PAR
a program announcement with special receipt, referral or review considerations
Grant
a type of financial assistance awarded to an organization for the conduct of research or other program as specified in an approved proposal.
Institutions must have a comprehensive effort reporting program that includes:
a) Systems b) Policies c) Documented procedures d) Oversight e) On-going training
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
What is the Equal Pay Act?
act prohibits employers and unions from paying different wages based on the employees sex
Department of Justice
administers False Claims Act - any government dealing
FAR at 48 CFR Part 200
agency specific supplements
Fastlane
an interactive real time system used to conduct NSF business over the internet.
Defense article
any item or data listed on the US munitions list and any technical data recorded or stored.
Final rate
applicable to specific past period with no adjustments
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
Executive Branch
branch of the government is responsible for enforcing the laws of the land. The president, vice president, department heads (cabinet members), and heads of independent agencies carry out this mission.
How many members are required on the IACUC Committee: a) 3 b) 4 c) 5 d) 6
c
USDA representatives conduct unannounced site visits at least... a) bi-monthly b) every 6 months c) annually d) every 3 three years
c
InfoEd Proposal Development module
can generate a new electronic proposal template that is pre-loadd with relevant Sponsor and program details from SPIN
Costs normally treated as indirect costs (F&A costs)
cannot be charged directly to a sponsored project unless the specific activities related to the project are clearly different in type of significant different in scale from institution norm. Direct charging of these types of costs may be appropriate if: Cost is included in the approved budgetWritten justification to substantiate the cost Project is classified as a major project Extensive data, accumulation, analysis, entry, etc. Large amount of travel/meetings Preparation of manuals, large reports, books Large, complex programs Geographically inaccessible project locations Conditions including human and animal controls, multiple PI coordination.
Procurement Integrity
certification required for $100k/year level - applies to all recipients of federal contract funds
OMB Circulars Regulatory
circulars issued by the Office of Management and Budget. (Link to the OMB circular as well as link to the specific circular). Definitions included in OMB Circulars A-21, 100, 122, 128, and 133.
Earmarks
circumvent Executive Branch merit-based or competitive allocation processes, specifies location/recipient
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
Indirect Cost
costs related to expenses incurred in conducting or supporting research or other externally funded activities but are not directly attributable to a specific project.
How often does the AAALAC conduct site visits? a) bi-monthly b) every 6 months c) annually d) every 3 three years
d
The Federal Animal Welfare Act applies to which of the following animal species? a) Nonhuman primates and fish b) Marine mammals and amphibians c) Reptiles and warm-blooded wild mammals d) All live vertebrate animals
d
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
Syphilis Study at Tuskegee
developed National "Commission" for the protection of Human Subjects of Biomedical and Behavioral Research; commission developed Belmont Report
beneficence
do not harm; maximize possible benefits; minimize risks
NIH Peer review process
dual review system - initial review and National Advisory Council/Board review
DOD sites (2)
eBrap (preaward); Wide Area Workflow (postaward)
NIHSites
eRA Commons (pre and Post) ASSIST (pre) IAR (internet assisted review) NIH reporter (Biomedical Research Database)
Small Business
employees don't exceed 500, independently owned, 51%
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
Deficit Expenditures
exceeds funds available
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
F&A Cost Categories
facilities, depreciation, interests, operation, maintenance, library, general and admin, sponsored program admin, departmental admin, student admin
SBIR Phase 1
feasibility study to evaluate technical and scientific merit up to 6 months $150k.
CFDA 5 digit number
first 2 digits represent federal agency, second 3 digits represent the program
How many Clinical Trial Phases are there
five
FAR at 48 CFR Part 53
forms
STTR Phase1
funding threshold is $100k
Administration-
general administration, expenses, administration, sponsored project admin, student administration
EAR99 Classification
given to any item that does not have a specific ECCN
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
Cost of Living Allowance COLA
granted to employees based in a foreign city, where cost of living is higher than in Washington, D.C.
On an SF 424 Form, what does resubmission mean?
has been previously submitted, but was not funded and is now being resubmitted.
Employer Identificaiton Number (EIN)
identification of a business to the US Internal revenue service also known and the federal tax identificaiton number. On SF424 form for grant application
Executive Branch Agencies
implement laws/rules using Code of Federal Regulations - 50 titles updated 1x each calendar year
FCA examples
improper cost allocation, noncompliance with contract specification; no minimum threshold
Public Health Security and Bioterrorism Preparedness and Response Act 2002
improve US ability to prepare for and respond to bioterrorism and prevent public health emergencies
Institutional Biosafety Committee
investigators must submit to OBA certain info about protocols annually
What is Catalog of Federal Domestic Assistance (CFDA)?
is a government-wide compendium of an online database listing all available federal programs.
FirstGov
is a public-private partnership, led by a cross agency board and administered by the office of ________ in General Services Administration's Office of Governmentwide Policy. Launched in 2000 - it is the only official US Gov't portal to 47 million pages of gov't information, services, and online transactions.
What is a Commercial And Government Entity Code (CAGE) and its purpose
is a unique identifier assigned to suppliers to various government or defense agencies, as well as to government agencies themselves and also various organizations. It provide a standardized method of identifying a given facility at a specific location.
Promulgation/Enactment -
is the act of formally proclaiming or declaring a new statutory or administrative law as in effect after it receives final approval
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
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
Fabrication
making up data or results and recording or reporting them
Limitation of Costs
mandatory clause for CR-type contracts
Falsification
manipulating research materials, equipment or processes; changing or omitting data or results
Sponsored Agreement-
means any grant, contract or other agreement between the institution and the Federal Government
Allocation-
means the process of assisting a cost or a group of costs to one or more cost objective in reasonable and realistic proportion to the benefit provided.
A chairperson, veterinarian, scientist, nonscientific person, and a person not affiliated with the university are _______ of an IACUC Committee.
members
Biosafety: Biological Hazards
microorganisms, recombinant DNS, CDC list of select agents, genetically engineered organisms and products
Encumbrance Funds
monies that have been set aside or "claimed" for projected expenses pending actual expenditure of the funds.
ADA
must be flowed down to recipients with 25 or more employees - applies to all agreements
COI Policy 13010
must disclose 3rd party travel
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
Common identifiers
names, SS#, address, birth date
Parent Announcements
new, continuing or expanded program interests of IC or to announce a new mechanism of support
proposalCENTRAL
non-federal proposal submissions and award management
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
What is a Request for Proposal (RFP)?
occurs when the agency isn't certain about what it wants and is looking to you to develop a solution and cost estimate.
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
In-kind Contributions
or assistance in a form other than money. Equipment, material, or services of recognized value that are offered in lieu of cash.
Drug free workplace exceptions
outside US, law enforcement with undercover agents, inconsistent with international obligations
NIH RePorter (formally CRISP)
part of the NIH Research Portfolio Online Reporting Tool (http://RePORT.nh.gov) , a new gateway to NIH reports and other information resources. A biomedical database system containing information on research projects and programs supported by DHHS
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
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
Title IX - Sex Discrimination
prohibits the exclusion of any person from participation in an educational program or the denial of benefits based on one's sex (1972)
What is Equal Employment Opportunity?
provide equal opportunity without regard to race, color, religion, sex, or nationality to persons employed or seeking employment
Service Contract Act of 1965
provide labor standards for certain persons employed by federal contractors to furnish services to federal agencies (contracts over $2500)
What is Small Business Innovative Research (SBIR)?
refers to the agency administered programs that are supported by ear-marked federal funds, making grants to small business entities
What is Small Business Technology Transfer (STTR)?
refers to the grant applications and/or programs for funding those small business that are teamed up with research institutions.
Office of the Library of Congress
regulates copyrights
Nuclear Regulatory Commission
regulates radiation safety; committee reviews use and protocols
What is debarment?
removes you as a contractor from eligibility for future government contracts for a fixed period of time.
On an SF 424 Form, what does renewal, mean?
requests additional funding for a period subsequent to that provided by a previous award and competes with all other applications.
Davis-Bacon Act
required to pay wages not less than 1x/week at rate no less than minimum wage - laborers/mechanics
Davis-Bacon Act
requires contractors and subcontractors working on federal government construction projects to pay "prevailing wages" to their employees: Laborers and Mechanics (UNION WAGES)
Belmont Report
respect for persons, beneficence, justice
Significant financial interest does not include
salary royalties or remuneration from employing institutions; income from seminars/lectures/teaching engagements, service/advisory committees, review panels
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
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
Recharge center
should charge private and government indirect and direct and the price should be the same for each customer
NIH RFA
should submit copies of applications concurrently to CSR and the soliciting IC
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
What is the Endangered Species Act?
species listed as endangered or threatened prohibits the unauthorized taking, possession, sale and transport of those species
Termination for default
sponsor is not obligated to any costs incurred
Termination for convenience
sponsor will pay for costs up to the termination notice
What is oncology?
study of cancer
PA
subject to common receipt dates, competitive and standard peer review
IACUC semi annual report
submits to institutional official and doesn't need to go to OLAW unless requested or submitting new/renewal
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
FAR
system of uniform policies and procedures governing acquisition or contracting actions of all executive agencies
What is suspension?
temporarily debars a contractor for the duration of any agency investigation of the contractor or ensuing legal proceedings.
Modified Total Direct Costs (MTDC)
the basic indirect costs are calculated on a subset of direct costs, normally excluding among other cost, equipment, patient care, space rental, alterations and renovations, and subcontract costs in excess of the first $25,000.
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
What is an Invitation For Bid (IFB)?
the method used for the sealed bid process. A contract is then awarded to the low bidder whose bid conforms with all requirements of the invitation and will be advantageous to the government in terms of price, and price-related factors
Deemed Exports
the release of technology or source code that is subject to the Export Administration Regulations, to a foreign national located in the United States.
What is pharmacokinetics?
the study of drug movement throughout the body
Total Direct Costs
the total of all direct costs of a project.
Export Control Classification Number
the way by which items are classified under EAR. The lower the number the higher the security required.
R03
this mechanism supports small research projects that can be carried out in a short period of time with limited resources. This mechanism has been standardized in order to accommodate investigator-initiated (unsolicited) applications. You may request a project period of up to two years and budget for direct costs of up to two $25,000 modules or $50,000 per year. The R03 cannot be renewed. One resubmission is allowed. Introduction required for the resubmission is limited to one page. Research strategy may not exceed 6 pages. A doctoral student may not apply for an R03 to support their thesis or dissertation research. An R03 may be used to assist students who are pursing dissertation studies when the work is within the scope of the R03 award.
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)
What is the Ruth L. Kirschstein NSRA Award? Why is it important
train fellows and residents, and are used to promote the education of future researchers. She was a champion of research training and a strong advocate for the inclusion of underrepresented individuals in the scientific workforce
Justice
treated fairly and selection
Buy American Act exceptions
unreasonable cost, quantity/quality, use outside of US, inconsistent with public interests, trade agreements
IACUC 5 members
vet, practicing scientist experienced with animals, non-scientific; not affiliated with university
Fundamentals of informed consent
voluntariness, comprehension, purpose of study (disclosure, benefits)
Community of Science
web server containing info about scientific expertise, funded scientific research and funding opportunities
What is voluntary uncommitted cost sharing?
when the PI chooses to expend some unspecified amount of effort more than proposed towards the award. This is usually the case when the PI is not requesting salary from the award, and so is volunteering his/her effort.
What is voluntary committed cost sharing?
when the proposing institution volunteers and commits to bear a specific portion of the costs of the project when it is not required.
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%
CFDA categories
15 total, including formula grants and project grants
Utility Patent and Plant Patent
20 years from date of effective filing
Copyrights
A form of protection to the authors of original works of authorship including literary, dramatic, musical, artistic, and certain other intellectual works. It is the right of the author of a work to prevent others from copying, modifying, distributing, and publicly displaying and performing works. It is good for the author's lifespan plus 70 years. If the Copyright is owned by a company, it lasts 100 years. Protects both published and unpublished work from the time the work is created in fixed form.
Audit
A formal examination of an organization's or individual's accounts or financial situation.
Request for Quotation (RFQ)
A formal request from TAMRF to vendors for a price quotation on equipment or supplies to be purchased.
Endowment
A fund usually in the form of an income-generating investment, established to provide long-term support (such as faculty/research positions).
Priority Score
A score derived from the rating given a research proposal by each member on a review committee.
Small Grant
A special type of award, often limited to a beginning researcher. Typically, such an award may be obtained for one year only.
Fiscal Year (FY)
A twelve-month period that is used for bookkeeping, or accounting, purposes. Usually, the fiscal year does not coincide with the calendar year. For example, the federal government's fiscal year runs from October 1 through September 30.
UBMTA provides a standardized approach for certain transfers between ______ _______?
Academic institutions
What is the America COMPETES Act?
America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education and Science- focuses on increasing research investment Strengthens STEM Research (science, technology, engineering and math) from elementary through grad school.
Unilateral Award
An award made by a sponsor to an organization without considering competitive proposals.
What is the name accreditation agency used by universities IACUC Committees?
Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC)
Which agency is responsible for maintaining these agreements?
Association of University Technology Managers (AUTM) is responsible for maintaining signed originals and the official list of signatory organizations.
What is Drug Free Work Force
DOD contractors must maintain records regarding drug-free work force programs provided to their employees. Also establishes a program testing for the use of illegal drugs by employees.
Appendix X
Data Collection Form (Form SF-SAC)
Expanded Authorities
Delegates to grantees authorization of one year, no cost extension
International Traffic in Arms Control Regulations (ITAR)
Department of State interprets and enforces ITAR to safeguard national security. Intends to manage or prevent the export of certain products or trade with certain countries. ITAR -governs the export of info related to military, weapons and space related items and services
Council on Financial Assistance Reform (COFAR)
Established pursuant to Chief Financial Officers (CFO) Act of 1990 (Public Law 101-576), is an organization of the CFOs and Deputy CFOs of the largest Federal agencies, senior officials of the OMB and the Department of the Treasury who work collaboratively to improve financial management in the U.S. Government. The Council was established to advise and coordinate the activities of the agencies of its members on such matters as consolidation and modernization of financial systems, improved quality of financial information, financial data and information standards, internal controls, legislation affecting financial operations and organizations, and any other financial management matter.
What are the roles and responsibilities of the Institution
Expedite hiring of staff and faculty to enable work to proceed from the start of the award; Assist departments, schools, the Office of Research, and the Office of Research Accounting to facilitate administrative tasks; Meet the terms and conditions of the sponsored award in collaboration with the Investigators;-Provide timely and accurate monthly accounting reports to Investigators
True or false: copyrights are relatively expensive and time-consuming to file.
False: copyrights are simple to file, and only cost a nominal fee.
SF425
Federal financial report form
It's required before an award at the proposal stage.
If you don't have ERA Commons password, when is it required for an IRB?
An Institutional Animal Care and Use Committee (IACUC) is what?
Is a committee established by each institution that receives federal funding for research that involves animal use in laboratories. They review research protocols and conduct evaluations of the institutes animal care and use. USDA requires 3 members; OLAW requires 5: - One VETERINARIAN - One practicing SCIENTIST - One COMMUNITY Member Meets at least every 6 months Semi-annual facility inspection & review of programs Protocols reviewed and renewed every 3 years
Office of Foreign Assets Control (OFAC)
Maintains a list of countries with which transfers of assets or anything of value including cash, payments, and services may be prohibited.
Cognizant agencies
ONR and DHHS
Drug-Free Workplace Act
Requires that no federal funding will be available for institutions or individuals that do not have a drug-free workplace policy.
R43/R44
SBIR
R41/R42
STTR
The sum of each employee's effort percentages must be 100% regardless of the number of hours worked per week or the percentage FTE (Full Time Equivalent) of their appointment.
TRUE
Which organization within the USDA is responsible for administering police?
The Animal and Plant Health Inspection Service (APHIS)
Once each calendar year and is issued on a quarterly basis
The CFR is divided into 50 titles that represent broad areas subject to regulation and is published by the Federal executive agencies/departments. Each volume of the CFR is updated
What does EAR regulate?
The EAR regulates "dual-use" commodities and certain military items
The FAR was issued pursuant to which Act of 1974?
The FAR was issued pursuant to the Office of Federal Procurement Policy Act of 1974
What is the Simplified Acquisition Threshold (SAT) $ amount for 2016? How often is the SAT recalculated?
The SAT is currently at $150,000 in 2016. The SAT is recalculated every 5 years.
26%
The administrative cap on federal negotiated F&A rates is equal to
Defense Acquisition Regulations - DAR
The source regulations for research projects sponsored by the Department of Defense.
Contract Work Hours and Safety Standards Act
This act would require that certain contracts contain a clause specifying that no laborer or mechanic doing any part of the work contemplated by the contract would be required or permitted to work more than a certain number of hours in any workweek
Hatch Act
This legislation was enacted to limit the political activities of employees whose principal employment activities are funded in whole or in part with federal funds.
What does TMF stand for?
Trial Master File
remain with the institution
Under federal grant conditions, the title to equipment must
individual account in an approved accounting system
Upon receipt of awarded projects, educational institutions are required to establish
1) Resubmit 2)Appeal 3)Advice to look for other opportunities
What happens to a proposal if it isn't funded?
Adobe
What is required to use Grants.gov
Rent
Which would you charge against F&A?
United States Department of Veterans Affairs
is a government-run military veteran benefit system with cabinet-level status. It is the United States government's second largest department, after the United States Department of Defense.
Copyrights and trademarks
protect the form in which ideas are fixed
What is the simplified acquisition threshold?
$150,000
Executive Level II
$185,100 effective 1/10/16
Name at least 5 Government Agencies that are EXCLUDED from making information available to the public?
(A) the Congress; (B) the courts of the United States; (C) the governments of the territories or possessions of the United States; (D) the government of the District of Columbia; E) agencies composed of representatives of the parties or of representatives of organizations of the parties to the disputes determined by them; (F) courts martial and military commissions; (G) military authority exercised in the field in time of war or in occupied territory (H) Courts have also held that the U.S. President is not an agency under the APA. Franklin v. Mass., 505 U.S. 788 (1992).
NIH Salary Cap
-Applies to grants, cooperative agreements and contract awards. -Executive Level II increased to $189,600 from $187,000; effective 3/7/18. -Amt typically increases annually and generally applies to the entire calendar year
FedConnect.net
-Find funding opportunities for federal grants and contracts and submit applications. -Electronic delivery of awards. -Used by USDA, DOE, Dept of Interior, Dept of Homeland security and EPA
3 eligibility requirements for small business applying to an SBIR or STTR
1)US-based, 2) less than 500 employees, 3) not publicly-owned.
RE Biomedical research, what are the basic principles of the Declaration of Helsinki created in 1964?
1. Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature. 2. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment and guidance. 3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent. 4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject. 5. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society. 6. The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject. 7. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits. 8. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. 9. In any research on human beings, each potential subject mustbe adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw visor her consent to participation at any time. The physician should then obtain the subject's freely given informed consent, preferably inheriting. 10. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who isn't engaged in the investigation and who is completely independent of this official relationship. 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian. 12. The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present declaration are complied with.
Reasonable Costs
1. Necessary for the operation/performance of sponsored project 2.Restraints or requirements are determined by arm's length bargaining 3.Individuals is in accordance with due prudence (of terms and conditions) 4.Consistent with established policies and practices
Employment of Handicapped Rehabilitate Act
1973 - must execute with award or have on file with agency assurance
How much work must the lead (small business) organization do in a STTR?
40% of the total project work (and budget must correspond).
STTR # of participating federal departments
5
What is FedBizOpps.gov ?
A portal where federal contract opportunities (in excess of $25k) are posted.
Acquisition of property or services
A procurement contract is used for the purpose of
Investigator-Initiated Proposal
A proposal submitted to a sponsor (by a researcher) that is not in response to an RFP, RFA, or a specific program announcement.
Supplemental (Re-budgeting or Modification) Proposal
A request to the sponsor for additional funds for an ongoing project during the previously approved performance period. A supplemental proposal may result from increased costs. modifications in design. or a desire to add a closely related component to the ongoing project.
Peer Review
A system using reviewers who are the professional equals of the principal investigator or program director who is to be responsible for directing or conducting the proposed project. It is a form of objective review.
Stevenson-Wydler Technology Innovation Act (1980)
Act to improve the economic, environmental and social well-being for the U.S. by encouraging the exchange of scientific and technical personnel among academia, industry, and federal laboratories. Established the foundation for technology transfer within the federal government. recognized the need for enhanced information dissemination from the federal government to private industry and required the federal laboratories to take a more active role in cooperation with potential users of federally-developed technology. This law also directed the laboratories to establish Offices of Research and Technology Applications in order to conduct technology transfer activities.
Applicability of A-21
All Federal agencies that sponsor research and development, training, and other work at educational institutions shall apply the provisions of this Circular in determining the costs incurred for such work. The principles shall also be used as a guide in the pricing of fixed price or lump sum agreements. b. In addition, Federally Funded Research and Development Centers associated with educational institutions shall be required to comply with the Cost Accounting Standards, rules and regulations issued by the Cost Accounting Standards Board, and set forth in 48 CFR part 99; provided that they are subject thereto under defense related contracts.
SBIR Qualifications
American-owned and independently operated; for-profit; principal researcher employed by business; company size limited to 500 employees
Proposal
An application for funding that contains all information necessary to describe project plans, staff capabilities, and funds requested.
Notices (NOT)
Announce policy and procedure changes to RFA or PA announcements, RFP's and other general information items.
Faculty have share in the company
Conflict of interest may exist when medical faculty members conduct drug clinical tests for a company if
Appendix II
Contract Provisions for Non-Federal Entity Contracts under Federal Awards
EHBs
Electronic Handbook System: HRSA post award
What is Fair Labor Standards Act?
Enacted to establish a minimum hourly wage, overtime pay and regulate child labor
Fair Labor Standard Act
Enacted to establish a minimum hourly wage, overtime pay and regulate child labor for full and part-time workers.
E-Verify
FAR 52.222-54, which requires that federal contractors or subcontractor verify the employment eligibility of all new hires on a contract through an electronic screening database.
Involves a conflict of interest
Faculty member is a major stockholder in a for profit company receiving a university contract
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."
USA.gov
Formerly known as FirstGov.gov. The US Government's official web portal, an easy-to-search, free-access website designed to give you a centralized place to find information from U.S. local, state, and federal government agency websites.
What is a Student Visa?
Generally, a citizen of a foreign country who wishes to enter the United States must first obtain a visa, either a nonimmigrant visa for temporary stay, or an immigrant visa for permanent residence. You must have a student visa to study in the United States. Your course of study and the type of school you plan to attend determine whether you need an F-1 visa (academic) or an M-1 visa (vocational).
Direct cost allocation principles-
If a cost benefits two or more projects or activities in proportions that can be determined without undue effort or cost, the cost should be allocated to the project based on proportional benefit
Let SRO review the proposal then allow the PI to submit
If a federal agency requires a PI to submit online, what should be done
advise student to apply to the federal agency to request a proposal 90 days after proposal was submitted
If a graduate student comes into a university sponsored research office claiming that because of the federal Freedom of Information Act (FOIA) he has the right to obtain a copy of a recently submitted proposal, the research administrator should
Just-In-Time (NIH)
Just-in-time refers to information that NIH requests after an application has been peer reviewed and is within a range of possible funding. Receiving a just-in-time request does not guarantee or indicate in any way whether an applicant will get an award. Information requested and submitted through NIH Commons: -Other support -IRB approval certificate -IACUC approval of proposed use of live vertebrate animals - Evidence of compliance with education in the protection of human subjects
What gets posted in the Federal Register? How often is it published?
Proposed and final administrative regulations of federal agencies. It is published daily.
Trade Secrets
Protected under State Law, trade secrets are any information that is used in business and that gives a competitive advantage over those who do not know the information. No expiration date.
COGR Publication: Materials Transfer in Academia
Referenced in the CRA BOK as the "COGR Q&A," this brochure was copyrighted in 2003 and "attempts to provide relevent information about the transfer of materials in academia," and addresses 20 specific questions & answers related to the topic. To access the publication & related materials: http://www.cogr.edu/Pubs_intellectual.cfm
STTR PI Special Conditions
Requires research partners at universities and other non-profit research institutions to have a formal collaborative relationship with the small business concern. At least 40 percent of the STTR research project is to be conducted by the small business concern and at least 30 percent of the work is to be conducted by the single, "partnering" research institution.
A cost reimbursement sub agreement
Requires that the subrecipient use best efforts to complete the research
Paperwork Reduction Act
Requires the gov't to collect information with a minimum burden upon the public at a minimum cost to the gov't (1980)
NSF Funding Mechanisms
Research Center RAPID & EAGER GOALI Equipment Fellowships
Research Compliance
Research Committee Requirements: - Human Subjects protections - Use of animals in research - Research involving recombinant DNA molecules - RCR training requirements - HIPAA
NIH: What are the main types of awards
Research Grants (R series) Career Development Awards (K series) Research Training and Fellowships (T & F series) Program Project/Center Grants (P series)
The UMBTA covers transfer of incoming and outgoing ___ ___?
Research materials
Compliance approvals
Retention of which records are required by the OMB
What is SAM?
SAM is the primary database of vendors doing business with the federal government. This registration is sometimes referred to as "self-certifying" your small business. Federal Acquisitions Regulations (FAR) require all prospective vendors to be registered in SAM prior to the award of a contract, basic agreement, basic ordering agreement, or blanket purchase agreement.
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
twice a year
The Institutional Animal Care and Use Committee (IACUC) is required to inspect animal facilities a MINIMUM of
Institutional National Research Service Awards
The National Institutes of Health requires a written description of a program for providing instruction in the responsible conduct of research for
SBIR PI Special Conditions
The Principal Investigator must have his/her primary employment (>50%) with the small business concern at the time of award and for the duration of the project period
Application Identification Numbers
The application number identifies: (1)Type of Application (R01) Activity code (NS) org to which it is assigned (123456) serial number assigned by CSR (-01) suffix showing support year of grant, other information: supplement (S1) Amendment (A1)
Plagiarism
The appropriation of another person's ideas, processes, results, or words without giving appropriate credit
SF272
The following is used to prepare a report of federal cash transactions
SF269
The following is used to prepare quarterly, semi-annual, annual, or end reports
SF270
The following is used to request for an advance or reimbursement
Office supplies, postage, administrative and clerical salaries, local telephone charges and general purpose equipment
The following items should normally be treated as F&A cost except when the particular cost item can be justified as an exceptional need. What are some examples of exceptional need
Code of Federal Regulations
The following provides information on patent rights and responsibilities currently applicable to universities and federally sponsored projects
Federal Financial Assistance Management Improvement Act 1999 Public Law 106-107
The impetus to change the ways in which federal agencies accept grant applications and manage grant awards has
NGA Notice of Grant Award
The legally binding document that serves as a notification to the recipient and others that a grant or cooperative agreement has been made; contains or references all terms of the award; and documents the obligation of funds.
Federal Register
The official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. It is updated daily by 6 a.m. and is published Monday through Friday, except Federal holidays. GPO Access contains volumes from 59 (1994) to the present.
Sponsor
The organization that funds a research project.
What is effort reporting
The percentage of total employment devoted to a particular project, activity, administrative task
Responsibilities of A-21
The successful application of cost accounting principles requires development of mutual understanding between representatives of educational institutions and of the Federal Government as to their scope, implementation, and interpretation.
What's 2 other names for a CRA?
Trial monitor, clinical monitor
T-F Preclinical trials don't have a phase?
True
Default and convenience
Two critical termination clauses of the General Provisions of a federal contract
2 CFR 215
UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND AGREEMENTS WITH INSTITUTIONS OF HIGHER EDUCATION, HOSPITALS, AND OTHER NON-PROFIT ORGANIZATIONS (OMB CIRCULAR A-110)
Grants.gov
Website with a mission to provide a common website for federal agencies to post discretionary funding opportunities and for grantees to find and apply to them.
Restricts the political activity of executive branch employees of the federal government, District of Columbia government, and some state and local employees who work in connection with federally funded programs
What is the Hatch Act?
protects certain health information and requires naming a Privacy Official and written policy and procedures.
What is the Health Insurance Portability and Accountability Act (HIPPA) Patient Privacy Rule?
Law passed to protect certain species of marine mammals deemed as being in danger of extinction
What is the Marine Mammal Protection Act?
Executive Level I, II, III
What is the highest level of salary?
Does A-21 apply to a. Subawards? b. Non-Federal awards? c. Fellowships?
a. Yes, FEDERAL subawards b. No c. No
Plagiarism
appropriation of another person's ideas, processes, results or words without giving appropriate credit
Patents and trade secrets
protect the substance of ideas
A-133 applies
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
What are the 10 points of the Nuremberg Code?
(from United States National Institutes of Health).[7] 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him/her to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
NIH Responsible Conduct of Research (RCR) requirements
- Applies to all NIH training, career, development, research educations and dissertation research. - Institution determines form and content of (RCR)training within the guidelines. Proposal requirements: - New (Type 1) applications must include RCR plans - Renewals (Type 2) must describe changes in formal instruction over past year and plan to address weaknesses - Proposals lacking a plan are considered incomplete
CFDA
- Catalog of Federal Domestic Assistance - Mandated by OMB Circular A-89 - Includes all federal programs - Not all programs listed have funding allocated - Assistance Vs Procurement - Use to search for funding opportunities in Grants.gov
Federal Acquisition Regulations - FAR
- The principal set of rules in the Federal Acquisition Regulation System. - Purpose is to provide uniform policies and procedures for acquisition by the federal government. - Codified in Chapter 1 of Title 48 of the CFR and has 53 parts. - Part 52 contains standard contract clauses and solicitation provisions. Solicitation provisions are certification requirements, notices, and instructions directed at firms that might be interested in competing for a specific contract. These provisions and clauses are of six types: (i) required solicitation provisions; (ii) required-when-applicable solicitation provisions; (iii) optional solicitation provisions; (iv) required contract clauses; (v) required-when-applicable contract clauses; and (vi) optional contract clauses - FAR clauses included in a contract are based on: a) purpose of the contract (service contract, goods procurement or construction) b) nature of contractor (for-profit, nonprofit, educational, state) c) financing method (fixed-price, cstr, time and materials) -Agency supplements place further requirements on contractors (DFAR)
IACUC's major responsibilities are?
-Meet at least once every 6 months - Semi annual reveiw of programs and inspections of facilities - Review of each protocol for approval - Suspending animal use if there is a violation of animal use policies - Reports violations to OLAW - the violation and the actions taken to correct it - Reports to NIH OLAW annually - Is issued by OLAW the animal welfare assuance number for the institution - animal research cannot occur without this assurance number
Health Insurance Portability and Accountability Act (HIPPA)
-Protects privacy of individuals identifiable health information -Privacy rule - 45 CFR 164.512(i)(1)(ii -Covered entities are bound by privacy standards -Approval for using PHI must be in place prior to undertaking research
Name the 7 Executive Branch funding Agencies 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.
In terms of intellectual property ownership, name 2 circumstances where a "work for hire" scenario would 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.
Contract Closeout
1) review contract data & confirm all deliveries accepted 2) Identify & de-obligate any excess funds 3) complete any price revisions 4) Ensure all subcontracts are settled by the prime contractor 5) Ensure all IDCs are settled 6) proper disposal of any classified info 7) contractor final closing statement & final invoice completed & audited
Name 6 crimes that a person is liable for and for which the Federal False Claims Act - 31 U.S.C. §§ 3729 - 3733 was enacted to punish.
1. Any person who knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; 2. Any person who knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim; 3. Any person who has possession, custody, or control of property or money used, or to be used, by the Government and knowingly delivers, or causes to be delivered, less than all of that money or property; 4. Any person who is authorized to make or deliver a document certifying receipt of property used, or to be used, by the Government and, intending to defraud the Government, makes or delivers the receipt without completely knowing that the information on the receipt is true; 5. Any person who knowingly buys, or receives as a pledge of an obligation or debt, public property from an officer or employee of the Government, or a member of the Armed Forces, who lawfully may not sell or pledge property; or 6. Any person who knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit money or property to the Government, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government.
4 Cost Accounting Standards (CAS)-
1. Consistently follow establish cost accounting practices when estimating (proposal costs), accumulating (incurred costs), and reporting costs 2. Consistently allocate costs incurred for the same purpose, in like circumstances as either indirect or direct 3. Identify and exclude unallowable costs from proposals and claims 4. Consistently use the same cost accounting period for purposes of estimating, accumulating and reporting costs.
What is the flowchart for Implementation of Clauses
1. Public Law 2. US Code 3. Code of Federal Regulations (CFR) 4. Federal Acquisition Regulations (FAR) 5. Federal Agency Supplements (FAS)
Which Acts provide regulations specific to contracts?
1. Small Business Act 2. Davis-Bacon Act 3. Contract Work Hours and Safety Standards Act 4. Walsh Healy Public Contracts Act 5. Copeland Anti-Kickback Act
Allocable Cost determined by:
1.Whether cost can be determined as direct or indirect 2.Allocable as a direct cost if the project benefits form the goods and services provided 3.If the cost benefits 2 or more projects, share costs
SBIR funded by 11 federal agencies
11 Federal agencies with extramural research and development (R&D) budgets that exceed $100 million are required to allocate 2.8 percent of their R&D budget to these programs. The below eleven Federal agencies participate in the program: Department of Agriculture Department of Commerce - National Institute of Standards and Technology Department of Commerce - National Oceanic and Atmospheric Administration Department of Defense Department of Education Department of Energy Department of Health and Human Services Department of Homeland Security Department of Transportation Environmental Protection Agency National Aeronautics and Space Administration National Science Foundation
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
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
Administrative requirements for grants and cooperative agreements only
2 CFR 215, OMB Circular A-110 provides regulations governing which of the following for educational institutions?
Biosafety Recombinant DNA
2 members not affiliated with institution who represent interest of community
What percentage of Federal Agency budget is set aside for SBIR/STTR funding (when budget exceeds 100 million).
2.5% of budget
What is the definition of research contained in 45 CFR 46.102(d)?
45 CFR 46.102 (d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
What is the definition of research contained in 45 CFR 46.102(f)?
45 CFR 46.102 (f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Human Subjects Research
45 CFR Part 46 (a.k.a. The common rule) - Establishes the IRB - Defines informed consent The Belmont report - Respect for persons - Beneficence - Justice Federal wide assurance - Issued by the Office of Human Research Protections (OHRP); renewed every 5 years Must have at least 5 MEMBERS. Membership must include at least one member: - whose primary concerns are SCIENTIFIC - whose primary concerns are NON-SCIENTIFIC - whose is NOT AFFILIATED with the institution Types of review a) Exempt b) Expedited and c) Full. Amendments and renewals OHRP reviews allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations, and determines whether to conduct a for-cause compliance evaluation
STTR funded by 5 federal agencies
5 Federal agencies with extramural research and development (R&D) budgets that exceed $1 billion are required to reserve 0.3% of the extramural research budget for STTR awards to small businesses. These agencies designate R&D topics and accept proposals. Currently, 5 federal agencies participate in the STTR program. These include the following: Department of Defense Department of Energy Department of Health and Human Services National Aeronautics and Space Administration National Science Foundation
IACUC members must consist of what?
5 members including (at least one of each, overlaps okay): - 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; - Practicing scientist experienced in research with animals; - Member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, member of the clergy); and - Member who is not affiliated with the institution other than as a member of the IACUC.
Animal Welfare Act (AWA) of 1966
9 CFR Chapter 1, Subchapter A -Implemented in 1966, AWA maintained by the USDA. Animal and Plant Health Inspection Service (APHIS) is named the responsible agency for site visits and review of records -Created standards for the handeling, housing, transportation and feeding of animals used in research -it is the minimally acceptable standard for animal treatment and care -covers these animals (alive or dead): cat, dog, hamster, rabbit, nonhuman primate, guinea pig, and any other warm-blooded animal determined by the Secretary of Agriculture for research, pet use or exhibition -It excludes birds, laboratory rats, laboratory mice, farm animals, and all cold-blooded animals -requires all animal dealers, carriers, exhibitors, handlers, operators, or research faciliies to be registered and licensed as well as liable to monitoring by Federal regulators and suspension of their license if they violate any provisions of the Act and may be assessed a penalty of no more than $10,000 for each violation. Any person who knowingly fails to obey an order made by the Secretary of Agriculture is subject to a civil penalty of $1,500 for each offense
The travel costs do not provide any benefit to the federally sponsored project
A PI on a federally awarded grant wants to charge travel costs to a project for attendance at a conference that is unrelated to the project. Which of the following BEST explains why the PI cannot charge the travel costs to the project
Pre-Proposal
A brief description, usually 2-10 pages, of research plans and estimated budgets that is sometimes submitted to determine the interest of a particular sponsor prior to submission of a formal proposal. Also term Preliminary Proposal.
Institutional Review Board (IRB)
A committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. An institutional review board ( IRB ), also known as an independent ethics committee ( IEC ), ethical review board ( ERB ), or research ethics board ( REB ), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical . Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans
Subcontract, Subgrant, or Subagreement
A document written under the authority of, and consistent with the terms and conditions of an award, that transfers a portion of the research of substantive effort of the prime award to another institution or organization.
unlike circumstances are present
A facilities and administrative cost (indirect cost) may be a direct cost if
prior actual cost
A facilities and administrative cost (indirect cost) rate is usually established based on
Request a one year, no cost extension of the grant while a revised continuation is under preparation
A faculty member has a five year National Institutes of Health (NIH) grant which will terminate August 31, with $14,000 remaining on July 15 of the same year. A competing continuation was recommended for approval but not funded. Which of the following is the most appropriate advice for the research administrator to give to the faculty member?
Consortium agreement
A formalized agreement whereby a research project is carrid out by the grantee and one or more other organizations that are separate legal entitiies.
Export Controls
A government measure implemented by the U.S. Dept. of Commerce through EAR and Department of State through ITAR that is intended to manage or prevent the export of certain products or trade with certain countries. In negotiating contracts, vigilance is required to ensure that the availability of the fundamental research and other exemptions for universities is not lost. -ITAR -EAR -OFAC
Patents
A grant of property right by the government to the inventor to exclude others from making, using, selling, offering for sale or importing your claimed invention.This includes, but is not limited to inventions or discoveries.
Challenge Grant
A grant that provided monies in response to monies from other sources, usually according to a formula. This form of grant is fairly common in the arts, humanities, and some other fields, but is less so in science.
Matching Grant
A grant that requires a specified portion of the cost of a supported item of equipment or project be obtained from other sources.
Bayh-Dole Act
A law encouraging universities and researchers to develop their inventions into marketable products
Task Order Agreement TOA
A legally binding document authorizing work and appropriating funds as a supplement to a basic contact.
Revision
A modified and resubmitted request for funding for a project that was previously not funded either because it was denied by the sponsor or withdrawn by the principal investigator.
FedConnect
A one stop location where you can find opportunities for federal contracts, grants, and other types of assistance funding. Can supplement postings on FedBizOpps and Grants.gov by providing bi-directional communication throughout the pre-award, award, and post award phases.
Patent Assignment
A patent can be transferred or sold by a written agreement called an assignment. When a patent has been assigned to you, you then have the full rights of the original patent holder.
Invitation for Bid (IFB)
A solicitation issued to prospective contractors or equipment suppliers, through a bidding process, to submit a proposal on a specific project to be realized or product or service to be furnished. It describes what is required and how the bidders will be evaluated. Award is based on the lowest bid. Negotiations are not conducted.
Program/Project Officer
A sponsor's designated individual officially responsible for the technical, scientific, or programmatic aspects of a particular grant, cooperative agreement, or contract.
Contract/Grant Officer
A sponsor's designated individual who is officially responsible for the business management aspects of a particular grant, cooperative agreement, or contract.
Mission
A sponsor's stated purpose, which is designed to address a specified set of problems. Almost all federal research agencies are designated as mission agencies.
A B C
Activity Based Casting - works by dividing large heterogenous cost pools into some smaller, homogeneous cost pools, then selects as the cost allocation base for each overhead cost pool a cost driver capable of best capturing the cause & effect relationship between the cost object ~ the occurance of overhead costs.
Data
All data are considered to be subject to this policy, as intellectual property is often present in data that are generated during research at the university. Data shall include, but not be limited to lab notes, results of analyses, etc.; research notes, research data reports, and research notebooks, etc.
Terms of Award
All legal requirements imposed on an agreement by the sponsor, whether by statute, regulation(s), or terms in the award document. The terms of an agreement may include both standards and special provisions that are considered necessary to protect the sponsor's interests.
IRB Members
An IRB consists of at least five members of varying backgrounds. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least: - one scientist member - at least one member whose primary concerns are nonscientific. - one member who is not otherwise affiliated with the institution (a community representative). The IRB should strive for appropriate representation in gender and racial and cultural heritage as well.
5 members
An IRB is required to have at least:
Extension
An additional period of time given by the sponsor to an organization for the completion of work on an approved grant or contract. An extension allows previously allocated funds to be spent after the original expiration date.
Teaming Agreement
An agreement between two or more parties to participate in a research project or teaching activity.
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. Members of all sectors cooperate in identifying, testing, and implementing new, more effective ways of managing the more than $15 Billion in federal research grants. The goal of improving the productivity of research without compromising its stewardship has benefits for the entire nation.
Modifiction
An award document that modifies any aspect of an existing award other than those named above. Example: Carryover approvals, adding, or deleting, special terms, and conditions, changes in funding levels (including NSF's Research Experience for Undergraduates, NIH's Minority Supplement, DOD's ASSERT Programs), administrative changes initiated by the agency, extensions that include changes in terms, change of PIs, etc.
Unilateral Award
An award made by a sponsored to an organization without considering competitive proposals. They are most often made when unsolicited proposals receive favorable treatment.
New Award
An award not previously awarded or a renewal or continuation award treated as a new award by the sponsor and given a new agency number.
cash flow statement
An important tool you may use to measure and track the flow of cash into and out of your operation
$165,000
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 which is the only item excluded from the indirect cost base. What is the total cost for the project?
$50,000
An investigator on a NIH grant has permission to rebudget $50,000 in supply monies into equipment. If the Institution's facilities and administrative cost (indirect cost) rate (based on MTDC) is 50% how much money will be available for the equipment
Request for Applications - RFA
Announcements that indicate the availability of funds for a topic of specific interest to a sponsor. If successful, they generally result in the award of a grant.
Request for Proposal (RFP)
Announcements that specify a topic of research, methods to be used, product to be delivered, and appropriate applicants sought. If successful, they generally result in the award of a contract.
PHS Form 398
Application Form for a PHS Grant (National Institutes of Health)
PHS 2590
Application for Continuation of a Public Health Service Grant. It is for non-competing continuations also known as progress reports.
Standard Form 424 Research & Related SF424 (R&R)
Application forms to be used with all competing applications for research, career development, institutional training awards, and SBIR/STTR Awards
PHS Form 2590
Applications for Continuation of a PHS Grant (National Institutes of Health).
Legislative Branch
Article I of the Constitution establishes the legislative or law making branch of government. It has a two-branch Congress—the Senate and the House of Representatives—and agencies that support Congress.
the Director of the institution's animal care
As required an IACUC Committee must contain all but one of the following a. a Doctor or Veterinary Medicine, b. a practicing scientist experienced in research with animals, c. the Director of the institution's animal care facility, d. a person not affiliated with the institution
Small Business Act
Assure fair portion of federal contracts are placed with small businesses. Utilization of Small Business concerns, is used in federal contracts when the contract amount is excess of the simplified acquisition threshold (currently $150,00) unless a personal service contract is contemplated or the contract, together with all the subcontract is to be performed entirely outside of the USA. (1958)
The Office of Research Integrity (ORI) is responsible for?
Assuring that all institutions applying for or receiving PHS funds have appropriate mechanisms for dealing with: - allegations of scientific misconduct and - the protection of whistleblowers; - conducting reviews of institutional programs to determine whether they comply with federal requirements, and - investigating and resolving problems of institutional compliance
IBC members must include?
At Least 5 members Collectively, the membership of an IBC should include: Experience and expertise in: o Recombinant or synthetic nucleic acid molecule research; and o Biosafety and physical containment Knowledge of: o Institutional commitments and policies; o Applicable laws; o Standards of professional conduct and practice; o Community attitudes; and o Environmental considerations The capability to: o Assess the safety of research involving recombinant and synthetic nucleic acid molecules; and o Identify potential risks to public health and safety Every committee is required to have two members not affiliated with the institution who represent the interest of the surrounding community with respect to health and protection of the environment. Depending on the kind of research conducted at your institution, you may also be required to have: BSO (biological safety officer) Plant Expert Animal Expert
What is the percentage that all STTR budgets must match
At least 40 percent of the STTR research project is to be conducted by the small business concern and at least 30 percent of the work is to be conducted by the single "partnering" research institution.
At which phase are patients NOT healthy?
At phase 2
Interim Funding
Authorization to expend funds on a project to a specified limit before the award document has been received from the sponsor.
The CDC list of special agents includes?
Category A: High-priority agents include organisms that pose a risk to national security because they -can be easily disseminated or transmitted from person to person; -result in high mortality rates and have the potential for major public health impact; -might cause public panic and social disruption; and require special action for public health preparedness. They include: Anthrax Botulism Plague Smallpox Tularemia Viral hemorrhagic fevers Category B: Second highest priority agents include those that -are moderately easy to disseminate; -result in moderate morbidity rates and low mortality rates; and -require specific enhancements of CDC's diagnostic capacity and enhanced disease surveillance. They include: Brucellosis Epsilon toxin of Clostridium perfringens Food safety threats (e.g., Salmonella species, Escherichia coli O157:H7, Shigella) Glanders Melioidosis Psittacosis Q fever Ricin toxin from Ricinus communis (castor beans) Staphylococcal enterotoxin B Typhus fever Viral encephalitis (alphaviruses [e.g., Venezuelan equine encephalitis, eastern equine encephalitis, western equine encephalitis]) Water safety threats (e.g., Vibrio cholerae, Cryptosporidium parvum) Category C: Third highest priority agents include emerging pathogens that could be engineered for mass dissemination in the future because of -availability; -ease of production and dissemination; and -potential for high morbidity and mortality rates and major health impact. They include: Emerging infectious diseases such as Nipah virus and hantavirus
Who approves an item to be listed in the CFDA?
Congress approves CFDA listings, but not all listings are funded.
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.
What information must Agencies make available to the public?
Each agency shall separately state and currently publish in the Federal Register for the guidance of the public-- (A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions; (B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available; (C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations; (D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and (E) each amendment, revision, or repeal of the foregoing.
provisions for an organizational program for the care and use of animals
Each organization using animals in Public Health Service sponsored projects must provide written assurance of its compliance with
COGR Primary Representative
Each university participating in support of COGR's programs is linked to the Council's operations by this individual on its campus. This individual serve as the focal points for consultation regarding positions the Council may take on advocacy issues, and will also designate a number of professionals at his/her university who serve as liaison. This serves the purpose of maintaining effective and mutually beneficial interaction between COGR and the academic community on specialized subject issues. Note: At GSU, this individual is currently Mr. Jerry Rackliffe, VP of Finance & Administration.
What is the Confidentiality of Patient Records?
Enacted to protect persons with substance abuse problems who seek treatment.
Grant Policy Committee (GPC)
Established by the CFO Council in 2001 to implement Public Law 106-107, and consists of grants policy experts from across the Federal government. The vision is to improve the effectiveness of Federal financial assistance by simplifying the application process, streamlining financial assistance award and administration, improving quality and timeliness of information related to assistance, and improving stewardship of Federal dollars.
Fulbright Program
Established in 1946 under legislation introduced by then Senator J. William Fulbright of Arkansas, this is the flagship international educational exchange program sponsored by the Bureau of Educational and Cultural Affairs of the United States Department of State. The program is designed to increase mutual understanding between the people of the United States and the people of other countries. Currently operating in more than 155 countries worldwide, it has provided approximately 310,000 participants with the opportunity to study, teach, or conduct research in each others' countries and exchange ideas. Approximately 8,000 competitive, merit-based grants are awarded annually in most academic disciplines and fields of study. Grants exist for a variety of applicants, including students, scholars, teachers, professionals and groups.
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).
What is a D&F (Determination and Finding)?
FAR 1.701 provides that a "Determination and Finding" is a special form of written approval by an authorized official that is required by statute or regulation as a prerequisite to taking certain contract actions. The "determination" is a conclusion or decision supported by the "findings.'' The findings are statements of fact or rationale essential to support the determination and must cover each requirement of the statute or regulation
Program Announcement (PA)
FOA which identifies areas of increased priority and/or emphasis on particular funding mechanisms for a specific area of science. Applications are accepted on standard receipt dates on an on-going basis. Remains active for three years from date of release unless a specific expiration is indicated.
Salary Cap
FY 2014 Awards Issued October 1, 2013 through January 11, 2014 (Executive Level II) $179,700 January 12, 2014 through September 30, 2014 (Executive Level II) $181,500
Misconduct in Research
Fabrications, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for purposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.
True or false: Patent applications protect a patent in perpetuity.
False. Patents provide protection for a set period of time.
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.
Rebudgeting
Federal expanded authorities permit which of the following without additional sponsored approval?
Utility Patent
Granted for 20 years from the date of filing; these protect the structure and function of an invention defined by the claims of the patent. Protects patentable inventions such as processes, machines, compositions of matter and improvements.
Consortium Agreement
Group of collaborative investigators/institutions; arrangement can be formalized with specified terms and conditions.
They upload it to their submission application. Not on the SF 424 form
If a PI wants to request a reviewer to a proposal submission, where can they do this
treated under organization's policy as exempt from review
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
$40,000
If an agency requires 20% cost sharing of the total project for a particular program and a proposal is requesting $200,000 from agency, what is the additional amount that the institution must cost share?
Annually
If an institution of higher education is subject to OMB Circular A-133, when must it have an independent audit?
90 days
If final financial reporting (FS 425 Report) to federal agencies is not completed with in the typical ___ days, the institution is out of compliance
approval of student's embassy
In order for a foreign national doctoral student researcher to work on a federal grant in an American institution, it is necessary for the student to have
When is the only time a patient is not healthy for phase 1?
It's the patient has aids or cancer; other than that all patients must be healthy in phase 1
Federal Financial Assistance Management Improvement Act (Public Law 106-107)
Law passed in 1999 to improve the effectiveness and performance of federal financial assistance programs, simplify federal assistance application and reporting requirements, improve the delivery of services to the public, and facilitate greater coordination among those responsible for delivering the services. Now known as the Grants Policy Committee (GPC)
Sunset Laws
Laws that include provisions for automatic expiration at the end of a specified period of time. These laws typically require a reauthorization of programs by the Legislature at stipulated intervals, such as five years. Without reauthorization, the program lapses or other conditions set forth in the provision take effect.
STTR Qualifications - Research Institution
Located in the US; Meet one of three definitions - (1) Nonprofit college or university; (2) Domestic nonprofit research organization; (3) Federally funded R&D center
Byrd Amendment
Maintain the integrity of the process by which the federal gov't makes awards to recipients by reducing or eliminating the impact of lobbyist seeking favorable considerations for specific clients (LOBBYIST)
STTR Congressional History
Modeled after the Small Business Innovation Research (SBIR) program, STTR was established as a pilot program by the Small Business Technology Transfer Act of 1992 (Public Law 102-564, Title II). Government agencies with R&D budgets of $1 billion or more are required to set aside a portion of these funds to finance the STTR activity. In 2001, Congress passed the Small Business Reauthorization Act of 1997 (P.L. 105-135). The program was reauthorized again until September 30, 2009, by the Small Business Technology Transfer Program Reauthorization Act of 2001 (P.L.107-50). Subsequently, Congress has passed numerous extensions, the most recent of which extends the STTR program through 2017. The goal of the STTR program is to facilitate the transfer of technology developed by a research institution through the entrepreneurship of a small business concern.
Electronic Research Administration (eRA)
NIH's infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards to biomedical and behavioral investigators worldwide. reg is required
HHS Agencies and Offices
OS - Office of the Secretary ACF - Administration for Children & Families ACL - Administration for Community Living AHRQ - Agency for Healthcare Research & Quality ATSDR - Agency for Toxic Substances & Disease CDC - Centers for Disease Control & Prevention CMS - Centers for Medicare & Medicaid Services FDA - Food & Drug Administration HRSA - Health Resources & Services Administration IHS - Indian Health Service NIH - National Institutes of Health OIG - Office of Inspector General SAMHSA - Substance Abuse & Mental Health Services Administration
Blood-borne Pathogens
OSHA promulgated this standard to eliminate and minimize occupational exposure to Hepatits B, HIV and other blood-borne Pathogens
OSHA
Occupational Safety and Health
PHS 2014-02 (STTR)
Omnibus solicitation of the NIH for Small Business Technology Transfer Grant Applications
PHS 2014-02 (SBIR)
Omnibus solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications
Office of Technology
Part of the SBA which administers the Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) programs.
F&A is not allowed to be charged on the following?
Participant support*, equipment, capital equipment, patient care, tuition, building renovations, rental costs for non-University owned space, scholarships/fellowships, Subawards in excess of $25,000. *NSF only
Bayh-Dole Act
Patent and Trademark Law Amendments Act (Pub. L. 96-517, December 12, 1980) is United States legislation dealing with intellectual property arising from federal government-funded research. The Act was adopted in 1980, is codified at 94 Stat. 3015, and in 35 U.S.C. § 200-212,[1] and is implemented by 37 C.F.R. 401.[2] The key change made by this Act was in ownership of inventions made with federal funding. Before this Act, federal research funding contracts and grants obligated inventors (wherever they worked) to assign inventions they made using federal funding to the federal government.[3] This permits a university, small business, or non-profit institution to elect to pursue ownership of an invention in preference to the government.[4]
COGR Publication: University-Industry Relations
Referenced in the CRA BOK as the "COGR Guide," "This brochure explores the nature and scope of university-industry research relatioships and seeks to provide context for some of the tensions that frequently can plague the creation and implementation of university industry collaborations.... hop[ing] to highlight some of the major issues that must be understood and addressed to facilitate successful collaborations." To access the publication: http://www.cogr.edu/Pubs_intellectual.cfm
COGR Publication: The Bayh-Dole Act: A Guide to the Law and Implementing Regulations
Referenced in the CRA BOK, and published as a brochure by COGR in 1999 to help "inform the public about the Patent & Trademark Law Amendment Act of 1980, more commonly known as the Bayh-Dole Act, which is the legal framework for transfer of university generated, federally funded inventions to the commercial market place. This brochure provides information about the Act, as well as about its implementing regulations and compliance requirements." To access the guide & related materials: http://www.cogr.edu/Pubs_intellectual.cfm
COGR Publication: Managing Externally Funded Research Programs
Referred to in the CRA BOK as "COGR Good Practices Principle." This guide may be used by institutions to help review their management systems and internal controls with regard to managing sponsored programs generally in the form of grants and contracts as distinguished from gifts and other supported activities at the institution. Readers must recognize that while general principles of effective management are stable and consistent and applicable to all externally-supported activities, rules and regulations imposed by external sponsors on grants and contracts obligate the institution to meet specific obligations and affects, among other things, the way the institution accounts for and reports on the use of the funds. The rules and regulations of external sponsors are subject to change requiring a different approach to management. This guide does not purport to set standards for sponsored program management; it only suggests effective management practices and indicators to test those practices. COGR periodically updates and revises this document. However, at any point in time, this document should be considered in the light of administrative and regulatory changes made subsequent to its latest revision date. To access the current guide: http://www.cogr.edu/Pubs_EffectiveManagement.cfm
Export Administration Regulation (EAR)
Regulations designed to control the export and re-export of most commercial items. EAR restrictions vary from country to country, and embargoed countries such as Cuba, North Korea, Sudan, Syria and Iran are prohibited from receiving US exports. EAR does not control all goods, services, and technologies, however. EAR -controls export or transfer of 'dual use' items. Prohibits US participation in certain restrictive trade practices/foreign boycotts
How does STTR differ from SBIR?
STTR differs from SBIR in three important aspects: The SBC and its partnering institution are required to establish an intellectual property agreement detailing the allocation of intellectual property rights and rights to carry out follow-on research, development or commercialization activities. STTR requires that the SBC perform at least 40% of the R&D and the single partnering research institution to perform at least 30% of the R&D. Unlike the SBIR program, STTR does not require the Principal Investigator to be primarily employed by the SBC.
Small Business Innovation Research (SBIR)
Set-aside program for small business concerns to engage in Federal R&D with -- potential for commercialization
Small Business Technology Transfer (STTR)
Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercializations.
Title IX
Sex Discrimination - prohibits exclusion of an individual on the basis of sex from any educational program or activity receiving federal support/assistance
Salary or other payments for service, equity interests, intellectual property rights.
Significant Financial Interest is defined by the regulation as anything of monetary value, including but not limited to:
NIH FCOI
Significant financial interests must be reported -Payments or ownership valued at $5,000 or more from a public corporation -Any royalty income from IP -Any travel paid by a non-granting agency - needs to be done for each proposal - transactional base. NSF threshold is $10,000
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.
FAR 52.219-9
Small Business and Subcontracting Plan
FAR at 48 CFR Part 52
Solicitation provisions and contract clauses
Request for Proposals (RFP)
Solicits contract proposals and usually has one receipt date. Announces that NIH would like to award a contract to meet a specific need.
Grants.gov
Source to find and apply for all federal discretionary grants (may search for funding opp. by FON or CFDA#, download instructions and pdf application pkgs); System doesn't store submitted proposals, just transmits them to sponsoring agency; Ability to track the progress of application pkg from initial submission to agency retrieval; resources available at no cost to applicant
Appendix V
State/Local Governmentwide Central Service Cost Allocation Plans
Appendix VII
States and Local Government and Indian Tribe Indirect Cost Proposals
The Federal Acquisition Regulations (FAR) is a
System of uniform policies and procedures governing acquisition of contracting actions of all executive agencies. The FAR System governs the "acquisition process" by which the government purchases (acquires) goods and services. The process consists of three phases: (1) need recognition and acquisition planning, (2) contract formation, and (3) contract administration. The FAR System regulates the activities of government personnel in carrying out that process. The FAR System is codified at Title 48, Chapter 1 of the United States Code of Federal Regulations.
R15
The Area program supports small-scale research projects in the biomedical and behavioral sciences conducted by faculty and students at educational institutions that have not been major recipients of NIH research grant funds. Project periods are limited to 3 years and direct costs are limited to $300,000 over the entire project period. Grants are renewable. Standard application deadlines of Feb. 25, June 25, and October 25. Institutions must be domestic, offer baccalaureate and advanced degrees in health-related sciences, and receive no more than $6 million per year in NIH support in each of 4 of the last 7 years in order to be eligible.
Who has the responsibility to investigate such crimes?
The Attorney General diligently shall investigate a violation under section 3729. If the Attorney General finds that a person has violated or is violating section 3729, the Attorney General may bring a civil action under this section against the person.
Code of Federal Regulations-
The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.
IRB protected populations include?
The Code of Federal Regulations requires that IRBs give special consideration to some classes of subjects: - children - prisoners - pregnant women - mentally disabled persons, and economically or educationally disadvantaged persons
What is eCFR?
The Electronic Code of Federal Regulations (e-CFR) is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.
eRA Commons
The Electronic Research Administration provides information technology solutions and support for the full life cycle of grants administration functions for the National Institutes of Health (NIH).
What Agencies Are Subject to the FAR?
The FAR applies to certain purchases, discussed below (see "What Purchases Are Subject to the FAR?"), by executive branch agencies, which the FAR defines to mean executive department[s], ... military department[s], or any independent establishment[s] within the meaning of 5 U.S.C. 101, 102, and 104(1), respectively, and any wholly owned Government corporation[s] within the meaning of 31 U.S.C. 9101.9However, although the FAR applies to executive branch agencies, it does not necessarily apply to all executive branch agencies, or to all organizational components of a particular executive branch agency.10 Exceptions include, for example, the Federal Aviation Administration (FAA), which Congress has authorized to establish its own acquisition system,11 and the U.S. Mint.
What Is the Federal Acquisition Regulation?
The FAR is a regulation, codified in Parts 1 through 53 of Title 48 of the Code of Federal Regulations (C.F.R.).8 As is discussed in more detail below (see "What Does the FAR Cover?"), each part of the FAR, such as Part 37—Service Contracting, is divided into subparts (e.g., Subpart 37.1, Service Contracts—General). Subparts are divided into sections (FAR 37.113, Severance payments to foreign nationals), which may be divided into subsections (Section 37.113-2, Solicitation provision and contract clause). The FAR also contains standard solicitation provisions and contract clauses (Part 52) and forms (Part 53). The various agency FAR supplements, codified in Chapters 2 through 63 of Title 48, and the Cost Accounting Standards (CAS), codified in Chapter 99 of Title 48, are not part of the FAR, although they can play a significant role in the acquisition process. "What Is the Relationship Between the FAR and Agency FAR Supplements?," below, discusses in more detail the relationship between the FAR and agency FAR supplements, such as the Defense Federal Acquisition Regulation Supplement (DFARS).
NIH/ORI FOIA Implications
The Freedom of Information Act (FOIA), 5 U.S.C. § 552, provides public access to ORI records except to the extent that the records are protected from disclosure by one or more of FOIA's nine exemptions. ORI records are primarily within the scope of Exemptions 5, 6, and 7. Exemption 5 covers intra- and interagency memoranda and documents. Exemption 6 provides protection for personal privacy interests and permits withholding, if disclosure would constitute a clearly unwarranted invasion of personal privacy. Exemption 7 protects records that the government has compiled for law enforcement purposes.
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.
National Academies
The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council are private, nonprofit institutions that provide expert advice on some of the most pressing challenges facing the nation and the world. Our work helps shape sound policies, inform public opinion, and advance the pursuit of science, engineering, and medicine. Most of their work is conducted by the National Research Council and the Institute of Medicine. The Research Council, the operating arm of the NAS and NAE, performs its studies and workshops through five major divisions; Behavioral and Social Sciences and Education, Earth and Life Studies, Engineering and Physical Sciences, Policy and Global Affairs, and the Transportation Research Board.
6-9 months
The National Science Foundation indicates decisions on the funding of grant proposals should normally take
Research.gov
The National Science Foundation's (NSF) grants management system that provides easy access to research-related information and grants management services in one location. This is considered the modernization of FastLane, providing the next generation of grants management capabilities for the research community.
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.
Briefly describe the Nuremberg Code (1946)
The Nuremberg Code is 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. The Nuremberg code includes such principles as informed consent and absence of coercion; properly formulated scientific experimentation; and beneficence towards experiment participants.
a cabinet-level department
The Office for Human Research Protection is administered by
How to do business internationally
The Office of Commercial and Business Affairs (CBA) plays a major role in coordinating trade and investment matters to support U.S. firms doing business overseas. Our mission is to engage U.S. government resources to assist and promote U.S. business interests overseas, and to ensure that private sector business concerns are fully integrated into U.S. foreign and economic policy.
live, vertebrate animals only
The PHS policy governing the use and care of animals covers
The Program Fraud Civil Remedies Act 3 USC 3801-3812 authorizes NSF to:
The Program Fraud Civil Remedies Act of 1986 (PFCRA), 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.
R13 and U13
The Purpose of the NIH Research Conference (R13) and Grant and Cooperative Agreement (U13) programs is to support high quality scientific conferences that are relevant to public health and to the scientific missions of the participating institutes and centers. Standard application deadlines are April 12, Aug. 12, and Dec. 12. Applicants are urged to initiate contact well in advance of the chosen application receipt date and no later than six weeks before that date. Eligibility is limited to domestic institutions or organizations including established scientific or professional societies. Individuals are not eligible to receive this grant.
What is the Simplified Acquisition Threshold (SAT) and why does it matter to federal contractors?
The SAT defines the lower boundary of complexity in Federal Contracting -- 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.
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.
SBIR Congressional History
The SBIR program was established under the Small Business Innovation Development Act of 1982 (P.L. 97-219) with the purpose of strengthening the role of innovative small business concerns in Federally-funded research and development (R&D). Through FY2009, over 112,500 awards have been made totaling more than $26.9 billion.
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 is the UBMTA Agreement?
The Uniform Biological Material Transfer Agreement (UBMTA) is an implementing letter to memorialize individual exchanges of materials under the UBMTA, and includes a simple letter of agreement for transferring nonproprietary biological materials among public and nonprofit organizations.
The UBMTA is primarily for biological material transfers between ____?
The Uniform Biological Material Transfer Agreement (UBMTA) is to be primarily used by participating public and nonprofit organizations. However, for-profit organizations may also choose to adopt these agreements as well.
minimum wages, maximum hours, child labor, convict labor and safe and sanitary working conditions
The Walsh-Healey Public Contracts Act deals with issues on
Budget Adjustment
The act of amending the budget by moving funds from one category or line item to another.
Close Out
The act of completing all internal procedures and sponsor requirements to terminate or complete a research project.
October 1
The federal fiscal year begins:
electronic funds transfer
The federal government prefers to disburse funds under federal grants via
Final Report
The final technical or financial report required by the sponsor to complete a research project.
OMB Circular A-133
The following establishes audit requirements and defines Federal responsibilities for implementing and monitoring these requirements for institutions of higher education and other nonprofit institutions receiving federal awards
NSF, NIH, ONR, DoEnergy, USDA, Florida State University System, and University of Miami
The founding members of the FDP (then the Florida Demonstration Project, now Federal Demonstration Project) - 5 federal agencies, one state university system, and one state university. Met in 1986 to begin this experiment to to test and evaluate a grant mechanism utilizing a standardized and simplified set of terms and conditions across all participating agencies, the FDP has evolved into an organization of 10 federal agencies and more that 90 research institutions dedicated to finding efficient and effective ways to support research by maximizing resources available for research and minimizing administrative costs.
Project Grants
The funding, for fixed or known periods, of specific projects. This can include fellowships, scholarships, research grants, training grants, traineeships, experimental and demonstration grants, evaluation grants, planning grants, technical assistance grants, survey grants, and construction grants.
Defense Services
The furnishing of assistance (including training) to foreign persons, whether in the US or abroad in the design, development, engineering, manufacture, production, assembly, testing, repair, maintenance, modification, operation , demilitarization, destruction, processing OR use of defense articles.
Federal Funding Accountability and Transparency Act of 2006 (FFATA)
The intent is to provide the citizenry with the ability to hold the government accountable for spending decisions, which the desired end result of reducing wasteful spending in government. The legislation requires that information on federal awards be made available to the public in a single, searchable website.
Budget Period
The interval of time - usually twelve months - into which the project period is divided for budgetary and funding purposes.
Budget Period
The intervals of time (usually 12 months) into which a project period is divided for budgetary and funding purposes.
What is FAR, Part 51?
The largest single part of the FAR is Part 52, which contains standard solicitation provisions and contract clauses. Solicitation provisions are certification requirements, notices, and instructions directed at firms that might be interested in competing for a specific contract. These provisions and clauses are of six types: (i) required solicitation provisions; (ii) required-when-applicable solicitation provisions; (iii) optional solicitation provisions; (iv) required contract clauses; (v) required-when-applicable contract clauses; and (vi) optional contract clauses."
Community of Science (COS)
The largest, most comprehensive database of available funding opportunities, including both federal and non-federal sponsors with key information provided about each. Now merged with PIVOT to form a comprehensive networking site for collaborations.
Copeland Act
The law "makes it unlawful to induce, by force, intimidation, threat of procuring dismissal from employment , or otherwise, any person employed in the construction or repair of public, building or public works, financed in whole or in part by the United States, to give up any part of the compensation to which that person is entitled under a contract of employment. (ANTI KICK-BACK / NO GIFTS)
SBIR Mission and Program Goals
The mission of the SBIR program is to support scientific excellence and technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy. The program's goals are four-fold: 1. Stimulate technological innovation. 2. Meet Federal research and development needs. 3. Foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged persons. 4. Increase private-sector commercialization of innovations derived from Federal research and development funding.
Modular Grants
The modular grant was designed to focus applicants on the science in the application rather than budget details. This concept establishes specific modules or increments in which direct costs must be requested, as well as a maximum level for requested budgets of $250,000 in direct costs. The modular grant budget does not require a categorical breakdown of the budget, however other requirements still apply.
SBIR Phase I
The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and to determine the quality of performance of the small business awardee organization prior to providing further Federal support in Phase II. SBIR Phase I awards normally do not exceed $150,000 total costs for 6 months.
STTR Phase I
The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed R/R&D efforts and to determine the quality of performance of the small businesses prior to providing further Federal support in Phase II. STTR Phase I awards normally do not exceed $100,000 total costs for 1 year.
STTR Phase II
The objective of Phase II is to continue the R/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 Phase II project proposed. Only Phase I awardees are eligible for a Phase II award. STTR Phase II awards normally do not exceed $750,000 total costs for 2 years.
SBIR Phase II
The objective of Phase II is to continue the R/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 I. Only Phase I awardees are eligible for a Phase II award. SBIR Phase II awards normally do not exceed $1,000,000 total costs for 2 years.
SBIR Phase III
The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase I/II R/R&D activities. The SBIR program does not fund Phase III. Some Federal agencies, Phase III may involve follow-on non-SBIR funded R&D or production contracts for products, processes or services intended for use by the U.S. Government.
Catalog of Federal Domestic Assistance (CFDA)
The online catalog provides access to a database of all federal programs available to state and local governments (including the District of Columbia); federally-recognized Indian tribal governments; territories (and possessions) of the United States; domestic public, quasi-public, and private profit and nonprofit organizations and institutions; specialized groups; and individuals.
FAR
The overall guiding principle of __________ is to have an acquisition system that can satisfy customer's needs yet minimize administrative overhead without sacrificing integrity, fairness, openness and public policy objectives.
If a person commits any of those crimes, what is his/her liability?
The person is liable to the United States Government for a civil penalty of not less than $5,000 and not more than $10,000, as adjusted by the Federal Civil Penalties Inflation Adjustment Act of 1990 (28 U.S.C. 2461 note; Public Law 104-410 [FN1]), plus 3 times the amount of damages which the Government sustains because of the act of that person.
Who is the reviewing official?
The regulations designate the NSF General Counsel or his or her designee as the reviewing official.
Prior Approval
The requirement for written documentation of permission to use project funds for purposes not in the approved budget, or to change aspects of the program from those originally planned and approved. Prior approval must be obtained before the performance of the act that requires such approval under the terms of the agreement.
FedBizOpps (FBO)
The single government point-of-entry (GPE) for Federal government procurement opportunities over $25,000. Government buyers are able to publicize their business opportunities by posting information directly via the Internet. Through one portal, commercial vendors seeking Federal markets for their products and services can search, monitor and retrieve opportunities solicited by the entire Federal contracting community.
Project Period - PP
The total time for which support of project has been programmatically approved. A proect period may consist of one or more budget periods. (Also see Budget Adjustment).
The Office and Grants and Contracts/Finance will monitor and draw cash on expenditures as appropriate
The university receives a grant from NIH that states the payment terms are DHHS Letter of Credit. This means:
What Does the FAR Cover?
The various parts of the FAR contain somewhat different types of information, as illustrated below. In particular, Parts 1 through 51 establish policies, requirements, exceptions, practices, and procedures to guide members of the acquisition workforce in performing their responsibilities, while Parts 52 and 53 provide standard solicitation and contract clauses and forms. In addition, while much of the FAR is arguably process oriented (e.g., specifying how agencies may obtain full and open competition), the opening sections of the FAR articulate "guiding principles" for the federal acquisition system that arguably inform all other sections of the FAR and federal procurement generally (e.g., satisfying the customer, minimizing administrative operating costs).
R56
These are NIH High Priority, Short-term Project Awards which cover 1 or 2 year projects. R56 will provide limited, interim research support based on the merit of the pending application. This support is designated to enable a principal investigator to gather additional data for revision of the current application. The funding will end after 1-2 years or when the PI succeeds in obtaining a traditional research project grant. It is available to R01 applicants only and you may not apply for this grant.
Americans with Disabilities Act
This act extends comprehensive civil rights protections to individuals with disabilities, similar to those provided to persons on the basis of race, sex, national origin, and religion. (1990)
Freedom of Information Act (FOIA)
This act provides that information is made available to the publicly: - Publication in the Federal Register - Providing an opportunity to read and copy records at convenient location OR - Upon request, providing a copy of a reasonably described record
Digital Accountability and Transparency (DATA) Act 2014
This act requires the federal government to increase availability, accuracy, and usefulness of online information regarding spending.
Restricted Parties
This can be sanctioned countries, entities, or individuals that appear on various lists used by the government including: Dept. of Commerce Denied Persons, Dept of State Designated Terrorist Organizations, Dept. of State Terrorist Exclusion List.
U01
This is a Research Cooperative Agreement which supports discrete, specified, circumscribed projects to be performed by investigators in an area representing their specific interests and competencies. This is used when substantial programmatic involvement is anticipated between the awarding Institute and Center. It has no dollar limit unless specified in the FOA.
R34
This is the NIH clinical trial planning grant program. It supports the development of Phase III clinical trials which includes establishment of the research team, development of tools for data management and research oversight, definition of recruitment strategies, finalization of protocol and preparation of an operations/procedures manual. R34 is not designated for the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial. R34s have a project period of one year and a budget for direct costs of up to $100,000 per year. They also require a rationale for a future clinical trial on health care, policy or practice. Provide adequate information for reviewers to evaluate how the clinical trial would be conducted. Address the availability of your subject population and address issues and challenges regarding adherence to the proposed intervention protocol.
R21
This is the NIH exploratory /developmental research grant award. This mechanism is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. R21 has been standardized to accommodate unsolicited grant applications as well. You may request a project period up to two years and the combined budget for direct costs for that period may not exceed $275,000. No more than $200,000 may be requested in any single year. R21 cannot be renewed. One resubmission is allowed and the introduction required is limited to one page. Research strategy may not exceed 6 pages. This mechanism is particularly for high risk/high reward studies that may lead to a breakthroughs in particular areas or result in novel techniques, agents methodologies, models or applications that will impact biomedical, behavioral or clinical research. Projects should be distinct from those supported by the R01 mechanism.
K99/R00
This is the pathway to independence award or the new investigators program. It 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 three years of independent support contingent on securing an independent research position. Award recipients will be expected to compete successfully for an independent R01 support from the NIH during the career transition award period.
SFR-424 (R&R)
This is used for electronic submission gradually replacing the PHS 398. This page provides versions applications guides and practice application packages for preparing for your application.
Cleary Act
This law is named for a Lehigh University freshman who was raped and murdered in her campus residence hall in 1986, the resulting backlash against unreported crimes on numerous campuses across the country led to this act. (REPORTING CAMPUS CRIMES)
Material Transfer Agreement
This type of document is 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.
Independent Agencies
Those agencies of the federal government that exist outside of the federal executive departments (those headed by a Cabinet Secretary). These agencies, while constitutionally part of the executive branch, are independent of presidential control, usually because the president's power to dismiss the agency head or a member is limited. These agencies are established through separate statutes passed by the Congress, and each respective statutory grant of authority defines the goals the agency must work towards as well as what substantive areas, if any, over which it may have power of rule making. These agencies currently include: Broadcasting Board of Governors, CIA, Corporation for National & Community Services, EPA, FCA, FDIC, FHFA, FLRA, GSA, IMLS, NASA, NARA, NCUA, NEA, NEH, AMTRAK, NSF, OGE, OPM, OPIC, Peace Corps, Pension Benefit Guaranty Corporation, SSS, SBA, SSA, TVA, TSP, USAID, USPS, US Trade & Development Agency
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 contractor need not undergo a full blown proposal/bid process
True or False? Contractors who provide products or services to the Federal Government are considered members of the Government's "Federal Acquisition Team."
True. Both FAR 1.102(b)(c) and FAR 1.102-3 note that the Acquisition Team consists of all in Government acquisition including not only representatives of the technical, supply, and procurement communities but also the customers they serve, and the contractors who provide the products and services.
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.
TINA
Truth and Negotiations Act
G5
US Dept of Education (OE) post award
USPTO
US Patent and Trademark Office (Filing agency for patents, inventions, and trademarks)
Privacy Act
USC amended in Gov't Act of 2002 Rights of individuals to determine what information about them is maintained at federal agency files and to know how that information is used and the right of individuals to have access to such records and to correct, amend, or request deletion in their records. System of records are defined as "any item, collection or grouping of information about an individual that is maintained including but not limited to: Education, Financial transactions, Medical history, Criminal, Employment history Can include: Name, Identifying number, Symbol, Fingerprint, Voiceprint, photograph The act requires that when a federal agency contract for the... Design / Development / Operation of a system of records on individuals This information may not be used for other purposes without the consent of the individual. Noncompliance - Civil or criminal penalties may apply. (1974)
Patent applications are filed with _______
USPTO -- US Patent and Trademark Office.
Untimely performance
Under a federal contract, which of the following is a reason for termination for default?
Martial status of applicant
Under federal Equal Employment Opportunity provisions, a supervisor should NOT ask which of the following during an employment interview:
False claims and statements subject to the PFCRA are to be investigated by:
Under the Act, false claims and statements subject to its provisions are to be investigated by an agency's investigating official. The results of the investigation are then reviewed by an agency reviewing official who determines whether there is adequate evidence to believe that the person named in the report is liable under the Act.
When does NSF notify the Attorney General?
Upon an affirmative finding of adequate evidence, the reviewing official sends to the Attorney General a written notice of the official's intent to refer the matter to a presiding officer for an administrative hearing.
What is the Solomon Act (Amendment)/ National Defense Authorization Act
What 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.
Formulation of the President's Budget; Action by the Congress; Presentation (to Congress) and-Execution of enacted budget laws
What are the 3 main phases in the Federal Budget Process
Requires employers to assure that employees hired are legally authorized to work in the US.
What is Immigration Reform and Control Act (IRCA)?
Requires the government to show 3 materials elements on all sole source contracts with a the current threshold applicable to all agencies is $700,000 for prime contracts awarded
What is Truth in Negotiations Act?
Material transfer agreement (MTA)
What is 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
A mechanism for procurement of a product or service with specific obligations for both sponsor and recipient. Designed to benefit the sponsor by achieving an expected outcome or product.
What is a contract?
protection provided to the authors of "original works of authorship" including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished
What is a copyright?
is the grant of a property right to the inventor, issued by the Patent and Trademark Office. The term of a new patent is 20 years from the date on which the application was filed
What is a patent?
a word, name, symbol or device which is used in trade with goods to indicate the source of the goods and to distinguish them from the goods of others
What is a trademark?
A vivarium
What is an area, usually enclosed, for keeping and raising animals or plants for observation or research
An award similar to a grant, and anticipates having substantial involvement in research activities once the award has been made.
What is cooperative agreement?
Research misconduct
What is defined as fabrication, falsification and plagiarism, and does not include honest error or differences of opinion
1.Publicly known information.2. Already known information.3. Information received from others. 4. Information shared with others. 5. Independently developed information. 6. Information not included in the nondisclosure agreement.
What is not included in a Nondisclosure Agreement?
You can't spend more than what you've got, or what congress had approved for them.
What is the Anti-deficiency Act?
Cooperative Research And Technology Enhancement Act hopes to enhance research among Universities, private and public sectors, by treating joint inventions as if they are a single owner but only if the collaborators sign an agreement prior to the invention being created.
What is the CREATE Act?
Is a binding contract made between two parties, one of whom is the "Sponsor" or the company or individual sponsoring the clinical trial, while the other is the "Institution" or the organization or hospital receiving the sponsorship for conducting clinical trials.
What is the Clinical Trial Agreement?
Provides an entitlement of up to 12 weeks of job-protected, unpaid leave funding any 12-month period for the following reasons; birth and care of the employees child, or placement for adoption or foster care of a child with the employees; care of an immediate family member who has a serious health condition or care of the employees own serious health condition.
What is the Family and Medical Leave Act?
Required information on federal awards be made available to the public via single, searchable website
What is the Federal Funding Accountability and Transparency Act (FFATA)?
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.
What is the Fly America Act?
Mandates that a "Responsible Party" register and report results of certain "applicable clinical trials". Interventional studies of drugs, biologics, or devices that are subject to FDA regulations.
What is the Food and Drug Administration Amendments Act (FDAAA)?
Information is made available to the public by publication in the Federal Register, upon request given a description of the records desired and provides an opportunity to read and copy records at convenient locations.
What is the Freedom of Information Act?
Established fundamental national policy for the environment and established the council on environmental quality
What is the National Environmental Policy Act?
Protects the rights of employees and employers. Encourages collective bargaining. And curtails certain private sector labor and management practices, which can harm the general welfare of workers, businesses and the US economy.
What is the National Labor Relations Act?
is to ensure that employers provide employees with an environment free from recognized hazards, such as exposure to toxic chemicals, excessive noise levels, mechanical dangers, heat or cold stress, or unsanitary conditions.
What is the Occupational Safety & Health Act?
Provides labor standards for certain persons employed by federal contractors over $2500 furnishing services to federal agencies.
What is the Service Contract Act?
enacted to assure that a fair portion of federal contracts are placed with small businesses.
What is the Small Business Act?
Is intended to give credit where credit is due. Requires acknowledgement of Federal grant support when issuing statements, press releases, requests for proposals, bid solicitations, etc.
What is the Stevens Amendment?
Provisions are intended to help secure the nation against bioterrorism acts.The act requires individuals and institutions to nor produce, acquire, retain (stockpile) or possess types and quantities of any biological materials including bona fide research.
What is the US Patriot Act?
System for Award Management (SAM)
What is the name of the system for requiring submission and maintenance of representations and certifications
The Regulation imposes a 6-year time limitation
What is the time limitation for occurrences of research misconduct to be brought to the attention of an institution or the Department of Health and Human Services (HHS) (see § 93.105)
Responsible Conduct of Research (RCR).
What process was created from America COMPETES act?
Proposal Central or Foundation web site.
What resource site do Private Foundations mostly submitted through?
Budget period is yearly. Project period is the life of the contract.
What's the difference between budget period and project period?
The first $25,000
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 cost(indirect cost)?
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 which of the following acts
Department of Agriculture
Which agencies is responsible for administering the Animal Welfare Act?
U.S. Department of Justice, under the False Claims Act
Which federal agency is responsible for prosecuting institutional violations of effort reporting
Clinical trial Agreement
Which of the Following types of documents is most appropriate for testing the efficacy and safety of a new drug, device, or vaccine?
Department of Energy
Which of the following agencies does NOT fund health science research
The Anti-Kickback Act of 1986
Which of the following aims at deterring subcontractors from making payments and contractors from accepting payments for the purpose of improperly obtaining or rewarding favorable treatment in connection with a prime contract or a subcontract relating to a prime contract?
Is usually riskier than a cost reimbursement contract
Which of the following best describes a fixed-price contract
Temporary rate subject to final negotiation
Which of the following best describes a provisional indirect cost rate
Basic and containment procedures designed to protect personnel and the environment
Which of the following best describes essential laboratory biosafety levels in medical research?
It is a public-private partnership
Which of the following correctly describes FirstGov
Payments to subjects
Which of the following costs is allowable according to OMB Circular A-21?
Subcontractor's normal rate
Which of the following establishes the actual facilities and administrative cost (indirect cost) rate for a subcontract?
Travel
Which of the following expenses would be included in the distribution base of modified total direct costs?
A citation of the contract clause authorizing the termination
Which of the following information must be included in the notification by a federal officer to the contractor to terminate a contract for convenience
Project travel
Which of the following is NOT included in the computation of an indirect cost rate
Salaries and wages
Which of the following is a base for facilities and administrative cost (indirect rate)?
The contractor fails to perform the services within the time specified or any extension
Which of the following is a reason for a federal contracting officer to send a "Show Cause" notice to a contractor?
Refer employee to appropriate institution representative
Which of the following is an appropriate response to sexual harassment reported by an employee in the work force?
Rental or usage fees from equipment purchased with grant funds
Which of the following is considered program income?
Material Safety Data Sheet (MSDS) file
Which of the following is essential to a Chemical Hygiene Plan?
Debarment and suspension rules
Which of the following is included in 2 CFR 215, OMB Circular A-110?
National Library of Medicine
Which of the following is located within the National Institutes of Health
Institutional Biosafety Committee
Which of the following is mandated for the oversight of research involving recombinant DNA
Should be closely followed
Which of the following is most appropriate use of federal agency guidelines for writing a proposal
Regular dissemination of funding opportunities
Which of the following is most important in developing a program of available support with a grantee institution?
Sponsor
Which of the following is responsible for clinical trial registration on ClinicalTrials.gov?
Assure that the highest quality proposals are selected for funding in an equitable manner
Which of the following is the primary purpose of federal proposal review processes?
A plan for expenditure of funds
Which of the following must be included in every federal grant budget?
Prisoners
Which of the following populations has special protection as research participants under federal guidelines?
Bayh-Dole Act
Which of the following was enacted as a uniform patent policy among the many federal agencies that fund research?
Institutions that have more than $25,000,000 in federal grants or contracts
Which of the following would be required to file a disclosure statement (DS-2) with the federal government?
RFP
Which of the following would serve the purpose of inviting proposals and specifying the general terms and conditions under which the relevant award can be made
Chief Executive Officer or Vice President of Research
Who appoints the chair for each committees at universities
Prisoners, pregnant women, mentally unstable, and minors.
Who cannot participate in clinical trials
Institutions, Investigators
Who is covered by the COI regulation
Cost Principals for Educational Institutes
Who is the 2 CRF 220, OMB Circular A-21 for
Director of Human Resource
Who should administer progressive discipline to an employee?
House of Representatives
a provision or report language included primarily at the request of a Member, Delegate, Resident Commissioner, or Senator providing, authorizing or recommending a specific amount of discretionary budget authority, credit authority, or other spending authority for a contract, loan, loan guarantee, grant, loan authority, or other expenditure with or to an entity, or targeted to a specific State, locality or Congressional district, other than through a statutory or administrative formula driven or competitive award process.
Multiple Allocation Base Method
agency has several major functions which benefits from indirect costs in varying amounts - seldom used by nonprofit
Investigational New Drug Studies require what?
aka IND, 21 CFR 312 a) A sponsor shall submit an Investigational New Drug (IND) to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug. (b) A sponsor shall not begin a clinical investigation until the FDA approves it. (c) A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent. Such a clinical investigation is not permitted to proceed without the prior written authorization from FDA. FDA shall provide a written determination 30 days after FDA receives the IND or earlier. Annual reports regarding the study
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
Drug free workplace
all federal contracts $25k or more
R01
an award made to support a discrete, specified, circumscribed project to be performed by the named investigator in an area representing the investigators specific interest and competencies. Application budgets are not limited, but need to reflect the actual needs of the proposed project. Modular applications are most prevalent. Applications are generally awarded for 1-5 years, those applications can be renewed by competing for an additional project period. Only one resubmission of a previously reviewed R01 grant application can be submitted. The Research plan must follow SF424 (R&R) guidelines and instructions. There are standard receipt dates Feb 5, June 5 and October 5. For renewal and resubmission applications deadlines are March 5, July 5, and November 5.
Gifts
are awards given with few or no conditions specified.
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
What is Health Resources and Services Administration (HRSA) and who do they fall under
improves access to healthcare for people who are uninsured, isolated, or medically vulnerable and under DHHS.
What is a Data Universal Numbering System (DUNS Number)?
is a system developed and regulated by Dun & Bradstreet that assigns a unique numeric identifier to a single business entity. That number is a nine-digit number issued to each business location in the D&B database having a unique, separate, and distinct operation for the purpose of identifying them.
Federal Commons
is an Internet grants and management portal serving the grantee organization community. This portal, organizes the bulk of its online grant information by topic, form agriculture and community development to technology and transportation. In layout and design, it resembles FirstGov.gov and the Catalog of Federal Domestic Assistance, both managed by the General Services Administration. The home page also links grant recipients to two electronic payment systems, the Health and Human Services Department's Payment Management System and the Financial Management Service's Automated Standard Application for payment.
Facilities-
is defined as depreciation and use allowances, interest on debt associated with buildings, equipment, and capital improvement, operation and maintenance, library expenses
What is a Request for Quote (RFQ)
is often used to determine current market pricing, but is not a binding offer and can't be accepted by the government. A Standard Form 26, which requires the signatures of both the contractor and the contracting officer, would be required to make the offer binding.
United States Department of Agriculture (USDA)
is the U.S. federal executive department responsible for developing and executing federal government policy on farming, agriculture, forestry, and food. It aims to meet the needs of farmers and ranchers, promote agricultural trade and production, work to assure food safety, protect natural resources, foster rural communities and end hunger in the United States and abroad.
Funding Cycle Range
of time during which proposals are accepted, reviewed, and funds are awarded. If a sponsor has sanding proposal review committees (or boards) that meet at specified times during the year, application deadline are set to correspond with those meetings. For some sponsors, if proposals are received too late to be considered in the current funding cycle, they may be held over for the next review meeting (i.e., National Science Foundation's Target Dates).
On an SF 424 Form, what does revision mean?
proposes a change in 1) the Federal government's financial obligations or contingent liability from an existing organization, or 2) any other changes in the terms and conditions of the existing award, including requests for additional specific aims.
Expression of the idea
protected under copyright
Walsh-Healey Public Contracts Act
provide conditions for the purchase of supplies and making of contrast by US (any amount exceeding $10K)
Amendment (amended or revised application
resubmission of an unfunded application revised in response to a prior review.
What government agencies are exempt from FAR
the Federal Aviation Administration, and the U.S. Mint
What is Lobbying
the act of attempting to influence decisions made by officials in the government, most often legislators or members of regulatory agencies.
Federal Register
updated daily by 6 am Mon-Fri, except federal holidays
