Tribal Self-Governance Study
Description of Program,
Service, Function or Activity (PSFA)
INVENTORY
1. Agency Name: U.S. Food and Drug Administration
2. Program Name: Food and Drug Administration: Research
3. CFDA: 93.103
4. Program Objectives: To assist profit-making organizations, public and other nonprofit institutions, and State and local governments to establish, expand, and improve research, demonstration, education and information dissemination activities concerned with acquired immunodeficiency syndrome (AIDS), biologics, blood and blood products, therapeutics, vaccines and allergenic projects; drug hazards, human and veterinary drugs, clinical trials on drugs and devices for orphans products development; nutrition, sanProgram Objectives: To assist profit-making organizations, public and other nonprofit institutions, and State and local governments to establish, expand, and improve research, demonstration, education and information dissemination activities concerned with acquired immunodeficiency syndrome (AIDS), biologics, blood and blood products, therapeutics, vaccines and allergenic projects; drug hazards, human and veterinary dr
5. Titles and Descriptions of at least Three Funded Grantees: Trustees of Boston University Studies of Adverse Effects of Marketed Drugs
Johns Hopkins University Adverse Effects of Drugs for HIV Disease
University of North Carolina Development of Viral Extraction Processing at Chapel Hill and Detection Methods
AUTHORITY
6. Authorizing Statutes(s): Public Health Service Act, Title III, Section 301, Public Law 78-410, as amended; Radiation Control for Health Safety Act of 1968, Public Law 90-602, 42 USC 241 and 263; 42 USC 300u, Title XVII; Small Business Innovation Research Program Reauthorization Act of 1992, as amended, Public Law 102-564.
7. Regulatory/Administrative Requirements: PHS (U.S. Public Health Service) Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, and (Rev.) April 1, 1994. Public Health Omnibus Solicitation for Small Business Innovation Research.
8. Mandatory Statutory Changes Needed to Operate PSFA as a Demonstration: Authority would need to modify the grant making process, enable the Department to make self-governance funding awards, and alter federal monitoringing mandates.
APPLICANTS, BENEFICIARIES and FORMULAS
9. Type of Funding: The Food and Drug Administration: Research program is a discretionary grant program for which funds are awarded competitively.
10. Eligible Applicants: Any public or private nonprofit university, college, hospital, laboratory or other institution including State and local units of government. Commercial and nonprofit organizations are also eligible. SBIR grants can only be awarded to domestic small businesses (entities that are independently owned and operated for a profit, are not dominant in the field in which research is proposed, and have no more than 500 employees.
11. Allotment Formulas, Etc.: This program has no statutory formula or matching requirements. Cost participation is not required.
8. Applicant Provisions/Allotments in Law for Indians: N/A
9. Eligible Beneficiaries: Colleges, universities, profit-making organizations, nonprofit institutions, and State and local governments.
10. Beneficiary Provisions/Allotments in Law for Indians: N/A
11. Amount and Percent of Total that is Mandatory for Indians: N/A
FINANCIAL
16. Total FY 2000 funding: $24, 386,740
17. Amount and Percent of Total Funding Awarded Indians: N/A
18. For Awards to Tribes: N/A
19. Total FY 2001 Funding $23,000,000 and Amount for Indians. N/A
OTHER
20. -- how long assistance is funded: Normally awards are made for one year with additional support (up to five years) depending on the recommendation of the dual review groups, successful annual performance and availability of funds. Small Business Innovation Research Phase I awards are generally for six months; Phase II awards are generally for two years.
-- fund use restrictions: Research grants are awarded to an eligible institution in the name of a principal investigator for a discrete project representing the investigator’s interest and competence. Funds are to be used for salaries and wages, equipment, supplies, travel, and other costs directly required to carry out the research. Small business Innovation Research Phase I grants (of about 6 months duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants for this program are for the competitive continuation of the research initiated in Phase I, and which are likely to result in commercial products or processes. Only Phase I awardees are eligible to apply for Phase II support. All approved applications compete for available SBIR set-aside funds on the basis of technical merit and program relevance. Conference grants provide partial support for domestic or scientific conferences.
-- reporting requirements: Semiannual program progress reports and a financial status report are required at the end of each budget period. A final program progress report, a final financial status report and an invention statement are required and must be submitted 90 days after completion of the project period end date. Progress reports, expenditures and other financial records must be retained for three (3) years from the day on which the grantee submits the final financial status report for the project period.
-- audit requirements: In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), Audits of States, Local Governments, and Non-Profit Organizations, nonfederal entities that receive financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal government officials.
CONTACTS
21. DHHS Workgroup Contact: Mary C. Wallace
Director of Consumer
Program
U.S. Food and Drug Administration
Office of International and
Constituent Relations
Office of Consumer Affairs
5600 Fishers Lane, Room
16-85
Rockville, Maryland 20857
(301) 827-4406
22. DHHS Agency/Program Contact: Mary C. Wallace
Director of Consumer
Program
U.S. Food and Drug Administration
Office of International and
Constituent Relations
Office of Consumer Affairs
5600 Fishers Lane, Room
16-85
Rockville, Maryland 20857
(301) 827-4406