Food and Drug Administration-Research (93.103)
Program
93.103 Food and Drug Administration-Research
Federal Agency
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Authorization
Public Health Service Act, Title III, Section 301(c), Public Law 78-410, as amended; Radiation Control for Health Safety Act of 1968, Public Law 90-602, 42 U.S.C. 241 and 263; 42 U.S.C. 300u, Title XVII; Small Business Innovation Research Program Reauthorization Act of 1992, as amended, Public Law 102-564 and 106-554.
Program Number
93.103
Last Known Status
Active
Objectives
To assist profit-making organizations, public and other nonprofit institutions, to establish, expand, and improve research, demonstration, education and information dissemination activities; 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 orphan products development; nutrition, sanitation and microbiological hazards; medical devices and diagnostic products, radiation emitting devices and materials; food safety and food additives. Small Business Innovation Research (SBIR) Programs: to stimulate technological innovation; to encourage the role of small business to meet Federal research and development needs; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation by minority and disadvantaged persons in technological innovation.
Types of Assistance
Project Grants.
Uses and 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 (SBIR) Phase I grants (of approximately 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. SBIR 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.
Eligibility Requirements
Applicant Eligibility
Research grants, including application for Orphan Product Developments, can be made to any public or private nonprofit university, college, hospital, laboratory or other institution, including State and local units of government. Commercial, nonprofit, and faith-based organizations are also eligible. Small Business Innovation Research (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). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of the award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the United States and its possessions.
Beneficiary Eligibility
Colleges, universities, profit-making organizations, nonprofit institutions, hospitals, faith-based and State and local governments.
Credentials/Documentation
Research, including Orphan Product Development and conference grant applicants must present a plan and furnish evidence that scientific competence, facilities, and equipment are appropriate to carry out the plan. For Small Business Innovation Research, each applicant must present a research plan and furnish evidence that scientific competence, experimental methods, facilities, equipment, and supplies are appropriate to carry out the plan. Furthermore, in Phase I, there should be an idea or concept with commercial potential, and in Phase II there should be evidence that commercialization of the research results is plausible. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments, for-profit organizations' with Subpart 31.2 of the Federal Acquisition Regulations (FAR), OMB Circular No. A-21 for universities, and OMB Circular No. A-122 for nonprofit organizations.
Application and Award Process
Preapplication Coordination
Not applicable. This program is excluded from coverage under Executive Order 12372.
Application Procedure
Consultation of Program Staff is available by contacting the Headquarters Office listed below. The standard application forms, as furnished by FDA and required by 45 CFR 74 and 92 must be used for this program. The applicant must complete PHS Form 398 for new competing continuations or supplemental research grants. State and local governments may use form PHS 5161-1 (rev 7-00). All unsolicited applications, with the exception of those directed to the Center for Veterinary Medicine, are submitted to the Center for Scientific Review, National Institutes of Health, Suite 1040, 6701 Rockledge Drive MSC 7710, Bethesda, MD 20892. Unsolicited applications directed to the Center for Veterinary Medicine will be subject to Field Reader review or ad hoc panel reviews directed by the Center. Applications in response to Federal Register Announcements (solicited) shall be sent to the address listed below for Information Contacts, Headquarters Office. All application kits may be obtained from the FDA office listed below or from the CSR/NIH at the above address. All applicants for solicited grant programs are cautioned to follow the specific mailing instructions published in the RFA.
Award Procedure
Research: All accepted research grant applications, including Orphan Product Development and Small Business and Innovative Research, receive a dual scientific review for technical merit, a recommendation for approval by an appropriate initial review group and a secondary review by a national advisory council. All approved applications compete for available funds on the basis of scientific merit and program emphasis. All applications accepted under the Radiation Control for Health Safety Act of 1968, Public Law 90-602 and Small Scientific Conference grants, are evaluated under objective review procedures and receive a single initial review.
Deadlines
Contact Headquarters Office listed below for solicited research application deadlines. Orphan Products Development Grant Applications and other Research grant applications due dates are published in the Federal Register and may vary from year to year. SBIR: April 15, August 15 and December 15. Conference grant applications: October 15, January 15, April 15, and July 15. Unsolicited and SBIR applications are received and processed by the Center for Scientific Review/ National Institutes of Health.
Range of Approval/Disapproval Time
Appeals
None.
Renewals
Renewals are available. Procedures are the same as for new applications.
Assistance Considerations
Formula and Matching Requirements
This program has no statutory formula or matching requirements. Cost participation is not required.
Length and Time Phasing of Assistance
Normally, awards are made for 1-year with additional support (up to 5 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 6 months; Phase II awards are generally for 2 years. Conference grant awards are for one year.
Post Assistance Requirements
Reports
Annual program progress reports and financial status reports are required for continuation at the end of each budget period. Final program progress and financial status reports and an invention statement on all projects must be submitted upon completion.
Audits
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 expend 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.
Records
Progress reports, expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the final financial status report for the report period.
Program Accomplishments
Research and Conference Grants: In fiscal year 2002, approximately 186 new competitive applications were received and 54 new awards were funded. 60 continuation awards were also funded in fiscal year 2002. It is anticipated that 28 new and approximately 60 continuation awards will be made in fiscal year 2003 and 50 new and 56 continuations in fiscal year 2004. SBIR: In fiscal year 2002 , 2 Phase II awards were made. 1 Phase II continuation and 4 new Phase I awards are expected to be made in fiscal year 2003. 6 conference grant awards were made in fiscal year 2002. 29 conference grant applications were received and approximately 10 conference grant awards will be made in fiscal year 2003. In fiscal year 2004 it is anticipated that 10 new conference grant awards will be made. 14 new and 14 continuation Task Force conference grants were made in fiscal year 2002. 8 new Task Foce conference grants and 14 continuations will be made in fiscal year 2003. 25 new Task Force conference grants are anticipated in fiscal year 2004.
Financial Information
Account Identification
75-0600-0-1-554.
Obligations
(Grants) FY 02 $29,272,427; FY 03 est $30,000,000; and FY 04 est $30,000,000.
Range and Average of Financial Assistance
$5,000 to $2,000,000; $206,250.
Regulations, Guidelines and Literature
42 CFR Part 52 - Grants for Research Project; 45 CFR Part 46 - Protection of Human Subjects; 45 CFR Part 74 - Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Nonprofit Organizations and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments and Indian Tribal Governments; 45 CFR Part 92 - Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments; the PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, (Rev.) April 1, 1994; and the Public Health Omnibus Solicitation for Small Business Innovation Research.
Related Programs
None.
Information Contacts
Regional or Local Office
Not applicable.
Headquarters Office
Program and Grants Management Contact: Peggy L. Jones, Chief Grants Management Officer, Division of Contracts and Grants Management, Office of Acquisition and Grant Services, Food and Drug Administration, Department of Health and Human Services, HFA-531, Room 2129, 5630 Fishers Lane, Rockville, MD 20857. Telephone: 301-827-7160; SBIR: 301-827-7182; Fax 301-827-7101; Internet address: pjones1@oc.fda.gov.
Web Site Address
Examples of Funded Projects
(1) Radiation Effects and Exposure Criteria; (2) Analytical Methodology for Animal Drug Tissue in Milk; (3) Post Marketing Surveillance of Adverse Drug Reactions; (4) International Program on Chemical Safety; (5) ADI-PEG for Metastatic Melanoma; (6) Continuation of the National Center for Food Safety and Technology; (7) Interferon Gamma Treatment of Osteoporosis; and (8) SBIR: Phase I - Detection of Campylobacteria in Foods, Phase II Point of Care Lead Instrument and Sensor.
Criteria for Selecting Proposals
The major elements in evaluating proposals include the assessment of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. For Small Business Innovation Research applications, the major elements in evaluating Phase I grant applications include the assessment of: (1) The technical merit of the proposed research; (2) the soundness of the proposed design and methods; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the potential of the proposed research for technological innovation and commercial application; (5) the appropriateness of the budget requested; and (6) the adequacy and suitability of the facilities and research environment. In review of Phase II applications, criteria include those listed above, in addition to the following: (1) the degree in which Phase I objectives were met and the feasibility demonstrated; and (2) the adequacy of the Phase I objectives and methodology for addressing the proposed research.
