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Grant Community.com Catalog of Federal Domestic Assistance Program Descriptions |
CATALOG OF FEDERAL DOMESTIC
ASSISTANCE
93.103: Food and Drug Administration: Research
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| PROGRAM AND AWARD | FINANCIAL AND INFORMATION CONTACTS |
| ELIGIBILITY REQUIREMENTS | FINANCIAL AND ADMINISTRATIVE INFO. |
| APPLICATION AND AWARD PROCESS | INFORMATION CONTACTS |
| RELATED PROGRAMS | ASSISTANCE CONSIDERATIONS |
| PROGRAM ACCOMPLISHMENTS | POST ASSISTANCE 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 and nonprofit organizations are also eligible. To be eligible for funding, a proposal must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. Small Business Innovation Research 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. To be eligible for funding, an SBIR application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. Applications involving Radiological Health and Small Scientific Conferences do not require dual peer review and will be reviewed and evaluated for their scientific and technical merit by a single review committee.
Beneficiary Eligibility: Colleges, universities, profit-making organizations, nonprofit institutions 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' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS non-service-connected Regulations 45 CFR, Part 74, Subpart Q and OMB Circular No. A-122.
Preapplication Coordination: Not applicable. This program is excluded from coverage under E.O. 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. SBIR must complete Forms PHS 6246-1 and 6426-2 for Phase I and Phase II applications, respectively. State and local governments may use form PHS 5161-1 (rev 6-99). All unsolicited applications, with the exception of those directed to the Center for Veterinary Medicine, are submitted to the Center for Review, National Institutes of Health, 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. This program is subject to the provisions of 45 CFR 74 and OMB Circular No. A-110 for nonprofit organizations. All applicants for solicited grant programs are cautioned to follow the specific mailing instruction 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. If sufficient funds are available, successful applicants will be issued a Notice of Grant Award by the FDA. 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 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 their Federal Register Announcements and may vary from year to year. Unsolicited grant applications: February 1, June 1, and October 1. 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: From 6 to 9 months for research grant applications. SBIR applications: About 6 months. Conference applications: About 3 months.
Appeals: None.
Renewals: Renewals are available. Procedures are the same as for new applications.
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.
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) Tobramycin for Inhalation in Patients with Cystic Fibrosis; (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.
Range and Average of Financial Assistance: From $5,000 to $2,000,000; $206,250.
Federal Agency: FOOD AND DRUG ADMINISTRATION, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Type of Assistance: Project Grants.
Obligations: (Grants) FY 99 $20,788,788; FY 00 est $22,000,000; and FY 01 est $23,000,000.
Budget Account Number: 75-0600-0-1-554.
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 Development Act of 1982, as amended, Public Law 97-219.
Regulations, Guidelines, and Literature: PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, (Rev.) April 1, 1994. Public Health Omnibus Solicitation for Small Business Innovation Research.
Regional or Local Office: Not applicable.
Headquarters Office: Program and Grants Management Contact: Olia M. Hopkins, Principal Official Responsible for Grants Administration, Division of Contracts and Procurement Management, OFACS, Food and Drug Administration, Public Health Service, Department of Health and Human Services, HFA-520, Room 2129, 5630 Fishers Lane, Rockville, MD 20852. Phone: 301-827-7184; SBIR: 301-827-7102; Fax 301-827-7103; Internet address: ohopkins@oc.fda.gov.
(See Appendix IV for more contact info.)
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.
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 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.
Reports: Annual program progress reports and financial status reports are required for continuation at the end of each budget period. Final progress and financial 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 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.
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.
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