Food and Drug Administration Research

 

To assist institutions and organizations, 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. These programs are supported directly or indirectly by the following Centers and Offices: Center for Biologics Evaluation and Research (CBER); Center for Drug Evaluation and Research (CDER); Center for Devices and Radiological Health (CDRH); Center for Veterinary Medicine (CVM), Center for Food Safety and Applied Nutrition (CFSAN), National Center for Toxicological Research (NCTR), the Office of Orphan Products Development (OPD), the Center for Tobacco Products (CTP), and Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC). 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. Funding support for scientific conferences that are relevant to the FDA scientific mission and public health are also available.

Active 93.103 Food and Drug Administration, Department of Health and Human Services B - Project Grants Not applicable. Public Health Service Act as amended, Title III, Section 301(c), Public Law 78-410, 42 U.S.C. 241 and 263
2012 Defense Authorization Act (P.L.112-81), Public Law 112-81
Pediatric Medical Device Safety and Improvement Act of 2007, Section 305
Radiation Control for Health Safety Act of 1968, Title XVII, Public Law 90-602, 42 U.S.C. 300u Applicants should review the individual funding opportunity announcement issued under this CFDA program to see which applicant organizations are eligible to apply. Applicants should review the individual funding opportunity announcement issued under this CFDA program to see which applicant organizations are eligible to apply. Applicants should review the individual funding opportunity announcement issued under this CFDA program for any required proof of certification which must be submitted prior to or simultaneous with submission of an application. Preapplication coordination is not applicable. This program is excluded from coverage under 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. Accepted research and non-research grant applications are subject to an objective review for scientific and technical merit. SBIR applications to be funded are subject to a second level review by a National Advisory Council or Board. All approved applications compete for available funds on the basis of scientific merit and programmatic relevance. Applicants should review the individual funding opportunity announcement issued under this CFDA program to see the specific award procedures that apply. Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the application deadline information. From 120 to 180 days. Research applications: Approximately 4 to 6 months. SBIR applications: Approximately 6 to 9 months. Conference applications: Approximately 6 to 9 months. Not applicable. From 120 to 180 days. Renewals (competiting continuation applications) are permitted as indicated in the published Funding Opportunity Announcements. Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific evaluation criteria that applies. Research grants are awarded to eligible institutions in the name of a principal investigator for applications that are responsive to programmatic requirements as stated in the Funding Opportunity Announcement (FOA). Funds are to be used for costs as identified in the FOA and as directly allocable, necessary and reasonable to carry out the proposed research aims and objectives. Small Business Innovation Research (SBIR) Phase I grants 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 are likely to result in commercial products or processes. Only Phase I awardees are eligible to apply for Phase II support. Conference grants provide partial support for domestic scientific conferences related to the FDA mission. Performance Reports: Performance monitoring is required as stated in the Funding Opportunity Announcement and the Terms and Conditions of award. Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific requirement that applies. Progress reports, financial and programmatic records, supporting documents, statistical records and all other records that are required by the terms and conditions of the grant or may be considered pertinent to grant expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the required final financial reports for the project period. Statutory formula is not applicable to this assistance listing.

Matching requirements are not applicable to this assistance listing.

MOE requirements are not applicable to this assistance listing. The length of support will depend on the nature of the projects, program relevance and the availability of funds. For those projects with an expected duration of more than 1 year, future recommended support will depend on (1) performance during the preceding year and (2) availability of Federal funds. Small Business Innovation Research Phase I awards are generally for 6 months; Phase II awards are generally for 2 years. Additional program time frames are stated in the Funding Opportunity Announcements. Domestic and foreign payments are made through the DHHS Payment Management System (PMS). None/Not specified. Kimberly M. Pendleton
4041 Powder Mill Road
Beltsville, MD 20705 US
kimberly.pendleton@fda.hhs.gov
Phone: 240-402-7610 http://www.fda.gov 75-0600-0-1-554 (Cooperative Agreements (Discretionary Grants)) FY 21$218,918,739.00; FY 22 est $255,910,458.00; FY 23 est $246,894,600.00; FY 20$212,448,590.00; FY 19$198,507,896.00; FY 18$173,077,408.00; FY 16$170,482,435.00; FY 17 est $208,900,832.00; - Varies by grant mechanism and program specific requirements. Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific regulations, guidelines and/or literature that applies. Not applicable.