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

credit:
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.

Agency - Department of Health and Human Services

The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.

Website Address

http://www.fda.gov


Relevant Nonprofit Program Categories





Selected Recipients for this Program


RecipientAmount Start DateEnd Date
Vanderbilt University, The $ 799,999   2010-09-102017-09-09
Pennsylvania State University, The $ 566,728   2009-09-152016-09-14
Bioo Scientific Corporation $ 566,616   2013-09-012016-08-31
Ohio State University, The $ 1,199,707   2011-08-152016-07-31
University Of Wisconsin System $ 1,538,169   2011-08-152016-07-31
Hugo W. Moser Research Institute At Kennedy Krieger, Inc. $ 1,198,854   2011-09-152016-07-31
Regents Of The University Of Colorado, The $ 399,906   2013-09-162016-06-30
Trustees Of Columbia University In The City Of New York $ 1,599,414   2011-06-012016-05-31
Johns Hopkins University, The $ 1,586,793   2011-06-222016-05-31
Trustees Of Columbia University In The City Of New York $ 1,587,148   2010-06-012016-05-31



Program Accomplishments

Not Applicable.

Uses and Use Restrictions

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.

Funding restrictions are noted in the Funding Opportunity Announcement and the Terms and Conditions of award.

Eligibility Requirements

Applicant Eligibility

Applicants should review the individual funding opportunity announcement issued under this CFDA program to see which applicant organizations are eligible to apply.

Beneficiary Eligibility

Applicants should review the individual funding opportunity announcement issued under this CFDA program to see which applicant organizations are eligible to apply.

Credentials/Documentation

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. 2 CFR 200, Subpart E - Cost Principles applies to this program.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is not applicable.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program.

Award Procedures

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.

Deadlines

Contact the headquarters or regional office, as appropriate, for application deadlines.

Authorization

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; Radiation Control for Health Safety Act of 1968, Title XVII, Public Law 90-602, 42 U.S.C 300u; Pediatric Medical Device Safety and Improvement Act of 2007, Section 305.

Range of Approval/Disapproval Time

From 120 to 180 days. Research applications: Approximately 4 to 6 months. SBIR applications: Approximately 90 days. Conference applications: Approximately 6 to 9 months.

Appeals

Not Applicable.

Renewals

From 120 to 180 days. Renewals (competiting continuation applications) are permitted as indicated in the published Funding Opportunity Announcements.

Assistance Considerations

Formula and Matching Requirements

Statutory formulas are not applicable to this program. Matching requirements are not applicable to this program. MOE requirements are not applicable to this program.

Length and Time Phasing of Assistance

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. See the following for information on how assistance is awarded/released: Domestic and foreign payments are made through the DHHS Payment Management System (PMS).

Post Assistance Requirements

Reports

Program reports are required as stated in the Funding Opportunity Announcement and the Terms and Conditions of award.

Cash reports are not applicable.

Progress reports are required as stated in the Funding Opportunity Announcement and the Terms and Conditions of award.

Expenditure reports are required as stated in the Funding Opportunity Announcement and the Terms and Conditions of award.

Performance monitoring is required as stated in the Funding Opportunity Announcement and the Terms and Conditions of award.

Audits

In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503.

Records

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.

Financial Information

Account Identification

75-0600-0-1-554.

Obigations

(Cooperative Agreements (Discretionary Grants)) FY 16 $170,482,435; FY 17 est $208,900,832; and FY 18 est $208,900,832

Range and Average of Financial Assistance

Varies by grant mechanism and program specific requirements.

Regulations, Guidelines, and Literature

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.

Information Contacts

Regional or Local Office

None.

Headquarters Office

Kimberly M. Pendleton 5630 Fishers Lane, Rockville, Maryland 20852 Email: kimberly.pendleton@fda.hhs.gov Phone: 240-402-7610

Criteria for Selecting Proposals

Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific evaluation criteria that applies.



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