Food and Drug Administration-Research (93.103)
Program
93.103 Food and Drug Administration-Research
Federal Agency
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Authorization
Public Health Service Act as amended, Title III, Section 301(c), Public Law 78-410, 42 U.S.C 241 and 263; Small Business Innovation Research Program Reauthorization Act of 1992 as amended, Public Law 102-564; Radiation Control for health Safety Act of 1968, Title XVII, Public Law 90-602, 42 U.S.C 300u.
Program Number
93.103
Last Known Status
Active
Objectives
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) 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 available. Funds are also provided to assist with State Food Safety Task Force and Protection meetings, Innovative Food Defense Projects, and Food Protection Rapid Response Team and Program Infrastructure Improvement Prototype Projects (RRT).
Types of Assistance
Cooperative Agreements; Project Grants; Project Grants (for specified projects)
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 and 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 which 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. Food Safety Task Force and Protection, Innovative Food Defense Projects and Rapid Response Team and Program Infrastructure Improvement Prototype project grant funds are to be used as stated in the FOA. As stated in the FOA and terms and conditions of award.
Eligibility Requirements
Applicant Eligibility
The grants are available to any domestic or foreign, public or private, for-profit or non-profit entity (including State and local units of government). Federal agencies that are not part of HHS may apply. Organizations that engage in lobbying activities, as described in section 501 (c) (4) of the Internal Revenue Code of 1968, are not eligible. Other eligible institutions include Private/Public and State Controlled institutions of higher education including Hispanic serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Nonprofit with 501(c)(3) IRS Status (other than Institution of Higher Education); Non-domestic (non-U.S.) entity; Small Business; For-Profit Organization (other than Small Business); State Government; Regional Organization; U.S. Territory or Possession; Indian/Native American Tribal Government (Federal recognized and other than Federally recognized); Indian/Native American Tribally Designated Organization; Faith-based or community based organizations.
Beneficiary Eligibility
Domestic or foreign entitities, public or private Colleges, universities, profit-making organizations, nonprofit institutions, hospitals, and State and local governments; U.S. Territory or Possession; Indian/Native American Tribal Government (Federal recognized and other than Federally recognized); Indian/Native American Tribally Designated Organizations and faith-based organizations.
Credentials/Documentation
All grant applications must present a research plan and provide evidence of scientific competence, experimental methods and programmatic relevance, and the available facility and resources to accomplish the proposed aims and objectives. Phase I Small Business Innovation Research applications should be an idea or concept with commercial potential; and Phase II applications should provide evidence that commercialization of the research results are plausible; for-profit organizations' with 48 CFR Subpart 31.2 of the Federal Acquisition Regulations (FAR); OMB Circular No. A-21 for educational institutions, 45 CFR 74 Appendix E for Hospitals; OMB Circular No. A-122 for nonprofit organizations and large non-profit organizations listed in Attachment C of OMB circular A-122 are subject to Federal Acquisition Regulation (FAR) 48 CFR Subpart 31.2 (A subawardee would be subject to the cost principles applicable to its type of organization). OMB Circular No. A-87 applies to this program.
Application 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 Procedure
OMB Circular No. A-102 applies to this program. OMB Circular No. A-110 applies to this program. The standard application forms, as provided by the FDA through Grants.gov and required by 45 CFR 74 and 92 must be used for this program. All research applicants must complete the SF-424 R&R application for new, competing continuations or competing supplemental research grants. Solicited applications in response to Funding Opportunity Announcements (FOA) must be submitted through Grants.gov unless otherwise stated in the FOA. Consultation with Program Staff is available by contacting the Headquarters Office listed below.
Award Procedure
All accepted research grant applications receive a dual scientific review for technical merit by an appropriate initial Ad Hoc Review group and a second level review by a National Advisory Council or Board, as appropriate. All approved applications compete for available funds on the basis of scientific merit and programmatic relevance. All applications accepted under the Radiation Control for Health Safety Act of 1968, Public Law 90-602 and Small Scientific Conference grants, and the ORA programs are evaluated under objective review procedures.
Deadlines
Dec 05, 2009: SBIR. Research grant applications due dates are stated in the Funding Opportunity Announcement as published in the Federal Register and/or in the NIH Guide. SBIR applications are received and processed by the Center for Scientific Review at the National Institutes of Health (NIH) on April 5, August 5 and December 5; Conference grant applications are received via Grants.gov on October 15, January 15, April 15, and July 15. Unsolicited grants should be sent to the Headquarters Office listed below.
Range of Approval/Disapproval Time
From 90 to 120 days. From 6 to 9 months for research grant applications. SBIR applications: Approximately 6 months. Conference applications: Approximately 3 months.
Appeals
From 30 to 60 days.
Renewals
From 90 to 120 days. Renewals (competiting continuation applications) are available. Procedures are the same as for new applications.
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
Routinely grants are awarded from 1 to up to 5 years years as requested and/or recommended by reviewing groups, successful annual performance and the availability of funds. Small Business Innovation Research Phase I awards are generally for 6 months; Phase II awards are generally for 2 years. See the following for information on how assistance is awarded/released: Domestic payments are made available through the DHHS Payment Management System (PMS).
Post Assistance Requirements
Reports
As noted in the terms and conditions of award. Cash reports are not applicable. Progress reports are not applicable. Expenditure reports are not applicable. Reporting requirements are as noted in the FOA and in the Terms and Conditions of Award.
Audits
In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. Non-Federal entities that expend $300,000 ($500,000 for fiscal years ending after December 31, 2003) or more in a year in Federal awards shall have a single or program-specific audit conducted for that year in accordance with the provisions in the most recently revised Circular A133.
Records
All grant and Cooperative agreement documentation must be retained for 3 years from the day on which the grantee submits the final financial status reports for the project period. Financial and Programmatic records, supporting documents, statistical records and all other records that are required by the terms of the grant, or may be considered pertinent to a grant must be retained for 3 years from the date the grantee submits the final financial status report for the report period. See 45 CFR 74.53 and 92.42 for exceptions and qualifications to the 3 year retention requirement. See 45 CFR 74.48 and 92.36 for record retention and access requirements for contracts and grants.
Program Accomplishments
Not Applicable.
Financial Information
Account Identification
75-0600-0-1-554.
Obligations
(Project Grants) FY 08 $36,823,882; FY 09 est $38,665,076; FY 10 est $40,598,329
Range and Average of Financial Assistance
Varies by grant mechanism and program specific requirements.
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 HHS Grants Policy Statement, (Most recent revision) available at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm; and the Public Health Omnibus Solicitation for Small Business Innovation Research Grant applications.
Related Programs
93.448 Food Safety and Security Monitoring Project; 93.449 Ruminant Feed Ban Support Project
Information Contacts
Regional or Local Office
See Regional Agency Offices.
Headquarters Office
Michelle Hawley Division of Acquisition Support and Grants, Office of Acquisition and Grant Services, Food and Drug Administration, Department of Health and Human Services, HFA-500, Room 2107, 5600 Fishers Lane, Rockville, Maryland 20857 Email: Michelle.Hawley@fda.hhs.gov Phone: 3018271991 Fax: 3018277101
Web Site Address
Examples of Funded Projects
Not Applicable.
Criteria for Selecting Proposals
The major elements in evaluating proposals include the assessment of: (1) 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 and suitability of the available facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance to programmatic objectives as noted in the FOAs 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 II objectives and methodology for addressing the proposed research. For conference programs, the support of scientific meetings is contingent on the programmatic interests and priorities of the individual centers and programs.
