Opportunity Information: Apply for RFA FD 10 001
Apply for RFA FD 10 001
- The Food Drug Administration in the agriculture business and commerce consumer protection education employment, labor and training environment health regional development science and technology and other research and development sector is offering a public funding opportunity titled "Minor Use Minor Species Development of Drugs Research Project Grant (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Mar 25, 2011 and posted on Apr 16, 2010.
- Applicants must submit their applications by May 14, 2010 This FOA has Multiple Receipt Dates. The first Application Receipt/Due Date is 05/14/2010. The Second Application Receipt/Due Date is September 3, 2010. The Third Application Receipt/Due Date is February 4, 2011. The Fourth and Final Receipt/Due Date is August 5, 2011. ATTENTION AS OF MAY 7, 2011 APPLICANTS WILL NO LONGER BE ABLE TO SUBMIT GRANTS USING THE ADOBE FORMS A TEMPLATE PACKAGE. THIS PACKAGE WILL EXPIRE. IF YOU DONT SUBMIT YOUR ADOBE FORMS A PACKAGE BEFORE MAY 7, 2011 YOU MUST USE ADOBE FORMS B1 TO APPLY TO THE FINAL RECEIPT DATE OF 8/5/2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $750,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $100,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: State governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities County governments Independent school districts For profit organizations other than small businesses City or township governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Small businesses Special district governments.
- Hispanic serving Institutions of Higher Education Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Faith based or Community based OrganizationFederal Government Agencies (that are not part of HHS)
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Opportunity Summary:
The Minor Use Minor Species Development of Drugs Research Project Grant (R01) is a discretionary grant opportunity from the U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), designed to help move certain new animal drugs closer to regulatory approval. The central purpose is to support research that develops, or supports the development of, animal drug products intended either for a minor use in a major species (for example, a limited market indication in cattle, swine, chickens, turkeys, dogs, cats, or horses) or for use in a minor species (species outside those major categories). The practical focus of the program is not basic discovery research, but studies that generate the kinds of safety and effectiveness evidence the FDA needs to evaluate a drug for approval or conditional approval.
A key eligibility gate is that the drug product must already be a "designated" new animal drug under the Minor Use and Minor Species (MUMS) provisions. Specifically, only products designated under section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and implemented through 21 CFR Part 516 can be funded. In other words, applicants cannot use this grant to seek designation; the designation must already be in place. The statutory authority behind the program allows FDA to award grants to help defray the costs of "qualified safety and effectiveness testing," meaning the funds are meant to offset expenses tied directly to generating pivotal or otherwise decision-relevant data for the FDA review process.
The FOA makes it explicit that funded work must either result in, or substantially contribute to, FDA approval or conditional approval of the designated MUMS drug. Because of that, applications are expected to draw a clear line between the proposed experiments and the regulatory endpoint. Applicants are required to explain in the application's "Background and Significance" section how the proposed study will help achieve product approval or conditional approval. This typically means laying out what approval pathway is being pursued, what data gaps remain, how the study design addresses those gaps, and why the results will be adequate and usable for FDA decision-making.
Operationally, this opportunity uses the Research Project Grant (R01) mechanism. The total estimated funding listed is $750,000, with an expected 10 awards. Individual award amounts are relatively modest compared to many R01 programs, with a stated award floor of $50,000 and ceiling of $100,000. There is no cost-sharing or matching requirement, so applicants are not required to contribute non-federal funds as a condition of receiving an award.
Eligibility is broad and includes many types of entities across government, academia, and the private and nonprofit sectors. Eligible applicants include state, county, city/township, and special district governments; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) nonprofits other than IHEs); for-profit organizations (including small businesses and other for-profits); and certain non-HHS federal government agencies. The FOA also highlights inclusivity for a range of institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, indicating that a wide range of organizations can compete as long as they meet the program's drug designation and study relevance requirements.
The announcement (Funding Opportunity Number RFA-FD-10-001; CFDA 93.103) was posted April 16, 2010, and it used multiple receipt dates: May 14, 2010; September 3, 2010; February 4, 2011; and a final due date of August 5, 2011. The listing notes an administrative submission change effective May 7, 2011, stating applicants could no longer submit using the older Adobe Forms A package template and would need to use Adobe Forms B1 for the final receipt date. While those dates are historical, they reflect the original structure of the solicitation and the multi-cycle submission approach that was offered during the active period of the FOA.
Finally, all funded studies are required to comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.), FDA regulations issued under that authority, and applicable Department of Health and Human Services statutes and regulations. That statement underscores that projects are expected to be conducted in a way that supports regulatory-quality evidence generation, with appropriate attention to the legal and regulatory framework governing animal drug development and review. For administrative questions or help accessing the full announcement, the contact listed is Vieda Hubbard, Grants Management Specialist, FDA Office of Acquisitions and Grants Services, in Rockville, Maryland (Vieda.Hubbard@fda.hhs.gov; 301-827-7177).
Frequently Asked Questions (FAQs)
What is the Minor Use Minor Species Development of Drugs Research Project Grant (R01)?
This is a discretionary grant opportunity from the U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM). It supports research intended to move certain new animal drugs closer to FDA regulatory approval or conditional approval by generating decision-relevant safety and effectiveness evidence.
What is the main goal of this grant program?
The central purpose is to fund studies that develop, or support the development of, new animal drug products for either:
- a minor use in a major species (a limited market indication in cattle, swine, chickens, turkeys, dogs, cats, or horses), or
- use in a minor species (species outside those major categories).
The program emphasizes research that produces the types of data FDA needs to evaluate a drug for approval or conditional approval, rather than basic discovery research.
Does this program fund basic or early-stage discovery research?
No. The practical focus is not basic discovery research. The funded work is expected to generate safety and effectiveness evidence that is usable for FDA review and that supports approval or conditional approval of a designated product.
What kinds of drug products are eligible for funding?
Only drug products that are already a “designated†new animal drug under the Minor Use and Minor Species (MUMS) provisions are eligible. The designation must be under section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and implemented through 21 CFR Part 516.
Can an applicant use the grant to obtain MUMS designation?
No. The designation must already be in place. Applicants cannot use this grant to seek or secure MUMS designation.
What does the grant funding pay for?
Funds are intended to help defray the costs of “qualified safety and effectiveness testing.†In practice, that means the funds are meant to offset expenses tied directly to generating pivotal or otherwise decision-relevant safety and effectiveness data needed for FDA review.
What regulatory outcome must the proposed work support?
The funded work must either result in, or substantially contribute to, FDA approval or conditional approval of the designated MUMS drug. Applications are expected to show a clear connection between the proposed studies and the regulatory endpoint.
What must applicants explain in the application about the regulatory path?
Applicants are required to explain in the “Background and Significance†section how the proposed study will help achieve product approval or conditional approval. Based on the announcement description, this typically includes:
- what approval pathway is being pursued,
- what data gaps remain,
- how the study design addresses those gaps, and
- why the results will be adequate and usable for FDA decision-making.
What grant mechanism is used for this opportunity?
This opportunity uses the Research Project Grant (R01) mechanism.
How much funding is available under this program?
The total estimated funding listed is $750,000, with an expected 10 awards.
What is the typical award size for an individual grant?
The stated individual award floor is $50,000 and the ceiling is $100,000.
Is cost sharing or matching required?
No. There is no cost-sharing or matching requirement, and applicants are not required to contribute non-federal funds as a condition of receiving an award.
Who is eligible to apply?
Eligibility is broad and includes organizations across government, academia, nonprofit, and private sectors. The listed eligible applicants include:
- State governments
- County governments
- City or township governments
- Special district governments
- Federally recognized tribal governments
- Other tribal organizations
- Public and private institutions of higher education
- Independent school districts
- Public housing authorities / Indian housing authorities
- Nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits other than IHEs)
- For-profit organizations (including small businesses and other for-profits)
- Certain non-HHS federal government agencies
Are certain institution types specifically encouraged or highlighted?
Yes. The announcement highlights inclusivity for a wide range of institution types, including Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, as long as the drug designation and study relevance requirements are met.
What is the Funding Opportunity Number and CFDA number?
The Funding Opportunity Number is RFA-FD-10-001, and the CFDA number is 93.103.
When was the opportunity posted, and what were the receipt dates?
The announcement was posted April 16, 2010. It used multiple receipt dates: May 14, 2010; September 3, 2010; February 4, 2011; and a final due date of August 5, 2011.
Were there any submission format changes noted in the announcement?
Yes. The listing notes an administrative submission change effective May 7, 2011: applicants could no longer submit using the older Adobe Forms A package template and needed to use Adobe Forms B1 for the final receipt date.
What laws and regulations must funded studies comply with?
All funded studies are required to comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.), FDA regulations issued under that authority, and applicable Department of Health and Human Services statutes and regulations.
Why does the announcement emphasize compliance with FDA and HHS requirements?
The compliance language underscores that projects are expected to be conducted in a way that supports regulatory-quality evidence generation, with appropriate attention to the legal and regulatory framework governing animal drug development and review.
Who is the contact for administrative questions?
The contact listed is Vieda Hubbard, Grants Management Specialist, FDA Office of Acquisitions and Grants Services, Rockville, Maryland. Email: Vieda.Hubbard@fda.hhs.gov. Phone: 301-827-7177.
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