Opportunity Information: Apply for RFA FD 09 008
Apply for RFA FD 09 008
- The Food Drug Administration in the business and commerce consumer protection education employment, labor and training health housing 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 May 22, 2009 and posted on May 22, 2009.
- Applicants must submit their applications by Jul 1, 2009. (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: Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities For profit organizations other than small businesses City or township governments Small businesses Special district governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Independent school districts County governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments.
- Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions For Profit Organizations (Other than Small Businesses) Indian/Native American Tribally Designated Organizations U.S. Territory or Possession Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Eligible Agencies of the Federal Government Agencies that are part of HHS may not apply Faith based or Community based Organizations
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Opportunity Summary:
The Minor Use Minor Species Development of Drugs Research Project Grant (R01) is an FDA funding opportunity designed to move specific animal drug products closer to approval by paying for the kinds of studies regulators actually need to see. It uses the familiar R01 research project mechanism, meaning the proposal is built around a discrete, clearly defined research plan led by named Project Directors/Principal Investigators (PDs/PIs), but the formal applicant is the institution or organization where the work will be done. FDA emphasizes that investigators can set the scientific focus based on their expertise, as long as the work fits FDA's mission and the purpose of this program: supporting the development of "MUMS" animal drugs.
This program sits under FDA's Office of Minor Use and Minor Species Animal Drug Development (OMUMS), which was created to encourage drug development where the market is too small to attract normal commercial investment. OMUMS focuses on two categories: drugs for "minor use" in a major species, and drugs intended for "minor species." FDA defines major species as horses, dogs, cats, cattle, pigs, turkeys, and chickens; essentially every other animal species (except humans) is treated as a minor species. A "minor use" in a major species is defined by how many animals would receive the drug annually in the United States, with thresholds listed as: horses 50,000; dogs 70,000; cats 120,000; cattle 310,000; pigs 1,450,000; turkeys 14,000,000; and chickens 72,000,000. The practical message is that the grant is meant for niche veterinary indications or less common species where generating the required safety and effectiveness data can be financially challenging.
A key eligibility gate is that the animal drug must already have a formal MUMS designation under 21 CFR Part 516. In other words, this is not meant to fund early discovery on an un-designated product; it is meant to help designated products clear regulatory hurdles. While FDA has authority to support several kinds of development costs for designated drugs, this specific funding announcement is narrowly aimed at defraying the costs of qualified safety and effectiveness testing, and only when the work will either result in, or substantially contribute to, approval or conditional approval of the designated MUMS drug. Applicants are required to spell out, in the application's "Background and Significance" section, exactly how the proposed study will support a path to approval or conditional approval, tying the experimental plan to regulatory decision-making rather than purely academic outcomes. Funded work must comply with the Federal Food, Drug, and Cosmetic Act and related FDA and HHS regulations.
From a funding and logistics standpoint, this was a discretionary grant opportunity (Funding Opportunity Number RFA-FD-09-008) posted May 22, 2009, with an application deadline of July 1, 2009 and an archive date of July 31, 2009. FDA anticipated making about 10 awards with an estimated total program funding level of $750,000. Individual award sizes were expected to fall between $50,000 (floor) and $100,000 (ceiling). There was no cost sharing or matching requirement stated, which matters for smaller institutions or projects that do not have flexible internal funds.
Eligibility was broad and included many types of domestic and non-domestic organizations, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including those other than small businesses), small businesses, state and local governments, tribal governments and tribal organizations, U.S. territories or possessions, and certain eligible federal agencies, with one explicit restriction: agencies that are part of HHS could not apply. The opportunity also explicitly called out categories of institutions such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian serving institutions, signaling that a wide range of applicants were encouraged so long as the proposed work aligned with the program's regulatory development purpose.
In plain terms, this FOA is best understood as a targeted bridge between veterinary drug development and FDA approval needs: it funds studies that generate the safety and effectiveness evidence required for FDA review for designated minor use/minor species animal drugs, with awards sized to support well-scoped, regulatory-relevant experiments rather than broad, exploratory research programs. For administrative questions or trouble accessing the full announcement, the listed contact was Marc Pitts (Electronic Research Administration Liaison) at 301-827-7162 or Marc.Pitts@FDA.HHS.GOV.
Frequently Asked Questions (FAQs)
What is the Minor Use Minor Species Development of Drugs Research Project Grant (R01)?
This is an FDA funding opportunity that uses the R01 research project mechanism to support specific studies needed to move certain animal drug products closer to approval. The focus is on generating the kinds of safety and effectiveness data FDA regulators need to see for review, rather than funding broad or exploratory research.
Which FDA office runs this program?
The program sits under FDA's Office of Minor Use and Minor Species Animal Drug Development (OMUMS), which was created to encourage drug development when the market is too small to attract typical commercial investment.
What does "MUMS" mean in this context?
"MUMS" refers to Minor Use and Minor Species animal drugs. OMUMS focuses on two categories: (1) drugs for a minor use in a major species, and (2) drugs intended for minor species.
What animals are considered "major species"?
FDA defines major species as horses, dogs, cats, cattle, pigs, turkeys, and chickens. In practical terms, every other animal species (except humans) is treated as a minor species under this framework.
What counts as a "minor use" in a major species?
A "minor use" in a major species is defined by how many animals would receive the drug annually in the United States. The thresholds listed are: horses (50,000), dogs (70,000), cats (120,000), cattle (310,000), pigs (1,450,000), turkeys (14,000,000), and chickens (72,000,000).
Is a formal MUMS designation required to be eligible?
Yes. A key eligibility gate is that the animal drug must already have a formal MUMS designation under 21 CFR Part 516. This opportunity is not intended to fund early discovery work on products that do not have a MUMS designation.
What types of studies does this grant pay for?
This funding announcement is narrowly aimed at defraying the costs of qualified safety and effectiveness testing. The work must either result in, or substantially contribute to, approval or conditional approval of the designated MUMS drug.
Does the program fund basic or purely academic research?
The emphasis is on regulatory-relevant studies tied to FDA decision-making. Applicants are expected to link the proposed work to a path toward approval or conditional approval, rather than positioning it solely as an academic or exploratory project.
What must applicants explain in the "Background and Significance" section?
Applicants are required to spell out exactly how the proposed study will support a path to approval or conditional approval, explicitly tying the experimental plan to regulatory needs and decision-making.
What grant mechanism is used, and who is the official applicant?
The opportunity uses the familiar R01 research project mechanism with a discrete, clearly defined research plan led by named Project Directors/Principal Investigators (PDs/PIs). However, the formal applicant is the institution or organization where the work will be done.
Can investigators choose the scientific focus?
FDA emphasizes that investigators can set the scientific focus based on their expertise, as long as the work fits FDA's mission and the purpose of the program: supporting development of designated MUMS animal drugs toward approval or conditional approval.
What laws and regulations must funded projects follow?
Funded work must comply with the Federal Food, Drug, and Cosmetic Act and related FDA and HHS regulations.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number listed is RFA-FD-09-008.
When was this opportunity posted, and what were the deadline and archive dates?
It was posted May 22, 2009. The application deadline was July 1, 2009, and the archive date was July 31, 2009.
How much funding was FDA expecting to award overall?
FDA anticipated making about 10 awards with an estimated total program funding level of $750,000.
What was the expected size of individual awards?
Individual award sizes were expected to range from $50,000 (floor) to $100,000 (ceiling).
Was cost sharing or matching required?
No cost sharing or matching requirement was stated for this opportunity.
Who could apply (organizational eligibility)?
Eligibility was broad and included domestic and non-domestic organizations, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (including those other than small businesses), small businesses, state and local governments, tribal governments and tribal organizations, U.S. territories or possessions, and certain eligible federal agencies.
Were any organizations explicitly not allowed to apply?
Yes. Agencies that are part of HHS could not apply.
Did the opportunity encourage applications from specific types of institutions?
It explicitly called out institutions such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian serving institutions, indicating that a wide range of applicants were encouraged if the proposed work matched the program's purpose.
What is the main practical purpose of this FOA?
In plain terms, it is a targeted bridge between veterinary drug development and FDA approval needs. It funds well-scoped studies that generate safety and effectiveness evidence required for FDA review for designated minor use/minor species animal drugs.
Who was the listed contact for administrative questions or access issues?
The listed contact was Marc Pitts (Electronic Research Administration Liaison). Phone: 301-827-7162. Email: Marc.Pitts@FDA.HHS.GOV.
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