Opportunity Information: Apply for PAR 21 179
The Minor Use Minor Species Development of Drugs (R01) opportunity (PAR 21-179) is a discretionary funding program run by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA), specifically the Center for Veterinary Medicine (CVM). Its purpose is to support research projects that move certain veterinary drugs closer to FDA approval when the intended market is too small to easily justify the cost of development. The program focuses on MUMS products, meaning either drugs intended for a minor use in a major animal species (for example, a narrowly used treatment in cattle, swine, chickens, turkeys, dogs, cats, or horses) or drugs intended for a minor species (such as fish, sheep, goats, rabbits, honey bees, zoo animals, and many other less-common species). The core idea is to help fill gaps where animal health needs exist but private investment may be limited because the population affected is relatively small.
Funding is aimed at qualified safety and effectiveness testing that can be used to meet FDA requirements for approval of new animal drugs that have received MUMS designation. In practical terms, that means the grant is meant to pay for research steps that generate data regulators can actually use, rather than basic exploratory science. Projects should be positioned to produce credible, well-controlled evidence that supports safety and/or effectiveness for the drug’s specific intended use, with the expectation that this work will contribute to a future approval package.
Eligibility is broad in the sense that many types of organizations can apply, including state, county, and local governments; public and private institutions of higher education; tribal governments and tribal organizations; nonprofits with or without 501(c)(3) status; public housing authorities/Indian housing authorities; for-profit organizations (including small businesses); and other entities as described in the NOFO’s additional eligibility language. Even with this broad list, the program has an important limiting condition: only entities that are developing veterinary drugs, or groups formally partnering as research collaborators with those developers, are eligible for funding. The intent is to ensure the funded work is tightly connected to an active drug development program and can realistically be incorporated into an FDA regulatory submission.
There are also several required regulatory readiness steps that must already be in place before a grant application can be submitted. The organization pursuing eventual approval of the new animal drug must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM. In addition, the drug and its specific intended use must already have a formal minor use or minor species designation from CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS), under section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and the designation regulations at 21 CFR Part 516. Finally, CVM’s Office of New Animal Drug Evaluation (ONADE) must have reviewed the proposed study protocol and concurred with it before the applicant submits the grant application. This pre-review requirement is a key feature of the program because it helps ensure that the studies being funded are designed in a way that will be acceptable for regulatory decision-making.
The award mechanism is a cooperative agreement, which generally indicates that FDA expects to have substantial involvement during the project rather than acting only as a passive funder. The opportunity is categorized under Agriculture, Consumer Protection, and Food and Nutrition, and is associated with CFDA number 93.103. The published maximum award amount is $500,000, and the opportunity anticipated about six awards. The opportunity was created on February 18, 2021, with an original closing date listed as February 3, 2024.Apply for PAR 21 179
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Minor Use Minor Species Development of Drugs (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Feb 18, 2021.
- Applicants must submit their applications by Feb 03, 2024. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 6 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: Minor Use Minor Species Development of Drugs (R01) - PAR 21-179
What is the Minor Use Minor Species Development of Drugs (R01) opportunity (PAR 21-179)?
It is a discretionary funding opportunity run by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA), specifically the Center for Veterinary Medicine (CVM). The program supports research projects intended to move certain veterinary drugs closer to FDA approval when the intended market is too small to easily justify the cost of development.
Which FDA office runs this program?
The program is administered through FDA's Center for Veterinary Medicine (CVM).
What is the main purpose of this grant?
The purpose is to support research that generates qualified safety and effectiveness data that can be used to meet FDA requirements for approval of new animal drugs that have received Minor Use Minor Species (MUMS) designation.
What does "MUMS" mean in this program?
MUMS refers to products intended either (1) for a minor use in a major animal species, or (2) for use in a minor species. The underlying concept is to help address animal health needs where private investment may be limited because the affected population is relatively small.
What is a "minor use" in a "major species"?
A minor use in a major species means a narrowly used treatment in a major animal species. Examples of major species listed include cattle, swine, chickens, turkeys, dogs, cats, and horses.
What are considered "minor species" under this opportunity?
Examples of minor species listed include fish, sheep, goats, rabbits, honey bees, zoo animals, and many other less-common species.
What types of research does the program aim to fund?
Funding is aimed at qualified safety and effectiveness testing that can support FDA requirements for approval of designated MUMS new animal drugs. The emphasis is on studies that can produce credible, well-controlled evidence supporting safety and/or effectiveness for the drug's specific intended use.
Is this grant meant for basic exploratory science?
No. The opportunity description emphasizes that the grant is intended to pay for research steps that generate data regulators can actually use, rather than basic exploratory science.
How close to approval should a project be?
Projects should be positioned to generate credible, well-controlled safety and/or effectiveness evidence for a specific intended use, with the expectation that the work will contribute to a future FDA approval package.
Who is eligible to apply?
Eligibility includes many organization types, such as state, county, and local governments; public and private institutions of higher education; tribal governments and tribal organizations; nonprofits with or without 501(c)(3) status; public housing authorities/Indian housing authorities; for-profit organizations (including small businesses); and other entities as described in the NOFO's additional eligibility language.
Is eligibility limited in any important way?
Yes. Only entities that are developing veterinary drugs, or groups formally partnering as research collaborators with those developers, are eligible for funding. The intent is to ensure the funded work is tied to an active drug development program and can realistically be incorporated into an FDA regulatory submission.
What is required before an application can be submitted?
Several regulatory readiness steps must already be in place. The organization pursuing eventual approval must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM, the drug and its specific intended use must already have a formal minor use or minor species designation from CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS), and CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed the proposed study protocol and concurred with it prior to submission.
What is an INAD and is it required here?
An Investigational New Animal Drug (INAD) file must be opened with FDA/CVM before a grant application can be submitted, according to the opportunity description.
Does the drug need to have MUMS designation before applying?
Yes. The drug and its specific intended use must already have a formal minor use or minor species designation from CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) before the application is submitted.
What legal and regulatory authorities are referenced for designation?
The designation is described as being under section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and the designation regulations at 21 CFR Part 516.
Is FDA review of the study protocol required before submitting the application?
Yes. CVM's Office of New Animal Drug Evaluation (ONADE) must review the proposed study protocol and concur with it before the applicant submits the grant application.
Why does the program require ONADE protocol concurrence in advance?
The pre-review requirement is described as a key feature intended to help ensure funded studies are designed in a way that will be acceptable for regulatory decision-making.
What is the award mechanism for this opportunity?
The award mechanism is a cooperative agreement, which generally indicates FDA expects substantial involvement during the project rather than acting only as a passive funder.
How much funding is available per award?
The published maximum award amount is $500,000.
How many awards were anticipated?
The opportunity anticipated about six awards.
What category is this opportunity associated with?
It is categorized under Agriculture, Consumer Protection, and Food and Nutrition.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.103.
When was the opportunity created and what was the listed closing date?
The opportunity was created on February 18, 2021, and the original closing date listed was February 3, 2024.
What kinds of animal species and use-cases are explicitly mentioned as examples?
Examples of major species include cattle, swine, chickens, turkeys, dogs, cats, and horses (for minor uses within those species). Examples of minor species include fish, sheep, goats, rabbits, honey bees, and zoo animals.
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