Minor Use Minor Species Development of Drugs (R01)
🏛 Food and Drug Administration (HHS-FDA)
✓ Free, no account · Source: Grants.gov · Last verified Oct 20, 2026
Can you apply?
This grant is for supporting the development of new drugs for minor uses and minor species. Eligible applicants typically include pharmaceutical companies, research institutions, academic centers, and nonprofit organizations engaged in drug development. The program prioritizes applications addressing unmet medical needs for animals or rare conditions where market incentives alone may not drive development. Activities supported include preclinical research, clinical trial design and execution, regulatory pathway planning, and submission of investigational new drug (IND) applications or new animal drug applications (NADA). The program is administered by the Food and Drug Administration and operates on a national scope, supporting both human and veterinary pharmaceutical development for underserved areas.
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Program description
This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS).
The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs.
Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants.
The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species “designation” granted by FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516.
FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (Application for Federal Assistance)
- Project narrative describing the unmet medical need, development rationale, and regulatory pathway
- Detailed budget and budget justification
- Curriculum vitae of key personnel with drug development experience
- Organizational capacity statement demonstrating experience with pharmaceutical development or clinical trials
- Letters of commitment from clinical trial sites or partner organizations, if applicable
- Regulatory correspondence or Pre-IND meeting summary showing FDA/CVM engagement
- Data or preliminary results supporting feasibility of the proposed drug development
Program contact
- 👤 Terrin Brown Grantor
- 📧 terrin.brown@fda.hhs.gov
- 📞 (240) 402-7610
Funding track record
Recent awards under CFDA 93.103 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$137,050,554
-
$76,105,626
-
$53,144,194
-
$52,672,417
-
$38,251,997
-
$36,000,000
-
$35,391,995
-
$32,562,281
-
$30,732,300
-
$25,132,999
Top States by Funding
- AZ 4 awards $149.9M
- CA 9 awards $114.6M
- MD 7 awards $112.8M
- VA 7 awards $104.5M
- PA 11 awards $86.3M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.103). How funding has trended year over year.
| 2016 | $170,482,435 | |
| 2017 est. | $208,900,832 | |
| 2018 | $173,077,408 | |
| 2019 | $198,507,896 | |
| 2020 | $212,448,590 | |
| 2021 | $218,918,739 | |
| 2022 est. | $255,910,458 | |
| 2023 est. | $246,894,600 |
FAQ
Who is eligible to apply for this grant?
Pharmaceutical companies, academic medical centers, research institutions, nonprofit organizations, and other entities conducting drug development research can apply. Both small businesses and large organizations are eligible.
What types of drug development activities are supported?
The program supports preclinical research, development of new formulations, clinical trial design and conduct, regulatory strategy development, and preparation of regulatory submissions (IND or NADA applications).
What is a "minor use" or "minor species"?
Minor uses refer to drugs for treating rare diseases or uncommon conditions in humans. Minor species refers to animals other than major food-producing species (cattle, swine, poultry) where veterinary drugs are needed.
How competitive is this program?
This is moderately to highly competitive. Success requires strong scientific rationale, clear regulatory pathway planning, demonstrated team expertise, and realistic budgets. Applications addressing significant unmet medical needs score higher.
What is the typical funding range?
Funding varies widely depending on scope and phase of development, typically ranging from $100,000 to several million dollars over the project period, though specific amounts depend on individual application budgets and agency availability.
💡 Tips for applicants
- Clearly articulate the unmet medical need: explain why this drug is needed and why market forces alone won't drive development. Strong public health or animal health justification is critical.
- Engage early with FDA/CVM regulatory staff: obtain a Pre-IND meeting or regulatory pathway consultation before applying to align your development plan with agency expectations.
- Develop a detailed and realistic regulatory strategy: include timelines for IND/NADA submission, anticipated trial phases, and regulatory milestones to demonstrate feasibility.
- Build a qualified team: highlight your organization's experience with drug development, regulatory submissions, and clinical or preclinical trial management.
- Justify your budget carefully: provide detailed cost breakdowns for preclinical studies, clinical trials, regulatory support, and personnel with realistic timelines and justification for each major expense.
⚠️ Common mistakes
Applications often lack a clear regulatory strategy or fail to demonstrate genuine engagement with FDA/CVM early in the development process. Weak justification of the unmet medical need—particularly insufficient explanation of why market incentives alone won't address the issue—is a frequent reason for rejection. Additionally, unrealistic budgets or timelines that don't account for the complexity of drug development and regulatory requirements significantly reduce competitiveness.
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