Opportunity Information: Apply for PAR 24 216
The Minor Use Minor Species Development of Drugs (R01) opportunity (PAR-24-216) is a discretionary grant program run by the Food and Drug Administration (FDA), specifically through the Center for Veterinary Medicine (CVM). Its purpose is to support research projects that move certain veterinary drugs closer to FDA approval when the market is too small to easily justify the cost of development. The program focuses on "MUMS" products, meaning either drugs intended for minor uses in major species (for example, a specialized condition in cattle, pigs, chickens, dogs, or cats that affects relatively few animals) or drugs intended for use in minor species (such as fish, sheep, goats, honeybees, zoo animals, ferrets, and other less-common species). The core idea is to help fill treatment gaps where approved options are limited, while still meeting FDA standards for safety and effectiveness.
The grant is designed to help defray the cost of qualified safety and effectiveness testing that could be used to satisfy FDA requirements for approval of a MUMS-designated new animal drug. In practical terms, that means funding can support well-designed studies that generate data suitable for regulatory review, such as pivotal effectiveness studies, target animal safety studies, and other FDA-relevant testing needed to build an approvable package. This is not basic exploratory science funding; the work is expected to be tightly connected to a specific drug, a specific intended use, and a development path that is already engaged with FDA.
Eligibility is broad in terms of organizational type, but narrow in terms of what the applicant must be doing. Eligible applicant types listed include state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. Faith-based and community-based organizations, regional organizations, and non-U.S. (foreign) entities are also noted as eligible. However, the program places a key restriction on who can actually apply: only entities developing veterinary drugs, or research partners working with those entities, may receive these grants. In other words, there needs to be a real drug developer behind the project who is actively pursuing FDA approval, not simply an academic interest in a disease area.
Several specific regulatory prerequisites must be in place before an application can be submitted. The organization seeking approval of the drug must have an open Investigational New Animal Drug (INAD) file with FDA/CVM, which is the formal mechanism for interacting with CVM during drug development and for submitting development plans and data. The drug must also have received a formal minor use or minor species designation for the particular intended use from FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS). That designation is authorized under section 573 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc-2) and implemented under 21 CFR part 516, and it is a central eligibility condition for this NOFO. In addition, FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must review and concur with the proposed study protocol before the grant application is submitted. This protocol concurrence requirement signals that FDA expects applicants to align study design, endpoints, and analysis with what CVM will accept for an eventual approval decision.
The funding instrument is an R01 research project grant, and the activity category is listed under agriculture, consumer protection, and food and nutrition (CFDA 93.103). The award ceiling is $250,000. The opportunity was created on May 29, 2024, and the listed closing date is January 29, 2027. Overall, the program is meant for later-stage, regulatory-facing veterinary drug development efforts where the proposed study is already coordinated with FDA reviewers and is intended to produce data that can directly support approval of a MUMS-designated product.Apply for PAR 24 216
- The 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 2024-05-29.
- Applicants must submit their applications by 2027-01-29.
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Browse more opportunities from the same category: Agriculture, Consumer Protection, Food and Nutrition
Next opportunity: Strengthening the Capacity of Civil Society Organizations to Promote Accountable Governance in The Gambia
Previous opportunity: High Priority HIV and Substance Use Research (RM1 Clinical Trial Optional)
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PAR 24 216
Applicants also applied for:
Applicants who have applied for this opportunity (PAR 24 216) also looked into and applied for these:
| Funding Opportunity |
|---|
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U18) - Clinical Trials Not Allowed Apply for RFA FD 24 017 Funding Number: RFA FD 24 017 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Animal and Veterinary Innovation Centers (U18) Apply for PAR 24 251 Funding Number: PAR 24 251 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,250,000 |
| Single Source Cooperative Agreement to Support HPAI H5N1 Research at Cornell University (U18) - Clinical Trails Not Allowed Apply for RFA FD 24 042 Funding Number: RFA FD 24 042 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,150,000 |
| Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required Apply for RFA FD 25 001 Funding Number: RFA FD 25 001 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $650,000 |
| Laboratory Flexible Funding Model (LFFM) Apply for RFA FD 25 007 Funding Number: RFA FD 25 007 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| A Research Study of Contaminants in School Meals (U18) Apply for RFA FD 25 024 Funding Number: RFA FD 25 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives Clinical Trials Not Allowed Apply for PAR 25 003 Funding Number: PAR 25 003 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Food Safety Capacity and Infrastructure Building (U2F) Apply for RFA FD 25 019 Funding Number: RFA FD 25 019 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Conformance with the Egg Regulatory Program Standards Apply for RFA FD 25 021 Funding Number: RFA FD 25 021 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $47,000 |
| Reissue of RFA-FD-22-001 - Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional) Apply for RFA FD 25 017 Funding Number: RFA FD 25 017 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens Apply for PAR 25 014 Funding Number: PAR 25 014 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) Apply for RFA FD 25 020 Funding Number: RFA FD 25 020 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $900,000 |
| Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities Apply for RFA FD 25 023 Funding Number: RFA FD 25 023 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| FDA's Integrated Food Safety System Training Delivery and Development Apply for RFA FD 25 016 Funding Number: RFA FD 25 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Establishing the Integrated Food Safety System (IFSS) Regulatory and Laboratory Training System (RLTS) National Coordination Center (NCC) and Learning Management System (LMS) Apply for RFA FD 25 005 Funding Number: RFA FD 25 005 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,750,000 |
| Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional Apply for RFA FD 25 015 Funding Number: RFA FD 25 015 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs Apply for RFA FD 25 022 Funding Number: RFA FD 25 022 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PAR 24 216", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.