Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed
About This Grant
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
Grant Summary
Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed is a Food and Drug Administration grant providing funding that varies by award for municipality. Applications are accepted on a rolling basis. Check eligibility and apply with FindGrants.
Focus Areas
Eligibility
Requirements
- 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
- must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application
How to Apply
Up to $0K
Rolling / Open
- 1Confirm your organization is eligible for Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed from Food and Drug Administration, checking organization type, location, and any population or project requirements.
- 2Gather the required documents and information, including your organization details, project plan, and budget figures.
- 3Draft your application narrative and budget addressing the funder's priorities and review criteria. FindGrants can draft each section for you to review and edit.
- 4Review every section against the requirements checklist, then export a submission-ready application pack and submit it to Food and Drug Administration before the deadline.
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Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed: Frequently Asked Questions
Who is eligible for the Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed?
Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed is offered by Food and Drug Administration and is generally open to municipality. It is open to organizations nationwide unless the funder specifies otherwise. Review the specific eligibility terms before applying, since funders set their own requirements around organization type, location, and the population or project being served.
How much funding does the Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed provide?
Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed provides an amount that varies by award per award from Food and Drug Administration. Actual award sizes depend on the scope of your project, available program funds, and the number of applicants, so build a budget that reflects realistic, allowable costs rather than the maximum figure.
When is the Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed deadline?
Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed accepts applications on a rolling or ongoing basis, so there is no single fixed deadline. Confirm current timing with the funder, Food and Drug Administration, before you apply, and submit as early as possible because rolling programs can close once funds are committed.
How do you apply for the Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed?
To apply for Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed, confirm your eligibility, gather the required documents, and prepare a narrative and budget that address the funder's priorities. FindGrants guides you step by step and can draft each section, then exports a submission-ready application pack for this grant from Food and Drug Administration.
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