Minor Use Minor Species Development of Drugs (R01)
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 51 6. 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.
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 51 6. 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.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $250,000
Office: Food and Drug Administration
Estimated Funding: $250,000
Who's Eligible
Obtain Full Opportunity Text:
PAR-24-216 Funding Opportunity Announcement
Additional Information of Eligibility:
• Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations)
Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/pa-files/PAR-24-216.html
Contact:
Agency Email Description:
terrin.brown@fda.hhs.gov
Agency Email:
Date Posted:
2024-05-29
Application Due Date:
Archive Date:
2027-02-28
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