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.

Government

• Public and Indian housing authorities
• County governments
• State governments
• Federally recognized Native American tribal governments
• Special district governments
• City or township governments

Nonprofit

• Other Native American tribal organizations
• Nonprofits non-higher education without 501(c)(3)
• Nonprofits non-higher education with 501(c)(3)

Education

• Independent school districts
• Private institutions of higher education
• Public and state institutions of higher education

Business

• For-profit organizations other than small businesses
• Small businesses

Miscellaneous

• Other