Minor Use Minor Species Development of Drugs (R01)
Food and Drug Administration · Food and Drug Administration Research (93.103)
Posted 29 May 2024 · About 4 months left
Summary
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…
Excerpt from the donor's page. The full text, annexes and forms are on the original call.
Eligibility and conditions
Show the eligibility text from the source
Applicant types: Native American tribal organizations (other than Federally recognized tribal governments); Public housing authorities/Indian housing authorities; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; City or township governments; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; Special district governments; Public and State controlled institutions of higher education; Private institutions of higher education; State governments; Independent school districts; Native American tribal governments (Federally recognized); Others (see text field entitled "Additional Information on Eligibility" for clarification); Small businesses; County governments; For profit organizations other than small businesses
• Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Organizations)