Value AD
CAN BE
ALTERNATIVE
INVESTMENT
Minor Use Minor Species Development of Drugs (R01)
FOR-FD-24-013
Terrin Brown Grantor
Funding Opportunity Number: FOR-FD-24-013
Opportunity Category: Discretionary
Expected Number of Awards: 6
CFDA Number(s): 93.103 -- Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Posted Date: Nov 30, 2023 12:00:00 AM EST
Closing Date: N/A
Award Ceiling: $250000
Award Floor: $250000
Eligible Applicants: Independent school districts,Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility",City or township governments,Small businesses,State governments,For profit organizations other than small businesses,Native American tribal organizations (other than Federally recognized tribal governments),Special district governments,Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education,Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education,County governments,Public and State controlled institutions of higher education,Public housing authorities/Indian housing authorities,Native American tribal governments (Federally recognized),Private institutions of higher education
Description:
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.
