This FDA/CVM grant supports the development of designated new animal drugs for minor uses in major species or for use in minor species (MUMS). The Food and Drug Administration’s Center for Veterinary Medicine (FDA/CVM) offers funding to defray costs of safety and effectiveness testing essential for FDA approval of MUMS drugs. Eligible applicants are entities developing veterinary drugs or their research partners. To qualify, organizations must have an Investigational New Animal Drug (INAD) file with FDA/CVM and a minor use/species ‘designation’ from OMUMS. Importantly, the proposed study protocol needs prior review and concurrence from FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) before applying.
Opportunity ID: 330332
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | FOR-FD-21-004 |
| Funding Opportunity Title: | Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 6 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 25, 2021 |
| Last Updated Date: | May 25, 2021 |
| Original Closing Date for Applications: | – Archiving forecast |
| Current Closing Date for Applications: | – Archiving forecast |
| Archive Date: | May 26, 2021 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Independent school districts Native American tribal governments (Federally recognized) Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) County governments City or township governments State governments |
| Additional Information on Eligibility: | Eligible OrganizationsHigher Education Institutions• Public/State Controlled Institutions of Higher Education • Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher Education• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations• Small Businesses• For-Profit Organizations (Other than Small Businesses)Governments• State Governments • County Governments• City or Township Governments• Special District Governments• Indian/Native American Tribal Governments (Federally Recognized) • Indian/Native American Tribal Governments (Other than Federally Recognized)• U.S. Territory or PossessionOther• Independent School Districts• Public Housing Authorities/Indian Housing Authorities• Native American Tribal Organizations (other than Federally recognized tribal governments)• Faith-based or Community-based Organizations• Regional Organizations• Non-domestic (non-U.S.) Entities (Foreign Institutions) Additional Information on Eligibility: 1) The organization (or applicant) seeking approval of the new animal drug under investigation must have already opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must already hold a minor use or minor species (MUMS) "designation" granted by FDA/CVM’s Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug prior to application submission; and 2) FDA/CVM’s Office of New Animal Drug Evaluation (ONADE) must have already reviewed and concurred with the protocol for the proposed study before the applicant applies. |
Additional Information
| Agency Name: | Food and Drug Administration |
| 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.
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 |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Rene Vasquez
Grants Management Specialist Email:rene.vasquez@fda.hhs.gov |
Version History
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