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Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed
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
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
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $1,983,273
Office: Food and Drug Administration
Estimated Funding: $1,983,273
Who's Eligible
Obtain Full Opportunity Text:
https://acl.gov/grants/open-opportunities
Additional Information of 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.
Full Opportunity Web Address:
https://acl.gov/grants/open-opportunities
Contact:
Agency Email Description:
rene.vasquez@fda.hhs.gov
Agency Email:
Date Posted:
2021-05-25
Application Due Date:
Archive Date:
2021-05-26
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