Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed

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Opportunity ID:330332
Opportunity Number:FOR-FD-21-004
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:
CFDA Number(s):93.103
Eligible Applicants:State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For profit organizations other than small businesses
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility:Eligible Organizations Higher 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 Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o 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 Possession Other • 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.
Agency Code:HHS-FDA
Agency Name:Department of Health and Human Services
Food and Drug Administration
Posted Date:Dec 11, 2020
Last Updated Date:Dec 11, 2020
Estimated Synopsis Post Date:
Fiscal Year:2021
Award Ceiling:
Award Floor:
Estimated Total Program Funding:
Expected Number of Awards:6
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
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