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Minor Use Minor Species Development of Drugs (R01)

Active

Grant

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The Food and Drug Administration's Center for Veterinary Medicine is soliciting R01 grant applications to support the development of new animal drugs intended for minor uses in major species or for use in minor species. These grants are designed to help eligible entities defray the costs associated with safety and effectiveness testing required for FDA approval. To be eligible, applicants must be developing drugs for veterinary use or acting as research partners. The organization seeking drug approval must have an open Investigational New Animal Drug file and a formal minor use or minor species designation from the Office of Minor Use and Minor Species Animal Drug Development. Additionally, the proposed study protocol must be reviewed and approved by the Office of New Animal Drug Evaluation prior to the submission of a grant application.

General Info

Funding for MUMS veterinary drug development with FDA approval and designated study protocols.

Agency

Department Of Health And Human Services → Food And Drug Administration

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

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Timeline

PostedNov 30

forecast

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → Food And Drug Administration

Contacts1 person available

OfficeUSA

Organization / Agency

Department Of Health And Human Services → Food And Drug Administration

Office AddressUSA

Contacts

Terrin Brown Grantor

contact@example.gov

+1 (555) 000-0000

Full 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.