ForecastedResearch announcementOpportunity FOR-FD-24-013

Minor Use Minor Species Development of Drugs (R01)

Food and Drug Administration · Department of Health and Human Services

At a glance

Minor Use Minor Species Development of Drugs (R01) is a forecasted federal grant opportunity from the Food and Drug Administration (Department of Health and Human Services). The agency has forecast this opportunity but has not yet set an application deadline. Individual awards are listed as $250K, with about 6 awards expected. The notice is unrestricted by applicant type, subject to any clarifications in the notice. Cost sharing is not required. It is funded under Assistance Listing 93.103 (Food and Drug Administration Research).

Summary assembled from the official notice's fields. The official notice governs.

Key facts

Posted: Nov 30, 2023
Est. close date: Not listed
Award floor: $250,000
Award ceiling: $250,000
Est. total funding: Not specified
Expected awards: 6
Cost sharing: Not required
Funding instrument: Grant, Cooperative Agreement
Opportunity category: Discretionary
Fiscal year: FY2025

Who can apply

State governments
County governments
City or township governments
Special district governments
Independent school districts
Public colleges & universities
Federally recognized tribal governments
Public & Indian housing authorities
Native American tribal organizations
501(c)(3) nonprofits
Nonprofits without 501(c)(3) status
Private colleges & universities
For-profit organizations (not small businesses)
Small businesses
Unrestricted (any entity type)

Can your organization apply?

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

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.

How to apply

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Read the full announcement (NOFO)Eligibility, evaluation criteria, page limits and required attachments are in the full notice on Grants.gov. Open ↗
Confirm eligibility and fitCheck your organization type above; no cost sharing is required.
Register (or renew) in SAM.gov and get a UEIFree. New registrations can take several weeks; registrations must be renewed every year. Open ↗
Set up Grants.gov accessCreate a Grants.gov account and make sure someone has the Authorized Organization Representative (AOR) role. Open ↗
Watch for the full noticeSave this grant to track when it opens.
Prepare narrative, budget and attachmentsFollow the notice's format exactly — page limits and required forms are common reasons applications are rejected.
Ask the agency contact any questions earlyTerrin Brown Grantor · terrin.brown@fda.hhs.gov Open ↗
Submit before the deadlineSubmit a few days early and keep your Grants.gov confirmation and validation emails.

Assistance Listing

What is an ALN?

93.103Food and Drug Administration ResearchProgram →

Reported obligations under ALN 93.103

Historical data · not a prediction

FY18

$173M

FY19

$199M

FY20

$212M

FY21

$219M

FY22

$256M est.

FY23

$247M est.

Source: SAM.gov Assistance Listing 93.103. Program-wide totals, not awards from this specific opportunity.

Agency contact (as published)

Terrin Brown Grantor
terrin.brown@fda.hhs.gov
(240) 402-7610

Quick answers

Is “Minor Use Minor Species Development of Drugs (R01)” open for applications yet?

Not yet. It is a forecast — an agency's advance notice of an expected opportunity. Forecast details and dates can change.

Who is eligible to apply for “Minor Use Minor Species Development of Drugs (R01)”?

The notice lists eligibility as unrestricted — open to any type of entity — subject to clarifications in the notice's additional eligibility information.

How much funding is available through “Minor Use Minor Species Development of Drugs (R01)”?

Per the notice, individual awards are listed as $250k and the agency expects to make about 6 awards.

How do I apply for “Minor Use Minor Species Development of Drugs (R01)”?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity FOR-FD-24-013), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.

OpenResearchALN 93.103