US Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM)
01/15/21 11:59 PM ET
Grants to USA, Canada, and International nonprofit organizations, for-profits, IHEs, and government agencies to develop new drugs for animals that may be used in minor species or for minor uses in major species. Applicants are advised that the required registrations may take up to six weeks to complete.
This Funding Opportunity Announcement (FOA) 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 new animal drugs intended for minor use in major species or for use in minor species.
The Food & Drug Administration’s (FDA) Center for Veterinary Medicine’s (CVM) Office of Minor Use & Minor Species Animal Drug Development (OMUMS) was created after “The Minor Use and Minor Species Animal Health Act of 2004” (MUMS act) was signed into law. The MUMS act helps make more medications legally available to veterinarians and animal owners to treat minor animal species and minor uses in major animal species (MUMS drugs). Major species of animals are: horses, dogs, cats, cattle, swine, turkeys, and chickens. All other animal species (except humans) are minor species. A minor use is the intended use of a new animal drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually in the United States.
Qualified safety and effectiveness testing eligible for funding includes studies that support target animal safety or effectiveness, environmental safety, human food safety, and certain manufacturing studies, as well as the analytical method validation studies described below.
GrantWatch ID#: 172152
It is anticipated that up to 10 awards will be made. The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for two (2) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.
There are two levels of funding available. The FDA will award grants up to $100,000 per year for up to 2 years (level one), or up to $150,000 per year for up to 3 years in certain cases (level two). Please note the dollar limitation will apply to total costs, not direct costs. Applications for the smaller level one grants ($100,000) may be for any routine safety or effectiveness study supportive of new animal drug approval or conditional approval of the designated product for the designated intended use. Study proposals for larger level two grants ($150,000) must be for necessary studies that are of unusual complexity, duration, or size. A third year of funding is available only for long-term toxicological studies.
Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):
- Year 01: $100,000
- Year 02: $100,000
- Year 01: $150,000
- Year 02: $150,000
- Year 03: $150,000 (long-term toxicological study only)
The length of support of award project periods will depend on the nature of the study, but is one-year from date of award for most studies. For those studies with an expected duration of more than one year, a second, or in some cases, a third year of noncompetitive continuation of support will depend on the following factors:
(1) Performance during the preceding year, (2) Compliance with the regulatory requirements of an Investigational New Animal Drug File (INAD) and those associated with designation, and (3) Availability of Federal funds.
The maximum project period is 3 years.
A third year of funding is available only for long-term toxicological studies.
Earliest Start Date:
- February 2019 for the August 27, 2018 Deadline
- June 2019 for the January 18, 2019 Deadline
- February 2020 for the August 16, 2019 Deadline
- June 2020 for the January 17, 2020 Deadline
- February 2021 for the August 14, 2020 Deadline
- June 2021 for the January 15, 2021 Deadline
Before starting your grant application, please review the funding source's website listed below for updates/changes/addendums/conferences/LOIs.
Apply online using ASSIST:
The letter of intent should be sent to:
Grants Management Specialist
Application Submission Contacts:
- eRA Service Desk - for questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues):
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
- Grants.gov Customer Support - For questions regarding Grants.gov registration and submission, downloading forms and application packages:
Contact CenterTelephone: 800-518-4726
Dr. Stuart Jeffrey
Office of Minor Use Minor Species Animal Drug Development (OMUMS)
Center for Veterinary Medicine (CVM)
Food and Drug Administration (FDA)
7500 Standish Place (HFV-50)
Rockville, MD 20855
Objective Review Contact(s):
Grants Management Specialist
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
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International country outside of the USA, Israel and Canada.
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