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Courtesy of NAA:

The Food and Drug Administration (FDA) has published a new Funding Opportunity Announcement (FOA) entitled “Minor Use Minor Species Development of Drugs; Research Project Grant (R01).” The grant program was established by the Minor Use and Minor Species Animal Health Act of 2004, and is administered by the Office of Minor Use and Minor Species Animal Drug Development (OMUMS) at the FDA Center for Veterinary Medicine (CVM).

The new FOA (#RFA-FD-15-004) contains open dates (earliest submission dates) and application due dates for a three year period. The two open periods for submission of grant applications for FY 2016 funds are from June 19, 2015, to August 14, 2015, and from November 20, 2015, to January 15, 2016.

The FOA solicits research 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 (MUMS). Eligibility requirements for application include:

1. Only studies in support of new animal drugs that have been “designated” by OMUMS in accordance with the provisions of the MUMS Act are eligible for grants, when a grant will either result in or substantially contribute to FDA approval or conditional approval of the designated drug for a designated intended use. The Designations List can be found at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm125445.htm;
2. The grant funding must be used to defray the costs of qualified safety and effectiveness testing expenses associated with the development of the drug for the designated intended use; and,
3. Interested parties must have a study protocol that has been accepted by CVM’s Office of New Animal Drug Evaluation (ONADE) prior to submitting the grant application.

Qualified studies include those intended to support target animal safety or effectiveness, environmental safety, or human food safety. For human food safety (HFS), a separate study to validate an analytical method prior to conduct of a HFS in-life study is eligible for funding, if a protocol for the stand-alone method validation study has been accepted by ONADE. Certain manufacturing studies as described in the FOA that are supportive of target animal safety or effectiveness are also eligible for funding, with an ONADE-accepted protocol.

Subject to the availability of funds, grants will be available for up to $100,000 per year for up to two years for routine studies; and up to $150,000 per year for up to two years for studies of unusual complexity, duration or size. A third year of funding is available only for long-term toxicology studies. An indirect cost rate of 10% of modified total direct costs will be allowed if the applicant organization does not have a negotiated Federal indirect cost rate agreement.

The new FOA is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-004.html and at www.grants.gov. Applications must be submitted electronically through www.grants.gov.