FDA Announces Grant Program Request for Applications to support the development of new animal drugs intended for minor species or minor uses in major species. Open Period due August 16, 2013
The grant program was established by the Minor Use and Minor Species Animal Health Act of 2004, and funding was authorized to start after finalization of regulations to implement the Designation provisions of Section 573 of the Federal Food, Drug & Cosmetic Act.
Eligibility requirements to apply for a MUMS grant include: the drug must be ‘designated’ by the Center for Veterinary Medicine’s (CVM) Office of Minor Use and Minor Species Animal Drug Development (OMUMS) under the MUMS Act; 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 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 safety studies include those intended to support target animal safety, environmental safety, and human food safety. For human food safety, a separate study to validate an analytical method prior to conduct of an in-life study is eligible for funding, if a protocol for the stand-alone method validation study has been accepted by ONADE.
Grants will be available for up to $75,000 per year for up to two years for routine studies; and up to $125,000 per year for up to two years for studies of unusual complexity, duration or size. A third year of funding may be available for long-term toxicology studies. Therefore, grants could range from under $75,000 for a routine study that could be completed in less than a year, to $250,000 for a complex study requiring two years for completion, to $375,000 for a long-term toxicology study. Indirect costs are limited to 15% of direct costs.
The complete Request for Applications is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-12-003.html2. Please note revisions to dates and text in Notice NOT-FD-13-014, at http://grants.nih.gov/grants/guide/notice-files/NOT-FD-13-014.html3.