December 26, 2017

FDA Announces Grant Program for New Animal Drugs

The FDA announced an open period for applications for grants to support the development of new animal drugs intended for minor species or minor uses in major species.
By American Veterinarian Editorial Staff
Now is the time to get your animal drug research funded and supported by the Food and Drug Administration (FDA). Applications for grants to support the development of new animal drugs intended for minor species or minor uses in major species (MUMS) will be accepted until January 12.

Established by the Minor Use and Minor Species Animal Health Act of 2004, this grant program is open to applications that meet eligibility requirements including:
  1. The drug must be “designated” by the FDA Center for Veterinary Medicine’s (CVM) Office of Minor Use and Minor Species Animal Drug Development under the MUMS Act.
  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.
  3. Interested parties must have a study protocol that has been accepted by FDA/CVM’s Office of New Animal Drug Evaluation prior to submitting the grant application.

According to the FDA, major species are horses, dogs, cats, cattle, pigs, turkeys, and chickens. All other animals are minor species, except humans.

To be qualified as a minor use, the new animal drug must be indicated for an incident that occurs infrequently and in only a small number of animals, or in limited areas and in only a small number of animals annually.

Qualified studies include those intended to support animal safety, animal effectiveness, environmental safety, or human food safety.

Grants will be available for up to $100,000 per year for up to 2 years for routine studies, and up to $150,000 per year for up to 2 years for more complex studies. Funds may extend to a third year only for long-term toxicological studies.

Applications can be submitted electronically through www.grants.gov. For more information about applying for the grant program, read the complete request for applications guide.

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