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November 29, 2018
The U.S. Food & Drug Administration announced Nov. 26 an open application period for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species — horses, dogs, cats, cattle, pigs, turkeys and chickens — or to treat minor species (MUMS).
The Minor Use & Minor Species Animal Health Act of 2004 (the MUMS act) provides innovative ways to bring products to market for these small populations and is designed to help veterinary pharmaceutical companies and others overcome the financial roadblocks they may face in providing animal drugs for a limited market. Before this legislation, veterinary pharmaceutical companies and others would rarely attempt to bring such drugs to market, FDA said.
The MUMS Act also established the grant program, and funding started after finalization of regulations to implement the designation provisions of Section 573 of the Federal Food, Drug & Cosmetic Act.
These grants support FDA’s continuing mission to assure that safe and effective animal drugs are available for a wide range of species and conditions.
FDA said only eligible applicants pursuing FDA approval of MUMS drugs for veterinary use, or their research partners, are eligible to apply for grants. The following are additional eligibility requirements:
1. The entity pursuing the drug approval:
Must have opened an Investigational New Animal Drug file with FDA’s Center for Veterinary Medicine (CVM), and
Must hold a MUMS designation granted by CVM’s Office of Minor Use & Minor Species Animal Drug Development for that drug for a specified intended use.
2. The entity or its research partner must use the funding, if awarded, to defray the costs of qualified safety and effectiveness testing associated with the development of the drug for the designated intended use, and
3. CVM’s Office of New Animal Drug Evaluation (ONADE) must have reviewed and accepted the proposed study protocol prior to grant application submission.
Qualified studies include those intended to support target animal safety or effectiveness, environmental safety or human food safety, FDA said. For human food safety, a separate study to validate an analytical method prior to conducting an in-life study is eligible for funding if ONADE has accepted a protocol for the stand-alone method validation study. Certain manufacturing studies that are supportive of target animal safety or effectiveness are also eligible for funding.
Subject to funding availability, FDA said there will be two grant levels: (1) up to $100,000 per year for up to two years for routine studies, and (2) up to $150,000 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.
The complete FOA is available at https://grants.nih.gov/grants/guide/pa-files/PAR-18-827.html.
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