February 11, 1999
FINALIZED MINOR USES/MINOR SPECIES GUIDANCE AVAILABLE
The Food and Drug Administration has finalized guidance entitled "Guidance for Industry -- FDA Approval of Animal Drugs for Minor Uses and Minor Species." This guidance document (number 61), supersedes Guideline 26, "Guidelines for the Preparation of Data to Satisfy the Requirements of Section 512 of the Act Regarding Minor Use of Animal Drugs."
The purpose of this document is to provide specific guidance on the means for generating effectiveness and safety data to support the approval of minor use animal drugs. A minor animal drug use is defined as use in a minor species or use in any animal species for a condition that is rare or that occurs in limited geographic areas. Minor species are defined by exclusion, as any species other than major species. Major species are defined as cattle, swine, chickens, turkeys, horses, dogs, and cats. According to current regulations, sheep are a minor species except with respect to human food safety data collection requirements, for which sheep are considered major species. Other guidance addresses issues related to exotic and wildlife species.
This document represents the Agency's current thinking on drug approval for minor uses and minor species. It does not create or confer any rights for or on any person and does not operate to bind the FDA or public. An alternative approval may be used if such approach satisfies the requirements or the applicable statute, regulations, or both.
Copies of this document may be obtained from the CVM's Internet Home Page. A copy of this guidance document may also be obtained by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Please include a self-addressed adhesive label to assist in processing your request.
Questions on this document may be directed to Dr. Meg Oeller, FDA/Center for Veterinary Medicine, HFV-130, 7500 Standish Place, Rockville, MD 20855, 301-827-7581 (email:moeller@cvm.fda.gov).
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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