October 6, 1997
MINOR USES/MINOR SPECIES DRAFT GUIDANCE PUBLISHED
The Food and Drug Administration has published draft guidance entitled "Guidance for Industry -- FDA Approval of Animal Drugs for Minor Uses and Minor Species." This guidance document (number 61), when finalized, will supersede Guideline 26, "Guidelines for the Preparation of Data to Satisfy the Requirements of Section 512 of the Act Regarding Minor Use of Animal Drugs." This guidance document is being distributed for comment purposes only.
The major purpose of this document is to suggest means of 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.
Copies of this draft guidance document may be obtained from the on-line library at CVM's Internet Home Page or by calling CVM's Communications Staff at 301-594-1755.
Comments and suggestions regarding this draft document should be submitted by December 29, 1997, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. Questions on this document may be directed to Dr. Meg Oeller, FDA/Center for Veterinary Medicine, HFV-130, 7500 Standish Place, Rockville, MD 20855, 301-594-1650.
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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