October 30, 1998
MINOR SPECIES/MINOR USE REPORT AVAILABLE
In the October 29, 1998, Federal Register, FDA announced the availability of a report entitled, "Proposals to Increase the Legal Availability of Approved Animal Drugs for Minor Species and Minor Uses." The report contains proposals for changes to the approval process for new animal drugs intended for use in minor species and for minor uses in major species. Minor species are defined in the Code of Federal Regulations as "animals other than cattle, horses, swine, chickens, turkeys, dogs, and cats."
This report is the Agency’s response to a requirement of the Animal Drug Availability Act (ADAA) of 1996 that the Secretary of Health and Human Services consider and announce proposals to facilitate approvals for minor use drugs. Implementation of these proposals should increase the number of legally available new animal drugs for use in minor species and for minor uses. Many of the proposals require changes in the Federal Food, Drug, and Cosmetic Act before regulations can be written and the changes implemented.
Copies of this report may be obtained from CVM's Internet Home Page or 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. Send one self-addressed adhesive label to assist in processing your requests.
The Agency is requesting comments on this report at any time. Written comments on the report should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with Docket Number 97N-0217. FDA will also accept e-mail comments. They should be labeled as comments, be identified with Docket Number 97N-0217, and be addressed to mailto:jbulter1@bangate.fda.gov. The Agency will make paper copies of these comments and will place them in the public docket.
Questions about the minor species/minor use section [section 2(f)] of the ADAA may be directed to Dr. George A. (Bert) Mitchell, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-5587, e-mail: gmitchel@bangate.fda.gov. Further information about the changes proposed in the report to the approval process is available from Dr. Linda Wilmot, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, (301) 827-7540, e-mail: mailto:lwilmot@bangate.fda.govv.
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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