June 26, 1997
REQUEST FOR COMMENTS ON MINOR SPECIES AND MINOR USES APPROVAL OPTIONS
In the June 23, 1997 Federal Register, FDA requested comments and suggestions relating to legislative and regulatory options to facilitate the approval of new animal drugs intended for use in minor species or intended for minor uses. Under the Animal Drug Availability Act of 1996 (the ADAA), FDA is required to announce proposals for legislative and regulatory changes to the approval process by April 9, 1998. Changes which facilitate approvals for minor uses and minor species will increase the availability of new animal drugs intended for these uses.
Minor use is defined in the Code of Federal Regulations (CFR) as "the use of: (a) New animal drugs in minor animal species, or (b) new animal drugs in animal species for the control of disease that (1) occurs infrequently or (2) occurs in limited geographic areas." Minor species are defined in the CFR as "animals other than cattle, horses, swine, chickens, turkeys, dogs, and cats. Sheep are a minor species with respect to effectiveness and animal safety data collection requirements; sheep are a major species with respect to human safety data collection requirements arising from the possible presence of drug residues in food."
FDA seeks comments on the scope of the definition of minor species or minor use, creating additional statutory authority, administrative and regulatory changes, creating incentives, and extending existing legal authority under the Animal Medicinal Drug Use Clarification Act for subjects such as medicated feeds and reproductive hormones. This list is not all-inclusive, and is not intended to limit the range of options available for public comment. The Agency asks that comments be as detailed as possible.
Written comments should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857 by September 8, 1997. Comments should be identified with the Docket Number 97N-0217.
Further information is included in the Federal Register which is available for review or downloading on CVM's Internet Website. Paper copies are available from the Communications Staff, FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, telephone 301-594-1755. Questions 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.
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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