July 2, 1999
FDA PROPOSES VETERINARY FEED DIRECTIVE RULES
In the July 2, 1999, Federal Register, the Food and Drug Administration proposed regulations to implement the Veterinary Feed Directive (VFD) drugs section of the Animal Drug Availability Act (ADAA). A VFD drug is a drug intended for use in animal feeds which is limited to use under the professional supervision of a licensed veterinarian. The regulation proposes requirements relating to the distribution and use of VFD drugs and animal feeds containing VFD drugs.
Although statutory controls on the distribution and use of VFD drugs are similar to those for prescription animal drugs, the implementing VFD regulations are tailored to the unique circumstances relating to the distribution of animal feeds containing a VFD drug. This proposal would ensure the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and cost-effectively as possible. No extra-label use of a VFD drug is permitted in the proposal.
A copy of the proposed regulations published in the Federal Register is available on CVM's Internet Home Page. A copy of these proposed rules 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.
FDA invites interested persons to submit comments regarding these proposed regulations. Written comments must be submitted by September 30, 1999, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
All comments submitted in response to these proposed regulations will be available for public inspection, during and after the comment period, in FDA's Dockets Management Branch (5630 Fishers Lane, Room 1061, Rockville, MD 20852) between the hours of 9:00 a.m. and 4:30 p.m., Monday through Friday except for Federal holidays.
Comments on the information collection provisions of this proposed rule must be submitted by August 2, 1999, to the Office of Management and Budget (OMB) at the following address: Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., Room 10235, Washington, DC 20503, Attn: Desk Officer for FDA.
Additional information on the proposed regulation is available in the July 2, 1999, Federal Register and from Dr. George Graber, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, Phone: 301 827-6651, e-mail: ggraber@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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