July 30, 1997
REQUEST FOR COMMENTS ON FEED MILL LICENSING PROPOSED RULE
The Food and Drug Administration (FDA) today published a proposed rule to amend the animal drug regulations and add a new Part 515 to provide for feed mill licensing in accordance with the Animal Drug Availability Act (ADAA) of 1996. The intent of the proposed rule is to reduce the paperwork imposed on manufacturers of medicated feed and FDA while maintaining current safeguards for the manufacture of medicated feed.
The licensing of feed mills is required by the ADAA to replace the previous system of regulating medicated feed. The former process required the approval of a medicated feed application (MFA) for certain medicated feeds. The ADAA eliminates the requirement that a feed mill submit a separate MFA for the manufacture of each type of medicated feed and instead provides for feed mills to be licensed and allows a licensed facility to manufacture any feed containing an approved new animal drug. The proposed rule deletes the procedural regulations that provided specifically for medicated feed applications in 21 CFR 514 and establishes regulations for feed mill licensing in a new section, 21 CFR 515.
The ADAA grants a transitional license to all feed manufacturing facilities currently holding an approved MFA. This transitional license expires April 9, 1998. These firms can obtain a permanent license by submitting a license application with a copy of an approved MFA to FDA. Feed manufacturers are still subject to the current good manufacturing practices regulations and inspection by State or FDA. All other existing reporting responsibilities for each drug remain unchanged.
Feed facilities that want a license and do not hold an MFA need to submit a license application (Form FDA 3448) to FDA and undergo a preapproval inspection. If the facility is in compliance with good manufacturing practices, FDA will issue the license.
A copy of the proposed rule can be obtained from the CVM Home Page or by calling CVM's Communications Staff at 301-594-1755.
Written comments on the proposed rule must be received by October 28, 1997. All comments should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. Comments may also be faxed to the Dockets Management Branch on 301-594-3215. Please identify comments with the Docket Number 97N-0276.
Further information on the proposed rule is available in the Federal Register and from Dr. William D. Price, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 301-594-1724.
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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