April 16, 1997
REQUEST FOR COMMENTS ON MEDICATED FEED MILL LICENSE APPLICATION FORM
In the Federal Register of March 31, 1997, the FDA published a notice announcing an opportunity for public comments on the collection of information on a medicated feed mill license application form (Form FDA 3448). A copy of the form is available on the CVM Home Page or by calling CVM's Communication Staff on 301-594-1755.
As a result of the enactment of the Animal Drug Availability Act (ADAA) of 1996, Feed Mill Licenses have taken the place of Medicated Feed Applications. The ADAA mandates that FDA replace the system for the approval of specific medicated feeds with a general licensing system.
Under the new licensing system, each feed manufacturing facility need submit only one feed mill license application to FDA for the manufacture of medicated feeds. In order to be licensed, a feed manufacturer must, among other things, provide a full statement of the business name, address, and registration number of the feed manufacturing facility, and the name and signature of the responsible individual for that facility. To implement these requirements, FDA's medicated feed mill license application form will request the following information of each applicant: (1) manufacturing site legal business name, (2) address, (3) phone number, (4) FAX number, (5) type of application, (6) FDA registration number, and (7) date and signature.
The information on the form will be used to issue medicated feed mill licenses. The information requested on the form is specifically mandated by the ADAA, except for the telephone and fax numbers. These numbers are needed so the FDA can contact the firm quickly when necessary.
Written comments on Form FDA 3448 should be submitted as soon as possible, preferably by May 1, 1997, to facilitate necessary clearance of the form. The final closing date is May 30, 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. They should be identified with the Docket Number 97N-0117.
Questions about feed mill licensing should be directed to the Division of Animal Feeds, Office of Surveillance and Compliance, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855, telephone 301-594-1724. Questions about the information collection aspects of the form may be directed to Denver Presley, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Room 16B-19, Rockville, MD 20857, 301-827-1472.
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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