March 15, 2001
PROCEDURAL CHANGES TO THE ANNUAL REGISTRATION OF DRUG ESTABLISHMENTS
FDA's Center for Drug Evaluation and Research (CDER) has implemented a new system for the 2001 annual registration of drug establishments. This includes veterinary drug establishments and licensed medicated feed mills. CDER will no longer issue to registered owners and operators of drug establishments the computer generated printout of the Form FDA 2656e (Annual Registration of Drug Establishment). The new renewal procedure will require registered establishments to obtain, complete, and submit a Form FDA 2656 (Registration of Drug Establishment) using one of the following formats:
If there is no change since previous registration -- the firm is to fill out the form with only the labeler code (not required for medicated feed mills), registration number, reporting firm name, and signature, title, and date. The Reason for Submission box should be filled out to read "Annual-No Change".
If there is a change(s) since previous registration -- the form is to be filled out with the labeler code (not required for medicated feed mills), registration number, reporting firm name, and signature, title, and date, and any applicable sections where a change has occurred. The Reason for Submission box should be filled out to read "Annual".
These directions are also available on the CDER information line at (301) 594-1086. This information line also instructs establishments on how to obtain copies of the Form FDA 2656. The Form also may be found on the Program Support Center Home Page.
CDER recommends that the establishments follow the registration schedule as outlined in 21 CFR 207.21(a).
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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