Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) listed below. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the NADAs because the products are no longer manufactured or marketed.
Withdrawal of approval is effective July 23, 2001.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5593.End Further Info End Preamble Start Supplemental Information
Heinold Feeds, Inc., P.O. Box 377, Kouts, IN 46347, has requested that FDA withdraw approval of NADA 95-628 for Tylosin® Antibiotic Premix and NADA 127-506 for Tylan® Sulfa-G Premixes because the products are no longer manufactured or marketed.
Therefore, under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10), redelegated to the Center for Veterinary Medicine (21 CFR 5.84), and in accordance with § 514.115 Withdrawal of approval of applications (21 CFR 514.115), notice is given that approval of NADAs 95-628 and 127-506, and all supplements and amendments thereto, is hereby withdrawn, effective July 23, 2001.
In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs.Start Signature
Dated: July 2, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-17408 Filed 7-10-01; 8:45 am]
BILLING CODE 4160-01-S