Animal drugs, feeds, and related products: Bacitracin zinc; approval withdrawn,

 
CONTENT

[Federal Register: August 28, 2007 (Volume 72, Number 166)]

[Notices]

[Page 49282]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr28au07-100]

[[Page 49282]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0324]

Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) for a bacitracin zinc Type A medicated article. 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 this NADA.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-7818; e-mail: pamela.esposito@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, has requested that FDA withdraw approval of NADA 128- 550 for ANCHOR Zinc Bacitracin Type A medicated article because the product is not manufactured or marketed.

Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with Sec. 514.115 Withdrawal of approval of applications (21 CFR 514.115), notice is given that approval of NADA 128-550, and all supplements and amendments thereto, are hereby withdrawn, effective August 28, 2007.

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 this NADA.

Dated: August 20, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

[FR Doc. E7-16985 Filed 8-27-07; 8:45 am]

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