E7-16984. New Animal Drugs For Use in Animal Feeds; Withdrawal of Approval of a New Animal Drug Application; Bacitracin Zinc

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of a new animal drug application (NADA) for a bacitracin zinc Type A medicated article. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of this NADA.

DATES:

This rule is effective August 28, 2007.

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: [e-mail].

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.

In a notice published elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 128-550 and all supplements and amendments thereto, are withdrawn, effective August 28, 2007. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect the withdrawal of approval.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

• Animal drugs
• Animal feeds

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. In § 558.78, in paragraph (a), remove “5,”; in the table in paragraph (d)(1)(i), in the “Sponsor” column, remove “048164”; and revise paragraph (b) to read as follows:

§ 558.78

Bacitracin zinc.

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(b) Approvals. See No. 046573 in § 510.600(c) of this chapter.

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Dated: August 20, 2007.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.