[Federal Register Volume 72, Number 166 (Tuesday, August 28, 2007)]
[Rules and Regulations]
[Pages 49191-49192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


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.

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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: 
[email protected].

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supplements and amendments thereto, are withdrawn,

[[Page 49192]]

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.

0
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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

0
2. In Sec.  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:


Sec.  558.78  Bacitracin zinc.

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

    Dated: August 20, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-16984 Filed 8-27-07; 8:45 am]
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