[Federal Register Volume 67, Number 232 (Tuesday, December 3, 2002)]
[Rules and Regulations]
[Page 71821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs; Change of Sponsor

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 to reflect a change of sponsor for an approved new 
animal drug application (NADA) from Boehringer Ingelheim Vetmedica, 
Inc., to Pennfield Oil Co.

DATES: This rule is effective December 3, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Hwy., St. Joseph, MO 64506-2002, has informed FDA that it 
has transferred ownership of, and all rights and interest in, NADA 128-
550 for ANCHOR Zinc Bacitracin Type A medicated article to Pennfield 
Oil Co., 14040 Industrial Rd., Omaha, NE 68137. Accordingly, the agency 
is amending the regulations in 21 CFR 558.78 to reflect the transfer of 
ownership.
    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.


Sec.  558.78  [Amended]

    2. Section 558.78 Bacitracin zinc is amended in paragraph (a)(2) by 
removing ``To 000010'' and by adding in its place ``No. 053389''.

    Dated: November 8, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-30638 Filed 12-2-02; 8:45 am]
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