[Federal Register Volume 67, Number 83 (Tuesday, April 30, 2002)]
[Rules and Regulations]
[Page 21171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10511]


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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 Alpharma, Inc.

DATES: This rule is effective April 30, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209, 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 39-
077 for CSP (chlortetracycline, sulfathiazole, penicillin) 250 and CSP 
500 Type A medicated articles to Alpharma, Inc., One Executive Dr., 
P.O. Box 1399, Fort Lee, NJ 07024. Accordingly, the agency is amending 
the regulations in 21 CFR 558.155 to reflect the change of sponsor.
    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. 558.155  [Amended]

    1. Section 558.155 Chlortetracycline, sulfathiazole, penicillin is 
amended in paragraphs (a)(1) and (a)(2) by removing ``Nos. 000010 and 
046573'' and by adding in its place ``No. 046573''.

    Dated: February 22, 2002.
Claire M. Lathers,
Director, Office of New Animal Drugs, Center for Veterinary Medicine.
[FR Doc. 02-10511 Filed 4-29-02; 8:45 am]
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