[Federal Register Volume 67, Number 100 (Thursday, May 23, 2002)]
[Rules and Regulations]
[Pages 36097-36098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12873]


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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; Decoquinate and 
Chlortetracycline

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 approval of a new animal drug application 
(NADA) filed by Alpharma, Inc. The NADA provides for use of approved 
decoquinate and chlortetracycline Type A medicated articles to make 
two-way combination Type B and Type C medicated feeds for calves, beef, 
and nonlactating dairy cattle used for prevention of coccidiosis, 
treatment of bacterial enteritis, and treatment of bacterial pneumonia.

DATES: This rule is effective May 23, 2002.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-185 that provides for use of 
DECCOX (decoquinate) and AUREOMYCIN (chlortetracycline) Type A 
medicated articles to make combination drug Type B and Type C medicated 
feeds for calves, beef and nonlactating dairy cattle. The combination 
Type C feeds are used for the prevention of coccidiosis caused by 
Eimeria bovis and E. zuernii, for treatment of bacterial enteritis 
caused by Escherichia coli, and for treatment of bacterial pneumonia 
caused by Pasteurella multocida organisms susceptible to 
chlortetracycline. The NADA is approved as of March 15, 2002, and the 
regulations are amended in 21 CFR 558.195 to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of each application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33(a)(2) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    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.

[[Page 36098]]


    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.


 558.195  [Amended]

    2. Section 558.195 Decoquinate is amended in the table in paragraph 
(d) in the entry for the combination ``Chlortetracycline approximately 
400'' in the ``Limitations'' column by removing ``Withdraw 24 hours 
prior to slaughter.'' and by adding in its place ``Withdraw 24 hours 
prior to slaughter when manufactured from CTC (chlortetracycline) Type 
A medicated articles under NADA 141-147. Zero withdrawal time when 
manufactured from AUREOMYCIN (chlortetracycline) Type A medicated 
articles under NADA 141-185.''.

    Dated: May 9, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-12873 Filed 5-22-02; 8:45 am]
BILLING CODE 4160-01-S