[Federal Register Volume 69, Number 167 (Monday, August 30, 2004)]
[Rules and Regulations]
[Page 52816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19696]


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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

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 supplemental new animal drug 
application (NADA) filed by Alpharma Inc. The supplemental NADA 
provides for the use of single-ingredient decoquinate and monensin Type 
A medicated articles to make two-way Type B and Type C medicated feeds 
for cattle at a broader range of concentrations.

DATES: This rule is effective August 30, 2004.

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 Drive, P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to NADA 141-148 for use of 
DECCOX (decoquinate) and RUMENSIN (monensin sodium) Type A medicated 
articles to make two-way Type B and Type C medicated feeds for cattle 
at the broader range of concentrations. The supplemental application is 
approved as of July 30, 2004, 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 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(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.
    The agency has determined under 21 CFR 25.33(a)(1) 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 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.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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

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

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


Sec.  558.195  [Amended]

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2. Section 558.195 Decoquinate is amended in paragraph (e)(2)(iv) in 
the table in the ``Decoquinate in grams/ton'' column by removing ``13.6 
to 27.2'' and by adding in its place ``12.9 to 90.8''; and in the 
``Limitations'' column after the fourth sentence by adding ``Do not 
feed to lactating dairy cattle.''

    Dated: August 18, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-19696 Filed 8-27-04; 8:45 am]
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