[Federal Register Volume 69, Number 93 (Thursday, May 13, 2004)]
[Rules and Regulations]
[Pages 26498-26499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10829]


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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; Chlortetracycline and 
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 an abbreviated new animal drug 
application (ANADA) filed by Pennfield Oil Co. The ANADA provides for 
the use of single-ingredient, chlortetracycline and decoquinate Type A 
medicated articles to make two-way combination drug Type B and Type C 
medicated feeds for calves, beef and nonlactating dairy cattle.

DATES: This rule is effective May 13, 2004.

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: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68144, filed ANADA 200-359 for use of PENNCHLOR 
(chlortetracycline) and DECCOX (decoquinate) single-ingredient Type A 
medicated articles to make two-way combination drug Type B and Type C 
medicated feeds for calves, beef and nonlactating dairy cattle. 
Pennfield Oil Co.'s ANADA 200-359 is approved as a generic copy of 
Alpharma, Inc.'s NADA 141-147. The ANADA is approved as of March 19, 
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)(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.

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

[[Page 26499]]

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 is amended in paragraph (e)(2)(iii) in the 
``Limitations'' column by removing ``CTC (chlortetracycline) Type A 
medicated articles under NADA 141-147'' and by adding in its place 
``chlortetracycline Type A medicated articles under NADA 141-147 and 
ANADA 200-359'' and by adding as the last sentence ``Chlortetracycline 
as provided by Nos. 046573 and 053389 in Sec.  510.600(c) of this 
chapter.''; and in paragraph (e)(2)(iii) in the ``Sponsor'' column by 
adding ``053389'' after ``046573''.

    Dated: April 23, 2004.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 04-10829 Filed 5-12-04; 8:45 am]
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