[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Rules and Regulations]
[Pages 41066-41067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17409]


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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; Salinomycin, 
Chlortetracycline, and Roxarsone

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 Type A medicated articles containing 
salinomycin, chlortetracycline, and roxarsone to make three-way 
combination drug Type C medicated feeds for broiler chickens.

DATES: This rule is effective July 10, 2003.

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 200-355 for use of PENNCHLOR 
(chlortetracycline), salinomycin, and roxarsone Type A medicated 
articles to make three-way combination drug Type C medicated feeds for 
broiler chickens. Pennfield Oil Co.'s ANADA 200-355 is approved as a 
generic copy of Alpharma, Inc.'s NADA 140-867. The ANADA is approved as 
of March 31, 2003, and the regulations are amended in 21 CFR 558.550 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 Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9

[[Page 41067]]

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.

0
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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

0
2. Section 558.550 is amended by adding paragraph (a)(3); and in 
paragraph (d)(1)(xv)(c) by removing ``and 046573'' and by adding in its 
place ``and 053389'' to read as follows:


Sec.  558.550  Salinomycin.

    (a) * * *
    (3) To 053389 for use as in paragraph (d)(1)(xv) of this section.
* * * * *

    Dated: June 26, 2003.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 03-17409 Filed 7-9-03; 8:45 am]
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