[Federal Register Volume 68, Number 81 (Monday, April 28, 2003)]
[Rules and Regulations]
[Page 22294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10418]


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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 
Sulfamethazine

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 a fixed-combination Type A medicated article containing 
chlortetracycline and sulfamethazine to make two-way combination drug 
Type C medicated feeds for beef cattle.

DATES: This rule is effective April 28, 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 68137, filed ANADA 200-314 for use of PENNCHLOR S 700 
(chlortetracycline/sulfamethazine), a fixed-combination Type A 
medicated article used to make two-way combination drug Type C 
medicated feeds for beef cattle. Pennfield Oil Co.'s PENNCHLOR S 700 
Type A medicated article is approved as a generic copy of Alpharma 
Inc.'s AUREO S 700, approved under NADA 35-805. The ANADA is approved 
as of January 29, 2003, and the regulations are amended in 21 CFR 
558.140 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 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 
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.  558.140  [Amended]

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2. Section 558.140 Chlortetracycline and sulfamethazine is amended in 
paragraph (a) by removing ``046573'' and by adding in its place ``Nos. 
046573 and 053389''.

    Dated: April 1, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-10418 Filed 4-25-03; 8:45 am]
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