[Federal Register Volume 68, Number 188 (Monday, September 29, 2003)]
[Rules and Regulations]
[Pages 55825-55826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24436]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Monensin and 
Chlortetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 
monensin and chlortetracycline to make two-way combination drug Type C 
medicated feeds for broiler chickens.

DATES: This rule is effective September 29, 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 200-354 for use of PENNCHLOR 
(chlortetracycline) and COBAN (monensin) Type A medicated articles to 
make two-way combination drug Type C medicated feeds for broiler 
chickens. Pennfield Oil Co.'s ANADA 200-354 is approved as a generic 
copy of Alpharma, Inc.'s NADA 121-553 for combination use of AUREOMYCIN 
(chlortetracycline) and COBAN. The ANADA is approved as of August 15, 
2003, and the regulations are amended in 21 CFR 558.355 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

[[Page 55826]]

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.


Sec.  558.355  [Amended]

0
2. Section 558.355 Monensin is amended in paragraph (f)(1)(xiv)(b) 
after ``046573'' by adding ``and 053389''.

    Dated: September 11, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 03-24436 Filed 9-26-03; 8:45 am]
BILLING CODE 4160-01-S