[Federal Register: September 29, 2003 (Volume 68, Number 188)]
[Rules and Regulations]
[Page 55825-55826]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se03-17]
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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; Monensin and
Chlortetracycline
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
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: lluther@cvm.fda.gov.
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.
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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. 558.355 [Amended]
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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]
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