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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule; technical amendment.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Chlortetracycline

DATES: This rule is effective August 18, 2004.

DOCUMENT 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 singleingredient Type A medicated articles containing bacitracin methylene disalicylate and chlortetracycline to make twoway combination drug Type B and Type C medicated feeds for swine.

SUMMARY: Bacitracin methylene disalicylate and chlortetracycline,

SUPPLEMENTAL INFORMATION

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed ANADA 200358 for use of PENNCHLOR
(chlortetracycline) and BMD (bacitracin methylene disalicylate) Type A medicated articles to make twoway combination drug Type B and Type C medicated feeds for swine. Pennfield Oil Co.'s ANADA 200358 is approved as a generic copy of Alpharma, Inc.'s new animal drug application 141059. The ANADA is approved as of July 2, 2004, and the regulations are amended in Sec. 558.76 (21 CFR 558.76) to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, FDA is amending Sec. 558.76 by removing specifications for a bacitracin methylene disalicylate and chlortetracycline combination drug Type B medicated feed that was added to the regulations in 1998 (63 FR 44385, August 19, 1998). The specification contains an error, but also was codified unnecessarily. This amendment is being done to improve the accuracy and consistency of the animal drug regulations.

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 (HFA305), 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. 801808.
List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.
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 558NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.
2. Section 558.76 is amended in the table by revising paragraph (d)(1)(iv) to read as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(1) * * *
Bacitracin
methylene Combination
disalicylate in grams per Indications Limitations Sponsor in grams per ton for use
ton
* * * * * * *
(iv) 10 to 30 ............. Swine: for For growing 046573 increased and 053389 rate of finishing
weight gain swine
and improved
feed
efficiency.
Chlortetracyc Swine; for Feed for not 046573 line increased more than 14 053389 approximatel rate of days;
y 400, weight gain chlortetracy varying with and improved cline
body weight feed provided by
and food efficiency; Nos. 046573
consumption for and 053389
to provide treatment of in Sec.
10 bacterial 510.600(c)
milligrams enteritis of this
per pound of caused by chapter.
body weight Escherichia
per day. coli and
Salmonella
choleraesuis
and
bacterial
pneumonia
caused by
Pasteurella
multocida
susceptible
to
chlortetracy
cline.
............. Swine; for Feed for not 046573 control of more than 14 porcine days;
proliferativ chlortetracy e cline and
enteropathie BMD as
s (ileitis) provided by
caused by 046573 in
Lawsonia Sec.
intracellula 510.600(c)
ris of this
susceptible chapter.
to
chlortetracy
cline.
[[Page 51173]]
* * * * * * *
* * * * *

Dated: August 2, 2004.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 0418845 Filed 81704; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Lonnie W. Luther, Center for Veterinary Medicine (HFV104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 3018278549, email:
lonnie.luther@fda.gov.

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