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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; correcting amendments.

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

DATES: This rule is effective September 27, 2004.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) that appeared in the Federal Register of August 18, 2004 (69 FR 51172). FDA is removing the drug labeler code for Pennfield Oil Co. in the entry for use of singleingredient bacitracin methylene disalicylate (BMD) in swine feed, which was added in error during document formatting; and is adding the approved source of BMD in the entry for use of BMD in combination with chlortetracycline. These corrections are being made so the BMD regulations accurately reflect approved new animal drug applications.

SUMMARY: Bacitracin methylene disalicylate and chlortetracycline; Correction,

SUPPLEMENTAL INFORMATION

For the reasons set forth in the preamble, FDA is correcting 21 CFR part 558 to read as follows:
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.
* * * * *
[[Page 57639]]
(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
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 bacitracin
varying with and improved methylene
body weight feed disalicylate and food efficiency; provided by
consumption for No. 046573;
to provide treatment of chlortetracy 10 bacterial cline
milligrams enteritis provided by
per pound of caused by Nos. 046573
body weight Escherichia and 053389
per day. coli and in Sec.
Salmonella 510.600(c)
choleraesuis of this
and chapter.
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.
* * * * * * *
* * * * *

Dated: September 2, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 0421560 Filed 92404; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT George K. Haibel, Center for Veterinary Medicine (HFV6), Food and Drug Administration, 7519 cvm.fda.gov.