[Federal Register Volume 69, Number 186 (Monday, September 27, 2004)]
[Rules and Regulations]
[Pages 57638-57639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21560]


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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; Bacitracin Methylene 
Disalicylate; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

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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 single-ingredient 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.

DATES: This rule is effective September 27, 2004.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4567, e-mail: ghaibel@ 
cvm.fda.gov.

SUPPLEMENTARY 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.

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

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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.

0
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.

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[[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.
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                              * * * * * * *
 
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    Dated: September 2, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-21560 Filed 9-24-04; 8:45 am]
BILLING CODE 4160-01-S