[Federal Register Volume 69, Number 159 (Wednesday, August 18, 2004)]
[Rules and Regulations]
[Pages 51172-51173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18845]


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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 and Chlortetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 
bacitracin methylene disalicylate and chlortetracycline to make two-way 
combination drug Type B and Type C medicated feeds for swine.

DATES: This rule is effective August 18, 2004.

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 200-358 for use of PENNCHLOR 
(chlortetracycline) and BMD (bacitracin methylene disalicylate) Type A 
medicated articles to make two-way combination drug Type B and Type C 
medicated feeds for swine. Pennfield Oil Co.'s ANADA 200-358 is 
approved as a generic copy of Alpharma, Inc.'s new animal drug 
application 141-059. 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 
(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 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.

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.

* * * * *
    (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.
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[[Page 51173]]

 
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    Dated: August 2, 2004.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 04-18845 Filed 8-17-04; 8:45 am]
BILLING CODE 4160-01-S