[Federal Register Volume 65, Number 175 (Friday, September 8, 2000)]
[Rules and Regulations]
[Pages 54410-54411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23054]


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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; Chlortetracycline and 
Bacitracin Methylene Disalicylate

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 a new animal drug application 
(NADA) filed by Alpharma,

[[Page 54411]]

Inc. The NADA provides for use of approved, single-ingredient 
chlortetracycline (CTC) and bacitracin methylene disalicylate Type A 
medicated articles to make two-way combination Type C medicated feeds 
used for control of porcine proliferative enteropathies (ileitis) and 
for increased rate of weight gain and improved feed efficiency in 
swine.

DATES: This rule is effective September 8, 2000.

FOR FURTHER INFORMATION CONTACT: Diane D. Jeang, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7574.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-059 that provides for use of 
ChlorMaxTM (50, 65, or 70 grams per pound (g/lb) 
chlortetracycline as chlortetracycline hydrochloride) and BMD 
(10, 25, 30, 40, 50, 60, or 75 g/lb bacitracin methylene disalicylate) 
Type A medicated articles to make combination Type C medicated feeds 
for use in growing and finishing swine. The Type C medicated feeds 
contain approximately 400 g/ton CTC (to provide 10 milligrams/lb body 
weight) and 10 to 30 g/ton bacitracin methylene disalicylate, and they 
are used for the control of porcine proliferative enteropathies 
(ileitis) caused byLawsonia intracellularis susceptible to 
chlortetracycline and for increased rate of weight gain and improved 
feed efficiency. The NADA is approved as of July 7, 2000, and the 
regulations in 21 CFR 558.76 are amended to reflect the approval. The 
basis for approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Dockets Management Branch (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.


    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

    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 in paragraph (d)(1) by 
adding an entry under item (iv) to read as follows:


Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (1) * * *

 
------------------------------------------------------------------------
  Bacitracin
  methylene     Combination
 disalicylate  in grams per   Indications for    Limitations    Sponsor
 in grams per       ton             use
     ton
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
(iv)       *                        * * *             * * *          * *
 * *                                                           *
  *                    *                    *                    *
                   *                    *                    *
                              Swine; for        Feed for not   046573
                              control of        more than 14
                              porcine           days;
                              proliferative     chlortetracy
                              enteropathies     cline and
                              (ileitis)         BMD as
                              Lawsonia          provided by
                              intracellularis   046573 in
                              susceptible to    Sec.  510.60
                              chlortetracycli   0(c) of this
                              ne.               chapter.
  *                    *                    *                    *
                   *                    *                    *
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* * * * *

    Dated: August 23, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-23054 Filed 9-7-00; 8:45 am]
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