[Federal Register Volume 65, Number 216 (Tuesday, November 7, 2000)]
[Rules and Regulations]
[Pages 66620-66621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28524]


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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; Decoquinate and 
Chlortetracycline

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, Inc. The NADA provides for use of approved 
decoquinate and chlortetracycline (CTC) Type A medicated articles to 
make two-way combination Type B and Type C medicated feeds for calves, 
beef and nonlactating dairy cattle used for prevention of coccidiosis, 
treatment of bacterial enteritis, and treatment of bacterial pneumonia.

DATES: This rule is effective November 7, 2000.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-147 that provides for use of 
Deccox<Register> (27.2 grams per pound g/lb) and ChlorMax<SUP>TM</SUP> 
(50, 65, or 70 g/lb CTC) Type A medicated articles to make combination 
drug Type B and Type C medicated feeds for calves, beef and 
nonlactating dairy cattle. The combination Type C feeds are for 
prevention of coccidiosis caused by Eimeria bovis and E. zuernii, for 
treatment of bacterial enteritis caused by Escherichia coli, and for 
treatment of bacterial pneumonia caused by Pasteurella multocida 
organisms susceptible to CTC. The NADA is approved as of September 29, 
2000, and the regulations are amended in the table in 21 CFR 558.195(d) 
to reflect the approval. The basis of 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 
the 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 558.195 is amended in the table in paragraph (d) by 
adding an entry following the indication for ``Cattle'' at the 13.6 to 
27.2 grams per ton decoquinate dose level and before the entry for 
``Cattle'' at the 13.6 to 535.7 grams per ton dose level, to read as 
follows:


Sec. 558.195  Decoquinate.

* * * * *
    (d) * * *

[[Page 66621]]



 
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  Decoquinate in    Combination in grams per
  grams per ton               ton                         Indications for use                              Limitations                       Sponsor
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            *                    *                    *                    *                    *                    *                    *
                   Chlortetracycline          Calves, beef and nonlactating dairy cattle:  Feed Type C feed to provide 22.7 mg          046573
                    approximately 400,         prevention of coccidiosis caused by          decoquinate and 1 g chlortetracycline/100
                    varying with body weight   Eimeria bovis and E. zuernii, for            lb body weight (0.5 mg/kg)/day for not
                    and feed consumption to    treatment of bacterial enteritis caused by   more than 5 days. Type C feed may be
                    provide 10 mg/lb of body   Escherichia coli, and for treatment of       prepared from Type B feed containing 535.8
                    weight per day.            bacterial pneumonia caused by Pasteurella    to 5,440 g/ton decoquinate and 6,700 to
                                               multocida organisms susceptible to           80,000 g/ton chlortetracycline. When
                                               chlortetracycline.                           consumed, feed 22.7 mg decoquinate/100 lb
                                                                                            body weight/day for a total of 28 days to
                                                                                            prevent coccidiosis. Withdraw 24 hours
                                                                                            prior to slaughter. Do not feed to calves
                                                                                            to be processed for veal. Do not feed to
                                                                                            animals producing milk for food.
            *                    *                    *                    *                    *                    *                    *
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    Dated: October 26, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-28524 Filed 11-6-00; 8:45 am]
BILLING CODE 4160-01-F