[Federal Register Volume 70, Number 10 (Friday, January 14, 2005)]
[Rules and Regulations]
[Pages 2567-2568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-789]


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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

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 two supplemental new animal 
drug applications (NADAs) filed by Alpharma Inc. The supplemental NADAs 
provide for the use of single-ingredient decoquinate and 
chlortetracycline Type A medicated articles to make two-way Type B and 
Type C medicated feeds for cattle at a broader range of concentrations.

DATES: This rule is effective January 14, 2005.

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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Drive, P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to NADA 141-147 for use of 
DECCOX (decoquinate) and CHLORMAX (chlortetracycline) Type A medicated 
articles to make two-way Type B and Type C medicated feeds for cattle 
at the broader range of concentrations. Alpharma Inc. also filed a 
supplement to NADA 141-185 for use of DECCOX and AUREOMYCIN 
(chlortetracycline) Type A medicated articles for the same revised 
conditions of use. The supplemental applications are approved as of 
December 16, 2004, and the regulations are amended in 21 CFR 558.195 to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summaries.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications 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)(1) that these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor 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 558.195 is amended by redesignating paragraphs (e)(2)(ii), 
(e)(2)(iii), and (e)(2)(iv) as paragraphs (e)(2)(vi), (e)(2)(iv), and 
(e)(2)(iii) respectively; and by adding new paragraphs (e)(2)(ii) and 
(e)(2)(vii) to read as follows:


Sec.  558.195  Decoquinate.

* * * * *
    (e) * * *
* * * * *
    (2) Cattle.

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  Decoquinate in    Combination in
    grams/ton          grams/ton        Indications for use                 Limitations                Sponsor
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                                                  * * * * * * *
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(ii) 12.9 to 90.8  Chlortetracyclin  Calves, beef, and          Feed Type C feed to provide 22.7 mg       046573
                    e 500 to 4,000.   nonlactating dairy         decoquinate and 1 gram
                                      cattle: As in paragraph    chlortetracycline per 100 lb body
                                      (e)(2)(i) of this          weight per day for not more than 5
                                      section; for treatment     days. When consumed, feed 22.7 mg
                                      of bacterial enteritis     decoquinate per 100 lb body weight/
                                      caused by Escherichia      day for a total of 28 days to
                                      coli; and for treatment    prevent coccidiosis. Withdraw 24
                                      of bacterial pneumonia     hours prior to slaughter when
                                      caused by Pasteurella      manufactured from CTC
                                      multocida organisms        (chlortetracycline) Type A
                                      susceptible to             medicated articles under NADA 141-
                                      chlortetracycline.         147. Zero withdrawal time when
                                                                 manufactured from AUREOMYCIN
                                                                 (chlortetracycline) Type A
                                                                 medicated articles under NADA 141-
                                                                 185. A withdrawal period has not
                                                                 been established for this product
                                                                 in preruminating calves. Do not
                                                                 use in calves to be processed for
                                                                 veal. Do not feed to animals
                                                                 producing milk for food.
                                                                 Chlortetracycline as provided by
                                                                 No. 046573 in Sec.   510.600(c) of
                                                                 this chapter.
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[[Page 2568]]

 
                                                  * * * * * * *
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(vii) 90.9 to      Chlortetracyclin  Calves, beef, and          Feed Type C medicated feed                046573
 535.7              e 4,000 to        nonlactating dairy         supplements as a top dress or mix
                    20,000.           cattle: As in paragraph    into the daily ration to provide
                                      (e)(2)(i) of this          22.7 mg decoquinate and 1 gram
                                      section; for treatment     chlortetracycline per 100 lb body
                                      of bacterial enteritis     weight per day for not more than 5
                                      caused by Escherichia      days. When consumed, feed 22.7 mg
                                      coli; and for treatment    decoquinate per 100 lb body weight
                                      of bacterial pneumonia     per day for a total of 28 days to
                                      caused by Pasteurella      prevent coccidiosis. Withdraw 24
                                      multocida organisms        hours prior to slaughter when
                                      susceptible to             manufactured from CTC
                                      chlortetracycline.         (chlortetracycline) Type A
                                                                 medicated articles under NADA 141-
                                                                 147. Zero withdrawal time when
                                                                 manufactured from AUREOMYCIN
                                                                 (chlortetracycline) Type A
                                                                 medicated articles under NADA 141-
                                                                 185. A withdrawal period has not
                                                                 been established for this product
                                                                 in preruminating calves. Do not
                                                                 use in calves to be processed for
                                                                 veal. Do not feed to animals
                                                                 producing milk for food.
                                                                 Chlortetracycline as provided by
                                                                 No. 046573 in Sec.   510.600(c) of
                                                                 this chapter.
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* * * * *

    Dated: January 7, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-789 Filed 1-13-05; 8:45 am]
BILLING CODE 4160-01-S