[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51824-51825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25911]


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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 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 a new animal drug application 
(NADA) filed by Alpharma Inc. The NADA provides for using approved 
bacitracin methylene disalicylate (BMD) and decoquinate Type A 
medicated articles to make Type C medicated broiler chicken feeds used 
for prevention of coccidiosis, and for increased rate of weight gain 
and improved feed efficiency.

EFFECTIVE DATE:  September 29, 1998.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1600.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Drive, P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-102 that provides for 
combining approved BMD (10, 25, 30, 40, 50, 60, or 75 grams 
per pound (g/lb) BMD), and Deccox (6 percent decoquinate) 
Type A medicated articles to make Type C medicated feeds for broiler 
chickens containing 4 to 50 grams per ton (g/t) BMD and 27.2 g/t 
decoquinate. The Type C medicated broiler feed is used for the 
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. 
mivati, E. acervulina, E. maxima, and E. brunetti, and for increased 
rate of weight gain and improved feed efficiency. The NADA is approved 
as of August 3, 1998, and the regulations in 21 CFR 558.76(d)(3) and 
the table in 21 CFR 558.195(d) 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.
    FDA 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.

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 558.76 is amended by adding paragraph (d)(3)(xviii) to 
read as follows:

Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) * * *
    (xviii) Decoquinate as in Sec. 558.195.
    3. Section 558.195 is amended in the table in paragraph (d) by 
adding an entry under ``27.2(0.003 pct)'' before the entry for 
``Bacitracin 10 to 50'' to read as follows:


Sec. 558.195  Decoquinate.

* * * * *
    (d) * * *

----------------------------------------------------------------------------------------------------------------
Decoquinate   Combination
  in grams    in grams per         Indications for use                    Limitations                 Sponsor
  per ton         ton
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *
                                                             *
27.2 (0.003
 pct)
  *                    *                    *                    *                    *                    *
                                                             *
             Bacitracin 4   Broiler chickens; for the          Do not feed to laying chickens;     046573
              to 50          prevention of coccidiosis caused   feed continuously as sole
                             by Eimeria tenella, E. necatrix,   ration; bacitracin methylene
                             E. mivati, E. acervulina, E.       disalicylate as provided by
                             maxima, and E. brunetti, and for   046573 in Sec.  510.600(c) of
                             increased rate of weight gain      this chapter.
                             and improved feed efficiency.
  *                    *                    *                    *                    *                    *
                                                             *
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[[Page 51825]]

    Dated: August 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-25911 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F