[Federal Register Volume 64, Number 95 (Tuesday, May 18, 1999)]
[Rules and Regulations]
[Pages 26844-26845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12393]


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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; Lasalocid and 
Bacitracin Zinc

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 Roche Vitamins, Inc. The NADA provides for the use of 
approved lasalocid Type A medicated articles and bacitracin zinc Type A 
medicated articles in making Type C medicated feed used for the 
prevention of coccidiosis caused by Eimeria meleagrimitis, E. 
gallopavonis, and E. adenoeides, and for increased rate of weight gain 
and improved feed efficiency in growing turkeys.

EFFECTIVE DATE: May 18, 1999.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd., 
Parsippany, NJ 07054-1298, is the sponsor of NADA 141-109 that provides 
for the use of 20 percent of lasalocid Type A medicated articles and 
bacitracin zinc Type A medicated articles containing 50 grams (g) per 
pound bacitracin activity in making Type C medicated feed containing 68 
to 113 g/ton (t) lasalocid and 4 to 50 g/t bacitracin zinc used for the 
prevention of coccidiosis caused by Eimeria meleagrimitis, E. 
gallopavonis, and E. adenoeides and for increased rate of weight gain 
and improved feed efficiency in growing turkeys. The NADA is approved 
as of April 15, 1999, and the regulations are amended in 21 CFR 558.78 
and 558.311 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.

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 558.78 is amended by revising paragraph (d)(3)(xii) to 
read as follows:

Sec. 558.78  Bacitracin zinc.

 * * * * *
    (d) * * *
    (3) * * *
    (xii) Lasalocid sodium alone or with roxarsone as in Sec. 558.311.
 * * * * *
    3. Section 558.311 is amended in the table by revising paragraph 
(e)(1)(xiv) to read as follows:

Sec. 558.311  Lasalocid.

* * * * *

[[Page 26845]]

    (e)(1) * * *

 
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   Lasalocid sodium
 activity in grams per   Combination in grams    Indications for use        Limitations             Sponsor
          ton                   per ton
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  *                    *                    *                    *                    *                    *
                                                             *
(xiv) 68 (0.0075 pct)                           Growing turkeys; for   Feed continuously as        000004
 to 113 (0.0125 pct)                             prevention of          sole ration
                                                 coccidiosis caused
                                                 by E. meleagrimitis,
                                                 E. gallopavonis, and
                                                 E. adenoeides.
                        Bacitracin 4 to 50      Growing turkeys; for   Feed continuously as        063238
                                                 prevention of          sole ration
                                                 coccidiosis caused
                                                 by E. meleagrimitis,
                                                 E. gallopavonis, and
                                                 E. adenoeides; for
                                                 increased rate of
                                                 weight gain and
                                                 improved feed
                                                 efficiency.
  *                    *                    *                    *                    *                    *
                                                             *
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    Dated: April 30, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-12393 Filed 5-17-99; 8:45 am]
BILLING CODE 4160-01-F