[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Rules and Regulations]
[Pages 29020-29021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13300]


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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 Alpharma, Inc. The NADA provides for use of approved 
lasalocid and bacitracin zinc Type A medicated articles to make two-way 
combination drug Type C medicated feeds used for prevention of 
coccidiosis, increased rate of weight gain, and improved feed 
efficiency in broiler chickens.

DATES: This rule is effective May 29, 2001.

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: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-083 that provides for use of 
Avatec<Register> (90.7 grams per pound (g/lb) lasalocid as lasalocid 
sodium) and Baciferm<Register> (50 g/lb bacitracin zinc) Type A 
medicated articles to make two-way combination drug Type C medicated 
chicken feeds. The combination Type C medicated feeds are used for 
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. 
acervulina, E. brunetti, E. mivati, and E. maxima, and for increased 
rate of weight gain and improved feed efficiency in broiler chickens. 
The NADA is approved as of April 18, 2001, and the regulations are 
amended in 21 CFR 558.311 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.
    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.
    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 558.311 is amended in paragraph (e)(1) in the table by 
redesignating paragraphs (e)(1)(xi) through (e)(1)(xvi) as paragraphs 
(e)(1)(xii) through (e)(1)(xvii), respectively, and by adding new 
paragraph (e)(1)(xi) to read as follows:


Sec. 558.311   Lasalocid.

* * * * *
    (e) *  *  *  
    (1) *  *  *  

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Lasalocid sodium
   activity in      Combination in        Indications for use                Limitations              Sponsor
  grams per ton     grams per ton
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   *                *                *                *                *                *                    *
(xi) 68 (0.0075   Bacitracin zinc 4  Broiler chickens. For          Feed continuously as sole      046573
 pct) to 113       to 50.             prevention of coccidiosis      ration. Bacitracin zinc and
 (0.0125 pct).                        caused by Eimeria tenella,     lasalocid sodium as provided
                                      E. necatrix, E. acervulina,    by No. 046573 in Sec.
                                      E. brunetti, E. mivati, and    510.600(c) of this chapter.
                                      E. maxima, and for increased
                                      rate of weight gain and
                                      improved feed efficiency.
 
   *                *                *                *                *                *                    *
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[[Page 29021]]

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    Dated: May 15, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-13300 Filed 5-25-01; 8:45 am]
BILLING CODE 4160-01-S