[Federal Register Volume 65, Number 180 (Friday, September 15, 2000)]
[Rules and Regulations]
[Pages 55893-55894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23799]


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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; Narasin 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 use of 
approved narasin and bacitracin zinc Type A medicated articles to make 
two-way combination 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 September 15, 2000.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV128), 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, filed NADA 140-865 that provides for use of 
Monteban (36, 45, 54, 72, or 90 grams per pound (g/lb) 
narasin activity) and Baciferm (10, 25, 40, or 50 g/lb 
bacitracin activity as bacitracin zinc) Type A medicated articles to 
make two-way combination Type C medicated feeds for broiler chickens. 
The combination Type C medicated feeds contain 54 to 72 g/ton narasin 
and 4 to 50 g/ton bacitracin zinc and are used for prevention of 
coccidiosis caused by Eimeria necatrix, E. tenella, 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 August 7, 2000, and the regulations are amended in 
Secs. 558.78 and 558.363 (21 CFR 558.78 and 558.363) to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.

[[Page 55894]]

    Section 558.78 is also amended editorially to consolidate the 
cross-references for approved combinations in paragraph (d)(3) and list 
them in alphabetical order.
    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 
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) to read 
as follows:


Sec. 558.78  Bacitracin zinc.

* * * * *
    (d) * * *
    (3) It may be used as approved in combination with:
    (i) Amprolium alone and with roxarsone as in Sec. 558.55.
    (ii) Amprolium and ethopabate alone and with roxarsone as in 
Sec. 558.58.
    (iii) Carbarsone as in Sec. 558.120.
    (iv) Clopidol alone and with roxarsone as in Sec. 558.175.
    (v) Decoquinate alone and with roxarsone as in Sec. 558.195.
    (vi) Hygromycin B alone and with penicillin as in Sec. 558.274.
    (vii) Lasalocid sodium alone or with roxarsone as in Sec. 558.311.
    (viii) Monensin alone and with roxarsone as in Sec. 558.355.
    (ix) Naracin as in Sec. 558.363.
    (x) Robenidine as in Sec. 558.515.
    (xi) Salinomycin alone and with roxarsone as in Sec. 558.550.
    (xii) Zoalene alone and with arsanilic acid or roxarsone as in 
Sec. 558.680.

    3. Section 558.363 is amended by adding paragraphs (a)(7) and 
(d)(1)(x) to read as follows:


Sec. 558.363  Narasin.

    (a) * * *
    (7) To 063238: 36, 45, 54, 72, or 90 grams per pound, with 10, 25, 
40, or 50 grams per pound bacitracin zinc, paragraph (d)(1)(x) of this 
section.
* * * * *
    (d) * * *
    (1) * * *
    (x) Amount per ton. Narasin, 54 to 72 grams and bacitracin zinc, 4 
to 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused 
by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, 
and E. maxima, and for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Do not allow adult turkeys, horses, or other equines 
access to formulations containing narasin. Ingestion of narasin by 
these species has been fatal. Narasin as provided by 000986, bacitracin 
zinc by 063238 in Sec. 510.600(c) of this chapter.
* * * * *

    Dated: August 5, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-23799 Filed 9-14-00; 8:45 am]
BILLING CODE 4160-01-F