[Federal Register Volume 65, Number 45 (Tuesday, March 7, 2000)]
[Rules and Regulations]
[Pages 11888-11889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5415]


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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; Nicarbazin 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 Koffolk, Inc. The NADA provides for using approved 
nicarbazin and bacitracin zinc Type A medicated articles to make 
combination Type C medicated broiler chicken feeds used for prevention 
of coccidiosis and for increased rate of weight gain and improved feed 
efficiency.

DATES: This regulation is effective March 7, 2000.

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: Koffolk, Inc., P.O. Box 675935, 14735 Las 
Quintas, Rancho Santa Fe, CA 92067, filed NADA 141-146 that provides 
for combining approved Nicarb (113.5 grams per pound (g/lb) 
nicarbazin) manufactured by Koffolk, Inc., and Baciferm (50 
g/lb bacitracin as bacitracin zinc) manufactured by Roche Vitamins, 
Inc., Type A medicated articles to make Type C medicated broiler 
chicken feeds. The Type C broiler feeds contain 113.5 g/ton (t) 
nicarbazin and 4 to 50 g/t bacitracin. The Type C broiler chicken feeds 
are used as an aid in preventing outbreaks of cecal (Eimeria tenella) 
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) 
coccidiosis, and for increased rate of weight gain and improved feed 
efficiency.
    The NADA is approved as of February 2, 2000, and the regulations 
are amended by adding 21 CFR 558.78(d)(3)(xxi) and by amending the 
table in 21 CFR 558.366(c) to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    This approval is for use of Type A medicated articles to make 
combination drug Type C medicated feeds. Nicarbazin is a category II 
drug as defined in 21 CFR 558.3(b)(1)(ii). As provided in 21 CFR 
558.4(b), an approved Form FDA 1900 is required to make a Type C 
medicated feed from a category II drug. Under 21 U.S.C. 360b(m), as 
amended by the Animal Drug Availability Act of 1996 (Public Law 104-
250), medicated feed applications have been replaced by a requirement 
for feedmill licenses. Therefore, use of Type A medicated articles to 
make Type C medicated feeds as provided in NADA 141-146 is limited to 
manufacture in a licensed feedmill.
    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:

[[Page 11889]]

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 adding paragraph (d)(3)(xxi) to 
read as follows:


Sec. 558.78  Bacitracin zinc.

* * * * *
    (d) * * *
    (3) * * *
    (xxi) Nicarbazin as in Sec. 558.366.
    3. Section 558.366 is amended in the table in paragraph (c) under 
the entry for ``113.5 (0.0125 pct)'' by alphabetically adding an entry 
for ``Bacitracin zinc 4 to 50'' to read as follows:


Sec. 558.366  Nicarbazin.

* * * * *
    (c) * * *

 
------------------------------------------------------------------------
 Nicarbazin   Combination
  in grams   in grams per    Indications        Limitations      Sponsor
  per ton         ton          for use
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
113.5                       * * *           * * *                 * * *
 (0.0125
 pct)
  *                    *                    *                    *
                   *                    *                    *
              Bacitracin    Broiler         For broiler           063271
              zinc 4 to     chickens; aid   chickens only. Feed
              50.           in preventing   continuously as
                            outbreaks of    sole ration from
                            cecal           time chicks are
                            (Eimeria        placed on litter
                            tenella) and    until past the time
                            intestinal      when coccidiosis is
                            (E.             ordinarily a
                            acervulina,     hazard. Discontinue
                            E. maxima, E.   medication 4 days
                            necatrix, and   before marketing
                            E. brunetti)    the birds for human
                            coccidiosis,    consumption to
                            and for         allow for
                            increased       elimination of the
                            rate of         drug from edible
                            weight gain     tissue. Do not feed
                            and improved    to laying hens in
                            feed            production.
                            efficiency.     Nicarbazin as
                                            provided by 063271,
                                            bacitracin zinc by
                                            063238.
  *                    *                    *                    *
                   *                    *                    *
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    Dated: February 25, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-5415 Filed 3-6-00; 8:45 am]
BILLING CODE 4160-01-F