[Federal Register Volume 63, Number 207 (Tuesday, October 27, 1998)]
[Rules and Regulations]
[Pages 57248-57249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28634]


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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 Nicarbazin 
With Lincomycin

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 Elanco Animal Health, Division of Eli Lilly and Co. The 
NADA provides for combining approved narasin, nicarbazin, and 
lincomycin Type A medicated articles to make combination drug Type C 
medicated broiler chicken feeds for prevention of certain forms of 
coccidiosis and for increased rate of weight gain and improved feed 
efficiency.

EFFECTIVE DATE: October 27, 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: Elanco Animal Health, a Division of Eli 
Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
NADA 140-947 that provides for combining approved narasin, nicarbazin, 
and lincomycin Type A medicated articles to make combination drug Type 
C medicated broiler chicken feeds containing 27 to 45 grams per ton (g/
t) narasin, 27 to 45 g/t nicarbazin, and 2 to 4 g/t lincomycin. The 
Type C medicated broiler chicken feed is used for the prevention of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
maxima, E. brunetti, and E. mivati, and for increased rate of weight 
gain and improved feed efficiency. The NADA is approved as of September 
3, 1998, and the regulations are amended in 21 CFR 558.325, 558.363, 
and 558.366 to reflect the approval.
    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.
    This approval is for use of approved Type A medicated articles to 
make combination drug Type C medicated feeds. One ingredient, 
nicarbazone, 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 for making a Type B or C medicated feed as in this 
application. Under section 512(m) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(m)), as amended by the Animal 
Drug Availability Act of 1996 (Pub. L. 104-250), medicated feed 
applications have been replaced by a requirement for manufacture in a 
licensed feed mill. Therefore, use of narasin, nicarbazin, and 
lincomycin Type A medicated articles to make Type C medicated feeds as 
provided in NADA 140-947 requires a licensed feed mill.
    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 
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 558.325 is amended by revising paragraph (c)(3)(xii) to 
read as follows:


Sec. 558.325  Lincomycin.

 * * * * *
    (c) *  *  *
    (3) *  *  *
    (xii) Nicarbazin with or without narasin as in Sec. 558.366.
 * * * * *
    3. Section 558.363 is amended by revising paragraph (d)(2) to read 
as follows:


Sec. 558.363  Narasin.

 * * * * *
    (d) * * *
    (2) Narasin may also be used for broilers in combination with:
    (i) Nicarbazin with lincomycin as in Sec. 558.366.
    (ii) [Reserved]
    4. Section 558.366 is amended in the table in paragraph (c) by 
revising the entry for ``27 to 45''to read as follows:


Sec. 558.366  Nicarbazin.

 * * * * *
    (c) *  *  *

[[Page 57249]]



----------------------------------------------------------------------------------------------------------------
Nicarbazin in grams   Combination in grams
      per ton                per ton            Indications for use            Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
27 to 45             Narasin 27 to 45        Broiler chickens;          Sec. 558.363(d)(1)(iii)    000986
                                              prevention of
                                              coccidiosis caused by
                                              Eimeria tenella, E.
                                              necatrix, E. acervulina,
                                              E. maxima, E. brunetti,
                                              E. mivati.
                     Narasin 27 to 45 and    Broiler chickens;          Feed continuously as       000986
                      Lincomycin 2 to 4       prevention of              sole ration. Withdraw 5
                                              coccidiosis caused by      days before slaughter.
                                              Eimeria tenella, E.        Do not allow turkeys,
                                              necatrix, E. acervulina,   horses, or other
                                              E. maxima, E. brunetti,    equines access to
                                              E. mivati; for increased   formulations containing
                                              rate of weight gain and    narasin. Ingestion of
                                              improved feed              narasin by these
                                              efficiency.                species has been fatal.
                                                                         Do not feed to laying
                                                                         hens. Do not allow
                                                                         rabbits, hamsters,
                                                                         guinea pigs, horses, or
                                                                         ruminants access to
                                                                         feeds containing
                                                                         lincomycin. Ingestion
                                                                         by these species may
                                                                         result in severe
                                                                         gastrointestinal
                                                                         effects. Narasin and
                                                                         nicarbazin as provided
                                                                         by 000986, lincomycin
                                                                         by 000009.
  *                    *                    *                    *                    *                    *
                                                             *
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    Dated: October 5, 1998.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 98-28634 Filed 10-26-98; 8:45 am]
BILLING CODE 4160-01-F