[Federal Register Volume 64, Number 79 (Monday, April 26, 1999)]
[Rules and Regulations]
[Pages 20163-20164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10291]


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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 Roxarsone

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, a Division of Eli Lilly and Co. 
The NADA provides for combining approved narasin/nicarbazin (1:1 fixed 
ratio) and roxarsone type A medicated articles to make combination drug 
type C medicated broiler chicken feeds for prevention of coccidiosis, 
for increased rate of weight gain, improved feed efficiency, and 
improved pigmentation.

EFFECTIVE DATE: April 26, 1999.
FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, a Division of Eli 
Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
NADA 141-113 that provides for combining approved narasin/nicarbazin 
(1:1 fixed ratio, 27 grams per pound (g/lb) each) (Maxiban) 
and roxarsone (45.4, 90, and 227 g/lb) (3-Nitro) type A 
medicated articles to make combination drug type C medicated broiler 
chicken feeds. The type C feeds contain 27 to 45 g/ton each of narasin 
and nicarbazin and 22.7 to 45.4 g/ton roxarsone. The type C broiler 
feeds are used for 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, improved feed efficiency, and 
improved pigmentation. The NADA is approved as of March 4, 1999, and 
the regulations are amended in 21 CFR 558.363, 558.366, and 558.530 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. These ingredients are 
Category II drugs 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 type 
B or C medicated feeds as in this application. Under section 512(m) of 
the Federal Food, Drug, and Cosmetic 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 roxarsone type A medicated articles to make type C 
medicated feeds as in NADA 141-113 is limited to manufacture in a 
licensed feed mill.
     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

[[Page 20164]]

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 558.363 is amended by adding paragraph (d)(2)(iv) to 
read as follows:


Sec. 558.363   Narasin.

* * * * *
     (d) * * *
     (2) * * *
     (iv) Nicarbazin and roxarsone as in Sec. 558.366.
     3. Section 558.366 is amended in the table in paragraph (c) under 
entry ``27 to 45'' by alphabetically adding an entry ``Narasin 27 to 45 
and roxarsone 22.7 to 45.4'' to read as follows:


Sec. 558.366   Nicarbazin.

* * * * *
     (c) * * *

 
----------------------------------------------------------------------------------------------------------------
 Nicarbazin in grams    Combination in grams
       per ton                per ton          Indications for use        Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
27 to 45
  *                    *                    *                    *                    *                    *
                                                             *
                       Narasin 27 to 45 and   Broiler chickens; for   Feed continuously as  000986
                        roxarsone 22.7 to      prevention of          sole ration. Use as
                        45.4.                  coccidiosis caused     sole source of
                                               by Eimeria tenella,    organic arsenic.
                                               E. necatrix, E.        Withdraw 5 days
                                               acervulina, E.         before slaughter. Do
                                               maxima, E. brunetti,   not allow turkeys,
                                               and  E. mivati; for    horses or other
                                               increased rate of      equines access to
                                               weight gain,           formulations
                                               improved feed          containing narasin.
                                               efficiency, and        Ingestion of narasin
                                               improved               by these species has
                                               pigmentation.          been fatal. Do not
                                                                      feed to laying hens.
                                                                      Use as sole source
                                                                      of organic arsenic.
                                                                      Narasin and
                                                                      nicarbazin as
                                                                      provided by 000986,
                                                                      roxarsone by 046573.
 *                      *                      *                      *                      *
----------------------------------------------------------------------------------------------------------------

     4. Section 558.530 is amended by adding paragraph (d)(5)(xxvi) to 
read as follows:


Sec. 558.530   Roxarsone.

* * * * *
     (d) * * *
     (5) * * *
     (xxvi) Narasin and nicarbazin as in Sec. 558.366.
* * * * *

    Dated: April 9, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-10291 Filed 4-23-99; 8:45 am]
BILLING CODE 4160-01-F