[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) * * *
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Nicarbazin in grams Combination in grams
per ton per ton Indications for use Limitations Sponsor
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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.
* * * * *
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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