[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]]
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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 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
