[Federal Register: September 29, 1998 (Volume 63, Number 188)]
[Rules and Regulations]
[Page 51823-51824]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se98-19]

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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 Bacitracin
Methylene Disalicylate 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 supplemental new animal drug
application (NADA) filed by Alpharma Inc. The supplemental NADA
provides for using approved narasin, bacitracin methylene disalicylate
(BMD), and roxarsone Type A medicated articles to make Type C medicated
broiler chicken feeds.

EFFECTIVE DATE: September 29, 1998

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1602.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, is sponsor of supplemental NADA 140-852 which
provides for combining approved Monteban<Register> (45 grams per pound
(g/lb) narasin), BMD<Register> (10, 25, 30, 40, 50, 60, or 75 g/lb
bacitracin methylene disalicylate), and 3-Nitro<Register> (45.4, 90, or
227 g/lb roxarsone) Type A medicated articles to make Type C medicated
broiler chicken feeds. The Type C medicated broiler chicken feed
containing 54 to 72 g/t narasin, 50 g/t bacitracin methylene
disalicylate, and 22.7 to 45.4 g/t roxarsone is used for prevention of
coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E.
brunetti, E. mivati, and E. maxima, as an aid in the prevention of
necrotic enteritis caused or complicated by Clostridium spp. or other
organisms susceptible to bacitracin, and for increased rate of weight
gain, improved feed efficiency, and improved pigmentation. The Type C
medicated broiler chicken feed containing 54 to 72 g/t narasin, 100 to
200 g/t bacitracin methylene disalicylate, and 22.7 to 45.4 g/t
roxarsone is used for prevention of coccidiosis caused by Eimeria
necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E.
maxima, as an aid in the control of necrotic enteritis caused or
complicated by Clostridium spp. or other organisms susceptible to
bacitracin, and for increased rate of weight gain, improved feed
efficiency, and improved pigmentation.
    The supplemental NADA is approved as of July 29, 1998, and the
regulations are amended by adding 21 CFR 558.363(a)(6), (d)(1)(viii),
and (d)(1)(ix) to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
    This approval is for use of single ingredient Type A medicated
articles to make combination drug Type C medicated feeds. One
ingredient, roxarsone, 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 Type C medicated feed from a Category II drug.
Under section 512(m) of 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 feed mill
licenses. Therefore, use of Type A medicated articles to make Type C
medicated feeds as provided in supplemental NADA 140-852 is limited to
manufacture in a licensed feed mill.
    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 supplemental
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) 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
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 paragraphs (a)(6),
(d)(1)(viii), and (d)(1)(ix) to read as follows:

Sec. 558.363   Narasin.

    (a) * * *
    (6) To 046573: 45 grams per pound with 10, 25, 30, 40, 50, 60, or
75 grams per pound bacitracin methylene disalicylate and 45.4, 90, or
227 grams per pound roxarsone, paragraphs (d)(1)(viii) and (d)(1)(ix)
of this section.
* * * * *
    (d) * * *
    (1) * * *
    (viii) Amount per ton. Narasin, 54 to 72 grams, and bacitracin
methylene disalicylate, 50 grams, with roxarsone, 22.7 to 45.4 grams.
    (A) Indications for use. For prevention of coccidiosis caused by
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and E. maxima, as an aid in the prevention of necrotic enteritis caused
or complicated by Clostridium spp. or other organisms susceptible to
bacitracin, and for increased rate of weight gain, improved feed
efficiency, and improved pigmentation.
    (B) Limitations. For broiler chickens only. Feed continuously as
sole ration. Withdraw 5 days before slaughter. Do not feed to laying
hens. Do not allow adult turkeys, horses, or other equines access to
narasin formulations. Ingestion of narasin by these species has been
fatal. Use as sole source of organic arsenic. Poultry should have
access to drinking water at all times. Drug overdose or lack of water
intake may result in leg weakness or paralysis. Narasin as provided by
000986, bacitracin methylene disalicylate and roxarsone by 046573 in
Sec. 510.600(c) of this chapter.
    (ix) Amount per ton. Narasin, 54 to 72 grams, and bacitracin
methylene disalicylate, 100 to 200 grams, with roxarsone, 22.7 to 45.4
grams.
    (A) Indications for use. For prevention of coccidiosis caused by
Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and E. maxima, as an aid in the control of necrotic enteritis caused or
complicated by Clostridium spp. or other organisms susceptible to
bacitracin, and for increased rate of weight gain, improved feed
efficiency, and improved pigmentation.
    (B) Limitations. For broiler chickens only. Feed continuously as
sole ration. Withdraw 5 days before slaughter. Do

[[Page 51824]]

not feed to laying hens. Do not allow adult turkeys, horses, or other
equines access to narasin formulations. Ingestion of narasin by these
species has been fatal. Use as sole source of organic arsenic. Poultry
should have access to drinking water at all times. Drug overdose or
lack of water intake may result in leg weakness or paralysis. Narasin
as provided by 000986, bacitracin methylene disalicylate and roxarsone
by 046573 in Sec. 510.600(c) of this chapter.

    Dated: August 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-25913 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F