[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51823-51824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25913]


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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 (45 grams per pound 
(g/lb) narasin), BMD (10, 25, 30, 40, 50, 60, or 75 g/lb 
bacitracin methylene disalicylate), and 3-Nitro (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