[Federal Register Volume 65, Number 172 (Tuesday, September 5, 2000)]
[Rules and Regulations]
[Pages 53583-53584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22620]


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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; Monensin, Bacitracin 
Methylene Disalicylate, and 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 Alpharma, Inc. The NADA provides for use of approved, 
single-ingredient monensin, bacitracin methylene disalicylate (BMD), 
and roxarsone Type A medicated articles to make three-way combination 
drug Type C medicated feed used as an aid in the prevention of 
coccidiosis, as an aid in the prevention and control of necrotic 
enteritis, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation in replacement chickens.

DATES: This rule is effective September 5, 2000.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-138 that provides for use of 
Coban (45 or 60 grams per pound (g/lb) of monensin as 
monensin sodium), BMD (10, 25, 30, 40, 50, 60, or 75 g/lb BMD), and 3-
Nitro (45.4, 90, 227, or 360 g/lb roxarsone) Type A medicated 
articles to make combination Type C medicated feeds for replacement 
chickens intended for use as caged layers. The Type C medicated feeds 
contain 90 to 110 g/ton monensin, 50 or 100 to 200 g/ton BMD, and 22.7 
to 45.4 g/ton roxarsone and are used as an aid in the prevention of 
coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. 
brunetti, E. mivati, and E. maxima; as an aid in the prevention (at 50 
g/ton BMD) or control (at 100 to 200 g/ton BMD) 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 NADA is 
approved as of June 28, 2000, and 21 CFR 558.355 is amended to reflect 
the approval. The basis for approval is discussed in the freedom of 
information summary.
    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.
    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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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 558.355 is amended by redesignating paragraphs 
(f)(4)(ii) and (f)(4)(iii) as paragraphs (f)(4)(i)(a) and (f)(4)(i)(b), 
and by adding new paragraphs (f)(4)(ii) and (f)(4)(iii) to read as 
follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * *
    (4) * * *
    (ii) Amount per ton. Monensin, 90 to 110 grams; bacitracin 
methylene disalicylate, 50 grams; plus roxarsone, 22.7 to 45.4 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. 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. Feed continuously as sole ration. Do not feed to 
laying chickens. Use as sole source of organic arsenic. Do not feed to 
chickens over 16 weeks of age. Poultry should have access to drinking 
water at all times. Drug overdosage or lack of water may result in leg 
weakness or paralysis. Withdraw 5 days before slaughter. As monensin 
sodium provided by 000986; bacitracin methylene disalicylate and 
roxarsone as provided by 046573 in Sec. 510.600(c) of this chapter.
    (iii) Amount per ton. Monensin, 90 to 110 grams; bacitracin 
methylene disalicylate, 100 to 200 grams; plus roxarsone, 22.7 to 45.4 
grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by E. 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. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of 
disease; vary bacitracin dosage based on the severity of infection; 
administer continuously for 5 to 7 days or as long as clinical signs 
persist, then reduce bacitracin to prevention level (50 grams/ton). Do 
not feed to laying chickens. Use as sole source of organic arsenic. Do 
not feed to chickens over 16 weeks of age. Poultry should have access 
to drinking water at all times. Drug overdosage or lack of water may 
result in leg weakness or paralysis. Withdraw 5 days before slaughter. 
As monensin sodium provided by 000986; bacitracin methylene 
disalicylate and roxarsone as

[[Page 53584]]

provided by 046573 in Sec. 510.600(c) of this chapter.
* * * * *

    Dated: August 24, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-22620 Filed 9-1-00; 8:45 am]
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