[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Rules and Regulations]
[Pages 13236-13238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5220]


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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.

[[Page 13237]]


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 and bacitracin methylene disalicylate Type A 
medicated articles to make two-way combination drug Type C medicated 
feeds for broiler and replacement chickens. These combination medicated 
feeds are 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 and improved feed efficiency.

DATES: This rule is effective March 5, 2001.

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 141-140 that provides for use of 
COBAN (45 or 60 grams per pound (g/lb) of monensin activity 
as monensin sodium) and BMD (10, 25, 30, 40, 50, 60, or 75 g/
lb bacitracin methylene disalicylate) Type A medicated articles to make 
combination Type C medicated feeds containing 90 to 110 grams per ton 
(g/ton) monensin and 4 to 50, 50, or 100 to 200 g/ton bacitracin 
methylene disalicylate for use in broiler chickens and replacement 
chickens intended for use as caged layers. The Type C medicated feeds 
containing 90 to 110 g/ton monensin and 4 to 50 g/ton bacitracin 
methylene disalicylate 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; and for increased rate of weight 
gain and improved feed efficiency in replacement chickens intended for 
use as caged layers. The Type C medicated feeds containing 90 to 110 g/
ton monensin and 50 g/ton bacitracin methylene disalicylate are used as 
an aid in the prevention of coccidiosis caused by E. necatrix, E. 
tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as 
an aid in the prevention of necrotic enteritis caused or complicated by 
Clostridium spp. or other organisms susceptible to bacitracin in 
broiler chickens and replacement chickens intended for use as caged 
layers. The Type C medicated feeds containing 90 to 110 g/ton monensin 
and 100 to 200 g/ton bacitracin methylene disalicylate are used as an 
aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, 
E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in 
the control of necrotic enteritis caused or complicated by Clostridium 
spp. or other organisms susceptible to bacitracin in broiler chickens 
and replacement chickens intended for use as caged layers. The NADA is 
approved as of January 2, 2001, and the regulations in 21 CFR 558.355 
are 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 
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 558.355 is amended by adding paragraphs (f)(1)(xxix) and 
(f)(1)(xxx), by redesignating paragraphs (f)(4)(ii), (f)(4)(iii), and 
(f)(4)(iv) as paragraphs (f)(4)(iv), (f)(4)(vi), and (f)(4)(vii), and 
by adding paragraphs (f)(4)(ii), (f)(4)(iii), and (f)(4)(v) to read as 
follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * *
    (1) * * *
    (xxix) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 50 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; and as an aid in the prevention of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. As 
monensin sodium provided by 000986; bacitracin methylene disalicylate 
as provided by 046573 in Sec. 510.600(c) of this chapter.
    (xxx) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 100 to 200 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; and as an aid in the control of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. To 
control necrotic enteritis, start medication at first clinical signs of 
disease; vary 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 per ton). As monensin 
sodium provided by 000986; bacitracin methylene disalicylate as 
provided by 046573 in Sec. 510.600(c) of this chapter.
* * * * *
    (4) * * *
    (ii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 4 to 50 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; for increased rate of weight gain, and improved 
feed efficiency.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. As 
monensin sodium provided by 000986; bacitracin methylene disalicylate 
as provided by 046573 in Sec. 510.600(c) of this chapter.
    (iii) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 50 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by

[[Page 13238]]

E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. 
maxima; and as an aid in the prevention of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. As 
monensin sodium provided by 000986; bacitracin methylene disalicylate 
as provided by 046573 in Sec. 510.600(c) of this chapter.
* * * * *
    (v) Amount per ton. Monensin, 90 to 110 grams; plus bacitracin 
methylene disalicylate, 100 to 200 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; and as an aid in the control of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
chickens over 16 weeks of age. Do not feed to laying chickens. To 
control necrotic enteritis, start medication at first clinical signs of 
disease; vary 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 per ton). As monensin 
sodium provided by 000986; bacitracin methylene disalicylate as 
provided by 046573 in Sec. 510.600(c) of this chapter.
* * * * *

    Dated: February 12, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-5220 Filed 3-2-01; 8:45 am]
BILLING CODE 4160-01-F