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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
CFR Citation: 21 CFR Part 558
NOTICE: RULES
ACTION: Animal drugs, feeds, and related products:
DOCUMENT ACTION: Final rule.
SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Monensin, Bacitracin Methylene Disalicylate, and Roxarsone
DATES: This rule is effective March 5, 2001.
DOCUMENT 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, singleingredient monensin and bacitracin methylene disalicylate Type A medicated articles to make twoway 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.
SUMMARY: Monensin, bactracin methylene disalicylate, and roxarsone,
SUPPLEMENTAL INFORMATION
Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141140 that provides for use of COBANIn 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 (HFA305), 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. 801808.
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 558NEW 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. 015220 Filed 3201; 8:45 am]
BILLING CODE 416001F
FOR FURTHER INFORMATION CONTACT Charles J. Andres, Center for Veterinary Medicine (HFV128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018271600.
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