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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; Lasalocid and Bacitracin Zinc
DATES: This rule is effective May 29, 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 lasalocid and bacitracin zinc Type A medicated articles to make twoway combination drug Type C medicated feeds used for prevention of coccidiosis, increased rate of weight gain, and improved feed efficiency in broiler chickens.
SUMMARY: Lasalocid and bacitracin zinc,
SUPPLEMENTAL INFORMATION
Alpharma Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141083 that provides for use of AvatecIn 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.
FDA 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 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 558.311 is amended in paragraph (e)(1) in the table by
redesignating paragraphs (e)(1)(xi) through (e)(1)(xvi) as paragraphs
(e)(1)(xii) through (e)(1)(xvii), respectively, and by adding new paragraph (e)(1)(xi) to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(1) * * *
Lasalocid sodium
activity in Combination in Indications for use Limitations Sponsor grams per ton grams per ton
* * * * * * *
(xi) 68 (0.0075 Bacitracin zinc 4 Broiler chickens. For Feed continuously as sole 046573
pct) to 113 to 50. prevention of coccidiosis ration. Bacitracin zinc and
(0.0125 pct). caused by Eimeria tenella, lasalocid sodium as provided
E. necatrix, E. acervulina, by No. 046573 in Sec.
E. brunetti, E. mivati, and 510.600(c) of this chapter.
E. maxima, and for increased
rate of weight gain and
improved feed efficiency.
* * * * * * * [[Page 29021]]
* * * * *
Dated: May 15, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 0113300 Filed 52501; 8:45 am]
BILLING CODE 416001S
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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