[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Rules and Regulations]
[Page 62243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30564]


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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; Clopidol and Bacitracin 
Zinc 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 an abbreviated new animal drug 
application (ANADA) filed by Alpharma Inc. The abbreviated NADA 
provides for using approved clopidol, bacitracin zinc, and roxarsone 
Type A medicated articles to make Type C medicated broiler chicken 
feeds used for prevention of coccidiosis, improved feed efficiency, 
improved pigmentation, and increased rate of weight gain.

EFFECTIVE DATE:  November 21, 1997.

FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, 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 ANADA 200-207 that provides for 
combining approved clopidol, bacitracin zinc, and roxarsone Type A 
medicated articles to make Type C medicated feeds for broilers 
containing clopidol 113.5 grams per ton (g/t) and bacitracin zinc 4 to 
25 g/t with roxarsone 45.4 g/t. The Type C medicated feed is used as an 
aid in the prevention of coccidiosis caused by Eimeria tenella, E. 
necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for 
increased rate of weight gain, improved feed efficiency, and improved 
pigmentation.
    Alpharma Inc.'s ANADA 200-207 is approved as a generic copy of 
Rhone-Poulenc, Inc.'s NADA 44-016. The ANADA is approved as of November 
21, 1997 and 21 CFR 558.175 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, from 
9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) 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.

Sec. 558.175  [Amended]

    2. Section 558.175 Clopidol is amended in paragraph (d)(1)(iii)(b) 
by removing ``No. 000061'' and adding in its place ``Nos. 000061 and 
046573.''

    Dated: November 7, 1997.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 97-30564 Filed 11-20-97; 8:45 am]
BILLING CODE 4160-01-F