[Federal Register Volume 62, Number 224 (Thursday, November 20, 1997)]
[Rules and Regulations]
[Pages 61911-61912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30408]


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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

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 ANADA provides for using 
approved clopidol and bacitracin zinc Type A medicated articles to make 
Type C medicated broiler chicken feeds used for prevention of 
coccidiosis, improved feed efficiency, and increased rate of weight 
gain.

EFFECTIVE DATE: November 20, 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 200-218 that provides for 
combining approved clopidol and bacitracin zinc Type A medicated 
articles to make Type C medicated feeds for broilers containing 
clopidol 113.5 grams per ton (g/t) and bacitracin zinc 5 to 25 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 and improved feed efficiency.
    Alpharma Inc.'s ANADA 200-218 is approved as a generic copy of 
Rhone-

[[Page 61912]]

Poulenc, Inc.'s NADA 49-934. The ANADA is approved as of November 20, 
1997 and the regulations are amended in Sec. 558.175 (21 CFR 558.175) 
to reflect the approval. The basis for approval is discussed in the 
freedom of information summary.
    In addition, Sec. 558.175 is amended to reflect the approval by 
redesignating paragraph (c) as paragraph (d), by reserving paragraph 
(c), and by amending newly redesignated paragraph (d)(1)(iv)(b).
    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, 
between 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

    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 by redesignating paragraph 
(c) as paragraph (d), by reserving paragraph (c), and in newly 
redesignated paragraph (d)(1)(iv)(b) by removing ``No. 000061'' and 
adding in its place ``Nos. 000061 and 046573''.

    Dated: October 30, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-30408 Filed 11-19-97; 8:45 am]
BILLING CODE 4160-01-F