[Federal Register Volume 62, Number 220 (Friday, November 14, 1997)]
[Rules and Regulations]
[Page 61011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30033]


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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; Carbarsone 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 carbarsone and bacitracin zinc Type A medicated articles to 
make Type C medicated turkey feeds used for prevention of blackhead, 
increased rate of weight gain, and improved feed efficiency.

EFFECTIVE DATE: November 14, 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 200-203 that provides for 
combining approved carbarsone and bacitracin zinc Type A medicated 
articles to make Type C medicated feeds for turkeys containing 
carbarsone 227 to 340.5 grams per ton (g/t) and bacitracin zinc 4 to 45 
g/t. The Type C medicated feed is used as an aid in the prevention of 
blackhead, for increased rate of weight gain, and improved feed 
efficiency.
    Alpharma Inc.'s, ANADA 200-203 is approved as a generic copy of 
Hoffmann-LaRoche's NADA 136-484. The ANADA is approved as of November 
14, 1997, and the regulations are amended in Sec. 558.120 (21 CFR 
558.120) to reflect the approval. The basis for approval is discussed 
in the freedom of information summary.
    In addition, Sec. 558.120 is revised by redesignating paragraph (c) 
as (d), by reserving paragraph (c), and newly redesignated paragraph 
(d)(1)(iii)(b) is amended to reflect the approval.
    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

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec. 558.120  [Amended]

    2. Section 558.120 Carbarsone (not U.S.P.) is amended by 
redesignating paragraph (c) as paragraph (d), by reserving paragraph 
(c), and in newly redesignated paragraph (d)(1)(iii)(b) by removing 
``No. 000004'' and adding in its place ``Nos. 000004 and 046573''.

    Dated: October 22, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-30033 Filed 11-13-97; 8:45 am]
BILLING CODE 4160-01-F