[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
