[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)]
[Rules and Regulations]
[Pages 66522-66523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33095]
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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; Decoquinate 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 decoquinate and bacitracin zinc Type A medicated
[[Page 66523]]
articles to make Type C medicated broiler chicken feeds used for
prevention of coccidiosis, increased rate of weight gain, and improved
feed efficiency.
EFFECTIVE DATE: December 19, 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 200-213 that provides for
combining approved decoquinate and bacitracin zinc Type A medicated
articles to make Type C medicated feeds for broilers containing
decoquinate 27.2 grams per ton (g/t) and bacitracin zinc 10 to 50 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.
ANADA 200-213, filed by Alpharma Inc., is approved as a generic
copy of Rhone Poulenc's NADA 45-348. The ANADA is approved as of
September 19, 1997, and the regulations are amended in the table in 21
CFR 558.195(d) 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,
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. 558.195 [Amended]
2. Section 558.195 Decoquinate is amended in the table in paragraph
(d), in the entry for ``27.2 (0.003 pct)'', in the second column, in
the entry for ``Bacitracin 10 to 50'', under the column ``Limitations''
by removing ``No. 000061'' and adding in its place ``Nos. 046573 and
011716''.
Dated: December 8, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-33095 Filed 12-18-97; 8:45 am]
BILLING CODE 4160-01-F
