[Federal Register Volume 62, Number 218 (Wednesday, November 12, 1997)]
[Rules and Regulations]
[Pages 60657-60658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29653]
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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; Amprolium Plus
Ethopabate With Bacitracin Zinc and 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 ANADA provides for using
approved amprolium plus ethopabate with bacitracin zinc and roxarsone
Type A medicated articles to make Type C medicated broiler chicken
feeds used as an aid in the prevention of coccidiosis and improved feed
efficiency or improved feed efficiency and improved pigmentation.
EFFECTIVE DATE: November 12, 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, filed ANADA 200-214 that provides for
combining approved amprolium plus ethopabate with bacitracin zinc and
roxarsone Type A medicated articles to make Type C medicated broiler
feeds. The Type C medicated feed containing amprolium 113.5 grams per
ton (g/t) plus ethopabate 36.3 g/t with bacitracin zinc 10 to 50 g/t
and roxarsone 15.4 to 45.4 g/t is used as an aid in the prevention of
coccidiosis where severe exposure to coccidiosis from Eimeria
acervulina, E. maxima, and E. brunetti is likely to occur, and for
improved feed efficiency. The Type C medicated feed containing
amprolium 113.5 g/t plus ethopabate
[[Page 60658]]
36.3 g/t with bacitracin zinc 10 g/t and roxarsone 30 to 45.4 g/t is
used as an aid in the prevention of coccidiosis where severe exposure
to coccidiosis from E. acervulina, E. maxima, and E. brunetti is likely
to occur, and for improved feed efficiency and improved pigmentation.
Alpharma Inc.'s ANADA 200-214 provides for combining approved
AMPROL HI-E (Merck Research Laboratories' amprolium and
ethopabate NADA 13-461), ALBAC (Alpharma Inc.'s bacitracin
zinc ANADA 200-223), and 3-NITRO (Alpharma Inc.'s roxarsone
NADA 7-891) Type A medicated articles to make the combination drug Type
C medicated feeds.
Alpharma Inc.'s ANADA 200-214 is approved as a generic copy of
Hoffmann-LaRoche, Inc.'s NADA 105-758. The ANADA is approved as of
November 12, 1997, and the regulations are amended in 21 CFR
558.58(d)(1)(iii) 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 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. 558.58 [Amended]
2. Section 558.58 Amprolium and ethopabate is amended in the table
in paragraph (d)(1)(iii) in the entry for ``Bacitracin 10 to 50 plus
roxarsone 15.4 to 45.4 (0.0017% to 0.005%)'' under ``Limitations'' by
removing ``No. 000004'' both times it appears and adding in their place
``Nos. 000004 and 046573'', and under ``Sponsor'' by removing
``000004'' and adding in its place ``000004, 046573''.
Dated: October 22, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-29653 Filed 11-10-97; 8:45 am]
BILLING CODE 4160-01-F
