[Federal Register Volume 62, Number 224 (Thursday, November 20, 1997)]
[Rules and Regulations]
[Page 61912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30483]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Monensin and Bacitracin 
Zinc With Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 monensin, bacitracin zinc, and roxarsone Type A medicated 
articles to make Type C medicated broiler chicken feeds used for 
prevention of coccidiosis and increased rate of weight gain, or for 
prevention of coccidiosis and improved feed efficiency and improved 
pigmentation.

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 200-211 that provides for 
combining approved monensin, bacitracin zinc, and roxarsone Type A 
medicated articles to make Type C medicated broiler feeds containing: 
Monensin 90 to 110 grams per ton (g/t) and bacitracin zinc 10 g/t with 
roxarsone 15 g/t for 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, or; monensin 90 to 110 
g/t and bacitracin zinc 4 to 50 g/t with roxarsone 15 to 45.4 g/t for 
prevention of coccidiosis caused by E. tenella, E. necatrix, E. 
acervulina, E. brunetti, E. mivati, and E. maxima, and for improved 
feed efficiency and improved pigmentation by enhancing carotenoid and 
xanthophyll utilization.
    ANADA 200-211, sponsored by Alpharma Inc., is approved as a generic 
copy of Hoffmann-La Roche's NADA 123-154. The ANADA is approved as of 
November 20, 1997 and the regulations are amended in 21 CFR 
558.355(f)(1) 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 Sec. 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 
the 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. 558.355  [Amended]

    2. Section 558.355 Monensin is amended in paragraphs (f)(1)(xv)(b) 
and (f)(1)(xvi)(b) by removing ``No. 000004'' and adding in its place 
``Nos. 000004 and 046573''.

    Dated: November 7, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-30483 Filed 11-19-97; 8:45 am]
BILLING CODE 4160-01-F