[Federal Register Volume 62, Number 247 (Wednesday, December 24, 1997)]
[Rules and Regulations]
[Page 67273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33638]



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 With 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 decoquinate, bacitracin zinc, and roxarsone Type A medicated 
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 24, 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 200-206 that provides for 
combining approved decoquinate, bacitracin zinc, and roxarsone Type A 
medicated articles to make Type C medicated feeds for broilers 
containing decoquinate 27.2 grams per ton (g/t) and bacitracin zinc 12 
to 50 g/t with roxarsone 11 to 45 g/t. The Type C medicated feed is 
used for the prevention of coccidiosis caused by Eimeria tenella, E. 
necatrix, E. acervulina, E. mivati, E. maxima, and E. brunetti, and for 
increased rate of weight gain and improved feed efficiency.
    ALPHARMA INC.'s, ANADA 200-206 is approved as a generic copy of 
Rhone Poulenc Inc.'s NADA 91-326. The ANADA is approved as of December 
24, 1997 and the regulations are amended in 21 CFR 558.195(d) to 
reflect the approval. The basis for approval is discussed in the 
freedom of information summary.
    This approval is for use of three single ingredient Type A 
medicated articles to make combination drug Type C medicated feeds. One 
ingredient, roxarsone, is a Category II drug as defined in 21 CFR 
558.3(b)(1)(ii). As provided in 21 CFR 558.4(b), an approved form FDA 
1900 is required to make a Type C medicated feed from a Category II 
drug. Under section 512(m) of the act (21 U.S.C. 360b(m)), as amended 
by the Animal Drug Availability Act of 1996 (Pub. L. 104-250), 
medicated feed applications have been replaced by a requirement for 
feed mill licenses. Therefore, use of decoquinate, bacitracin zinc, and 
roxarsone Type A medicated articles to make Type C medicated feeds as 
provided in NADA 200-206 is limited to manufacture in a licensed feed 
mill.
    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. 558.195  [Amended]

    2. Section 558.195 Decoquinate is amended in the table in paragraph 
(d) in the entry for ``27.2 (0.003 pct), Roxarsone 11 to 45 (0.0012-
0.005 pct.) plus Bacitracin 12 to 50'' under ``Limitations'' by 
removing ``No. 011716'' and adding in its place ``Nos. 011716 and 
046573''.

    Dated: October 30, 1997.
Stephen F. Sundlof,
Director, Center for Veterinar Medicine.
[FR Doc. 97-33638 Filed 12-23-97; 8:45 am]
BILLING CODE 4160-01-F