[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Rules and Regulations]
[Page 66986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33489]



[[Page 66986]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Robenidine 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 robenidine and bacitracin zinc Type A medicated articles to 
make Type C medicated broiler chicken feeds used for prevention of 
coccidiosis and increased rate of weight gain and improved feed 
efficiency.

EFFECTIVE DATE: December 23, 1997.

FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, Center for 
Veterinary Medicine (HFV-28), 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 the sponsor of ANADA 200-212 which 
provides for combining approved robenidine and bacitracin zinc Type A 
medicated articles to make Type C medicated broiler feeds containing 
robenidine hydrochloride 30 grams per ton (g/t) and bacitracin zinc 4 
to 50 g/t for prevention of coccidiosis caused by Eimeria tenella, E. 
necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and 
with bacitracin zinc 4 to 30 g/t, for increased rate of weight gain, 
and with bacitracin zinc 27 to 50 g/t, for improved feed efficiency.
    Alpharma Inc.'s ANADA 200-212 is approved as a generic copy of 
Hoffmann-La Roche, Inc.'s NADA 96-933. The ANADA is approved as of 
December 23, 1997, and the regulations are amended in 21 CFR 
558.515(d)(1)(vi)(b) to reflect the approval. The basis for approval is 
discussed in the freedom of information summary.
    This approval is for use of two single ingredient Type A medicated 
articles to make combination drug Type C medicated feeds. One 
ingredient, robenidine, 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 Type C medicated feed from a Category II drug. 
Under section 512(m) of the Federal Food, Drug, and Cosmetic 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 robenidine and 
bacitracin zinc Type A medicated articles to make Type C medicated 
feeds as provided in NADA 200-212 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. 558.515  [Amended]

    2. Section 558.515 Robenidine hydrochloride is amended in paragraph 
(d)(1)(vi)(b) by removing ``000004 and 000061'' and adding in its place 
``000004, 000061, and 046573''.

    Dated: October 30, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-33489 Filed 12-22-97; 8:45 am]
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