[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Rules and Regulations]
[Pages 66984-66985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33370]


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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; Salinomycin, 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 two abbreviated new animal drug 
applications (ANADA's) filed by Alpharma Inc. The ANADA's provide for 
using approved salinomycin, 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 23, 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's 200-209 and 200-215 
that provide for combining approved salinomycin, bacitracin zinc, and 
roxarsone Type A medicated articles to make Type C medicated broiler 
feeds containing salinomycin 40 to 60 grams per ton (g/t), bacitracin 
zinc 10 to
50 g/t, and roxarsone 34.1 g/t. The Type C medicated feed is used for 
the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, 
E. acervulina, E. brunetti, E. mivati, and E. maxima, increased rate of 
weight gain, and improved feed efficiency.
    Alpharma Inc.'s ANADA 200-209 provides for using approved 
SACOX (Hoechst-Roussel Vet's salinomycin ANADA 200-075), 
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 200-215 provides for using approved BIO-COX 
(Hoffmann-LaRoche, Inc.'s salinomycin NADA 128-686), 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 200-209 is approved as a generic copy of 
Hoechst-Roussel Vet's ANADA 200-143. Alpharma Inc.'s ANADA 200-215 is 
approved as a generic copy of Hoffmann-LaRoche, Inc.'s NADA 139-190. 
The ANADA's are approved as of December 23, 1997, and the regulations 
are amended in 21 CFR 558.550(b)(1)(ix)(c) to reflect the approvals. 
The basis for approval is discussed in the freedom of information 
summaries.
    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 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 salinomycin, bacitracin zinc, and roxarsone 
Type A medicated articles to make Type C medicated feeds as provided in 
ANADA's 200-209 and 200-215 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 each of these 
applications may be seen in the Dockets Management Branch (HFA-305), 
Food and Drug

[[Page 66985]]

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 these actions are 
of a type that do 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. 558.550  [Amended]

    2. Section 558.550 Salinomycin is amended in paragraph 
(b)(1)(ix)(c) by removing ``No. 000004'' and adding in its place ``Nos. 
000004 and 046573''.

    Dated: October 30, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-33370 Filed 12-22-97; 8:45 am]
BILLING CODE 4160-01-F