[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
