[Federal Register Volume 59, Number 97 (Friday, May 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12289]
[[Page Unknown]]
[Federal Register: May 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Salinomycin in
Combination With Bacitracin Zinc, or Lincomycin, or 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 three abbreviated new animal
drug applications (ANADA's) filed by Hoechst-Roussel Agri-Vet Co. The
ANADA's provide for using approved Type A medicated articles to make
Type C medicated broiler feeds containing salinomycin with bacitracin
zinc, salinomycin with lincomycin, or salinomycin with roxarsone.
EFFECTIVE DATE: May 20, 1994.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center For
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1602.
SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., P.O. Box 2500,
Somerville, NJ 08876-1258, filed the following ANADA's:
ANADA 200-089, salinomycin with bacitracin zinc, which provides for
using approved single ingredient Type A medicated articles to make Type
C medicated broiler feeds containing 40 to 60 grams per ton (g/t)
salinomycin sodium activity and 10 to 50 g/t bacitracin zinc for
prevention of coccidiosis and for increased rate of weight gain. The
ANADA is approved as a generic copy of American Cyanamid's new animal
drug application (NADA) 139-235.
ANADA 200-093, salinomycin with lincomycin, which provides for
using approved single ingredient Type A medicated articles to make Type
C medicated broiler feeds containing 40 to 60 g/t salinomycin sodium
activity with 2 to 4 g/t lincomycin, for prevention of coccidiosis and
for improved feed efficiency. The ANADA is approved as a generic copy
of Agri-Bio Corp.'s NADA 137-537.
ANADA 200-097, salinomycin with roxarsone, which provides for using
approved single ingredient Type A medicated articles to make Type C
medicated broiler feeds containing 40 to 60 g/t salinomycin sodium
activity with 22.7 to 45.4 g/t roxarsone for prevention of coccidiosis
and for improved feed efficiency. The ANADA is approved as a generic
copy of Agri-Bio Corp.'s NADA 132-447.
ANADA's 200-089 and 200-093 are approved as of April 6, 1994. ANADA
200-097 is approved as of May 20, 1994. The regulations are amended in
21 CFR 558.550 to reflect the approvals.
These approvals are for use of Type A medicated articles to make
Type C medicated feeds. Salinomycin, bacitracin zinc, and lincomycin
are Category I drugs which, as provided in Sec. 558.4 (21 CFR 558.4),
do not require an approved Form FDA 1900. However, roxarsone is a
Category II drug which, as provided in Sec. 558.4, requires an approved
Form FDA 1900 for making a Type C medicated feed. Use of salinomycin
and roxarsone to make Type C medicated feeds as in ANADA 200-097
requires an approved Form FDA 1900.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a
summary of safety and effectiveness data and information submitted to
support approval of these applications may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has determined under 21 CFR 25.24(d)(1)(ii) that these
actions are of a type that do not individually or cumulatively have a
significant impact 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: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
Sec. 558.550 [Amended]
2. Section 558.550 Salinomycin is amended in paragraph (a)(2) by
removing ``(b)(1)(vi), (b)(1)(viii), (b)(1)(x), (b)(1)(xi),'' and
``(b)(1)(xii),'' and adding in its place ``(b)(1)(v), (b)(1)(vi),
(b)(1)(vii), (b)(1)(viii), (b)(1)(x), (b)(1)(xi), (b)(1)(xii),
(b)(1)(xiii),''.
Dated: May 3, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-12289 Filed 5-19-94; 8:45 am]
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