[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]
BILLING CODE 4160-01-F