[Federal Register Volume 59, Number 59 (Monday, March 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7149]


[Federal Register: March 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


 New Animal Drugs For Use In Animal Feeds; Salinomycin, 
Bambermycins, 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 an abbreviated new animal drug 
application (ANADA) filed by Hoechst-Roussel Agri-Vet Co. The ANADA 
provides for using approved single ingredient Type A medicated articles 
to make Type C medicated broiler feeds containing salinomycin with 
bambermycins and roxarsone.

EFFECTIVE DATE: March 28, 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 ANADA 200-080 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, 1 to 2 g/t bambermycins, and 45.4 g/t 
roxarsone. The Type C feed is used for prevention of coccidiosis in 
broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, 
E. maxima, E. brunetti, and E. mivati, including some field strains of 
E. tenella that are more susceptible to roxarsone combined with 
salinomycin than salinomycin alone; and for improved feed efficiency. 
ANADA 200-080 is as a generic copy of Agri-Bio's NADA 134-185. ANADA 
200-080 is approved as of March 28, 1994. The regulations are amended 
in 21 CFR 558.95(b)(1)(xi)(b) to indicate that Hoechst-Roussel is an 
approved source for salinomycin in the combination and in 21 CFR 
558.550(a) to indicate that Hoechst-Roussel has an approval for the 
combination.
     This approval is for use of single ingredient Type A medicated 
articles to make Type C medicated feeds. Roxarsone is a Category II 
drug which, as provided in 21 CFR 558.4, requires an approved form FDA 
1900 for making a Type C medicated feed. Use of salinomycin, 
bambermycins, and roxarsone Type A medicated articles to make Type C 
medicated feeds requires an approved form FDA 1900.
     In addition, FDA published a rule in the Federal Register of March 
11, 1992 (57 FR 8577) which reflected the change of sponsor of NADA 
007-891 (3-NITRO (roxarsone) Type A medicated article) from Solvay to 
A. L. Laboratories. Inadvertently, the references concerning roxarsone 
in Sec. 558.550 were not amended to reflect the new sponsor. At this 
time, the references are amended accordingly.
     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 this application 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.
     FDA has determined under 21 CFR 25.24(d)(1)(ii) that this action 
is of a type that does 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: Sec. 512, 701 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360b, 371).

Sec. 558.95  [Amended]

     2. Section 558.95 Bambermycins is amended in paragraph 
(b)(1)(xi)(b) by removing ``No. 042835'' and adding in its place ``Nos. 
012799 and 042835.''
     3. Section 558.550 Salinomycin is amended by revising paragraph 
(a) and by removing in paragraphs (b)(1)(ii)(c), (b)(1)(v)(c), 
(b)(1)(ix)(c), (b)(1)(xii)(c), (b)(1)(xiv)(c), and (b)(1)(xv)(c) 
``053501'' and adding in its place ``046573'', and in paragraph 
(b)(1)(iv)(c) by removing the words ``as provided by No. 053501'' to 
read as follows:


Sec. 558.550  Salinomycin.

     (a)  Approvals. Type A medicated articles--30 grams of salinomycin 
activity per pound from salinomycin sodium biomass:
     (1) To 042835 in Sec. 510.600(c) of this chapter for use as in 
paragraph (b) of this section.
     (2) To 012799 for use as in paragraph (b)(1)(i) and (b)(3)(i) of 
this section.
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    Dated: March 17, 1994.
 Richard H. Teske,
 Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-7149 Filed 3-25-94; 8:45 am]
BILLING CODE 4160-01-F