[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.
* * * * *
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
