[Federal Register Volume 59, Number 78 (Friday, April 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9697]
[[Page Unknown]]
[Federal Register: April 22, 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 Methylene Disalicylate or Bambermycins
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 two abbreviated new animal drug
applications (ANADA's) filed by Hoechst-Roussel Agri-Vet Co. The
ANADA's provide for using approved single ingredient Type A medicated
articles to make Type C medicated broiler feeds containing salinomycin
with bacitracin methylene disalicylate (bacitracin MD) or bambermycins.
EFFECTIVE DATE: April 22, 1994.
FOR FURTHER INFORMATION CONTACT: Glen A. Peterson, 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 200-082, salinomycin with bacitracin MD, 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) of
salinomycin sodium activity with either: (1) 4 to 30 g/t of bacitracin
MD for the prevention of coccidiosis caused by Eimeria tenella, E.
necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati,
increased rate of weight gain, and improved feed efficiency; or (2) 4
to 50 g/t of bacitracin MD for the prevention of coccidiosis caused by
the aforementioned Eimeria species and for improved feed efficiency.
ANADA 200-083, salinomycin with bambermycins, which provides for
using approved single ingredient Type A medicated articles to make Type
C medicated broiler feeds containing 40 to 60 g/t of salinomycin sodium
activity with 1 to 3 g/t of bambermycins for prevention of coccidiosis
caused by the aforementioned Eimeria species and improved feed
efficiency.
ANADA's 200-082 and 200-083 are approved as generic copies of Agri-
Bio Corp.'s NADA's 135-746 and 134-284, respectively. ANADA's 200-082
and 200-083 are approved as of March 18, 1994, and the regulations in
21 CFR 558.95 and 558.550 are amended to reflect the approvals.
These approvals are for use of single ingredient Type A medicated
articles to make Type C medicated feeds. Salinomycin, bacitracin MD,
and bambermycins are Category I drugs which, as provided in 21 CFR
558.4(a) and (d), do not require an approved Form FDA 1900 for making
Type C medicated feeds.
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)),
summaries 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. to 4 p.m.,
Monday through Friday.
FDA 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 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: Secs. 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)(xii)(b) by removing ``No. 042835'' and adding in its place
``Nos. 012799 and 042835''.
Sec. 558.550 [Amended]
3. Section 558.550 Salinomycin is amended in paragraph (a)(2) by
removing ``(b)(1)(i), (b)(1)(iv), and (b)(3)(i)'' and adding in its
place ``(b)(1)(i), (b)(1)(iii), (b)(1)(iv), (b)(1)(vi), (b)(3)(i), and
(b)(3)(ii)''.
Dated: April 14, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-9697 Filed 4-21-94; 8:45 am]
BILLING CODE 4160-01-F