[Federal Register Volume 59, Number 159 (Thursday, August 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20260]
[[Page Unknown]]
[Federal Register: August 18, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Penicillin G Potassium in
Turkey Drinking Water
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 I. D. Russell Co. Laboratories. The ANADA
provides for use of penicillin G potassium powder to make a turkey
drinking water for the treatment of erysipelas caused by Erysipelotrix
rhusiopathiae.
EFFECTIVE DATE: August 18, 1994.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center For
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: I. D. Russell Co. Laboratories, 1301 Iowa
Ave., Longmont, CO 80501, filed ANADA 200-106 which provides for use of
a penicillin G potassium powder to make a medicated drinking water for
turkeys used for the treatment of erysipelas in turkeys caused by
Erysipelothrix rhusiopathiae.
Approval of I. D. Russell's ANADA 200-106 for penicillin G
potassium powder to make a turkey drinking water is as a generic copy
of Solvay's NADA 55-060 for the same product. The ANADA is approved as
of July 21, 1994, and the regulations are amended by revising
Sec. 520.1696b(b)(21 CFR 520.1696b(b)) to reflect the approval.
In addition, the infective agent of turkey erysipelas has been
renamed from Erysipelothrix insidiosa to E. rhusiopathiae. The labeling
of the pioneer and the generic products use the new name. The
regulations are amended in Sec. 520.1696b(c)(2) to reflect the new
name.
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.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 520
Animal drugs.
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 520.1696b is amended by revising paragraph (b) and in
paragraph (c)(2) by removing the word ``insidiosa'' and adding in its
place the word ``rhusiopathiae'' to read as follows:
Sec. 520.1696b Penicillin G potassium in drinking water.
* * * * *
(b) Sponsors. See Nos. 017144 and 053501 in Sec. 510.600(c) of this
chapter.
* * * * *
Dated: August 10, 1994.
Richard H. Teske,
Deputy Director, Pre-market Surveillance and Compliance, Center for
Veterinary Medicine.
[FR Doc. 94-20260 Filed 8-17-94; 8:45 am]
BILLING CODE 4160-01-F
