[Federal Register Volume 59, Number 219 (Tuesday, November 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28062]


[[Page Unknown]]

[Federal Register: November 15, 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 a 
Medicated Water Solution for Turkeys

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 Sanofi Animal Health, Inc. The ANADA 
provides for use of penicillin G potassium powder to make a medicated 
water solution for turkeys for the treatment of erysipelas caused by 
Erysipelothrix rhusiopathiae.

EFFECTIVE DATE: November 15, 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: Sanofi Animal Health, Inc., 7101 College 
Blvd., suite 610, Overland Park, KS 66210, filed ANADA 200-103, which 
provides for use of a penicillin G potassium powder to make a medicated 
water solution for turkeys for use in the treatment of erysipelas 
caused by E. rhusiopathiae.
    Approval of Sanofi's ANADA 200-103 for penicillin G potassium 
powder to make a medicated water solution for turkeys is as a generic 
copy of Solvay's NADA 55-060 for the same product. The ANADA is 
approved as of October 18, 1994, and the regulations are amended by 
revising Sec. 520.1696b(b) (21 CFR 520.1696b(b)) to reflect the 
approval.
    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 below) between 9 a.m. and 4 p.m., Monday 
through Friday.
    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.

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) to read 
as follows:


Sec. 520.1696b  Penicillin G potassium in drinking water.

* * * * *
    (b) Sponsors. See Nos. 017144, 050604, and 053501 in 
Sec. 510.600(c) of this chapter.
* * * * *

    Dated: November 2, 1994.
Richard H. Teske,
Deputy Director, Pre-market Review, Center for Veterinary Medicine.
[FR Doc. 94-28062 Filed 11-14-94; 8:45 am]
BILLING CODE 4160-01-F