[Federal Register Volume 60, Number 95 (Wednesday, May 17, 1995)]
[Rules and Regulations]
[Page 26359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12095]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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.

-----------------------------------------------------------------------

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 Wade Jones Co., Inc. The ANADA provides 
for use of penicillin G potassium powder to make a medicated turkey 
drinking water for the treatment of erysipelas caused by Erysipelothrix 
rhusiopathiae.
EFFECTIVE DATE: May 17, 1995.

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: Wade Jones Co., Inc., Highway 71 North, 409 
North Bloomington, Lowell, AR 72745, has filed ANADA 200-122, which 
provides for use of penicillin G potassium powder to make a medicated 
turkey drinking water used for the treatment of erysipelas in turkeys 
caused by E. rhusiopathiae.
    Wade Jones' ANADA 200-122 for penicillin G potassium powder is 
approved as a generic copy of Solvay's NADA 55-060 for the same 
product. The ANADA is approved as of April 17, 1995, and the 
regulations are amended in 21 CFR 520.1696b(b) to reflect the approval. 
The basis for this approval is discussed in the freedom of information 
summary.
    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) to read 
as follows:


Sec. 520.1696b  Penicillin G potassium in drinking water.

* * * * *
    (b) Sponsors. See Nos. 017144, 047864, 050604, and 053501 in 
Sec. 510.600(c) of this chapter.
* * * * *

    Dated: May 5, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-12095 Filed 5-16-95; 8:45 am]
BILLING CODE 4160-01-F