[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
