[Federal Register Volume 69, Number 131 (Friday, July 9, 2004)]
[Rules and Regulations]
[Pages 41427-41428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Penicillin G Potassium in 
Drinking Water

AGENCY:  Food and Drug Administration, HHS.

[[Page 41428]]


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 G. C. Hanford Manufacturing Co. The ANADA 
provides for the use of penicillin G potassium in the drinking water of 
turkeys for the treatment of erysipelas caused by Erysipelothrix 
rhusiopathiae.

DATES: This rule is effective July 9, 2004.

FOR FURTHER INFORMATION CONTACT:  Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: G. C. Hanford Manufacturing Co., P.O. Box 
1017, Syracuse, NY 13201, filed ANADA 200-372 that provides for use of 
Penicillin G Potassium, USP, in the drinking water of turkeys for the 
treatment of erysipelas caused by Erysipelothrix rhusiopathiae. G. C. 
Hanford Manufacturing Co.'s HAN-PEN (penicillin G potassium, USP) is 
approved as a generic copy of Fort Dodge Animal Health's Penicillin G 
Potassium, USP, approved under NADA 55-060. The ANADA is approved as of 
May 21, 2004, and the regulations are amended in 21 CFR 520.1696b to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
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. 010515, 046573, 053501, 059130, 059320, and 
061623 in Sec.  510.600(c) of this chapter.
* * * * *

    Dated: June 17, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-15657 Filed 7-8-04; 8:45 am]
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