[Federal Register Volume 69, Number 42 (Wednesday, March 3, 2004)]
[Rules and Regulations]
[Pages 9946-9947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4653]


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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.

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 V[eacute]toquinol N.-A., Inc. The ANADA 
provides for the use of penicillin G in the drinking water of turkeys 
for the treatment of erysipelas caused by Erysipelothrix rhusiopathiae.

DATES: This rule is effective March 3, 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: V[eacute]toquinol N.-A., Inc., 2000 chemin 
Georges, Lavaltrie (PQ), Canada J0K 1H0, filed ANADA 200-307 that 
provides for use of Penicillin G Potassium, USP, in the drinking water 
of turkeys for the treatment of erysipelas caused by Erysipelothrix 
rhusiopathiae. V[eacute]toquinol N.-A., Inc.'s 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 January 29, 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.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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

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

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

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2. Section 520.1696b is amended by revising paragraph (b) to read as 
follows:

[[Page 9947]]

Sec.  520.1696b  Penicillin G potassium in drinking water.

* * * * *
    (b) Sponsors. See Nos. 046573, 053501, 059130, 059320, and 061623 
in Sec.  510.600(c) of this chapter.
* * * * *

    Dated: February 23, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-4653 Filed 3-2-04; 8:45 am]
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