Justia Regulation Tracker

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[Federal Register: December 8, 2006 (Volume 71, Number 236)]
[Rules and Regulations]               
[Page 71038-71039]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de06-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

 
Oral Dosage Form New Animal Drugs; Oxytetracycline Powder

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 a supplemental abbreviated new 
animal drug application (ANADA) filed by IVX Animal Health, Inc. The 
supplemental ANADA revises labeling of generic oxytetracycline soluble 
powder with the current scientific names of the causative bacteria of 
foulbrood of honeybees.

DATES:  This rule is effective December 8, 2006.

FOR FURTHER INFORMATION CONTACT:  Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-247 
that provides for the use of Oxytetracycline HCl Soluble Powder-343 in 
several species. The supplement revises labeling of generic 
oxytetracycline soluble powder with the current scientific names of the 
causative bacteria of foulbrood of honeybees. The supplemental ANADA is 
approved as of November 9, 2006, and the regulations are amended in 21 
CFR 520.1660d to reflect the approval and a current format.
    Approval of this supplemental ANADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    FDA 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 
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:

[[Page 71039]]

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

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2. In Sec.  520.1660d, revise paragraph (d)(2)(ii) to read as follows:

Sec.  520.1660d  Oxytetracycline powder.

* * * * *
    (d) * * *
    (2) * * *
    (ii) Indications for use. For control of American foulbrood caused 
by Paenibacillus larvae and European foulbrood caused by Streptococcus 
pluton susceptible to oxytetracycline.
* * * * *

    Dated: November 22, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-20928 Filed 12-7-06; 8:45 am]

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