Skip to Content

Rule

Oral Dosage Form New Animal Drugs; Oxytetracycline Powder

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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.

Start List of Subjects

List of Subjects in 21 CFR Part 520

End List of Subjects Start Amendment Part

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,

End Amendment Part Start Part

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

Start Printed Page 71039 Authority: 21 U.S.C. 360b.

End Authority Start Amendment Part

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

End Amendment Part
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.

Start Signature

Dated: November 22, 2006.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. E6-20928 Filed 12-7-06; 8:45 am]

BILLING CODE 4160-01-S