Food and Drug Administration, HHS.
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 Vétoquinol NA, Inc. The ANADA provides for use of oxytetracycline soluble powder to prepare medicated drinking water for the treatment of various bacterial diseases of livestock.
This rule is effective July 5, 2006.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0223, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Vétoquinol NA, Inc., 2000 chemin Georges, Lavaltrie (PQ), Canada J5T 3S5, filed a supplement to ANADA 200-305 that provides for use of Oxytetracycline HCl Soluble Powder to prepare medicated drinking water for the treatment of various bacterial diseases of livestock. Vétoquinol NA, Inc.'s Oxytetracycline HCl Soluble Powder is approved as a generic copy of Alpharma, Inc.'s OXY-TET (oxytetracycline hydrochloride) Soluble approved under NADA 130-435. The ANADA is approved as of June 2, 2006, and the regulations are amended in 21 CFR 520.1660d 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.Start List of Subjects
List of Subjects in 21 CFR Part 520End 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 DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Amend § 520.1660d as follows:End Amendment Part Start Amendment Part
a. Revise the section heading;End Amendment Part Start Amendment Part
b. In paragraphs (d)(1)(ii)(A)(End Amendment Part Start Amendment Part
c. Add paragraphs (a)(10) and (b)(8).End Amendment Part
The revisions read as follows:
(a) * * *
(10) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 9.87 and 19.74 oz; pails: 5 lb).
(b) * * *
(8) No. 059320 for use of OTC concentration in paragraph (a)(10) of this section in chickens, turkeys, and swine as in paragraph (d) of this section.
Dated: June 22, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-10445 Filed 7-3-06; 8:45 am]
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