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 Agri Laboratories, Ltd. The ANADA provides for the oral use of lincomycin and spectinomycin soluble powder to create a solution administered in the drinking water of chickens as an aid in the control of airsacculitis.
This rule is effective December 8, 2006.Start Further Info
FOR FURTHER INFORMATION CONTACT:
John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503, filed ANADA 200-407 that provides for use of Lincomycin-Spectinomycin (lincomycin hydrochloride and spectinomycin dihydrochloride pentahydrate) Water Soluble Powder to create a solution administered in the drinking water of chickens as an aid in the control of airsacculitis caused by either Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin. Agri Laboratories, Ltd.'s Lincomycin-Spectinomycin Water Soluble Powder is approved as a generic copy of L-S 50 Water Soluble Powder, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 046-109. The ANADA is approved as of November 9, 2006, and the regulations are amended in 21 CFR 520.1265 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.
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 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 Start Amendment Part
2. In § 520.1265, revise the section heading and paragraph (b)(2) to read as follows:End Amendment Part
(b) * * *
(2) Nos. 057561, 059130, and 061623 for use of product described in paragraph (a)(2) of this section.Start Signature
Dated: November 28, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-20929 Filed 12-7-06; 8:45 am]
BILLING CODE 4160-01-S