05-13975. Oral Dosage Form New Animal Drugs; Lincomycin and Spectinomycin Soluble Powder

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 an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group 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.

DATES:

This rule is effective July 15, 2005.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200-380 that provides for use of SPECLINX-50 (spectinomycin dihydrochloride pentahydrate and lincomycin hydrochloride monohydrate) Water Soluble Powder to create a solution administered in the drinking water of chickens. This solution acts 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. Cross Vetpharm Group Ltd.'s SPECLINX-50, Water Soluble Powder is approved as a generic copy of Pharmacia & Upjohn Co.'s L-S 50 Water Soluble Powder, approved under NADA 046-109. The ANADA is approved as of June 7, 2005, 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.

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

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

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

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

§ 520.1265

[Amended]

2. Section 520.1265 is amended in paragraph (b)(2) by removing “No. 059130” and by adding in its place “Nos. 059130 and 061623”.

Dated: July 1, 2005.

Catherine P. Beck,

Acting Director, Center for Veterinary Medicine.