E6-14509. Implantation or Injectable Dosage Form New Animal Drugs; Lincomycin

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 use of lincomycin injectable solution in swine for the treatment of infectious arthritis and mycoplasma pneumonia.

DATES:

This rule is effective September 1, 2006.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200-368 that provides for use of LINCOMED 100 (lincomycin hydrochloride) and LINCOMED 300 (lincomycin hydrochloride) in swine for the treatment of infectious arthritis and mycoplasma pneumonia. Cross Vetpharm Group Ltd.'s LINCOMED 100 and LINCOMED 300 are approved as generic copies of LINCOMIX 100 Injectable and LINCOMIX 300 Injectable, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 034 025. The ANADA is approved as of July 27, 2006, and the regulations are amended in § 522.1260 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 Subject in 21 CFR Part 522

• 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 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 522 continues to read as follows:

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

2. In § 522.1260, add paragraphs (a)(4) and (b)(4) to read as follows:

§ 522.1260

Lincomycin.

(a) * * *

(4) 100 or 300 mg lincomycin.

(b) * * *

(4) No. 061623 for use of concentrations in paragraph (a)(4) of this section as in paragraph (e)(2) of this section.

Dated: August 10, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.