05-23294. New Animal Drugs; Flunixin

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 new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for the veterinary prescription use of flunixin meglumine solution by intramuscular injection for the control of pyrexia associated with swine respiratory disease.

DATES:

This rule is effective November 25, 2005.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

Schering-Plough Animal Health Corp., 1095 Morris Ave., Union, NJ 07083, filed a supplement to NADA 101-479 that provides for the veterinary prescription use of BANAMINE-S (flunixin meglumine) Injectable Solution by intramuscular injection for the control of pyrexia associated with swine respiratory disease. The supplemental NADA is approved as of November 1, 2005, and the regulations are amended in 21 CFR 522.970 and 556.286 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.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning November 1, 2005.

FDA has determined under § 25.33(d)(5) 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

21 CFR Part 522

• Animal drugs

21 CFR Part 556

• Animal drugs
• Foods

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 parts 522 and 556 are 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. Section 522.970 is amended by adding paragraph (e)(3) to read as follows:

§ 522.970

Flunixin.

* * * * *

(e) * * *

(3) Swine—(i) Amount. Administer 2.2 mg/kg (1.0 mg/lb) of body weight as a single intramuscular injection.

(ii) Indications for use. For the control of pyrexia associated with swine respiratory disease.

(iii) Limitations. Swine must not be slaughtered for human consumption within 12 days of last treatment.

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

3. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

4. Section 556.286 is amended by adding paragraph (b)(2) to read as follows:

§ 556.286

Flunixin.

* * * * *

(b) * * *

(2) Swine. The tolerance for flunixin free acid (the marker residue) is:

(i) Liver (the target tissue). 30 ppb.

(ii) Muscle. 25 ppb.

* * * * *

Dated: November 15, 2005.

Steven D. Vaughn,

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