E9-4758. New Animal Drugs; Change of Sponsor; Methoxyflurane

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Schering-Plough Animal Health, Inc., to Medical Developments International, Ltd.

DATES:

This rule is effective March 6, 2009.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 14-485 for ANAFANE (methoxyflurane) Volatile Liquid for Inhalation Anesthesia to Medical Developments International, Ltd., P.O. Box 21, Sandown Village, 3171 VIC Australia.

Medical Developments International, Ltd., is not currently listed in the animal drug regulations as a sponsor of an approved application. In addition, FDA has noticed that this new animal drug has not been previously codified in 21 CFR part 529. Accordingly, the regulations are amended in 21 CFR 510.600(c) to add entries for Medical Developments International, Ltd., and in 21 CFR part 529 to add this new animal drug.

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 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 529

• 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 parts 510 and 529 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. In § 510.600, in the table in paragraph (c)(1) alphabetically add an entry for “Medical Developments International, Ltd.”; and in the table in paragraph (c)(2) numerically add an entry for “025245” to read as follows:

§ 510.600

Names, addresses, and drug labeler codes of sponsors of approved applications.

(c) * * *

(1) * * *

Firm name and address	Drug labeler code
*    *    *    *    *
Medical Developments International, Ltd.,P.O. Box 21, Sandown Village, 3171 VIC Australia	025245
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
025245	Medical Developments International, Ltd.,P.O. Box 21, Sandown Village, 3171 VIC Australia
*    *    *    *    *

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 529 continues to read as follows:

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

4. Add § 529.1455 to read as follows:

§ 529.1455

Methoxyflurane.

(a) Specifications. Methoxyflurane liquid.

(b) Sponsor. See No. 025245 in § 510.600 of this chapter.

(c) Conditions of use—(1) Amount. The amount of methoxyflurane used depends on the weight of the patient, the depth of anesthesia, and the type of equipment used. Anesthesia may be induced with methoxyflurane alone, or by the intravenous administration of a short-acting general anesthetic or by inhalation of another anesthetic agent.

(2) Indications for use. For the induction and maintenance of general anesthesia.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: March 3, 2009.

Steven D. Vaughn,

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