2010-9371. Certain Other Dosage Form New Animal Drugs; Detomidine

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 new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of detomidine hydrochloride oromucosal gel for sedation and restraint of horses.

DATES:

This rule is effective April 23, 2010.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Orion Corp., Orionintie 1, 02200 Espoo, Finland, filed NADA 141-306 for veterinary prescription use of DORMOSEDAN GEL (detomidine hydrochloride) for sedation and restraint of horses. The application is approved as of March 22, 2010, and the regulations in 21 CFR part 529 are amended by adding new § 529.536 to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), summaries of the safety and effectiveness data and information submitted to support approval of these applications 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 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.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

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 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 part 529 is amended as follows:

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

2. Add § 529.536 to read as follows:

§ 529.536

Detomidine.

(a) Specifications. Each milliliter of gel contains 7.6 milligrams (mg) of detomidine hydrochloride.

(b) Sponsor. See No. 052483 in § 510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer 0.018 mg per pound (mg/lb) (0.040 mg/kilogram (kg) sublingually.

(2) Indications for use. For sedation and restraint.

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

Dated: April 19, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.