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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 522

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule, technical amendment.

SUBJECT CATEGORY: Implantation or Injectable Dosage Form New Animal Drugs; Mepivacaine

DATES: This rule is effective July 13, 2006.

DOCUMENT 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 Pharmacia & Upjohn Co. The supplemental NADA provides for revised food safety labeling for mepivacaine injectable solution used in horses for local anesthesia.

SUMMARY: Mepivacaine,

SUPPLEMENTAL INFORMATION

Pharmacia & Upjohn Co., a Division of Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement to NADA 100 703 for CARBOCAINEV (mepivacaine hydrochloride) Sterile Aqueous Solution. The supplemental NADA provides for revised food safety labeling for mepivacaine injectable solution used in horses for local anesthesia. The application is approved as of June 2, 2006, and the regulations are amended in Sec. 522.1372 (21 CFR 522.1372) to reflect the approval.

In addition, FDA has found that the April 1, 2005, edition of parts 500 to 599 of title 21 of the Code of Federal Regulations (CFR) does not accurately reflect the approved conditions of use for mepivacaine solution used in horses. These conditions of use were inadvertently deleted as a publication error. At this time, the regulations are being amended in Sec. 522.1372 to correct this error and to format portions of this section to reflect a current format. This action is being taken to improve the accuracy of the regulations.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

The agency has determined under Sec. 25.33(d)(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. 801808.
List of Subjects 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 522IMPLANTATION 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. Revise Sec. 522.1372 to read as follows:
Sec. 522.1372 Mepivacaine.
(a) Specifications. Each milliliter (mL) of solution contains 20 milligrams mepivacaine hydrochloride.
(b) Sponsor. See No. 000009 in Sec. 510.600(c) of this chapter. (c) Conditions of use in horses(1) Amount. For nerve block, 3 to 5 mL; for epidural anesthesia, 5 to 20 mL; for intraarticular anesthesia, 10 to 15 mL; for infiltration, as required; for anesthesia of the laryngeal mucosa prior to ventriculectomy, by topical spray, 25 to 40 mL, by infiltration, 20 to 50 mL.
(2) Indications for use. For use as a local anesthetic for infiltration, nerve block, intraarticular and epidural anesthesia, and topical and/or infiltration anesthesia of the laryngeal mucosa prior to ventriculectomy.
(3) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: June 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E610970 Filed 71206; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Melanie R. Berson, Center for Veterinary Medicine (HFV110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018277543, email:
melanie.berson@fda.hhs.gov.