New Animal Drugs; Change of Sponsor: Ketamine

Federal Register: February 13, 2008 (Volume 73, Number 30)

Rules and Regulations

Page 8191-8192

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr13fe08-4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Parts 510 and 522

New Animal Drugs; Change of Sponsor; Ketamine

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 an abbreviated new animal drug application (ANADA) for ketamine hydrochloride injectable solution from Veterinary Research Associates, Inc., to Putney, Inc.

DATES: This rule is effective February 13, 2008.

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: david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Veterinary Research Associates, Inc., 2817

West Country Rd., 54G, Fort Collins, CO 80524, has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-073 for Ketamine Hydrochloride Injection, USP, to Putney, Inc., 400

Congress St., suite 200, Portland, ME 04101. Accordingly, the regulations are amended in 21 CFR 522.1222a to reflect this change of sponsorship.

Following these changes of sponsorship, Veterinary Research

Associates, Inc., is no longer the sponsor of an approved application.

In addition, Putney, Inc., is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21

CFR 510.600(c) is being amended to remove the entries for Veterinary

Research Associates, Inc., and to add entries for Putney, Inc.

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 522

Animal drugs.

Page 8192

0

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 522 are amended as follows:

PART 510--NEW ANIMAL DRUGS 0 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. 0 2. In Sec. 510.600, in the table in paragraph (c)(1) remove the entry for ``Veterinary Research Associates, Inc.'' and alphabetically add a new entry for ``Putney, Inc.''; and in the table in paragraph (c)(2) remove the entry for ``064408'' and numerically add an entry for

``026637'' to read as follows:

Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address

Drug labeler code

* * * * *

Putney, Inc., 400 Congress St., suite 200,

026637

Portland, ME 04101

* * * * *

(2) * * *

Drug labeler code

Firm name and address

* * * * *

026637

Putney, Inc., 400 Congress St., suite 200,

Portland, ME 04101

* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for 21 CFR part 522 continues to read as follows:

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

Sec. 522.1222a [Amended] 0 4. In Sec. 522.1222a, revise paragraph (b) by removing ``064408'' and numerically adding ``026637''.

Dated: January 31, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

FR Doc. E8-2607 Filed 2-12-08; 8:45 am

BILLING CODE 4160-01-S