New Animal Drugs; Change of Sponsor's Name and Address

Federal Register: January 20, 2010 (Volume 75, Number 12)

Rules and Regulations

Page 3159

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

DOCID:fr20ja10-9

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 510

Docket No. FDA-2009-N-0665

New Animal Drugs; Change of Sponsor's Name and Address

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's name from Fort Dodge

Animal Health, A Division of Wyeth Holdings Corp. to Fort Dodge Animal

Health, Division of Wyeth Holdings Corp., a wholly owned subsidiary of

Pfizer, Inc. In a separate action, FDA is amending the animal drug regulations to reflect a change of sponsor's name from Fort Dodge

Animal Health, Division of Wyeth to Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc. In each case, the sponsor's mailing address will be changed.

DATES: This rule is effective January 20, 2010.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for

Veterinary Medicine (HFV-100), Food and Drug Administration, 7520

Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, A Division of

Wyeth Holdings Corp., P.O. Box 1339, Fort Dodge, IA 50501 has informed

FDA of a change of name and mailing address to Fort Dodge Animal

Health, Division of Wyeth Holdings Corp., a wholly owned subsidiary of

Pfizer, Inc., 235 East 42d St., New York, NY 10017. In a separate action, Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW.,

Fort Dodge, IA 50501 has informed FDA of a change of name and mailing address to Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017.

Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes.

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 510

Administrative practice and procedure, Animal drugs, Labeling,

Reporting and recordkeeping requirements. 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 part 510 is 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), revise the entries for ``Fort Dodge Animal Health, A Division of Wyeth Holdings

Corp.'' and ``Fort Dodge Animal Health, Division of Wyeth''; and in the table in paragraph (c)(2), revise the entries for ``000856'' and

``053501'' 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

* * * * *

Fort Dodge Animal Health, Division of Wyeth 053501

Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New

York, NY 10017

Fort Dodge Animal Health, Division of Wyeth, 000856 a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017

* * * * *

(2) * * *

Drug labeler code

Firm name and address

* * * * *

000856

Fort Dodge Animal Health, Division of

Wyeth, a wholly owned subsidiary of

Pfizer, Inc., 235 East 42d St., New York,

NY 10017

* * * * *

053501

Fort Dodge Animal Health, Division of Wyeth

Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New

York, NY 10017

* * * * *

Dated: January 8, 2010.

Elizabeth Rettie,

Deputy Director, Office of New Animal Drug Evaluation, Center for

Veterinary Medicine.

FR Doc. 2010-930 Filed 1-19-10; 8:45 am

BILLING CODE 4160-01-S