Document ID: FDA-2009-N-0665-0085
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor - Final Rule
Posted Date: 2010-01-20T05:00Z

[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