Document ID: FDA-2011-N-0003-0070
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor's Name
Posted Date: 2012-01-27T05:00Z

[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Pages 4224-4225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1756]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2011-N-0003]

New Animal Drugs; Change of Sponsor's Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor's name from Nycomed US, 
Inc., to Fougera Pharmaceuticals, Inc.

DATES: This rule is effective January 27, 2012.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, (240) 276-8300, email: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Nycomed US, Inc., 60 Baylis Rd., Melville, 
NY 11747 has informed FDA of a change of name to Fougera 
Pharmaceuticals, Inc. 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.

    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), remove the entry 
for ``Nycomed US, Inc.''; alphabetically add a new entry for ``Fougera 
Pharmaceuticals, Inc.''; and in the table

[[Page 4225]]

in paragraph (c)(2), revise the entry for ``025463''.
    The addition and revision read as follows:

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

* * * * *
    (c) * * *
    (1) * * *

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                                                           Drug labeler
                  Firm name and address                        code
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                                * * * * *
Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis           025463
 Rd., Melville, NY 11747................................
 
                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
          Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
025463..............................  Fougera Pharmaceuticals, Inc.,
                                       P.O. Box 2006, 60 Baylis Rd.,
                                       Melville, NY 11747.
 
                                * * * * *
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    Dated: January 24, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1756 Filed 1-26-12; 8:45 am]
BILLING CODE 4160-01-P