[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Rules and Regulations]
[Pages 72920-72921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24974]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


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

[[Page 72921]]

animal drug regulations to reflect a change of sponsor's name from 
Altana, Inc., to Nycomed US, Inc.

DATES: This rule is effective December 26, 2007.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Altana, Inc., 60 Baylis Rd., Melville, NY 
11747, has informed FDA that it has changed its name to Nycomed US, 
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.

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), remove the entry 
for ``Altana, Inc.'' and alphabetically add a new entry for ``Nycomed 
US, Inc.''; and in the table in paragraph (c)(2), revise the entry for 
``025463'' 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
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                                * * * * *
Nycomed US, Inc., 60 Baylis Rd., Melville,    025463
 NY 11747.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
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                                * * * * *
025463                       Nycomed US, Inc., 60 Baylis Rd., Melville,
                              NY 11747
                                * * * * *
------------------------------------------------------------------------


    Dated: December 12, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-24974 Filed 12-21-07; 8:45 am]
BILLING CODE 4160-01-S