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Rule

New Animal Drugs; Change of Sponsor's Name

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Information about this document as published in the Federal Register.

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the Start Printed Page 72921animal 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.

Start Further Info

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: david.newkirk@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

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.

Start List of Subjects

List of Subjects in 21 CFR Part 510

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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,

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PART 510—NEW ANIMAL DRUGS

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1. The authority citation for

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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2. In § 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:

End Amendment Part
Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747025463
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
025463Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747
*    *    *    *    *
Start Signature

Dated: December 12, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. E7-24974 Filed 12-21-07; 8:45 am]

BILLING CODE 4160-01-S