Document ID: FDA-2009-N-0665-0070
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsor
Posted Date: 2009-12-14T05:00Z

[Federal Register: December 14, 2009 (Volume 74, Number 238)]
[Rules and Regulations]               
[Page 66047]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14de09-9]                         

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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.

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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 Schering-
Plough Animal Health Corp. to Intervet, Inc., and to change the 
sponsor's mailing address.

DATES:  This rule is effective December 14, 2009.

FOR FURTHER INFORMATION CONTACT:  David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: 
david.newkirk@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, has informed FDA of a change of name and 
mailing address to Intervet, Inc., 56 Livingston Ave., Roseland, NJ 
07068. 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 ``Schering-Plough Animal Health Corp.'' and alphabetically add a 
new entry for ``Intervet, Inc.''; and in the table in paragraph (c)(2), 
revise the entry for ``000061'' 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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                                * * * * *
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Intervet, Inc., 56 Livingston Ave.,           000061
 Roseland, NJ 07068
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                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
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                                * * * * *
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000061                       Intervet, Inc., 56 Livingston Ave.,
                              Roseland, NJ 07068
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                                * * * * *
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    Dated: December 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29627 Filed 12-11-09; 8:45 am]

BILLING CODE 4160-01-S