Document ID: FDA-2010-N-0002-0077
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Change of Sponsors Name
Posted Date: 2010-11-10T05:00Z

[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Rules and Regulations]
[Page 68972]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28307]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

[Docket No. FDA-2010-N-0002]

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 North 
American Nutrition Companies, Inc., to Provimi North America, Inc.

DATES: This rule is effective November 10, 2010.

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, E-mail: 
steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: North American Nutrition Companies, Inc., 
6531 State Rte. 503, Lewisburg, OH 45338, has informed FDA that it has 
changed its name to Provimi North America, Inc. Accordingly, the Agency 
is amending the regulations in 21 CFR 510.600 to reflect this change.
    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 ``North American Nutrition Companies, Inc.''; and alphabetically 
add a new entry for ``Provimi North America, Inc.''; and in the table 
in paragraph (c)(2), revise the entry for ``017790'' to read as 
follows:

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

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

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
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                                * * * * *
Provimi North America, Inc., 6531 State Rte. 503,                 017790
 Lewisburg, OH 45338....................................
 
                                * * * * *
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     (2) * * *

------------------------------------------------------------------------
             Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
017790....................................  Provimi North America, Inc.,
                                             6531 State Rte. 503,
                                             Lewisburg, OH 45338.
 
                                * * * * *
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    Dated: October 28, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2010-28307 Filed 11-9-10; 8:45 am]
BILLING CODE 4160-01-P