Document ID: FDA-2011-N-0003-0020
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor's Address
Posted Date: 2011-07-06T04:00Z

[Federal Register Volume 76, Number 129 (Wednesday, July 6, 2011)]
[Rules and Regulations]
[Page 39278]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16845]

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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 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 address for Huvepharma AD, a 
sponsor of approved new animal drug applications.

DATES: This rule is effective July 6, 2011.

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: Huvepharma AD, 33 James Boucher Blvd., 
Sophia 1407, Bulgaria, has informed FDA that it has changed its address 
to 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria. 
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.

    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), revise the entry 
for ``Huvepharma AD''; and in the table in paragraph (c)(2), revise the 
entry for ``016592'' to read as follows:

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

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

------------------------------------------------------------------------
                                                                  Drug
                    Firm name and address                       labeler
                                                                  code
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                                * * * * *
Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia,     016592
 Bulgaria....................................................
 
                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
016592............................  Huvepharma AD, 5th Floor, 3A Nikolay
                                     Haitov Str., 1113 Sofia, Bulgaria.
 
                                * * * * *
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    Dated: June 24, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2011-16845 Filed 7-5-11; 8:45 am]
BILLING CODE 4160-01-P