Document ID: FDA-2010-N-0002-0029
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor
Posted Date: 2010-04-20T04:00Z

[Federal Register: April 20, 2010 (Volume 75, Number 75)]
[Rules and Regulations]               
[Page 20522-20523]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap10-6]                         

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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 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 Minrad, 
Inc. to Piramal Critical Care, Inc. The sponsor's mailing address will 
also be changed.

DATES: This rule is effective April 20, 2010.

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: Minrad, Inc., 836 Main St., 2d floor, 
Buffalo, NY 14202 has informed FDA that it has changed its name and 
address to Piramal Critical Care, Inc., 3950 Schelden Circle, 
Bethlehem, PA 18017. Accordingly, the agency is amending the 
regulations in 21 CFR 510.600(c) to reflect this change.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because

[[Page 20523]]

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 ``Minrad, Inc.'' and alphabetically add a new entry for ``Piramal 
Critical Care, Inc.''; and in the table in paragraph (c)(2), revise the 
entry for ``060307'' 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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Piramal Critical Care, Inc., 3950 Schelden    060307
 Circle, Bethlehem, PA 18017
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                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
060307.....................  Piramal Critical Care, Inc., 3950 Schelden
                              Circle, Bethlehem, PA 18017
------------------------------------------------------------------------
                                * * * * *
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    Dated: April 15, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-9045 Filed 4-19-10; 8:45 am]
BILLING CODE 4160-01-S