[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Rules and Regulations]
[Pages 20522-20523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9045]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
[email protected].
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
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Piramal Critical Care, Inc., 3950 Schelden 060307
Circle, Bethlehem, PA 18017
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
060307..................... Piramal Critical Care, Inc., 3950 Schelden
Circle, Bethlehem, PA 18017
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
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