Document ID: FDA-2010-N-0002-0095
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Change of Sponsor's Name and Address; Corrections
Posted Date: 2011-03-24T04:00Z

[Federal Register Volume 76, Number 57 (Thursday, March 24, 2011)]
[Rules and Regulations]
[Pages 16532-16533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6795]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529

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

New Animal Drugs; Change of Sponsor's Name and Address; 
Corrections

AGENCY: Food and Drug Administration, HHS.

ACTION: Correcting amendments.

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SUMMARY: The Food and Drug Administration (FDA) published a document in 
the Federal Register of April 20, 2010 (75 FR 20522) amending the 
animal drug regulations to reflect changes to a sponsor's name and 
address. That document contained errors in the regulatory text. FDA is 
correcting the tables listing sponsors of approved animal drug 
applications (NADAs) by adding a change to the sponsor's drug labeler 
code (DLC). Cross-references to the sponsor's DLC are amended in two 
sections of the Code of Federal Regulations (CFR) containing the 
conditions of use approved animal drug products. These corrections are 
being made to improve the accuracy of the animal drug regulations.

DATES: This rule is effective March 24, 2011.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) 
published a document in the Federal Register of April 20, 2010 (75 FR 
20522) amending the animal drug regulations to reflect changes to a 
sponsor's name and address. That document contained errors in the 
regulatory text. FDA is correcting the tables listing sponsors of 
approved animal drug applications (NADAs) by adding a change to the 
sponsor's drug labeler code (DLC). Cross-references to the sponsor's 
DLC are amended in two sections of the Code of Federal Regulations 
(CFR) containing the conditions of use approved animal drug products. 
These corrections are being made to improve the accuracy of the animal 
drug regulations.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and Recordkeeping requirements.

21 CFR Part 529

    Animal drugs.

    Accordingly, 21 CFR parts 510 and 529 are corrected by making the 
following correcting amendments:

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 ``Piramal Critical Care, Inc.''; and in the table in paragraph 
(c)(2), remove the

[[Page 16533]]

entry for ``060307'' and in numerical sequence, add an entry for 
``066794'' 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
------------------------------------------------------------------------
 
                                * * * * *
Piramal Critical Care, Inc., 3850 Schelden Circle,                066794
 Bethlehem, PA 18017.......................................
 
                                * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                                * * * * *
066794............................  Piramal Critical Care, Inc., 3850
                                     Schelden Circle, Bethlehem, PA
                                     18017.
 
                                * * * * *
------------------------------------------------------------------------

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec.  529.1186  [Corrected]

0
4. In paragraph (b) of Sec.  529.1186, remove ``060307, and 065085'' 
and in its place add ``065085, and 066794''.

Sec.  529.2150  [Corrected]

0
5. In paragraph (b) of Sec.  529.2150, remove ``060307'' and in its 
place add ``066794''.

    Dated: March 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6795 Filed 3-23-11; 8:45 am]
BILLING CODE 4160-01-P