Document ID: FDA-2009-E-0084-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension: PRISTIQ; Correction
Posted Date: 2011-05-16T04:00Z

[Federal Register Volume 76, Number 94 (Monday, May 16, 2011)]
[Notices]
[Page 28235]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11903]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-E-0084 and FDA-2009-E-0086]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; PRISTIQ; Correction and Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction and reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting notices 
concerning FDA's determination of the regulatory review period for 
PRISTIQ that appeared in the Federal Registers of August 31, 2010 (75 
FR 53314) and September 2, 2010 (75 FR 53969). The documents omitted 
docket number FDA-2009-E-0086. This document corrects those omissions. 
Because the comment period for the notices closed on February 28, 2011, 
FDA is reopening the comment period to allow interested parties to 
submit comments or petitions to docket number FDA-2009-E-0086.

DATES: Submit either electronic or written comments and written 
petitions by June 15, 2011.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION:

I. Correction

    In FR Doc. 2010-21586, appearing on page 53314, in the Federal 
Register of Tuesday, August 31, 2010, the following correction is made:
    1. On page 53314, in the first column, in the heading of the 
document, ``[Docket No. FDA-2009-E-0084]'' is corrected to read 
``[Docket Nos. FDA-2009-E-0084 and FDA-2009-E-0086]''.
    In FR Doc. C1-2010-21586, appearing on page 53969, in the Federal 
Register of Thursday, September 2, 2010, the following correction is 
made:
    2. On page 53969, in the third column, in the heading of the 
document, ``[Docket No. FDA-2009-E-0084]'' is corrected to read 
``[Docket Nos. FDA-2009-E-0084 and FDA-2009-E-0086]''.

II. Comments and Petitions

    FDA's notice concerning the Agency's determination of the 
regulatory review period for PRISTIQ (75 FR 53314) inadvertently 
omitted docket number FDA-2009-E-0086. Because the period for 
submitting comments and petitions closed on February 28, 2011, FDA is 
reopening the comment period to provide the opportunity for interested 
parties to submit comments or petitions to docket number FDA-2009-E-
0086.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is no longer necessary to send three copies of mailed comments. 
However, if you submit a written petition, you must submit three copies 
of the petition. Identify comments with docket number FDA-2009-E-0086. 
Comments and petitions that have not been made publicly available on 
regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 28, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-11903 Filed 5-13-11; 8:45 am]
BILLING CODE 4160-01-P