Determination of Regulatory Review Period for Purposes of Patent Extension; PRISTIQ; 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.

References

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