Determination of Regulatory Review Period for Purposes of Patent Extension; PRISTIQ; Correction and Reopening of the Comment Period, 28235 [2011-11903]

Download as PDF erowe on DSK5CLS3C1PROD with NOTICES Federal Register / Vol. 76, No. 94 / Monday, May 16, 2011 / Notices the ACA and hence eligible for the Rate Review Grants. 46 States and 5 U.S. territories plus the District of Columbia were awarded grants. CCIIO is seeking to publish the Cycle II Funding Opportunity Announcement and associated grantee reporting requirements consisting of (4) Quarterly reports, rate review transaction data (quarterly), (1) annual report per year, and (1) final report from all grantees. This information collection is required for effective monitoring of grantees and to fulfill statutory requirements under Section 2794(b)(1)(a) that requires grantees, as a condition of receiving a grant authorized under Section 2794(c), to report to The Secretary information about premium increases. Form Number: CMS–10380 (OCN: 0938– 1121); Frequency: Annually, On Occasion; Affected Public: Public Sector: State and Territory Governments; Number of Respondents: 107; Number of Responses: 1,075; Total Annual Hours 42,872. (For policy questions regarding this collection, contact Jacqueline Roche at 301–492– 4171. For all other issues call (410) 786– 1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web site at https://www.cms.gov/ PaperworkReductionActof1995/PRAL/ list.asp#TopOfPage or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office at 410–786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by July 15, 2011: 1. Electronically. You may submit your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. VerDate Mar<15>2010 15:14 May 13, 2011 Jkt 223001 Dated: May 10, 2011. Martique Jones, Director, Regulations Development Group, Division B, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2011–11836 Filed 5–13–11; 8:45 am] BILLING CODE 4120–01–P 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. Notice; correction and reopening of the comment period. ACTION: 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 https:// 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: SUMMARY: 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, PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 28235 ‘‘[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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Neurodifferentiation, Plasticity, and Regeneration Study Section, June 1, 2011, 8 a.m. to June 2, 2011, 4 p.m., Westin Alexandria, 400 Courthouse Square, Alexandria, VA 22314 which was published in the Federal Register on May 9, 2011, 76 FR 26736–26737. The meeting will be held at the Hotel Monaco, 480 King Street, Alexandria, VA 22314. The meeting dates and time E:\FR\FM\16MYN1.SGM 16MYN1

Agencies

[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]


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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 https://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

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