Determination of Regulatory Review Period for Purposes of Patent Extension; KALBITOR; Correction, 34051 [2012-13902]

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Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: In FR Doc. 2012–26017 in the Federal Register of Wednesday, May 2, 2012, the following correction is made: 1. On page 26017, in the third column, in the last paragraph, ‘‘U.S. Patent Nos. 5,795,685 and 7,276,480’’ is corrected to read ‘‘U.S. Patent Nos. 5,795,865 and 7,276,480.’’ Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Food and Drug Administration Authority: 5 U.S.C. App. 2, section 10(a). Dated: June 5, 2012. Marilyn Tavenner, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2012–13988 Filed 6–7–12; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2010–E–0333 and FDA– 2010–E–0334] Determination of Regulatory Review Period for Purposes of Patent Extension; KALBITOR; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 2, 2012 (77 FR 26017). The document concerned FDA’s determination of the regulatory review period for KALBITOR. The document published with an incorrect patent number for KALBITOR. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:23 Jun 07, 2012 Jkt 226001 Dated: May 29, 2012. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2012–13902 Filed 6–7–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2012–N–0548] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on October 29, 2012, from 8 a.m. to 5 p.m. and October 30, 2012, from 8 a.m. to 3 p.m. ADDRESSES: FDA is opening a docket for public comment on this meeting. The docket number is FDA–2012–N–0548. The docket will open for public comment on June 8, 2012. The docket will close on November 6, 2012. Interested persons may submit either electronic or written comments regarding this meeting. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments received will be posted without change, including any personal information provided. It is only necessary to send one set of comments. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 34051 Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Comments received on or before October 15, 2012, will be provided to the committee before the meeting. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. 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A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On October 29 and 30, 2012, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 77, Number 111 (Friday, June 8, 2012)]
[Notices]
[Page 34051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0333 and FDA-2010-E-0334]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; KALBITOR; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of May 2, 2012 (77 FR 26017). The 
document concerned FDA's determination of the regulatory review period 
for KALBITOR. The document published with an incorrect patent number 
for KALBITOR. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6284, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: In FR Doc. 2012-26017 in the Federal 
Register of Wednesday, May 2, 2012, the following correction is made:
    1. On page 26017, in the third column, in the last paragraph, 
``U.S. Patent Nos. 5,795,685 and 7,276,480'' is corrected to read 
``U.S. Patent Nos. 5,795,865 and 7,276,480.''

    Dated: May 29, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-13902 Filed 6-7-12; 8:45 am]
BILLING CODE 4160-01-P

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