Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 34051-34052 [2012-13868]

Download as PDF Federal Register / Vol. 77, No. 111 / Friday, June 8, 2012 / Notices • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. • Inspection of vehicle’s interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. • Inspection, via metal detector or other applicable means, of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. 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. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Kristina Toliver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, email: DSaRM@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. 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 mstockstill on DSK4VPTVN1PROD with NOTICES 34052 Federal Register / Vol. 77, No. 111 / Friday, June 8, 2012 / Notices location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see the ADDRESSES section of this document) on or before October 15, 2012, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 9:15 a.m. on October 30, 2012. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 4, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 5, 2012. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristina Toliver at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 4, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–13868 Filed 6–7–12; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 16:23 Jun 07, 2012 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0494] Pfizer, Inc.; Withdrawal of Approval of Familial Adenomatous Polyposis Indication for CELEBREX AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of the familial adenomatous polyposis (FAP) indication for CELEBREX (celecoxib) Capsules held by Pfizer, Inc. (Pfizer), 235 East 42nd St., New York, NY 10017–5755. Pfizer has voluntarily requested that approval of this indication be withdrawn, thereby waiving its opportunity for a hearing. DATES: Effective June 8, 2012. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6250, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: FDA approved the FAP indication for CELEBREX on December 23, 1999, under the Agency’s accelerated approval regulations, 21 CFR part 314, subpart H. In addition to FAP, CELEBREX is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in patients 2 years and older, ankylosing spondylitis, primary dysmenorrhea, and for the management of acute pain in adults. Withdrawal of approval of the FAP indication does not affect any other approved indication for CELEBREX. On February 2, 2011, FDA requested that Pfizer voluntarily withdraw the FAP indication for CELEBREX (celecoxib) Capsules from the market because the postmarketing study intended to verify clinical benefit and required as a condition of approval under subpart H was never completed. In a letter dated February 3, 2011, Pfizer requested that FDA withdraw the FAP indication for CELEBREX (celecoxib) Capsules from the market. In that letter, Pfizer waived any opportunity for a hearing otherwise provided under 21 CFR 314.150 and 314.530, and noted that withdrawal of the FAP indication was not ‘‘due to any new efficacy or safety data.’’ In FDA’s letter of February 4, 2011, the Agency acknowledged Pfizer’s agreement to permit FDA to withdraw the FAP indication for CELEBREX (celecoxib) SUMMARY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Capsules under 21 CFR 314.150(d) and waive its opportunity for a hearing. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) and 21 CFR 314.150(d), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of the FAP indication for CELEBREX (celecoxib) Capsules is withdrawn (see DATES). Dated: May 4, 2012. Janet Woodcock, Director, Center for Drug Evaluation and Research. [FR Doc. 2012–13900 Filed 6–7–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Form I–102; Revision of an Existing Information Collection; Comment Request 30-Day Notice of Information Collection Under Review; Form I–102, Application for Replacement/Initial Nonimmigrant Arrival-Departure Document. ACTION: The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the Federal Register on February 28, 2012 at 77 FR 12070, allowing for a 60-day public comment period. USCIS did not receive any comments for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until July 9, 2012. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Management and Budget (OMB) USCIS Desk Officer. Comments may be submitted to: USCIS, Chief Regulatory Coordinator, Regulatory Coordination Division, Office of Policy and Strategy, Clearance E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 77, Number 111 (Friday, June 8, 2012)]
[Notices]
[Pages 34051-34052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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. 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. Information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Contact Person: Kristina Toliver, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, email: DSaRM@fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and 
follow the prompts to the desired center or product area. Please call 
the Information Line for up-to-date information on this meeting. 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

[[Page 34052]]

location of the advisory committee meeting, and the background material 
will be posted on FDA's Web site after the meeting. Background material 
is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
All electronic and written submissions submitted to the Docket (see the 
ADDRESSES section of this document) on or before October 15, 2012, will 
be provided to the committee. Oral presentations from the public will 
be scheduled between approximately 8:15 a.m. and 9:15 a.m. on October 
30, 2012. Those individuals interested in making formal oral 
presentations should notify the contact person and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their presentation 
on or before October 4, 2012. Time allotted for each presentation may 
be limited. If the number of registrants requesting to speak is greater 
than can be reasonably accommodated during the scheduled open public 
hearing session, FDA may conduct a lottery to determine the speakers 
for the scheduled open public hearing session. The contact person will 
notify interested persons regarding their request to speak by October 
5, 2012.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Kristina Toliver at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13868 Filed 6-7-12; 8:45 am]
BILLING CODE 4160-01-P

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