Document ID: FDA-2012-N-0548-0086
Agency: fda
Document Type: Notice
Title: Drug Safety and Risk Management Advisory Committee Notice of Meeting
Posted Date: 2012-12-19T05:00Z

[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75176-75177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30517]

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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.

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    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. This meeting is being rescheduled due to the 
postponement of the October 29-30, 2012, Drug Safety and Risk 
Management Advisory Committee meeting due to unanticipated weather 
conditions caused by Hurricane Sandy.
    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 January 24, 2013, from 8 
a.m. to 6 p.m., and January 25, 2013, from 8 a.m. to 5 p.m. This 
meeting is a reschedule of a postponed meeting announced in the Federal 
Register of June 8, 2012 (77 FR 34051-34052), originally scheduled for 
October 29-30, 2012.

ADDRESSES: FDA has opened a docket for public comment on this meeting. 
The docket number is FDA-2012-N-0548. The docket opened for public 
comment on June 8, 2012. The docket will close on February 1, 2013. 
Interested persons may submit either electronic or written comments 
regarding this meeting. Submit electronic comments to http://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 January 9, 2013, will be provided to the committee before the 
meeting. Any comments received for the originally scheduled October 29 
and 30, 2012, Drug Safety and Risk Management Advisory Committee 
meeting will be provided to the committee. It is not necessary to 
resubmit any comments previously submitted to the docket. If a comment 
originally submitted to the docket is resubmitted prior to January 9, 
2013, both comments will be provided to the committee.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD, 
20993-

[[Page 75177]]

0002. Information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: http://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). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: On January 24 and 25, 2013, 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. The committee will also discuss the impact of 
rescheduling these hydrocodone products from Schedule III to Schedule 
II.
    Background materials for the originally scheduled October 29-30, 
2012, Drug Safety and Risk Management Advisory Committee meeting are 
currently available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm307385.htm. FDA intends 
to make background material available to the public no later than 2 
business days before the January 24 and 25, 2013, Drug Safety and Risk 
Management Advisory Committee meeting at: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate 
advisory committee meeting link. If FDA is unable to post background 
material on its Web site prior to the meeting, the background material 
will be made publicly available at the location of the advisory 
committee meeting, and background material will be posted on FDA's Web 
site after the meeting.
    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 January 9, 2013, will 
be provided to the committee. Oral presentations from the public will 
be scheduled between approximately 8:15 a.m. and 10:15 a.m. on January 
25, 2013. Those individuals interested in making formal oral 
presentations, including those who have previously requested time to 
speak at the originally scheduled October 29-30, 2012, Drug Safety and 
Risk Management Advisory Committee meeting, 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 January 3, 2013. Any 
individuals who requested time to speak at the originally scheduled 
October 29-30, 2012, Drug Safety and Risk Management Advisory Committee 
meeting, will need to follow the above instructions to request time to 
speak at the January 24-25, 2013, Drug Safety and Risk Management 
Advisory Committee meeting, as any previous requests to speak at the 
originally scheduled meeting do not convey to this new January 24-25, 
2013, Drug Safety and Risk Management Advisory Committee meeting. 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 January 4, 2013.
    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 http://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: December 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30517 Filed 12-18-12; 8:45 am]
BILLING CODE 4160-01-P