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