[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Notices]
[Pages 41937-41938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16711]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0816]
Joint Meeting of the Gastroenterology-Urology Panel and the
Radiological Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting
AGENCY: Office of the Commissioner, 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.
Name of Committee: Gastroenterology-Urology Panel and Radiological
Devices Panel of the Medical Devices 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 September 9, 2013, from
8 a.m. to 6 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993.
Information regarding special accommodations due to a disability,
[[Page 41938]]
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: Daniel Sigelman, Food and Drug Administration,
Office of the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm.
4254, Silver Spring, MD 20993-0002, 301-796-4706,
[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 September 9, 2013, the joint committee, convened by the
Office of the Commissioner, will discuss current evidence on the risks
and benefits of computed tomography colonography for screening of
asymptomatic patients for colorectal cancer. The joint committee will
provide advice that will assist FDA's consideration of evolving
research on this topic and inform the Agency's continuing regulation of
these devices.
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 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 http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues being discussed at the meeting
pending before the committee. Written submissions may be made to the
docket on or after July 12, 2013. Oral presentations from the public
will be scheduled between approximately 1 p.m. and 2 p.m. 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
August 22, 2013. 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 August 29, 2013.
FDA has opened a docket for public comment on this meeting. The
docket number is FDA-2013-N-0816. The docket will open for public
comment on July 12, 2013. Comments received to the docket on or before
September 3, 2013, will be provided to the committee before the
meeting. Comments received after that date will not be provided to the
committee, but will be taken into consideration by the Agency. The
docket will remain open for 30 days after the meeting for additional
written submissions.
Interested persons may submit either electronic comments regarding
this meeting to http://www.regulations.gov or 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 FDA-2013-N-0816. Received comments may
be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
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 Daniel Sigelman 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: July 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16711 Filed 7-11-13; 8:45 am]
BILLING CODE 4160-01-P