Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 41937-41938 [2013-16711]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Notices]
[Pages 41937-41938]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16711]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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: 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: 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, 
Daniel.Sigelman@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 https://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 https://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 https://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 https://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 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: 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