[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Page 12068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03963]
[[Page 12068]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Device Good Manufacturing Practice 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 (Agency or FDA). The
meeting will be open to the public.
Name of Committee: Device Good Manufacturing Practice 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 April 11, 2013, from 8
a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is 301-977-8900.
Contact Person: Natasha Facey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg
66, rm. 1544, Silver Spring, MD 20993-0002, 301-796-5290,
[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 April 11, 2013, the committee will discuss the potential
effects of extreme weather and natural disasters on medical device
manufacturing chain processes and marketed medical device safety and
quality. The committee will further discuss how to optimize the use of
FDA's current regulatory framework to address risks and vulnerabilities
to the manufacturing chain resulting from extreme weather conditions.
Future steps may be identified to help industry mitigate or better
tolerate challenges to the manufacturing chain as a result of extreme
weather conditions. In a separate Federal Register notice, FDA is
seeking additional broad public input about the effects of extreme
weather on medical device safety and quality.
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 pending before the committee.
Written submissions may be made to the contact person on or before
April 4, 2013. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 p.m. Oral presentations from
industry, professional organizations, and societies that have an
interest in this topic 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 March 27, 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 March 29,
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 AnnMarie Williams,
Committee Management Staff, at [email protected] or 301-
796-5966, 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: February 14, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-03963 Filed 2-20-13; 8:45 am]
BILLING CODE 4160-01-P