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U.S. Department of Health and Human Services

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March 25, 2010: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 

 

SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of November 17, 2009 (74 FR 59194). The amendment is being made to reflect a change in the Contact Person and Procedure portions of the document, and to provide notice of the availability of a docket for public comment. There are no other changes. FOR FURTHER INFORMATION CONTACT: Margaret McCabe-Janicki, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., White Oak 66, rm. 1535, Silver Spring, MD 20993, 301-796-7029, or FDA Advisory Committee Information Line, 1-800-741- 8138 (301-443-0572 in the Washington, DC area), code 3014512519. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In FR Doc. E9-27491, appearing on page 59194, in the Federal Register of Tuesday, November 17, 2009, the following corrections are made: 1. On page 59194, in the second column, under Contact Person, the first six lines ``Peter L. Hudson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., White Oak 66, rm. 3618, Silver Spring, MD 20993, 301-796-6440 or FDA Advisory'' are removed and replaced with ``Margaret McCabe-Janicki, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue., White Oak 66, rm. 1535, Silver Spring, MD 20993, 301-796-7029, or FDA Advisory''. 2. On page 59194, in the third column, a Comments portion is added before the Agenda portion of the document to read: ``Comments: FDA is opening a docket for public comment on this document. The docket number is FDA-2009-N-0606. The docket will open for public comment on January 11, 2010. The docket will close on March 19, 2010. Interested persons may submit electronic or written comments regarding this document. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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.'' 3. On pages 59194 and 59195, beginning on page 59194 in the third column, under Procedure, the year ``2009'' is changed to read ``2010'' everywhere that it appears. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: January 5, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010-172 Filed 1-8-10; 8:45 am] BILLING CODE 4160-01-S

General and Plastic Surgery Devices Panel of the Medical Devices 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.

 

Original Meeting Notice is as follows:


Name of Committee: General and Plastic Surgery 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 March 25, 2010, from 8 a.m.
to 6 p.m.


Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: Peter L. Hudson, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., White
Oak 66, rm. 3618, Silver Spring, MD 20993, 301–796–6440 or FDA Advisory
Committee Information Line, 1–800–741–8138 (301–443–0572 in the
Washington, DC area), code 3014512519. Please call the Information Line for
up-to-date information on this meeting. 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 and
call the appropriate advisory committee hot line/phone line to learn about
possible modifications before coming to the meeting.
Agenda: On March 25, 2010, the committee will review and discuss recent
information, including recent literature regarding the possible risks to the
general public from intentional exposure to ultraviolet radiation (UV) from use
of tanning lamps. There continues to be a growing body of literature showing
association of skin cancer with use of tanning lamps and the committee will
discuss this information and other information related to the association of UV
and skin cancer (both melanoma and non-melanoma). The committee will be
asked to recommend whether changes to current classification or current
regulatory controls of UV emitting devices (lamps) used for tanning are needed.
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 link.


Procedure: Interested persons may present data, information, or views
orally or in writing on the issues pending before the committee. Written
submissions may be made to the contact person on or before March 11, 2009.
Oral presentations from the public will be scheduled between approximately
1 p.m. and 2 p.m. Those desiring to make 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 3, 2009. 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 4, 2009.
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, 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: November 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.