[Federal Register: September 1, 2005 (Volume 70, Number 169)]
[Notices]
[Page 52110]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se05-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
General Hospital and Personal Use Devices Panel of the Medical
Devices 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 (FDA). The meeting will
be open to the public.
Name of Committee: General Hospital and Personal Use 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 27, 2005, from
8 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Scott Colburn, Center for Devices and Radiological
Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-1287, ext. 177, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512520. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will hear a presentation on FDA's Critical
Path Initiative. Subsequently, the committee will discuss and make
recommendations regarding general issues related to the model used for
validation testing to support a claim of decontamination of potentially
transmissible spongiform encephalopathy (TSE)-contaminated surgical
instruments. Background information for the topics, including the
agenda and questions for the committee, will be available to the public
1 business day before the meeting, on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html
.
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 by September 13,
2005. Oral presentations from the public will be scheduled for
approximately 60 minutes at the beginning of deliberations and for
approximately 30 minutes near the end of deliberations. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before September
13, 2005, 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.
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 Willliams
at 240-276-0450, ext. 113, at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 23, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-17412 Filed 8-31-05; 8:45 am]
BILLING CODE 4160-01-S