[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