[Federal Register: May 6, 2005 (Volume 70, Number 87)]
[Notices]               
[Page 24080]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06my05-88]                         


[[Page 24080]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Gastroenterology and Urology 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: Gastroenterology and Urology 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 June 8, 2005, from 9 
a.m. to 5 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: Jeffrey Cooper, Center for Devices and Radiological 
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-1220, ext. 121, or FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512523. Please call the information Line for up-to-date 
information on this meeting.
    Agenda: The committee will hear a presentation on the FDA Critical 
Path Initiative and a presentation by the Office of Surveillance and 
Biometrics in the Center for Devices and Radiological Health outlining 
their responsibility for the review of postmarket study design. The 
committee will also discuss and make recommendations regarding general 
issues related to the premarket requirements for the safe and effective 
use of hemodialysis equipment labeled for nocturnal hemodialysis 
therapies. 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 May 25, 2005. 
Oral presentations from the public will be scheduled for approximately 
30 minutes at the beginning of committee deliberations and for 
approximately 30 minutes near the end of the deliberations. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person by May 25, 
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 Williams, 
Conference Management Staff, 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: April 28, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-9008 Filed 5-5-05; 8:45 am]

BILLING CODE 4160-01-S