[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Notices]
[Page 18765]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ap06-88]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Radiological 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Radiological 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 May 23, 2006, from 9:30
a.m. to 4:30 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Nancy Wersto, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-1212, ext. 144, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512526. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will hear a presentation explaining FDA's
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. Subsequently, FDA will present key points for the
committee to consider for the reclassification of full field digital
mammography (FFDM) systems from Class III to Class II devices. The
committee will discuss and make recommendations on the reclassification
of FFDMs. Background information for this meeting, 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/panel
.
Procedure: On May 23, 2006, from 10 a.m. to 4:30 p.m., the meeting
is open to the public. 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 9, 2006. Oral presentations from the public will be scheduled
between approximately 11:45 a.m. and 12:45 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before May 9, 2006, 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.
Closed Committee Deliberations: On May 23, 2006, from 9:30 a.m. to
10 a.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) on
current and pending issues regarding radiological devices.
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 5, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-5411 Filed 4-11-06; 8:45 am]
BILLING CODE 4160-01-S