[Federal Register: July 27, 2005 (Volume 70, Number 143)]
[Notices]
[Page 43439]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy05-96]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
General and Plastic Surgery 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 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 August 25 and 26, 2005,
from 8 a.m. to 6 p.m on both days.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: David Krause, Center for Devices and Radiological
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-3090, ext. 141, 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.
Agenda: On August 25, 2005, 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. On August 25 and 26, 2005, the committee will discuss and
make recommendations on the classification of five preamendments
medical devices: Bone wax, medical maggots, medicinal leeches, tissue
expander, and wound dressing with a drug. Background information for
this meeting, including the agenda and questions for the committee,
will be made available at least 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 August 11,
2005. On August 25, 2005, oral presentations from the public will be
scheduled between approximately 10:15 a.m. and 10:45 a.m., 1:45 p.m.
and 2:15 p.m., and 4:30 p.m. and 5 p.m. On August 26, 2005, oral
presentations from the public will be scheduled between approximately
9:30 a.m. and 10 a.m., 1 p.m. and 1:30 p.m., and 3:45 p.m. and 4:15
p.m. Time allotted for each presentation may be limited. Those desiring
to make formal oral presentations should notify the contact person
before 5 p.m. on August 11, 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 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: July 20, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-14749 Filed 7-26-05; 8:45 am]
BILLING CODE 4160-01-S