[Federal Register: August 27, 2001 (Volume 66, Number 166)]
[Notices]
[Page 45053]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au01-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Circulatory System 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: Circulatory System 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 10, 2001, from
9 a.m. to 6 p.m., and September 11, 2001, from 8 a.m. to 6 p.m.
Location: Marriott Hotel, Salons D, E, and F, 9751 Washingtonian
Blvd., Gaithersburg, MD.
Contact: Megan Moynahan, Center for Devices and Radiological Health
(HFZ-450), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-443-8517, ext. 171, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12625. Please call the Information Line for up-to-date
information on this meeting.
Agenda: On September 10, 2001, the committee will discuss, make
recommendations, and vote on two premarket approval applications (PMAs)
for septal occluders. On September 11, 2001, the committee will
discuss, make recommendations, and vote on two PMAs, one for a surgical
sealant and one for a biological glue. Background information for each
day's topic, 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://www.fda.gov/cdrh/panelmtg.html. Material for the
September 10, 2001, meeting will be posted on September 7, 2001;
material for the September 11, 2001, meeting will be posted on
September 10, 2001.
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 31,
2001. On both days, oral presentations from the public will be
scheduled for approximately 30 minutes at the beginning of each topic
and for approximately 30 minutes near the end of the committee
deliberations. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person before August 31, 2001, 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 20, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-21528 Filed 8-24-01; 8:45 am]
BILLING CODE 4160-01-S