Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 42097 [E6-11773]

Download as PDF Federal Register / Vol. 71, No. 142 / Tuesday, July 25, 2006 / Notices Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 17, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–11772 Filed 7–24–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES ACTION: Notice. 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 the Committee: Obstetrics and Gynecology 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 29, 2006, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Montgomery Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact: Michael Bailey, Center for Devices and Radiological Health (HFZ– 470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–1180 or FDA Advisory Committee Information Hotline, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512524. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss, make recommendations, and vote on a premarket approval application for a non-invasive device for use as a complement to clinical breast examination in asymptomatic women between the ages of 30 to 39. Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at https://www.fda.gov/cdrh/ panel (click on ‘‘Upcoming CDRH Advisory Panel/Committee Meetings’’). Procedure: Interested persons may present data, information, or views, VerDate Aug<31>2005 18:02 Jul 24, 2006 Jkt 208001 orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 22, 2006. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 8:45 a.m., and between approximately 3:30 p.m. and 4 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person 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 on or before August 22, 2006. 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 least 7 days in advance of the meeting at 301–827–7291. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 17, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–11773 Filed 7–24–06; 8:45 am] BILLING CODE 4160–01–S 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. 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: 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. PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 42097 Date and Time: The meeting will be held on August 24, 2006, from 8 a.m. to 5 p.m., and on August 25, 2006, from 9 a.m. to 5 p.m. Location: Holiday Inn, Walker/ Whetstone Rooms, Two Montgomery Village Ave., 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 24, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients and a second PMA for the same device intended for use as a filler material to restore soft tissue facial contours such as nasolabial folds. On August 25, 2006, the committee will discuss and make recommendations on the reclassification, to Class II, of a Class III medical device: Cyanoacrylate tissue adhesive. 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 https://www.fda.gov/cdrh/panel (click on ‘‘Upcoming CDRH Advisory Panel/ Committee Meetings’’). Material for the August 24 and 25 sessions will be posted on August 23, 2006. Procedure: On August 24, 2006, from 8 a.m. to 5 p.m., and on August 25, 2006, from 9:30 a.m. to 5 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 on or before August 10, 2006. On August 24, 2006, oral presentations from the public will be scheduled between approximately 8:30 a.m. and 9 a.m., approximately 11:45 a.m. and 12:15 p.m., approximately 1:45 p.m. and 2:15 p.m., and approximately 3:45 p.m. and 4:15 p.m. On August 25, 2006, oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the E:\FR\FM\25JYN1.SGM 25JYN1

Agencies

[Federal Register Volume 71, Number 142 (Tuesday, July 25, 2006)]
[Notices]
[Page 42097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11773]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Obstetrics and Gynecology Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

    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 the Committee: Obstetrics and Gynecology 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 29, 2006, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Montgomery 
Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact: Michael Bailey, Center for Devices and Radiological Health 
(HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-1180 or FDA Advisory Committee Information 
Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014512524. Please call the Information Line for up-to-date information 
on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for a non-invasive device for use 
as a complement to clinical breast examination in asymptomatic women 
between the ages of 30 to 39. Background information, including the 
agenda and questions for the committee, will be available to the public 
one business day before the meeting on the Internet at https://
www.fda.gov/cdrh/panel (click on ``Upcoming CDRH Advisory Panel/
Committee Meetings'').
    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 on or before 
August 22, 2006. Oral presentations from the public will be scheduled 
between approximately 8:15 a.m. and 8:45 a.m., and between 
approximately 3:30 p.m. and 4 p.m. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person 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 on or before 
August 22, 2006.
    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 
least 7 days in advance of the meeting at 301-827-7291.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 17, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11773 Filed 7-24-06; 8:45 am]
BILLING CODE 4160-01-S

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