General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 62419 [2011-25969]

Download as PDF Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.) Dated: October 4, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2011–25976 Filed 10–6–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. jlentini on DSK4TPTVN1PROD 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 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 December 1, 2011, from 8 a.m. to 6 p.m. Location: Hilton Washington, DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Avena Russell, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993–0002, 301–796–3805, Avena.Russell@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about VerDate Mar<15>2010 16:33 Oct 06, 2011 Jkt 226001 possible modifications before coming to the meeting. Agenda: On December 1, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Contura, Inc., for AQUAMID, a new material (polyacrylamide) for use as a dermal filler for aesthetic treatment of wrinkles in the face. The AQUAMID dermal filler is intended for use in midto-deep sub-dermal implantation for the aesthetic treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https:// www.fda.gov/AdvisoryCommittees/ Calendar/default.htm. Scroll down to the appropriate advisory committee link. 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 November 22, 2011. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m., immediately following lunch. Those individuals interested in making 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 November 14, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 15, 2011. 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 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 62419 disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, 301–796–5966, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 4, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2011–25969 Filed 10–6–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0695] Science of Abuse Liability Assessment; Public Workshop AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public workshop to discuss the science of abuse liability assessment. The Controlled Substance Staff (CSS) in FDA’s Center for Drug Evaluation and Research, Office of the Center Director; the National Institute on Drug Abuse (NIDA) at the National Institutes of Health; and the College on Problems of Drug Dependence (CPDD) at the Temple University School of Medicine are cosponsoring the 1-day workshop. Date and Time: The public workshop will be held on Thursday, November 10, 2011, from 8 a.m. to 5 p.m. Location: The public workshop will be held at The Legacy Hotel and Meeting Centre, 1775 Rockville Pike, Rockville, MD 20852, 301–881–2300, accessible on the Metro Red Line, Twinbrook Station. Contact Person: Ellen B. Geller, CPDD, Temple University School of Medicine, 3400 North Broad Street, Philadelphia, PA 19140, 215–707–5307, e-mail: ebgeller@temple.edu; or Corinne P. Moody, Center for Drug Evaluation and Research, Food and Drug E:\FR\FM\07OCN1.SGM 07OCN1

Agencies

[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Page 62419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25969]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


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). 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 December 1, 2011, from 8 
a.m. to 6 p.m.
    Location: Hilton Washington, DC North/Gaithersburg, Salons A, B, C 
and D, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Avena Russell, Food and Drug Administration, Center 
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 
66, rm. 1535, Silver Spring, MD 20993-0002, 301-796-3805, 
Avena.Russell@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow 
the prompts to the desired center or product area. Please call the 
Information Line for up-to-date information on this meeting. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On December 1, 2011, the committee will discuss, make 
recommendations, and vote on information related to the premarket 
approval application, sponsored by Contura, Inc., for AQUAMID, a new 
material (polyacrylamide) for use as a dermal filler for aesthetic 
treatment of wrinkles in the face. The AQUAMID dermal filler is 
intended for use in mid-to-deep sub-dermal implantation for the 
aesthetic treatment of moderate to severe facial wrinkles and folds, 
such as the nasolabial folds. FDA intends to make background material 
available to the public no later than 2 business days before the 
meeting. If FDA is unable to post the background material on its Web 
site prior to the meeting, the background material will be made 
publicly available at the location of the advisory committee meeting, 
and the background material will be posted on FDA's Web site after the 
meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate 
advisory committee link.
    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 
November 22, 2011. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m., immediately following lunch. 
Those individuals interested in making 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 
November 14, 2011. Time allotted for each presentation may be limited. 
If the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by November 15, 
2011.
    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, 301-796-5966, at least 7 days in advance 
of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 4, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-25969 Filed 10-6-11; 8:45 am]
BILLING CODE 4160-01-P

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