Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 44273 [2010-18416]
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Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Radiological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD 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: 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 September 24, 2010, 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: Shanika Craig, Food
and Drug Administration, Center for
Devices and Radiological Health, 10903
New Hampshire Ave., Bldg 66, rm.
1613, Silver Spring, MD 20993–0002,
301–796–6639, 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. 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 September 24, 2010, the
committee will discuss, make
recommendations, and vote on a
premarket approval application for the
Selenia C Digital Breast Tomosynthesis
System, sponsored by Hologic, Inc. The
Selenia C Digital Breast Tomosynthesis
System is intended for use in the same
clinical applications as traditional
mammographic systems.
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
VerDate Mar<15>2010
19:05 Jul 27, 2010
Jkt 220001
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 September 16, 2010.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m., immediately following
lunch. 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 September 9, 2010. 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
September 10, 2010.
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/Advisory
Committees/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).
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
44273
Dated: July 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–18416 Filed 7–27–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; Supplemental Center Grants
For Community Outreach.
Date: August 12, 2010.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709 (Telephone
Conference Call).
Contact Person: Linda K. Bass, PhD,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research and Training, Nat. Institute
Environmental Health Sciences, P.O. Box
12233, MD EC–30, Research Triangle Park,
NC 27709, (919) 541–1307,
malone@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation Health Risks from Environmental
Exposures; 93.142, NIEHS Hazardous Waste
Worker Health and Safety Training; 93.143,
NIEHS Superfund Hazardous Substances—
Basic Research and Education; 93.894,
Resources and Manpower Development in
the Environmental Health Sciences; 93.113,
Biological Response to Environmental Health
Hazards; 93.114, Applied Toxicological
Research and Testing, National Institutes of
Health, HHS)
E:\FR\FM\28JYN1.SGM
28JYN1
]]>Agencies
[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Notices]
[Page 44273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18416]
[[Page 44273]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Radiological 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: 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 September 24, 2010, 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: Shanika Craig, Food and Drug Administration, Center
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg 66,
rm. 1613, Silver Spring, MD 20993-0002, 301-796-6639, 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. 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 September 24, 2010, the committee will discuss, make
recommendations, and vote on a premarket approval application for the
Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic,
Inc. The Selenia C Digital Breast Tomosynthesis System is intended for
use in the same clinical applications as traditional mammographic
systems.
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
September 16, 2010. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m., immediately
following lunch. 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
September 9, 2010. 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 September 10,
2010.
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: July 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-18416 Filed 7-27-10; 8:45 am]
BILLING CODE 4160-01-S
