Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 58416 [E6-16319]
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Federal Register / Vol. 71, No. 191 / Tuesday, October 3, 2006 / Notices
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VerDate Aug<31>2005
19:59 Oct 02, 2006
Jkt 211001
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: September 28, 2006.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. 06–8430 Filed 9–29–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Immunology 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: Immunology
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 November 16, 2006, from 8 a.m.
to 5 p.m.
Location: Holiday Inn, Walker/
Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Rufina Carlos, Office
of In Vitro Diagnostic Device Evaluation
and Safety (HFZ–440), Food and Drug
Administration, 2098 Gaither Rd.,
Rockville, MD. 20850, 240–276–0493
ext. 167, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512516. 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
laboratory assay designed for the rapid
detection of clinically relevant (greater
than 0.2 millimeters) metastases in
lymph node tissue removed from breast
cancer patients. Results from the assay
can be used to guide the surgeon’s
decision to excise additional lymph
nodes and aid in staging.
Background information for the 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 https://
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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 October 30, 2006.
Oral presentations from the public will
be scheduled for approximately 30
minutes at the beginning of committee
deliberations and for approximately 30
minutes near the end of the
deliberations. 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 October
30, 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 Shirley
Meeks, Conference Management Staff, at
301–827–7292, 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: September 25, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–16319 Filed 10–2–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERIVCES
Health Resources and Services
Administration
Agency Information Collection
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Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506 (c)(2)(A) of Title 44,
United States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 71, Number 191 (Tuesday, October 3, 2006)]
[Notices]
[Page 58416]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16319]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Immunology 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: Immunology 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 November 16, 2006, from
8 a.m. to 5 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Rufina Carlos, Office of In Vitro Diagnostic Device
Evaluation and Safety (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD. 20850, 240-276-0493 ext. 167, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512516. 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 laboratory assay designed for
the rapid detection of clinically relevant (greater than 0.2
millimeters) metastases in lymph node tissue removed from breast cancer
patients. Results from the assay can be used to guide the surgeon's
decision to excise additional lymph nodes and aid in staging.
Background information for the 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 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
October 30, 2006. Oral presentations from the public will be scheduled
for approximately 30 minutes at the beginning of committee
deliberations and for approximately 30 minutes near the end of the
deliberations. 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 October 30, 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 Shirley Meeks,
Conference Management Staff, at 301-827-7292, 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: September 25, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16319 Filed 10-2-06; 8:45 am]
BILLING CODE 4160-01-S
