Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 36402 [05-12401]
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36402
Federal Register / Vol. 70, No. 120 / Thursday, June 23, 2005 / Notices
K.A.
Jagannathan, Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, phone: 202–205–4829.
FOR FURTHER INFORMATION CONTACT:
Dated: June 18, 2005.
Naomi Goldstein,
Director, Office of Planning, Research and
Evaluation.
[FR Doc. 05–12431 Filed 6–22–05; 8:45 am]
BILLING CODE 4184–01–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 July 15, 2005, from 8:30 a.m. to 5 p.m.
Location: Holiday Inn, Ballroom, Two
Montgomery Village Ave., Gaithersburg, MD.
Contact Person: Rufina Carlos, Center for
Devices and Radiological Health (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 hear a
presentation on the FDA Critical Path
Initiative and a presentation by the Office of
Surveillance and Biometrics in the Center for
Devices and Radiological Health outlining
their responsibility for the review of
postmarket study design. The committee will
also discuss, make recommendations, and
vote on a premarket approval application for
a laboratory assay designed to measure levels
of neural thread protein in urine specimens
from patients presenting with cognitive
complaints or other signs and symptoms of
suspected Alzheimer’s disease. Results from
VerDate jul<14>2003
18:40 Jun 22, 2005
Jkt 205001
this test are intended for use, in conjunction
with and not in lieu of current standard
diagnostic procedures, to aid the physician in
the differential diagnosis of Alzheimer’s
disease.
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/
panelmtg.html.
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 July 1, 2005.
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 before July 1, 2005,
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.
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
240–276–0450, ext. 105, 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: June 15, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–12401 Filed 6–22–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
Reports, Forms, and Recordkeeping
Requirements: Agency Information
Collection Activity Under OMB Review;
TSA Airspace Waiver Program
Transportation Security
Administration (TSA), DHS.
AGENCY:
PO 00000
Frm 00036
Fmt 4703
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ACTION:
Notice.
SUMMARY: This notice announces that
TSA has forwarded the Information
Collection Request (ICR) abstracted
below to the Office of Management and
Budget (OMB) for review and clearance
under the Paperwork Reduction Act.
The ICR describes the nature of the
information collection and its expected
burden. TSA published a Federal
Register notice, with a 60-day comment
period soliciting comments, of the
following collection of information on
November 22, 2004, 69 FR 67933.
Send your comments by July 25,
2005. A comment to OMB is most
effective if OMB receives it within 30
days of publication.
DATES:
Comments may be faxed to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: DHS–TSA Desk
Officer, at (202) 395–5806.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Katrina Wawer, Information Collection
Specialist, Office of Transportation
Security Policy, TSA–9, Transportation
Security Administration, 601 South
12th Street, Arlington, VA 22202–4220;
telephone (571) 227–1995; facsimile
(571) 227–2594.
SUPPLEMENTARY INFORMATION:
Transportation Security Administration
(TSA)
Title: TSA Airspace Waiver Program.
Type of Request: New collection.
OMB Control Number: Not yet
assigned.
Form(s): TSA Waiver Request Form.
Affected Public: General aviation
community.
Abstract: TSA is seeking approval for
this collection of information in order to
operate its airspace waiver program. The
airspace waiver program allows general
aviation aircraft operators to apply for
approval to operate in restricted
airspace. This collection of information
allows TSA to conduct security threat
assessments on these aircraft operators
to enhance the security of aviation and
assets on the ground that are subject to
restricted airspace. TSA is requesting
approval to respond to the needs of the
general aviation community and to
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]]>Agencies
[Federal Register Volume 70, Number 120 (Thursday, June 23, 2005)]
[Notices]
[Page 36402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12401]
-----------------------------------------------------------------------
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 July 15, 2005, from
8:30 a.m. to 5 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Rufina Carlos, Center for Devices and
Radiological Health (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 hear a presentation on the FDA
Critical Path Initiative and a presentation by the Office of
Surveillance and Biometrics in the Center for Devices and
Radiological Health outlining their responsibility for the review of
postmarket study design. The committee will also discuss, make
recommendations, and vote on a premarket approval application for a
laboratory assay designed to measure levels of neural thread protein
in urine specimens from patients presenting with cognitive
complaints or other signs and symptoms of suspected Alzheimer's
disease. Results from this test are intended for use, in conjunction
with and not in lieu of current standard diagnostic procedures, to
aid the physician in the differential diagnosis of Alzheimer's
disease.
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/panelmtg.html.
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 July 1,
2005. 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
before July 1, 2005, 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.
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 240-276-0450, ext. 105, 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: June 15, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-12401 Filed 6-22-05; 8:45 am]
BILLING CODE 4160-01-S
