National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 34461 [2010-14648]
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Federal Register / Vol. 75, No. 116 / Thursday, June 17, 2010 / Notices
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areas of expertise and jurisdiction
between the Agencies. This information
will simplify and expedite the
introduction of new and important
medical technologies and techniques
while maintaining safety and efficacy
levels appropriate to the various
technologies and devices.
During each session, members of the
public may present oral comments
related to the topic of that session.
Specific questions for comment are
listed in section III of this document.
Individuals who are interested in giving
an oral presentation during any of the
sessions must indicate this interest at
the time of registration and must also
identify the session(s) at which they
would like to present (see Registration
and Requests for Oral Presentation). In
order to keep each session focused on
the topic at hand, each oral presentation
should address only the topic specified
for that session. Persons who wish to
comment are free to submit written
comments on any topic(s) to the open
docket (see Comments). FDA and FCC
will schedule speakers for each session
as time permits.
In advance of the meeting, additional
information, including a meeting agenda
with a speakers’ schedule for each
session, will be made available on the
Internet. This information will be
placed on file in the public docket
(docket number found in brackets in the
heading of this document), which is
available at https://www.regulations.gov
and in the FDA and FCC public
reference rooms listed previously. This
information will also be available at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list) and from https://
www.fcc.gov/workshops.
III. Questions for Comment
FDA and FCC are planning to focus
the public meeting on the following
topics:
1. Data integrity and reliability issues
arising from the use of allocated
spectrum, the use of unlicensed devices,
and the use of commercial networks and
applications, and needs, uses, and risks
for ‘medical-grade’ wireless technology
and communications.
2. Medical device and system security
issues—inadvertent and intentional
intrusion—nonfunction and
malfunction.
3. Trends in medical devices using
allocated spectrum and using
unlicensed operation, and medical
devices and applications using
commercial networks. Consideration of
various wireless networking scenarios
and use cases.
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4. Risks Management:
• The need to define levels of
‘‘criticality’’ of device function that can
be used for determining reliability
requirements.
• Environmental factors and delivery
setting—hospitals, users, clinics, home,
travel, etc.
5. Views on current FDA and FCC
regulatory requirements:
• Relationship between FDA
approval/clearance and FCC
certification of applications, post market
and compliance requirements.
Each of the previous topics will cover:
1. Defining topics and scope;
2. Identifying the needs, goals, and
stakeholders; and
3. Recommendations.
FDA and FCC are seeking comments
on the topics and soliciting suggestions
on alternate or additional topics that
commenters deem closely related. All
comments and suggestions will be
considered with the constraint of
completing the workshop in no more
than 2 days. To be considered, topics
proposed must be relevant to the
objective and intent of the workshop.
IV. Transcripts
Transcripts of the public meeting may
be requested in writing from the
Freedom of Information Office (HFI–35),
Food and Drug Administration, 5600
Fishers Lane, rm. 6–30, Rockville, MD
20857 or at the Federal Communications
Commission, Reference Information
Center, 445 12th St. SW., rm. CY–A257,
Washington, DC 20554, Monday
through Thursday, between the hours of
8 a.m. and 4:30 p.m. and on Fridays
between 8 a.m. and 12 noon,
approximately 15 working days after the
public meeting at a cost of 10 cents per
page. A transcript of the public meeting
will be available on the Internet at
https://www.regulations.gov.
Dated: June 14, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–14687 Filed 6–14–10; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; 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
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34461
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 Heart, Lung,
and Blood Institute Special Emphasis Panel,
Effectiveness Research on Smoking Cessation
in Hospitalized Patients.
Date: June 22–23, 2010.
Time: 6 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Shelley S. Sehnert, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7206,
Bethesda, MD 20892–7924. 301–435–
0303.ssehnert@nhlbi.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: June 11, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–14648 Filed 6–16–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
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]]>Agencies
[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Notices]
[Page 34461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14648]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; 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 Heart, Lung, and Blood Institute
Special Emphasis Panel, Effectiveness Research on Smoking Cessation
in Hospitalized Patients.
Date: June 22-23, 2010.
Time: 6 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select),
8120 Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Shelley S. Sehnert, PhD, Scientific Review
Officer, Review Branch/DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7206, Bethesda, MD 20892-7924.
301-435-0303.ssehnert@nhlbi.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: June 11, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-14648 Filed 6-16-10; 8:45 am]
BILLING CODE 4140-01-P
