Public Meeting of the Presidential Commission for the Study of Bioethical Issues, 21883-21884 [2016-08504]
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Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Notices
(FDA). The meeting will be open to the
public.
Name of Committee: Circulatory
System 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 May 24, 2016, 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
20877. The hotel’s phone number is
301–977–8900.
Contact Person: Evella Washington,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 1535, Silver Spring, MD 20993–
0002, Evella.Washington@fda.hhs.gov,
301–796–6683, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On May 24, 2016, the
committee will discuss, make
recommendations and vote on
information related to the premarket
approval application regarding St. Jude
Medical’s AMPLATZER Patent Foramen
Ovale (PFO) Occluder. The
AMPLATZER PFO Occluder is a
percutaneously delivered permanent
cardiac implant for PFO closure. The
device is indicated for preventing
recurrent ischemic stroke in patients
who have had a cryptogenic stroke due
to a presumed paradoxical embolism.
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
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appropriate advisory committee meeting
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 May 10, 2016. Oral
presentations from the public will be
scheduled on May 24, 2016 between
approximately 1 p.m. and 2 p.m. 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 April 28, 2016. 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 May 2, 2016.
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 disabilities.
If you require accommodations due to a
disability, please contact AnnMarie
Williams, AnnMarie.Williams@
fda.hhs.gov, 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: April 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–08530 Filed 4–12–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Meeting of the Presidential
Commission for the Study of
Bioethical Issues
Office of the Secretary, Office
of the Assistant Secretary for Health,
Presidential Commission for the Study
of Bioethical Issues, Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
The Presidential Commission
for the Study of Bioethical Issues (the
Commission) will conduct its twenty
fifth meeting on May 3, 2016. At this
meeting, the Commission will reflect on
the past, present, and future impact of
national bioethics advisory bodies.
Topics will include the history of
national bioethics advisory bodies and
their contributions to health policy,
perspectives about similar bodies
elsewhere, and discussion about what
the future holds for groups like the
Commission.
SUMMARY:
The meeting will take place May
3, 2016, from 9 a.m. to approximately 5
p.m.
ADDRESSES: Grand Hyatt Washington
Hotel, 1000 H St. NW., Washington, DC
20001
FOR FURTHER INFORMATION CONTACT: Lisa
M. Lee, Executive Director, Presidential
Commission for the Study of Bioethical
Issues, 1425 New York Avenue NW.,
Suite C–100, Washington, DC 20005.
Telephone: 202–233–3960. Email:
Lisa.Lee@bioethics.gov. Additional
information may be obtained at
www.bioethics.gov.
DATES:
Pursuant
to the Federal Advisory Committee Act
of 1972, Public Law 92–463, 5 U.S.C.
app. 2, notice is hereby given of the
twenty fifth meeting of the Commission.
The meeting will be open to the public
with attendance limited to space
available. The meeting will also be
webcast at www.bioethics.gov.
Under authority of Executive Order
13521, dated November 24, 2009, the
President established the Commission.
The Commission is an expert panel of
not more than 13 members who are
drawn from the fields of bioethics,
science, medicine, technology,
engineering, law, philosophy, theology,
or other areas of the humanities or
social sciences. The Commission
advises the President on bioethical
issues arising from advances in
biomedicine and related areas of science
and technology. The Commission seeks
to identify and promote policies and
practices that ensure scientific research,
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
health care delivery, and technological
innovation are conducted in a socially
and ethically responsible manner.
The main agenda for the
Commission’s twenty fifth meeting is to
reflect upon the role of national
bioethics advisory bodies, both in the
US and abroad, in the past, present, and
future. The Commission welcomes
input from anyone wishing to provide
public comment on any issue before it.
Respectful consideration of opposing
views and active participation by
citizens in public exchange of ideas
enhances overall public understanding
of the issues at hand and conclusions
reached by the Commission. The
Commission is particularly interested in
receiving comments and questions
during the meeting that are responsive
to specific sessions. Written comments
will be accepted in advance, during, and
after the meeting and are especially
welcome. Comments will be publicly
available, including any personally
identifiable or confidential business
information that they contain. Trade
secrets should not be submitted.
Written comments will be accepted by
email to info@bioethics.gov, or by mail
to the following address: Public
Commentary, Presidential Commission
for the Study of Bioethical Issues, 1425
New York Avenue NW., Suite C–100,
Washington, DC 20005. To
accommodate as many individuals as
possible, the time for each question or
comment may be limited. If the number
of individuals wishing to pose a
question or make a comment is greater
than can reasonably be accommodated
during the scheduled meeting, the
Commission may make a random
selection. Time permitting, we will read
aloud as many comments as possible.
Anyone planning to attend the
meeting who needs special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify Esther Yoo by telephone
at (202) 233–3960, or email at
Esther.Yoo@bioethics.gov at least one
week in advance of the meeting. The
Commission will make every effort to
accommodate persons who need special
assistance.
Dated: March 28, 2016.
Lisa M. Lee,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2016–08504 Filed 4–12–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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 meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cellular Aspects of Spinal Cord
Injury, Epilepsy, and other Neurological
Disorders and Diseases.
Date: April 20, 2016.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Samuel C Edwards, Ph.D.,
IRG CHIEF, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD
20892, (301) 435–1246, edwardss@
csr.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.
Name of Committee: Center for Scientific
Review, Special Emphasis Panel; Calcium
Channels and Retinal Mechanisms.
Date: April 22, 2016.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Mary Custer, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4148,
MSC 7850, Bethesda, MD 20892, (301) 435–
1164, custerm@csr.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. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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Dated: April 6, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–08433 Filed 4–12–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meetings
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 meetings.
The meetings 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 on
Deafness and Other Communication
Disorders Special Emphasis Panel; Loan
Repayment Program.
Date: April 18, 2016.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Sheo Singh, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
6001 Executive Blvd., Room 8351, Bethesda,
MD 20892, 301–496–8683, singhs@
nidcd.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.
Name of Committee: National Institute on
Deafness and Other Communication
Disorders Special Emphasis Panel; AIED
Clinical Trial Review.
Date: April 27, 2016.
Time: 2:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
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.
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[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Notices]
[Pages 21883-21884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08504]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Meeting of the Presidential Commission for the Study of
Bioethical Issues
AGENCY: Office of the Secretary, Office of the Assistant Secretary for
Health, Presidential Commission for the Study of Bioethical Issues,
Department of Health and Human Services.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Presidential Commission for the Study of Bioethical Issues
(the Commission) will conduct its twenty fifth meeting on May 3, 2016.
At this meeting, the Commission will reflect on the past, present, and
future impact of national bioethics advisory bodies. Topics will
include the history of national bioethics advisory bodies and their
contributions to health policy, perspectives about similar bodies
elsewhere, and discussion about what the future holds for groups like
the Commission.
DATES: The meeting will take place May 3, 2016, from 9 a.m. to
approximately 5 p.m.
ADDRESSES: Grand Hyatt Washington Hotel, 1000 H St. NW., Washington, DC
20001
FOR FURTHER INFORMATION CONTACT: Lisa M. Lee, Executive Director,
Presidential Commission for the Study of Bioethical Issues, 1425 New
York Avenue NW., Suite C-100, Washington, DC 20005. Telephone: 202-233-
3960. Email: Lisa.Lee@bioethics.gov. Additional information may be
obtained at www.bioethics.gov.
SUPPLEMENTARY INFORMATION: Pursuant to the Federal Advisory Committee
Act of 1972, Public Law 92-463, 5 U.S.C. app. 2, notice is hereby given
of the twenty fifth meeting of the Commission. The meeting will be open
to the public with attendance limited to space available. The meeting
will also be webcast at www.bioethics.gov.
Under authority of Executive Order 13521, dated November 24, 2009,
the President established the Commission. The Commission is an expert
panel of not more than 13 members who are drawn from the fields of
bioethics, science, medicine, technology, engineering, law, philosophy,
theology, or other areas of the humanities or social sciences. The
Commission advises the President on bioethical issues arising from
advances in biomedicine and related areas of science and technology.
The Commission seeks to identify and promote policies and practices
that ensure scientific research,
[[Page 21884]]
health care delivery, and technological innovation are conducted in a
socially and ethically responsible manner.
The main agenda for the Commission's twenty fifth meeting is to
reflect upon the role of national bioethics advisory bodies, both in
the US and abroad, in the past, present, and future. The Commission
welcomes input from anyone wishing to provide public comment on any
issue before it. Respectful consideration of opposing views and active
participation by citizens in public exchange of ideas enhances overall
public understanding of the issues at hand and conclusions reached by
the Commission. The Commission is particularly interested in receiving
comments and questions during the meeting that are responsive to
specific sessions. Written comments will be accepted in advance,
during, and after the meeting and are especially welcome. Comments will
be publicly available, including any personally identifiable or
confidential business information that they contain. Trade secrets
should not be submitted.
Written comments will be accepted by email to info@bioethics.gov,
or by mail to the following address: Public Commentary, Presidential
Commission for the Study of Bioethical Issues, 1425 New York Avenue
NW., Suite C-100, Washington, DC 20005. To accommodate as many
individuals as possible, the time for each question or comment may be
limited. If the number of individuals wishing to pose a question or
make a comment is greater than can reasonably be accommodated during
the scheduled meeting, the Commission may make a random selection. Time
permitting, we will read aloud as many comments as possible.
Anyone planning to attend the meeting who needs special assistance,
such as sign language interpretation or other reasonable
accommodations, should notify Esther Yoo by telephone at (202) 233-
3960, or email at Esther.Yoo@bioethics.gov at least one week in advance
of the meeting. The Commission will make every effort to accommodate
persons who need special assistance.
Dated: March 28, 2016.
Lisa M. Lee,
Executive Director, Presidential Commission for the Study of Bioethical
Issues.
[FR Doc. 2016-08504 Filed 4-12-16; 8:45 am]
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