Public Meeting of the Presidential Commission for the Study of Bioethical Issues, 64423-64424 [2015-26905]
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Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices
Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That Are
Not Individually Identifiable—OMB
Control Number 0910–0582—Extension
FDA’s investigational device
regulations are intended to encourage
the development of new, useful devices
in a manner that is consistent with
public health, safety, and compliant
with ethical standards. Investigators
should have freedom to pursue the least
burdensome means of accomplishing
this goal. However, to ensure that the
balance is maintained between product
development and the protection of
public health, safety, and ethical
standards, FDA has established human
subject protection regulations
addressing requirements for informed
consent and institutional review board
(IRB) review that apply to all FDAregulated clinical investigations
involving human subjects. In particular,
informed consent requirements further
both safety and ethical considerations
by allowing potential subjects to
consider both the physical and privacy
risks they face if they agree to
participate in a trial.
Under FDA regulations, clinical
investigations using human specimens
conducted in support of premarket
submissions to FDA are considered
human subject investigations (see 21
CFR 812.3(p)). Many investigational
device studies are exempt from most
provisions of part 812, Investigational
Device Exemptions, under 21 CFR
812.2(c)(3), but FDA’s regulations for
the protection of human subjects (21
CFR parts 50 and 56) apply to all
clinical investigations that are regulated
by FDA (see 21 CFR 50.1, 21 CFR
56.101, 21 U.S.C. 360j(g)(3)(A), and 21
U.S.C. 360j(g)(3)(D)).
FDA regulations do not contain
exceptions from the requirements of
informed consent on the grounds that
the specimens are not identifiable or
that they are remnants of human
specimens collected for routine clinical
care or analysis that would otherwise
have been discarded. Nor do FDA
64423
regulations allow IRBs to decide
whether or not to waive informed
consent for research involving leftover
or unidentifiable specimens.
In a level 1 guidance document,
entitled ‘‘Guidance on Informed
Consent for In Vitro Diagnostic Device
Studies Using Leftover Human
Specimens that are Not Individually
Identifiable,’’ issued under the Good
Guidances Practices regulation, 21 CFR
10.115, FDA outlines the circumstances
in which it intends to exercise
enforcement discretion as to the
informed consent regulations for
clinical investigators, sponsors, and
IRBs.
The recommendations of the guidance
impose a minimal burden on industry.
FDA estimates that 700 studies will be
affected annually. Each study will result
in one annual record, estimated to take
4 hours to complete. This results in a
total recordkeeping burden of 2,800
hours (700 × 4 = 2,800).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
FD&C Act section
No. of
recordkeepers
No. of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
520(g) ...............................................................
700
1
700
4
2,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
[FR Doc. 2015–26985 Filed 10–22–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0793]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Medical Device Recall Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Medical Device Recall Authority’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
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SUMMARY:
VerDate Sep<11>2014
18:05 Oct 22, 2015
On June
15, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Medical Device Recall
Authority’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0432. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Jkt 238001
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26924 Filed 10–22–15; 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
Presidential Commission for
the Study of Bioethical Issues, Office of
the Assistant Secretary for Health,
Office of the Secretary, 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
third meeting on November 17, 2015. At
this meeting, the Commission will
continue to discuss the role of
deliberation and deliberative methods to
engage the public and inform
consideration in bioethics, and how to
integrate pubic dialogue into the
bioethics conversation; bioethics
education as a forum for fostering
deliberative skills, and preparing
students to participate in public
dialogue in bioethics; goals and
methods of bioethics education; and
integrating bioethics education across a
SUMMARY:
E:\FR\FM\23OCN1.SGM
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Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices
range of professional disciplines and
educational levels.
DATES: The meeting will take place
November 17, 2015, from 9 a.m. to
approximately 5 p.m.
ADDRESSES: Hilton Arlington Hotel, 950
North Stafford Street, Arlington, VA
22203.
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.
FOR FURTHER INFORMATION CONTACT:
Pursuant
to the Federal Advisory Committee Act
of 1972, Public Law 92–463, 5 U.S.C.
app. 2, notice is hereby given for the
twenty-third 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,
health care delivery, and technological
innovation are conducted in a socially
and ethically responsible manner.
The main agenda items for the
Commission’s twenty-third meeting are
to continue discussing the role of
deliberation and deliberative methods to
engage the public in bioethics, and how
to integrate pubic dialogue into the
bioethics conversation; bioethics
education as a forum for fostering
deliberative skills, and preparing
students to participate in public
dialogue in bioethics; goals and
methods of bioethics education; and
integrating bioethics education across a
range of professional disciplines and
educational levels. The draft meeting
agenda and other information about the
Commission, including information
about access to the webcast, will be
available at www.bioethics.gov.
The Commission welcomes input
from anyone wishing to provide public
comment on any issue before it.
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SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:05 Oct 22, 2015
Jkt 238001
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 at the registration desk
and comment forms will be provided to
members of the public in order to write
down questions and comments for the
Commission as they arise. 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.
Written comments will also be
accepted in advance of the meeting and
are especially welcome. Please address
written comments 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. Comments will be publicly
available, including any personally
identifiable or confidential business
information that they contain. Trade
secrets should not be submitted.
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 in advance of
the meeting. The Commission will make
every effort to accommodate persons
who need special assistance.
Dated: October 9, 2015.
Lisa M. Lee,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2015–26905 Filed 10–22–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Blood and Tissue Safety and
Availability
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
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As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Advisory Committee on Blood and
Tissue Safety and Availability
(ACBTSA) will hold a meeting. The
meeting will be open to the public.
DATES: The meeting will take place
Monday, November 9, 2015, from 8:00
a.m.–4:30 p.m. and Tuesday, November
10, 2015, from 8:00 a.m.–4:00 p.m.
ADDRESSES: Veterans’ Health
Administration National Conference
Center, 2011 Crystal Drive, 1st floor
Conference Center, Crystal City, VA
22202.
FOR FURTHER INFORMATION CONTACT: Mr.
James Berger, Designated Federal Officer
for the ACBTSA, Senior Advisor for
Blood and Tissue Policy, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
250, Rockville, MD 20852. Phone: (240)
453–8803; Fax (240) 453–8456; Email
ACBTSA@hhs.gov.
SUPPLEMENTARY INFORMATION: The
ACBTSA provides advice to the
Secretary through the Assistant
Secretary for Health. The Committee
advises on a range of policy issues to
include: (1) Identification of public
health issues through surveillance of
blood and tissue safety issues with
national biovigilance data tools; (2)
identification of public health issues
that affect availability of blood, blood
products, and tissues; (3) broad public
health, ethical and legal issues related to
the safety of blood, blood products, and
tissues; (4) the impact of various
economic factors (e.g., product cost and
supply) on safety and availability of
blood, blood products, and tissues; (5)
risk communications related to blood
transfusion and tissue transplantation;
and (6) identification of infectious
disease transmission issues for blood,
organs, blood stem cells and tissues.
The Committee has met regularly since
its establishment in 1997.
In December 2013, the Committee
made recommendations regarding the
blood system. At that time, the
Committee expressed concern about the
ongoing reductions in blood use, the
number of large scale consolidations
occurring, the cost recovery issues for
blood centers, and the potential effects
on safety and innovation due to
instability. Past recommendations made
by the ACBTSA may be viewed at
www.hhs.gov/bloodsafety.
This meeting will provide a focused
examination of the mechanisms to fund
recently approved blood safety
innovations, such as pathogen
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64423-64424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26905]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Meeting of the Presidential Commission for the Study of
Bioethical Issues
AGENCY: Presidential Commission for the Study of Bioethical Issues,
Office of the Assistant Secretary for Health, Office of the Secretary,
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 third meeting on November 17,
2015. At this meeting, the Commission will continue to discuss the role
of deliberation and deliberative methods to engage the public and
inform consideration in bioethics, and how to integrate pubic dialogue
into the bioethics conversation; bioethics education as a forum for
fostering deliberative skills, and preparing students to participate in
public dialogue in bioethics; goals and methods of bioethics education;
and integrating bioethics education across a
[[Page 64424]]
range of professional disciplines and educational levels.
DATES: The meeting will take place November 17, 2015, from 9 a.m. to
approximately 5 p.m.
ADDRESSES: Hilton Arlington Hotel, 950 North Stafford Street,
Arlington, VA 22203.
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
for the twenty-third 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, health care delivery, and
technological innovation are conducted in a socially and ethically
responsible manner.
The main agenda items for the Commission's twenty-third meeting are
to continue discussing the role of deliberation and deliberative
methods to engage the public in bioethics, and how to integrate pubic
dialogue into the bioethics conversation; bioethics education as a
forum for fostering deliberative skills, and preparing students to
participate in public dialogue in bioethics; goals and methods of
bioethics education; and integrating bioethics education across a range
of professional disciplines and educational levels. The draft meeting
agenda and other information about the Commission, including
information about access to the webcast, will be available at
www.bioethics.gov.
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
at the registration desk and comment forms will be provided to members
of the public in order to write down questions and comments for the
Commission as they arise. 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.
Written comments will also be accepted in advance of the meeting
and are especially welcome. Please address written comments 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. Comments
will be publicly available, including any personally identifiable or
confidential business information that they contain. Trade secrets
should not be submitted.
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 in advance of the meeting.
The Commission will make every effort to accommodate persons who need
special assistance.
Dated: October 9, 2015.
Lisa M. Lee,
Executive Director, Presidential Commission for the Study of Bioethical
Issues.
[FR Doc. 2015-26905 Filed 10-22-15; 8:45 am]
BILLING CODE 4154-06-P
