Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health, 38345-38346 [2013-15324]
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Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
protections requirements should be
applied to research studying one or
more interventions which are used as
standard of care treatment in the nonresearch context. HHS specifically is
requesting input regarding how an IRB
should assess the risks of research
involving randomization to one of more
standard of care interventions, and what
reasonably foreseeable risks of the
research should be disclosed to research
subjects in the informed consent
process. This meeting and the written
comments are intended to assist HHS,
through the OHRP, OASH, in
developing guidance regarding what
constitutes reasonably foreseeable risk
in research involving standard of care
interventions such that the risk is
required to be disclosed to research
subjects.
While HHS is considering whether
other processes should be incorporated
into OHRP’s compliance oversight
procedures and guidance, including, but
not limited to, consultation with subject
matter experts during the course of a
compliance oversight investigation, and
an administrative process for appealing
OHRP determinations of
noncompliance, this meeting is not
intended to specifically address possible
revisions to OHRP’s compliance
oversight procedures.
B. Format of the Meeting
The meeting will be conducted by a
panel of HHS officials, including the
Director of OHRP. The majority of the
meeting will be reserved for
presentations of comments,
recommendations, and data from
registered presenters. The time for each
presenter’s comments will be
determined by HHS and will be based
on the number of registered presenters.
Presenters will be scheduled to speak in
the order in which they register. Only
the HHS panel members may question
any presenter during or at the
conclusion of each presentation. The
meeting will be recorded and
transcribed.
In addition, written comments will
also be accepted and presented at the
meeting, time permitting, if they are
received by the date specified in the
DATES section of this notice.
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C. Security and Building Guidelines
Because the public meeting will be
located on federal property, for security
reasons any persons wishing to attend
this meeting must register by the date
specified in the DATES section of this
notice. Attendees should allow
sufficient time to go through the
security checkpoints. Attendees should
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arrive at the Hubert H. Humphrey
Building no later than 8:30 a.m.
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Guard Service personnel.
• Passing through a metal detector
and inspection of items brought into the
building; note that all items brought to
HHS are subject to inspection.
Note: Individuals who are not registered in
advance will not be permitted to enter the
building and will be unable to attend the
meeting in person. The public may not enter
the building earlier than 45 minutes prior to
the convening of the meeting(s). All visitors
must be escorted while in the building.
D. Live Streaming Information
For participants who cannot attend
the public meeting in person there will
be an option to view the public meeting
via live streaming technology.
Information on the option to view the
meeting via live streaming technology
will be posted at a later time on the
OHRP Web site at https://www.hhs.gov/
ohrp. Any other updates to information
on the meeting will be posted on the
OHRP Web site.
III. Issues for Discussion
HHS invites comment at the public
meeting about how an IRB should assess
the risks of research involving
randomization to one or more standard
of care interventions, and what risks of
the research should be disclosed to
research subjects in the informed
consent process. HHS is specifically
interested in public input on the
following questions:
1. How should an IRB assess the risks
of standard of care interventions
provided to subjects in the research
context?
a. Under what circumstances should
an IRB consider those to be risks that
may result from the research?
b. Under what circumstances should
an IRB refrain from considering those
risks as unrelated to the research?
c. What type of evidence should an
IRB evaluate in identifying these risks?
2. What factors should an IRB
consider in determining that the
research-related risks of standard of care
interventions, provided to research
subjects in the research context, are
reasonably foreseeable and therefore
required to be disclosed to subjects?
a. What criteria should be used by the
IRB to evaluate whether the risks to
subjects are reasonably foreseeable?
3. How should randomization be
considered in research studying one or
more interventions within the standards
of care? Should the randomization
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38345
procedure itself be considered to
present a risk to the subjects? Why or
why not? If so, is the risk presented by
randomization more than minimal risk?
Should an IRB be allowed to waive
informed consent for research involving
randomization of subjects to one or
more standard of care interventions?
Why or why not?
4. How, and to what extent, does
uncertainty about risk within the
standard of care affect the answers to
these questions? What if the risk
significantly varies within the standard
of care?
5. Under what circumstances do
potential risks qualify as reasonably
foreseeable risks? For example, is it
sufficient that there be a documented
belief in the medical community that a
particular intervention within the
standard of care increases the risk of
harm, or is it necessary that there be
published studies identifying the risk?
IV. Transcripts
As soon as a transcript of the public
meeting is available, it will be accessible
on the OHRP Web site, https://
www.hhs.gov/ohrp. A transcript also
will be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the PHS FOIA
Office, 7700 Wisconsin Avenue, Suite
#920, Bethesda, MD 20857; telephone
(301) 492–4800; fax (301) 492–4848;
email FOIARequest@psc.hhs.gov.
Dated: June 19, 2013.
Howard K. Koh,
Assistant Secretary for Health.
[FR Doc. 2013–15160 Filed 6–25–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Group on
Prevention, Health Promotion, and
Integrative and Public Health
Office of the Surgeon General
of the United States Public Health
Service, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
In accordance with Section
10(a) of the Federal Advisory Committee
Act, Public Law 92–463, as amended (5
U.S.C. App.), notice is hereby given that
a meeting is scheduled to be held for the
Advisory Group on Prevention, Health
Promotion, and Integrative and Public
Health (the ‘‘Advisory Group’’). The
meeting will be open to the public.
SUMMARY:
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38346
Federal Register / Vol. 78, No. 123 / Wednesday, June 26, 2013 / Notices
Information about the Advisory Group
and the agenda for this meeting can be
obtained by accessing the following
Web site: https://
www.surgeongeneral.gov/initiatives/
prevention/advisorygrp/.
DATES: The meeting will be held on July
15, 2013 from 12–2 p.m.
ADDRESSES: The meeting will be held
via teleconference. For conference
information and to register for the
meeting, please send an email to
prevention.council@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Office of the Surgeon General, 200
Independence Ave. SW.; Hubert H.
Humphrey Building, Room 701H;
Washington, DC 20201; 202–205–9517;
prevention.council@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Advisory Group is a non-discretionary
Federal advisory committee that was
initially established under Executive
Order 13544, dated June 1, 2012, to
comply with the statutes under Section
4001 of the Patient Protection and
Affordable Care Act, Public Law 111–
148. The Advisory Group was
established to assist in carrying out the
mission of the National Prevention,
Health Promotion, and Public Health
Council (the Council). The Advisory
Group provides recommendations and
advice to the Council. Under Executive
Order 13591, dated November 23, 2011,
operation of the Advisory Group was
terminated on September 30, 2012. On
December 7, 2012, President Obama
issued Executive Order 13631 to reestablish the Advisory Group. The
Advisory Group is authorized to operate
until September 30, 2013.
It is authorized for the Advisory
Group to consist of not more than 25
non-federal members. The Advisory
Group currently has 22 members who
were appointed by the President. The
membership includes a diverse group of
licensed health professionals, including
integrative health practitioners who
have expertise in (1) worksite health
promotion; (2) community services,
including community health centers; (3)
preventive medicine; (4) health
coaching; (5) public health education;
(6) geriatrics; and (7) rehabilitation
medicine.
This will be the eighth meeting of the
Advisory Group. Topics for discussion
during this meeting include the status of
the Advisory Group’s third set of
recommendations, updates from the
working groups, and the draft agenda for
the next Advisory Group meeting,
which is planned to be held on
September 26–27, 2013.
Members of the public who wish to
attend must register by 12:00 p.m. EST
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on July 10, 2013. Individuals should
register for public attendance at
prevention.council@hhs.gov by
providing your full name and affiliation.
The public will have the opportunity to
provide comments to the Advisory
Group during this meeting; public
comment will be limited to 3 minutes
per speaker. Registration through the
designated contact for the public
comment session is also required.
Dated: June 20, 2013.
Corinne M. Graffunder,
Designated Federal Officer, Advisory Group
on Prevention, Health Promotion, and
Integrative and Public Health Office of the
Surgeon General.
[FR Doc. 2013–15324 Filed 6–25–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. During the
July meeting, the Advisory Council will
discuss the National Plan to Address
Alzheimer’s Disease: 2013 Update, and
the 2013 recommendations. The
Advisory Council will discuss
international activities related to
Alzheimer’s disease since the April
meeting. The Advisory Council will
discuss issues related to long-term care
financing.
DATES: The meeting will be held on July
19, 2013 from 9:00 a.m. to 5:00 p.m.
EDT.
ADDRESSES: The meeting will be held at
the U.S. Department of Health and
Human Services, 200 Independence
Avenue SW., Room 800, Washington,
DC 20201.
Comments: Time is allocated on the
agenda to hear public comments. In lieu
of oral comments, formal written
comments may be submitted for the
record to Helen Lamont, Ph.D., OASPE,
200 Independence Avenue SW., Room
424E, Washington, DC 20201.
Comments may also be sent to
napa@hhs.gov. Those submitting
written comments should identify
SUMMARY:
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themselves and any relevant
organizational affiliations.
FOR FURTHER INFORMATION CONTACT:
Helen Lamont, Ph.D. (202) 690–7996,
helen.lamont@hhs.gov. Note: Seating
may be limited. Those wishing to attend
the meeting must send an email to
napa@hhs.gov and put ‘‘July 19 meeting
attendance’’ in the Subject line by
Friday, July 5, 2013, so that their names
may be put on a list of expected
attendees and forwarded to the security
officers at the Department of Health and
Human Services. Any interested
member of the public who is a non-U.S.
citizen should include this information
at the time of registration to ensure that
the appropriate security procedure to
gain entry to the building is carried out.
Although the meeting is open to the
public, procedures governing security
and the entrance to Federal buildings
may change without notice. If you wish
to make a public comment, you must
note that within your email.
SUPPLEMENTARY INFORMATION: Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: The
Advisory Council will discuss the
National Plan to Address Alzheimer’s
Disease: 2013 Update, and the 2013
recommendations. The Advisory
Council will discuss international
activities related to Alzheimer’s disease
since the April meeting. The Advisory
Council will discuss issues related to
long-term care financing.
Procedure and Agenda: This meeting
is open to the public.
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Dated: June 25, 2013.
Donald Moulds,
Acting Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2013–15326 Filed 6–25–13; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Subcommittee on Procedures Review,
Advisory Board on Radiation and
Worker Health (ABRWH), National
Institute for Occupational Safety and
Health (NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
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]]>Agencies
[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38345-38346]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15324]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Group on Prevention, Health Promotion,
and Integrative and Public Health
AGENCY: Office of the Surgeon General of the United States Public
Health Service, Office of the Assistant Secretary for Health, Office of
the Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with Section 10(a) of the Federal Advisory
Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is
hereby given that a meeting is scheduled to be held for the Advisory
Group on Prevention, Health Promotion, and Integrative and Public
Health (the ``Advisory Group''). The meeting will be open to the
public.
[[Page 38346]]
Information about the Advisory Group and the agenda for this meeting
can be obtained by accessing the following Web site: https://www.surgeongeneral.gov/initiatives/prevention/advisorygrp/.
DATES: The meeting will be held on July 15, 2013 from 12-2 p.m.
ADDRESSES: The meeting will be held via teleconference. For conference
information and to register for the meeting, please send an email to
prevention.council@hhs.gov.
FOR FURTHER INFORMATION CONTACT: Office of the Surgeon General, 200
Independence Ave. SW.; Hubert H. Humphrey Building, Room 701H;
Washington, DC 20201; 202-205-9517; prevention.council@hhs.gov.
SUPPLEMENTARY INFORMATION: The Advisory Group is a non-discretionary
Federal advisory committee that was initially established under
Executive Order 13544, dated June 1, 2012, to comply with the statutes
under Section 4001 of the Patient Protection and Affordable Care Act,
Public Law 111-148. The Advisory Group was established to assist in
carrying out the mission of the National Prevention, Health Promotion,
and Public Health Council (the Council). The Advisory Group provides
recommendations and advice to the Council. Under Executive Order 13591,
dated November 23, 2011, operation of the Advisory Group was terminated
on September 30, 2012. On December 7, 2012, President Obama issued
Executive Order 13631 to re-establish the Advisory Group. The Advisory
Group is authorized to operate until September 30, 2013.
It is authorized for the Advisory Group to consist of not more than
25 non-federal members. The Advisory Group currently has 22 members who
were appointed by the President. The membership includes a diverse
group of licensed health professionals, including integrative health
practitioners who have expertise in (1) worksite health promotion; (2)
community services, including community health centers; (3) preventive
medicine; (4) health coaching; (5) public health education; (6)
geriatrics; and (7) rehabilitation medicine.
This will be the eighth meeting of the Advisory Group. Topics for
discussion during this meeting include the status of the Advisory
Group's third set of recommendations, updates from the working groups,
and the draft agenda for the next Advisory Group meeting, which is
planned to be held on September 26-27, 2013.
Members of the public who wish to attend must register by 12:00
p.m. EST on July 10, 2013. Individuals should register for public
attendance at prevention.council@hhs.gov by providing your full name
and affiliation. The public will have the opportunity to provide
comments to the Advisory Group during this meeting; public comment will
be limited to 3 minutes per speaker. Registration through the
designated contact for the public comment session is also required.
Dated: June 20, 2013.
Corinne M. Graffunder,
Designated Federal Officer, Advisory Group on Prevention, Health
Promotion, and Integrative and Public Health Office of the Surgeon
General.
[FR Doc. 2013-15324 Filed 6-25-13; 8:45 am]
BILLING CODE 4163-18-P
