Meeting of the Secretary's Advisory Committee on Human Research Protections, 58006-58007 [2011-23863]
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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Consumer Health IT Pledge Program
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of availability for
Consumer Health IT Pledge Program.
AGENCY:
The U.S. Department of
Health & Human Services’ Office of the
National Coordinator for Health
Information Technology (ONC) is
leading a national campaign to educate
and engage the public on the value and
benefits of health information
technology (health IT) in improving
health and health care. As part of the
campaign, we encourage entities that
touch Americans’ lives to pledge to
empower individuals to be partners in
their health through health IT. There are
two types of pledges: One for those who
manage or maintain individually
identifiable health data (e.g., providers,
hospitals, payers, retail pharmacies) and
another for those who do not manage or
maintain consumer health data, but
have the ability to educate consumers
about the importance of getting access to
and using their health information (e.g.,
employers, consumer and disease-based
organizations, healthcare associations,
product developers).
Taking the pledge is voluntary, and
does not represent any endorsement by
the U.S. Department of Health and
Human Services or any other part of the
federal government.
To learn more about the details of the
pledge, please visit: https://
www.healthit.gov/pledge.
Notice of this schedule is given under
the American Recovery and
Reinvestment Act of 2009 (Pub. L. 111–
5), section 3003.
SUMMARY:
Dated: September 9, 2011.
Jodi Daniel,
Office of Policy and Planning, Office of the
National Coordinator for Health Information
Technology.
[FR Doc. 2011–23889 Filed 9–16–11; 8:45 am]
successor, the authorities vested in the
Secretary under section 1704 of Title
XVII of the Public Health Service Act
(PHSA) (42 U.S.C. 300u–3), as amended,
to conduct and support by grant or
contract (and encourage others to
support) such activities as may be
required to make information respecting
health information and health
promotion, preventive health services,
and education in the appropriate use of
health care available to the consumers
of medical care, providers of such care,
schools, and others who are or should
be informed respecting such matters.
Limitations
The delegation of authority granted
herein under section 1704 of Title XVII
of the PHSA (42 U.S.C. 300u–3) does
not supersede any previous delegations
of this authority.
The delegation of authority granted
herein under section 1704 of the PHSA,
as amended, is limited to making
information available to the consumers
of medical care, providers of such care,
schools, and others who are or should
be informed about the use of health
information technology as it relates to
health information and health
promotion, preventive health services,
and education in the appropriate use of
health care.
The authority under section 1704 of
the PHSA, as amended, shall be
exercised under the Department’s policy
on regulations and the existing
delegation of authority to approve and
issue regulations.
This delegation of authority may be
re-delegated.
This delegation of authority is
effective immediately.
I hereby affirm and ratify any actions
taken by the National Coordinator, or
his or her subordinates, which involved
the exercise of the authority under
section 1704 of Title XVII of the PHSA
(42 U.S.C. 300u–3), as amended,
delegated herein prior to the effective
date of this delegation of authority.
Authority: 44 U.S.C. 3101.
Dated: September 12, 2011.
Kathleen Sebelius,
Secretary.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–23886 Filed 9–16–11; 8:45 am]
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Office of the Secretary
Office of the National Coordinator for
Health Information Technology;
Delegation of Authority
Notice is hereby given that I have
delegated to the National Coordinator
for Health Information Technology
(National Coordinator), or his or her
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
AGENCY:
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Secretary, Department of Health and
Human Services.
ACTION: Notice.
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold its
twenty-sixth meeting. The meeting will
be open to the public. Information about
SACHRP and the meeting agenda will
be posted on the SACHRP Web site at:
https://www.dhhs.gov/ohrp/sachrp/
mtgings/.
DATES: The meeting will be held on
Tuesday, October 4, 2011 from 8:30 a.m.
until 5 p.m. and Wednesday, October 5,
2011 from 8:30 a.m. until 5 p.m.
ADDRESSES: U.S. Department of Health
and Human Services, 200 Independence
Avenue SW., Hubert H. Humphrey
Building, Room 800, Washington, DC
20201.
FOR FUTHER INFORMATION CONTACT: Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; e-mail address:
Julia.Gorey@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services and the
Assistant Secretary for Health on issues
and topics pertaining to or associated
with the protection of human research
subjects.
Both days of this meeting will be
devoted to SACHRP discussion of the
recent Advance Notice of Proposed
Rulemaking (ANPRM), Human Subjects
Research Protections: Enhancing
Protections for Research Subjects and
Reducing Burden, Delay, and Ambiguity
for Investigators, published in the July
26 Federal Register. The meeting will
open October 4 with remarks from
SACHRP Chair Dr. Barbara Bierer and
OHRP Director Dr. Jerry Menikoff,
followed by presentation of joint
recommendations on the ANPRM from
the Subpart A Subcommittee (SAS) and
the Subcommittee on Harmonization
(SOH).
SAS is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment; this
SUMMARY:
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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices
subcommittee was established by
SACHRP in October 2006. SOH was
established by SACHRP at its July 2009
meeting, and is charged with identifying
and prioritizing areas in which
regulations and/or guidelines for human
subjects research adopted by various
agencies or offices within HHS would
benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
Public Comment will be heard on
both days.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
opportunity to provide comments on
both days of the meeting. Public
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
materials to the Executive Director,
SACHRP, prior to the close of business
September 30, 2011.
Dated: September 13, 2011.
Jerry Menikoff,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. 2011–23863 Filed 9–16–11; 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
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health, Office of the Surgeon General of
the United States Public Health Service.
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.
Information about the Advisory Group
can be obtained by accessing the
following Web site: https://
www.healthcare.gov/center/councils/
nphpphc/.
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SUMMARY:
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The meeting will be held on
October 3–4, 2011.
ADDRESSES: Will be announced on the
Web site: https://www.healthcare.gov/
center/councils/nphpphc/.
FOR FURTHER INFORMATION CONTACT:
Office of the Surgeon General, 200
Independence Ave., SW.; Hubert H.
Humphrey Building, Room 701H;
Washington, DC 20001; 202–205–9517;
prevention.council@hhs.gov.
SUPPLEMENTARY INFORMATION: On June
10, 2010, the President issued Executive
Order 13544 to comply with the statutes
under Section 4001 of the Patient
Protection and Affordable Care Act,
Public Law 111–148. This legislation
mandated that the Advisory Group was
to be established within the Department
of Health and Human Services. The
charter for the Advisory Group was
established by the Secretary of Health
and Human Services on June 23, 2010;
the charter was filed with the
appropriate Congressional committees
and Library of Congress on June 24,
2010. The Advisory Group has been
established as a non-discretionary
Federal advisory committee.
The Advisory Group has been
established to provide recommendations
and advice to the National Prevention,
Health Promotion and Public Health
Council (the ‘‘Council’’). The Advisory
Group shall provide assistance to the
Council in carrying out its mission.
The Advisory Group membership
shall consist of not more than 25 nonFederal members to be appointed by the
President. The membership shall
include 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. There are currently 16
members of the Advisory Group
appointed by the President. This will be
the third meeting of the Advisory
Group.
Public attendance at the meeting is
limited to the space available. Members
of the public who wish to attend must
register by 12 p.m. EST September 26,
2011. Individuals should register for
public attendance at
prevention.council@hhs.gov by
providing your full name and affiliation.
Individuals who plan to attend the
meeting and need special assistance
and/or accommodations, i.e., sign
language interpretation or other
reasonable accommodations, should
notify the designated point of contact
DATES:
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58007
for the Advisory Group. The public will
have the opportunity to provide
comments to the Advisory Group on
October 3, 2011; public comment will
be limited to 3 minutes per speaker.
Registration through the designated
contact for the public comment session
is also required. Any member of the
public who wishes to have printed
materials distributed to the Advisory
Group for this scheduled meeting
should submit material to the designed
point of contact no later than 12 p.m.
EST September 26, 2011.
Dated: September 8, 2011.
Corinne M. Graffunder,
Acting Designated Federal Officer, Advisory
Group on Prevention, Health Promotion, and
Integrative and Public Health Office of the
Surgeon General.
[FR Doc. 2011–23869 Filed 9–16–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
Privacy Act of 1974; Report of a New
System of Records
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice to establish a new system
of records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
CMS is establishing a new system of
records to support its shared savings
programs, the first of which are the
Medicare Shared Savings Program and
Pioneer ACO Model (collectively
referred to as the ACO program). The
ACO program implements recent health
care reform provisions of the Patient
Protection and Affordable Care Act
(PPACA), amending the Social Security
Act (the Act). The system of records will
contain personally identifiable
information (PII) about certain
individuals who participate in, or
whose PII is used to determine
eligibility of an Accountable Care
Organization (ACO) to participate in, a
shared savings program; i.e., Medicare
fee-for-service (FFS) beneficiaries, sole
proprietor health care ACO participants
and ACO suppliers/providers, key
leaders and managers of accountable
care organizations (ACOs), and contact
persons for ACOs. The program and the
system of records are more thoroughly
described in the Supplementary
Information section and System of
Records Notice (SORN), below.
SUMMARY:
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Agencies
[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58006-58007]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23863]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's
Advisory Committee on Human Research Protections (SACHRP) will hold its
twenty-sixth meeting. The meeting will be open to the public.
Information about SACHRP and the meeting agenda will be posted on the
SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
DATES: The meeting will be held on Tuesday, October 4, 2011 from 8:30
a.m. until 5 p.m. and Wednesday, October 5, 2011 from 8:30 a.m. until 5
p.m.
ADDRESSES: U.S. Department of Health and Human Services, 200
Independence Avenue SW., Hubert H. Humphrey Building, Room 800,
Washington, DC 20201.
FOR FUTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director,
Office for Human Research Protections (OHRP), or Julia Gorey, J.D.,
Executive Director, SACHRP; U.S. Department of Health and Human
Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852;
240-453-8141; fax: 240-453-6909; e-mail address: Julia.Gorey@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a,
Section 222 of the Public Health Service Act, as amended, SACHRP was
established to provide expert advice and recommendations to the
Secretary of Health and Human Services and the Assistant Secretary for
Health on issues and topics pertaining to or associated with the
protection of human research subjects.
Both days of this meeting will be devoted to SACHRP discussion of
the recent Advance Notice of Proposed Rulemaking (ANPRM), Human
Subjects Research Protections: Enhancing Protections for Research
Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,
published in the July 26 Federal Register. The meeting will open
October 4 with remarks from SACHRP Chair Dr. Barbara Bierer and OHRP
Director Dr. Jerry Menikoff, followed by presentation of joint
recommendations on the ANPRM from the Subpart A Subcommittee (SAS) and
the Subcommittee on Harmonization (SOH).
SAS is charged with developing recommendations for consideration by
SACHRP regarding the application of subpart A of 45 CFR part 46 in the
current research environment; this
[[Page 58007]]
subcommittee was established by SACHRP in October 2006. SOH was
established by SACHRP at its July 2009 meeting, and is charged with
identifying and prioritizing areas in which regulations and/or
guidelines for human subjects research adopted by various agencies or
offices within HHS would benefit from harmonization, consistency,
clarity, simplification and/or coordination.
Public Comment will be heard on both days.
Public attendance at the meeting is limited to space available.
Individuals who plan to attend the meeting and need special assistance,
such as sign language interpretation or other reasonable
accommodations, should notify the designated contact persons. Members
of the public will have the opportunity to provide comments on both
days of the meeting. Public comment will be limited to five minutes per
speaker. Any members of the public who wish to have printed materials
distributed to SACHRP members for this scheduled meeting should submit
materials to the Executive Director, SACHRP, prior to the close of
business September 30, 2011.
Dated: September 13, 2011.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary,
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2011-23863 Filed 9-16-11; 8:45 am]
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