81_FR_9520 81 FR 9483 - Health Insurance MarketplaceSM

81 FR 9483 - Health Insurance MarketplaceSM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 37 (February 25, 2016)

Page Range9483-9485
FR Document2016-04091

This notice announces the new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of Health Insurance Marketplace\SM\,\1\ Medicare, Medicaid, and Children's Health Insurance Program (CHIP) consumer education strategies. This meeting is open to the public. ---------------------------------------------------------------------------

Federal Register, Volume 81 Issue 37 (Thursday, February 25, 2016)
[Federal Register Volume 81, Number 37 (Thursday, February 25, 2016)]
[Notices]
[Pages 9483-9485]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-7040-N]


Health Insurance Marketplace\SM\, Medicare, Medicaid, and the 
Children's Health Insurance Program; Meeting of the Advisory Panel on 
Outreach and Education (APOE)

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice of meeting.

-----------------------------------------------------------------------

SUMMARY: This notice announces the new meeting of the Advisory Panel on 
Outreach and Education (APOE) (the Panel) in accordance with the 
Federal Advisory Committee Act. The Panel advises and makes 
recommendations to the Secretary of the U.S. Department of Health and 
Human Services (HHS) and the Administrator of the Centers for Medicare 
& Medicaid Services (CMS) on opportunities to enhance the effectiveness 
of Health Insurance Marketplace\SM\,\1\ Medicare, Medicaid, and 
Children's Health Insurance Program (CHIP) consumer education 
strategies. This meeting is open to the public.
---------------------------------------------------------------------------

    \1\ Health Insurance Marketplace\SM\ and Marketplace\SM\ are 
service marks of the U.S. Department of Health & Human Services.

DATES: 
    Meeting Date: Wednesday, March 23, 2016, 8:30 a.m. to 4:00 p.m. 
eastern daylight time (e.d.t.).
    Deadline for Meeting Registration, Presentations, Special 
Accommodations and Comments: Wednesday, March 9, 2016, 5:00 p.m., 
eastern standard time (e.s.t.).

ADDRESSES: 
    Meeting Location: U.S. Department of Health & Human Services, 
Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 425A, 
Conference Room, Washington, DC 20201.
    Presentations and Written Comments: Presentations and written 
comments should be submitted to: Abigail Huffman, Designated Federal 
Official (DFO), Division of Forum and Conference Development, Office of 
Communications, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Mailstop S1 05-06, Baltimore, MD 21244 1850 or via email at 
[email protected].
    Registration: The meeting is open to the public, but attendance is 
limited to the space available. Persons wishing to attend this meeting 
must register at the Web site https://www.regonline.com/apoemar2016meeting or by contacting the DFO as listed in the FOR 
FURTHER INFORMATION CONTACT section of this notice, by the date listed 
in the DATES section of this notice. Individuals requiring sign 
language interpretation or other special accommodations should contact 
the DFO at the address listed in the ADDRESSES section of this notice 
by the date listed in the DATES section of this notice.

FOR FURTHER INFORMATION CONTACT: Abigail Huffman, Designated Federal 
Official, Office of Communications, CMS, 7500 Security Boulevard, Mail 
Stop S1-05-06, Baltimore, MD 21244, 410-786-0897, email 
[email protected]. Additional information about the APOE is 
available on the Internet at: http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/APOE.html. Press inquiries are handled through 
the CMS Press Office at (202) 690-6145.

SUPPLEMENTARY INFORMATION:

I. Background

    The Advisory Panel for Outreach and Education (APOE) (the Panel) is 
governed by the provisions of Federal Advisory Committee Act (FACA) 
(Pub. L. 92-463), as amended (5 U.S.C. Appendix 2), which sets forth 
standards for the formation and use of federal advisory committees. The 
Panel is authorized by section 1114(f) of the Social Security Act (42 
U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 
U.S.C. 217a).
    The Secretary of the U.S. Department of Health and Human Services 
(HHS) (the Secretary) signed the charter establishing the Citizen's 
Advisory Panel on Medicare Education \2\ (the predecessor to the APOE) 
on January 21, 1999 (64 FR 7899, February 17, 1999) to advise and make 
recommendations to the Secretary and the Administrator of the Centers 
for Medicare & Medicaid Services (CMS) on the effective implementation 
of national Medicare education programs, including with respect to the 
Medicare+Choice (M+C) program added by the Balanced Budget Act of 1997 
(Pub. L. 105-33).
---------------------------------------------------------------------------

    \2\ We note that the Citizens' Advisory Panel on Medicare 
Education is also referred to as the Advisory Panel on Medicare 
Education (65 FR 4617). The name was updated in the Second Amended 
Charter approved on July 24, 2000.
---------------------------------------------------------------------------

    The Medicare Modernization Act of 2003 (MMA) (Pub. L. 108-173) 
expanded the existing health plan options and benefits available under 
the M+C program and renamed it the Medicare Advantage (MA) program. We 
have had substantial responsibilities to provide information to 
Medicare beneficiaries about the range of health plan options available 
and better tools to evaluate these options. The successful MA program 
implementation required CMS to consider the views and policy input from 
a variety of private sector constituents and to develop a broad range 
of public-private partnerships.
    In addition, Title I of the MMA authorized the Secretary and the 
Administrator of CMS (by delegation) to establish the Medicare 
prescription drug benefit. The drug benefit allows beneficiaries to 
obtain qualified prescription drug coverage. In order to effectively 
administer the MA program and the Medicare prescription drug benefit, 
we have substantial responsibilities to provide information to Medicare 
beneficiaries about the range of health plan options and benefits 
available, and to develop better tools to evaluate these plans and 
benefits.
    The Affordable Care Act (Patient Protection and Affordable Care 
Act, Pub. L. 111-148, and Health Care and Education Reconciliation Act 
of 2010, Pub. L. 111-152) expanded the availability of other options 
for health care coverage and enacted a number of changes to Medicare as 
well as to Medicaid and the Children's Health Insurance Program (CHIP). 
Qualified individuals and qualified employers are

[[Page 9484]]

now able to purchase private health insurance coverage through 
competitive marketplaces, called Affordable Insurance Exchanges (we 
also call an Exchange a Health Insurance Marketplace\SM\ or 
Marketplace\SM\). In order to effectively implement and administer 
these changes, we must provide information to consumers, providers, and 
other stakeholders through education and outreach programs regarding 
how existing programs will change and the expanded range of health 
coverage options available, including private health insurance coverage 
through a Marketplace\SM\. The APOE (the Panel) allows us to consider a 
broad range of views and information from interested audiences in 
connection with this effort and to identify opportunities to enhance 
the effectiveness of education strategies concerning the Affordable 
Care Act.
    The scope of this panel also includes advising on issues pertaining 
to the education of providers and stakeholders with respect to the 
Affordable Care Act and certain provisions of the Health Information 
Technology for Economic and Clinical Health (HITECH) Act enacted as 
part of the American Recovery and Reinvestment Act of 2009 (ARRA).
    On January 21, 2011, the Panel's charter was renewed and the Panel 
was renamed the Advisory Panel for Outreach and Education. The Panel's 
charter was most recently renewed on January 21, 2015, and will 
terminate on January 21, 2017 unless renewed by appropriate action.
    Under the current charter, the APOE will advise the Secretary and 
the Administrator on optimal strategies for the following:
     Developing and implementing education and outreach 
programs for individuals enrolled in, or eligible for, Medicare, 
Medicaid, and the Children's Health Insurance Program (CHIP), or 
coverage available through a Health Insurance Marketplace\SM\.
     Enhancing the federal government's effectiveness in 
informing Health Insurance Marketplace\SM\, Medicare, Medicaid, and 
CHIP consumers, issuers, providers, and stakeholders, through education 
and outreach programs, on issues regarding these programs, including 
the appropriate use of public-private partnerships to leverage the 
resources of the private sector in educating beneficiaries, providers, 
and stakeholders.
     Expanding outreach to vulnerable and underserved 
communities, including racial and ethnic minorities, in the context of 
Health Insurance Marketplace\SM\, Medicare, Medicaid, and CHIP 
education programs.
     Assembling and sharing an information base of ``best 
practices'' for helping consumers evaluate health coverage options.
     Building and leveraging existing community infrastructures 
for information, counseling, and assistance.
     Drawing the program link between outreach and education, 
promoting consumer understanding of health care coverage choices, and 
facilitating consumer selection/enrollment, which in turn support the 
overarching goal of improved access to quality care, including 
prevention services, envisioned under the Affordable Care Act.
    The current members of the Panel are: Kellan Baker, Associate 
Director, Center for American Progress; Robert Blancato, President, 
Matz, Blancato & Associates; Dale Blasier, Professor of Orthopedic 
Surgery, Department of Orthopedics, Arkansas Children's Hospital; 
Deborah Britt, Executive Director of Community & Public Relations, 
Piedmont Fayette Hospital; Deena Chisolm, Associate Professor of 
Pediatrics & Public Health, The Ohio State University, Nationwide 
Children's Hospital; Josephine DeLeon, Director, Anti-Poverty 
Initiatives, Catholic Charities of California; Robert Espinoza, Vice 
President of Policy, Paraprofessional Healthcare Institute; Jennifer 
Gross, Manager of Political Field Operations, Planned Parenthood of 
Montana; Louise Scherer Knight, Director, The Sidney Kimmel 
Comprehensive Cancer Center at Johns Hopkins; Miriam Mobley-Smith, 
Director of Strategic Alliances, Pharmacy Technician Certification 
Board; Roanne Osborne-Gaskin, M.D., Senior Medical Director, MDWise, 
Inc.; Cathy Phan, Outreach and Education Coordinator, Asian American 
Health Coalition DBA HOPE Clinic; Kamilah Pickett, Litigation Support, 
Independent Contractor; Brendan Riley, Outreach and Enrollment 
Coordinator, NC Community Health Center Association; Jeanne Ryer, 
Director, New Hampshire Citizens Health Initiative, University of New 
Hampshire; Alvia Siddiqi, Medicaid Managed Care Community Network 
(MCCN) Medical Director, Advocate Physician Partners, Carla Smith, 
Executive Vice President, Healthcare Information and Management Systems 
Society (HIMSS); Tobin Van Ostern, Vice President and Co-Founder, Young 
Invincible Advisors; and Paula Villescaz, Senior Consultant, Assembly 
Health Committee, California State Legislature.

II. Meeting Agenda

    In accordance with section 10(a) of the FACA, this notice announces 
a meeting of the APOE. The agenda for the March 23, 2016 meeting will 
include the following:

 Welcome and listening session with CMS leadership
 Recap of the previous (January 13, 2016) meeting
 Affordable Care Act initiatives
 An opportunity for public comment
 Meeting summary, review of recommendations, and next steps

    Individuals or organizations that wish to make a 5-minute oral 
presentation on an agenda topic should submit a written copy of the 
oral presentation to the DFO at the address listed in the ADDRESSES 
section of this notice by the date listed in the DATES section of this 
notice. The number of oral presentations may be limited by the time 
available. Individuals not wishing to make a presentation may submit 
written comments to the DFO at the address listed in the ADDRESSES 
section of this notice by the date listed in the DATES section of this 
notice.

III. Security, Building, and Parking Guidelines

    This meeting will be held in a federal government building; 
therefore, federal security measures are applicable. The Real ID Act, 
enacted in 2005, establishes minimum standards for the issuance of 
state-issued driver's licenses and identification (ID) cards. It 
prohibits Federal agencies from accepting an official driver's license 
or ID card from a state unless the Department of Homeland Security 
determines that the state meets these standards. Beginning October 
2015, photo IDs (such as a valid driver's license) issued by a state or 
territory not in compliance with the Real ID Act will not be accepted 
as identification to enter Federal buildings. Visitors from these 
states/territories will need to provide alternative proof of 
identification (such as a valid passport) to gain entrance into CMS 
buildings. The current list of states from which a Federal agency may 
accept driver's licenses for an official purpose is found at http://www.dhs.gov/real-id-enforcement-brief. We recommend that confirmed 
registrants arrive reasonably early, but no earlier than 45 minutes 
prior to the start of the meeting, to allow additional time to clear 
security. Security measures include the following:
     Presentation of government issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel.

[[Page 9485]]

     Inspection of vehicle's interior and exterior (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Inspection, via metal detector or other applicable means, 
of all persons entering the building. We note that all items brought 
into CMS, whether personal or for the purpose of presentation or to 
support a presentation, are subject to inspection. We cannot assume 
responsibility for coordinating the receipt, transfer, transport, 
storage, set up, safety, or timely arrival of any personal belongings 
or items used for presentation or to support a presentation.

    Note:  Individuals who are not registered in advance will not be 
permitted to enter the building and will be unable to attend the 
meeting. The public may not enter the building earlier than 45 
minutes prior to the convening of the meeting.

    All visitors must be escorted in areas other than the lower and 
first floor levels in the Central Building.

    Authority:  Sec. 222 of the Public Health Service Act (42 U.S.C. 
217a) and sec. 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, sec. 10(a) 
and 41 CFR 102-3).

    Dated: February 18, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-04091 Filed 2-24-16; 8:45 am]
 BILLING CODE 4120-01-P



                                                                              Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices                                                    9483

                                                  public comments on four separate                        strategies. This meeting is open to the               authorized by section 1114(f) of the
                                                  information collection requests.                        public.                                               Social Security Act (42 U.S.C. 1314(f))
                                                  Through the publication of this                         DATES:                                                and section 222 of the Public Health
                                                  correction document, we are notifying                      Meeting Date: Wednesday, March 23,                 Service Act (42 U.S.C. 217a).
                                                  the public that we are no longer                        2016, 8:30 a.m. to 4:00 p.m. eastern                     The Secretary of the U.S. Department
                                                  requesting or accepting public                          daylight time (e.d.t.).                               of Health and Human Services (HHS)
                                                  comments on the information collection                     Deadline for Meeting Registration,                 (the Secretary) signed the charter
                                                  request that published on Wednesday,                    Presentations, Special Accommodations                 establishing the Citizen’s Advisory
                                                  February 10, 2016 (81 FR 7124), and is                  and Comments: Wednesday, March 9,                     Panel on Medicare Education 2 (the
                                                  titled ‘‘Medicare Prior Authorization of                2016, 5:00 p.m., eastern standard time                predecessor to the APOE) on January 21,
                                                  Home Health Services Demonstration.’’                   (e.s.t.).                                             1999 (64 FR 7899, February 17, 1999) to
                                                  Form number: CMS–10599 (OMB                                                                                   advise and make recommendations to
                                                                                                          ADDRESSES:
                                                  control number: 0938—New). All public                      Meeting Location: U.S. Department of               the Secretary and the Administrator of
                                                  comments regarding CMS–10599 should                     Health & Human Services, Hubert H.                    the Centers for Medicare & Medicaid
                                                  be submitted via the instructions listed                                                                      Services (CMS) on the effective
                                                                                                          Humphrey Building, 200 Independence
                                                  in the original notice. The original                                                                          implementation of national Medicare
                                                                                                          Avenue SW., Room 425A, Conference
                                                  notice for CMS–10599 published on                                                                             education programs, including with
                                                                                                          Room, Washington, DC 20201.
                                                  Friday, February 5, 2016 (81 FR 6275).                     Presentations and Written Comments:                respect to the Medicare+Choice (M+C)
                                                  The original 60-day comment period for                  Presentations and written comments                    program added by the Balanced Budget
                                                  the notice that published on February 5,                should be submitted to: Abigail                       Act of 1997 (Pub. L. 105–33).
                                                  2016 (81 FR 6275) remains in effect and                                                                          The Medicare Modernization Act of
                                                                                                          Huffman, Designated Federal Official
                                                  ends on April 5, 2016.                                                                                        2003 (MMA) (Pub. L. 108–173)
                                                                                                          (DFO), Division of Forum and
                                                                                                                                                                expanded the existing health plan
                                                     Dated: February 19, 2016.                            Conference Development, Office of
                                                                                                                                                                options and benefits available under the
                                                  William N. Parham, III,                                 Communications, Centers for Medicare                  M+C program and renamed it the
                                                  Director, Paperwork Reduction Staff, Office             & Medicaid Services, 7500 Security                    Medicare Advantage (MA) program. We
                                                  of Strategic Operations and Regulatory                  Boulevard, Mailstop S1 05–06,                         have had substantial responsibilities to
                                                  Affairs.                                                Baltimore, MD 21244 1850 or via email                 provide information to Medicare
                                                  [FR Doc. 2016–03922 Filed 2–24–16; 8:45 am]             at Abigail.Huffman1@cms.hhs.gov.                      beneficiaries about the range of health
                                                                                                             Registration: The meeting is open to
                                                  BILLING CODE 4120–01–P                                                                                        plan options available and better tools
                                                                                                          the public, but attendance is limited to
                                                                                                                                                                to evaluate these options. The
                                                                                                          the space available. Persons wishing to               successful MA program implementation
                                                  DEPARTMENT OF HEALTH AND                                attend this meeting must register at the              required CMS to consider the views and
                                                  HUMAN SERVICES                                          Web site https://www.regonline.com/                   policy input from a variety of private
                                                                                                          apoemar2016meeting or by contacting                   sector constituents and to develop a
                                                  Centers for Medicare & Medicaid                         the DFO as listed in the FOR FURTHER                  broad range of public-private
                                                  Services                                                INFORMATION CONTACT section of this
                                                                                                                                                                partnerships.
                                                                                                          notice, by the date listed in the DATES                  In addition, Title I of the MMA
                                                  [CMS–7040–N]                                            section of this notice. Individuals                   authorized the Secretary and the
                                                                                                          requiring sign language interpretation or             Administrator of CMS (by delegation) to
                                                  Health Insurance MarketplaceSM,                         other special accommodations should                   establish the Medicare prescription drug
                                                  Medicare, Medicaid, and the Children’s                  contact the DFO at the address listed in              benefit. The drug benefit allows
                                                  Health Insurance Program; Meeting of                    the ADDRESSES section of this notice by               beneficiaries to obtain qualified
                                                  the Advisory Panel on Outreach and                      the date listed in the DATES section of               prescription drug coverage. In order to
                                                  Education (APOE)                                        this notice.                                          effectively administer the MA program
                                                                                                          FOR FURTHER INFORMATION CONTACT:                      and the Medicare prescription drug
                                                  AGENCY: Centers for Medicare &                          Abigail Huffman, Designated Federal                   benefit, we have substantial
                                                  Medicaid Services (CMS), HHS.                           Official, Office of Communications,                   responsibilities to provide information
                                                  ACTION:   Notice of meeting.                            CMS, 7500 Security Boulevard, Mail                    to Medicare beneficiaries about the
                                                                                                          Stop S1–05–06, Baltimore, MD 21244,                   range of health plan options and
                                                  SUMMARY:   This notice announces the                    410–786–0897, email                                   benefits available, and to develop better
                                                  new meeting of the Advisory Panel on                    Abigail.Huffman1@cms.hhs.gov.                         tools to evaluate these plans and
                                                  Outreach and Education (APOE) (the                      Additional information about the APOE                 benefits.
                                                  Panel) in accordance with the Federal                   is available on the Internet at: http://                 The Affordable Care Act (Patient
                                                  Advisory Committee Act. The Panel                       www.cms.gov/Regulations-and-                          Protection and Affordable Care Act,
                                                  advises and makes recommendations to                    Guidance/Guidance/FACA/APOE.html.                     Pub. L. 111–148, and Health Care and
                                                  the Secretary of the U.S. Department of                 Press inquiries are handled through the               Education Reconciliation Act of 2010,
                                                  Health and Human Services (HHS) and                     CMS Press Office at (202) 690–6145.                   Pub. L. 111–152) expanded the
                                                  the Administrator of the Centers for                    SUPPLEMENTARY INFORMATION:                            availability of other options for health
                                                  Medicare & Medicaid Services (CMS) on                                                                         care coverage and enacted a number of
                                                                                                          I. Background                                         changes to Medicare as well as to
                                                  opportunities to enhance the
                                                                                                                                                                Medicaid and the Children’s Health
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  effectiveness of Health Insurance                          The Advisory Panel for Outreach and
                                                  MarketplaceSM,1 Medicare, Medicaid,                     Education (APOE) (the Panel) is                       Insurance Program (CHIP). Qualified
                                                  and Children’s Health Insurance                         governed by the provisions of Federal                 individuals and qualified employers are
                                                  Program (CHIP) consumer education                       Advisory Committee Act (FACA) (Pub.
                                                                                                                                                                  2 We note that the Citizens’ Advisory Panel on
                                                                                                          L. 92–463), as amended (5 U.S.C.
                                                                                                                                                                Medicare Education is also referred to as the
                                                    1 Health Insurance MarketplaceSM and                  Appendix 2), which sets forth standards               Advisory Panel on Medicare Education (65 FR
                                                  MarketplaceSM are service marks of the U.S.             for the formation and use of federal                  4617). The name was updated in the Second
                                                  Department of Health & Human Services.                  advisory committees. The Panel is                     Amended Charter approved on July 24, 2000.



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                                                  9484                        Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices

                                                  now able to purchase private health                     MarketplaceSM, Medicare, Medicaid,                    II. Meeting Agenda
                                                  insurance coverage through competitive                  and CHIP education programs.                             In accordance with section 10(a) of
                                                  marketplaces, called Affordable                           • Assembling and sharing an                         the FACA, this notice announces a
                                                  Insurance Exchanges (we also call an                    information base of ‘‘best practices’’ for            meeting of the APOE. The agenda for
                                                  Exchange a Health Insurance                             helping consumers evaluate health                     the March 23, 2016 meeting will include
                                                  MarketplaceSM or MarketplaceSM). In                     coverage options.                                     the following:
                                                  order to effectively implement and
                                                                                                            • Building and leveraging existing                  • Welcome and listening session with
                                                  administer these changes, we must
                                                                                                          community infrastructures for                            CMS leadership
                                                  provide information to consumers,                                                                             • Recap of the previous (January 13,
                                                  providers, and other stakeholders                       information, counseling, and assistance.
                                                                                                                                                                   2016) meeting
                                                  through education and outreach                            • Drawing the program link between
                                                                                                                                                                • Affordable Care Act initiatives
                                                  programs regarding how existing                         outreach and education, promoting                     • An opportunity for public comment
                                                  programs will change and the expanded                   consumer understanding of health care                 • Meeting summary, review of
                                                  range of health coverage options                        coverage choices, and facilitating                       recommendations, and next steps
                                                  available, including private health                     consumer selection/enrollment, which
                                                                                                                                                                   Individuals or organizations that wish
                                                  insurance coverage through a                            in turn support the overarching goal of
                                                                                                                                                                to make a 5-minute oral presentation on
                                                  MarketplaceSM. The APOE (the Panel)                     improved access to quality care,
                                                                                                                                                                an agenda topic should submit a written
                                                  allows us to consider a broad range of                  including prevention services,
                                                                                                                                                                copy of the oral presentation to the DFO
                                                  views and information from interested                   envisioned under the Affordable Care
                                                                                                                                                                at the address listed in the ADDRESSES
                                                  audiences in connection with this effort                Act.
                                                                                                                                                                section of this notice by the date listed
                                                  and to identify opportunities to enhance                  The current members of the Panel are:               in the DATES section of this notice. The
                                                  the effectiveness of education strategies               Kellan Baker, Associate Director, Center              number of oral presentations may be
                                                  concerning the Affordable Care Act.                     for American Progress; Robert Blancato,               limited by the time available.
                                                     The scope of this panel also includes                President, Matz, Blancato & Associates;               Individuals not wishing to make a
                                                  advising on issues pertaining to the                    Dale Blasier, Professor of Orthopedic                 presentation may submit written
                                                  education of providers and stakeholders                 Surgery, Department of Orthopedics,                   comments to the DFO at the address
                                                  with respect to the Affordable Care Act                 Arkansas Children’s Hospital; Deborah                 listed in the ADDRESSES section of this
                                                  and certain provisions of the Health                    Britt, Executive Director of Community                notice by the date listed in the DATES
                                                  Information Technology for Economic                     & Public Relations, Piedmont Fayette                  section of this notice.
                                                  and Clinical Health (HITECH) Act                        Hospital; Deena Chisolm, Associate
                                                  enacted as part of the American                         Professor of Pediatrics & Public Health,              III. Security, Building, and Parking
                                                  Recovery and Reinvestment Act of 2009                   The Ohio State University, Nationwide                 Guidelines
                                                  (ARRA).                                                 Children’s Hospital; Josephine DeLeon,                   This meeting will be held in a federal
                                                     On January 21, 2011, the Panel’s                     Director, Anti-Poverty Initiatives,                   government building; therefore, federal
                                                  charter was renewed and the Panel was                   Catholic Charities of California; Robert              security measures are applicable. The
                                                  renamed the Advisory Panel for                          Espinoza, Vice President of Policy,                   Real ID Act, enacted in 2005, establishes
                                                  Outreach and Education. The Panel’s                     Paraprofessional Healthcare Institute;                minimum standards for the issuance of
                                                  charter was most recently renewed on                    Jennifer Gross, Manager of Political                  state-issued driver’s licenses and
                                                  January 21, 2015, and will terminate on                 Field Operations, Planned Parenthood                  identification (ID) cards. It prohibits
                                                  January 21, 2017 unless renewed by                      of Montana; Louise Scherer Knight,                    Federal agencies from accepting an
                                                  appropriate action.                                     Director, The Sidney Kimmel                           official driver’s license or ID card from
                                                     Under the current charter, the APOE                  Comprehensive Cancer Center at Johns                  a state unless the Department of
                                                  will advise the Secretary and the                       Hopkins; Miriam Mobley-Smith,                         Homeland Security determines that the
                                                  Administrator on optimal strategies for                 Director of Strategic Alliances,                      state meets these standards. Beginning
                                                  the following:                                          Pharmacy Technician Certification                     October 2015, photo IDs (such as a valid
                                                     • Developing and implementing                        Board; Roanne Osborne-Gaskin, M.D.,                   driver’s license) issued by a state or
                                                  education and outreach programs for                     Senior Medical Director, MDWise, Inc.;                territory not in compliance with the
                                                  individuals enrolled in, or eligible for,               Cathy Phan, Outreach and Education                    Real ID Act will not be accepted as
                                                  Medicare, Medicaid, and the Children’s                  Coordinator, Asian American Health                    identification to enter Federal buildings.
                                                  Health Insurance Program (CHIP), or                     Coalition DBA HOPE Clinic; Kamilah                    Visitors from these states/territories will
                                                  coverage available through a Health                     Pickett, Litigation Support, Independent              need to provide alternative proof of
                                                  Insurance MarketplaceSM.                                Contractor; Brendan Riley, Outreach                   identification (such as a valid passport)
                                                     • Enhancing the federal government’s                 and Enrollment Coordinator, NC                        to gain entrance into CMS buildings.
                                                  effectiveness in informing Health                       Community Health Center Association;                  The current list of states from which a
                                                  Insurance MarketplaceSM, Medicare,                      Jeanne Ryer, Director, New Hampshire                  Federal agency may accept driver’s
                                                  Medicaid, and CHIP consumers, issuers,                  Citizens Health Initiative, University of             licenses for an official purpose is found
                                                  providers, and stakeholders, through                    New Hampshire; Alvia Siddiqi,                         at http://www.dhs.gov/real-id-
                                                  education and outreach programs, on                     Medicaid Managed Care Community                       enforcement-brief. We recommend that
                                                  issues regarding these programs,                        Network (MCCN) Medical Director,                      confirmed registrants arrive reasonably
                                                  including the appropriate use of public-                Advocate Physician Partners, Carla                    early, but no earlier than 45 minutes
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                                                  private partnerships to leverage the                    Smith, Executive Vice President,                      prior to the start of the meeting, to allow
                                                  resources of the private sector in                      Healthcare Information and                            additional time to clear security.
                                                  educating beneficiaries, providers, and                 Management Systems Society (HIMSS);                   Security measures include the
                                                  stakeholders.                                           Tobin Van Ostern, Vice President and                  following:
                                                     • Expanding outreach to vulnerable                   Co-Founder, Young Invincible Advisors;                   • Presentation of government issued
                                                  and underserved communities,                            and Paula Villescaz, Senior Consultant,               photographic identification to the
                                                  including racial and ethnic minorities,                 Assembly Health Committee, California                 Federal Protective Service or Guard
                                                  in the context of Health Insurance                      State Legislature.                                    Service personnel.


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                                                                              Federal Register / Vol. 81, No. 37 / Thursday, February 25, 2016 / Notices                                                 9485

                                                     • Inspection of vehicle’s interior and               workshop will focus on the standards                  Center (see ADDRESSES) are eligible for a
                                                  exterior (this includes engine and trunk                relevant to the qualification of a range              reduced rate of $226 per night
                                                  inspection) at the entrance to the                      of safety biomarkers and examine case                 (equivalent to the government per diem
                                                  grounds. Parking permits and                            studies in several different organ                    rate), not including applicable taxes. To
                                                  instructions will be issued after the                   systems.                                              receive the reduced rate, follow the Web
                                                  vehicle inspection.                                     DATES: The public workshop will be                    link that will be provided to you upon
                                                     • Inspection, via metal detector or                  held on April 14, 2016, from 9 a.m. to                completion of online registration.
                                                  other applicable means, of all persons                  5 p.m. and April 15, 2016, from 8 a.m.                   If you need special accommodations
                                                  entering the building. We note that all                 to 5 p.m.                                             due to a disability, please contact
                                                  items brought into CMS, whether                         ADDRESSES: The public workshop will                   Janelle Lewis (see FOR FURTHER
                                                  personal or for the purpose of                          be held at the Bethesda North Marriott                INFORMATION CONTACT) at the Foundation
                                                  presentation or to support a                            Hotel and Conference Center, 5701                     for the NIH at least 7 days in advance
                                                  presentation, are subject to inspection.                Marinelli Rd., Bethesda, MD 20852.                    of the workshop.
                                                  We cannot assume responsibility for                                                                             Dated: February 19, 2016.
                                                                                                          FOR FURTHER INFORMATION CONTACT:
                                                  coordinating the receipt, transfer,
                                                                                                          Janelle Lewis, Foundation for the                     Leslie Kux,
                                                  transport, storage, set up, safety, or                  National Institutes of Health, 9650                   Associate Commissioner for Policy.
                                                  timely arrival of any personal                          Rockville Pike, Bethesda, MD 20814,                   [FR Doc. 2016–04027 Filed 2–24–16; 8:45 am]
                                                  belongings or items used for                            301–594–2919, FAX: 301–480–2752,
                                                  presentation or to support a                                                                                  BILLING CODE 4164–01–P
                                                                                                          email: jlewis@fnih.org.
                                                  presentation.
                                                                                                          SUPPLEMENTARY INFORMATION: The need
                                                    Note: Individuals who are not registered in           for evidentiary standards to qualify                  DEPARTMENT OF HEALTH AND
                                                  advance will not be permitted to enter the              biomarkers was identified in FDA’s                    HUMAN SERVICES
                                                  building and will be unable to attend the
                                                                                                          Critical Path Initiative as essential to
                                                  meeting. The public may not enter the                                                                         Office of the Secretary
                                                  building earlier than 45 minutes prior to the
                                                                                                          improving the efficiency and
                                                  convening of the meeting.                               effectiveness of drug development.
                                                                                                          Evidentiary standards vary among                      [Document Identifier: OS–4040–0010 60D]
                                                    All visitors must be escorted in areas                different types of biomarkers and
                                                  other than the lower and first floor                    according to the context(s) of use (COU)              Agency Information Collection
                                                  levels in the Central Building.                         for which qualification is being                      Activities; Submission to OMB for
                                                    Authority: Sec. 222 of the Public Health              considered, and there are specific                    Review and Approval; Public Comment
                                                  Service Act (42 U.S.C. 217a) and sec. 10(a)             challenges involved in qualifying drug                Request
                                                  of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a)          safety biomarkers. This workshop is
                                                  and 41 CFR 102–3).                                                                                            AGENCY:    Electronic Government Office,
                                                                                                          aimed at creating alignment among
                                                                                                                                                                HHS.
                                                    Dated: February 18, 2016.                             scientific stakeholders including FDA,
                                                                                                          the National Institutes of Health (NIH),              ACTION:   Notice.
                                                  Andrew M. Slavitt,
                                                  Acting Administrator, Centers for Medicare              the biopharmaceutical industry,                       SUMMARY:    In compliance with section
                                                  & Medicaid Services.                                    academic researchers, and patient                     3507(a)(1)(D) of the Paperwork
                                                  [FR Doc. 2016–04091 Filed 2–24–16; 8:45 am]             groups regarding a proposed framework                 Reduction Act of 1995, the Electronic
                                                  BILLING CODE 4120–01–P
                                                                                                          for determining the levels of evidence                Government Office (EGOV), Department
                                                                                                          required to qualify biomarkers for use in             of Health and Human Services, has
                                                                                                          drug development, with an emphasis on                 submitted an Information Collection
                                                  DEPARTMENT OF HEALTH AND                                biomarkers used in determinations of                  Request (ICR), described below, to the
                                                  HUMAN SERVICES                                          drug safety assessments. Development                  Office of Management and Budget
                                                                                                          of a general framework for biomarker                  (OMB) for review and approval. The ICR
                                                  Food and Drug Administration                            qualification will be discussed, along                is for a 3-year extension for OMB
                                                                                                          with specific application to different                Control Number 4040–0010. The ICR
                                                  [Docket No. FDA–2016–N–0001]
                                                                                                          COUs related to drug safety, including                will expire on September 30, 2016. The
                                                  Developing an Evidentiary Standards                     consideration of several specific case                4040–0010 is composed of the following
                                                  Framework for Safety Biomarkers                         studies involving qualification of                    forms: Project Abstract; Project
                                                  Qualification; Public Workshop                          clinical markers of toxicity in different             Performance Site Location(s); and Key
                                                                                                          organ systems.                                        Contacts. The ICR also requests
                                                  AGENCY:    Food and Drug Administration,                   Registration: There is no fee to attend
                                                                                                                                                                categorizing these forms as common
                                                  HHS.                                                    the workshop, but attendees must
                                                                                                                                                                forms, meaning HHS will only request
                                                  ACTION:   Notice of public workshop.                    register in advance. Space is limited,
                                                                                                                                                                approval for its own use of the form
                                                                                                          and registration will be on a first-come,
                                                  SUMMARY:   The Food and Drug                                                                                  rather than aggregating the burden
                                                                                                          first-served basis. Persons interested in
                                                  Administration (FDA), in co-                                                                                  estimate across all Federal Agencies as
                                                                                                          attending this workshop must register
                                                  sponsorship with the Foundation for the                                                                       was done for previous actions on this
                                                                                                          online at www.fnih.org/
                                                  National Institutes of Health Biomarkers                                                                      OMB control number. Comments
                                                                                                          evidentiarystandardsworkshop by April
                                                  Consortium (FNIH BC), is announcing a                                                                         submitted during the first public review
                                                                                                          1, 2016. For those persons without
                                                                                                                                                                of this ICR will be provided to OMB.
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  public workshop entitled ‘‘Developing                   Internet access, please contact Janelle
                                                  an Evidentiary Standards Framework for                                                                        OMB will accept further comments from
                                                                                                          Lewis at the Foundation for the NIH (see
                                                  Safety Biomarkers Qualification                                                                               the public on this ICR during the review
                                                                                                          FOR FURTHER INFORMATION CONTACT) to
                                                  Workshop.’’ The purpose of the                                                                                and approval period.
                                                                                                          register.
                                                  workshop is to discuss the evidentiary                     Attendees are responsible for their                DATES: Comments on the ICR must be
                                                  standards needed to support biomarker                   own hotel accommodations. Attendees                   received on or before April 25, 2016.
                                                  qualification with a particular emphasis                making reservations at the Bethesda                   ADDRESSES: Submit your comments to
                                                  on drug safety markers. The 2-day                       North Marriott Hotel and Conference                   ed.calimag@hhs.gov or (202) 690–7569.


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Document Created: 2018-02-02 14:35:26
Document Modified: 2018-02-02 14:35:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of meeting.
DatesMeeting Date: Wednesday, March 23, 2016, 8:30 a.m. to 4:00 p.m. eastern daylight time (e.d.t.).
ContactAbigail Huffman, Designated Federal Official, Office of Communications, CMS, 7500 Security Boulevard, Mail Stop S1-05-06, Baltimore, MD 21244, 410-786-0897, email [email protected] Additional information about the APOE is available on the Internet at: http://www.cms.gov/Regulations-and- Guidance/Guidance/FACA/APOE.html. Press inquiries are handled through the CMS Press Office at (202) 690-6145.
FR Citation81 FR 9483 

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