80_FR_23357 80 FR 23277 - Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Additional Request for Nominations for the Advisory Panel on Outreach and Education (APOE)

80 FR 23277 - Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Additional Request for Nominations for the Advisory Panel on Outreach and Education (APOE)

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

Federal Register Volume 80, Issue 80 (April 27, 2015)

Page Range23277-23279
FR Document2015-09730

This notice requests nominations for individuals to serve on the Advisory Panel on Outreach and Education (APOE).

Federal Register, Volume 80 Issue 80 (Monday, April 27, 2015)
[Federal Register Volume 80, Number 80 (Monday, April 27, 2015)]
[Notices]
[Pages 23277-23279]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09730]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-7036-N2]


Health Insurance Marketplace, Medicare, Medicaid, and Children's 
Health Insurance Programs; Additional Request for Nominations for the 
Advisory Panel on Outreach and Education (APOE)

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

ACTION: Notice.

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

SUMMARY: This notice requests nominations for individuals to serve on 
the Advisory Panel on Outreach and Education (APOE).

DATES: Nominations will be considered if we receive them at the 
appropriate address, provided in the ``ADDRESSES'' section of this 
notice, no later than 5 p.m., Eastern Daylight Time (e.d.t.) on May 18, 
2015.

ADDRESSES: Mail or deliver nominations to the following address: 
Abigail Huffman, Designated Federal Official, Office of Communications, 
CMS, 7500 Security Boulevard, Mail Stop S1-05-06, Baltimore, MD 21244-
1850 or email nominations to Abigail.Huffman1@cms.hhs.gov.

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, 
Abigail.Huffman1@cms.hhs.gov or visit the Web site 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 on Medicare Education (the predecessor to the 
APOE) was created in 1999 to advise and make 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 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).
    The Medicare Modernization Act of 2003 (MMA) (Pub. L. 108-173) 
expanded the existing health plan options and benefits available under 
the

[[Page 23278]]

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. Successful MA program 
implementation required us 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, the Secretary, and by delegation, the Administrator of 
CMS were authorized under Title I of MMA 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 now able to purchase 
private health insurance coverage through a competitive marketplace, 
called the Affordable Insurance Exchange (or Health Insurance 
Marketplace, or ``Marketplace''). 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 the Marketplace. 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 APOE charter was originally created in 1999, as the charter for 
the Advisory Panel on Medicare Education. The panel's charter was 
renewed, and the panel was renamed the Advisory Panel for Outreach and 
Education, on January 21, 2011. The charter was most recently renewed 
on January 21, 2015. The APOE will advise HHS and CMS on developing and 
implementing education programs for individuals with, or who are 
eligible for, the Health Insurance Marketplace, Medicare, Medicaid, and 
CHIP about options for selecting health care coverage under these and 
other programs intended to ensure improved access to quality care, 
including preventive services. The scope of this panel, convened under 
the Federal Advisory Committee Act (FACA), also includes advising on 
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).
    The charter will terminate on January 21, 2017, unless renewed by 
appropriate action. The APOE was chartered under 42 U.S.C. 222 of the 
Public Health Service Act, as amended. The APOE is governed by the 
provisions of 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.
    In accordance with the renewed 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 the Health Insurance Marketplace.
     Enhancing the federal government's effectiveness in 
informing Health Insurance Marketplace, Medicare, Medicaid, and CHIP 
consumers, issuers, providers, and stakeholders through education and 
outreach programs of 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, 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.
     Establishing links 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 
preventive services, envisioned under the Affordable Care Act.
    In the February 27, 2015 Federal Register (80 FR 10688), we 
published a notice titled ``Health Insurance Marketplace, Medicare, 
Medicaid, and Children's Health Insurance Programs; Renewal of the 
Advisory Panel on Outreach and Education (APOE) and Request for 
Nominations''. The notice announced the renewal of the APOE charter and 
requested nominations for individuals to serve on the APOE.

II. Provisions of this Notice

    This notice is an additional solicitation of nominees for the 
Panel. The APOE shall consist of no more than 20 members. The Chair 
shall either be appointed from among the 20 members, or a federal 
official will be designated to serve as the Chair. The charter requires 
that meetings shall be held approximately four times per year. Members 
will be expected to attend all meetings. The members and the Chair 
shall be selected from authorities knowledgeable in one or more of the 
following fields:
     Senior citizen advocacy
     Outreach to minority and underserved communities
     Health communications
     Disease-related advocacy
     Disability policy and access
     Health economics research
     Behavioral health
     Health insurers and plans
     Health information technology (IT)
     Social media
     Direct patient care
     Matters of labor and retirement

Representatives of the general public may also serve on the APOE.

    This notice announces that, in July 2015, the terms of 11 existing 
members will expire, and in October 2015, the terms of 2 additional 
members will expire. This notice invites interested organizations or 
individuals to submit nominations for membership for all 13 upcoming 
vacancies on the APOE (no self-nominations will be accepted). The 
Secretary, or designee, will appoint new members to the APOE from among 
those candidates determined to have the expertise required to meet 
specific agency needs, in a manner to ensure an appropriate balance of 
membership. We are committed to ensuring that the interests of both 
women and men, members of all racial and ethnic groups, and disabled 
individuals are adequately

[[Page 23279]]

represented on the APOE. Therefore, we encourage nominations of 
qualified candidates who can represent these interests. Any interested 
organization or person may nominate one or more qualified persons.
    Each nomination must include a letter stating that the nominee has 
expressed a willingness to serve as a Panel member and must be 
accompanied by a curricula vitae and a brief biographical summary of 
the nominee's experience.
    While we are looking for experts in a number of fields, our most 
critical needs are for experts in Health IT, Tribal Affairs, Community 
Health Centers/Medically Underserved Populations, African-American 
Health/Disparities, Health/Disability, Quality/Disparities, and State 
Programs/Medicaid/Rural.
    We are requesting that all curricula vitae include the following:
     Date of birth
     Place of birth
     Title and current position
     Professional affiliation
     Home and business address
     Telephone and fax numbers
     Email address
     List of areas of expertise

Phone interviews of nominees may also be requested after review of the 
nominations.

    In order to permit an evaluation of possible sources of conflict of 
interest, potential candidates will be asked to provide detailed 
information concerning such matters as financial holdings, 
consultancies, and research grants or contracts.
    Members are invited to serve for 2-year terms, contingent upon the 
renewal of the APOE by appropriate action prior to its termination. A 
member may serve after the expiration of his or her term until a 
successor takes office. Any member appointed to fill a vacancy for an 
unexpired term shall be appointed for the remainder of that term.

III. Copies of the Charter

    The Secretary's Charter for the APOE is available on the CMS Web 
site at: http://www.cms.gov/Regulations-andGuidance/Guidance/FACA/APOE.html, or you may obtain a copy of the charter by submitting a 
request to the contact listed in the FOR FURTHER INFORMATION CONTACT 
section of this notice.

    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: April 21, 2015.
Andrew M. Slavitt
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-09730 Filed 4-24-15; 8:45 am]
 BILLING CODE 4120-01-P



                                                                              Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices                                           23277

                                               DEPARTMENT OF HEALTH AND                                DEPARTMENT OF HEALTH AND                              DEPARTMENT OF HEALTH AND
                                               HUMAN SERVICES                                          HUMAN SERVICES                                        HUMAN SERVICES

                                               Centers for Disease Control and                         Centers for Disease Control and                       Centers for Medicare & Medicaid
                                               Prevention                                              Prevention                                            Services

                                               Disease, Disability, and Injury                                                                               [CMS–7036–N2]
                                                                                                       Disease, Disability, and Injury
                                               Prevention and Control Special                          Prevention and Control Special                        Health Insurance Marketplace,
                                               Emphasis Panel (SEP): Initial Review                    Emphasis Panel (SEP): Initial Review                  Medicare, Medicaid, and Children’s
                                                  In accordance with Section 10(a)(2) of                                                                     Health Insurance Programs; Additional
                                               the Federal Advisory Committee Act                         In accordance with Section 10(a)(2) of             Request for Nominations for the
                                               (Pub. L. 92–463), the Centers for Disease               the Federal Advisory Committee Act                    Advisory Panel on Outreach and
                                               Control and Prevention (CDC)                            (Pub. L. 92–463), the Centers for Disease             Education (APOE)
                                               announces a meeting for the initial                     Control and Prevention (CDC)
                                                                                                       announces a meeting for the initial                   AGENCY: Centers for Medicare &
                                               review of applications in response to                                                                         Medicaid Services (CMS), HHS.
                                               Special Interest Projects (SIP) 15–007,                 review of applications in response to
                                                                                                       Special Interest Projects (SIP) 15–002,               ACTION: Notice.
                                               HPV Vaccine Impact among Men who
                                               have Sex with Men (MSM), and, SIP 15–                   Economic Impact of Clinical Trials                    SUMMARY:    This notice requests
                                               009, Serosorting and Other Seroadaptive                 among Children Diagnosed with Cancer,                 nominations for individuals to serve on
                                               Behaviors among Men who have Sex                        and, SIP 15–005, Economic Costs of                    the Advisory Panel on Outreach and
                                               with Men (MSM) in the US-designing a                    Quality Assurance in Lung Cancer                      Education (APOE).
                                               Brief Survey Tool for Use in Clinical                   Screening Programs.                                   DATES: Nominations will be considered
                                               Practice.                                                  Time and Date: 11:00 a.m.–6:00 p.m.,               if we receive them at the appropriate
                                                  Time and Date: 10:00 a.m.–6:00 p.m.,                 May 19, 2015.                                         address, provided in the ‘‘ADDRESSES’’
                                               May 18, 2015 (Closed).                                                                                        section of this notice, no later than 5
                                                  Place: Teleconference.                                  Place: Teleconference.
                                                                                                                                                             p.m., Eastern Daylight Time (e.d.t.) on
                                                  Status: The meeting will be closed to                   Status: The meeting will be closed to              May 18, 2015.
                                               the public in accordance with                           the public in accordance with                         ADDRESSES: Mail or deliver nominations
                                               provisions set forth in Section                         provisions set forth in Section                       to the following address: Abigail
                                               552b(c)(4) and (6), Title 5 U.S.C., and                 552b(c)(4) and (6), Title 5 U.S.C., and               Huffman, Designated Federal Official,
                                               the Determination of the Director,                      the Determination of the Director,                    Office of Communications, CMS, 7500
                                               Management Analysis and Services                        Management Analysis and Services                      Security Boulevard, Mail Stop S1–05–
                                               Office, CDC, pursuant to Public Law 92–                 Office, CDC, pursuant to Public Law 92–               06, Baltimore, MD 21244–1850 or email
                                               463.                                                    463.                                                  nominations to Abigail.Huffman1@
                                                  Matters for Discussion: The meeting                                                                        cms.hhs.gov.
                                                                                                          Matters for Discussion: The meeting
                                               will include the initial review,
                                                                                                       will include the initial review,                      FOR FURTHER INFORMATION CONTACT:
                                               discussion, and evaluation of
                                                                                                       discussion, and evaluation of                         Abigail Huffman, Designated Federal
                                               applications received in response to
                                               ‘‘HPV Vaccine Impact among Men who                      applications received in response to                  Official, Office of Communications,
                                               have Sex with Men (MSM), SIP 15–007,                    ‘‘Economic Impact of Clinical Trials                  CMS, 7500 Security Boulevard, Mail
                                               and, Serosorting and Other Seroadaptive                 among Children Diagnosed with Cancer,                 Stop S1–05–06, Baltimore, MD 21244,
                                               Behaviors among Men who have Sex                        SIP 15–002, and, Economic Costs of                    410–786–0897, email,
                                               with Men (MSM) in the US-designing a                    Quality Assurance in Lung Cancer                      Abigail.Huffman1@cms.hhs.gov or visit
                                               Brief Survey Tool for Use in Clinical                   Screening Programs, SIP 15–005.’’                     the Web site at http://www.cms.gov/
                                               Practice, SIP 15–009.’’                                    Contact Person for More Information:               Regulations-and-Guidance/Guidance/
                                                  Contact Person for More Information:                 Brenda Colley Gilbert, Ph.D., M.S.P.H.,               FACA/APOE.html. Press inquiries are
                                               Brenda Colley Gilbert, Ph.D., M.S.P.H.,                 Director, Extramural Research Program                 handled through the CMS Press Office
                                               Director, Extramural Research Program                   Operations and Services, CDC, 4770                    at (202) 690–6145.
                                               Operations and Services, CDC, 4770                      Buford Highway NE., Mailstop F–80,                    SUPPLEMENTARY INFORMATION:
                                               Buford Highway NE., Mailstop F–80,                      Atlanta, Georgia 30341, Telephone:                    I. Background
                                               Atlanta, Georgia 30341, Telephone:                      (770) 488–6295, BJC4@cdc.gov.
                                               (770) 488–6295, BJC4@cdc.gov.                                                                                   The Advisory Panel on Medicare
                                                                                                          The Director, Management Analysis                  Education (the predecessor to the
                                                  The Director, Management Analysis
                                                                                                       and Services Office, has been delegated               APOE) was created in 1999 to advise
                                               and Services Office, has been delegated
                                                                                                       the authority to sign Federal Register                and make recommendations to the
                                               the authority to sign Federal Register
                                                                                                       notices pertaining to announcements of                Secretary of the U.S. Department of
                                               notices pertaining to announcements of
                                               meetings and other committee                            meetings and other committee                          Health and Human Services (HHS), and
                                               management activities, for both the                     management activities, for both the                   the Administrator of the Centers for
                                               Centers for Disease Control and                         Centers for Disease Control and                       Medicare & Medicaid Services (CMS) on
                                               Prevention and the Agency for Toxic                     Prevention and the Agency for Toxic                   the effective implementation of national
                                                                                                       Substances and Disease Registry.                      Medicare education programs, including
Rmajette on DSK2VPTVN1PROD with NOTICES




                                               Substances and Disease Registry.
                                                                                                                                                             with respect to the Medicare + Choice
                                               Elaine L. Baker,                                        Elaine L. Baker,                                      (M + C) program added by the Balanced
                                               Director, Management Analysis and Services              Director, Management Analysis and Services            Budget Act of 1997 (Pub. L. 105–33).
                                               Office, Centers for Disease Control and                 Office, Centers for Disease Control and                 The Medicare Modernization Act of
                                               Prevention.                                             Prevention.                                           2003 (MMA) (Pub. L. 108–173)
                                               [FR Doc. 2015–09647 Filed 4–24–15; 8:45 am]             [FR Doc. 2015–09645 Filed 4–24–15; 8:45 am]           expanded the existing health plan
                                               BILLING CODE 4163–18–P                                  BILLING CODE 4163–18–P                                options and benefits available under the


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                                               23278                          Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices

                                               M + C program and renamed it the                        The APOE will advise HHS and CMS on                   choices, and facilitating consumer
                                               Medicare Advantage (MA) program. We                     developing and implementing education                 selection/enrollment, which in turn
                                               have had substantial responsibilities to                programs for individuals with, or who                 support the overarching goal of
                                               provide information to Medicare                         are eligible for, the Health Insurance                improved access to quality care,
                                               beneficiaries about the range of health                 Marketplace, Medicare, Medicaid, and                  including preventive services,
                                               plan options available and better tools                 CHIP about options for selecting health               envisioned under the Affordable Care
                                               to evaluate these options. Successful                   care coverage under these and other                   Act.
                                               MA program implementation required                      programs intended to ensure improved                    In the February 27, 2015 Federal
                                               us to consider the views and policy                     access to quality care, including                     Register (80 FR 10688), we published a
                                               input from a variety of private sector                  preventive services. The scope of this                notice titled ‘‘Health Insurance
                                               constituents and to develop a broad                     panel, convened under the Federal                     Marketplace, Medicare, Medicaid, and
                                               range of public-private partnerships.                   Advisory Committee Act (FACA), also                   Children’s Health Insurance Programs;
                                                  In addition, the Secretary, and by                   includes advising on education of                     Renewal of the Advisory Panel on
                                               delegation, the Administrator of CMS                    providers and stakeholders with respect               Outreach and Education (APOE) and
                                               were authorized under Title I of MMA                    to the Affordable Care Act and certain                Request for Nominations’’. The notice
                                               to establish the Medicare prescription                  provisions of the Health Information                  announced the renewal of the APOE
                                               drug benefit. The drug benefit allows                   Technology for Economic and Clinical                  charter and requested nominations for
                                               beneficiaries to obtain qualified                       Health (HITECH) Act enacted as part of                individuals to serve on the APOE.
                                               prescription drug coverage. In order to                 the American Recovery and
                                               effectively administer the MA program                   Reinvestment Act of 2009 (ARRA).                      II. Provisions of this Notice
                                               and the Medicare prescription drug                         The charter will terminate on January                This notice is an additional
                                               benefit, we have substantial                            21, 2017, unless renewed by appropriate               solicitation of nominees for the Panel.
                                               responsibilities to provide information                 action. The APOE was chartered under                  The APOE shall consist of no more than
                                               to Medicare beneficiaries about the                     42 U.S.C. 222 of the Public Health                    20 members. The Chair shall either be
                                               range of health plan options and                        Service Act, as amended. The APOE is                  appointed from among the 20 members,
                                               benefits available, and to develop better               governed by the provisions of FACA                    or a federal official will be designated to
                                               tools to evaluate these plans and                       (Pub. L. 92–463), as amended (5 U.S.C.                serve as the Chair. The charter requires
                                               benefits.                                               Appendix 2), which sets forth standards               that meetings shall be held
                                                  The Affordable Care Act (Patient                     for the formation and use of federal                  approximately four times per year.
                                               Protection and Affordable Care Act,                     advisory committees.                                  Members will be expected to attend all
                                               Pub. L. 111–148, and Health Care and                       In accordance with the renewed                     meetings. The members and the Chair
                                               Education Reconciliation Act of 2010,                   charter, the APOE will advise the                     shall be selected from authorities
                                               Pub. L. 111–152) expanded the                           Secretary and the Administrator on                    knowledgeable in one or more of the
                                               availability of other options for health                optimal strategies for the following:                 following fields:
                                               care coverage and enacted a number of                      • Developing and implementing                        • Senior citizen advocacy
                                               changes to Medicare as well as to                       education and outreach programs for                     • Outreach to minority and
                                               Medicaid and the Children’s Health                      individuals enrolled in, or eligible for,             underserved communities
                                               Insurance Program (CHIP). Qualified                     Medicare, Medicaid, and the Children’s                  • Health communications
                                               individuals and qualified employers are                 Health Insurance Program (CHIP), or                     • Disease-related advocacy
                                               now able to purchase private health                     coverage available through the Health                   • Disability policy and access
                                               insurance coverage through a                            Insurance Marketplace.                                  • Health economics research
                                               competitive marketplace, called the                        • Enhancing the federal government’s                 • Behavioral health
                                               Affordable Insurance Exchange (or                       effectiveness in informing Health                       • Health insurers and plans
                                               Health Insurance Marketplace, or                        Insurance Marketplace, Medicare,                        • Health information technology (IT)
                                               ‘‘Marketplace’’). In order to effectively               Medicaid, and CHIP consumers, issuers,                  • Social media
                                               implement and administer these                          providers, and stakeholders through                     • Direct patient care
                                               changes, we must provide information                    education and outreach programs of                      • Matters of labor and retirement
                                               to consumers, providers, and other                      issues regarding these programs,
                                               stakeholders through education and                                                                            Representatives of the general public
                                                                                                       including the appropriate use of public-
                                               outreach programs regarding how                                                                               may also serve on the APOE.
                                                                                                       private partnerships to leverage the
                                               existing programs will change and the                   resources of the private sector in                      This notice announces that, in July
                                               expanded range of health coverage                       educating beneficiaries, providers, and               2015, the terms of 11 existing members
                                               options available, including private                    stakeholders.                                         will expire, and in October 2015, the
                                               health insurance coverage through the                      • Expanding outreach to vulnerable                 terms of 2 additional members will
                                               Marketplace. The APOE (the Panel)                       and underserved communities,                          expire. This notice invites interested
                                               allows us to consider a broad range of                  including racial and ethnic minorities,               organizations or individuals to submit
                                               views and information from interested                   in the context of Health Insurance                    nominations for membership for all 13
                                               audiences in connection with this effort                Marketplace, Medicare, Medicaid, and                  upcoming vacancies on the APOE (no
                                               and to identify opportunities to enhance                CHIP education programs.                              self-nominations will be accepted). The
                                               the effectiveness of education strategies                  • Assembling and sharing an                        Secretary, or designee, will appoint new
                                               concerning the Affordable Care Act.                     information base of ‘‘best practices’’ for            members to the APOE from among those
                                                  The APOE charter was originally                      helping consumers evaluate health                     candidates determined to have the
Rmajette on DSK2VPTVN1PROD with NOTICES




                                               created in 1999, as the charter for the                 coverage options.                                     expertise required to meet specific
                                               Advisory Panel on Medicare Education.                      • Building and leveraging existing                 agency needs, in a manner to ensure an
                                               The panel’s charter was renewed, and                    community infrastructures for                         appropriate balance of membership. We
                                               the panel was renamed the Advisory                      information, counseling, and assistance.              are committed to ensuring that the
                                               Panel for Outreach and Education, on                       • Establishing links between outreach              interests of both women and men,
                                               January 21, 2011. The charter was most                  and education, promoting consumer                     members of all racial and ethnic groups,
                                               recently renewed on January 21, 2015.                   understanding of health care coverage                 and disabled individuals are adequately


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                                                                              Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices                                          23279

                                               represented on the APOE. Therefore, we                    Dated: April 21, 2015.                              the Division of Drug Information (HFD–
                                               encourage nominations of qualified                      Andrew M. Slavitt                                     240), Center for Drug Evaluation and
                                               candidates who can represent these                      Acting Administrator, Centers for Medicare            Research (CDER), Food and Drug
                                               interests. Any interested organization or               & Medicaid Services.                                  Administration, 10001 New Hampshire
                                               person may nominate one or more                         [FR Doc. 2015–09730 Filed 4–24–15; 8:45 am]           Ave., Hillandale Building, 4th Floor,
                                               qualified persons.                                      BILLING CODE 4120–01–P                                Silver Spring, MD 20993–0002; or the
                                                 Each nomination must include a letter                                                                       Office of Communication, Outreach and
                                               stating that the nominee has expressed                                                                        Development, Center for Biologics
                                               a willingness to serve as a Panel                       DEPARTMENT OF HEALTH AND                              Evaluation and Research (CBER), Food
                                               member and must be accompanied by a                     HUMAN SERVICES                                        and Drug Administration, 10903 New
                                               curricula vitae and a brief biographical                                                                      Hampshire Ave., Bldg. 71, rm. 3128,
                                               summary of the nominee’s experience.                    Food and Drug Administration                          Silver Spring, MD 20993–0002. Send
                                                                                                       [Docket No. FDA–2015–D–1309]                          one self-addressed adhesive label to
                                                 While we are looking for experts in a
                                                                                                                                                             assist the office in processing your
                                               number of fields, our most critical needs
                                                                                                       M8 Electronic Common Technical                        requests. The draft documents may also
                                               are for experts in Health IT, Tribal
                                                                                                       Document v4.0 Draft Implementation                    be obtained by mail by calling CBER at
                                               Affairs, Community Health Centers/
                                                                                                       Guide v2.0; Electronic Common                         1–800–835–4709 or 240–402–7800. See
                                               Medically Underserved Populations,
                                                                                                       Technical Document v4.0                               the SUPPLEMENTARY INFORMATION section
                                               African-American Health/Disparities,
                                                                                                       Implementation Package Draft                          for electronic access to the draft
                                               Health/Disability, Quality/Disparities,
                                                                                                       Specification for Submission Formats                  guidance documents.
                                               and State Programs/Medicaid/Rural.
                                                                                                       v2.0; International Conference on                       Submit electronic comments on the
                                                 We are requesting that all curricula                  Harmonisation; Draft Guidance for                     draft documents to http://
                                               vitae include the following:                            Industry; Availability                                www.regulations.gov. Submit written
                                                 • Date of birth                                                                                             comments to the Division of Dockets
                                                                                                       AGENCY:    Food and Drug Administration,              Management (HFA–305), Food and Drug
                                                 • Place of birth                                      HHS.                                                  Administration, 5630 Fishers Lane, rm.
                                                 • Title and current position                          ACTION:   Notice.                                     1061, Rockville, MD 20852.
                                                 • Professional affiliation                                                                                  FOR FURTHER INFORMATION CONTACT:
                                                 • Home and business address                           SUMMARY:    The Food and Drug
                                                                                                       Administration (FDA or Agency) is                     Regarding the guidance: Jared Lantzy,
                                                 • Telephone and fax numbers                           announcing the availability of a draft                Center for Drug Evaluation and
                                                 • Email address                                       guidance entitled ‘‘M8 Electronic                     Research, Food and Drug
                                                                                                                                                             Administration, 10903 New Hampshire
                                                 • List of areas of expertise                          Common Technical Document (eCTD)
                                                                                                                                                             Ave., Bldg. 22, Rm. 1116, Silver Spring,
                                                                                                       v4.0 Draft Implementation Guide v2.0’’
                                               Phone interviews of nominees may also                   (the M8 eCTD draft implementation                     MD 20993–0002, 301–796–0597; or
                                               be requested after review of the                        guidance) and a related document                      Mark Gray, Center for Biologics
                                               nominations.                                            entitled ‘‘eCTD v4.0 Implementation                   Evaluation and Research, Food and
                                                                                                       Package Draft Specification for                       Drug Administration, 10903 New
                                                  In order to permit an evaluation of                                                                        Hampshire Ave., Bldg. 71, Rm. 7217,
                                               possible sources of conflict of interest,               Submission Formats v2.0’’ (the draft
                                                                                                       specifications document). The M8 eCTD                 Silver Spring, MD 20993–0002, 301–
                                               potential candidates will be asked to                                                                         796–2081.
                                               provide detailed information concerning                 draft implementation guidance and the
                                                                                                                                                               Regarding the ICH: Michelle Limoli,
                                               such matters as financial holdings,                     draft specifications document were
                                                                                                                                                             Center for Drug Evaluation and
                                               consultancies, and research grants or                   prepared under the auspices of the
                                                                                                                                                             Research, International Programs, Food
                                               contracts.                                              International Conference on
                                                                                                                                                             and Drug Administration, 10903 New
                                                                                                       Harmonisation (ICH) of Technical
                                                  Members are invited to serve for 2-                                                                        Hampshire Ave., Bldg. 51, Rm. 1174,
                                                                                                       Requirements for Registration of
                                               year terms, contingent upon the renewal                                                                       Silver Spring, MD 20993–0002, 301–
                                                                                                       Pharmaceuticals for Human Use. The
                                               of the APOE by appropriate action prior                                                                       796–8377.
                                                                                                       M8 eCTD draft implementation
                                               to its termination. A member may serve                                                                        SUPPLEMENTARY INFORMATION:
                                                                                                       guidance provides instructions for
                                               after the expiration of his or her term
                                                                                                       creating the eCTD v4.0 Health Level 7                 I. Background
                                               until a successor takes office. Any
                                                                                                       Regulated Product Submission (RPS)
                                               member appointed to fill a vacancy for                                                                          In recent years, many important
                                                                                                       message for Modules 2 through 5 of the
                                               an unexpired term shall be appointed                                                                          initiatives have been undertaken by
                                                                                                       eCTD. The draft specifications
                                               for the remainder of that term.                                                                               regulatory authorities and industry
                                                                                                       document provides specifications for
                                               III. Copies of the Charter                              creating files for inclusion in the eCTD.             associations to promote international
                                                                                                       These draft documents represent major                 harmonization of regulatory
                                                  The Secretary’s Charter for the APOE                 updates to the eCTD specifications.                   requirements. FDA has participated in
                                               is available on the CMS Web site at:                                                                          many meetings designed to enhance
                                                                                                       DATES: Although you can comment on
                                               http://www.cms.gov/Regulations-                                                                               harmonization and is committed to
                                               andGuidance/Guidance/FACA/                              any guidance at any time (see 21 CFR                  seeking scientifically based harmonized
                                               APOE.html, or you may obtain a copy of                  10.115 (g)(5)), to ensure that the Agency             technical procedures for pharmaceutical
                                               the charter by submitting a request to                  considers your comment on these draft                 development. One of the goals of
Rmajette on DSK2VPTVN1PROD with NOTICES




                                               the contact listed in the FOR FURTHER                   documents before it begins work on the                harmonization is to identify and then
                                               INFORMATION CONTACT section of this
                                                                                                       final versions of the documents, submit               reduce differences in technical
                                               notice.                                                 either electronic or written comments                 requirements for drug development
                                                                                                       on the draft documents by May 27,                     among regulatory agencies.
                                                 Authority: Sec. 222 of the Public Health              2015.
                                               Service Act (42 U.S.C. 217a) and sec. 10(a)                                                                     ICH was organized to provide an
                                               of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a)          ADDRESSES:  Submit written requests for               opportunity for tripartite harmonization
                                               and 41 CFR 102–3).                                      single copies of the draft documents to               initiatives to be developed with input


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Document Created: 2015-12-16 08:29:54
Document Modified: 2015-12-16 08:29:54
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.
DatesNominations will be considered if we receive them at the
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] or visit the Web site 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 Citation80 FR 23277 

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