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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces a meeting for the initial 

review of applications in response to 

Special Interest Projects (SIP) 15–007, 

HPV Vaccine Impact among Men who 

have Sex with Men (MSM), and, SIP 15– 

009, Serosorting and Other Seroadaptive 

Behaviors among Men who have Sex 

with Men (MSM) in the US-designing a 

Brief Survey Tool for Use in Clinical 

Practice. 

Time and Date: 10:00 a.m.–6:00 p.m., 

May 18, 2015 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to 

the public in accordance with 

provisions set forth in Section 

552b(c)(4) and (6), Title 5 U.S.C., and 

the Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

Matters for Discussion: The meeting 

will include the initial review, 

discussion, and evaluation of 

applications received in response to 

‘‘HPV Vaccine Impact among Men who 

have Sex with Men (MSM), SIP 15–007, 

and, Serosorting and Other Seroadaptive 

Behaviors among Men who have Sex 

with Men (MSM) in the US-designing a 

Brief Survey Tool for Use in Clinical 

Practice, SIP 15–009.’’ 

Contact Person for More Information: 

Brenda Colley Gilbert, Ph.D., M.S.P.H., 

Director, Extramural Research Program 

Operations and Services, CDC, 4770 

Buford Highway NE., Mailstop F–80, 

Atlanta, Georgia 30341, Telephone: 

(770) 488–6295, BJC4@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–09647 Filed 4–24–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces a meeting for the initial 

review of applications in response to 

Special Interest Projects (SIP) 15–002, 

Economic Impact of Clinical Trials 

among Children Diagnosed with Cancer, 

and, SIP 15–005, Economic Costs of 

Quality Assurance in Lung Cancer 

Screening Programs. 

Time and Date: 11:00 a.m.–6:00 p.m., 

May 19, 2015. 

Place: Teleconference. 

Status: The meeting will be closed to 

the public in accordance with 

provisions set forth in Section 

552b(c)(4) and (6), Title 5 U.S.C., and 

the Determination of the Director, 

Management Analysis and Services 

Office, CDC, pursuant to Public Law 92– 

463. 

Matters for Discussion: The meeting 

will include the initial review, 

discussion, and evaluation of 

applications received in response to 

‘‘Economic Impact of Clinical Trials 

among Children Diagnosed with Cancer, 

SIP 15–002, and, Economic Costs of 

Quality Assurance in Lung Cancer 

Screening Programs, SIP 15–005.’’ 

Contact Person for More Information: 

Brenda Colley Gilbert, Ph.D., M.S.P.H., 

Director, Extramural Research Program 

Operations and Services, CDC, 4770 

Buford Highway NE., Mailstop F–80, 

Atlanta, Georgia 30341, Telephone: 

(770) 488–6295, BJC4@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–09645 Filed 4–24–15; 8:45 am] 

BILLING CODE 4163–18–P 

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 


Rmajette on DSK2VPTVN1PROD with NOTICES
23278 Federal Register / Vol. 80, No. 80 / Monday, April 27, 2015 / Notices 

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 publicprivate 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 


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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–1309] 

M8 Electronic Common Technical 

Document v4.0 Draft Implementation 

Guide v2.0; Electronic Common 

Technical Document v4.0 

Implementation Package Draft 

Specification for Submission Formats 

v2.0; International Conference on 

Harmonisation; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance entitled ‘‘M8 Electronic 

Common Technical Document (eCTD) 

v4.0 Draft Implementation Guide v2.0’’ 

(the M8 eCTD draft implementation 

guidance) and a related document 

entitled ‘‘eCTD v4.0 Implementation 

Package Draft Specification for 

Submission Formats v2.0’’ (the draft 

specifications document). The M8 eCTD 

draft implementation guidance and the 

draft specifications document were 

prepared under the auspices of the 

International Conference on 

Harmonisation (ICH) of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use. The 

M8 eCTD draft implementation 

guidance provides instructions for 

creating the eCTD v4.0 Health Level 7 

Regulated Product Submission (RPS) 

message for Modules 2 through 5 of the 

eCTD. The draft specifications 

document provides specifications for 

creating files for inclusion in the eCTD. 

These draft documents represent major 

updates to the eCTD specifications. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115 (g)(5)), to ensure that the Agency 

considers your comment on these draft 

documents before it begins work on the 

final versions of the documents, submit 

either electronic or written comments 

on the draft documents by May 27, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft documents to 

the Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research (CDER), Food and Drug 

Administration, 10001 New Hampshire 

Ave., Hillandale Building, 4th Floor, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft documents may also 

be obtained by mail by calling CBER at 

1–800–835–4709 or 240–402–7800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance documents. 

Submit electronic comments on the 

draft documents to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Jared Lantzy, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 1116, Silver Spring, 

MD 20993–0002, 301–796–0597; or 

Mark Gray, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7217, 

Silver Spring, MD 20993–0002, 301– 

796–2081. 

Regarding the ICH: Michelle Limoli, 

Center for Drug Evaluation and 

Research, International Programs, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1174, 

Silver Spring, MD 20993–0002, 301– 

796–8377. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 


Rmajette on DSK2VPTVN1PROD with NOTICES