10166 Federal Register / Vol. 79, No. 36 / Monday, February 24, 2014 / Notices 

Government issued photo identification, 

preferably a driver’s license, at the time 

of entry. Participants will also be subject 

to a vehicle security inspection before 

access to the complex is granted. 

Participants not in possession of a valid 

identification or who are in possession 

of prohibited items will be denied 

access to the complex. Prohibited items 

on Federal property include but are not 

limited to, alcoholic beverages, illegal 

narcotics, explosives, firearms or other 

dangerous weapons (including pocket 

knives), dogs or other animals except 

service animals. Once cleared for entry 

to the complex participants will be 

directed to visitor parking by a security 

officer. 

In order to ensure expedited entry 

into the building it is recommended that 

participants have their ID and a copy of 

their written meeting registration 

confirmation readily available and that 

they do not bring large/bulky items into 

the building. Participants are reminded 

that photography on the CMS complex 

is prohibited. CMS has also been 

declared a tobacco free campus and 

violators are subject to legal action. In 

planning arrival time, we recommend 

allowing additional time to clear 

security. 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 before the convening of 

the meeting each day. 

Guest access to the complex is limited 

to the meeting area, the main lobby, and 

the cafeteria. If a visitor is found outside 

of those areas without proper escort 

they may be escorted off of the 

premises. Also be mindful that there 

will be an opportunity for everyone to 

speak and we request that everyone 

waits for the appropriate time to present 

their product or opinions. Disruptive 

behavior will not be tolerated and may 

result in removal from the meetings and 

escort from the complex. No visitor is 

allowed to attach USB cables, thumb 

drives or any other equipment to any 

CMS information technology (IT) system 

or hardware for any purpose at anytime. 

Additionally, CMS staff is prohibited 

from taking such actions on behalf of a 

visitor or utilizing any removable media 

provided by a visitor. 

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 

demonstration or to support a 

presentation. Special arrangements and 

approvals are required at least 2 weeks 

prior to each public meeting in order to 

bring pieces of equipment or medical 

devices. These arrangements need to be 

made with the public meeting 

coordinator. It is possible that certain 

requests made in advance of the public 

meeting could be denied because of 

unique safety, security or handling 

issues related to the equipment. A 

minimum of 2 weeks is required for 

approvals and security procedures. Any 

request not submitted at least 2 weeks 

in advance of the public meeting will be 

denied. 

CMS policy requires that every 

foreign national (as defined by the 

Department of Homeland Security, a 

foreign national is ‘‘an individual who 

is a citizen of any country other than the 

United States’’) is assigned a host (in 

accordance with the Department 

Foreign Visitor Management Policy, 

Appendix C, Guidelines for Hosts and 

Escorts). The host/hosting official is 

required to inform the Division of 

Critical Infrastructure Protection (DCIP) 

at least 12 business days in advance of 

any visit by a foreign national. Foreign 

nationals will be required to produce a 

valid passport at the time of entry. 

Attendees that are foreign nationals 

must identify themselves as such, and 

provide the following information for 

security clearance to the public meeting 

coordinator by the date specified in the 

DATES section of this notice: 

• Visitor’s full name (as it appears on 

passport). 

• Gender. 

• Country of origin and citizenship. 

• Biographical data and related 

information. 

• Date of birth. 

• Place of birth. 

• Passport number. 

• Passport issue date. 

• Passport expiration date. 

• Visa Type. 

• Visa Number. 

• Dates of visits. 

• Company Name. 

• Position/Title. 

Dated: February 10, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–03902 Filed 2–21–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7032–N] 

Health Insurance Marketplace, 

Medicare, Medicaid, and Children’s 

Health Insurance Programs; Meeting of 

the Advisory Panel on Outreach and 

Education (APOE), March 17, 2014 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces a 

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 Health and Human 

Services and the Administrator of the 

Centers for Medicare & Medicaid 

Services on opportunities to enhance 

the effectiveness of consumer education 

strategies concerning Health Insurance 

Marketplace, Medicare, Medicaid, and 

the Children’s Health Insurance 

Program (CHIP). This meeting is open to 

the public. 

DATES: Meeting Date: Monday, March 

17, 2014, 8:30 a.m. to 4:00 p.m. eastern 

daylight time (e.d.t.). 

Deadline for Meeting Registration, 

Presentations and Comments: Monday, 

March 3, 2014, 5:00 p.m., e.d.t. 

Deadline for Requesting Special 

Accommodations: Monday, March 3, 

2014, 5:00 p.m., e.d.t. 

ADDRESSES: 

Meeting Location: Department of 

Health & Human Services, Hubert H. 

Humphrey Building, 200 Independence 

Avenue SW., Room 705A, Washington, 

DC 20201. 

Presentations and Written Comments: 

Kirsten Knutson, Acting Designated 

Federal Official (DFO), Division of 

Forum and Conference Development, 

Office of Communications, Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Mailstop S1–13–05, 

Baltimore, MD 21244–1850 or contact 

Ms. Knutson via email at 

Kirsten.Knutson@cms.hhs.gov. 

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 http://events.SignUp4.com/

APOEMAR2014MTG or by contacting 

the DFO at the address listed in the 

ADDRESSES section of this notice or by 

telephone at number listed in the FOR

FURTHER INFORMATION CONTACT section of 

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Federal Register / Vol. 79, No. 36 / Monday, February 24, 2014 / Notices 10167 

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. In accordance with the 

Department of Health & Human Services 

standards, and an effort for the public to 

engage virtually in the open meetings, 

this APOE meeting will be available to 

view via live web streaming by visiting 

the link www.cms.gov/live during the 

designated time of the meeting. 

FOR FURTHER INFORMATION CONTACT: 

Kirsten Knutson, (410) 786–5886. 

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: In 

accordance with section 10(a) of the 

Federal Advisory Committee Act 

(FACA), this notice announces a 

meeting of the Advisory Panel on 

Outreach and Education (APOE) (the 

Panel). Section 9(a)(2) of the Federal 

Advisory Committee Act authorizes the 

Secretary of Health and Human Services 

(the Secretary) to establish an advisory 

panel if the Secretary determines that 

the panel is ‘‘in the public interest in 

connection with the performance of 

duties imposed . . . by law.’’ Such 

duties are imposed by section 1804 of 

the Social Security Act (the Act), 

requiring the Secretary to provide 

informational materials to Medicare 

beneficiaries about the Medicare 

program, and section 1851(d) of the Act, 

requiring the Secretary to provide for 

‘‘activities . . . to broadly disseminate 

information to [M]edicare beneficiaries 

. . . on the coverage options provided 

under [Medicare Advantage] in order to 

promote an active, informed selection 

among such options.’’ 

The Panel is also authorized by 

section 1114(f) of the Act (42 U.S.C. 

1314(f)) and section 222 of the Public 

Health Service Act (42 U.S.C. 217a). The 

Secretary signed the charter establishing 

this Panel on January 21, 1999 (64 FR 

7899, February 17, 1999) and approved 

the renewal of the charter on December 

18, 2012 (78 FR 105, May, 31, 2013). 

Pursuant to the amended charter, the 

Panel advises and makes 

recommendations to the Secretary of 

Health and Human Services and the 

Administrator of the Centers for 

Medicare & Medicaid Services (CMS) 

concerning optimal strategies for the 

following: 

• Developing and implementing 

education and outreach programs for 

individuals enrolled in, or eligible for, 

Health Insurance Marketplace, 

Medicare, Medicaid and the Children’s 

Health Insurance Program (CHIP). 

• Enhancing the federal government’s 

effectiveness in informing Health 

Insurance Marketplace, Medicare, 

Medicaid and CHIP consumers, 

providers and stakeholders pursuant to 

education and outreach programs of 

issues regarding these and other health 

coverage 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 plan 

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 health care reform. 

The current members of the Panel are: 

Joseph Baker, President, Medicare 

Rights Center; Philip Bergquist, 

Manager, Health Center Operations, 

CHIPRA Outreach & Enrollment Project 

and Director, Michigan Primary Care 

Association; Marjorie Cadogan, 

Executive Deputy Commissioner, 

Department of Social Services; Jonathan 

Dauphine, Senior Vice President, AARP; 

Barbara Ferrer, Executive Director, 

Boston Public Health Commission; 

Shelby Gonzales, Senior Health 

Outreach Associate, Center on Budget & 

Policy Priorities; Jan Henning, Benefits 

Counseling & Special Projects 

Coordinator, North Central Texas 

Council of Governments’ Area Agency 

on Aging; Sandy Markwood, Chief 

Executive Officer, National Association 

of Area Agencies on Aging; Miriam 

Mobley-Smith, Dean, Chicago State 

University, College of Pharmacy; Ana 

Natale-Pereira, Associate Professor of 

Medicine, University of Medicine & 

Dentistry of New Jersey; Megan Padden, 

Vice President, Sentara Health Plans; 

Winston Wong, Medical Director, 

Community Benefit Director, Kaiser 

Permanente. 

The agenda for the March 17, 2014 

meeting will include the following: 

• Welcome and Listening Session with 

CMS Leadership 

• Recap of the Previous (September 16, 

2013) 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. 

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). 

(Catalog of Federal Domestic Assistance 

Program No. 93.733, Medicare—Hospital 

Insurance Program; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 12, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–03909 Filed 2–21–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1675] 

Draft Guidance for Industry on New 

Chemical Entity Exclusivity 

Determinations for Certain FixedCombination Drug Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘New Chemical Entity 

Exclusivity Determinations for Certain 

Fixed-Combination Drug Products.’’ 

This draft guidance sets forth a change 

in the Agency’s interpretation of the 5- 

year new chemical entity (NCE) 

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