### 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


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

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 Fixed Combination 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)