Federal Register / Vol. 77, No. 198 / Friday, October 12, 2012 / Notices 62241 

intervals, most recently, August 3, 2011, 

and will expire on August 3, 2013. 

Purpose: This Advisory Board is 

charged with (a) providing advice to the 

Secretary, HHS, on the development of 

guidelines under Executive Order 

13179; (b) providing advice to the 

Secretary, HHS, on the scientific 

validity and quality of dose 

reconstruction efforts performed for this 

program; and c) upon request by the 

Secretary, HHS, advising the Secretary 

on whether there is a class of employees 

at any Department of Energy facility 

who were exposed to radiation but for 

whom it is not feasible to estimate their 

radiation dose, and on whether there is 

reasonable likelihood that such 

radiation doses may have endangered 

the health of members of this class. 

Matters to be Discussed: The agenda 

for the conference call includes: SEC 

Petition for Battelle Laboratories—King 

Avenue (Columbus, Ohio); 

Subcommittee and Work Group 

Updates; SEC Petition Evaluations 

Update for the December 2012 Advisory 

Board Meeting; Plans for December 2012 

Advisory Board Meeting; and Advisory 

Board Correspondence. 

The agenda is subject to change as 

priorities dictate. Because there is not 

an oral public comment period, written 

comments may be submitted. Any 

written comments received will be 

included in the official record of the 

meeting and should be submitted to the 

contact person below in advance of the 

meeting. 

Contact Person for More Information: 

Theodore M. Katz, M.P.A., Executive 

Secretary, NIOSH, CDC, 1600 Clifton 

Road NE., Mailstop: E–20, Atlanta, 

Georgia 30333, Telephone (513)533– 

6800, Toll Free 1–800–CDC–INFO, 

Email ocas@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. 

Dated: October 5, 2012. 

John Kastenbauer, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2012–25097 Filed 10–11–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10237 and CMS– 

10137] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection. Title of 

Information Collection: Part C Medicare 

Advantage and 1876 Cost Plan 

Expansion Application; Use: Collection 

of this information is mandated in Part 

C of the Medicare Prescription Drug, 

Improvement and Modernization Act of 

2003 (MMA) in Subpart K of 42 CRF 422 

entitled ‘‘Contracts with Medicare 

Advantage Organizations.’’ In addition, 

the Medicare Improvements for Patients 

and Providers Act of 2008 (MIPPA) 

amended titles XVII and XIX of the 

Social Security Act to improve the 

Medicare program. 

In general, coverage for the 

prescription drug benefit is provided 

through prescription drug plans (PDPs) 

that offer drug-only coverage or through 

Medicare Advantage (MA) organizations 

that offer integrated prescription drug 

and health care products (MA–PD 

plans). PDPs must offer a basic drug 

benefit. Medicare Advantage 

Coordinated Care Plans (MA–CCPs) 

either must offer a basic benefit or may 

offer broader coverage for no additional 

cost. Medicare Advantage Private Fee 

for Service Plans (MA–PFFS) may 

choose to offer enrollees a Part D 

benefit. Employer Group Plans may also 

provide Part D benefits. If any of the 

contracting organizations meet basic 

requirements, they may also offer 

supplemental benefits through 

enhanced alternative coverage for an 

additional premium. 

Organizations wishing to provide 

healthcare services under MA and/or 

MA–PD plans must complete an 

application, file a bid, and receive final 

approval from CMS. Existing MA plans 

may request to expand their contracted 

service area by completing the Service 

Area Expansion (SAE) application. 

Applicants may offer a local MA plan in 

a county, a portion of a county (i.e., a 

partial county) or multiple counties. 

Applicants may offer a MA regional 

plan in one or more of the 26 MA 

regions. 

Since the publication of the 60-day 

notice, the information collection 

request has been revised to provide 

clarification to applicants, to ensure 

consistency throughout the entire 

application, and to reduce confusion 

among applicants. As a result of those 

changes, the overall burden associated 

with the collection has decreased from 

22,995 to 21,581 hours. Form Number: 

CMS–10237 (OCN 0938–0935). 

Frequency: Yearly. Affected Public: 

Private Sector (Business or other forprofits, Not-for-profit institutions). 

Number of Respondents: 566. Total 

Annual Responses: 566. Total Annual 

Hours: 21,581. (For policy questions 

regarding this collection contact Barbara 

Gullick at 410–786–0563. For all other 

issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title: Application 

for New and Expanding Medicare 

Prescription Drug Plans and Medicare 

Advantage Prescription Drug (MA–PD), 

including Cost Plans and Employer 

Group Waiver Plans; Use: The Medicare 

Prescription Drug Benefit program was 

established by section 101 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) and is codified in section 

1860D of the Social Security Act (the 

Act). Section 101 of the MMA amended 

Title XVIII of the Social Security Act by 

redesignating Part D as Part E and 

inserting a new Part D, which 

establishes the voluntary Prescription 

Drug Benefit Program (‘‘Part D’’). The 

MMA was amended on July 15, 2008 by 

the enactment of the Medicare 

Improvements for Patients and 

Providers Act of 2008 (MIPPA), on 

March 23, 2010 by the enactment of the 

Patient Protection and Affordable Care 

Act and on March 30, 2010 by the 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
62242 Federal Register / Vol. 77, No. 198 / Friday, October 12, 2012 / Notices 

enactment the Health Care and 

Education Reconciliation Act of 2010 

(collectively the Affordable Care Act). 

Coverage for the prescription drug 

benefit is provided through contracted 

prescription drug plans (PDPs) or 

through Medicare Advantage (MA) 

plans that offer integrated prescription 

drug and health care coverage (MA–PD 

plans). Cost Plans that are regulated 

under Section 1876 of the Social 

Security Act, and Employer Group 

Waiver Plans (EGWP) may also provide 

a Part D benefit. Organizations wishing 

to provide services under the 

Prescription Drug Benefit Program must 

complete an application, negotiate rates, 

and receive final approval from CMS. 

Existing Part D Sponsors may also 

expand their contracted service area by 

completing the Service Area Expansion 

(SAE) application. 

Collection of this information is 

mandated in Part D of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) in 

Subpart 3. The application requirements 

are codified in Subpart K of 42 CFR 423 

entitled ‘‘Application Procedures and 

Contracts with PDP Sponsors.’’ 

Effective January 1, 2006, the Part D 

program established an optional 

prescription drug benefit for individuals 

who are entitled to Medicare Part A or 

enrolled in Part B. In general, coverage 

for the prescription drug benefit is 

provided through PDPs that offer drugonly coverage, or through MA 

organizations that offer integrated 

prescription drug and health care 

coverage (MA–PD plans). PDPs must 

offer a basic drug benefit. Medicare 

Advantage Coordinated Care Plans 

(MA–CCPs) must offer either a basic 

benefit or may offer broader coverage for 

no additional cost. Medicare Advantage 

Private Fee for Service Plans (MA– 

PFFS) may choose to offer a Part D 

benefit. Cost Plans that are regulated 

under Section 1876 of the Social 

Security Act, and Employer Group Plans 

may also provide a Part D benefit. If any 

of the contracting organizations meet 

basic requirements, they may also offer 

supplemental benefits through 

enhanced alternative coverage for an 

additional premium. 

Applicants may offer either a PDP or 

MA–PD plan with a service area 

covering the nation (i.e., offering a plan 

in every region) or covering a limited 

number of regions. MA–PD and Cost 

Plan applicants may offer local plans. 

There are 34 PDP regions and 26 MA 

regions in which PDPs or regional MA– 

PDs may be offered respectively. The 

MMA requires that each region have at 

least two Medicare prescription drug 

plans from which to choose, and at least 

one of those must be a PDP. 

Requirements for contracting with Part 

D Sponsors are defined in Part 423 of 42 

CFR. 

This clearance request is for the 

information collected to ensure 

applicant compliance with CMS 

requirements and to gather data used to 

support determination of contract 

awards. Form Number: CMS– 

10137(OCN: 0938–0936); Frequency: 

Yearly; Affected Public: Private Sector— 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 241; Total Annual 

Responses: 241; Total Annual Hours: 

2,132. (For policy questions regarding 

this collection contact Linda Anders at 

410–786–0459. For all other issues call 

410–786–1326.) 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on November 13, 2012. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: October 5, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–25062 Filed 10–11–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Risk Communication Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Risk 

Communication Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on November 2, 2012, from 8 a.m. 

to 3 p.m. 

Location: FDA White Oak Campus, 

Building 31 Conference Center, Great 

Room, 10903 New Hampshire Ave., 

Silver Spring, MD 20993. Information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Lee L. Zwanziger, 

Risk Communication Staff, Office of 

Planning, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 3278, Silver Spring, 

MD 20993, 301–796–9151, FAX: 301– 

847–8611, email: RCAC@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), to find out 

further information regarding FDA 

advisory committee information. A 

notice in the Federal Register about last 

minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

Agenda: On November 2, 2012, the 

Committee will discuss general factors 

in risk communication about FDA 

regulated products, including 

approaches to avoid message fatigue and 

related communication barriers such as 

prevention or warning fatigue or 

inaccurate risk perception. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 25, 2012. 

Oral presentations from the public will 


wreier-aviles on DSK5TPTVN1PROD with NOTICES