Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Notices 73033 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number _________, Room C4– 

26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Dated: December 4, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–29627 Filed 12–6–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10333 and 

CMS–10381] 

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: Consumer 

Assistance Program Grants Use: Section 

1002 of the Affordable Care Act 

provides for the establishment of 

consumer assistance (or ombudsman) 

programs, starting in FY 2010. Federal 

grants will support these programs. 

These programs will assist consumers 

with filing complaints and appeals, 

assist consumers with enrollment into 

health coverage, collect data on 

consumer inquiries and complaints to 

identify problems in the marketplace, 

educate consumers on their rights and 

responsibilities, and with the 

establishment of the new Exchange 

marketplaces, resolve problems with 

premium credits for Exchange coverage. 

Importantly, these programs must 

provide detailed reporting on the types 

of problems and questions consumers 

may experience with health coverage, 

and how these problems and questions 

are resolved. In order to strengthen 

oversight, the law requires programs to 

report data to the Secretary of the 

Department of Health and Human 

Services (HHS). ‘‘As a condition of 

receiving a grant under subsection (a), 

an office of health insurance consumer 

assistance or ombudsman program shall 

be required to collect and report data to 

the Secretary on the types of problems 

and inquiries encountered by 

consumers’’ (Sec. 2793 (d)). Analysis of 

this data reporting will help identify 

patterns of practice in the insurance 

marketplaces and uncover suspected 

patterns of noncompliance. HHS must 

share program data reports with the 

Departments of Labor and Treasury, and 

state regulators. Program data also can 

offer CCIIO one indication of the 

effectiveness of state enforcement, 

affording opportunities to provide 

technical assistance and support to state 

insurance regulators and, in extreme 

cases, inform the need to trigger federal 

enforcement. 

The 60-day Federal Register notice 

published on July 27, 2012, and the 

comment period ended September 25, 

2012. We received a total of 21 

comments. All comments were 

summarized, consolidated (where 

overlap existed), and addressed. The 

majority of comments involved feedback 

on providing CAPs with more flexibility 

in collecting and reporting data. The 

implementation of a new progress report 

will allow CAPs to provide more 

information about their progress and 

activities. In addition, CMS received 

comments suggesting that collection of 

all of the CMS-required data elements is 

difficult and that adjustments to preexisting databases is too expensive and 

laborious. CMS recognizes these 

concerns and acknowledges that CAPs 

are in the best situation to determine the 

level of information that is able to be 

collected for any given consumer. CMS 

also received comments suggesting that 

CMS provide guidance to CAPs on how 

to accurately measure savings to 

consumers. CMS has provided CAPs 

with suggestions on ways to calculate 

recovered benefits and will explore 

whether more comprehensive guidance 

is necessary. The comments received in 

response to the 60-day notice have not 

resulted in a change in burden 

estimates. Form Number: CMS–10333 

(OCN: 0938–1097); Frequency: 

Quarterly and Annual; Affected Public: 

Private Sector: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 504; Total 

Annual Hours: 261 hours. (For policy 

questions regarding this collection 

contact Eliza Bangit at 301–492–4219. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title: ICD–10 

Industry Readiness Assessment; Use: 

The Congress addressed the need for a 

consistent framework for electronic 

transactions and other administrative 

simplification issues in the Health 

Insurance Portability and 

Accountability Act of 1996 (HIPAA), 

Public Law 104–191, enacted on August 

21, 1996. Through subtitle F of title II 

of HIPAA, the Congress added to title XI 

of the Social Security Act (the Act) a 

new Part C, entitled ‘‘Administrative 

Simplification.’’ Part C of title XI of the 

Act now consists of sections 1171 

through 1180, which define various 

terms and impose several requirements 

on HHS, health plans, health care 

clearinghouses, and certain health care 

providers concerning the transmission 

of health information. Specifically, 

HIPAA requires the Secretary of HHS to 

adopt standards that covered entities are 

required to use in conducting certain 

health care administrative transactions, 

such as claims, remittance, eligibility, 

and claims status requests and 

responses. Findings from the ICD–10 

industry readiness assessment will be 

used by CMS to understand each 

sector’s progress toward compliance and 

to determine what communication and 

educational efforts can best help 

affected entities obtain the tools and 

resources they need to achieve timely 

compliance with ICD–10. Insights 

gleaned from the proposed research will 

be valid for education and outreach 

purposes only, and will not be used for 

policy purposes. Form Number: CMS– 

10381 (OMB#: 0938–1149); Frequency: 

Annual; Affected Public: Private 

Sector—Business or other for-profits, 

Not-for-profits; Number of Respondents: 

1,200; Total Annual Responses: 1,200; 

Total Annual Hours: 204. (For policy 

questions regarding this collection 

contact Rosali Topper at 410–786–7260. 

For all other issues call 410–786–1326.) 


tkelley on DSK3SPTVN1PROD with 
73034 Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Notices 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (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 January 7, 2013. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, 

Email: OIRA_submission@omb.eop.gov. 

Dated: December 4, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–29626 Filed 12–6–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Neurological Devices Panel of the 

Medical Devices 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: Neurological 

Devices Panel of the Medical Devices 

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 February 22, 2013, from 8 a.m. 

to 6 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503), Silver Spring, MD 20993– 

0002. 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: Natasha Facey, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, rm. 

1544, Silver Spring, MD 20993–0002, 

Natasha.Facey@fda.hhs.gov, 301–796– 

5290, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). 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 February 22, 2013, the 

committee will discuss, make 

recommendations and vote on 

information regarding the premarket 

approval application (PMA) for the 

NeuroPace Responsive 

Neurostimulation (RNS) System 

sponsored by NeuroPace, Inc. 

The RNS System is indicated for use 

as an adjunctive therapy in reducing the 

frequency of seizures in individuals 18 

years of age or older with partial onset 

seizures from no more than two foci that 

are refractory to two or more 

antiepileptic medications. 

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 February 13, 2013. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

4, 2013. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 6, 2013. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams at 

Annmarie.Williams@fda.hhs.gov or 

301–796–5966, at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: December 3, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–29538 Filed 12–6–12; 8:45 am] 

BILLING CODE 4160–01–P 


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