Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices 56379 

study, such as protocols, instructions, 

participant-specific data, statistical 

analyses, and contracts with the test’s 

researchers. There is an exception for a 

‘‘Reliably Reported’’ test, defined as a 

test published in a peer-reviewed 

journal that was not conducted, 

controlled, or sponsored by HLS, its 

affiliates, or others in the manufacturing 

and supply chain. Also, the published 

report must provide sufficient 

information about the test for experts in 

the relevant field to assess the reliability 

of the results. 

Parts VII through X of the proposed 

order require HLS to: Deliver a copy of 

the order to principals, officers, 

directors and other employees having 

responsibilities with respect to the 

subject matter of the order; notify the 

Commission of changes in corporate 

structure that might affect compliance 

obligations under the order; and file 

compliance reports with the 

Commission. 

Part XI provides that the order will 

terminate after twenty (20) years, with 

certain exceptions. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed order, and it is not intended 

to constitute an official interpretation of 

the complaint or proposed order, or to 

modify the proposed order’s terms in 

any way. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2014–22402 Filed 9–18–14; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10137, CMS– 

10305, CMS–10068 and CMS–10343] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the 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 functions; (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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by October 20, 2014. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/Paperwork

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Solicitation for 

Applications for Medicare Prescription 

Drug Plan 2015 Contracts; Use: The 

information will be collected under the 

solicitation of proposals from PDP, MA– 

PD, Cost Plan, PACE, and EGWP 

applicants. We will use the information 

to ensure that applicants meet our 

requirements and support the 

determination of contract awards. 

Participation in the Part D program is 

voluntary in nature. Only organizations 

that are interested in participating in the 

program will respond to the solicitation. 

The MA–PDs that voluntarily 

participate in the Part C program must 

submit a Part D application and 

successful bid. Form Number: CMS– 

10137 (OMB control number: 0938– 

0936); Frequency: Yearly; Affected 

Public: Private sector—Business or other 

for-profits and Not-for-profit 

institutions; Number of Respondents: 

254; Total Annual Responses: 254; Total 

Annual Hours: 2,193. (For policy 

questions regarding this collection 

contact Arianne Spaccarelli at 410–786– 

5715). 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare Part C 

and Part D Data Validation; Use: 

Organizations contracted to offer 

Medicare Part C and Part D benefits are 

required to report data to us on a variety 

of measures. For the data to be useful for 

monitoring and performance 

measurement, the data must be reliable, 

valid, complete, and comparable among 

sponsoring organizations. To meet this 

goal, we have developed reporting 

standards and data validation 

specifications with respect to the Part C 

and Part D reporting requirements. 

These standards provide a review 

process for Medicare Advantage 

Organizations, Cost Plans, and Part D 

sponsors to use to conduct data 

validation checks on their reported Part 

C and Part D data. The currently 

approved information collection is 

being revised to reflect decreases in the 

number of reporting sections being 

validated and an increase in the average 

number of data elements per reporting 

section for 2015–2017. The package has 

been revised subsequent to the 

publication of the 60-day Federal 


tkelley on DSK3SPTVN1PROD with NOTICES
56380 Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices 

Register notice (June 13, 2014; 79 FR 

33927). Form Number: CMS–10305 

(OMB control number: 0938–1115); 

Frequency: Yearly; Affected Public: 

Private sector—Business or other forprofits; Number of Respondents: 706; 

Total Annual Responses: 706; Total 

Annual Hours: 202,578. (For policy 

questions regarding this collection 

contact Terry Lied at 410–786–8973). 

3. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Medicare 

Ombudsman Customer Service 

Feedback Survey; Use: The Centers for 

Medicare and Medicaid Services 

stresses a continuing need for setting 

customer service goals that include 

providing accurate, timely, and relevant 

information to its customers. With these 

goals in mind, we periodically survey 

our customers to ensure that the needs 

of Medicare beneficiaries are being met. 

This survey will be used to measure 

overall satisfaction of the customer 

service that the Medicare Ombudsman 

Group (MOG) within CMS provides to 

Medicare beneficiaries and their 

representatives. The information 

provided will be used by management 

and staff to measure and improve the 

quality and timeliness of responses to 

written and verbal correspondence. 

Form Numbers: CMS–10068 (OMB 

control number: 0938–0894); Frequency: 

Annually, occasionally; Affected Public: 

Private Sector; Business or other forprofit and not-for-profit institutions; 

Number of Respondents: 2,380; Total 

Annual Responses: 2,380; Total Annual 

Hours: 317. (For policy questions 

regarding this collection contact Nancy 

Conn at 410–786–8374.) 

4. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: State 

Plan Preprint for Medicaid Recovery 

Audit Contractors (RACs); Use: Under 

section 1902(a)(42)(B)(i) of the Social 

Security Act, States are required to 

establish programs to contract with one 

or more Medicaid Recovery Audit 

Contractors (RACs) for the purpose of 

identifying underpayments and 

recouping overpayments under the State 

plan and any waiver of the State plan 

with respect to all services for which 

payment is made to any entity under 

such plan or waiver. Further, the statute 

requires States to establish programs to 

contract with Medicaid RACs in a 

manner consistent with State law, and 

generally in the same manner as the 

Secretary contracts with Medicare 

RACs. State programs contracted with 

Medicaid RACs are not required to be 

fully operational until after December 

31, 2010. States may submit, to CMS, a 

State Plan Amendment (SPA) attesting 

that they will establish a Medicaid RAC 

program. States have broad discretion 

regarding the Medicaid RAC program 

design and the number of entities with 

which they elect to contract. Many 

States already have experience utilizing 

contingency-fee-based Third Party 

Liability recovery contractors. Form 

Number: CMS–10343 (OMB control 

number: 0938–1126); Frequency: Once; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 56. (For policy questions 

regarding this collection contact 

Yolanda Green at 410–786–0798.) 

Dated: September 16, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–22379 Filed 9–18–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request, Process 

Assessment Review of the Division of 

Acquired Immunodeficiency Syndrome 

(DAIDS) Critical Events, Policy 

Implementation (CEPI) Program 

(NIAID) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health, has submitted to the 

Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on April 9, 2013, 

page 19633 and allowed 60-days for 

public comment. No comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institute of 

Allergy and Infectious Diseases (NIAID), 

National Institutes of Health, may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, or request more 

information on the proposed project, 

contact: Lynda Lahl, RN, MS, Office for 

Policy in Clinical Research Operations, 

DAIDS, NIAID, 5601 Fishers Lane, 

9B25, Rockville, MD 20852, or call nontoll-free number 240–292–4887, or 

Email your request, including your 

address to: Lynda.Lahl@nih.gov. Formal 

requests for additional plans and 

instruments must be requested in 

writing. 

Proposed Collection: Process 

Assessment Review of the Division Of 

Acquired Immunodeficiency Syndrome 

(DAIDS) Critical Events Policy 

Implementation (CEPI) Program, 0925- 

New, National Institute of Allergy and 

Infectious Diseases (NIAID), National 

Institutes of Health (NIH). 

Need and Use of Information 

Collection: This is a new data collection 

to assess the CEPI program’s progression 

to fulfillment of its program goals and 

will assess whether the CEPI program is 

implemented and functioning as 

intended. The program goals for CEPI 

are: 1) Awareness & Accessibility—The 

target populations (DAIDS Staff, 

extramural researchers, external 

stakeholders) are aware of the DAIDS 

Critical Events (CE) policy and manual 

and associated documents and whether 

the policy and associated documents are 

readily accessible.; 2) 

Understandability—The Critical Events 

policy and manual clearly articulate 

DAIDS expectations for CE policy 

implementation by the target 

populations. The CE policy and manual 

should establish a common base of 

understanding and promote positive 

attitudes towards event reporting; and 3) 

Applicability—Target populations are 

able to correctly identify which Critical 

Events have occurred at their sites and 

are able to apply the CE policy and 

manual to their events. 

Findings will provide data to inform 

DAIDS and Protection of Participants, 

Evaluation and Policy (ProPEP) 

leadership regarding further policy 

deployment decisions. Information 

collected will be used to determine how 

effectively the CEPI Program meets 

extramural researchers’ needs. By 

assessing the CEPI Program, DAIDS will 


tkelley on DSK3SPTVN1PROD with NOTICES