1872 Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices 

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 February 10, 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/

PaperworkReductionActof1995. 

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: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Healthcare 

Fraud Prevention Partnership (HFPP): 

Data Sharing and Information Exchange; 

Use: Section 1128C(a)(2) of the Social 

Security Act (42 U.S.C. 1320a–7c(a)(2)) 

authorizes the Secretary and the 

Attorney General to consult with, and 

arrange for the sharing of data with 

representatives of health plans to 

establish a Fraud and Abuse Control 

Program as specified in Section 

1128(C)(a)(1) of the Social Security Act. 

This is known as the Healthcare Fraud 

Prevention Partnership (HFPP). It was 

officially established by a Charter in fall 

2012 and signed by HHS Secretary 

Sibelius and US Attorney General 

Holder. The HFPP is a joint initiative 

established by the Department of Health 

and Human Services (HHS) and 

Department of Justice (DOJ) to detect 

and prevent the prevalence of 

healthcare fraud through data and 

information-sharing and applying 

analytic capabilities by the public and 

private sectors. The HFPP collaboration 

provides a unique opportunity to 

transition from traditional ‘‘pay and 

chase’’ approaches for fraud detection 

and recovery towards a data-driven 

model for identifying and predicting 

aberrant activity. A central goal of the 

HFPP is to identify the optimal way to 

coordinate nationwide sharing of health 

care claims information, including 

aggregating claims and payment 

information from large public healthcare 

programs and private insurance payers. 

In addition to sharing data and 

information, the HFPP is focused on 

advancing analytics, training, outreach, 

education to support anti-fraud efforts 

and achieving its objectives, primarily 

through goal-oriented, well-designed 

fraud studies. Form Number: CMS– 

10501 (OCN: 0938–New); Frequency: 

Occasionally; Affected Public: Private 

sector (Business or other for-profits); 

Number of Respondents: 75; Total 

Annual Responses: 75; Total Annual 

Hours: 180,000. (For policy questions 

regarding this collection contact 

Johnalyn Lyles at 410–786–8410.) 

Dated: January 6, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–00188 Filed 1–9–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–102 and 105, 

and CMS–10209] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

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 (the 

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 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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 must be received by 

March 11, 2014. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). To be 

assured consideration, comments and 

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Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices 1873 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are 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 ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

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/

PaperworkReductionActof1995. 

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: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–102 and 105 Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) Budget Workload Reports and 

Supporting Regulations 

CMS–10209 Medicare Advantage 

Chronic Care Improvement Program 

(CCIP) and Quality Improvement (QI) 

Project Reporting Tools 

Under the 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 

requires federal agencies to publish a 

60-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. 

Information Collections 

1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) Budget Workload 

Reports and Supporting Regulations; 

Use: We will use the collected 

information to determine the amount of 

Federal reimbursement for surveys 

conducted. Use of the information 

includes program evaluation, audit, 

budget formulation and budget 

approval. Form CMS–102 is a multipurpose form designed to capture and 

record all budget and expenditure data. 

Form CMS–105 captures the annual 

projected CLIA workload that the State 

survey agency will accomplish. Our 

regional offices also use the information 

to approve the annual projected CLIA 

workload. The information is required 

as part of the section 1864 agreement 

with the state. Form Numbers: CMS–102 

and CMS–105 (OCN: 0938–0599); 

Frequency: Quarterly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 50; Total 

Annual Responses: 50; Total Annual 

Hours: 4,500. (For policy questions 

regarding this collection contact Angela 

Stancel at 410–786–4876.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Advantage Chronic Care Improvement 

Program (CCIP) and Quality 

Improvement (QI) Project Reporting 

Tools; Use: Medicare Advantage 

Organizations (MAOs) are required to 

have an ongoing quality improvement 

(QI) program that meets our 

requirements and includes at least one 

chronic care improvement program 

(CCIP) and one QI Project. Every MAO 

must have a QI program that monitors 

and identifies areas where 

implementing appropriate interventions 

would improve patient outcomes and 

patient safety. Information collected 

using the CCIP and QIP reporting tools 

is an integral resource for oversight, 

monitoring, compliance, and auditing 

activities necessary to ensure high 

quality value-based health care for 

Medicare beneficiaries. Form Number: 

CMS–10209 (OCN: 0938–1023); 

Frequency: Yearly; Affected Public: 

Private sector (Business or other forprofits and Not-for-profit institutions); 

Number of Respondents: 1,904; Total 

Annual Responses: 1,904; Total Annual 

Hours: 28,560. (For policy questions 

regarding this collection contact Ellen 

Dieujuste at 410–786–2191). 

Dated: January 6, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–00195 Filed 1–9–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1630] 

Draft Guidance for Industry on 

Qualification of Exacerbations of 

Chronic Pulmonary Disease Tool for 

Measurement of Symptoms of Acute 

Bacterial Exacerbation of Chronic 

Bronchitis in Patients With Chronic 

Obstructive Pulmonary Disease; 

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 ‘‘Qualification of 

Exacerbations of Chronic Pulmonary 

Disease Tool for Measurement of 

Symptoms of Acute Bacterial 

Exacerbation of Chronic Bronchitis in 

Patients with Chronic Obstructive 

Pulmonary Disease.’’ This draft 

guidance provides a statement of 

qualification for the Exacerbations of 

Chronic Pulmonary Disease Tool 

(EXACT) patient-reported outcome 

instrument and summarizes the concept 

of interest and context of use (COU) for 

which the tool is qualified through the 

Center for Drug Evaluation and 

Research’s (CDER’s) drug development 

tool (DDT) qualification program. 

Qualification of the EXACT represents a 

conclusion that, within the stated COU, 

the instrument can be relied on to have 

a specific interpretation and application 

in drug development and regulatory 

review. This draft guidance is an 

attachment to the guidance for industry 

entitled ‘‘Qualification Process for Drug 

Development Tools.’’ 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

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