47142 Federal Register / Vol. 79, No. 155 / Tuesday, August 12, 2014 / Notices 

Services (HHS) is hereby giving notice 

that the National Vaccine Advisory 

Committee (NVAC) will hold a meeting 

September 9–10, 2014. The meeting is 

open to the public. However, preregistration is required for both public 

attendance and public comment. 

Individuals who wish to attend the 

meeting and/or participate in the public 

comment session should register at 

http://www.hhs.gov/nvpo/nvac. 

Participants may also register by 

emailing nvpo@hhs.gov or by calling 

202–690–5566 to provide your name, 

organization, and email address. 

DATES: The meeting will be held on 

September 9–10, 2014. The meeting 

times and agenda will be posted on the 

NVAC Web site at http://www.hhs.gov/ 

nvpo/nvac as soon they become 

available. 

ADDRESSES: U.S. Department of Health 

and Human Services, Hubert H. 

Humphrey Building, Room 800, 200 

Independence Avenue SW., 

Washington, DC 20201. 

The meeting can also be accessed 

through a live webcast the day of the 

meeting. For more information, visit 

http://www.hhs.gov/nvpo/nvac/

meetings/upcomingmeetings/

index.html. 

FOR FURTHER INFORMATION CONTACT: 

National Vaccine Program Office, U.S. 

Department of Health and Human 

Services, Room 715–H, Hubert H. 

Humphrey Building, 200 Independence 

Avenue SW., Washington, DC 20201. 

Phone: (202) 690–5566; email: nvpo@

hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 2101 of the Public Health 

Service Act (42 U.S.C. 300aa–1), the 

Secretary of Health and Human Services 

was mandated to establish the National 

Vaccine Program to achieve optimal 

prevention of human infectious diseases 

through immunization and to achieve 

optimal prevention against adverse 

reactions to vaccines. The NVAC was 

established to provide advice and make 

recommendations to the Director of the 

National Vaccine Program on matters 

related to the Program’s responsibilities. 

The Assistant Secretary for Health 

serves as Director of the National 

Vaccine Program. 

The topics planned for NVAC 

discussion will include a presentation 

on the progress of the development of a 

National Adult Immunization Plan; 

plans by the NVPO to conduct a midcourse review of the 2010 National 

Vaccine Plan; the recent findings of a 

comprehensive review of vaccine safety; 

and an overview of vaccine research and 

development efforts for developing 

vaccines for use in pregnant women. In 

addition, the NVAC working group on 

Vaccine Confidence will present their 

findings and recommendations for 

NVAC consideration and discussion. 

The NVAC also will hear an overview 

of Canada’s efforts to strengthen the 

Canadian immunization system and an 

update on our national progress towards 

the Healthy People 2020 immunization 

goals. Finally, the NVAC HPV Working 

Group will provide an update on its 

progress. The meeting agenda will be 

posted on the NVAC Web site: http://

www.hhs.gov/nvpo/nvac prior to the 

meeting. 

Public attendance at the meeting is 

limited to the available space. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the National Vaccine Program 

Office at the address/phone listed above 

at least one week prior to the meeting. 

For those unable to attend in person, a 

live webcast will be available. More 

information on registration and 

accessing the webcast can be found at 

http://www.hhs.gov/nvpo/nvac/

meetings/upcomingmeetings/

index.html. 

Members of the public will have the 

opportunity to provide comments at the 

NVAC meeting during the public 

comment periods designated on the 

agenda. Individuals who would like to 

submit written statements should email 

their comments to the National Vaccine 

Program Office (nvpo@hhs.gov) at least 

five business days prior to the meeting. 

Dated: July 29, 2014. 

Bruce Gellin, 

Executive Secretary, National Vaccine 

Advisory Committee, Deputy Assistant 

Secretary for Health, Director, National 

Vaccine Program Office. 

[FR Doc. 2014–19046 Filed 8–11–14; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘Evaluation of the AHRQ Healthcare 

Horizon Scanning System.’’ In 

accordance with the Paperwork 

Reduction Act of 1995, Public Law 104– 

13 (44 U.S.C. 3506(c)(2)(A)), AHRQ 

invites the public to comment on this 

proposed information collection. 

DATES: Comments on this notice must be 

received by October 14, 2014. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

email at doris.lefkowitz@ahrq.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘Evaluation of the AHRQ Healthcare 

Horizon Scanning System’’ 

The American Recovery and 

Reinvestment Act (ARRA) appropriated 

$1.1 billion for comparative 

effectiveness research (CER), of which 

$300 million was made available to the 

Agency for Healthcare Research and 

Quality (AHRQ). The goal of CER is to 

improve patient outcomes by providing 

clinicians and patients the information 

they need to choose between preventive 

and diagnostic treatments, and other 

health care options to identify the 

options that best fit an individual 

patient’s needs and preferences. The 

EHC Program was created in response to 

Section 1013 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act (MMA) of 2003. 

To better inform comparative 

effectiveness research investments at the 

EHC Program, AHRQ used some of the 

ARRA funds to develop a horizon 

scanning system to identify and monitor 

emerging health care technologies and 

innovations. While horizon scanning 

systems exist in other countries, these 

systems do not take into account the 

unique political, regulatory, cultural, 

and economic context of the U.S. health 

care system. To meet this need, the 

AHRQ Healthcare Horizon Scanning 

System was implemented in November 

2010. The AHRQ Healthcare Horizon 

Scanning System provides a systematic 

process to identify and monitor target 

technologies and innovations in health 

care and to create an inventory of target 

technologies that have the highest 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 155 / Tuesday, August 12, 2014 / Notices 47143 

potential for impact on clinical care, the 

health care system, patient outcomes, 

and costs. It is also a tool for the public 

to identify and find information on new 

health care technologies and 

interventions. Additionally, the AHRQ 

Healthcare Horizon Scanning System 

serves as a resource for those involved 

in decision making about adoption, 

implementation, and coverage of new 

health care interventions. 

To fulfill its purpose, the AHRQ 

Healthcare Horizon Scanning System 

performs three functions: (1) 

Identification and prioritization of 

interventions in late phase development 

for tracking and monitoring; (2) 

monitoring of target interventions 

through the development of detailed 

information on interventions in late 

phase development; and (3) assessment 

of potential impact of target 

interventions through the gathering and 

synthesizing the perspectives of experts 

from various areas of the health care 

community about the potential impact 

those target interventions may have on 

the health care system, clinical care, 

patient outcomes, and health care costs. 

As the first and only U.S. horizon 

scanning system, it is important to 

understand whether the AHRQ 

Healthcare Horizon Scanning System is 

implementing its functions effectively. 

This evaluation is also essential to 

determining whether the AHRQ 

Healthcare Horizon Scanning System is 

meeting the needs of patients, 

clinicians, private industry, and 

policymakers and how it can be 

improved to better meet those needs. 

The evaluation will address the 

following research questions: 

1. How successfully did the AHRQ 

Healthcare Horizon Scanning System 

identify and prioritize interventions for 

monitoring? 

2. How successfully did the AHRQ 

Healthcare Horizon Scanning System 

monitor the selected target 

interventions? 

3. How accurately did the AHRQ 

Healthcare Horizon Scanning System 

assess the potential impact of the 

interventions? 

4. How can the processes for 

identification, prioritization, 

monitoring, and assessment of potential 

impact of the interventions be 

improved? 

This research has the following goals: 

1. To assess the performance of the 

AHRQ Healthcare Horizon Scanning 

System in the identification and 

prioritization of interventions which are 

important topics for further assessment. 

2. To assess the performance of the 

AHRQ Healthcare Horizon Scanning 

System in terms of the quality of 

information provided on the topics 

selected, and the accuracy of the 

assessment of potential impact. 

3. To identify which, if any, of these 

areas of performance may require 

improvement so as to strengthen the 

effectiveness of the AHRQ Healthcare 

Horizon Scanning System. 

This evaluation is being conducted by 

AHRQ through its contractor, ECRI 

Institute, and ECRI’s subcontractor, 

Mathematica Policy Research, pursuant 

to AHRQ’s statutory authority to 

conduct and support research on health 

care and on systems for the delivery of 

such care, including activities with 

respect to the quality, effectiveness, 

efficiency, appropriateness and value of 

health care services and with respect to 

quality measurement and improvement. 

42 U.S.C. 299a(a)(1) and (2). 

Method of Collection 

To achieve the goals of this project the 

following data collections will be 

implemented: 

1. Expert Survey—The purpose of this 

survey, completed by domain experts, is 

to measure the accuracy and 

completeness of the AHRQ Healthcare 

Horizon Scanning System Potential 

High Impact reports and to collect their 

assessment of the potential for high 

impact for the included Potential High 

Impact interventions. 

2. Expert Consultation—The purpose 

of this consultation with experts is to 

confirm the cases of inaccurate or 

missing information identified by a sole 

expert in the Expert Survey. 

3. Stakeholder Survey—The purpose 

of this survey, completed by 

stakeholders and likely users of the 

reports issued by the AHRQ Healthcare 

Horizon Scanning System, is to rate the 

relevance, clarity, and usefulness of the 

Potential High Impact reports. 

4. Key Informant Interview—The 

purpose of these interviews of the 

AHRQ Healthcare Horizon Scanning 

System staff is to learn about areas and 

suggestions for improvement in the 

identification, monitoring, and impact 

assessment processes. 

The data collected by the Expert 

Survey will be used to measure the 

accuracy and completeness of the 

Potential High Impact reports and the 

accuracy of the potential for high impact 

assessments. If the expert survey 

identifies cases of inaccurate or missing 

information that are not reported by 

multiple experts, we will conduct an 

Expert Consultation with another expert 

to confirm these cases. Accuracy of the 

potential for high impact assessments 

will be measured by the level of 

sensitivity (if experts agree that the 

Potential High Impact interventions 

identified by the AHRQ Healthcare 

Horizon Scanning System are high 

impact interventions) and specificity (if 

experts agree that the No Potential High 

Impact interventions identified by the 

AHRQ Healthcare Horizon Scanning 

System should be excluded from the 

group of Potential High Impact 

interventions). 

The Stakeholder Survey will collect 

data to measure the usability of the 

Potential High Impact reports and the 

specific report sections that include the 

potential high impact assessment, 

summary, and synthesis of expert 

comments. These data will be used to 

inform the improvement of the format 

and content of the report. The survey 

will also collect information on the 

sources and media these stakeholders 

use to find CER information to help 

AHRQ better target distribution of these 

reports to stakeholders. 

A series of semi-structured Key 

Informant Interviews will be conducted 

with staff and domain experts at ECRI 

Institute and other organizations that 

participate in the AIIRQ Healthcare 

Horizon Scanning System in order to 

identify opportunities for improvements 

to the AHRQ Healthcare Horizon 

Scanning System process. Qualitative 

interviews are the main vehicle for 

gathering data to (1) learn which 

elements of the AHRQ Healthcare 

Horizon Scanning System Protocol are 

working well and the reasons why they 

are working well; and (2) understand 

which elements of the AHRQ Healthcare 

Horizon Scanning System Protocol can 

be improved, how they might be 

improved, and the relative importance 

of suggested improvements. 

All of these information collection 

activities will allow for an evaluation of 

the AHRQ Healthcare Horizon Scanning 

System, thereby creating the 

opportunity to both maintain and 

improve this important national 

resource. The findings will be presented 

in a report to ECRI Institute and AHRQ. 

Estimated Annual Respondent Burden 

Mathematica expects a response rate 

of 80 percent from the sample of 67 

experts for the Expert Survey ¥54 

completed surveys. The Expert Survey 

is expected to require about 20 minutes, 

on average, to complete. Mathematica 

expects that Expert Consultation with 

15 experts will be needed to confirm 

cases of inaccurate or missing 

information identified in the Expert 

Survey. The follow-ups should be about 

10 minutes. 

For the Stakeholder Survey, 

Mathematica expects that 30 percent of 

the sample of 700 stakeholders will be 

ineligible (i.e. will not find any of the 


emcdonald on DSK67QTVN1PROD with NOTICES
47144 Federal Register / Vol. 79, No. 155 / Tuesday, August 12, 2014 / Notices 

presented reports relevant and therefore 

unable to rate a report) and that 65 

percent of the eligible sample will 

complete, resulting in 319 completes. It 

should take about 30 minutes to 

complete the Stakeholder Survey. 

Mathematica will conduct seniistructured Key Informant Interviews, on 

average lasting 50 minutes, with 23 

respondents. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Expert Survey .................................................................................................. 54 1 .33 18 

Expert Consultation ......................................................................................... 15 1 .17 3 

Stakeholder Survey ......................................................................................... 319 1 .50 160 

Key Informant Interviews ................................................................................. 23 1 .83 19 

Total .......................................................................................................... 411 ........................ ........................ 200 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

Expert Survey .................................................................................................. 54 17.8 $92.25 $1,642 

Expert Consultation ......................................................................................... 15 2.5 ** 92.25 231 

Stakeholder Survey ......................................................................................... 319 59.5 *** 48.72 7,771 

Key Informant Interviews ................................................................................. 23 19.1 38.68 739 

Total .......................................................................................................... 411 ........................ ........................ 10,383 

* May 2013 National Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of Labor Statistics. 

** Based on average wage for physicians and surgeons. 

*** Based on average wage for medical and health services managers. 

**** Based on average wage for social scientists and related workers. 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: July 30 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–18972 Filed 8–11–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10305] 

Agency Information Collection 

Activities: Proposed Collection; 

Extension of Comment Period 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Agency information collection 

activities: Proposed collection; comment 

request; extension of comment period. 

SUMMARY: This notice extends the 

comment period for a 60-day notice 

request for proposed information 

collection request associated with the 

notice [Document Identifier: CMS– 

10305] entitled ‘‘Medicare Part C and 

Part D Data Validation’’ that was 

published in the June 13, 2014 (79 FR 

33927) Federal Register. The comment 

period for the information collection 

request, which would have ended on 

August 12, 2014, is extended to August 

26, 2014. 

DATES: The comment period for the 

information collection request 

published in the June 13, 2014, Federal 

Register (79 FR 33927) is extended to 

August 26, 2014. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

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 lll, 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: 


emcdonald on DSK67QTVN1PROD with NOTICES