Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices 34101 

The Subcommittee is interested in learning 

about industry innovations underway in 

health information technology and standards 

as the convergence between clinical and 

administrative information exchanges occurs, 

and industry moves from a claim-centric, 

transaction-based administrative information 

infrastructure to a quality-oriented and 

outcomes-based reporting and information 

exchange. 

Contact Person for More Information: 

Marjorie S. Greenberg, Executive Secretary, 

NCVHS, National Center for Health Statistics, 

Centers for Disease Control and Prevention, 

3311 Toledo Road, Room 2402, Hyattsville, 

Maryland 20782, telephone (301) 458–4245 

or Lorraine Doo, lead staff for the Standards 

Subcommittee, NCVHS, Centers for Medicare 

and Medicaid Services, Office of E-Health 

Standards and Services, 7500 Security 

Boulevard, Baltimore, Maryland, 21244, 

telephone (410) 786–6597. Program 

information as well as summaries of meetings 

and a roster of committee members are 

available on the NCVHS home page of the 

HHS Web site: http://www.ncvhs.hhs.gov/, 

where further information including an 

agenda will be posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment Opportunity on 

(301) 458–4EEO (4336) as soon as possible. 

Dated: May 29, 2013. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. 2013–13476 Filed 6–5–13; 8:45 am] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Meeting 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting. 

Name: National Committee on Vital and 

Health Statistics (NCVHS), Full Committee 

Meeting. 

Time and Date: 

June 19, 2013 9:00 a.m.–3:15 p.m. e.s.t. 

June 20, 2013 10:00 a.m.–12:15 p.m. e.s.t. 

Place: Centers for Disease Control and 

Prevention, National Center for Health 

Statistics, 3311 Toledo Road, Auditorium 

B & C, Hyattsville, Maryland 20782, (301) 

458–4524. 

Status: Open. 

Purpose: At this meeting the Committee 

will hear presentations and hold discussions 

on several health data policy topics. On the 

morning of the first day, the Committee will 

hear updates from the Department (HHS), the 

Centers for Medicare and Medicaid Services 

(CMS), the Office of the National Coordinator 

(ONC), the Office of Civil Rights (OCR), and 

the National Center for Health Statistics. The 

Committee will also review and discuss the 

letter and recommendations on attachments 

standards for healthcare initiated by the 

Standards Subcommittee. 

After the lunch break, Subcommittee Cochairs will brief the Committee on the 

hearing organized by the Population Health 

and Privacy Subcommittees to explore 

aspects of the Community as a Learning 

Health System. Members of the Population 

Health Subcommittee will brief the 

Committee about the Community Health 

Project Panel being organized for the 2013 

APHA Annual Meeting, and NCHS staff will 

report on elements of convergence between 

electronic health records and vital records. 

Finally, the Subcommittee co-chairs will 

discuss convergence as it relates to concepts, 

priorities, opportunities and challenges. 

On the morning of the second day, the 

Committee will discuss and vote on the 

attachments standards recommendation letter 

and hear a report on quality measures from 

the Quality Subcommittee Chair. Finally, a 

member of Academy Health’s Health Data 

Consortium will present on their current 

activities and goals, and the Committee Chair 

will give final remarks and receive feedback 

from the membership regarding NCVHS 

strategic implementation. Once the full 

Committee adjourns, the NCVHS Working 

Group on HHS Data Access & Use will 

convene to discuss best practices and 

suggestions for release of open HHS data, and 

summarize future plans of the Working 

Group. Further information will be provided 

on the NCVHS Web site at http:// 

www.ncvhs.hhs.gov/. 

The times shown above are for the full 

Committee meeting. Subcommittee breakout 

sessions are scheduled for late in the 

afternoon on the first day. Agendas for these 

breakout sessions will be posted on the 

NCVHS Web site (URL below) when 

available. 

Contact Person for More Information: 

Substantive program information may be 

obtained from Marjorie S. Greenberg, 

Executive Secretary, NCVHS, National Center 

for Health Statistics, Centers for Disease 

Control and Prevention, 3311 Toledo Road, 

Room 2402, Hyattsville, Maryland 20782, 

telephone (301) 458–4245. Summaries of 

meetings and a roster of committee members 

are available on the NCVHS home page of the 

HHS Web site: http://www.ncvhs.hhs.gov/, 

where further information including an 

agenda and a copy of the recommendation 

letter will be posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment Opportunity on 

(301) 458–4EEO (4336) as soon as possible. 

Dated: May 29, 2013. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. 2013–13479 Filed 6–5–13; 8:45 am] 

BILLING CODE 4251–05–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: ‘‘A 

Prototype Consumer Reporting System 

For Patient Safety Events.’’ In 

accordance with the Paperwork 

Reduction Act; 44 U.S.C. 3501–3521, 

AHRQ invites the public to comment on 

this proposed information collection. 

This proposed information collection 

was previously published in the Federal 

Register on September 11th, 2012 and 

allowed 60 days for public comment. 

AHRQ received 45 substantive 

comments and 64 personal stories from 

members of the public. These comments 

and personal stories raised 37 issues in 

the wording of the intake form, two 

issues with wording in other supporting 

documentation to the intake form, and 

69 design issues that we categorized 

into 18 types of design concerns. To 

address these comments substantial 

revisions were made to the data 

collection tools and supporting 

documentation. The purpose of this 

notice is to allow an additional 30 days 

for public comment. 

DATES: Comments on this notice must be 

received by July 8, 2013. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at 

OIRA_submission@OMB.EOP.gov 

(attention: AHRQ’s desk 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 

A Prototype Consumer Reporting 

System for Patient Safety Events 

The Agency for Healthcare Research 

and Quality (AHRQ) requests that the 

Office of Management and Budget 

(OMB) approve, under the Paperwork 

Reduction Act of 1995, AHRQ’s 

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34102 Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices 

collection of information for a Prototype 

Consumer Reporting System for Patient 

Safety Events. This project aims to 

design and test a system for collecting 

information from patients about health 

care safety events following standard 

definitions and formats. When 

complete, project findings will be 

available for use by local providers that 

wish to create or enhance their own 

local consumer reporting systems. 

There is a growing body of evidence 

that many adverse medical events go 

unreported in current systems 

(Weissman et al., 2008). One important 

reason for this reporting gap is that most 

reporting systems do not presently 

accept or elicit reports from patients and 

their families (RTI 2010). AHRQ 

recognizes that the unique perspective 

of health care consumers could reveal 

important information that is not 

reported by health care providers. 

Patient reports could complement and 

enhance reports from providers and 

thus produce a more complete and 

accurate understanding of the 

prevalence and characteristics of 

medical adverse events (RTI, 2010). 

In an effort to realize untapped 

potential of health care consumers to 

provide important information about 

patient safety events, AHRQ has funded 

the development of a prototype 

Consumer Reporting System for Patient 

Safety (CRSPS), designed to collect 

information from patients about medical 

errors that resulted or nearly resulted in 

harm or injury. The purpose of this 

project is to test the prototype for its 

ability to record data from consumers 

about patient safety events defined as an 

incident or near miss by the AHRQ 

Common Formats (AHRQ, 2010, details 

at: www.pso.ahrq.gov/formats/ 

commonfmt.htm). 

Currently there is no mechanism for 

consumers to report information about 

patient safety events defined as 

incidents or near misses by the AHRQ 

Common Formats, which were designed 

for use by providers of care. Such 

information is necessary for research on 

how to improve the quality of health 

care, promote patient safety, and reduce 

medical errors. There is a need to collect 

information about patient safety events 

from consumers and match these 

consumer reports to the information 

collected by providers, because the two 

sources may differ and, even when 

reporting on the same event, may 

provide complementary information. 

Examining data from both sources 

allows the project to determine to what 

extent patients are able to contribute to 

more complete and/or more detailed 

information. 

This research has the following goals: 

1. To develop and design a prototype 

system to collect information about 

patient safety events. 

2. To develop and test web and 

telephone modes of a prototype 

questionnaire. 

3. To develop and test protocols for a 

follow-up survey of health care 

providers. 

This demonstration project is being 

conducted by AHRQ through its 

contractor, RAND Corporation, with 

Brigham and Women’s Hospital, Dana 

Farber Cancer Institute, and ECRI 

Institute, 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 goal of this project the 

following data collection efforts will be 

implemented: 

1. Safety event intake form and follow 

up. The safety event intake form asks 

about a medical error or mistake, harm 

or injury as well as near misses. 

Patients, consumers, family members 

and other caregivers voluntarily report 

safety events through a Web site or by 

telephone. The questions ask what 

happened, details of the event, when, 

where, whether there was harm, the 

type of harm, contributing factors, 

disclosure, and whether the patient 

reported the event and to whom. 

Information is also collected regarding 

whether the respondent is willing to 

have CRSPS staff follow up to clarify 

information. If a respondent consents, 

CRSPS staff will follow up by phone 

and ask questions about any information 

that was not clear in the initial report 

and annotate the report with this 

information. 

2. Health care provider follow up. For 

the subset of consumers that consent, 

patient safety officers at health care 

provider organizations who maintain 

the adverse event reporting system will 

contribute supplemental information 

about the consumer-reported incident 

which occurred at their facility. CRSPS 

staff will contact the health care 

organization to share the consumer 

report with the patient safety officer or 

other appointed liaison. The liaison will 

determine if the consumer-reported 

incident matches an event in the 

provider’s Incident Reporting System, 

and if so, provide additional 

information. 

Data collected will be analyzed to 

produce estimates and basic descriptive 

statistics on the quantity and type of 

consumer-reported patient safety events, 

examine the variability of responses to 

questions, examine the mode of data 

collection by event types, and conduct 

correlations, cross tabulations of 

responses and other statistical analysis. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for 

respondents’ time to participate in this 

information collection based on the 

expected number of respondents, 840 to 

the intake form and 84 to the provider 

follow up. The number of respondents 

is based on the size of the selected 

community, estimates of health care 

utilization, rates of adverse events, and 

response rates in similar investigations. 

The intake form is expected to 

maximally require 25 minutes via the 

web or telephone including the optional 

10 minutes of follow-up questions, 

resulting in a total burden of 490 hours. 

The health care provider follow up is 

expected to take 20 minutes and only 

occurs for the estimated 10% of patients 

consenting; this form carries a total 

burden of 28 hours. The total burden is 

518 hours annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Safety event intake form and follow up ......................................................... 840 1 35/60 490 

Health care provider follow up ....................................................................... 84 1 20/60 28 

Total ........................................................................................................ 924 NA NA 518 

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Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices 34103 

Exhibit 2 shows the estimated 

annualized cost burden for patients, 

$10,652, and for the health care 

organization, $885, for a total 

annualized cost burden of $11,537. 

Respondents will not incur any other 

costs beyond those associated with their 

time to participate. 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form Name Number of 

respondents 

Total burden 

hours 

Average 

hourly 

wage rate 

Total cost 

burden 

Safety event intake form and follow up ........................................................... 840 490 * $21.74 $10,652 

Health care provider follow up ......................................................................... 84 28 ** 31.61 885 

Total .......................................................................................................... 924 518 NA 11,537 

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States, May 2011, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#00-0000. 

** Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States, May 2011: Occupational Health and Safety Specialists (General Medical and Surgical Hospitals). U.S. Department of Labor, Bureau of Labor Statistics. http:// 

www.bls.gov/oes/current/oes299011.htm. 

Estimated Annual Cost to the 

Government 

AHRQ is supporting the conduct of 

this project as part of a contract with the 

RAND Corporation and the ECRI 

Institute. The estimated cost for this 

work is $899,827. 

EXHIBIT 3—ESTIMATED ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Intake Form Development ....................................................................................................................................... $364,375 $242,917 

System Development ............................................................................................................................................... 413,860 275,907 

Project Management ................................................................................................................................................ 35,325 23,550 

Overhead ................................................................................................................................................................. 86,267 57,511 

Total .................................................................................................................................................................. 899,827 599,885 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 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: May 30, 2013. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2013–13341 Filed 6–5–13; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60-Day–13–13UW] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–7570 or send 

comments to Ron Otten, at CDC 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an email to omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection 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 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Enhanced Utilization of Personal Dust 

Monitor Feedback—New—National 

Institute for Occupational Safety and 

Health (NIOSH), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

NIOSH, under Public Law 91–596, 

Sections 20 and 22 (Section 20–22, 

Occupational Safety and Health Act of 

1970) has the responsibility to conduct 

research relating to innovative methods, 

techniques, and approaches dealing 

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