Attachment L -- Federal Register Notice

Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Meeting

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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

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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]
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34101

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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:
SUMMARY:

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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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.

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EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Hours per
response

Total burden
hours

Safety event intake form and follow up .........................................................
Health care provider follow up .......................................................................

840
84

1
1

35/60
20/60

490
28

Total ........................................................................................................

924

NA

NA

518

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Federal Register / Vol. 78, No. 109 / Thursday, June 6, 2013 / Notices
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
Number of
respondents

Form Name

Total burden
hours

Average
hourly
wage rate

Total cost
burden

Safety event intake form and follow up ...........................................................
Health care provider follow up .........................................................................

840
84

490
28

* $21.74
** 31.61

$10,652
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

Intake Form Development .......................................................................................................................................
System Development ...............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................
Total ..................................................................................................................................................................

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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.

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Dated: May 30, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013–13341 Filed 6–5–13; 8:45 am]
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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.

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$364,375
413,860
35,325
86,267
899,827

Annualized
cost
$242,917
275,907
23,550
57,511
599,885

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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