Attachment E -- Federal Register Notice

Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices
Dated: January 17, 2012.
Carolyn M. Clancy,
Director.

Proposed Project

[FR Doc. 2012–1400 Filed 1–25–12; 8:45 am]
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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.

AGENCY:
ACTION:

Notice.

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:
‘‘Assessing the Feasibility of
Disseminating Effective Health Care
Products through a Shared Electronic
Medical Record Serving Member
Organization of a Health Information
Exchange.’’ 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 November 15th, 2011 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.

SUMMARY:

Comments on this notice must be
received by February 27, 2012.

DATES:

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
[email protected]
(attention: AHRQ’s desk officer).
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.

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ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at [email protected].
SUPPLEMENTARY INFORMATION:

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Assessing the Feasibility of
Disseminating Effective Health Care
Products through a Shared Electronic
Medical Record Serving Member
Organization of a Health Information
Exchange
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 this collection of
information from users of work products
and services initiated by the John M.
Eisenberg Clinical Decisions and
Communications Science Center
(Eisenberg Center).
AHRQ is the lead agency charged
with supporting research designed to
improve the quality of healthcare,
reduce its cost, improve patient safety,
decrease medical errors, and broaden
access to essential services. AHRQ’s
Eisenberg Center’s mission is improving
communication of findings to a variety
of audiences (‘‘customers’’), including
consumers, clinicians, and health care
policy makers. The Eisenberg Center
compiles research results into useful
formats for customer stakeholders. The
Eisenberg Center also conducts
investigations into effective
communication of research findings in
order to improve the usability and rapid
incorporation of findings into medical
practice. The Eisenberg Center is one of
three components of AHRQ’s Effective
Health Care (EHC) Program. The
collections proposed under this
clearance include activities to assess the
feasibility of disseminating materials
developed by the Eisenberg Center
through the use of an electronic medical
record (EMR) shared by a network of
clinical care providers that are part of a
Health Information Exchange (HIE)
operating in multiple sites in several
states. Our Community Health
Information Network (OCHIN) members
include 30 clinical care organizations
operating more than 230 primary care
clinics in six states. Data will be
gathered from three different OCHINmember organizations representing a
total of 10 primary care clinics. The
information generated will be provided
to AHRQ to guide decision making and
planning for additional efforts to foster
EHC Program product distribution via
EMR prompting and product linkages.
This research has the following goals:
(1) Identify facilitators and barriers to
successful efforts to implement
processes that: (a) Support use of EHC
Program products by clinicians in
practice, and (b) place relevant clinical
information in the hands of patients and
family members in languages and

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formats that are appropriate to patients’
information needs;
(2) Examine ways in which EHC
Program products can be used in
concert with other support programs
and products (e.g., healthwise®
resources available through the EMR;
brief patient instructions and letters,
including those designed for use with
persons having very low literacy skills);
(3) Assess the extent to which EHC
Program products are used (e.g.,
accessed by clinicians, provided to
patients in relevant formats) in settings
where use is supported by automated
EMR features, such as on-screen
prompts and reminders; and
(4) Document the perceived value of
integrating EHC Program products into
systems of care supported by an EMR
system as self-reported by clinicians
involved in direct care of patients and
clinic support personnel who interact
with patients.
This study is being conducted by
AHRQ through its contractor, the
Eisenberg Center—Baylor College of
Medicine, pursuant to AHRQ’s statutory
authority to conduct and support
research, and disseminate information,
on healthcare and on systems for the
delivery of such care, including
activities with respect to the quality,
effectiveness, efficiency,
appropriateness and value of healthcare
services and clinical practice. 42 U.S.C.
299a(a)(1) and (4).
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
(1) Automated Data Capture from
EMR Usage Logs. Electronic usage data
will be collected to determine the extent
to which EHC Program guides for
clinicians and patients were accessed to
support shared decision making and
patient education. The data will be
retrieved from the existing EMR-linked
database operated by the Kaiser
Permanente staff in their coordination of
activities related to the OCHIN HIE.
Data will include: (a) Number and
frequency of retrieval of EHC resource
materials; (b) specific types of materials
retrieved; and (c) health topic or
condition targeted in the EHC materials.
These data will inform the development
of follow-up questions to be
administered to clinicians and patients
in the interviews and surveys described
below. Because the data will be
obtained using automated systems
already in place, no special effort will
be needed to generate these data, and
thus this task is not included in the
burden estimates in Exhibits 1 and 2.

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Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices

(2) Interviews with Clinicians.
Interviews will be held with clinical
service providers for the following
purposes: (a) Obtain perceptions of the
overall value, relevancy, currency and
appropriateness of EHC Program
products in addressing the health
service needs of patients treated in
clinical settings; (b) assess ease of use of
the materials in terms of access via the
EMR; (c) determine perceived success of
efforts to employ EHC Program products
and related materials in addressing the
needs of patients with limited language
skills and/or low literacy levels; and (d)
describe the relative success of efforts to
use the EHC Program products in
concert with other tools (e.g.,
healthwise® resources) in promoting
patient engagement in their own health
care or in the care of family members.
(3) Interviews with Support Staff.
Interviews will be held with nonclinical support staff to characterize
perceptions of how the introduction of
EHC Program products: (a) Affected
clinic workflows and influenced the
work that staff was required to do in
supporting clinician-patient
interactions; and (b) facilitated or
impeded efforts to inform patients about
actions they could take in being more
fully involved in their own health care.
(4) Interviews with Patients.
Interviews will be held with recruited
patients to determine if they: (a) Viewed
the EHC Program products that they

were provided as useful to them in
understanding their health issues; (b)
were able to understand the EHC
Program-related information that was
provided to them sufficiently to take
actions in their own health care; and (c)
have suggestions about how the EHC
Program materials could be changed or
the delivery of them done in a different
way to make the materials more useful
and/or accessible to patients.
(5) Survey of Clinicians. A
questionnaire will be administered to
clinical care providers near the end of
the study to gather quantitative data
around their assessments of: (a) The
relevancy of the EHC Program materials
to the patients they serve; (b) the
appropriateness of the products in
addressing specific clinical issues; (c)
the ease of use of the system created to
provide access to EHC Program products
through the EMR; and (d) overall ratings
of the approach in addressing patient
needs with regard to specific conditions
addressed by the products available.
The interviews with clinicians,
clinical staff, and patients will be
conducted throughout the project
period, approximately every three
months with different sets of
participants, to inform and refine
delivery mechanisms and monitor
progress.
This information will be used to
determine the feasibility of: (a)
Mounting broader efforts to distribute
clinician and consumer guides, as well

as other EHC products using EMRs as
the primary vehicle for providing
product access at the point of care; and
(b) initiating additional studies to
identify factors that encourage or deter
effective integration of EHC products
into care processes using electronic
tools and care delivery support systems,
like the EMR, that are increasingly
common in clinical work settings.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden for the respondents’
time to participate in this research.
Three rounds of interviews will be
conducted during the project period
(each round of interviews to be held
approximately every three months with
separate sets of participants) to assess
progress and adjust methods or refine
materials as needed. Interviews will be
conducted with 100 patients, 50
clinicians and 50 clinical support staff.
Each interview is estimated to last no
more than 30 minutes. All clinicians in
each participating clinic will have
access to the EMR and will be invited
to participate in an online
questionnaire. Approximately 200
clinicians will complete the 10-minute
questionnaire.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total annual cost
burden is estimated to be $6,274.

EXHIBIT 1—ESTIMATED ANNUALIZED TOTAL BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Type of data collection

Hours per
response

Total burden
hours

Interviews with Clinicians .................................................................
Interviews with Support Staff ...........................................................
Interviews with Patients ...................................................................
Survey of Clinicians .........................................................................

50
50
100
200

1
1
1
1

30/60
30/60
30/60
10/60

25
25
50
33

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

400

na

na

133

EXHIBIT 2—ESTIMATED ANNUALIZED TOTAL COST BURDEN’>
Number of
respondents

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Type of data collection

Total burden
hours

Average hourly
wage rate

Total cost burden

Interviews with Clinicians .................................................................
Interviews with Support Staff ...........................................................
Interviews with Patients ...................................................................
Survey of Clinicians .........................................................................

50
50
100
200

25
25
50
33

$83.59
14.31
21.35
83.59

$2,090
358
1,068
2,758

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

400

133

na

6,274

Based upon the mean wages for clinicians (29–1062 family and general practitioners), clinical team members (31–9092 medical assistants)
and patients/consumers (00–0000 all occupations), National Compensation Survey: Occupational wages in the United States May 2010, ‘‘U.S.
Department of Labor, Bureau of Labor Statistics.’’

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Federal Register / Vol. 77, No. 17 / Thursday, January 26, 2012 / Notices
Estimated Annual Costs to the Federal
Government

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

The maximum cost to the Federal
Government is estimated to be $217,451
annually for two years.
Exhibit 3 shows the total and
annualized cost by the major cost
components.

Agency for Healthcare Research and
Quality

EXHIBIT 3—ESTIMATED TOTAL AND
ANNUALIZED COST
Cost component

Total cost

Annualized
cost

Scientific Information Request on the
Use of Natriuretic Peptide
Measurement in the Management of
Heart Failure
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for scientific
information submissions.
AGENCY:

The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
medical device manufacturers of
natriuretic peptide measurement assays.
Scientific information is being solicited
to inform our Comparative Effectiveness
Review of Use of Natriuretic Peptide
Measurement in the Management of
Heart Failure, which is currently being
conducted by the Evidence-based
Practice Centers for the AHRQ Effective
Health Care Program. Access to
published and unpublished pertinent
scientific information on this device
will improve the quality of this
comparative effectiveness review.
AHRQ is requesting this scientific
information and conducting this
comparative effectiveness review
pursuant to Section 1013 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173.
DATES: Submission Deadline on or
before February 27, 2012.
ADDRESSES: Online submissions: http://
effectivehealthcare.AHRQ.gov/
index.cfm/submit-scientificinformation-packets/. Please select the
study for which you are submitting
information from the list of current
studies and complete the form to upload
your documents.
Email submissions: [email protected]
(please do not send zipped files—they
are automatically deleted for security
reasons).
Print submissions: Robin Paynter,
Oregon Health and Science University,
Oregon Evidence-based Practice Center,
3181 SW. Sam Jackson Park Road, Mail
Code: BICC, Portland, OR 97239–3098.
FOR FURTHER INFORMATION CONTACT:
Robin Paynter, Research Librarian,
Telephone: (503) 494–0147 or Email:
[email protected].
SUMMARY:

Project Development ..................
Data Collection Activities ................
Data Processing
and Analysis ......
Project Management ..................
Overhead ..............
Total ...............

$153,750

$76,875

162,465

81,233

33,563

16,781

22,625
62,500

11,313
31,250

434,903

217,451

Request for Comments

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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 healthcare
research and healthcare 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: January 17, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–1398 Filed 1–25–12; 8:45 am]
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In
accordance with Section 1013 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003, Public Law 108–173, the Agency

SUPPLEMENTARY INFORMATION:

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for Healthcare Research and Quality has
commissioned the Effective Health Care
(EHC) Program Evidence-based Practice
Centers to complete a comparative
effectiveness review of the evidence for
use of natriuretic peptide measurement
in the management of heart failure.
The EHC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by systematically requesting
information (e.g., details of studies
conducted) from medical device
industry stakeholders through public
information requests, including via the
Federal Register and direct postal and/
or online solicitations. We are looking
for studies that report on natriuretic
peptide measurement assays, including
those that describe adverse events, as
specified in the key questions detailed
below. The entire research protocol,
including the key questions, is also
available online at: http://
effectivehealthcare.ahrq.gov/index.cfm/
search-for-guides-reviews-and-reports/
?pageaction=displayproduct&
productid=899#4210.
This notice is a request for industry
stakeholders to submit the following:
• A current product label, if
applicable (preferably an electronic PDF
file).
• Information identifying published
randomized controlled trials and
observational studies relevant to the
clinical outcomes. Please provide both a
list of citations and reprints if possible.
• Information identifying
unpublished randomized controlled
trials and observational studies relevant
to the clinical outcomes. If possible,
please provide a summary that includes
the following elements: Study number,
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to withdrawn/follow-up/
analyzed, and effectiveness/efficacy and
safety results.
• Registered ClinicalTrials.gov
studies. Please provide a list including
the ClinicalTrials.gov identifier,
condition, and intervention.
Your contribution is very beneficial to
this program. AHRQ is not requesting
and will not consider marketing
material, health economics information,
or information on other indications.
This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter. In addition to your scientific

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