Attachment F -- Federal Register Notice

Attachment F -- Federal Register Notice.pdf

Understanding Development Methods from Other Industries to Improve the Design of Consumer Health IT

Attachment F -- Federal Register Notice

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Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Notices
EXHIBIT 2—ESTIMATED COST BURDEN OVER 3 YEARS—Continued
Number of respondents

Type of information collection

Total burden
hours

Average hourly wage rate*

Total cost burden

Telephone ........................................................................................................
Web-based .......................................................................................................
Focus Groups ..................................................................................................
In-person ..........................................................................................................

600
15,000
1,500
600

400
2,500
3,000
500

33.51
33.51
33.51
33.51

13,404
83,775
100,530
16,755

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

32,700

10,150

na

340,127

* Based upon the average wages for 29–000 (Healthcare Practitioner and Technical Occupations), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2009,’’ U.S. Department of Labor, Bureau of Labor Statistics.

Estimated Annual Costs to the Federal
Government

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Information collections conducted
under this generic clearance will in
some cases be carried out under
contract. Assuming the contract cost per
survey are $50,000–$100,000, and for
each focus group are $20,000, total
contract costs could run $720,000 per
year.

Agency for Healthcare Research and
Quality

Request for Comments

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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 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: March 17, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–7430 Filed 3–30–11; 8:45 am]
BILLING CODE 4160–90–M

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:
‘‘Understanding Development Methods
from Other Industries to Improve the
Design of Consumer Health IT.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection
was previously published in the Federal
Register on January 27th, 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.
DATES: Comments on this notice must be
received by May 2, 2011.
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 [email protected]
(attention: AHRQs 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.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
[email protected].
SUMMARY:

SUPPLEMENTARY INFORMATION:

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Proposed Project
Understanding Development Methods
From Other Industries to Improve the
Design of Consumer Health IT
Consumer health information
technology (IT) is the collection of tools,
technologies, and artifacts that
individuals can use to support their
health care management tasks (Agarwal
and Khuntia, 2009). Consumer health IT
can play an important role in patients’
efforts to coordinate their care and in
ensuring that their personal values and
interests help guide all clinical
decisions. In order to accomplish this,
consumer health IT solutions must take
into account the particular needs of the
consumer.
Useful consumer health IT products
may enhance the quality of health care
by empowering individual consumers to
take a more active, effective, and
collaborative role in their own personal
health care. These products could
provide the following capabilities to
consumers:
• Information storage, archiving, and
retrieval: The capabilities to search
results of past examinations or lab tests,
to interact with electronic versions of
their health records, and identify when
to seek health care services.
• Health monitoring: The capability
to report data (e.g., blood pressure,
weight) from various locations.
• Information seeking and searching:
The capability to interactively search for
a wealth of health-related information.
Despite the potential power of
consumer health IT, consumers have not
adopted these technologies to the same
degree that they have adopted
technology products marketed from
other consumer product industries. One
reason for slow adoption is that the
marketplace lacks robust tools that
allow for the complexity and diversity
of personal health information
management (PHIM) practices. These
types of practices are influenced by a
variety of user and contextual factors,
including demographics, personal
attitudes, the goals and objectives of
users, and the broad range of tasks that

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users wish to perform. There is no
comprehensive list of problems that
users encounter as they collect and
reflect on personal information; this
creates a barrier for design of consumer
health IT tools.
New practices for the development of
consumer-facing digital tools are
emerging in a variety of industries. The
success of information management
tools in other industries offers much to
be learned and applied to the health
care field.
In July of 2009, AHRQ held the
Building Bridges: Consumer Needs and
the Design of Health Information
Technology workshop. The workshop
brought together leaders from multiple
disciplines, including health
informatics, health sciences,
information science, consumer health
IT, and human factors to discuss the
diverse needs of different consumer
groups in managing their personal
health information, and how these
needs could be incorporated into the
design of consumer health IT solutions.
The outcome of the workshop was a
framework to further the design of
consumer health IT systems, based on
an understanding of practices that
consumers use in their PHIM. The final
report also included a set of
recommendations for additional work in
the health IT field related to research
and industry and policy. Recognizing
that design plays a key role in consumer
use of personal tools, one researchrelated recommendation that resulted
from the workshop was to investigate
the application of design methodologies

used in other industries to consumer
health IT design.
This project has the following goals:
(1) To investigate the product
development approaches, methods, and
philosophies from a variety of industries
in order to identify promising design
and development techniques that will
be most applicable to consumer health
IT.
(2) To disseminate the project
findings and recommendations to
vendors and developers of consumer
health IT products to assist them in
developing health IT products that are
consumer-focused. This study is being
conducted by AHRQ through its
contractors, Westat and the University
of Wisconsin, pursuant to AHRQ’s
statutory authority to conduct and
support research (1) on health care and
on systems for the delivery of such care,
including activities with respect to
health care technologies, 42 U.S.C.
299a(a)(5), and (2) to advance the use of
computer-based health records, 42
U.S.C. 299b–3(a)(6).
Method of Collection
To achieve the goals of this project the
following activities will be
implemented:
(1) Semi-structured interviews will be
conducted with key informants
identified as being experts in the design,
management, and/or marketing of
consumer products that are relevant to
consumer health IT products. The
purpose of these interviews is to gather
information related to their experiences
in developing consumer products,
focusing on the design processes that

their company uses, how they segment
the market, the role of users in testing
during the various product development
phases, and the factors that affect the
success of their product development
approaches.
(2) The final report will be provided
in PDF format for easy download from
the AHRQ National Resource Center for
Health IT Web site.
Information collected by the study
will support the development of
recommendations for those developers
and vendors who design, develop, and
market consumer health IT products.
The ultimate goal is to improve
consumer health IT design and impact
the adoption of this technology by
consumers. This project will identify
principles that led to the success of
other consumer products, so that they
can be evaluated for extension to the
design and development of consumer
health IT.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
research. Semi-structured interviews
will be conducted with no more than 15
individuals representing a variety of
consumer-focused industries. The
average burden will be 90 minutes per
interview. The total annual burden is
estimated to be 23 hours.
Exhibit 2 shows the estimated annual
cost burden associated with the
respondent’s time to participate in this
research. The total annual cost burden
is estimated to be $1,770.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
technical experts

Form name

Number of responses per
expert

Hours per response

Total burden
hours

Semi-structured interviews ..............................................................................

15

1

1.50

23

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

15

1

1.50

23

Average hourly wage rate*

Total cost burden

$76.94
76.94

$1,770
1,770

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
technical experts

Form name

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Semi-structured interviews ..............................................................................
Total ..........................................................................................................

Total burden
hours

15
15

23
23

*Wage rates calculations were not possible using data from the U.S. Department of Labor, Bureau of Labor Statistics, National Occupational
Employment and Wage Estimates for the United States, Occupational Employment Statistics (OES). The OES categories are too broad to determine a wage rate for a ‘‘Director of Product Development.’’ Instead wage rate calculations are based on information from the Web site http://
www.salary.com which has a tool providing a range of salaries for a variety of specific job titles. The salary for a ‘‘Product Development Director’’
generally ranges from $130,313 (25t percentile) to $189,771 (75t percentile) with an anticipated median of $160,042. Assuming 2,080 hours per
year (40 hours per week), the resulting median hourly rate is $76.94.

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Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Notices
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated total
and annualized cost to the Federal

Government for this research project.
Since this project’s activities will span
a single year the total and annualized

costs are identical. The estimated total
cost is $409,388.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUAL COST* TO THE FEDERAL GOVERNMENT
Cost component

Total cost

Annualized
cost

Administration and Coordination Activities ..............................................................................................................
Technical Expert Panel ............................................................................................................................................
Environmental Scan and Grey Literature Review ...................................................................................................
0MB Submission Package .......................................................................................................................................
Interviews with Study Participants ...........................................................................................................................
Recommendations for Health IT Vendors and Developers ....................................................................................
Dissemination Activities ...........................................................................................................................................
508 Compliance .......................................................................................................................................................

$91,673
74,217
58,413
11,574
102,018
48,612
14,325
8,556

$91,673
74,217
58,413
11,574
102,018
48,612
14,325
8,556

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

409,388

409,388

*Costs are fully loaded including overhead, G&A and fees.

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 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: March 17, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–7443 Filed 3–30–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[30Day-11–09BK]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Agency for Toxic Substances and
Disease Registry (ATSDR) publishes a
list of information collection requests
under review by the Office of
Management and Budget (OMB) in
compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35).
To request a copy of these requests, call
the CDC/ATSDR Reports Clearance
Officer at (404) 639–5960 or send an
email to [email protected]. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Registration of Individuals Displaced
by the Hurricanes Katrina and Rita
(Pilot Project)—New—Agency for Toxic
Substances and Disease Registry
(ATSDR), Office of Noncommunicable
Diseases, Injury, and Environmental
Health (ONDIEH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
On August 29, 2005, Hurricane
Katrina made landfall on the coast of the
Gulf of Mexico near New Orleans,
Louisiana, and became one of the most
deadly and destructive storms in U.S.
history. Also occurring in 2005,
Hurricane Rita was the fourth-most
intense Atlantic hurricane ever recorded
and the most intense tropical cyclone

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ever observed in the Gulf of Mexico.
Following the initial phase of the
response, the Federal Emergency
Management Agency (FEMA) assumed
the primary role for housing displaced
persons over the intermediate term. To
support those needing temporary
housing, FEMA provided over 143,000
travel trailers, park homes, and mobile
homes for persons displaced by the
above mentioned storms. However,
some persons living in trailers
complained of an odor or of eye or
respiratory tract irritation.
FEMA entered into an Interagency
Agreement with the Centers for Disease
Control and Prevention (CDC)/ATSDR
on August 16, 2007 to conduct a
comprehensive public health
assessment, based on objective and
credible research, of air quality
conditions present in FEMA housing
units to guide FEMA policy makers and
inform the public as to the actual
conditions in the field and any actions
required to better promote a safe and
healthful environment for the disaster
victims FEMA housed in the units.
FEMA’s agreement with the CDC
includes an initial formaldehyde
exposure assessment as well as a
subsequent long-term study of the
health effects among residents if
feasible. Formaldehyde testing
conducted and evaluated by the CDC
pursuant to the initial exposure
assessment has identified the need to
evaluate the feasibility of establishing a
national registry to identify and monitor
the health of disaster victims who
occupied FEMA-provided temporary
housing units. The establishment of
such a registry would complement the
long-term health effects study set forth
in the FEMA–CDC Interagency
Agreement.

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