Agency Information Collection Activities: Proposed Collection; Comment Request, 22497-22499 [2014-09168]
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Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
before May 22, 2014. Write ‘‘FTC
Generic Clearance ICR, Project No.
P035201’’ on your comment. Your
comment—including your name and
your state—will be placed on the public
record of this proceeding, including, to
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this Notice appears at https://
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may file a comment through that Web
site.
If you file your comment on paper,
write ‘‘FTC Generic Clearance ICR,
Project No. P035201’’ on your comment
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it to the following address: Federal
Trade Commission, Office of the
Secretary, Room H–113 (Annex J), 600
Pennsylvania Avenue NW., Washington,
DC 20580. If possible, submit your
paper comment to the Commission by
courier or overnight service.
Comments on any proposed
information collection requirements
subject to review under the PRA should
additionally be submitted to OMB. If
sent by U.S. mail, they should be
addressed to Office of Information and
Regulatory Affairs, Office of
Management and Budget, Attention:
Desk Officer for the Federal Trade
Commission, New Executive Office
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725 17th Street NW., Washington, DC
20503. Comments sent to OMB by U.S.
postal mail, however, are subject to
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precautions. Thus, comments instead
should be sent by facsimile to (202)
395–5167.
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Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before May 22, 2014. You can find more
information, including routine uses
permitted by the Privacy Act, in the
Commission’s privacy policy, at https://
www.ftc.gov/ftc/privacy.htm.
David C. Shonka,
Principal Deputy General Counsel.
[FR Doc. 2014–09173 Filed 4–21–14; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration;
Delegation of Authorities
Notice is hereby given that I have
delegated to the Commissioner, Food
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22497
and Drug Administration (FDA), with
authority to re-delegate, the authorities
vested in the Secretary of the
Department of Health and Human
Services under the Drug Quality and
Security Act (DQSA), Public Law 113–
54, insofar as these authorities pertain to
the functions and operations of FDA.
This delegation includes, but is not
limited to, authority to communicate
with state Boards of Pharmacy under
Section 105 of the DQSA.
This delegation shall be exercised in
accordance with the Department’s
applicable policies, procedures, and
guidelines.
I hereby affirm and ratify any actions
taken by the Commissioner, FDA, or
other FDA officials that involved the
exercise of these authorities prior to the
effective date of this delegation.
This delegation of authorities is
effective upon date of signature.
Authority: 44 U.S.C. 3101.
Dated: April 11, 2014.
Kathleen Sebelius,
Secretary.
[FR Doc. 2014–09033 Filed 4–21–14; 8:45 am]
BILLING CODE 4160–01–P
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:
‘‘SelectMD 2.0 Clinician Choice
Experiment.’’ In accordance with the
Paperwork Reduction Act of 1995, 44
U.S.C. 3506(c)(2)(A), AHRQ invites the
public to comment on this proposed
information collection.
SUMMARY:
This proposed information collection
was previously published in the Federal
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Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices
Register on January, 29th 2014 and
allowed 60 days for public comment.
One comment was 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 22, 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
tkelley on DSK3SPTVN1PROD with NOTICES
SelectMD 2.0 Clinician Choice
Experiment
This study builds on previous
research conducted as part of the
Consumer Assessment of Healthcare
Providers and Systems (CAHPS)
program to explore new ways of
integrating patient comments with other
performance metrics in web-based
quality reports for consumers to support
their choice of physicians. Our previous
consumer choice study, referred to as
SelectMD 1.0 (approved by OMB on 3/
8/10 under OMB Control Number 0935–
0161), revealed important risks and
opportunities of using patient comments
that require additional research in order
to develop effective guidance for report
sponsors. Sponsors of performance
reports in both the public and private
sectors, including Federal agencies such
as the Centers for Medicare & Medicaid
Services (CMS), have indicated strong
interest in receiving such guidance on
strategies for effectively incorporating
patient comments to increase
consumers’ use of public reports and to
enhance their ability to interpret CAHPS
and other performance measures.
This follow-on study (referred to as
SelectMD 2.0) will use an experimental
design to test different methods of
incorporating patient comments along
with CAHPS survey results, the
Healthcare Effectiveness Data and
Information Set (HEDIS)-like measures
of effective clinical treatments, and
indicators of patient safety in web-based
physician quality reports. The study
will help AHRQ understand how people
choose a doctor as their regular source
of medical care and advice.
The study has three stages. In the first
stage, respondents will be asked some
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questions about their health care
experiences and how they go about
choosing a doctor. In the second stage
the respondents will log onto an
experimental Web site that has
information about a fictitious set of
doctors from which to choose.
Respondents will be asked to use the
information on the Web site to select a
doctor who they think would be the best
for their health care needs. Although
they will not really be selecting a
doctor, they will be asked to consider
the choice as carefully as if they were
making it for themselves. In the third
stage, following their selection of a
doctor, respondents will answer a set of
questions about how they made their
choice of doctor, how useful they found
the Web site, and how confident they
were in the choice they made.
This research has the following goals:
(1) to expand on the findings from
AHRQ’s previous choice experiment
regarding how including narrative
patient comments in web-based
physician quality reports influences the
ways in which consumers learn about
and select among clinicians, and
(2) to assess whether and how patient
comments can be presented in a way
that promotes learning about physician
quality and complements rather than
detracts from standardized measures of
quality.
This study is being conducted by
AHRQ through its contractors, RAND
and Yale University, pursuant to
AHRQ’s statutory authority to conduct
and support research 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 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 over the three stages of the
experiment:
(1) Pre-Choice Survey—The purpose
of this survey is to measure the
respondents’ previous exposure to
information on health care provider
performance and how they go about
choosing a physician.
(2) Experimental Web site—The
purpose of this site is to present
different combinations and displays of
performance information that
respondents will use to select a doctor.
Respondents will be randomly assigned
to one of eight different versions of the
experimental SelectMD Web site that
will vary according to the level of detail
presented, how patient comments are
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grouped and labeled, whether
respondents can choose which and how
much information to review, and
whether respondents have access to live
telephone assistance when making their
choices.
(3) Post-Choice Survey—The purpose
of the post-choice survey is to assess
how respondents made their doctor
selection, how useful the Web site
version assigned to them was in helping
to make their choice, and how confident
they are in the choice they made.
Responses to the post-choice survey will
provide insights into which of the
experimental Web site versions are more
effective in supporting consumer choice
of doctors and why.
The results of this study will be used
to develop recommendations for helping
consumers to better understand and
more effectively use complex
information to select health care
providers, with the aim of making
performance information less
burdensome and more accessible,
useful, and transparent to the public. In
particular, the study findings will
inform the design and content of the
growing number of web-based reports
on provider performance incorporating
patient comments along with other
measures of quality. By adding to the
evidence base on the types and
combination of information that are
most salient and useful to consumers in
choosing among provider options, the
study will make a significant
contribution to improving current
reporting initiatives. In addition, the
simulated web-based reports will be
made available as examples for other
report developers to use.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
experiment. The portion of the
experiment involving respondent
participation will take place over a
period of approximately two months,
once OMB approval has been received.
All participants will complete the prechoice survey, which is estimated to
take 10 minutes. To assess the impact of
their exposure to the SelectMD Web
site, several questions on the initial prechoice survey are replicated on the postchoice questionnaire. To reduce the
likelihood that respondents will simply
repeat the answers that they provided
on the pre-choice survey (in an effort to
appear consistent), it is essential to
allow some time to elapse between the
two surveys. Consequently, participants
will not have access to the SelectMD
Web site until one week after
completing the pre-choice survey. Since
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Federal Register / Vol. 79, No. 77 / Tuesday, April 22, 2014 / Notices
we expect that about 5% of participants
taking the pre-choice survey will not
return to participate in the experiment
one week later, the number of
respondents initially required is 5%
higher (1,575) than the full sample of
1,500 required for the experiment. We
estimate based on our previous
experience with the SelectMD 1.0
experiment that participants will
require about 10 minutes to review the
information on the Web site and select
their preferred physician from the set of
doctors available. The average time
required to complete the post-choice
survey is estimated to be 20 minutes.
Consequently, respondents will average
about 40 minutes completing all three
phases of the study.
Exhibit 2 shows the respondents’ cost
burden for their time to participate in
this experiment. The total cost burden is
estimated to be $22,297.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Pre-Choice Survey ...........................................................................................
Time on Website (Choosing MD) ....................................................................
Post-Choice Survey .........................................................................................
Total Hours ...............................................................................................
Number of
responses per
respondent
1575
1500
1500
4,575
1
1
1
na
Hour per
response
(min/60)
10/60
10/60
20/60
na
Total burden
hours
263
250
500
1,013
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Form name
Number of
respondents
Total burden
hours
Average
hourly wage
rate *
Pre-Choice Survey ...........................................................................................
Time on Website (Choosing MD) ....................................................................
Post-Choice Survey .........................................................................................
Total Cost .................................................................................................
1575
1500
1500
........................
263
250
500
........................
$22.01
22.01
22.01
........................
Total cost
burden
$5,789
5,503
11,005
22,297
* Based upon the national mean hourly wage for all occupations from the ‘‘May 2012 Occupational Employment and Wage Estimates’’, U.S.
Department of Labor, Bureau of Labor Statistics.
tkelley on DSK3SPTVN1PROD with NOTICES
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 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: April 9, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–09168 Filed 4–21–14; 8:45 am]
BILLING CODE 4160–90–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0374]
Postmarketing Requirements for the
Class-Wide Extended-Release/LongActing Opioid Analgesics; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting to obtain stakeholder
input on the design and conduct of the
postmarketing requirements (PMRs) for
the class-wide extended-release/longacting (ER/LA) opioid analgesic drug
products to further assess the serious
risks of misuse, abuse, hyperalgesia,
addiction, overdose, and death
associated with their long-term use.
FDA is seeking input on these issues
from stakeholders, including patients,
academia, researchers, State and other
Federal regulators, health care
organizations, health care providers, the
pharmaceutical industry, and others
from the general public.
DATES: The public meeting will be held
on May 19 and 20, 2014, from 8 a.m. to
SUMMARY:
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5 p.m. Individuals who wish to present
at the meeting must register by May 9,
2014. See section III under the
SUPPLEMENTARY INFORMATION section for
information on how to register to speak
at the meeting.
ADDRESSES: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Participants must enter through
Building 1 and undergo security
screening. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit either electronic or written
comments by June 19, 2014. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify all
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Janelle Derbis, Center for Drug
Evaluation and Research, Food and
Drug Administration, 20 North
Michigan Ave., Suite 510, Chicago, IL
60602, 312–596–6516, FAX: 312–886–
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]]>Agencies
[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Notices]
[Pages 22497-22499]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09168]
-----------------------------------------------------------------------
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: ``SelectMD 2.0 Clinician Choice Experiment.'' In accordance
with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ
invites the public to comment on this proposed information collection.
This proposed information collection was previously published in
the Federal
[[Page 22498]]
Register on January, 29th 2014 and allowed 60 days for public comment.
One comment was 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 22, 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
SelectMD 2.0 Clinician Choice Experiment
This study builds on previous research conducted as part of the
Consumer Assessment of Healthcare Providers and Systems (CAHPS) program
to explore new ways of integrating patient comments with other
performance metrics in web-based quality reports for consumers to
support their choice of physicians. Our previous consumer choice study,
referred to as SelectMD 1.0 (approved by OMB on 3/8/10 under OMB
Control Number 0935-0161), revealed important risks and opportunities
of using patient comments that require additional research in order to
develop effective guidance for report sponsors. Sponsors of performance
reports in both the public and private sectors, including Federal
agencies such as the Centers for Medicare & Medicaid Services (CMS),
have indicated strong interest in receiving such guidance on strategies
for effectively incorporating patient comments to increase consumers'
use of public reports and to enhance their ability to interpret CAHPS
and other performance measures.
This follow-on study (referred to as SelectMD 2.0) will use an
experimental design to test different methods of incorporating patient
comments along with CAHPS survey results, the Healthcare Effectiveness
Data and Information Set (HEDIS)-like measures of effective clinical
treatments, and indicators of patient safety in web-based physician
quality reports. The study will help AHRQ understand how people choose
a doctor as their regular source of medical care and advice.
The study has three stages. In the first stage, respondents will be
asked some questions about their health care experiences and how they
go about choosing a doctor. In the second stage the respondents will
log onto an experimental Web site that has information about a
fictitious set of doctors from which to choose. Respondents will be
asked to use the information on the Web site to select a doctor who
they think would be the best for their health care needs. Although they
will not really be selecting a doctor, they will be asked to consider
the choice as carefully as if they were making it for themselves. In
the third stage, following their selection of a doctor, respondents
will answer a set of questions about how they made their choice of
doctor, how useful they found the Web site, and how confident they were
in the choice they made.
This research has the following goals:
(1) to expand on the findings from AHRQ's previous choice
experiment regarding how including narrative patient comments in web-
based physician quality reports influences the ways in which consumers
learn about and select among clinicians, and
(2) to assess whether and how patient comments can be presented in
a way that promotes learning about physician quality and complements
rather than detracts from standardized measures of quality.
This study is being conducted by AHRQ through its contractors, RAND
and Yale University, pursuant to AHRQ's statutory authority to conduct
and support research 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 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 over the three stages of the experiment:
(1) Pre-Choice Survey--The purpose of this survey is to measure the
respondents' previous exposure to information on health care provider
performance and how they go about choosing a physician.
(2) Experimental Web site--The purpose of this site is to present
different combinations and displays of performance information that
respondents will use to select a doctor. Respondents will be randomly
assigned to one of eight different versions of the experimental
SelectMD Web site that will vary according to the level of detail
presented, how patient comments are grouped and labeled, whether
respondents can choose which and how much information to review, and
whether respondents have access to live telephone assistance when
making their choices.
(3) Post-Choice Survey--The purpose of the post-choice survey is to
assess how respondents made their doctor selection, how useful the Web
site version assigned to them was in helping to make their choice, and
how confident they are in the choice they made. Responses to the post-
choice survey will provide insights into which of the experimental Web
site versions are more effective in supporting consumer choice of
doctors and why.
The results of this study will be used to develop recommendations
for helping consumers to better understand and more effectively use
complex information to select health care providers, with the aim of
making performance information less burdensome and more accessible,
useful, and transparent to the public. In particular, the study
findings will inform the design and content of the growing number of
web-based reports on provider performance incorporating patient
comments along with other measures of quality. By adding to the
evidence base on the types and combination of information that are most
salient and useful to consumers in choosing among provider options, the
study will make a significant contribution to improving current
reporting initiatives. In addition, the simulated web-based reports
will be made available as examples for other report developers to use.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in this experiment. The portion of the
experiment involving respondent participation will take place over a
period of approximately two months, once OMB approval has been
received. All participants will complete the pre-choice survey, which
is estimated to take 10 minutes. To assess the impact of their exposure
to the SelectMD Web site, several questions on the initial pre-choice
survey are replicated on the post-choice questionnaire. To reduce the
likelihood that respondents will simply repeat the answers that they
provided on the pre-choice survey (in an effort to appear consistent),
it is essential to allow some time to elapse between the two surveys.
Consequently, participants will not have access to the SelectMD Web
site until one week after completing the pre-choice survey. Since
[[Page 22499]]
we expect that about 5% of participants taking the pre-choice survey
will not return to participate in the experiment one week later, the
number of respondents initially required is 5% higher (1,575) than the
full sample of 1,500 required for the experiment. We estimate based on
our previous experience with the SelectMD 1.0 experiment that
participants will require about 10 minutes to review the information on
the Web site and select their preferred physician from the set of
doctors available. The average time required to complete the post-
choice survey is estimated to be 20 minutes. Consequently, respondents
will average about 40 minutes completing all three phases of the study.
Exhibit 2 shows the respondents' cost burden for their time to
participate in this experiment. The total cost burden is estimated to
be $22,297.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Hour per
Form name Number of responses per response (min/ Total burden
respondents respondent 60) hours
----------------------------------------------------------------------------------------------------------------
Pre-Choice Survey............................... 1575 1 10/60 263
Time on Website (Choosing MD)................... 1500 1 10/60 250
Post-Choice Survey.............................. 1500 1 20/60 500
Total Hours................................. 4,575 na na 1,013
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form name respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
Pre-Choice Survey............................... 1575 263 $22.01 $5,789
Time on Website (Choosing MD)................... 1500 250 22.01 5,503
Post-Choice Survey.............................. 1500 500 22.01 11,005
Total Cost.................................. .............. .............. .............. 22,297
----------------------------------------------------------------------------------------------------------------
* Based upon the national mean hourly wage for all occupations from the ``May 2012 Occupational Employment and
Wage Estimates'', U.S. Department of Labor, Bureau of Labor Statistics.
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
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: April 9, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-09168 Filed 4-21-14; 8:45 am]
BILLING CODE 4160-90-P
