Agency Information Collection Activities: Proposed Collection; Comment Request, 26684-26685 [2019-11949]
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Federal Register / Vol. 84, No. 110 / Friday, June 7, 2019 / Notices
functions of the agency, including
whether the information will have
practical utility.
(ii) Enhance the accuracy of the
agency’s estimates of the burden of the
proposed collection of information.
(iii) Enhance the quality, utility, and
clarity of the information to be
collected.
(iv) Minimize the burden of the
collections of information on those who
are to respond, including the use of
appropriate automated, electronic
collection technologies or other forms of
information technology.
III. The Official Record
The official record is the paper
electronic record maintained at the
address at the beginning of this
document. FMCS will transfer all
electronically received comments into
printed-paper form as they are received.
Dated: June 4, 2019.
Jeannette Walters-Marquez,
Certifying Official/Deputy General Counsel.
[FR Doc. 2019–12035 Filed 6–6–19; 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.
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 ‘‘Online
Submission Form for Supplemental
Evidence and Data for Systematic
Reviews for the Evidence-based Practice
Center Program.’’ In accordance with
the Paperwork Reduction Act, AHRQ
invites the public to comment on this
proposed information collection.
This proposed information collection
was previously published in the Federal
Register on April 1, 2019 and allowed
60 days for public comment. AHRQ
received no substantive comments. 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, 2019.
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). 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:
SUMMARY:
Proposed Project
Online Submission Form for
Supplemental Evidence and Data for
Systematic Reviews for the EvidenceBased Practice Center Program
The AHRQ Evidence-based Practice
Center (EPC) Program develops
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
evidence reports and technology
assessments that summarize evidence
for federal and other partners on topics
relevant to clinical and other health care
organization and delivery issues—
specifically those that are common,
expensive, and/or significant for the
Medicare and Medicaid populations.
Better understanding and use of
evidence in practice, policy, and
delivery of care improves the quality of
health care.
These reports, reviews, and
technology assessments are based on
rigorous, comprehensive syntheses and
analyses of the scientific literature on
topics. EPC reports and assessments
emphasize explicit and detailed
documentation of methods, rationale,
and assumptions. EPC reports are
conducted in accordance with an
established policy on financial and
nonfinancial interests.
This research has the following goals:
• Use research methods to gather
knowledge on the effectiveness or
comparative effectiveness of treatments,
screening, diagnostic, management or
healthcare delivery strategies for
specific medical conditions, both
published and unpublished, to evaluate
the quality of research studies and the
evidence from these studies.
• Promote the use of evidence in
healthcare decision making to improve
healthcare and health.
• Identify research gaps to inform
future research investments.
The 2011 Institute of Medicine report
‘‘Finding What Works in Health Care:
Standards for Systematic Review’’
includes an assessment of publication
bias through the identification of
unpublished studies. This is an
important source for bias which could
affect the nature and direction of
research findings. Identifying and
including the results of these additional
unpublished studies may provide a
more complete and accurate assessment
of an intervention’s effect on outcomes.
An important way to identify
unpublished studies is through requests
to medical device manufacturers,
pharmaceutical companies, and other
intervention developers. The proposed
project involves sending a notification
via an email listserv and via Federal
Register notice as needed of the
opportunity to submit information on
unpublished studies or other scientific
information to the EPC Program website,
with one request per systematic review
topic. Because research on each topic
must be completed in a timely manner
in order for it to be useful, the
collections are never ongoing—there is
one request and collection per topic.
Investigators in the EPC Program will
E:\FR\FM\07JNN1.SGM
07JNN1
26685
Federal Register / Vol. 84, No. 110 / Friday, June 7, 2019 / Notices
review the information and assess
potential risk of bias from both
published and unpublished studies and
its impact on the EPC Program’s
findings. This study is being conducted
by AHRQ, 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 healthcare
services. 42 U.S.C. 299a(a)(1).
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
• Online Submission Form
Instrument. This information is
collected for the purposes of providing
supplemental evidence and data for
systematic reviews (SEADS). The
purpose of SEADS requests is not to
collect generalizable data, but to
supplement the published and grey
literature searches EPC investigators are
conducting. The online submission form
(OSF) collects data from respondents on
their name and the information packet.
This happens following notification of
opportunity to submit via email listserv
and/or Federal Register notice as
needed, with one request per topic. For
the purposes of meta-analyses, trial
summary data from missing and
unidentified studies are sought. For the
purposes of constructing evidence tables
and quality ratings (e.g., on public
reporting of cost measures or health
information exchange), data can vary
(e.g., URLs, study designs, and
consumer-mediated exchange forms).
Submitters are informed of the types of
information that would be most helpful
to include in the information packet,
which includes a list of all sponsored
but unpublished studies (both
completed and ongoing), as well as
comment on the completeness of
information provided.
The EPC Program currently uses a
broad-based email announcement via
email listserv and a Federal Register
notice, as needed, to publicize the
opportunity to submit scientific
information about each topic. The
proposed project does not duplicate
other available sources of this
information. Available study registries
and databases may not sufficiently
inform the Program’s research. The EPC
Program does not anticipate more than
15 topics per year with SEADS requests.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the
reporting burden hours for the data
collection efforts. Time estimates are
based on pilot testing of materials and
what can reasonably be requested of
respondents. The number of
respondents listed in ‘‘Number of
respondents per SEADS request’’ of
Exhibit 1 reflects a projected 33%
response rate with approximately 1–2
responses per request and assumes
about 15 SEADS requests per year.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Number of
SEADS
requests
Number of
SEADS
request that
receive
response
Number of
responses
per SEADS
request
Annual
number
of SEADS
responses
Hours per
response
Total
burden hours
per annum
Online Submission Form (OSF) ..............
15
5
1.5
7.5
15/60
1.87
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Form name
Number of
SEADS
requests
Total
burden hours
per SEADS
Average
hourly
wage rate *
Total
cost burden
OSF ..................................................................................................................
15
1.87
a $61.39
$115.10
* Occupational Employment Statistics, May 2017 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm#11-0000.
a Based on the mean wages for Public Relations and Fundraising Managers, 11–2031, the occupational group most likely tasked with completing the OSF.
jbell on DSK3GLQ082PROD 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’s 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
VerDate Sep<11>2014
18:13 Jun 06, 2019
Jkt 247001
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.
Nonalcoholic Steatohepatitis With
Compensated Cirrhosis: Developing
Drugs for Treatment; Draft Guidance
for Industry; Availability
Food and Drug Administration,
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Nonalcoholic Steatohepatitis with
SUMMARY:
BILLING CODE 4160–90–P
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[Docket No. FDA–2019–D–1516]
HHS.
[FR Doc. 2019–11949 Filed 6–6–19; 8:45 am]
Frm 00045
Food and Drug Administration
AGENCY:
Virginia L. Mackay-Smith,
Associate Director.
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
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]]>Agencies
[Federal Register Volume 84, Number 110 (Friday, June 7, 2019)]
[Notices]
[Pages 26684-26685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11949]
=======================================================================
-----------------------------------------------------------------------
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 ``Online Submission Form for Supplemental Evidence and Data for
Systematic Reviews for the Evidence-based Practice Center Program.'' In
accordance with the Paperwork Reduction Act, AHRQ invites the public to
comment on this proposed information collection.
This proposed information collection was previously published in
the Federal Register on April 1, 2019 and allowed 60 days for public
comment. AHRQ received no substantive comments. 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, 2019.
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: 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.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Online Submission Form for Supplemental Evidence and Data for
Systematic Reviews for the Evidence-Based Practice Center Program
The AHRQ Evidence-based Practice Center (EPC) Program develops
evidence reports and technology assessments that summarize evidence for
federal and other partners on topics relevant to clinical and other
health care organization and delivery issues--specifically those that
are common, expensive, and/or significant for the Medicare and Medicaid
populations. Better understanding and use of evidence in practice,
policy, and delivery of care improves the quality of health care.
These reports, reviews, and technology assessments are based on
rigorous, comprehensive syntheses and analyses of the scientific
literature on topics. EPC reports and assessments emphasize explicit
and detailed documentation of methods, rationale, and assumptions. EPC
reports are conducted in accordance with an established policy on
financial and nonfinancial interests.
This research has the following goals:
Use research methods to gather knowledge on the
effectiveness or comparative effectiveness of treatments, screening,
diagnostic, management or healthcare delivery strategies for specific
medical conditions, both published and unpublished, to evaluate the
quality of research studies and the evidence from these studies.
Promote the use of evidence in healthcare decision making
to improve healthcare and health.
Identify research gaps to inform future research
investments.
The 2011 Institute of Medicine report ``Finding What Works in
Health Care: Standards for Systematic Review'' includes an assessment
of publication bias through the identification of unpublished studies.
This is an important source for bias which could affect the nature and
direction of research findings. Identifying and including the results
of these additional unpublished studies may provide a more complete and
accurate assessment of an intervention's effect on outcomes. An
important way to identify unpublished studies is through requests to
medical device manufacturers, pharmaceutical companies, and other
intervention developers. The proposed project involves sending a
notification via an email listserv and via Federal Register notice as
needed of the opportunity to submit information on unpublished studies
or other scientific information to the EPC Program website, with one
request per systematic review topic. Because research on each topic
must be completed in a timely manner in order for it to be useful, the
collections are never ongoing--there is one request and collection per
topic. Investigators in the EPC Program will
[[Page 26685]]
review the information and assess potential risk of bias from both
published and unpublished studies and its impact on the EPC Program's
findings. This study is being conducted by AHRQ, 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 healthcare services. 42 U.S.C. 299a(a)(1).
Method of Collection
To achieve the goals of this project the following data collections
will be implemented:
Online Submission Form Instrument. This information is
collected for the purposes of providing supplemental evidence and data
for systematic reviews (SEADS). The purpose of SEADS requests is not to
collect generalizable data, but to supplement the published and grey
literature searches EPC investigators are conducting. The online
submission form (OSF) collects data from respondents on their name and
the information packet. This happens following notification of
opportunity to submit via email listserv and/or Federal Register notice
as needed, with one request per topic. For the purposes of meta-
analyses, trial summary data from missing and unidentified studies are
sought. For the purposes of constructing evidence tables and quality
ratings (e.g., on public reporting of cost measures or health
information exchange), data can vary (e.g., URLs, study designs, and
consumer-mediated exchange forms). Submitters are informed of the types
of information that would be most helpful to include in the information
packet, which includes a list of all sponsored but unpublished studies
(both completed and ongoing), as well as comment on the completeness of
information provided.
The EPC Program currently uses a broad-based email announcement via
email listserv and a Federal Register notice, as needed, to publicize
the opportunity to submit scientific information about each topic. The
proposed project does not duplicate other available sources of this
information. Available study registries and databases may not
sufficiently inform the Program's research. The EPC Program does not
anticipate more than 15 topics per year with SEADS requests.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the reporting burden hours for the
data collection efforts. Time estimates are based on pilot testing of
materials and what can reasonably be requested of respondents. The
number of respondents listed in ``Number of respondents per SEADS
request'' of Exhibit 1 reflects a projected 33% response rate with
approximately 1-2 responses per request and assumes about 15 SEADS
requests per year.
Exhibit 1--Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of SEADS request Number of Annual number Hours per Total burden
Form name SEADS requests that receive responses per of SEADS response hours per
response SEADS request responses annum
--------------------------------------------------------------------------------------------------------------------------------------------------------
Online Submission Form (OSF)...................... 15 5 1.5 7.5 15/60 1.87
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Total burden
Form name Number of hours per Average hourly Total cost
SEADS requests SEADS wage rate * burden
----------------------------------------------------------------------------------------------------------------
OSF......................................... 15 1.87 \a\ $61.39 $115.10
----------------------------------------------------------------------------------------------------------------
* Occupational Employment Statistics, May 2017 National Occupational Employment and Wage Estimates United
States, U.S. Department of Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm#11-0000 0000.
\a\ Based on the mean wages for Public Relations and Fundraising Managers, 11-2031, the occupational group most
likely tasked with completing the OSF.
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's 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.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-11949 Filed 6-6-19; 8:45 am]
BILLING CODE 4160-90-P
