[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]
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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: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
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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
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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
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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
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Online Submission Form (OSF)...................... 15 5 1.5 7.5 15/60 1.87
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Exhibit 2--Estimated Annualized Cost Burden
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Total burden
Form name Number of hours per Average hourly Total cost
SEADS requests SEADS wage rate * burden
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OSF......................................... 15 1.87 \a\ $61.39 $115.10
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* 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]
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