[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12254-12256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06192]


-----------------------------------------------------------------------

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.''

DATES: Comments on this notice must be received by May 31, 2019.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    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

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection. 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:
    [cir] Use research methods to gather knowledge on the effectiveness 
or comparative effectiveness of treatments, screening, diagnostic, 
management or health care delivery strategies for specific medical 
conditions, both published and unpublished, to evaluate the quality of 
research studies and the evidence from these studies.

[[Page 12255]]

    [cir] Promote the use of evidence in health care decision making to 
improve health care and health
    [cir] 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 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 health 
care 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 SEADS
                                                    Number of SEADS    request that      Number of      Annual number      Hours per       Total burden
                     Form name                          requests         receive       responses per       of SEADS         response     hours per annum
                                                                         response      SEADS request      responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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      $61.39 \a\         $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

[[Page 12256]]

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.

Gopal Khanna,
Director.
[FR Doc. 2019-06192 Filed 3-29-19; 8:45 am]
 BILLING CODE 4160-90-P