[Federal Register Volume 80, Number 238 (Friday, December 11, 2015)]
[Notices]
[Pages 76990-76992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31159]


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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, 44 U.S.C. 
3501-3521, AHRQ invites the public to comment on this proposed 
information collection.
    This proposed information collection was previously published in 
the Federal Register on September 21st, 2015 and allowed 60 days for 
public comment. AHRQ did not receive any 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 January 11, 2016.

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.

[[Page 76991]]

eop.gov (attention: AHRQ's desk officer).

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

    This is a new activity of AHRQ's Evidence-based Practice Center 
Program.

Evidence-Based Practice Center Program

    AHRQ's Evidence-based Practice Center (EPC) Program develops 
evidence reports and technology assessments 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. For example recent reviews have 
focused on clinical conditions, such as ``Treatment of Nonmetastatic 
Muscle-Invasive Bladder Cancer''; health delivery topics such as 
``Management Strategies to Reduce Psychiatric Admissions''; and 
specific technologies such as ``Imaging Techniques for Treatment 
Evaluation for Metastatic Breast Cancer.'' These evidence reports 
include systematic reviews and technical briefs, and provide an 
essential foundation from which to understand what we know from 
existing research and what critical research gaps remain. 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. These scientific syntheses may include meta-
analyses and cost analyses.
    The EPC Program supports AHRQ's mission by synthesizing and 
disseminating the available research as a ``science partner'' with 
private and public organizations in their efforts to improve the 
quality, effectiveness, and appropriateness of health care. The EPC 
Program is a trusted source of rigorous, comprehensive, and unbiased 
evidence reviews for stakeholders. The resulting evidence reports and 
technology assessments are used by Federal and State agencies, private-
sector professional societies, health delivery systems, providers, 
payers, and others committed to evidence-based health care. These end 
users may use EPC Program evidence reports to inform policy decisions, 
clinical practice guidelines, and other health care decisions.
    EPC research has the following goals:
    [cir] Use research methods to gather knowledge on the effectiveness 
of certain treatments for specific medical conditions, both published 
and unpublished, to evaluate the quality of research studies and the 
evidence from these studies.
    [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 Institute of Medicine standards for quality systematic reviews 
include 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 request letter to relevant 
medical device manufacturers, pharmaceutical companies and other 
intervention developers to invite them to submit unpublished studies or 
other scientific information to the EPC Program Web site, 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. AHRQ believes the 
display of these assessments in the systematic review's evidence tables 
will improve the response and submission rates of industry stakeholders 
by informing the health care community of the impact of potential bias 
on the research conclusions, and for health care decision making.
    This activity is being conducted by AHRQ's EPC Program through its 
contractor, the Scientific Resource Center (SRC), pursuant to AHRQ's 
statutory authority to conduct and support research on health care and 
on systems for the delivery of such care and to disseminate government-
funded research relevant to comparative clinical effectiveness 
research. 42 U.S.C. 299a(a); 42 U.S.C. 299b-37(a).

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 online submission form (OSF) 
collects data from respondents on their organization name, their 
product's name, and whether they are providing all information on 
requested studies characteristic of the review in progress. This 
happens following receipt of a request letter from the SRC. These 
requests will be sent to relevant sponsors of preventive and treatment 
interventions (e.g., medical device manufacturers, pharmaceuticals, and 
other intervention and health care system developers), 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). 
Information on both completed and ongoing studies are requested.
    The EPC Program, through the SRC, currently uses a Federal Register 
notice and broad-based email announcement to stakeholders to allow the 
public to know about each topic, and the opportunity to submit 
scientific information. In 2014, the Program sent 517 notifications to 
336 industry stakeholders. Of those 517 announcements sent, 14.1% 
received a response; 56.2% of the responses (or 7.9% of all requests) 
contained submissions of information on the results of interventions. 
This experience has prompted this proposed project.
    The additional use of direct requests to relevant organizations 
would improve the Program's ability to obtain this information. 
Contacting intervention sponsors for missing and potentially 
unidentified studies could improve the impact of research efforts and 
downstream dissemination efforts and could positively impact the health 
of individuals, burdened by poor health along with their supporting 
communities. Including information about response data to these 
requests to more accurately characterize the

[[Page 76992]]

completeness of the evidence in the systematic reviews may also address 
this issue.
    The proposed project does not duplicate other available sources of 
this information. Available study registries and databases may not be 
complete to sufficiently inform the Program's research.
    The purpose of SEADS requests is not to collect generalizable data, 
but to supplement the published and grey literature searches EPC 
investigators are conducting. Furthermore, considering the evidence and 
data included in responses collected from industry stakeholders, an 
assessment pertaining to the completeness of the evidence-base will be 
produced. This, AHRQ believes, will increase the value of AHRQ's 
research reviews to end users and potentially provide stakeholders a 
better understanding of how their submissions are used.

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 80% response rate.
    Online Submission Form: A form for submitting scientific evidence 
and data related to medical interventions sponsored by organizations 
and individuals such as pharmaceutical companies and independent 
researchers. The form has three required fields: The organization's 
name, the intervention in question, and whether the information they 
provide is all the information they know to exist. They may upload 
documents and they are also provided a data entry form if they wish to 
offer greater details on their studies.
    An Optional Data Entry Form is available as an alternative to the 
Online Submission form. The time requirements for response would be 
same as the Online Submission Form.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                     Number of
                                                    respondents      Number of       Hours per     Total burden
                    Form name                        per SEADS     responses per     response        hours per
                                                      request       respondent                         SEADS
----------------------------------------------------------------------------------------------------------------
Online Submission Form (OSF)....................              70               1           15/60            17.5
                                                 ---------------------------------------------------------------
    Total.......................................              70               1           15/60            17.5
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                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden       Average
                    Form name                          SEADS         hours per      hourly wage     Total cost
                                                     requests          SEADS          rate *          burden
----------------------------------------------------------------------------------------------------------------
OSF.............................................              70            17.5      \a\ $55.48         $970.90
                                                 ---------------------------------------------------------------
    Total.......................................              70            17.5           55.48          970.90
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* Occupational Employment Statistics, May 2014 National Occupational Employment and Wage Estimates United
  States, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#b29-0000 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 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.

Sharon Arnold,
Deputy Director.
[FR Doc. 2015-31159 Filed 12-10-15; 8:45 am]
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