[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 56992-56993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23574]


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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: ``Developing a Registry of Registries.'' In accordance with 
the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the 
public to comment on this proposed information collection.

DATES: Comments on this notice must be received by November 20, 2015.

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 Renewal of an Existing Project: ``Developing a Registry of 
Registries.'' OMB Control Number 0935-0203

    Patient registries have received significant attention and funding 
in recent years. Similar to controlled studies, patient registries 
represent some burden to patients (e.g., time to complete patient 
reported outcome measures, risk of loss of privacy), who often 
participate voluntarily in hopes of improving the public's and medical 
community's knowledge about a disease or condition. Patient registries 
also represent a substantial investment of health research resources. 
Despite these factors, patient registries are not required to be 
registered in ClinicalTrials.gov, presenting the potential for 
duplication of efforts and insufficient dissemination of findings that 
are not published in the peer-reviewed literature. To fulfill the 
obligation of advancing the quality and specificity of patient 
healthcare, and to ensure that resources are used in the most efficient 
manner, patient registries need to be listed in a manner similar to 
that of trials in ClinicalTrials.gov.
    By creating a central point of collection for information about all 
patient registries in the United States, the Registry of Patient 
Registries (RoPR) furthers AHRQ's goals by making information regarding 
quality, appropriateness, and effectiveness of health services (and 
patient registries in particular) more readily available, in a central 
location.
    This research has the following goals:
    (1) Maintaining and updating the RoPR database system to be 
compatible with ClinicalTrials.gov; meeting the following objectives:
    a. Providing a searchable database of patient registries in the 
United States (to promote collaboration, reduce redundancy, and improve 
transparency);
    b. Facilitating the use of common data fields and definitions in 
similar health conditions (to improve opportunities for sharing, 
comparing, and linkage) and free-text search field for highlighting 
information specific to an individual registry;
    c. Providing a public repository of searchable summary results 
(including results from registries that have not yet been published in 
the peer-reviewed literature);
    d. Offering a search tool to locate existing data that researchers 
can request for use in new studies; and
    e. Serving as a recruitment tool for researchers and patients 
interested in participating in patient registries.
    The RoPR is a web-based application, and does not require users to 
submit any type of paper form.
    The RoPR collects patient registry data in two ways: users are able 
to enter information into the web-based system manually, or use an 
automated upload feature.
    Information being collected in the RoPR Record is visible to the 
public and patient registries visiting the RoPR Web site, and is 
available for public use in this capacity.
    The RoPR system provides email notification to registry holders 
informing them on an annual basis of the need to update basic 
statistics and contact information. It is the responsibility of the 
registry holder to update the information.
    If a Registry Profile has not been reviewed and updated to the RoPR 
search site within four (4) years, it is archived.
    As of August 8, 2015, the RoPR has 138 patient registries listed.
    This study is being conducted by AHRQ through its contractor L&M 
Policy Research and sub-contractor to L&M, Quintiles, pursuant to 
AHRQ's statutory authority to conduct and support research and 
disseminate information 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 and with respect to database development. 42 U.S.C. 299a(a)(1) 
and (8).

[[Page 56993]]

Method of Collection

    To achieve the goals of this project, the following data collection 
will be implemented: Collect information from users who populate the 
RoPR database system, which will achieve all of the above goals.
    The purpose and the use of the RoPR is to provide a readily 
available public resource strictly for patient registries, following 
the model of ClinicalTrials.gov, allowing for the increased 
availability and efficacy of patient registries. The information being 
collected in the RoPR Record is visible to the public visiting the RoPR 
Web site, and is readily available for public use. The RoPR is an 
ongoing data collection initiative.

Estimated Annual Respondent Burden

    Between July 2014 and June 2015, 59 respondents entered their RoPR 
record manually.
    Each respondent need enter his or her new RoPR record only once. 
The RoPR system sends an automated reminder to any registry owner who 
has not updated his or her RoPR record in the past year. Approximately, 
57.25% of RoPR records were estimated to have been eligible for updates 
between July 2014 and June 2015, either on the registry owner's own 
initiative, or prompted by the automated reminder. As the RoPR 
continues to grow and more patient registry records are added over 
time, this percentage represents a growing, cumulative number.
    Prior to the deployment of the live RoPR system, Quintiles 
conducted six (6) usability sessions with RoPR stakeholders using a 
web-based prototype.
    In February 2015, Quintiles conducted a knowledge transfer webinar 
for registry contacts to learn how to enter new records into the RoPR. 
As a result of the knowledge gained during these processes, it is 
estimated that it takes users 45 minutes to manually enter a new RoPR 
record; and 15 minutes to upload a new RoPR record (an average of 30 
minutes using either method). It takes 15 minutes for a user to review 
and make updates to an existing RoPR record.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of      Minutes per    Total burden
                    Form name                        Number of     responses per     response          hours
                                                    respondents     respondent       (average)       (average)
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New RoPR Record (manually--entered or uploaded                59               1           30/60            29.5
 electronically method).........................
Review/update existing RoPR Record..............              79               1           15/60           19.75
                                                 ---------------------------------------------------------------
    Total.......................................             138  ..............  ..............           49.25
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                  Average hourly
                    Form name                        Number of     Total burden      wage rate      Total cost
                                                    respondents        hours         [dagger]         burden
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New RoPR Record (manually--entered or uploaded                59            29.5          $36.54       $1,077.93
 electronically method).........................
Review/update existing RoPR Record..............              79           19.75           36.54          721.67
                                                 ---------------------------------------------------------------
    Total.......................................             138           44.25  ..............       $1,799.60
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[dagger] * Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29-0000. National
  Compensation Survey: Occupational wages in the United States May 2014, ``U.S. Department of Labor, Bureau of
  Labor Statistics.'' Available at: http://www.bls.gov/oes/current/oes_nat.htm#b29-0000..

    In order to highlight patient registry concerns about using the 
RoPR system and turning user feedback into future system maintenance 
and upgrade initiatives (increasing the usability of the RoPR and 
lowering the burden of entering patient registry information), plans 
for a voluntary user satisfaction survey is being considered for 
development and deployment in 2Q 2016. Its full nature and design is 
still in the concept stage and so this survey is not part of the 
Estimated Annualized Respondent Hourly/Cost Burden noted in Exhibits 1 
and 2.

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.

Sharon Arnold,
Deputy Director.
[FR Doc. 2015-23574 Filed 9-18-15; 8:45 am]
 BILLING CODE 4160-90-P