[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19723-19725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08650]


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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 changes to the 
currently approved information collection project: ``Developing a 
Registry of Registries.''

DATES: Comments on this notice must be received by June 27, 2017.

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 Revision of a Currently Approved Collection Project: 
``Developing a Registry of Registries.'' OMB Control Number 0935-0203

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection on the development of a registry of patient registries. 
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 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 to patients and to ensure that 
resources are used in the most efficient manner, registries need to be 
listed in a manner similar to that of trials in ClinicalTrials.gov.
    By providing a centralized point of collection for information 
about all patient registries in the United States, the Registry of 
Patient Registries (RoPR) enhances patient registry information, 
extracted from ClinicalTrials.gov, building on AHRQ's efforts to 
describe the quality, appropriateness, and effectiveness of health 
services (and patient registries in particular) in a more readily 
available, central location.
    The RoPR database system aims to achieve the following objectives:
    (1) Provide a searchable database of patient registries in the 
United States (to promote collaboration, reduce redundancy, and improve 
transparency);
    (2) Facilitate the use of common data fields and definitions in 
similar health conditions (to improve opportunities for sharing, 
comparing, and linkage);
    (3) Provide a public repository of searchable summary results 
(including results from registries that have not yet been published in 
the peer-reviewed literature);
    (4) Offer a search tool to locate existing data that researchers 
can request for use in new studies; and
    (5) Serve as a recruitment tool for researchers and patients 
interested in participating in patient registries.

[[Page 19724]]

    To achieve the objectives of this project, the following data 
collections will be implemented:
    (1) Collect information on registries from users who populate the 
RoPR database system.
    AHRQ is proposing to add a self-registration option to the RoPR 
database so that registry owners do not need a National Library of 
Medicine Protocol Registration System (PRS) account to contribute. The 
current OMB-approved RoPR system requires users to have a PRS account. 
In the current data entry process, registry owners enter most of the 
registry information using the ClinicalTrials.gov PRS. If a user 
defines the ClinicalTrials.gov record as a patient registry, that user 
will have the option of following a link to the RoPR submission page to 
input additional information about the registry. Patient registry data 
entered in the PRS is uploaded to the RoPR system daily and is 
accessible (along with information entered directly into RoPR) to the 
public via the RoPR search function.
    Under the AHRQ proposal, these users can complete a simple 
registration on the RoPR site, which would be less burdensome than the 
PRS registration process, and then enter all registry information 
directly on RoPR. The rationale behind this alternative registration 
pathway is that many registries are created for quality reporting, 
outcome tracking, and quality improvement purposes, rather than for 
research purposes. Registering in ClinicalTrials.gov implies a research 
purpose, so it is not necessarily appropriate for non-research 
registries to register in ClinicalTrials.gov, and many have expressed 
that they do not wish to do so. AHRQ anticipates that more than 75 
percent of registries will still register through the 
ClinicalTrials.com. However, the remaining registries are extremely 
important for health policy, and providing them with a registration 
pathway furthers the goal of creating a central place where 
stakeholders can find information on research and non-research 
registries pertinent to a specific clinical topic.
    The new self-registration pathway is being developed by AHRQ 
through its contractor, L&M Policy Research and subcontractor Truven 
Health Analytics, an IBM Company, 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 and with respect to database development. 42 U.S.C. 
299a(a)(1) and (8).
    AHRQ, in collaboration with the Centers for Medicare & Medicaid 
Services (CMS), is also proposing to add three fields to the self-
registration pathway related to the CMS initiative to create a 
Centralized Repository for Public Health Agencies and Clinical Data 
Registry Reporting. The purpose of the repository is to assist eligible 
professionals, eligible hospitals, and critical access hospitals in 
finding entities that accept electronic public health data. By adding 
these fields to the existing RoPR database, AHRQ will further the goal 
of creating a central place where stakeholders can find all pertinent 
information on registries.

Method of Collection

    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

    Exhibit 1 shows the estimated annualized burden hours for the 
respondent's time to participate in the RoPR. In 2016, 65 respondents 
manually entered a new RoPR record. It is expected that more than 75% 
of patient registries are research-focused and will continue to use the 
original ClinicalTrials.gov pathway described above. Thus, it is 
estimated that once the self-registration pathway is available, 
approximately 65 respondents will enter RoPR records through the 
ClinicalTrials.gov link annually, and an additional 16 respondents 
(roughly 25% of 65), representing non-research registries, will enter 
RoPR records through the new self-registration pathway.
    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. In 2016, 132 
RoPR entries were updated and released. Using the same logic as above, 
it is estimated that an additional 33 entries (25% of 132) might be 
updated annually once the self-registration pathway is available.
    In January 2017, Truven Health Analytics used a sample of existing 
ClinicalTrials.gov registry entries to estimate the time needed to 
enter all additional fields added through the self-registration 
process. The sample included records representing a range of depth and 
complexity. For example, one registry record contained only one primary 
outcome measure. Another record contained three more detailed outcome 
measures (one primary, one secondary, and one other.)
    As a result of the knowledge gained during these processes, it is 
estimated that it will take users 10 minutes, on average, to manually 
enter the additional fields added through the self-registration 
process. Adding this time to the estimated burden of completing the 
original RoPR fields (45 minutes), it is estimated that it will take 
users 55 minutes to complete all fields through the self-registration 
pathway.
    It is estimated that it will take users 5 minutes to review and 
update the fields added through the self-registration pathway. Adding 
this time to the estimated burden of reviewing and updating the 
original RoPR fields (15 minutes), it is estimated that it will take 20 
minutes for a person to review and make updates to an existing RoPR 
record created through the self-registration pathway.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per    Minutes per    Total burden
                                                    respondents     respondent       response          hours
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New RoPR Record entered manually through self-                16               1           55/60           14.67
 registration process...........................
New RoPR Record entered through                               65               1           45/60           48.75
 ClinicalTrials.gov pathway.....................
Review/update existing RoPR Record created                    33               1           20/60              11
 through self-registration process..............

[[Page 19725]]

 
Review/update existing RoPR Record created                   132               1           15/60              33
 through ClinicalTrials.gov pathway.............
                                                 ---------------------------------------------------------------
    Total.......................................             246  ..............  ..............          107.42
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    Exhibit 2 shows the estimated cost burden associated with the 
respondent's time to participate in the RoPR. The total cost burden to 
respondents is estimated at an average of $4,017.51 annually.

                                   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] ($)     burden ($)
----------------------------------------------------------------------------------------------------------------
New RoPR Record entered manually through self-                16           14.67          $37.40         $548.66
 registration process...........................
New RoPR Record entered through                               65           48.75           37.40        1,823.25
 ClinicalTrials.gov pathway.....................
Review/update existing RoPR Record created                    33              11           37.40          411.40
 through self-registration process..............
Review/update existing RoPR Record created                   132              33           37.40        1,234.20
 through ClinicalTrials.gov pathway.............
                                                 ---------------------------------------------------------------
    Total.......................................             246          107.42           37.40        4,017.51
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* Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29-0000. National Compensation
  Survey: Occupational wages in the United States May 2015, ``U.S. Department of Labor, Bureau of Labor
  Statistics.'' Available at: https://www.bls.gov/oes/current/oes290000.htm.

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 B. Arnold,
Acting Director.
[FR Doc. 2017-08650 Filed 4-27-17; 8:45 am]
 BILLING CODE 4160-90-P