82 FR 32366 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 133 (July 13, 2017)

Page Range		32366-32368
FR Document		2017-14703

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.'' 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 28, 2017, 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.

Federal Register, Volume 82 Issue 133 (Thursday, July 13, 2017)

[Federal Register Volume 82, Number 133 (Thursday, July 13, 2017)]
[Notices]
[Pages 32366-32368]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-14703]

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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.

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

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.''
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 28, 2017, 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 August 14, 2017.

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

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
doris.lefkowitz@AHRQ.hhs.gov.

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 is extending the comment period for this 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

[[Page 32367]]

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.
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 could 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 would
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 would to 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.

[[Page 32368]]

Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Minutes per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
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..............
Review/update existing RoPR Record created 132 1 15/60 33
through ClinicalTrials.gov pathway.............
---------------------------------------------------------------
Total....................................... 246 .............. .............. 107.42
----------------------------------------------------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
[dagger] 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,
Deputy Director.
[FR Doc. 2017-14703 Filed 7-12-17; 8:45 am]
BILLING CODE 4160-90-P

32366 Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices

in this draft FPL is intended to enable Council looks forward to hearing from
the Council to most effectively meet the public on this proposal.
these fundamental commitments. The

APPENDIX A—COUNCIL COMPREHENSIVE PLAN COMMITMENTS
Topic Commitment Page No.

Development of Funded Priority Take a holistic approach to restoration ........................................................................................ 13, 14
Lists. Continue to improve Submission Guidelines ............................................................................... 17
The Council adopted the watershed/estuary-based approach as a strategic planning principle 22
for future FPL development.
Healthy and sustainable ecosystems are essential for thriving and resilient coastal commu- 23
nities.
Encourage partnerships and additional public and private financial and technical support to 23
maximize outcomes and impacts.
Identify and leverage new sources of funding to support current and future restoration work 25
by exploring creative conservation funding.
The Council will refine its processes for considering public input on draft FPLs before final- 25
izing changes to the final FPL.
Project evaluation and selection will be conducted in the most open manner feasible .............. 25
Will update and improve the process for applying BAS to FPL proposals, including exploring 27
the use of one or more science review panels.
Collaboration and Coordination Sponsor and participate in meetings and workshops in 2017 and into 2018 ............................. 17
Facilitate meaningful engagement with range of stakeholders ................................................... 17
Maximize outcomes by leveraging funds and expertise .............................................................. 17
Coordination and collaboration among members and our restoration partners is critical to the 24
success of Gulf restoration.
Coordinate regulatory efforts across Council membership .......................................................... 26
Science ..................................... Decisions made pursuant to the FPL will be based on the best available science .................... 6, 17, 27
The Council recognizes the importance of measuring outcomes and impacts in order to 27
achieve tangible results and ensure that funds are invested in a meaningful way.

Document Availability: Copies of the Budget (OMB) approve the proposed for this this proposed information
draft CPS FPL are available at the changes to the currently approved collection on the development of a
following office during regular business information collection project: registry of patient registries. Patient
hours: Gulf Coast Ecosystem Restoration ‘‘Developing a Registry of Registries.’’ registries have received significant
Council, Hale Boggs Federal Building, In accordance with the Paperwork attention and funding in recent years.
500 Poydras Street, Suite 1117, New Reduction Act, AHRQ invites the public Similar to controlled studies, patient
Orleans, LA 70130. The draft CPS FPL to comment on this proposed registries represent some burden to
can also be viewed and downloaded at information collection. This proposed patients (e.g., time to complete patient
www.restorethegulf.gov. information collection was previously reported outcome measures, risk of loss
Legal Authority: The statutory program published in the Federal Register on of privacy), who often participate
authority for the draft FPL is found at 33 April 28, 2017, and allowed 60 days for voluntarily in hopes of improving
U.S.C. 1321(t)(2). public comment. AHRQ did not receive knowledge about a disease or condition.
any substantive comments. The purpose Patient registries also represent a
Will D. Spoon, of this notice is to allow an additional substantial investment of health
Program Analyst, Gulf Coast Ecosystem 30 days for public comment.
Restoration Council. research resources. Despite these
DATES: Comments on this notice must be factors, patient registries are not
[FR Doc. 2017–14690 Filed 7–12–17; 8:45 am]
received by August 14, 2017. required to be registered in
BILLING CODE 6560–58–P
ADDRESSES: Written comments should ClinicalTrials.gov, presenting the
be submitted to: AHRQ’s OMB Desk potential for duplication of efforts and
Officer by fax at (202) 395–6974 insufficient dissemination of findings
DEPARTMENT OF HEALTH AND (attention: AHRQ’s desk officer) or by that are not published in the peer-
HUMAN SERVICES email at OIRA_submission@ reviewed literature. To fulfill the
Agency for Healthcare Research and omb.eop.gov (attention: AHRQ’s desk obligation to patients and to ensure that
Quality officer). resources are used in the most efficient
FOR FURTHER INFORMATION CONTACT: manner, registries need to be listed in a
Agency Information Collection Doris Lefkowitz, AHRQ Reports manner similar to that of trials in
Activities: Proposed Collection; Clearance Officer, (301) 427–1477, or by ClinicalTrials.gov.
Comment Request email at doris.lefkowitz@AHRQ.hhs.gov. By providing a centralized point of
collection for information about all
sradovich on DSK3GMQ082PROD with NOTICES

AGENCY: Agency for Healthcare Research SUPPLEMENTARY INFORMATION:
and Quality, HHS. Proposed Revision of a Currently patient registries in the United States,
ACTION: Notice. Approved Collection Project: the Registry of Patient Registries (RoPR)
‘‘Developing a Registry of Registries.’’ enhances patient registry information,
SUMMARY: This notice announces the OMB Control Number: 0935–0203. extracted from ClinicalTrials.gov,
intention of the Agency for Healthcare In accordance with the Paperwork building on AHRQ’s efforts to describe
Research and Quality (AHRQ) to request Reduction Act, 44 U.S.C. 3501–3521, the quality, appropriateness, and
that the Office of Management and AHRQ is extending the comment period effectiveness of health services (and

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32368 Federal Register / Vol. 82, No. 133 / Thursday, July 13, 2017 / Notices

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
Number of Minutes per Total burden
Form name responses per
respondents response hours
respondent

New RoPR Record entered manually through self-registration process ........ 16 1 55/60 14.67
New RoPR Record entered through ClinicalTrials.gov pathway ..................... 65 1 45/60 48.75
Review/update existing RoPR Record created through self-registration proc-
ess ................................................................................................................ 33 1 20/60 11
Review/update existing RoPR Record created through ClinicalTrials.gov
pathway ........................................................................................................ 132 1 15/60 33

Total .......................................................................................................... 246 ........................ ........................ 107.42

Exhibit 2 shows the estimated cost time to participate in the RoPR. The estimated at an average of $4,017.51
burden associated with the respondent’s total cost burden to respondents is annually.

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Number of Total burden Total cost
Form name hourly wage
respondents hours burden
rate †

New RoPR Record entered manually through self-registration process ........ 16 14.67 $37.40 $548.66
New RoPR Record entered through ClinicalTrials.gov pathway ..................... 65 48.75 37.40 1,823.25
Review/update existing RoPR Record created through self-registration proc-
ess ................................................................................................................ 33 11 37.40 411.40
Review/update existing RoPR Record created through ClinicalTrials.gov
pathway ........................................................................................................ 132 33 37.40 1,234.20

Total .......................................................................................................... 246 107.42 37.40 4,017.51
† 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 comments will become a matter of published and unpublished pertinent
public record. scientific information will improve the
In accordance with the Paperwork quality of this review.
Reduction Act, comments on AHRQ’s Sharon B. Arnold,
DATES: Submission Deadline on or
information collection are requested Deputy Director.
before August 14, 2017.
with regard to any of the following: (a) [FR Doc. 2017–14703 Filed 7–12–17; 8:45 am]
ADDRESSES:
Whether the proposed collection of BILLING CODE 4160–90–P
Email submissions: SEADS@epc-
information is necessary for the proper src.org.
performance of AHRQ health care Print submissions:
DEPARTMENT OF HEALTH AND
research and health care information Mailing Address: Portland VA
HUMAN SERVICES
dissemination functions, including Research Foundation, Scientific
whether the information will have Agency for Healthcare Research and Resource Center, ATTN: Scientific
practical utility; (b) the accuracy of Quality Information Packet Coordinator, P.O.
AHRQ’s estimate of burden (including Box 69539, Portland, OR 97239.
hours and costs) of the proposed Supplemental Evidence and Data Shipping Address (FedEx, UPS, etc.):
collection(s) of information; (c) ways to Request on Stroke Prevention in Atrial Portland VA Research Foundation,
enhance the quality, utility, and clarity Fibrillation Patients: A Systematic Scientific Resource Center, ATTN:
of the information to be collected; and Review Update Scientific Information Packet
(d) ways to minimize the burden of the Coordinator, 3710 SW U.S. Veterans
AGENCY: Agency for Healthcare Research Hospital Road, Mail Code: R&D 71,
collection of information upon the and Quality (AHRQ), HHS. Portland, OR 97239.
respondents, including the use of ACTION: Request for supplemental
automated collection techniques or FOR FURTHER INFORMATION CONTACT:
evidence and data submissions. Ryan McKenna, Telephone: 503–220–
other forms of information technology.
SUMMARY: The Agency for Healthcare 8262 ext. 51723 or Email: SEADS@epc-
Comments submitted in response to Research and Quality (AHRQ) is seeking src.org.
this notice will be summarized and scientific information submissions from SUPPLEMENTARY INFORMATION: The
sradovich on DSK3GMQ082PROD with NOTICES

included in the Agency’s subsequent the public. Scientific information is Agency for Healthcare Research and
request for OMB approval of the being solicited to inform our review of Quality has commissioned the
proposed information collection. All Stroke Prevention in Atrial Fibrillation Evidence-based Practice Centers (EPC)
Patients: A Systematic Review Update, Program to complete a review of the
which is currently being conducted by evidence for Stroke Prevention in Atrial
the AHRQ’s Evidence-based Practice Fibrillation Patients: A Systematic
Centers (EPC) Program. Access to Review Update. AHRQ is conducting

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Document Created: 2017-07-13 01:00:44
Document Modified: 2017-07-13 01:00:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on this notice must be received by August 14, 2017.
Contact		Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation		82 FR 32366

82 FR 32366 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 82, Issue 133 (July 13, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality