82 FR 19723 - 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 81 (April 28, 2017)
Agency for Healthcare Research and Quality
Federal Register Volume 82, Issue 81 (April 28, 2017)
| Page Range | 19723-19725 | |
| FR Document | 2017-08650 |
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)] [Notices] [Pages 19723-19725] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-08650] ======================================================================= ----------------------------------------------------------------------- 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.'' 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 ---------------------------------------------------------------------------------------------------------------- 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.............. [[Page 19725]] 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 ---------------------------------------------------------------------------------------------------------------- * 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
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information collection requirement C. Public Comment Proposed Revision of a Currently
concerning Standard Form 94, Public comments are particularly Approved Collection Project:
Statement of Witness. invited on: Whether this collection of ‘‘Developing a Registry of Registries.’’
DATES: Submit comments on or before information is necessary and whether it OMB Control Number 0935–0203
June 27, 2017. will have practical utility; whether our In accordance with the Paperwork
FOR FURTHER INFORMATION CONTACT: Ray estimate of the public burden of this Reduction Act, 44 U.S.C. 3501–3521,
Wynter, Federal Vehicle Policy collection of information is accurate, AHRQ invites the public to comment on
Division, 202–501–3802, or via email at and based on valid assumptions and this proposed information collection on
ray.wynter@gsa.gov. methodology; ways to enhance the the development of a registry of patient
quality, utility, and clarity of the registries. Patient registries have
ADDRESSES: Submit comments
information to be collected. received significant attention and
identified by Information Collection Obtaining Copies of Proposals: funding in recent years. Similar to
3090–0118, Statement of Witness, SF Requesters may obtain a copy of the controlled studies, patient registries
94, by any of the following methods: information collection documents from represent some burden to patients (e.g.,
Regulations.gov: http:// the General Services Administration, time to complete patient reported
www.regulations.gov. Regulatory Secretariat Division (MVCB), outcome measures, risk of loss of
Submit comments via the Federal 1800 F Street NW., Washington, DC privacy), who often participate
eRulemaking portal by searching the 20405, telephone 202–501–4755. Please voluntarily in hopes of improving
OMB control number. Select the link cite OMB Control No. 3090–0118, knowledge about a disease or condition.
‘‘Submit a Comment’’ that corresponds Statement of Witness, SF 94, in all Patient registries also represent a
with ‘‘Information Collection 3090– correspondence. substantial investment of health
0118, Statement of Witness, SF 94.’’ research resources. Despite these
Dated: April 18, 2017.
Follow the instructions provided at the factors, patient registries are not
‘‘Submit a Comment’’ screen. Please Steve Grewal,
Deputy Chief Information Officer, General
required to be registered in
include your name, company name (if ClinicalTrials.gov, presenting the
any), and ‘‘Information Collection 3090– Services Administration.
[FR Doc. 2017–08603 Filed 4–27–17; 8:45 am]
potential for duplication of efforts and
0118, Statement of Witness, SF 94’’ on insufficient dissemination of findings
your attached document. BILLING CODE 6820–34–P
that are not published in the peer-
• Mail: General Services reviewed literature. To fulfill the
Administration, Regulatory Secretariat obligation to patients and to ensure that
Division (MVCB), 1800 F Street NW., DEPARTMENT OF HEALTH AND resources are used in the most efficient
Washington, DC 20405. ATTN: Ms. HUMAN SERVICES manner, registries need to be listed in a
Sosa/IC 3090–0118, Statement of manner similar to that of trials in
Witness, SF 94. Agency for Healthcare Research and ClinicalTrials.gov.
Instructions: Please submit comments Quality
By providing a centralized point of
only and cite Information Collection collection for information about all
Agency Information Collection
3090–0118, Statement of Witness, SF patient registries in the United States,
Activities: Proposed Collection;
94, in all correspondence related to this the Registry of Patient Registries (RoPR)
Comment Request
collection. Comments received generally enhances patient registry information,
will be posted without change to http:// AGENCY: Agency for Healthcare Research extracted from ClinicalTrials.gov,
www.regulations.gov, including any and Quality, HHS. building on AHRQ’s efforts to describe
personal and/or business confidential ACTION: Notice. the quality, appropriateness, and
information provided. To confirm effectiveness of health services (and
receipt of your comment(s), please SUMMARY: This notice announces the patient registries in particular) in a more
check www.regulations.gov, intention of the Agency for Healthcare readily available, central location.
approximately two to three days after Research and Quality (AHRQ) to request The RoPR database system aims to
submission to verify posting (except that the Office of Management and achieve the following objectives:
allow 30 days for posting of comments Budget (OMB) approve the proposed (1) Provide a searchable database of
submitted by mail). changes to the currently approved patient registries in the United States (to
SUPPLEMENTARY INFORMATION: information collection project: promote collaboration, reduce
‘‘Developing a Registry of Registries.’’ redundancy, and improve
A. Purpose DATES: Comments on this notice must be transparency);
GSA is requesting the Office of received by June 27, 2017. (2) Facilitate the use of common data
Management and Budget (OMB) to ADDRESSES: Written comments should fields and definitions in similar health
review and approve information be submitted to: Doris Lefkowitz, conditions (to improve opportunities for
collection, 3090–0118, Statement of Reports Clearance Officer, AHRQ, by sharing, comparing, and linkage);
Witness, SF 94. This form is used by all email at doris.lefkowitz@AHRQ.hhs.gov. (3) Provide a public repository of
Federal agencies to report accident Copies of the proposed collection searchable summary results (including
information involving U.S. Government plans, data collection instruments, and results from registries that have not yet
asabaliauskas on DSK3SPTVN1PROD with NOTICES
motor vehicles. specific details on the estimated burden been published in the peer-reviewed
B. Annual Reporting Burden can be obtained from the AHRQ Reports literature);
Clearance Officer. (4) Offer a search tool to locate
Respondents: 874. FOR FURTHER INFORMATION CONTACT: existing data that researchers can
Responses per Respondent: 1. Doris Lefkowitz, AHRQ Reports request for use in new studies; and
Total Annual Responses: 874. Clearance Officer, (301) 427–1477, or by (5) Serve as a recruitment tool for
Hours per Response: .333. email at doris.lefkowitz@AHRQ.hhs.gov. researchers and patients interested in
Total Burden Hours: 291. SUPPLEMENTARY INFORMATION: participating in patient registries.
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EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of Total
Number of Minutes per
Form name responses per burden
respondents response
respondent hours
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 $4,017.51
burden associated with the respondent’s total cost burden to respondents is annually.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Total Total cost
Number of hourly
Form name burden burden
respondents wage rate †
hours ($)
($)
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 DEPARTMENT OF HEALTH AND Clearance Officer, (301) 427–1477, or by
HUMAN SERVICES email at doris.lefkowitz@AHRQ.hhs.gov.
In accordance with the Paperwork
SUPPLEMENTARY INFORMATION:
Reduction Act, comments on AHRQ’s Agency for Healthcare Research and
information collection are requested Quality Proposed Project
with regard to any of the following: (a)
Agency Information Collection Medical Expenditure Panel Survey—
Whether the proposed collection of
Activities: Proposed Collection; Insurance Component
information is necessary for the proper
performance of AHRQ health care Comment Request In accordance with the Paperwork
research and health care information Reduction Act, 44 U.S.C. 3501–3521,
AGENCY:Agency for Healthcare Research AHRQ invites the public to comment on
dissemination functions, including
and Quality, HHS. this proposed information collection.
whether the information will have
practical utility; (b) the accuracy of ACTION: Notice. Employer-sponsored health insurance is
AHRQ’s estimate of burden (including the source of coverage for 84.4 million
hours and costs) of the proposed SUMMARY: This notice announces the current and former workers, plus many
collection(s) of information; (c) ways to intention of the Agency for Healthcare of their family members, and is a
Research and Quality (AHRQ) to request cornerstone of the U.S. health care
enhance the quality, utility, and clarity
that the Office of Management and system. The Medical Expenditure Panel
of the information to be collected; and
Budget (OMB) reapprove the proposed Survey—Insurance Component (MEPS–
(d) ways to minimize the burden of the
information collection project: ‘‘Medical IC) measures the extent, cost, and
collection of information upon the
Expenditure Panel Survey—Insurance coverage of employer-sponsored health
respondents, including the use of Component.’’ insurance on an annual basis. These
automated collection techniques or
DATES: Comments on this notice must be statistics for private industry are
other forms of information technology.
received by June 27, 2017. produced at the National, State, and
Comments submitted in response to sub-State (metropolitan area) level.
this notice will be summarized and ADDRESSES: Written comments should Statistics are also produced for State
included in the Agency’s subsequent be submitted to: Doris Lefkowitz, and Local governments.
request for OMB approval of the Reports Clearance Officer, AHRQ, by This research has the following goals:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
proposed information collection. email at doris.lefkowitz@AHRQ.hhs.gov. (1) Provide data for Federal
All comments will become a matter of Copies of the proposed collection policymakers evaluating the effects of
public record. plans, data collection instruments, and National and State health care reforms.
specific details on the estimated burden (2) Provide descriptive data on the
Sharon B. Arnold, can be obtained from the AHRQ Reports current employer-sponsored health
Acting Director. Clearance Officer. insurance system and data for modeling
[FR Doc. 2017–08650 Filed 4–27–17; 8:45 am] FOR FURTHER INFORMATION CONTACT: the differential impacts of proposed
BILLING CODE 4160–90–P Doris Lefkowitz, AHRQ Reports health policy initiatives.
VerDate Sep<11>2014 17:38 Apr 27, 2017 Jkt 241001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1](https://thefederalregister.org/doc/82_FR_19804/page/3.svg)
Document Created: 2017-04-28 03:03:06
Document Modified: 2017-04-28 03:03:06
| 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 June 27, 2017. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 82 FR 19723 |
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