80 FR 56992 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 80, Issue 182 (September 21, 2015)
Agency for Healthcare Research and Quality
Federal Register Volume 80, Issue 182 (September 21, 2015)
| Page Range | 56992-56993 | |
| FR Document | 2015-23574 |
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)] [Notices] [Pages 56992-56993] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23574] ----------------------------------------------------------------------- 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 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 ---------------------------------------------------------------------------------------------------------------- Number of Minutes per Total burden Form name Number of responses per response hours respondents respondent (average) (average) ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- 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 (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 ---------------------------------------------------------------------------------------------------------------- [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
![56992 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
5. Healthcare Information Technology SUMMARY: This notice announces the This research has the following goals:
Research (HITR) intention of the Agency for Healthcare (1) Maintaining and updating the
Date: October 22–23, 2015 (Open from Research and Quality (AHRQ) to request RoPR database system to be compatible
8:30 a.m. to 9:00 a.m. on October that the Office of Management and with ClinicalTrials.gov; meeting the
22nd and closed for remainder of Budget (OMB) approve the proposed following objectives:
the meeting) information collection project: a. Providing a searchable database of
ADDRESSES: Gaithersburg Marriott ‘‘Developing a Registry of Registries.’’ In patient registries in the United States (to
Washingtonian Center, 9751 accordance with the Paperwork promote collaboration, reduce
Washingtonian Blvd., Gaithersburg, MD Reduction Act, 44 U.S.C. 3501–3521, redundancy, and improve
20878. AHRQ invites the public to comment on transparency);
FOR FURTHER INFORMATION CONTACT: (To
this proposed information collection. b. Facilitating the use of common data
obtain a roster of members, agenda or DATES: Comments on this notice must be fields and definitions in similar health
minutes of the non-confidential portions received by November 20, 2015. conditions (to improve opportunities for
of the meetings.) ADDRESSES: Written comments should sharing, comparing, and linkage) and
be submitted to: Doris Lefkowitz, free-text search field for highlighting
Mrs. Bonnie Campbell, Committee
Reports Clearance Officer, AHRQ, by information specific to an individual
Management Officer, Office of
email at doris.lefkowitz@AHRQ.hhs.gov. registry;
Extramural Research Education and
Priority Populations, AHRQ, 540 Copies of the proposed collection c. Providing a public repository of
Gaither Road, Suite 2000, Rockville, plans, data collection instruments, and searchable summary results (including
Maryland 20850, Telephone (301) specific details on the estimated burden results from registries that have not yet
427–1554. can be obtained from the AHRQ Reports been published in the peer-reviewed
Clearance Officer. literature);
SUPPLEMENTARY INFORMATION: In d. Offering a search tool to locate
FOR FURTHER INFORMATION CONTACT:
accordance with section 10 (a)(2) of the existing data that researchers can
Doris Lefkowitz, AHRQ Reports
Federal Advisory Committee Act (5 request for use in new studies; and
Clearance Officer, (301) 427–1477, or by
U.S.C. App. 2), AHRQ announces e. Serving as a recruitment tool for
email at doris.lefkowitz@AHRQ.hhs.gov.
meetings of the scientific peer review researchers and patients interested in
SUPPLEMENTARY INFORMATION:
groups listed above, which are participating in patient registries.
subcommittees of AHRQ’s Health Proposed Renewal of an Existing The RoPR is a web-based application,
Services Research Initial Review Group Project: ‘‘Developing a Registry of and does not require users to submit any
Committees. Each subcommittee Registries.’’ OMB Control Number type of paper form.
meeting will commence in open session 0935–0203 The RoPR collects patient registry
before closing to the public for the Patient registries have received data in two ways: users are able to enter
duration of the meeting. The significant attention and funding in information into the web-based system
subcommittee meetings will be closed to recent years. Similar to controlled manually, or use an automated upload
the public in accordance with the studies, patient registries represent feature.
provisions set forth in 5 U.S.C. App. 2 some burden to patients (e.g., time to Information being collected in the
section 10(d), 5 U.S.C. 552b(c)(4), and 5 complete patient reported outcome RoPR Record is visible to the public and
U.S.C. 552b(c)(6). The grant applications measures, risk of loss of privacy), who patient registries visiting the RoPR Web
and the discussions could disclose often participate voluntarily in hopes of site, and is available for public use in
confidential trade secrets or commercial improving the public’s and medical this capacity.
property such as patentable material, community’s knowledge about a disease The RoPR system provides email
and personal information concerning or condition. Patient registries also notification to registry holders
individuals associated with the grant represent a substantial investment of informing them on an annual basis of
applications, the disclosure of which health research resources. Despite these the need to update basic statistics and
would constitute a clearly unwarranted factors, patient registries are not contact information. It is the
invasion of personal privacy. required to be registered in responsibility of the registry holder to
Agenda items for these meetings are update the information.
ClinicalTrials.gov, presenting the
subject to change as priorities dictate. If a Registry Profile has not been
potential for duplication of efforts and
Sharon B. Arnold, insufficient dissemination of findings reviewed and updated to the RoPR
Deputy Director. that are not published in the peer- search site within four (4) years, it is
[FR Doc. 2015–23575 Filed 9–18–15; 8:45 am] reviewed literature. To fulfill the archived.
BILLING CODE 4160–90–P
obligation of advancing the quality and As of August 8, 2015, the RoPR has
specificity of patient healthcare, and to 138 patient registries listed.
ensure that resources are used in the This study is being conducted by
DEPARTMENT OF HEALTH AND most efficient manner, patient registries AHRQ through its contractor L&M
HUMAN SERVICES need to be listed in a manner similar to Policy Research and sub-contractor to
that of trials in ClinicalTrials.gov. L&M, Quintiles, pursuant to AHRQ’s
Agency for Healthcare Research and By creating a central point of statutory authority to conduct and
Quality collection for information about all support research and disseminate
patient registries in the United States, information on health care and on
rmajette on DSK7SPTVN1PROD with NOTICES
Agency Information Collection the Registry of Patient Registries (RoPR) systems for the delivery of such care,
Activities: Proposed Collection; furthers AHRQ’s goals by making including activities with respect to the
Comment Request information regarding quality, quality, effectiveness, efficiency,
AGENCY: Agency for Healthcare Research appropriateness, and effectiveness of appropriateness and value of health care
and Quality, HHS. health services (and patient registries in services and with respect to database
particular) more readily available, in a development. 42 U.S.C. 299a(a)(1) and
ACTION: Notice.
central location. (8).
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![Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices 56993
Method of Collection Estimated Annual Respondent Burden Prior to the deployment of the live
To achieve the goals of this project, Between July 2014 and June 2015, 59 RoPR system, Quintiles conducted six
the following data collection will be respondents entered their RoPR record (6) usability sessions with RoPR
implemented: Collect information from manually. stakeholders using a web-based
users who populate the RoPR database Each respondent need enter his or her prototype.
system, which will achieve all of the new RoPR record only once. The RoPR In February 2015, Quintiles
above goals. system sends an automated reminder to conducted a knowledge transfer webinar
The purpose and the use of the RoPR any registry owner who has not updated for registry contacts to learn how to
is to provide a readily available public his or her RoPR record in the past year. enter new records into the RoPR. As a
resource strictly for patient registries, Approximately, 57.25% of RoPR records
result of the knowledge gained during
following the model of were estimated to have been eligible for
these processes, it is estimated that it
ClinicalTrials.gov, allowing for the updates between July 2014 and June
increased availability and efficacy of 2015, either on the registry owner’s own takes users 45 minutes to manually
patient registries. The information being initiative, or prompted by the automated enter a new RoPR record; and 15
collected in the RoPR Record is visible reminder. As the RoPR continues to minutes to upload a new RoPR record
to the public visiting the RoPR Web site, grow and more patient registry records (an average of 30 minutes using either
and is readily available for public use. are added over time, this percentage method). It takes 15 minutes for a user
The RoPR is an ongoing data collection represents a growing, cumulative to review and make updates to an
initiative. number. existing RoPR record.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of Minutes per Total burden
Number of
Form name responses per response hours
respondents respondent (average) (average)
New RoPR Record (manually—entered or uploaded electronically method) 59 1 30/60 29.5
Review/update existing RoPR Record ............................................................ 79 1 15/60 19.75
Total .......................................................................................................... 138 ........................ ........................ 49.25
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Number of Total burden Total cost
Form name hourly wage
respondents hours burden
rate †
New RoPR Record (manually—entered or uploaded electronically method) 59 29.5 $36.54 $1,077.93
Review/update existing RoPR Record ............................................................ 79 19.75 36.54 721.67
Total .......................................................................................................... 138 44.25 ........................ $1,799.60
†*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 research and information dissemination comments will become a matter of
concerns about using the RoPR system functions, including whether the public record.
and turning user feedback into future information will have practical utility; Sharon Arnold,
system maintenance and upgrade (b) the accuracy of AHRQ’s estimate of
initiatives (increasing the usability of Deputy Director.
burden (including hours and costs) of
the RoPR and lowering the burden of [FR Doc. 2015–23574 Filed 9–18–15; 8:45 am]
the proposed collection(s) of
entering patient registry information), information; (c) ways to enhance the BILLING CODE 4160–90–P
plans for a voluntary user satisfaction quality, utility, and clarity of the
survey is being considered for information to be collected; and (d)
development and deployment in 2Q DEPARTMENT OF HEALTH AND
ways to minimize the burden of the HUMAN SERVICES
2016. Its full nature and design is still collection of information upon the
in the concept stage and so this survey respondents, including the use of Centers for Disease Control and
is not part of the Estimated Annualized Prevention
automated collection techniques or
Respondent Hourly/Cost Burden noted
other forms of information technology.
in Exhibits 1 and 2.
Comments submitted in response to [60 Day–15–15BFV; Docket No. CDC–2015–
Request for Comments this notice will be summarized and 0085]
rmajette on DSK7SPTVN1PROD with NOTICES
In accordance with the Paperwork included in the Agency’s subsequent Proposed Data Collection Submitted
Reduction Act, comments on AHRQ’s request for OMB approval of the for Public Comment and
information collection are requested proposed information collection. All Recommendations
with regard to any of the following: (a)
Whether the proposed collection of AGENCY: Centers for Disease Control and
information is necessary for the proper Prevention (CDC), Department of Health
performance of AHRQ health care and Human Services (HHS).
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Document Created: 2015-12-15 09:39:27
Document Modified: 2015-12-15 09:39:27
| 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 November 20, 2015. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 80 FR 56992 |
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