Agency Information Collection Activities: Proposed Collection; Comment Request, 56992-56993 [2015-23574]
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Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
5. Healthcare Information Technology
Research (HITR)
Date: October 22–23, 2015 (Open from
8:30 a.m. to 9:00 a.m. on October
22nd and closed for remainder of
the meeting)
ADDRESSES: Gaithersburg Marriott
Washingtonian Center, 9751
Washingtonian Blvd., Gaithersburg, MD
20878.
FOR FURTHER INFORMATION CONTACT: (To
obtain a roster of members, agenda or
minutes of the non-confidential portions
of the meetings.)
Mrs. Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research Education and
Priority Populations, AHRQ, 540
Gaither Road, Suite 2000, Rockville,
Maryland 20850, Telephone (301)
427–1554.
SUPPLEMENTARY INFORMATION: In
accordance with section 10 (a)(2) of the
Federal Advisory Committee Act (5
U.S.C. App. 2), AHRQ announces
meetings of the scientific peer review
groups listed above, which are
subcommittees of AHRQ’s Health
Services Research Initial Review Group
Committees. Each subcommittee
meeting will commence in open session
before closing to the public for the
duration of the meeting. The
subcommittee meetings will be closed to
the public in accordance with the
provisions set forth in 5 U.S.C. App. 2
section 10(d), 5 U.S.C. 552b(c)(4), and 5
U.S.C. 552b(c)(6). The grant applications
and the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Agenda items for these meetings are
subject to change as priorities dictate.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2015–23575 Filed 9–18–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
rmajette on DSK7SPTVN1PROD with NOTICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
15:14 Sep 18, 2015
Jkt 235001
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 doris.lefkowitz@AHRQ.hhs.gov.
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 doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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 peerreviewed 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.
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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).
E:\FR\FM\21SEN1.SGM
21SEN1
56993
Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
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
respondents
Form name
Number of
responses per
respondent
Minutes per
response
(average)
Total burden
hours
(average)
New RoPR Record (manually—entered or uploaded electronically method)
Review/update existing RoPR Record ............................................................
59
79
1
1
30/60
15/60
29.5
19.75
Total ..........................................................................................................
138
........................
........................
49.25
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate †
Total cost
burden
New RoPR Record (manually—entered or uploaded electronically method)
Review/update existing RoPR Record ............................................................
59
79
29.5
19.75
$36.54
36.54
$1,077.93
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: https://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.
rmajette on DSK7SPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
15:14 Sep 18, 2015
Jkt 235001
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
PO 00000
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–15–15BFV; Docket No. CDC–2015–
0085]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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
doris.lefkowitz@AHRQ.hhs.gov.
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
doris.lefkowitz@AHRQ.hhs.gov.
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: https://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
