Notice of Meetings, 56991-56992 [2015-23575]
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56991
Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
information. Available study registries
and databases may not be complete to
sufficiently inform the Program’s
research.
The purpose of SEADS requests is not
to collect generalizable data, but to
supplement the published and grey
literature searches EPC investigators are
conducting. Furthermore, considering
the evidence and data included in
responses collected from industry
stakeholders, an assessment pertaining
to the completeness of the evidencebase will be produced. This, AHRQ
believes, will increase the value of
AHRQ’s research reviews to end users
and potentially provide stakeholders a
better understanding of how their
submissions are used.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the
reporting burden hours for the data
collection efforts. Time estimates are
based on pilot testing of materials and
what can reasonably be requested of
respondents. The number of
respondents listed in ‘‘Number of
respondents per SEADS request’’ of
Exhibit 1 reflects a projected 80%
response rate.
Online Submission Form: A form for
submitting scientific evidence and data
related to medical interventions
sponsored by organizations and
individuals such as pharmaceutical
companies and independent
researchers. The form has three required
fields: The organization’s name, the
intervention in question, and whether
the information they provide is all the
information they know to exist. They
may upload documents and they are
also provided a data entry form if they
wish to offer greater details on their
studies.
An Optional Data Entry Form is
available as an alternative to the Online
Submission form. The time
requirements for response would be
same as the Online Submission Form.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
per SEADS
request
Form name
Online Submission Form (OSF) ......................................................................
Total ..........................................................................................................
Number of
responses per
respondent
70
70
1
1
Hours per
response
15/60
15/60
Total
burden hours
per SEADS
17.5
17.5
EXHIBIT 2—ESTIMATED ANNUALIZED COST HOURS
Number of
SEADS
requests
Form name
OSF ..................................................................................................................
Total ..........................................................................................................
Total
burden hours
per SEADS
70
70
17.5
17.5
Average
hourly wage
rate *
$55.48 a
55.48
Total cost
burden
$970.90
970.90
* Occupational Employment Statistics, May 2014 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm#b29-0000.
a Based on the mean wages for Public Relations and Fundraising Managers, 11–2031, the occupational group most likely tasked with completing the OSF.
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
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
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15:14 Sep 18, 2015
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comments will become a matter of
public record.
Sharon Arnold,
Deputy Director.
[FR Doc. 2015–23573 Filed 9–18–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meetings
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of Five AHRQ
Subcommittee Meetings.
AGENCY:
The subcommittees listed
below are part of AHRQ’s Health
Services Research Initial Review Group
Committee. Grant applications are to be
reviewed and discussed at these
meetings. Each subcommittee meeting
will commence in open session before
SUMMARY:
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closing to the public for the duration of
the meeting. These meetings will be
closed to the public in accordance with
5 U.S.C. App. 2 section 10(d), 5 U.S.C.
552b(c)(4), and 5 U.S.C. 552b(c)(6).
DATES: See below for dates of meetings:
1. Healthcare Effectiveness and
Outcomes Research (HEOR)
Date: October 7, 2015 (Open from 8:30
a.m. to 9:00 a.m. on October 7th and
closed for remainder of the meeting)
2. Health System and Value Research
(HSVR)
Date: October 7, 2015 (Open from 8:30
a.m. to 9:00 a.m. on October 7th and
closed for remainder of the meeting)
3. Healthcare Safety and Quality
Improvement Research (HSQR)
Date: October 14–15, 2015 (Open from
8:00 a.m. to 8:30 a.m. on October
14th and closed for remainder of
the meeting)
4. Health Care Research and Training
(HCRT)
Date: October 15–16, 2015 (Open from
8:00 a.m. to 8:30 a.m. on October
15th and closed for remainder of
the meeting)
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56992
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:
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15:14 Sep 18, 2015
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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.
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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).
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]]>Agencies
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 56991-56992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23575]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Notice of Meetings
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Notice of Five AHRQ Subcommittee Meetings.
-----------------------------------------------------------------------
SUMMARY: The subcommittees listed below are part of AHRQ's Health
Services Research Initial Review Group Committee. Grant applications
are to be reviewed and discussed at these meetings. Each subcommittee
meeting will commence in open session before closing to the public for
the duration of the meeting. These meetings will be closed to the
public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C.
552b(c)(4), and 5 U.S.C. 552b(c)(6).
DATES: See below for dates of meetings:
1. Healthcare Effectiveness and Outcomes Research (HEOR)
Date: October 7, 2015 (Open from 8:30 a.m. to 9:00 a.m. on October
7th and closed for remainder of the meeting)
2. Health System and Value Research (HSVR)
Date: October 7, 2015 (Open from 8:30 a.m. to 9:00 a.m. on October
7th and closed for remainder of the meeting)
3. Healthcare Safety and Quality Improvement Research (HSQR)
Date: October 14-15, 2015 (Open from 8:00 a.m. to 8:30 a.m. on
October 14th and closed for remainder of the meeting)
4. Health Care Research and Training (HCRT)
Date: October 15-16, 2015 (Open from 8:00 a.m. to 8:30 a.m. on
October 15th and closed for remainder of the meeting)
[[Page 56992]]
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
