80 FR 56991 - Notice of Meetings
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 | 56991-56992 | |
| FR Document | 2015-23575 |
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)] [Notices] [Pages 56991-56992] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices 56991
information. Available study registries better understanding of how their sponsored by organizations and
and databases may not be complete to submissions are used. individuals such as pharmaceutical
sufficiently inform the Program’s companies and independent
Estimated Annual Respondent Burden
research. researchers. The form has three required
The purpose of SEADS requests is not Exhibit 1 presents estimates of the fields: The organization’s name, the
to collect generalizable data, but to reporting burden hours for the data intervention in question, and whether
supplement the published and grey collection efforts. Time estimates are the information they provide is all the
literature searches EPC investigators are based on pilot testing of materials and information they know to exist. They
conducting. Furthermore, considering what can reasonably be requested of may upload documents and they are
the evidence and data included in respondents. The number of also provided a data entry form if they
responses collected from industry respondents listed in ‘‘Number of wish to offer greater details on their
stakeholders, an assessment pertaining respondents per SEADS request’’ of studies.
to the completeness of the evidence- Exhibit 1 reflects a projected 80% An Optional Data Entry Form is
base will be produced. This, AHRQ response rate. available as an alternative to the Online
believes, will increase the value of Online Submission Form: A form for Submission form. The time
AHRQ’s research reviews to end users submitting scientific evidence and data requirements for response would be
and potentially provide stakeholders a related to medical interventions same as the Online Submission Form.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of Number of Total
respondents Hours per
Form name responses per burden hours
per SEADS response
respondent per SEADS
request
Online Submission Form (OSF) ...................................................................... 70 1 15/60 17.5
Total .......................................................................................................... 70 1 15/60 17.5
EXHIBIT 2—ESTIMATED ANNUALIZED COST HOURS
Number of Total Average Total cost
Form name SEADS burden hours hourly wage burden
requests per SEADS rate *
OSF .................................................................................................................. 70 17.5 $55.48 a $970.90
Total .......................................................................................................... 70 17.5 55.48 970.90
* Occupational Employment Statistics, May 2014 National Occupational Employment and Wage Estimates United States, U.S. Department of
Labor, Bureau of Labor Statistics. http://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 com-
pleting the OSF.
Request for Comments comments will become a matter of closing to the public for the duration of
public record. the meeting. These meetings will be
In accordance with the Paperwork closed to the public in accordance with
Reduction Act, comments on AHRQ’s Sharon Arnold,
5 U.S.C. App. 2 section 10(d), 5 U.S.C.
information collection are requested Deputy Director. 552b(c)(4), and 5 U.S.C. 552b(c)(6).
with regard to any of the following: (a) [FR Doc. 2015–23573 Filed 9–18–15; 8:45 am]
DATES: See below for dates of meetings:
Whether the proposed collection of BILLING CODE 4160–90–P
information is necessary for the proper 1. Healthcare Effectiveness and
performance of AHRQ health care Outcomes Research (HEOR)
DEPARTMENT OF HEALTH AND Date: October 7, 2015 (Open from 8:30
research and health care information
HUMAN SERVICES a.m. to 9:00 a.m. on October 7th and
dissemination functions, including
closed for remainder of the meeting)
whether the information will have
Agency for Healthcare Research and 2. Health System and Value Research
practical utility; (b) the accuracy of
Quality (HSVR)
AHRQ’s estimate of burden (including Date: October 7, 2015 (Open from 8:30
hours and costs) of the proposed Notice of Meetings a.m. to 9:00 a.m. on October 7th and
collection(s) of information; (c) ways to closed for remainder of the meeting)
enhance the quality, utility, and clarity AGENCY: Agency for Healthcare Research 3. Healthcare Safety and Quality
of the information to be collected; and and Quality (AHRQ), HHS. Improvement Research (HSQR)
(d) ways to minimize the burden of the Date: October 14–15, 2015 (Open from
ACTION: Notice of Five AHRQ
collection of information upon the 8:00 a.m. to 8:30 a.m. on October
Subcommittee Meetings.
respondents, including the use of 14th and closed for remainder of
rmajette on DSK7SPTVN1PROD with NOTICES
automated collection techniques or SUMMARY: The subcommittees listed the meeting)
other forms of information technology. below are part of AHRQ’s Health 4. Health Care Research and Training
Comments submitted in response to Services Research Initial Review Group (HCRT)
this notice will be summarized and Committee. Grant applications are to be Date: October 15–16, 2015 (Open from
included in the Agency’s subsequent reviewed and discussed at these 8:00 a.m. to 8:30 a.m. on October
request for OMB approval of the meetings. Each subcommittee meeting 15th and closed for remainder of
proposed information collection. All will commence in open session before the meeting)
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![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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Document Created: 2015-12-15 09:38:21
Document Modified: 2015-12-15 09:38:21
| 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 of Five AHRQ Subcommittee Meetings. | |
| Dates | See below for dates of meetings: | |
| Contact | (To obtain a roster of members, agenda or minutes of the non-confidential portions of the meetings.) | |
| FR Citation | 80 FR 56991 |
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