Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Telehealth Resource Center Performance Measurement Tool, OMB No. 0915-0361-Revision, 1749-1751 [2019-01107]
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Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Notices
entitled ‘‘The Least Burdensome
Provisions of the FDA Modernization
Act of 1997: Concept and Principles’’
(October 4, 2002).
III. Electronic Access
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘The Least
Burdensome Provisions: Concept and
Principles.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm.
Persons unable to download an
electronic copy of ‘‘The Least
Burdensome Provisions: Concept and
Principles; Guidance for Industry and
1749
Food and Drug Administration Staff’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1332 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in the following FDA
regulations, guidance, form, and
statutory provision have been approved
by OMB as listed in the following table:
OMB control
No.
21 CFR part or section; guidance; FDA form; or statute
Topic
820 ..............................................................................................
812 ..............................................................................................
807, subpart E ............................................................................
860.123 .......................................................................................
814, subparts A through E ..........................................................
814, subpart H ............................................................................
806 ..............................................................................................
803 ..............................................................................................
822 ..............................................................................................
Form FDA 3670 ..........................................................................
801 and 809 ................................................................................
‘‘Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’.
807, subparts A through D .........................................................
807, 812, and 814 .......................................................................
Quality System Regulation ........................................................
Investigational Device Exemption ..............................................
Premarket Notification ................................................................
Reclassification Petition .............................................................
Premarket Approval ...................................................................
Humanitarian Device Exemption ...............................................
Medical Devices; Reports of Corrections and Removals ..........
Medical Device Reporting ..........................................................
Postmarket Surveillance ............................................................
Adverse Event Reports/MedSun Program ................................
Labeling ......................................................................................
CLIA Waiver ...............................................................................
0910–0073
0910–0078
0910–0120
0910–0138
0910–0231
0910–0332
0910–0359
0910–0437
0910–0449
0910–0471
0910–0485
0910–0598
Registration and Listing .............................................................
Human Subject Protection; Acceptance of Data from Clinical
Studies for Medical Devices.
Q-Submissions ...........................................................................
0910–0625
0910–0741
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
42 U.S.C. 241 .............................................................................
830 ..............................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic
Class III Designation)’’.
Dated: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019–01022 Filed 2–4–19; 8:45 am]
Electronic Submission of Allegations of Regulatory Misconduct
Associated with Medical Devices.
Unique Device Identification System .........................................
De Novo Classification Process ................................................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
BILLING CODE 4164–01–P
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Telehealth Resource
Center Performance Measurement
Tool, OMB No. 0915–0361—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
SUMMARY:
VerDate Sep<11>2014
17:22 Feb 04, 2019
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0910–0756
0910–0769
0910–0720
0910–0844
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than March 7, 2019.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
(202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
E:\FR\FM\05FEN1.SGM
05FEN1
1750
Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Notices
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Telehealth Resource Center Performance
Measurement Tool, OMB No. 0915–
0361, Revision
Abstract: To ensure the best use of
public funds and to meet the
Government Performance Review Act
requirements, the Office for the
Advancement of Telehealth (OAT) in
collaboration with the Telehealth
Resource Centers (TRCs) created a set of
performance measures that grantees can
use to evaluate the technical assistance
services provided by the TRCs. Grantee
goals are to provide customized
telehealth technical assistance across
the country. The TRCs provide technical
assistance to health care organizations,
health care networks, and health care
providers in the implementation of costeffective telehealth programs to serve
rural and medically underserved areas
and populations.
Need and Proposed Use of the
Information: In order to evaluate
existing programs, data are submitted to
OAT through HRSA’s Performance
Improvement Management System
(PIMS). The data are used to measure
the effectiveness of the technical
assistance. There are two data reporting
periods each year; during these biannual
reporting periods data are reported for
the previous six months of activity.
Programs have approximately six weeks
to enter their data into the PIMS system
during each biannual reporting period.
The instrument was developed with
the following four goals in mind:
1. Improving access to needed
services;
2. Reducing rural practitioner
isolation;
3. Improving health system
productivity and efficiency; and
4. Improving patient outcomes.
The TRCs currently report on existing
performance data elements using PIMS.
The performance measures are designed
to assess how the TRC program is
meeting its goals to:
1. Expand the availability of
telehealth services in underserved
communities;
2. Improve the quality, efficiency, and
effectiveness of telehealth services;
3. Promote knowledge exchange and
dissemination about efficient and
effective telehealth practices and
technology; and
4. Establish sustainable technical
assistance (TA) centers providing
quality, unbiased TA for the
development and expansion of effective
and efficient telehealth services in
underserved communities.
Additionally, the PIMS tool allows
OAT to:
1. Determine the value added from the
TRC Cooperative Agreement;
2. Justify budget requests;
3. Collect uniform, consistent data
which enables OAT to monitor
programs;
4. Provide guidance to grantees on
important indicators to track over time
for their own internal program
management;
5. Measure performance relative to the
mission of OAT/HRSA as well as
individual goals and objectives of the
program;
6. Identify topics of interest for future
special studies; and
7. Identify changes in healthcare
needs within rural communities,
allowing programs to shift focus in
order to meet those needs.
This renewal request proposes
changes to existing measures. After
compiling data from the previous tool
over the last three years, OAT
conducted an analysis of the data and
compared the findings with the program
needs. Based on the findings, the
measures are being revised to better
capture information necessary to
measure the effectiveness of the
program. The measure changes include:
additional demographic details from
organizations requesting technical
assistance, streamlined methods of
inquiry; additional topics of technical
assistance inquiries aligning with the
current telehealth landscape;
streamlined types of services provided
by the grantees; deletion of client
satisfaction survey results; and deletion
of telehealth sites developed as a result
of grantee technical assistance. A 60-day
Federal Register Notice was published
in the Federal Register on April 9, 2018,
vol. 83, No. 68; pp. 15164–65. There
were no public comments.
Likely Respondents: The likely
respondents will be telehealth
associations, telehealth providers, rural
health providers, clinicians that deliver
services via telehealth, technical
assistance providers, research
organizations, and academic medical
centers.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Telehealth Resource Center Performance Data Collection
Total ..............................................................................
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17:22 Feb 04, 2019
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Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
14
42
588
0.07
41
14
........................
588
........................
41
Sfmt 4703
E:\FR\FM\05FEN1.SGM
05FEN1
1751
Federal Register / Vol. 84, No. 24 / Tuesday, February 5, 2019 / Notices
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–01107 Filed 2–4–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Medicare
Rural Hospital Flexibility Program
Performance, OMB No. 0915–0363—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than April 8, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail to Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer, Room
14N136B, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
SUMMARY:
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Medicare Rural Hospital Flexibility
Program Performance Measures, OMB
No. 0915–0363—Extension
Abstract: This information collection
comment request is for continued
approval of the Medicare Rural Hospital
Flexibility Program Performance
Measures. HRSA is proposing to
continue this data collection with no
changes. The current performance
measures are collected electronically in
the Performance Improvement and
Measurement System, which awardees
access securely through the HRSA
Electronic Handbooks.
The Medicare Rural Hospital
Flexibility Program (Flex Program) is
authorized by Section 1820 of the Social
Security Act (42 U.S.C. 1395i–4), as
amended. The purpose of the Flex
Program is to enable state designated
entities to support critical access
hospitals in quality improvement,
quality reporting, performance
improvement, and benchmarking; to
assist facilities seeking designation as
critical access hospitals; and to create a
program to establish or expand the
provision of rural emergency medical
services.
Need and Proposed Use of the
Information: For this program,
performance measures were developed
to provide data useful to the Flex
program and to enable HRSA to provide
aggregate program data required by
Congress under the Government
Performance and Results Modernization
Act of 2010 (GPRA). These measures
cover principal topic areas of interest to
the Federal Office of Rural Health
Policy, including: (a) Quality reporting,
(b) quality improvement interventions,
(c) financial and operational
improvement initiatives, (d) population
health management, and (e) innovative
care models. In addition to informing
the Office’s progress toward meeting the
goals set in GPRA, the information is
important in identifying and
understanding programmatic
improvement across program areas, as
well as guiding future iterations of the
Flex Program and prioritizing areas of
need and support.
Likely Respondents: Respondents are
the Flex Program coordinators for the
states participating in the Flex Program.
There are currently 45 states
participating in the Flex Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total Burden
Hours
Medicare Rural Hospital Flexibility Program .......................
45
1
45
70
3,150
Total ..............................................................................
45
........................
45
........................
3,150
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17:22 Feb 04, 2019
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PO 00000
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Fmt 4703
Sfmt 4703
E:\FR\FM\05FEN1.SGM
05FEN1
]]>Agencies
[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1749-1751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01107]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Information Collection
Request Title: Telehealth Resource Center Performance Measurement Tool,
OMB No. 0915-0361--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period.
DATES: Comments on this ICR should be received no later than March 7,
2019.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by fax to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests
[[Page 1750]]
submitted to OMB for review, email Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer, at paperwork@hrsa.gov or call
(301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Telehealth Resource Center
Performance Measurement Tool, OMB No. 0915-0361, Revision
Abstract: To ensure the best use of public funds and to meet the
Government Performance Review Act requirements, the Office for the
Advancement of Telehealth (OAT) in collaboration with the Telehealth
Resource Centers (TRCs) created a set of performance measures that
grantees can use to evaluate the technical assistance services provided
by the TRCs. Grantee goals are to provide customized telehealth
technical assistance across the country. The TRCs provide technical
assistance to health care organizations, health care networks, and
health care providers in the implementation of cost-effective
telehealth programs to serve rural and medically underserved areas and
populations.
Need and Proposed Use of the Information: In order to evaluate
existing programs, data are submitted to OAT through HRSA's Performance
Improvement Management System (PIMS). The data are used to measure the
effectiveness of the technical assistance. There are two data reporting
periods each year; during these biannual reporting periods data are
reported for the previous six months of activity. Programs have
approximately six weeks to enter their data into the PIMS system during
each biannual reporting period.
The instrument was developed with the following four goals in mind:
1. Improving access to needed services;
2. Reducing rural practitioner isolation;
3. Improving health system productivity and efficiency; and
4. Improving patient outcomes.
The TRCs currently report on existing performance data elements
using PIMS. The performance measures are designed to assess how the TRC
program is meeting its goals to:
1. Expand the availability of telehealth services in underserved
communities;
2. Improve the quality, efficiency, and effectiveness of telehealth
services;
3. Promote knowledge exchange and dissemination about efficient and
effective telehealth practices and technology; and
4. Establish sustainable technical assistance (TA) centers
providing quality, unbiased TA for the development and expansion of
effective and efficient telehealth services in underserved communities.
Additionally, the PIMS tool allows OAT to:
1. Determine the value added from the TRC Cooperative Agreement;
2. Justify budget requests;
3. Collect uniform, consistent data which enables OAT to monitor
programs;
4. Provide guidance to grantees on important indicators to track
over time for their own internal program management;
5. Measure performance relative to the mission of OAT/HRSA as well
as individual goals and objectives of the program;
6. Identify topics of interest for future special studies; and
7. Identify changes in healthcare needs within rural communities,
allowing programs to shift focus in order to meet those needs.
This renewal request proposes changes to existing measures. After
compiling data from the previous tool over the last three years, OAT
conducted an analysis of the data and compared the findings with the
program needs. Based on the findings, the measures are being revised to
better capture information necessary to measure the effectiveness of
the program. The measure changes include: additional demographic
details from organizations requesting technical assistance, streamlined
methods of inquiry; additional topics of technical assistance inquiries
aligning with the current telehealth landscape; streamlined types of
services provided by the grantees; deletion of client satisfaction
survey results; and deletion of telehealth sites developed as a result
of grantee technical assistance. A 60-day Federal Register Notice was
published in the Federal Register on April 9, 2018, vol. 83, No. 68;
pp. 15164-65. There were no public comments.
Likely Respondents: The likely respondents will be telehealth
associations, telehealth providers, rural health providers, clinicians
that deliver services via telehealth, technical assistance providers,
research organizations, and academic medical centers.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Telehealth Resource Center 14 42 588 0.07 41
Performance Data Collection....
-------------------------------------------------------------------------------
Total....................... 14 .............. 588 .............. 41
----------------------------------------------------------------------------------------------------------------
[[Page 1751]]
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-01107 Filed 2-4-19; 8:45 am]
BILLING CODE 4165-15-P
