Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Office for the Advancement of Telehealth Outcome Measures, OMB No. 0915-0311-Revision, 1264-1265 [2018-00253]
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1264
Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices
account the probable risks and benefits
of currently available devices or
alternative forms of treatment.
Respondents may submit a
humanitarian device exemption (HDE)
application seeking exemption from the
effectiveness requirements of sections
514 and 515 of the FD&C Act as
authorized by section 520(m)(2). The
information collected will assist FDA in
making determinations on the
following: (1) Whether to grant HUD
designation of a medical device; (2)
whether to exempt an HUD from the
effectiveness requirements under
sections 514 and 515 of the FD&C Act,
provided that the device meets
requirements set forth under section
520(m) of the FD&C Act; and (3)
whether to grant marketing approval(s)
for the HUD. Failure to collect this
information would prevent FDA from
making a determination on the factors
listed previously in this document.
Further, the collected information
would also enable FDA to determine
whether the holder of an HUD is in
compliance with the HUD provisions
under section 520(m) of the FD&C Act.
In the Federal Register of October 16,
2017 (82 FR 48096), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR section
Number of
responses
per
respondent
Average
burden per
response
Total annual
responses
Total
hours
Request for HUD designation—814.102 .............................
HDE Application—814.104 ..................................................
HDE Amendments and resubmitted HDEs—814.106 .........
HDE Supplements—814.108 ...............................................
Notification of withdrawal of an HDE—814.116(e)(3) .........
Notification of withdrawal of Institutional Review Board approval—814.124(b) ...........................................................
Periodic reports—814.126(b)(1) ..........................................
19
3
6
110
1
1
1
5
1
1
19
3
30
110
1
40
320
50
80
1
760
960
1,500
8,800
1
1
35
1
1
1
35
2
120
2
4,200
Total ..............................................................................
........................
........................
........................
........................
16,223
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeping
Total annual
records
Average
burden per
recordkeeping
Total
hours
HDE Records—814.126(b)(2) ..............................................
247
1
247
2
494
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total
hours
Notification of emergency use—814.124(a) ........................
22
1
22
1
22
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in tables
1, 2, and 3 of this document are an
average based on data for the previous
3 years, i.e., fiscal years 2014 through
2016. The number of annual reports
submitted under § 814.126(b)(1) in table
1 reflects 35 respondents with approved
HUD applications. Under
§ 814.126(b)(2) in table 2, the estimated
number of recordkeepers is 247.
The number of respondents has been
adjusted to reflect updated respondent
data. This has resulted in an overall
decrease of 2,971 hours to the total
estimated annual reporting burden.
There have been no program changes
and the estimated Average Burden per
Response has not changed for any of the
VerDate Sep<11>2014
18:23 Jan 09, 2018
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information collections since the last
OMB approval.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Health Resources and Services
Administration
[FR Doc. 2018–00241 Filed 1–9–18; 8:45 am]
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Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Office for the
Advancement of Telehealth Outcome
Measures, OMB No. 0915–0311—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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Federal Register / Vol. 83, No. 7 / Wednesday, January 10, 2018 / Notices
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 March 12, 2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
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
SUMMARY:
information request collection title for
reference.
Information Collection Request Title:
Office for the Advancement of
Telehealth Outcome Measures, OMB
No. 0915–0311—Revision.
Abstract: In order to help carry out its
mission, the Office for the Advancement
of Telehealth (OAT) created a set of
performance measures that grantees can
use to evaluate the effectiveness of their
services programs and monitor their
progress through the use of performance
reporting data.
Need and Proposed Use of the
Information: As required by the
Government Performance and Review
Act of 1993 (GPRA), all federal agencies
must develop strategic plans describing
their overall goal and objectives. OAT
has worked with its grantees to develop
performance measures used to evaluate
and monitor the progress of the
grantees. Grantee goals are to improve
access to needed services, reduce rural
practitioner isolation, improve health
system productivity and efficiency, and
improve patient outcomes.
In each of these categories, specific
indicators were designed to be reported
through a performance monitoring
website. New measures are being added
to the Telehealth Network Grant
Program and all measures speak to
OAT’s progress toward meeting the
goals, specifically telehealth services
delivered through rural schools.
Likely Respondents: Telehealth
Network Grantees.
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
Performance Improvement Measurement System (PIMS) ..
21
1
21
7
147
Total ..............................................................................
21
........................
21
........................
147
HRSA specifically requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–00253 Filed 1–9–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Environmental Health Sciences Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
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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.
Name of Committee: National Advisory
Environmental Health Sciences Council.
Date: February 12–13, 2018.
Closed: February 12, 2018, 8:30 a.m. to
10:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Open: February 12, 2018, 10:30 a.m. to 4:45
p.m.
Agenda: Discussion of program and issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Open: February 13, 2018, 8:30 a.m. to 10:30
a.m.
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]]>Agencies
[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1264-1265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00253]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: Office for
the Advancement of Telehealth Outcome Measures, OMB No. 0915-0311--
Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 1265]]
SUMMARY: 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 March 12,
2018.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] 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: Office for the Advancement of
Telehealth Outcome Measures, OMB No. 0915-0311--Revision.
Abstract: In order to help carry out its mission, the Office for
the Advancement of Telehealth (OAT) created a set of performance
measures that grantees can use to evaluate the effectiveness of their
services programs and monitor their progress through the use of
performance reporting data.
Need and Proposed Use of the Information: As required by the
Government Performance and Review Act of 1993 (GPRA), all federal
agencies must develop strategic plans describing their overall goal and
objectives. OAT has worked with its grantees to develop performance
measures used to evaluate and monitor the progress of the grantees.
Grantee goals are to improve access to needed services, reduce rural
practitioner isolation, improve health system productivity and
efficiency, and improve patient outcomes.
In each of these categories, specific indicators were designed to
be reported through a performance monitoring website. New measures are
being added to the Telehealth Network Grant Program and all measures
speak to OAT's progress toward meeting the goals, specifically
telehealth services delivered through rural schools.
Likely Respondents: Telehealth Network Grantees.
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
----------------------------------------------------------------------------------------------------------------
Performance Improvement 21 1 21 7 147
Measurement System (PIMS)......
-------------------------------------------------------------------------------
Total....................... 21 .............. 21 .............. 147
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on: (1) The necessity and
utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-00253 Filed 1-9-18; 8:45 am]
BILLING CODE 4165-15-P
