Agency Information Collection Activities: Proposed Collection: Public Comment Request; Telehealth Resource Center Performance Measurement Tool, OMB No. 0915-0361-Extension, 1421-1422 [2022-00328]
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1421
Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Sec. 582 of the FD&C Act; activity
Average time
per response
(in hours)
Total annual
responses
Total hours
Request renewals (Waivers Guidance, sec. III) ..................
1
1
1
16
16
Total ..............................................................................
........................
........................
........................
........................
114,932
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL DISCLOSURE BURDEN 1
Number of
respondents
Sec. 582 of the FD&C Act; activity
Illegitimate product notifications to trading partners (Notifications Guidance, sec. III.B) ............................................
Illegitimate product notification terminations to trading partners (Notifications Guidance, sec. III) ..............................
Total ..............................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
Number of
disclosures
per respondent
Total
disclosures
Average time
per disclosure
(in hours)
Total hours
500
310
155,000
8
1,240,000
500
310
155,000
4
620,000
........................
........................
........................
........................
1,860,000
are no capital costs or operating and maintenance costs associated with this collection of information.
We have reorganized the information
collection by respondent activity and
clarified where information collection
elements are discussed in the respective
guidance documents. Based on
illegitimate product notifications FDA
has already received, we previously
estimated a total of 250 respondents.
However, we have considered industry
feedback indicating that more
notifications may be submitted based on
stakeholder understanding of FDA’s
recent clarification of stolen product in
the ‘‘Definitions of Suspect Product and
Illegitimate Product for Verification
Obligations Under the Drug Supply
Chain Security Act’’ draft guidance
(June 2021; available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
definitions-suspect-product-andillegitimate-product-verificationobligations-under-drug-supply). As
such, we have increased our number of
estimated respondents to 500 and
assume 40 percent are manufacturers
(200), 50 percent are wholesale
distributors (250), and 10 percent are
pharmacies (50). Because
manufacturers, repackagers, and
wholesale distributors are collectively
responsible for prescription drugs from
the point of manufacturing through
distribution in the drug supply chain,
we continue to assume that these three
trading partners submit most
notifications of illegitimate products.
In response to industry feedback, we
have increased our estimate of the
average time per response from 1 hour
to 8 hours to more accurately reflect the
burden respondents may incur in
satisfying the information collection.
VerDate Sep<11>2014
20:03 Jan 10, 2022
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We have otherwise retained the average
burden per response for activities
associated with consultations and
waiver/exception/exemption requests.
Finally, also based on public comment
and industry feedback, we have
increased our estimate of the average
number of disclosures/notifications per
respondent, as well as our assumption
of the average time necessary for each
disclosure notification, for an increase
from 66,070 to 1,860,000 hours
annually.
As a result of these adjustments, our
estimated burden for the information
collection reflects a cumulative increase
since the last OMB review and approval.
We attribute this increase to a more
recent evaluation of the information
collection and informal
communications with industry and
other interested stakeholders regarding
burden estimates.
Dated: January 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–00327 Filed 1–10–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Telehealth
Resource Center Performance
Measurement Tool, OMB No. 0915–
0361—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 March 14, 2022.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N136B, 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 Samantha Miller, the acting
SUMMARY:
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11JAN1
1422
Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Notices
HRSA Information Collection Clearance
Officer at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information collection request title for
reference.
Information Collection Request Title:
Telehealth Resource Center Performance
Measurement Tool OMB No. 0915–
0361—Extension
Abstract: HRSA requests an extension
of their Telehealth Resource Center
Performance Measurement Tool. The
Telehealth Resource Centers (TRC)
deliver telehealth technical assistance.
There are two types of HRSA TRC
programs:
• Two National Telehealth Resource
Center Programs focus on policy
and technology.
• 12 Regional Telehealth Resource
Center Programs host activities and
provide resources to rural and
underserved areas.
The HRSA Telehealth Resource
Centers:
• Provide training and support
• Publicize information and research
findings
• Support collaboration and
partnerships
• Promote effective partnerships
• Promote the use of telehealth by
providing health care information and
education to the public and medical
specialists.
The TRCs share expertise through
individual consults, training, webinars,
conference presentations, and the web.
Need and Proposed Use of the
Information: In order to evaluate
existing programs, data are submitted to
HRSA’s Office for the Advancement of
Telehealth (OAT) through HRSA’s
Performance Improvement Management
System (PIMS). The data are used to
measure the effectiveness of the
technical assistance (TA). There is one
data reporting period each year; during
these reporting periods, data are
reported for the previous twelve months
of activity. Programs have
approximately six weeks to enter their
data into the PIMS system during each
annual reporting period.
The instrument was developed with
the following four goals in mind:
1. Improving access to needed
services,
2. Reducing rural and underserved
population 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:
• Expand the availability of telehealth
services in underserved communities;
• Improve the quality, efficiency, and
effectiveness of telehealth services;
• Promote knowledge exchange and
dissemination about efficient and
effective telehealth practices and
technology; and
• Establish sustainable 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:
• Determine the value added from the
TRC Cooperative Agreement;
• Justify budget requests;
• Collect uniform, consistent data
which enables OAT to monitor
programs;
• Provide guidance to grantees on
important indicators to track over time
for their own internal program
management;
• Measure performance relative to the
mission of OAT/HRSA as well as
individual goals and objectives of the
program;
• Identify topics of interest for future
special studies; and
• Identify changes in health care
needs within rural and underserved
communities, allowing programs to shift
focus in order to meet those needs.
Likely Respondents: The likely
respondents will be telehealth
associations, telehealth providers, rural
and underserved 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
khammond on DSKJM1Z7X2PROD with NOTICES
Telehealth Resource Center Performance Measurement
Tool ...................................................................................
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
VerDate Sep<11>2014
20:22 Jan 10, 2022
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14
14
Number of
responses per
respondent
Total
responses
42
........................
588
588
Average
burden per
response
(in hours)
Total
burden hours
0.07
........................
technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
[Document Identifier OS–0990–0478]
[FR Doc. 2022–00328 Filed 1–10–22; 8:45 am]
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Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
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]]>Agencies
[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Notices]
[Pages 1421-1422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00328]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Telehealth Resource Center Performance
Measurement Tool, OMB No. 0915-0361--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
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 14,
2022.
ADDRESSES: Submit your comments to [email protected] or by mail to the
HRSA Information Collection Clearance Officer, Room 14N136B, 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 Samantha Miller,
the acting
[[Page 1422]]
HRSA Information Collection Clearance Officer at (301) 443-9094.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information collection request title
for reference.
Information Collection Request Title: Telehealth Resource Center
Performance Measurement Tool OMB No. 0915-0361--Extension
Abstract: HRSA requests an extension of their Telehealth Resource
Center Performance Measurement Tool. The Telehealth Resource Centers
(TRC) deliver telehealth technical assistance. There are two types of
HRSA TRC programs:
Two National Telehealth Resource Center Programs focus on
policy and technology.
12 Regional Telehealth Resource Center Programs host
activities and provide resources to rural and underserved areas.
The HRSA Telehealth Resource Centers:
Provide training and support
Publicize information and research findings
Support collaboration and partnerships
Promote effective partnerships
Promote the use of telehealth by providing health care
information and education to the public and medical specialists.
The TRCs share expertise through individual consults, training,
webinars, conference presentations, and the web.
Need and Proposed Use of the Information: In order to evaluate
existing programs, data are submitted to HRSA's Office for the
Advancement of Telehealth (OAT) through HRSA's Performance Improvement
Management System (PIMS). The data are used to measure the
effectiveness of the technical assistance (TA). There is one data
reporting period each year; during these reporting periods, data are
reported for the previous twelve months of activity. Programs have
approximately six weeks to enter their data into the PIMS system during
each annual reporting period.
The instrument was developed with the following four goals in mind:
1. Improving access to needed services,
2. Reducing rural and underserved population 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:
Expand the availability of telehealth services in
underserved communities;
Improve the quality, efficiency, and effectiveness of
telehealth services;
Promote knowledge exchange and dissemination about
efficient and effective telehealth practices and technology; and
Establish sustainable 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:
Determine the value added from the TRC Cooperative
Agreement;
Justify budget requests;
Collect uniform, consistent data which enables OAT to
monitor programs;
Provide guidance to grantees on important indicators to
track over time for their own internal program management;
Measure performance relative to the mission of OAT/HRSA as
well as individual goals and objectives of the program;
Identify topics of interest for future special studies;
and
Identify changes in health care needs within rural and
underserved communities, allowing programs to shift focus in order to
meet those needs.
Likely Respondents: The likely respondents will be telehealth
associations, telehealth providers, rural and underserved 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 Measurement Tool...
14 .............. 588 .............. 41
----------------------------------------------------------------------------------------------------------------
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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-00328 Filed 1-10-22; 8:45 am]
BILLING CODE 4165-15-P
