Agency Information Collection Activities: Proposed Collection: Public Comment Request; Office for the Advancement of Telehealth Outcome Measures, OMB No. 0915-0311-Extension, 12385-12386 [2023-03912]
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
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that the NNV impurity can be controlled
within the acceptable intake limit by
sponsors of varenicline products within
the context of their particular
applications.
CHANTIX (varenicline tartrate)
tablets, 0.5 mg and 1 mg, is currently
listed in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Medley Pharmaceuticals Ltd.
submitted a citizen petition dated June
6, 2022 (Docket No. FDA–2022–P–
1013), under 21 CFR 10.30, requesting
that the Agency determine whether
CHANTIX (varenicline tartrate) tablets,
0.5 mg and 1 mg, were withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CHANTIX (varenicline
tartrate) tablets, 0.5 mg and 1 mg, has
not been withdrawn for reasons of safety
or effectiveness to the extent that the
drug can be manufactured or formulated
in a manner that satisfies any applicable
acceptable intake limit for nitrosamine
impurities.
Accordingly, the Agency will
continue to list CHANTIX (varenicline
tartrate) tablets, 0.5 mg and 1 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may be approved by
the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs, including
satisfying any applicable acceptable
intake limit for nitrosamine impurities.
If FDA determines that labeling for this
drug product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: February 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03947 Filed 2–24–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: Revised Amount of the
Average Cost of a Health Insurance
Policy
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
HRSA is publishing an
updated monetary amount of the
average cost of a health insurance policy
as it relates to the National Vaccine
Injury Compensation Program (VICP).
FOR FURTHER INFORMATION CONTACT: CDR
George Reed Grimes, Director, Division
of Injury Compensation Programs,
Health Systems Bureau, HRSA, by mail
at 5600 Fishers Lane, 08N186B,
Rockville, Maryland 20857; or call (301)
443–9350.
SUPPLEMENTARY INFORMATION: Section
100.2 of the VICP’s implementing
regulation (42 CFR part 100) states that
the revised amount of an average cost of
a health insurance policy, as determined
by the Secretary of Health and Human
Services (the Secretary), is effective
upon its delivery by the Secretary to the
United States Court of Federal Claims
(the Court) and will be published
periodically in a notice in the Federal
Register. The Secretary delegated this
responsibility to the HRSA
Administrator. This figure is calculated
using the most recent Medical
Expenditure Panel Survey-Insurance
Component data available as the
baseline for the average monthly cost of
a health insurance policy. This baseline
is adjusted by the annual percentage
increase/decrease obtained from the
most recent annual Kaiser Family
Foundation (KFF) Employer Health
Benefits Survey.
In 2022, Medical Expenditure Panel
Survey-Insurance Component, available
at www.meps.ahrq.gov, published the
annual 2021 average total single
premium per enrolled employee at
private-sector establishments that
provide health insurance. The figure
published was $7,380. This figure is
divided by 12 to determine the cost per
month of $615.00. The $615.00 figure is
increased or decreased by the
percentage change reported by the most
recent KFF Employer Health Benefits
Survey, available at www.kff.org. The
increase from 2021 to 2022 was 2.2
percent. By adding this percentage
increase, the calculated average monthly
SUMMARY:
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12385
cost of a health insurance policy for a
12-month period is $628.53.
Therefore, the Secretary announces
that the revised average cost of a health
insurance policy under the VICP is
$628.53 per month. In accordance with
§ 100.2, the revised amount was
effective upon its delivery by the
Secretary to the Court. Such notice was
delivered to the Court on February 21,
2023.
Carole Johnson,
Administrator.
[FR Doc. 2023–03919 Filed 2–24–23; 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; Office for the
Advancement of Telehealth Outcome
Measures, OMB No. 0915–0311—
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 28, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail 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 HRSA
Information Collection Clearance
Officer, at 301–594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUMMARY:
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12386
Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
Information Collection Request Title:
Office for the Advancement of
Telehealth Outcome Measures OMB No.
0915–0311—Extension.
Abstract: This clearance request is for
extending the approval of the Office for
Advancement of Telehealth Outcome
Measures that are currently approved
under OMB No. 0915–0311, with an
expiration date of October 31, 2023. To
help carry out its mission, HRSA
created this set of performance measures
that grantees of the Telehealth Network
Grant Program can use to evaluate the
effectiveness of their services programs
and monitor their progress using
performance reporting data.
Need and Proposed Use of the
Information: As required by the
Government Performance and Review
Act of 1993, all federal agencies must
develop strategic plans describing their
overall goal and objectives. HRSA has
worked with grantees of the Telehealth
Network Grant Program to develop
performance measures to be 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.
Measures for the Telehealth Network
Grant Program capture awardee-level
and aggregate data that illustrate the
impact and scope of federal funding
along with assessing these efforts. The
measures speak to the Office for
Advancement of Telehealth’s progress
toward meeting the goals, specifically
telehealth services delivered through
Emergency Departments.
Likely Respondents: Telehealth
Network Grant Program 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
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
Performance Improvement Measurement System ................................
29
1
29
7
203
Total ................................................................................................
29
........................
29
....................
203
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.
SUMMARY:
Maria G. Button,
Director, Executive Secretariat.
DATES:
[FR Doc. 2023–03912 Filed 2–24–23; 8:45 am]
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
Notice.
VerDate Sep<11>2014
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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 HRSA
Information Collection Clearance
Officer, at (301) 594–4394.
FOR FURTHER INFORMATION CONTACT:
Health Resources and Services
Administration
ACTION:
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.
Comments on this ICR should be
received no later than April 28, 2023.
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Number of
responses per
respondent
Number of
respondents
Form name
When
submitting comments or requesting
information, please include the
information collection request title for
reference.
SUPPLEMENTARY INFORMATION:
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Information Collection Request Title:
Enhancing HIV Care of Women, Infants,
Children and Youth Building Capacity
through Communities of Practice OMB
No. 0915–xxxx–New.
Abstract: HRSA aims to increase
delivery of evidence-based interventions
that enhance client outcomes, increase
the skill level of the HIV workforce
providing care and treatment to Women,
Infants, Children and Youth, and
involve partnerships for dissemination
of best practices to Ryan White HIV/
AIDS Program (RWHAP) Part D
participants. To that end, HRSA seeks to
implement a Communities of Practice
(CoP) platform for RWHAP Part D
recipients. A CoP engages recipient
teams in improvement learning sessions
using subject matter experts along with
application experts who help recipient
teams select, test, and implement
changes on the front line of care.
Through organizational selfassessments, didactic learning on
specific care topics, goals setting, and
work plan development, each team can
strategically benefit their organization.
CoPs afford participants the opportunity
to work in a group to solve a recognized
challenge related to a CoP domain and
support dialogue among participants
and the consultant/subject matter
experts. Recipient teams commit to
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[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12385-12386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03912]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Office for the Advancement of Telehealth
Outcome Measures, OMB No. 0915-0311--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 April 28,
2023.
ADDRESSES: Submit your comments to [email protected] or mail 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 HRSA Information Collection Clearance Officer, at 301-594-4394.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
[[Page 12386]]
Information Collection Request Title: Office for the Advancement of
Telehealth Outcome Measures OMB No. 0915-0311--Extension.
Abstract: This clearance request is for extending the approval of
the Office for Advancement of Telehealth Outcome Measures that are
currently approved under OMB No. 0915-0311, with an expiration date of
October 31, 2023. To help carry out its mission, HRSA created this set
of performance measures that grantees of the Telehealth Network Grant
Program can use to evaluate the effectiveness of their services
programs and monitor their progress using performance reporting data.
Need and Proposed Use of the Information: As required by the
Government Performance and Review Act of 1993, all federal agencies
must develop strategic plans describing their overall goal and
objectives. HRSA has worked with grantees of the Telehealth Network
Grant Program to develop performance measures to be 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.
Measures for the Telehealth Network Grant Program capture awardee-level
and aggregate data that illustrate the impact and scope of federal
funding along with assessing these efforts. The measures speak to the
Office for Advancement of Telehealth's progress toward meeting the
goals, specifically telehealth services delivered through Emergency
Departments.
Likely Respondents: Telehealth Network Grant Program 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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total
Form name respondents responses per responses response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Performance Improvement Measurement System.. 29 1 29 7 203
-------------------------------------------------------------------
Total................................... 29 .............. 29 ........... 203
----------------------------------------------------------------------------------------------------------------
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. 2023-03912 Filed 2-24-23; 8:45 am]
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