National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy, 12385 [2023-03919]
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES
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0.5 mg and 1 mg, were withdrawn from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not been withdrawn for reasons of safety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]
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; 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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]]>Agencies
[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Page 12385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03919]
-----------------------------------------------------------------------
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
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 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 Sec. 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]
BILLING CODE 4165-15-P
