National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy, 69629-69630 [2020-24314]
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Federal Register / Vol. 85, No. 213 / Tuesday, November 3, 2020 / Notices
clinics seeking FTCA coverage for their
employees, officers, board members,
contractors, and volunteers must submit
deeming applications in the specified
form and manner on behalf of named
individuals for review and approval,
resulting in a ‘‘deeming determination’’
that includes associated FTCA coverage
for these individuals.
HRSA is proposing several changes to
the FTCA Program Deeming
Applications for Free Clinics, to be used
for Free Clinic deeming sponsorship
applications for Calendar Year 2021 and
thereafter, to improve question clarity
and clarify required documentation.
Specifically, the Application includes
the following proposed changes:
• Updated application language:
Specifically, throughout the application,
alternate terminology was utilized to
provide greater clarity and specificity.
These changes were based on
stakeholder feedback and information
received from the HRSA Health Center
Program Support. These changes are not
substantive in nature.
• Added Service Type and
clarifications regarding professional
designation: Specifically, section VI of
the application was updated to include
service type which will allow HRSA to
verify whether an individual is
performing clinical or non-clinical
services. In addition to the inclusion of
service type, a note was added to
request that free clinics include the
professional designation for each
individual.
• Deleted remark in section IX: It has
been determined that the information
requested in this section, which related
to offsite events and particularized
determinations is no longer necessary to
evaluate eligibility for deeming.
The FTCA Program has a web based
application system, the Electronic
Handbooks. These electronic
application forms decrease the time and
effort required to complete the older,
paper-based OMB approved FTCA
application forms. The application
includes: Contact Information, Site
Information, Information on the
Sponsoring Free Clinic Eligibility,
Information on the Credentialing and
Privileging Systems, Information on the
Risk Management Systems, Information
on the Free Clinic Volunteer Health
Care Professionals, Board Members,
Officers, Employees, and Individual
Contractors and Patient Visit Data.
A 60-day notice was published in the
Federal Register on August 6, 2020, vol.
85, No. 152; pp. 47803–04. HRSA
received one public comment regarding
FTCA coverage of Urban Indian
Organizations, which is outside of the
scope of this ICR.
Need and Proposed Use of the
Information: Deeming applications must
address certain criteria required by law
in order for the Secretary to deem an
individual sponsored by a qualifying
free clinic as a PHS employee for
purposes of liability protections,
including FTCA coverage. This
determination cannot be made without
the collection of this information.
Specifically, the deeming sponsorship
application form seeks information
verifying that the free clinic meets the
criteria to sponsor a deeming
application and that the individual
being sponsored is eligible to be deemed
as a PHS employee. The FTCA
application form for free clinics has
been updated to improve clarity and
thereby improve applicants’ and
deemed individuals’ compliance with
applicable requirements.
Likely Respondents: Respondents
include free clinics seeking deemed
PHS employee status on behalf of their
sponsored individuals for purposes of
liability protections including FTCA
coverage.
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
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Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total
burden
hours
FTCA Program Deeming Application for Free Clinics .........
374
3
1,122
2
2,244
Total ..............................................................................
374
........................
1,122
........................
2,244
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, Division of the Executive Secretariat.
[FR Doc. 2020–24337 Filed 11–2–20; 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 (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing an
updated monetary amount of the
SUMMARY:
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average cost of a health insurance policy
as it relates to the National Vaccine
Injury Compensation Program (VICP).
FOR FURTHER INFORMATION CONTACT:
Tamara Overby, Acting Director,
Division of Injury Compensation
Programs, Healthcare Systems Bureau,
HRSA, HHS by mail at 5600 Fishers
Lane, 08N186B, Rockville, Maryland
20857; or call (301) 443–9350.
SUPPLEMENTARY INFORMATION: Section
100.2 of 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 HHS (the Secretary), is
effective upon its delivery by the
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Federal Register / Vol. 85, No. 213 / Tuesday, November 3, 2020 / Notices
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 SurveyInsurance 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 Employer Health
Benefits Survey or other authoritative
source that may be more accurate or
appropriate.
In 2020, Medical Expenditure Panel
Survey-Insurance Component, available
at www.meps.ahrq.gov, published the
annual 2019 average total single
premium per enrolled employee at
private-sector establishments that
provide health insurance. The figure
published was $6,972. This figure is
divided by 12 to determine the cost per
month of $581. The $581 figure is
increased or decreased by the
percentage change reported by the most
recent Kaiser Family Foundation
Employer Health Benefits Survey,
available at www.kff.org. The increase
from 2019 to 2020 was 4.0 percent. By
adding this percentage increase, the
calculated average monthly cost of a
health insurance policy for a 12-month
period is $604.24.
Therefore, the Secretary announces
that the revised average cost of a health
insurance policy under the VICP is
$604.24 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 October 29,
2020.
Thomas J. Engels,
Administrator.
[FR Doc. 2020–24314 Filed 11–2–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Review and Revision of the Screening
Framework Guidance for Providers of
Synthetic Double-Stranded DNA
Office of the Secretary,
Assistant Secretary for Preparedness
and Response (ASPR), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
Synthetic biology is a
multidisciplinary field of research that
involves the design, modification, and
SUMMARY:
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creation of biological systems and holds
broad promise to advance both basic
and applied research in areas ranging
from materials science to molecular
medicine. However, synthetic nucleic
acids and associated technologies may
also pose risks if misused. To reduce the
risk that individuals with ill intent may
exploit the application of nucleic acid
synthesis technology to obtain genetic
material derived from or encoding
Select Agents and Toxins and, as
applicable, agents on the Export
Administration Regulations’ (EAR’s)
Commerce Control List (CCL), the U.S.
Government issued guidance in 2010
providing a framework for screening
synthetic double-stranded DNA
(dsDNA). This document, the Screening
Framework Guidance for Providers of
Synthetic Double-Stranded DNA
(Guidance), sets forth recommended
baseline standards for the gene and
genome synthesis industry and other
providers of synthetic dsDNA products,
regarding the screening of orders, so
they are filled in compliance with U.S.
regulations prohibiting the possession,
use, and transfer of specific pathogens
and biological toxins. The other goals of
the Guidance are to encourage best
practices in addressing biosecurity
concerns associated with the potential
misuse of these products to inflict harm
or bypass existing regulatory controls
and to minimize any negative impacts
on the conduct of research and business
operations. Rapid and continued
advances in nucleic acid synthesis
technologies and synthetic biology
applications necessitate periodic
reevaluation of associated risks and
mitigation measures. We invite public
comments on whether and, if so, how
the Guidance should be modified to
address new and emerging challenges
posed by advances in this area.
Please submit all comments related to
this request for information (RFI)
through the web form on the Screening
Framework Guidance for Providers of
Synthetic Double-Stranded DNA
website at https://www.phe.gov/syndna/
update2020.
DATES: Responses to this RFI must be
received no later than 12 p.m. (ET) on
the revised submission deadline of
January 4, 2021. This notice was
originally published with an earlier
date. Please note that the close date for
comments has been changed from the
original notice.
FOR FURTHER INFORMATION CONTACT: Dr.
C. Matthew Sharkey; Division of Policy;
Office of Strategy, Policy, Planning, and
Requirements; Office of the Assistant
Secretary for Preparedness and
Response; U.S. Department of Health
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and Human Services; phone: 202–401–
1448; email: Matthew.Sharkey@hhs.gov;
website: https://www.phe.gov/syndna/
update2020.
SUPPLEMENTARY INFORMATION:
Disclaimer and Important Notes: The
U.S. Government is seeking feedback
from life sciences stakeholders,
including from the commercial, health
care, academic, and non-profit sectors;
federal and state, local, tribal, and
territorial (SLTT) law enforcement
organizations; SLTT governments; and
others, including the members of the
public. The focus of this RFI is to help
inform whether updates or
modifications of the Guidance are
needed and, if so, what updates or
modifications are desired. The U.S.
Government will review and consider
all responses to this RFI. The U.S.
Government will not provide
reimbursement for costs incurred in
responding to this RFI. Respondents are
advised that the U.S. Government is
under no obligation to acknowledge
receipt of the information received or to
provide feedback to respondents with
respect to any information submitted
under this RFI. Responses to this RFI do
not bind the U.S. Government to any
further actions related to this topic.
Respondents are welcome to answer all
or any subset of the questions and are
strongly advised to not include any
information in their responses that
might be considered attributable,
business sensitive, proprietary, or
otherwise confidential, as comments
may be made available for public
review.
Categories and Questions
Scope of the Guidance
Nucleic acid synthesis technologies
are fundamental for biomedical
research and allow for the generation
and modification of some viruses,
bacteria, and toxins. Such technologies
serve as tools to advance important
research to understand such agents
better as well as in developing medical
countermeasures. Additionally, dsDNA
synthesis could pose biosecurity risks,
including enabling individuals with ill
intent or who are not authorized to
possess Select Agents and Toxins (or,
for international orders, items listed on
the CCL) to obtain them using materials
ordered from providers of synthetic
dsDNA.
The Guidance sets forth
recommended baseline standards for
the gene and genome synthesis industry
and other providers of synthetic dsDNA,
regarding the screening of orders, to
ensure they are filled in compliance
with Select Agent Regulations (SAR)
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]]>Agencies
[Federal Register Volume 85, Number 213 (Tuesday, November 3, 2020)]
[Notices]
[Pages 69629-69630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24314]
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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
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
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: Tamara Overby, Acting Director,
Division of Injury Compensation Programs, Healthcare Systems Bureau,
HRSA, HHS by mail at 5600 Fishers Lane, 08N186B, Rockville, Maryland
20857; or call (301) 443-9350.
SUPPLEMENTARY INFORMATION: Section 100.2 of 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 HHS (the Secretary), is effective upon its delivery by the
[[Page 69630]]
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 Employer Health Benefits
Survey or other authoritative source that may be more accurate or
appropriate.
In 2020, Medical Expenditure Panel Survey-Insurance Component,
available at www.meps.ahrq.gov, published the annual 2019 average total
single premium per enrolled employee at private-sector establishments
that provide health insurance. The figure published was $6,972. This
figure is divided by 12 to determine the cost per month of $581. The
$581 figure is increased or decreased by the percentage change reported
by the most recent Kaiser Family Foundation Employer Health Benefits
Survey, available at www.kff.org. The increase from 2019 to 2020 was
4.0 percent. By adding this percentage increase, the calculated average
monthly cost of a health insurance policy for a 12-month period is
$604.24.
Therefore, the Secretary announces that the revised average cost of
a health insurance policy under the VICP is $604.24 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 October 29, 2020.
Thomas J. Engels,
Administrator.
[FR Doc. 2020-24314 Filed 11-2-20; 8:45 am]
BILLING CODE 4165-15-P
