Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request; Application for Federally Supported Health Centers Assistance Act/Federal Tort Claims Act Particularized Determination of Coverage, 0906-XXXX, New, 42085-42086 [2023-13822]
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42085
Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of information collection
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Cognitive Testing .................................................................
700
1
700
1.41
987
Total ..............................................................................
5,575
........................
5,575
........................
3482
1 May
2 May
include telephone non-response follow-up in which case the burden will not change.
include testing of database software, Computer Assisted Personal Interviewing software, or other automated technologies.
Maria G. Button,
Director, Executive Secretariat.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request; Application for Federally
Supported Health Centers Assistance
Act/Federal Tort Claims Act
Particularized Determination of
Coverage, 0906–XXXX, New
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 submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
DATES: Comments on this ICR must be
received no later than July 31, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
SUMMARY:
VerDate Sep<11>2014
17:21 Jun 28, 2023
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 paperwork@hrsa.gov or call
(301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Application for Federally Supported
Health Centers Assistance Act/Federal
Tort Claims Act Particularized
Determination of Coverage. OMB No.
0906–XXXX–New.
Abstract: Section 224(g)–(n) of the
Public Health Service (PHS) Act (42
U.S.C. 233(g)–(n)), as amended,
authorizes the Secretary to ‘‘deem’’
entities receiving funds under section
330 of the PHS Act (HRSA’s Health
Center Program) as PHS employees for
the purposes of establishing eligibility
for liability protections under the
Federally Supported Health Centers
Assistance Act (FSHCAA) including
Federal Tort Claims Act (FTCA)
coverage, for covered activities and
individuals. Health centers submit
deeming applications annually to
HRSA’s Bureau of Primary Health Care,
which administers the Health Center
Program and the Health Center FTCA
Program, in the prescribed form and
manner to obtain deemed PHS
employee status for this purpose.
FSHCAA and 42 CFR 6.6(d) authorize
FTCA coverage for the provision of
medical services to non-health center
patients in certain situations. Section
224(g)(1)(C) of the PHS Act and 42 CFR
6.6(d) explain the criteria by which the
Secretary will determine whether
FSHCAA’s liability protections,
including FTCA coverage, will extend to
the provision of medical care to
individuals who are not patients of the
health center. 42 CFR 6.6(e) identifies
examples that are approvable for FTCA
coverage under 42 CFR 6.6(d) and
section 224(g)(1)(B)(ii) of the PHS Act if
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2023–13829 Filed 6–28–23; 8:45 am]
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there is compliance with all other
coverage requirements under FSHCAA.
42 CFR 6.6(e)(4) provides examples of
specific activities that the Department
has determined are eligible for
FSCHAA’s liability protections,
including FTCA coverage, without the
need for a specific application for a
coverage determination. As indicated in
42 CFR 6.6(e)(4), if any element of an
activity or arrangement does not fit
squarely into the examples listed in 42
CFR 6.6(e), the covered entity should
request a particularized determination
of coverage. Acts and omissions related
to services provided to individuals who
are not patients of a covered entity that
do not fit squarely within the examples
in 42 CFR 6.6(e)(4) will be covered only
if the Secretary makes a coverage
determination under 42 CFR 6.6(d). The
FTCA program uses a web-based
application system within HRSA’s
Electronic Handbooks (EHB) system for
deeming applications. These electronic
application forms decrease the time and
effort required to complete the older,
paper-based approved deeming
application forms. HRSA is proposing a
new paper application that will be
transitioned into an electronic
application within the EHB system for
Particularized Determinations (PD). PDs
extend liability protections under
FSCHAA, including FTCA coverage, for
certain medical services provided to
individuals who are not patients of a
covered entity. This application will
help ensure health centers provide all
the necessary information required to
make determinations appropriately and
efficiently in response to their requests.
By including the application within the
EHBs, health centers will have access to
all information from prior applications
and have that information readily
available if making future requests. The
paper form of the application is an
interim solution to support health
centers until the electronic application
becomes available in the FTCA module
of the EHBs. After the electronic
application is available in the EHBs, all
PD requests will be submitted
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42086
Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
electronically, and the paper application
will no longer be used for submissions.
A 60-day notice published in the
Federal Register on March 8, 2023, Vol.
88, No. 45; pp. 14377, received no
public comments.
Need and Proposed Use of the
Information: PDs of coverage
applications are provided in compliance
with 42 CFR 6.6 and must address
certain specified criteria for coverage
determinations to be issued. The
application provides the Bureau of
Primary Health Care with the
information that is essential for
evaluation of compliance with legal
requirements and making a deeming
determination of coverage under 42 CFR
6.6.
Likely Respondents: Respondents
include recipients of Health Center
Program funds with deemed PHS
employee status under section 224(g)–
(n) of the PHS Act (42 U.S.C. 233(g)–
(n)).
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
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Application for Federally Supported Health Center Assistance Act (FSHCAA)/Federal Tort Claims Act (FTCA)
Particularized Determination ............................................
12
1
12
2
24
Total ..............................................................................
12
1
12
24
24
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. 2023–13822 Filed 6–28–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Pursuant to the Federal
Advisory Committee Act, notice is
hereby given that the Secretary’s
Advisory Committee on Human
Research Protections (SACHRP) will
hold a meeting that will be open to the
public. Information about SACHRP, the
full meeting agenda, and instructions for
linking to public access will be posted
SUMMARY:
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Number of
responses per
respondent
VerDate Sep<11>2014
17:21 Jun 28, 2023
Jkt 259001
on the SACHRP website at https://
www.dhhs.gov/ohrp/sachrp-committee/
meetings/.
DATES: The meeting will be held on
Wednesday, July 19, 2023 from 11:00
a.m. until 5:00 p.m., and Thursday, July
20, 2023, from 11:00 a.m. until 5:00 p.m.
(times are tentative and subject to
change). The confirmed times and
agenda will be posted on the SACHRP
website as this information becomes
available.
ADDRESSES: This meeting will be held
via webcast. Members of the public may
also attend the meeting via webcast.
Instructions for attending via webcast
will be posted at least one week prior
to the meeting at https://www.hhs.gov/
ohrp/sachrp-committee/meetings/
index.html.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
The Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
The SACHRP meeting will open to the
public at 11:00 a.m., on Wednesday,
July 19, 2023, followed by opening
remarks from Julie Kaneshiro, Acting
Director of OHRP and Dr. Douglas
Diekema, SACHRP Chair. The meeting
will begin with a discussion of IRB
effectiveness, topic #4 of the recently
published GAO report #GAO–23–
104721, Institutional Review Boards:
Actions Needed to Improve Federal
Oversight and Examine Effectiveness.
This will be followed by commentary on
the FDA draft guidance, Decentralized
Clinical Trials for Drugs, Biological
Products, and Devices, in addition to
discussion of recommendations that
address the ethical conduct of
decentralized clinical trials in human
subjects research more broadly.
Discussion of both topics will
continue on July 20, in addition to
commentary on the recently released
E:\FR\FM\29JNN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42085-42086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13822]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Information Collection
Request; Application for Federally Supported Health Centers Assistance
Act/Federal Tort Claims Act Particularized Determination of Coverage,
0906-XXXX, New
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 submitted an Information Collection Request (ICR),
described below, to the Office of Management and Budget (OMB) for
review and approval. Comments submitted during the first public review
of this ICR will be provided to OMB. OMB will accept further comments
from the public during the review and approval period. OMB may act on
HRSA's ICR only after the 30-day comment period for this notice has
closed.
DATES: Comments on this ICR must be received no later than July 31,
2023.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
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
[email protected] or call (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: Application for Federally
Supported Health Centers Assistance Act/Federal Tort Claims Act
Particularized Determination of Coverage. OMB No. 0906-XXXX-New.
Abstract: Section 224(g)-(n) of the Public Health Service (PHS) Act
(42 U.S.C. 233(g)-(n)), as amended, authorizes the Secretary to
``deem'' entities receiving funds under section 330 of the PHS Act
(HRSA's Health Center Program) as PHS employees for the purposes of
establishing eligibility for liability protections under the Federally
Supported Health Centers Assistance Act (FSHCAA) including Federal Tort
Claims Act (FTCA) coverage, for covered activities and individuals.
Health centers submit deeming applications annually to HRSA's Bureau of
Primary Health Care, which administers the Health Center Program and
the Health Center FTCA Program, in the prescribed form and manner to
obtain deemed PHS employee status for this purpose.
FSHCAA and 42 CFR 6.6(d) authorize FTCA coverage for the provision
of medical services to non-health center patients in certain
situations. Section 224(g)(1)(C) of the PHS Act and 42 CFR 6.6(d)
explain the criteria by which the Secretary will determine whether
FSHCAA's liability protections, including FTCA coverage, will extend to
the provision of medical care to individuals who are not patients of
the health center. 42 CFR 6.6(e) identifies examples that are
approvable for FTCA coverage under 42 CFR 6.6(d) and section
224(g)(1)(B)(ii) of the PHS Act if there is compliance with all other
coverage requirements under FSHCAA. 42 CFR 6.6(e)(4) provides examples
of specific activities that the Department has determined are eligible
for FSCHAA's liability protections, including FTCA coverage, without
the need for a specific application for a coverage determination. As
indicated in 42 CFR 6.6(e)(4), if any element of an activity or
arrangement does not fit squarely into the examples listed in 42 CFR
6.6(e), the covered entity should request a particularized
determination of coverage. Acts and omissions related to services
provided to individuals who are not patients of a covered entity that
do not fit squarely within the examples in 42 CFR 6.6(e)(4) will be
covered only if the Secretary makes a coverage determination under 42
CFR 6.6(d). The FTCA program uses a web-based application system within
HRSA's Electronic Handbooks (EHB) system for deeming applications.
These electronic application forms decrease the time and effort
required to complete the older, paper-based approved deeming
application forms. HRSA is proposing a new paper application that will
be transitioned into an electronic application within the EHB system
for Particularized Determinations (PD). PDs extend liability
protections under FSCHAA, including FTCA coverage, for certain medical
services provided to individuals who are not patients of a covered
entity. This application will help ensure health centers provide all
the necessary information required to make determinations appropriately
and efficiently in response to their requests. By including the
application within the EHBs, health centers will have access to all
information from prior applications and have that information readily
available if making future requests. The paper form of the application
is an interim solution to support health centers until the electronic
application becomes available in the FTCA module of the EHBs. After the
electronic application is available in the EHBs, all PD requests will
be submitted
[[Page 42086]]
electronically, and the paper application will no longer be used for
submissions.
A 60-day notice published in the Federal Register on March 8, 2023,
Vol. 88, No. 45; pp. 14377, received no public comments.
Need and Proposed Use of the Information: PDs of coverage
applications are provided in compliance with 42 CFR 6.6 and must
address certain specified criteria for coverage determinations to be
issued. The application provides the Bureau of Primary Health Care with
the information that is essential for evaluation of compliance with
legal requirements and making a deeming determination of coverage under
42 CFR 6.6.
Likely Respondents: Respondents include recipients of Health Center
Program funds with deemed PHS employee status under section 224(g)-(n)
of the PHS Act (42 U.S.C. 233(g)-(n)).
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
----------------------------------------------------------------------------------------------------------------
Application for Federally 12 1 12 2 24
Supported Health Center
Assistance Act (FSHCAA)/Federal
Tort Claims Act (FTCA)
Particularized Determination...
-------------------------------------------------------------------------------
Total....................... 12 1 12 24 24
----------------------------------------------------------------------------------------------------------------
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. 2023-13822 Filed 6-28-23; 8:45 am]
BILLING CODE 4165-15-P
