Notice2023-13822
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 29, 2023
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 124 (Thursday, June 29, 2023)</title>
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[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42085-42086]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13822]
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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.
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="/cdn-cgi/l/email-protection#2c5c4d5c495e5b435e476c445e5f4d024b435a"><span class="__cf_email__" data-cfemail="5d2d3c2d382f2a322f361d352f2e3c733a322b">[email protected]</span></a> or call Samantha Miller,
the HRSA Information Collection Clearance Officer, at
<a href="/cdn-cgi/l/email-protection#88f8e9f8edfaffe7fae3c8e0fafbe9a6efe7fe"><span class="__cf_email__" data-cfemail="097968796c7b7e667b6249617b7a68276e667f">[email protected]</span></a> 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
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Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
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Application for Federally 12 1 12 2 24
Supported Health Center
Assistance Act (FSHCAA)/Federal
Tort Claims Act (FTCA)
Particularized Determination...
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Total....................... 12 1 12 24 24
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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
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