[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]


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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 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
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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]
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