[Federal Register Volume 89, Number 62 (Friday, March 29, 2024)]
[Notices]
[Pages 22163-22165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06687]



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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; Applications for Deemed 
Public Health Service Employment With Liability Protections Under the 
Federal Tort Claims Act for Health Centers, Deemed Health Center 
Volunteers, and Free Clinic Sponsored Individuals

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA 
submitted an Information Collection Request (ICR) 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 should be received no later than April 29, 
2024.

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 a copy of the clearance 
requests submitted to OMB for review, email Joella Roland, the HRSA 
Information Collection Clearance Officer, at [email protected] or call 
(301) 443-3983.

SUPPLEMENTARY INFORMATION: 
    Information Collection Request Title: Applications for Deemed 
Public Health Service (PHS) Employment with Liability Protections Under 
the Federal Tort Claims Act (FTCA) for Health Centers, Deemed Health 
Center Volunteers, and Free Clinic Sponsored Individuals OMB No. 0915-
xxxx-New.
    Abstract: Section 224(g)-(n) of the PHS Act (42 U.S.C. 233(g)-(n)) 
states that entities receiving funds under section 330 of the PHS Act 
and specified individuals of that entity may be deemed to be PHS 
employees for the purpose of eligibility for liability protections, 
including FTCA coverage, for the performance of medical, surgical, 
dental, and related functions within the scope of deemed employment 
upon approval of an application for deemed employment. The Health 
Center Program and Health Center FTCA Program are administered by HRSA. 
Health centers submit deeming applications annually to HRSA in the 
prescribed form and manner in order to obtain deemed PHS employee 
status, with the associated eligibility for FTCA coverage. Such 
applications must be approved by HRSA in a Notice of Deeming Action. 
Deemed health centers must resubmit applications annually meeting all 
deeming requirements in order to maintain deemed status.

Volunteer Health Professionals (VHPs)

    Section 224(q) of the PHS Act (42 U.S.C. 233(q)), extends 
eligibility for deemed PHS employee status to VHPs sponsored by deemed 
health centers upon approval of an individual deeming sponsorship 
application for deemed PHS employment. The Health Center VHP FTCA 
Program is administered by HRSA. In order to maintain deemed status for 
VHPs, deemed health centers must submit to HRSA an annual deeming 
sponsorship application on behalf of individually named VHPs. For 
liability protections to apply, such applications must be approved by 
HRSA in a Notice of Deeming Action applicable to the individual VHP, 
which, absent other intervening facts, generally is applicable to 
covered activities within the scope of such deemed PHS employment for a 
calendar year.

Free Clinics

    Section 224(o) of the PHS Act (42 U.S.C. 233(o)) extends 
eligibility for deemed PHS employee status to free clinic health 
professionals, including employees, officers, board members, 
contractors, and volunteer health professionals, at qualifying free 
clinics. The Free Clinics FTCA Program is administered by HRSA. Free 
clinics must submit deeming sponsorship applications to HRSA in the 
specified form and manner on behalf of named individuals for HRSA's 
review and approval. In order to continue to participate in the Free 
Clinics FTCA Program and maintain deemed status for individuals, free 
clinics must submit to HRSA an annual deeming sponsorship application 
on behalf of named individuals. For liability protections to apply, 
such applications must be approved by HRSA in a Notice of Deeming 
Action applicable to the sponsored individual, which, absent other 
intervening facts, generally is applicable to covered activities within 
the scope of such deemed PHS employment for a calendar year. Approvals 
result in a ``deeming determination'' that includes associated FTCA 
coverage for these individuals.
    HRSA is proposing to combine the three existing ICRs for these 
programs into a single ICR consisting of the three application forms. 
The three existing ICRs are: (1) Application for Health Center Program 
Recipients for Deemed PHS Employment with Liability Protections Under 
the FTCA (OMB No. 0906-0035), (2) Application for Deemed Health Center 
Program Award Recipients to Sponsor VHPs for Deemed PHS Employment (OMB 
No. 0906-0032), and (3) FTCA Program Deeming Sponsorship Applications 
for Free Clinics (OMB No. 0915-0293). HRSA recognizes that the content 
of these three FTCA applications differs but is proposing to combine 
these three separate ICRs in order to increase efficiencies, decrease 
burden on stakeholders, and allow commentors to more easily provide 
feedback where applicable to commonalities that may impact all three 
ICRs. Pursuant to section 224(g)-(o), and (q) of the PHS Act (42 U.S.C. 
233(g)-(o) and (q)), as amended, all three collections are done for the 
purpose of collecting information from certain health centers that 
receive grant funding under section 330 of the PHS Act and free clinics 
to determine eligibility for liability protections, including FTCA 
coverage. Applications for these programs must be submitted through 
HRSA's 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. In 
order to make the terminology more consistent, the names of the 
applications are now as follows: (1) Application for Health Center 
Program Recipients for Deemed PHS Employment with Liability Protections 
Under the FTCA, (2) Application for Deemed Health Center Program 
Recipients to Sponsor VHPs for Deemed PHS Employment with Liability 
Protections Under the FTCA, and (3) Application for Free Clinics to 
Sponsor Individuals for Deemed PHS Employment with Liability 
Protections Under the FTCA. In this single ICR, HRSA is proposing to 
update the content of the applications forms, which OMB has previously 
approved as three

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individual ICRs. These revisions are described below.

Proposed Revisions

1. Application for Health Center Program Recipients for Deemed PHS 
Employment With Liability Protections Under the FTCA

    HRSA is proposing several changes to the content of the Application 
for Health Center Program Recipients for Deemed PHS Employment with 
Liability Protections Under the FTCA, to be used for health center 
deeming applications for calendar year (CY) 2024 and thereafter, to 
improve question clarity and clarify required documentation. The 
application includes: Contact Information, Section 1: Review of Risk 
Management Systems; Section 2: Quality Improvement/Quality Assurance 
(QI/QA); Section 3: Credentialing and Privileging; Section 4: Claims 
Management; and Section 5: Additional Information, Certification, and 
Signatures. In addition to minor grammatical changes made for clarity, 
the application includes the following proposed changes:
     A disclaimer regarding training for health center staff 
was added to the beginning of the Review of Risk Management Systems, 
QI/QA, Credentialing and Privileging, and Claims Management sections.
    Review of Risk Management Systems:
     Questions related to required FTCA trainings for 
Obstetrics, Infection Control, the Health Insurance Portability and 
Accountability Act, and other specific areas of risk were separated 
into four questions, and detailed guidance for Obstetrics training was 
added for clarity.
     To facilitate the verification of compliance with training 
requirements, applicants will be required to enter their training 
tracking information in a Word or PDF document that will be part of the 
information collection tool.
     To enhance clarity and ensure accurate uploading of 
information, the quarterly assessments have been divided into four 
separate questions. This change aims to outline the required elements 
and information necessary for each risk assessment.
    Credentialing and Privileging:
     The credentialing and privileging section was revised to 
include clarification regarding policy and procedure requirements for 
temporary privileging.
     A new attestation question was added to clearly outline 
the requirements of Chapter 5 of the Health Center Compliance Manual, 
Clinical Staffing regarding Credentialing and Privileging of health 
care practitioners.
     A new question was added to ensure health centers ensure 
credentialing and privileging for all provider types, including 
Licensed Independent Practitioners, Other Licensed or Certified 
Practitioners, and Other Clinical Staff.
    Claims Management:
    A new claims management question was added to ensure documents 
relating to potential tort claims are in the correct format when 
transmitted to the Department of Health and Human Services, Office of 
the General Counsel's General Law Division.

2. Application for Deemed Health Center Program Recipients To Sponsor 
VHPs for Deemed PHS Employment With Liability Protections Under the 
FTCA

    HRSA is proposing several changes to the content of the Application 
for Deemed Health Center Program Recipients to Sponsor VHPs for Deemed 
PHS Employment with Liability Protections Under the FTCA, to be used 
for deeming sponsorship applications for CY 2024 and thereafter, to 
improve question clarity, clarify required documentation, and support 
HRSA's analysis and understanding of program impact. The application 
includes the following sections: Acknowledgments of Deemed Status 
Requirements, Acknowledgment of Required Performance Conditions, and 
Information on the Volunteers Sponsored for Deeming. Specifically, the 
application includes the following proposed changes:
     Volunteers Sponsored for Deeming: Since the publication of 
the 60-day notice, HRSA has decided to no longer add a new question to 
the VHP application tool related to performing activities during 
declared emergencies. Instead, HRSA is adopting a new streamlined VHP 
Emergency Deeming Sponsorship Application, that may be used by certain 
health centers (as identified by HRSA) that are affected by a declared 
emergency or other emergency, to seek expedited deemed status for 
sponsored VHPs for a limited time period to support short-term staffing 
needs based on the impact of the identified emergencies. The purpose of 
this streamlined deeming sponsorship application is to facilitate rapid 
onboarding of VHPs for health centers affected by a declared emergency 
or other emergency situation. This application will be an abbreviated 
version of the normal VHP application and will require less attachments 
and uses primarily attestation statements. Health centers affected by a 
declared emergency or other emergency situation requesting FTCA 
coverage on behalf of a subrecipient's VHPs must submit a VHP Emergency 
Deeming Sponsorship Application on behalf of each individually named 
volunteer health practitioner on the subrecipient's behalf. This tool 
will be made available in the Electronic Handbooks at HRSA's 
discretion.
     Credentialing and Privileging: Language has been added to 
ensure grantees understand the 2-year requirement for credentialing and 
privileging.

3. Application for Free Clinics To Sponsor Individuals for Deemed PHS 
Employment With Liability Protections Under the FTCA

    HRSA is proposing several changes to the content of the 
Applications for Free Clinics to Sponsor Individuals for Deemed PHS 
Employment with Liability Protections Under the FTCA, to be used for 
deeming sponsorship applications for CY 2024 and thereafter, to improve 
question clarity and clarify required documentation. Specifically, the 
application includes the following proposed changes:
     In Section III, ``Sponsoring Free Clinic Eligibility,'' a 
note was added to clarify the non-profit status documentation 
requirements for free clinics; and
     In Section VII, ``Patient Visit Data,'' clarifying 
language was added to ensure that free clinics provide precise and 
accurate data.
    A 60-day notice published in the Federal Register on December 13, 
2023, 88 FR 86346, received no public comments.
    Need and Proposed Use of the Information: Deeming applications must 
address certain specified criteria required by law to be approved, and 
FTCA application forms are critical to HRSA's deeming determination 
process. The application submissions provide HRSA with the information 
essential to evaluate the application and make a deeming determination. 
Moreover, the application information is also used to determine whether 
a site visit is appropriate to assess issues relating to quality of 
care and to determine technical assistance needs.
    Likely Respondents: Respondents include Health Center Program 
funding recipients seeking deemed PHS employee status for purposes of 
eligibility for liability protections, including FTCA coverage; Health 
Center Program funding recipients that have been deemed as PHS 
employees and that seek to sponsor VHPs for deemed PHS employee status 
for purposes of eligibility for liability protections,

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including FTCA coverage; and free clinics that seek to sponsor 
individuals for deemed PHS employee status for purposes of eligibility 
for 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:

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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 Health Center              1,160               1           1,160             2.5           2,900
 Program Recipients for Deemed
 PHS Employment with Liability
 Protections Under the FTCA.....
Application for Deemed Health              1,156               3           3,468             2.0           6,936
 Center Program Recipients to
 Sponsor Volunteer Health
 Professionals for Deemed PHS
 Employment with Liability
 Protections Under the FTCA.....
Volunteer Health Professionals                60               1              60             1.0              60
 Emergency Deeming Sponsorship
 Application....................
Application for Free Clinics to              374               3           1,122             2.0           2,244
 Sponsor Individuals for Deemed
 PHS Employment with Liability
 Protections Under the FTCA.....
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    Total.......................           2,750  ..............           5,810  ..............          12,140
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Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-06687 Filed 3-28-24; 8:45 am]
BILLING CODE 4165-15-P