[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86346-86348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Information Collection Request Title: 
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, 
OMB No. 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 announces plans to submit an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the 
public regarding the burden estimate, below, or any other aspect of the 
ICR.

DATES: Comments on this ICR should be received no later than February 
12, 2024.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N39, 5600 Fishers 
Lane, Rockville, Maryland 20857.

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 Joella Roland, the 
HRSA Information Collection Clearance Officer, at (301) 443-3983.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the ICR title for reference.
    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. 0906-
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 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

[[Page 86347]]

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 
are reflected, resulting in a ``deeming determination'' that includes 
associated FTCA coverage for these individuals.
    HRSA proposes combining 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. 
0915-0032); 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 proposes combining these 
three separate ICRs in order to increase efficiencies, decrease burden 
on stakeholders, and allow commentors to provide feedback more easily 
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 proposes updating 
the content of the applications forms, which OMB has previously 
approved as three individual ICRs. The 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, 
Section 3: Credentialing and Privileging, Section 4: Claims Management, 
and Section 5: Additional Information, Certification, and Signatures. 
In addition to minor 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, 
Quality Improvement/Quality Assurance, 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 for 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

[[Page 86348]]

Performance Conditions, and Information on the Volunteers Sponsored for 
Deeming. Specifically, the application includes the following proposed 
changes:
     Volunteers Sponsored for Deeming: A new question has been 
added to better assist health centers sponsoring VHPs who perform 
activities during declared emergencies. The question asks if the 
submitted application relates to services provided during a declared 
emergency.
     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.
    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, 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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                                                                                              Average
                                                    Number of      Number of       Total     burden per   Total
                    Form name                      respondents   responses per   responses    response    burden
                                                                  respondent                 (in hours)   hours
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Application for Health Center Program Recipients         1,160               1       1,160          2.5    2,900
 for Deemed PHS Employment with Liability
 Protections Under the FTCA.....................
Application for Deemed Health Center Program             1,156               3       3,468          2.0    6,936
 Recipients to Sponsor Volunteer Health
 Professionals (VHPs) for Deemed PHS Employment
 with Liability Protections Under the FTCA......
Application for Free Clinics to Sponsor                    374               3       1,122          2.0    2,244
 Individuals for Deemed PHS Employment with
 Liability Protections Under the FTCA...........
                                                 ---------------------------------------------------------------
    Total.......................................         2,655               7       5,705            9   12,080
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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. 2023-27362 Filed 12-12-23; 8:45 am]
BILLING CODE 4165-15-P