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, 86346-86348 [2023-27362]
Download as PDF
<![CDATA[
86346
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices
I. General Description of the Genetic
Metabolic Diseases Advisory
Committee’s Duties
The Committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational human
drug and biologic products for use in
the treatment of genetic metabolic
diseases and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
II. Qualifications
Persons nominated for the Committee
should be full-time employees of firms
that develop human drug and biologic
products, or consulting firms that
represent human drug and biologic
product developers or have similar
appropriate ties to industry.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interest must send a
letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 60 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current re´sume´s or curriculum
vitae. The letter will also state that it is
the responsibility of the interested
organizations to confer with one another
and to select a candidate, to represent
industry interest for the committee,
within 60 days after the receipt of the
FDA letter. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select temporary
nonvoting members to represent
industry interests.
IV. Nomination Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a
temporary nonvoting industry
representative. Nominations must
include a cover letter and a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business and/or home address,
telephone number, and email address if
available; and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Committee Membership Nomination
Portal (see ADDRESSES). Nominations
should specify the advisory committee
for which the nominee is recommended
within 60 days of publication of this
VerDate Sep<11>2014
16:54 Dec 12, 2023
Jkt 262001
document (see DATES). Nominations
should also acknowledge that the
nominee is aware of the nomination,
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. Only interested industry
organizations participate in the
selection process. Persons who
nominate themselves as nonvoting
industry representatives will not
participate in the selection process.
FDA seeks to include the views of
members of all gender groups, members
of all racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
and, therefore encourages nominations
of appropriately qualified candidates
from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14,
relating to advisory committees.
Dated: December 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–27303 Filed 12–12–23; 8:45 am]
BILLING CODE 4164–01–P
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
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 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.
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Submit your comments to
paperwork@hrsa.gov 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 paperwork@hrsa.gov
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.
ADDRESSES:
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
E:\FR\FM\13DEN1.SGM
13DEN1
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
16:54 Dec 12, 2023
Jkt 262001
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:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
86347
• 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
E:\FR\FM\13DEN1.SGM
13DEN1
86348
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices
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
Application for Health Center Program Recipients for Deemed PHS Employment with Liability Protections Under the FTCA ...............................
Application for Deemed Health Center Program Recipients to Sponsor
Volunteer Health Professionals (VHPs) for Deemed PHS Employment
with Liability Protections Under the FTCA ...............................................
Application for Free Clinics to Sponsor Individuals for Deemed PHS Employment with Liability Protections Under the FTCA ...............................
khammond on DSKJM1Z7X2PROD with NOTICES
Total ......................................................................................................
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.
BILLING CODE 4165–15–P
VerDate Sep<11>2014
16:54 Dec 12, 2023
Jkt 262001
Total
responses
1,160
1
1,160
2.5
2,900
1,156
3
3,468
2.0
6,936
374
3
1,122
2.0
2,244
2,655
7
5,705
9
12,080
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of the Fourth Meeting
of the 2025 Dietary Guidelines
Advisory Committee
Office of Disease Prevention
and Health Promotion, Department of
Health and Human Services (HHS),
Office of the Assistant Secretary for
Health (OASH); Department of
Agriculture (USDA), Food, Nutrition,
and Consumer Services (FNCS).
AGENCY:
ACTION:
[FR Doc. 2023–27362 Filed 12–12–23; 8:45 am]
Notice.
The Departments of Health
and Human Services and Agriculture
announce the fourth meeting of the 2025
Dietary Guidelines Advisory Committee
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Form name
Total
burden
hours
(Committee). This meeting will be open
to the public virtually.
DATES: The fourth Committee meeting
will be held on January 19, 2024, from
8:30 a.m. to 3:00 p.m. Eastern Time.
ADDRESSES: The meeting will be
accessible online via livestream and
recorded for later viewing. Registrants
will receive the livestream information
prior to the meeting.
FOR FURTHER INFORMATION CONTACT:
Designated Federal Officer, 2025 Dietary
Guidelines Advisory Committee, Janet
M. de Jesus, MS, RD; Office of Disease
Prevention and Health Promotion, 1101
Wootton Parkway, Suite 420, Rockville,
MD 20852; Phone: 240–453–8266; Email
DietaryGuidelines@hhs.gov. Additional
information is at DietaryGuidelines.gov.
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total
Form name respondents responses per responses response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
