Rule2023-13423
Removal of the Vaccine Requirements for Head Start Programs
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 26, 2023
Effective
June 26, 2023
Issuing agencies
Health and Human Services DepartmentChildren and Families Administration
Abstract
This final rule removes the vaccine and testing requirements included in the Interim Final Rule with Comment Period (IFC) titled, "Vaccine and Mask Requirements To Mitigate the Spread of COVID-19 in Head Start Programs," which the Administration for Children and Families published on November 30, 2021. Specifically, this rescission removes the requirement from the Head Start Program Performance Standards (HSPPS) that all Head Start staff, contractors whose activities involve contact with or providing direct services to children and families, and volunteers working in classrooms or directly with children are fully vaccinated for COVID-19. The associated HSPPS requirement that staff who are exempt from the vaccination requirement have "at least weekly" COVID-19 testing is also removed.
Full Text
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<title>Federal Register, Volume 88 Issue 121 (Monday, June 26, 2023)</title>
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[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Rules and Regulations]
[Pages 41326-41334]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13423]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
45 CFR Part 1302
RIN 0970-AC90
Removal of the Vaccine Requirements for Head Start Programs
AGENCY: Office of Head Start (OHS), Administration for Children and
Families (ACF), Department of Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This final rule removes the vaccine and testing requirements
included in the Interim Final Rule with Comment Period (IFC) titled,
``Vaccine and Mask Requirements To Mitigate the Spread of COVID-19 in
Head Start Programs,'' which the Administration for Children and
Families published on November 30, 2021. Specifically, this rescission
removes the requirement from the Head Start Program Performance
Standards (HSPPS) that all Head Start staff, contractors whose
activities involve contact with or providing direct services to
children and families, and volunteers working in classrooms or directly
with children are fully vaccinated for COVID-19. The associated HSPPS
requirement that staff who are exempt from the vaccination requirement
have ``at least weekly'' COVID-19 testing is also removed.
DATES: Effective date: This final rule is effective June 26, 2023.
FOR FURTHER INFORMATION CONTACT: Kate Troy, OHS, at
<a href="/cdn-cgi/l/email-protection#8bc3eeeaefd8ffeaf9ffcbeee8e7e0e8a5e2e5ede4"><span class="__cf_email__" data-cfemail="753d1014112601140701351016191e165b1c1b131a">[email protected]</span></a> or 1-866-763-6481. Telecommunications Relay
Service users can first dial 7-1-1, then share the 1-866-763-6481
number with the operator.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Background
III. Rationale for the Rescission
IV. Overview of Public Comments on the Interim Final Rule With
Comment Period
V. Public Comments Analysis
VI. Regulatory Process Matters
VII. Regulatory Impact Analysis
VIII. Tribal Consultation Statement
I. Executive Summary
(1) Purpose of the Regulatory Action
The purpose of this regulatory action is to remove the COVID-19
vaccination and testing requirements established by the Interim Final
Rule with Comment Period (IFC), Vaccine and Mask Requirements to
Mitigate the Spread of COVID-19 in Head Start Programs, which ACF
issued on November 30, 2021 (86 FR 68052), from the Head Start Program
Performance Standards (HSPPS). Specifically, this final rule removes
the requirement that all Head Start staff, contractors whose activities
involve contact with or providing direct services to children and
families, and volunteers working in classrooms or directly with
children are fully
[[Page 41327]]
vaccinated for COVID-19. Accordingly, the removal of the vaccine
requirement also removes the related ``at least weekly testing''
requirement that staff who are granted an exemption from the vaccine
requirement undergo. These requirements are no longer part of the
HSPPS.
Factors that have led ACF to remove these requirements include (1)
the expiration of the COVID-19 Public Health Emergency on May 11, 2023
declared by the Secretary of Health and Human Services under the Public
Health Service Act and the national emergency concerning COVID-19 ended
on April 10, 2023 when the President signed Public Law 118-3, (2) the
fact that Head Start programs are required, through a final rule issued
on January 6, 2023, to have an evidence-based COVID-19 mitigation
policy included in their policies and procedures, and (3) comments
received on the IFC (86 FR 68052).
HHS finds good cause for promulgating this final rule with an
immediate effective date to promote efficient planning and ease of
implementation. A delayed effective date could harm Head Start
programs' ability to plan for the upcoming program year, as many Head
Start programs use the summer months to recruit and hire staff. Any
confusion or uncertainty created by the continued presence of the
COVID-19 vaccination and testing requirements within the HSPPS could
prevent programs from hiring otherwise qualified staff during the
typical hiring season. Further, delays in hiring staff for the upcoming
program year ultimately limits the number of children and families
served by Head Start. This outcome is contrary to the public interest
and subverts the intended purpose of this regulatory action.
(2) Summary of Costs and Benefits
This final rule removes the COVID-19 vaccination and testing
requirements established on November 30, 2021 through an Interim Final
Rule with Comment (IFC), ``Vaccine and Mask Requirements To Mitigate
the Spread of COVID-19 in Head Start Programs.'' \1\ In this analysis,
we evaluate the impacts of the final rule in comparison to a primary
analytic baseline scenario in which these IFC requirements continue
over the time horizon of the analysis. We also discuss the impacts in
comparison to an alternative baseline scenario of no vaccination and
testing requirements.
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\1\ 86 FR 68052.
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The final rule will result in fewer COVID-19 tests performed under
the testing requirement for individuals granted an exemption from the
vaccine requirement. This analysis estimates $16.8 million in cost
savings associated with fewer tests performed. The final rule will also
result in reduced vaccine uptake among some individuals hired by Head
Start programs over the time horizon of this analysis, who would become
fully vaccinated under the IFC but who will not become fully vaccinated
without the vaccination requirement. We estimate $1.7 million in cost
savings associated with fewer new hires becoming fully vaccinated. We
also identify foregone benefits in the form of reduced COVID-19
mortality and morbidity risks associated with vaccination. We monetize
these mortality risks using a value per statistic life approach and
report a primary value of these disbenefits of about $0.7 million. Over
a one-year time horizon, we estimate that this final rule will result
in about $18.5 million in total cost savings. Subtracting disbenefits
from the cost savings, we conclude that this final rule will result in
net benefits of about $17.8 million.
These estimates are reported in 2022 dollars and do not depend on
the choice of 3% or 7% discount rate. As discussed in greater detail in
the full analysis, we acknowledge some uncertainty in these estimates,
including that some Head Start programs likely adopted evidence-based
COVID-19 mitigation policies that include testing or vaccination
strategies.
We have developed a comprehensive regulatory impact analysis that
assesses the impacts of the final rule. The full analysis of economic
impacts is available Section VIII of this document.
II. Background
Since its inception in 1965, Head Start has been a leader in
supporting children from low-income families in reaching kindergarten
healthy and ready to thrive in school and life. The program was founded
on research showing that health and wellbeing are pre-requisites to
maximum learning and improved short- and long-term outcomes. In fact,
OHS identifies health as the foundation of school readiness.
The Head Start Program Performance Standards (HSPPS) require
programs to comply with state immunization enrollment and attendance
requirements and to work with families to ensure children who are
behind on immunizations or other care get on a schedule to catch up (45
CFR 1302.15(e) and 1302.42(b)(1)). Additionally, education, family
service, nutrition, and health staff help children learn healthy
habits, monitor each child's growth and development, and help parents
access needed health care.
It is vitally important that the Head Start program itself is safe
for all children, families, and staff. For this reason, the HSPPS
specify that the program must ensure Head Start staff do not pose a
significant risk of communicable disease (45 CFR 1302.93(a)). Ensuring
that children and families can benefit from program services as safely
as possible is OHS' highest priority. While this is always important,
the COVID-19 pandemic highlighted the need to ensure staff are as
protected as possible so that young children are also protected. At the
time of the IFC's publication, November 30, 2021, the COVID-19 vaccine
was the most effective risk reduction strategy available to avoid
severe illness, hospitalization, and death, as well as the most
important measure for reducing risk for SARS-CoV-2 transmission \2\ for
the predominant variants of SARS-CoV-2. Data at the time suggested
fully vaccinated staff were at much lower risk of infection and
therefore, posed lower transmission risk to the young unvaccinated
children in their care.\3\ Young children who get the virus can also
spread it to others in their homes and communities. Ensuring Head Start
staff were fully vaccinated thus had the ancillary benefit of
significantly reducing the possibility of the program playing an
unwitting part in community spread of SARS-CoV-2.
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\2\ Centers for Disease Control and Prevention. ``Science Brief:
COVID Vaccines and Vaccination.'' <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html</a>.
\3\ CDC. ``Overview of Testing for SARS-CoV-2 (COVID-19)''
October 22, 2021. Available at: <a href="https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html">https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html</a>.
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ACF published an Interim Final Rule with Comment Period (IFC) in
the Federal Register on November 30, 2021 (86 FR 68052). ACF issued the
IFC on the basis of its authority in Section 641A of the Head Start
Act, which allows the Secretary to ``modify, as necessary, program
performance standards by regulation applicable to Head Start agencies
and programs,'' including ``administrative and financial management
standards,'' ``standards relating to the condition and location of
facilities (including indoor air quality assessment standards, where
appropriate) for such agencies, and programs,'' and ``such other
standards as the Secretary finds to be appropriate,'' 42 U.S.C.
9836a(a)(1)(C), (D), and (E). In developing these modifications, the
Secretary included
[[Page 41328]]
relevant considerations pursuant to section 641A(a)(2) of the Head
Start Act, 42 U.S.C. 9836a(a)(2).\4\ The Secretary consulted with
experts in child health, including pediatricians, a pediatric
infectious disease specialist, and the recommendations of the CDC and
FDA.<SUP>5 6 7 8</SUP> The Secretary considered OHS's past experience
with the longstanding health and safety Head Start Program Performance
Standards that have sought to protect Head Start staff and participants
from communicable and contagious diseases. The Secretary also
considered the circumstances and challenges typically facing children
and families served by Head Start agencies. Challenges considered
included the disproportionate effect of COVID-19 on low-income
communities served by Head Start agencies and the potential for
devastating consequences for children and families of program closures
and service interruptions due to SARS-CoV-2 exposures. Based on all
these factors, the Secretary found it necessary and appropriate to set
health and safety standards for the condition of Head Start facilities
that help to reduce transmission of the SARS-CoV-2 and to help avoid
severe illness, hospitalization, and death among program participants.
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\4\ Not all the listed considerations are included because they
are only relevant to certain standards, such as curriculum.
\5\ CDC. ``Science Brief: COVID Vaccines and Vaccination.''
<a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html</a>.
\6\ CDC. ``Delta Variant: What We Know About the Science.''
August 26, 2021. Available at: <a href="https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html">https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html</a>.
\7\ Trends in COVID-19 Cases, Emergency Department Visits, and
Hospital Admissions Among Children and Adolescents Aged 0-17 Years--
United States, August 2020-August 2021 [verbar] MMWR.
\8\ <a href="https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status">https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status</a> MMWR Morb Mortal Wkly Rep 2021;70:1255-1260. DOI: <a href="http://dx.doi.org/10.15585/mmwr.mm7036e2">http://dx.doi.org/10.15585/mmwr.mm7036e2</a>.
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As of Jan. 1, 2022,<SUP>9 10</SUP> following a decision by the
United States District Court for the Northern District of Texas and the
Western District of Louisiana, implementation and enforcement of the
IFC was preliminarily enjoined in the following 25 states: Alabama,
Alaska, Arizona, Arkansas, Florida, Georgia, Indiana, Iowa, Kansas,
Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, North
Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas,
Utah, West Virginia, and Wyoming. Head Start, Early Head Start, and
Early Head Start-Child Care Partnership grant recipients in those 25
states were not required to comply with the IFC pending future
developments in the litigation. The IFC remained in effect in all other
states, the District of Columbia, and U.S. territories.
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\9\ Texas et al. v. Becerra, et al., No. 21-cv-00300, 2021 WL
6198109 (N.D. Tex. Dec. 31, 2021).
\10\ Louisiana, et al. v. Becerra, et al., 21-cv-04370, 2022 WL
16571 (Jan. 1, 2022 W.D. La.).
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As of the date of publication of the IFC, children under the age of
5 were not eligible for the COVID-19 vaccine. On June 17, 2022, the
U.S. Food and Drug Administration (FDA) authorized the emergency use of
the Moderna and Pfizer-BioNTech COVID-19 vaccines to include children 6
months through 5 years of age. While becoming fully vaccinated takes
time, and uptake for this cohort has been slow, this remains a critical
milestone in the pandemic response. Because vaccinations are now
available to children 6 months through 5 years of age, Head Start
children are now less vulnerable to the effects of COVID-19. COVID-19
vaccines continue to protect against severe disease, hospitalization,
and death in children and adolescents.
On March 31, 2023, the United States District Court for the
Northern District of Texas vacated the Vaccine and Mask Requirements to
Mitigate the Spread of COVID-19 in Head Start Programs, 86 FR 68052
(Nov. 30, 2021) (the ``Interim Final Rule'' or ``IFC''). That decision
took effect on April 7, 2023. Because of this ruling, as of April 7,
there is no longer a Head Start requirement for vaccination and testing
for Head Start, Early Head Start, and Early Head Start-Child Care
Partnership grant recipients in all states, tribes, and territories.
On April 10, 2023, President Biden signed legislation that ended
the COVID-19 national emergency declared by the President under the
National Emergencies Act. On May 11, 2023, the COVID-19 public health
emergency expired.
III. Rationale for the Rescission of the Vaccine Requirements
In enacting the IFC, OHS pointed to the substantial evidence at the
time of the efficacy of COVID-19 vaccines and the use of masks in
reducing transmission of SARS-CoV-2, offering both personal and
communal benefits. The COVID-19 vaccine was the most effective risk
reduction strategy available to avoid severe illness, hospitalization,
and death, as well as the most important measure for reducing risk for
SARS-CoV-2 transmission \11\ for the predominant variants of SARS-CoV-
2.
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\11\ CDC. ``Science Brief: Vaccines and Vaccination.'' <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html</a>.
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The rationale for the removal of the vaccination requirements
through this Final Rule is threefold. First, the Public Health
Emergency (PHE) declaration came to an end on May 11, 2023 and the
national emergency concerning COVID-19 ended on April 10, 2023 when the
President signed Public Law 118-3. While vaccination remains one of the
most important tools in advancing the health and safety of individuals,
this phase of the response is different than it was when ACF required
vaccination of Head Start staff.<SUP>12 13 14 15 16</SUP> As of May 1,
2023, COVID-19 deaths have declined by 97%, and hospitalizations are
down nearly 81%, since November 2021.\17\ Globally, COVID-19 deaths are
at their lowest levels since the start of the pandemic.\18\
Additionally, due to the nature of a prolonged pandemic, the majority
of Americans have experienced multiple immunization effects--natural
and inoculative. Data indicate infection- and vaccine-induced
population immunity in the United States was 95% by December 2021.\19\
To mitigate the consequences of the pandemic, approximately 675 million
COVID-19 vaccine doses were administered, including 55 million updated
(bivalent) booster doses.\20\ Relatedly, and
[[Page 41329]]
particularly impactful for the population Head Start programs serve, is
the availability and uptake of the COVID-19 vaccine for young children
and its inclusion in the CDC's Immunization Schedules.\21\ Note that
there is waning immunity following vaccination, however, immunization
efforts are improving due to greater access to vaccination and more
widespread natural immunity. Though COVID-19 is still an ongoing public
health issue, it is no longer a societal emergency as it was at the
onset of the pandemic and no longer necessitates the same level of
federal response. Similarly, the change in pandemic conditions
reflected in the termination of the national emergency and public
health emergency likewise would make it appropriate to rescind the
masking requirement if that requirement were still in effect.
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\12\ Trends in COVID-19 Cases, Emergency Department Visits, and
Hospital Admissions Among Children and Adolescents Aged 0-17 Years--
United States, August 2020-August 2021 [verbar] MMWR.
\13\ <a href="https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status">https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status</a> MMWR Morb Mortal Wkly Rep 2021;70:1255-1260. DOI: <a href="http://dx.doi.org/10.15585/mmwr.mm7036e2">http://dx.doi.org/10.15585/mmwr.mm7036e2</a>.
\14\ <a href="https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination">https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination</a>.
\15\ Johnson AG, Amin AB, Ali AR, et al. COVID-19 Incidence and
Death Rates Among Unvaccinated and Fully Vaccinated Adults with and
Without Booster Doses During Periods of Delta and Omicron Variant
Emergence--25 U.S. Jurisdictions, April 4-December 25, 2021. MMWR
Morb Mortal Wkly Rep 2022;71:132-138. DOI: <a href="http://dx.doi.org/10.15585/mmwr.mm7104e2externalicon">http://dx.doi.org/10.15585/mmwr.mm7104e2externalicon</a>.
\16\ Centers for Disease Control and Prevention. ``Science
Brief: Vaccines and Vaccination.'' <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html">https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html</a>.
\17\ Centers for Disease Control and Prevention. COVID Data
Tracker. Atlanta, GA: U.S. Department of Health and Human Services,
CDC; 2023, May 26. <a href="https://covid.cdc.gov/covid-data-tracker">https://covid.cdc.gov/covid-data-tracker</a>.
\18\ <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/01/the-biden-administration-will-end-covid-19-vaccination-requirements-for-federal-employees-contractors-international-travelers-head-start-educators-and-cms-certified-facilities/">https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/01/the-biden-administration-will-end-covid-19-vaccination-requirements-for-federal-employees-contractors-international-travelers-head-start-educators-and-cms-certified-facilities/</a>.
\19\ Jones JM, Opsomer JD, Stone M, et al. Updated U.S.
infection- and vaccine-induced SARS-CoV-2 seroprevalence estimates
based on blood donations, July 2020-December 2021. JAMA
2022;328:298-301. <a href="https://doi.org/10.1001/jama.2022.9745">https://doi.org/10.1001/jama.2022.9745</a>
PMID:35696249.
\20\ CDC. COVID-19 data review: update on COVID-19-related
mortality. Atlanta, GA: U.S. Department of Health and Human
Services, CDC; 2023. Accessed April 14, 2023. <a href="https://www.cdc.gov/coronavirus/2019-ncov/science/data-review/index.html">https://www.cdc.gov/coronavirus/2019-ncov/science/data-review/index.html</a>.
\21\ CDC. ``Child and Adolescent Immunization Schedule by Age.''
Recommendations for Ages 18 Year and Younger, United States, 2023.
Available at: <a href="https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html">https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html</a>.
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Second, on January 6, 2023, ACF issued a Final Rule (88 FR 993)
requiring Head Start grant recipients to have an evidence-based COVID-
19 mitigation policy, which considers multiple mitigation strategies
such as vaccination, masking, ventilation, testing, and staying home
when sick that can be scaled up or down as COVID-19 conditions
necessitate. ACF strongly recommends that Head Start programs use
vaccines and tests as part of their mitigation policy to reduce the
spread of COVID-19 and reduce the likelihood of mortality or morbidity
from infection. Head Start programs may choose to include their own
requirements to support vaccination efforts, including for example,
requiring staff remain up to date on COVID-19 vaccines, sharing
information on COVID-19 vaccination with staff and families, and/or
partnering with local agencies to increase vaccination access. With
this new requirement of an evidence-based COVID-19 mitigation policy in
place, Head Start grant recipients are better positioned to respond to
future surges of SARS-CoV-2.
Finally, as discussed in detail below, ACF considered public
comments on the IFC when making the decision to rescind the vaccine and
testing requirements.
IV. Overview of Public Comments on the Interim Final Rule With Comment
Period
The comment period for the IFC was open for 30 days and closed on
December 30, 2021. OHS received 2,794 comments, of which 2,690 were
unique submissions. Most comments came from individuals, including Head
Start directors, other Head Start staff members, Members of Congress,
and parents. A smaller subset of comments came from associations on
behalf of their membership.
We discussed many of these comments in the Final Rule issued on
January 6, 2023, including global comments pertaining to the perceived
burden of the vaccine and masking requirements, the reported challenged
to enrollment, the implementation timeline, and the open-ended,
indefinite nature of the requirements. In Part V. Public Comments
Analysis of this Final Rule, we focus on comments that are specific to
the vaccination requirement, and the associated ``at least weekly''
testing requirement for those who are granted an exemption to the
vaccination requirement. These comments account for approximately one-
quarter of the comments received on the IFC.
V. Public Comments Analysis
In this section, we provide a summary of the comments we received
on the IFC related to the vaccine and testing requirements outlined in
Section 1302.93(a)(1)-(2) and 1302.94(a)(1)-(2).
Comment: Commenters raised concerns with the lack of the
termination date for the vaccine requirements. In the IFC, ACF invited
comment on the decision to leave an undetermined end date or set a
finite end date, such as 6 months from the effective date of the rule.
Programs reported concerns that the indefinite nature of the
requirement impedes their ability to update their internal policies,
inform staff of expectations, update parents and families, budget for
next year and outline expectations for prospective staff and families.
Several commenters noted that public health emergency declarations come
to an end and objected that the vaccine and testing requirements were
``made permanent'' by including them in the Head Start Program
Performance Standards.
Response: ACF is removing the vaccine requirement in this final
rule, which means Head Start programs are no longer determining which
staff are exempt from the vaccine requirement and requiring ``at least
weekly'' testing for those granted an exemption unless their program
opts to include such requirements under its COVID mitigation policy.
Comment: Commentors raised concerns about providers paid partially
with Head Start funds who are subject to the Head Start vaccination
requirement but are not required by their employer to be vaccinated.
There is concern that school districts and other partners that do not
have a masking or vaccination requirement will opt out of partnerships
and consider withdrawing contracts. This would result in the loss of
services to children and families--a loss in classroom space,
transportation options, etc. Similarly, there was also concern that
children in Head Start programs situated within partnerships would be
unfairly singled out and/or discriminated against by other children in
the setting (who are not subject to the mask requirement).
Response: OHS understands this concern and appreciates the comments
from those who described the partnerships Head Start programs have
established and sustained in their communities over many years. OHS is
removing the national vaccine requirement in this final rule and, in
doing so, has addressed the concerns from these commenters.
As noted, ACF issued a Final Rule, Mitigating the Spread of COVID-
19 in Head Start Programs, on January 6, 2023, that requires Head Start
programs to have an evidence-based COVID-19 mitigation policy developed
in consultation with the program's Health Services Advisory Committee
(HSAC). ACF recommends that Head Start programs use vaccines and tests
as part of their mitigation policy to reduce the spread of COVID-19 and
reduce the likelihood of mortality or morbidity from infection. Head
Start programs may choose to include their own requirements to support
vaccination efforts, including for example, requiring staff remain up
to date on COVID-19 vaccination, sharing information on COVID-19
vaccination with staff and families, and/or partnering with local
agencies to increase vaccination access.
Comment: Commentors were concerned about the impact of these
requirements on access to special education services under Individuals
with Disabilities Education Act (IDEA). Comments expressed concern that
early intervention providers and other professionals providing special
education and related services to enrolled children through Part B and
C of IDEA, some of whom may not be required to be vaccinated by their
employers, are required to be vaccinated under the IFC. There were
concerns that
[[Page 41330]]
there will be a reduction in children's access to early identification,
early intervention, and special education services, which could
potentially result in children not receiving services to which they are
legally entitled under IDEA if Local Education Agencies (LEA) do not
have similar vaccination requirements.
Response: OHS has removed the national vaccine requirement in this
final rule and therefore, addressed these concerns. Though special
education, early intervention, health service providers and other
related service providers (e.g., IDEA Part B/C providers) are neither
staff of Head Start programs nor contractors and were never included in
the vaccination requirement, the removal of the vaccine requirement
should address any concerns about the reduction in services or
perceived barriers in services for children in need of early
intervention, special education, or related services. Given the
critical nature of the services provided through these partnerships, to
further address the concerns raised, OHS released an FAQ that made
clear these providers were not included in the requirement.
Additionally, in partnership with the U.S. Department of Education's
Office of Special Education Programs, OHS authored a Dear Colleague
Letter and guidance document stating that state and local educational
agencies and Head Start programs have responsibilities for implementing
IDEA to ensure that children with disabilities enrolled in Head Start
programs receive a free appropriate public education in the least
restrictive environment.
Comment: Commentors were concerned that those given an exemption
were being discriminated against because they were being singled out
for testing. Some suggested requiring testing for all, regardless of
vaccination status. Others encouraged an opt-out option for all staff
with the hopes of fewer staff leaving for employment elsewhere.
Conversely, commentors were concerned with the burden imposed on
grantees to implement and track weekly testing, especially in rural
areas with limited access to tests.
Response: OHS has removed the vaccination requirement and
consequently the ``at least weekly'' testing requirement for those
staff exempt from the vaccine requirement. Though OHS did not receive
any reports of widespread difficulty accessing tests and/or tracking of
test results or indication of discrimination on the basis of being
singled out for testing, the rescission of this requirement in the
final rule should also address any remaining concerns with regard to
testing.
Comment: Some commentors reported that Head Start staff do not have
to provide their COVID-19 vaccination status or proof of vaccination
status because that information is protected by the Health Insurance
Portability and Accountability Act of 1996 (HIPAA). Other commentors
raised general concerns that the vaccination requirements should not be
mandated by their place of employment. Commentors felt that medical
requirements are a violation of employee rights and that vaccines
should be a personal choice.
Response: In accordance with HHS guidance, HIPAA does not prohibit
any person from asking whether an individual has received a particular
vaccine, including COVID-19 vaccines. Since 1998, OHS has required that
programs ensure staff do not pose a significant risk of communicable
disease (45 CFR 1302.93(a)). At the time of the IFC's publication, the
COVID-19 vaccine was an important requirement that reduced transmission
of SARS-COV-2. While OHS disagrees with these comments, OHS is no
longer requiring all Head Start staff, contractors whose activities
involve contact with or providing direct services to children and
families, and volunteers working in classrooms or directly with
children to be vaccinated for COVID-19.
VII. Regulatory Process Matters
Treasury and General Government Appropriations Act of 1999
Section 654 of the Treasury and General Government Appropriations
Act of 1999 requires federal agencies to determine whether a policy or
regulation may negatively affect family well-being. If the agency
determines a policy or regulation negatively affects family well-being,
then the agency must prepare an impact assessment addressing seven
criteria specified in the law. ACF believes it is not necessary to
prepare a family policymaking assessment, see Public Law 105-277,
because the action it takes in this final rule will not have any impact
on the autonomy or integrity of the family as an institution.
Federalism Assessment Executive Order 13132
Executive Order 13132 requires federal agencies to consult with
state and local government officials if they develop regulatory
policies with federalism implications. Federalism is rooted in the
belief that issues that are not national in scope or significance are
most appropriately addressed by the level of government close to the
people. This rule will not have substantial direct impact on the
states, on the relationship between the federal government and the
states, or on the distribution of power and responsibilities among the
various levels of government. Therefore, in accordance with section 6
of Executive Order 13132, it is determined that this action does not
have sufficient federalism implications to warrant the preparation of a
federalism summary impact statement.
Congressional Review Act
Subtitle E of the Small Business Regulatory Enforcement Fairness
Act of 1996 (also known as the Congressional Review Act or CRA) allows
Congress to review certain rules issued by federal agencies before the
rules take effect. See 5 U.S.C. 801(a). The CRA defines such a rule as
one that has resulted, or is likely to result, in (1) an annual effect
on the economy of $100 million or more; (2) a major increase in costs
or prices for consumers, individual industries, Federal, State, or
local government agencies, or geographic regions; or (3) significant
adverse effects on competition, employment, investment, productivity,
or innovation, or on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic and export markets.
See 5 U.S.C. 804(2). The Office of Information and Regulatory Affairs
in the Office of Management and Budget has determined that this action
does not fall within the scope of 5 U.S.C. 804(2).
Paperwork Reduction Act of 1995
The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501 et seq.,
minimizes government-imposed burden on the public. In keeping with the
notion that government information is a valuable asset, it also is
intended to improve the practical utility, quality, and clarity of
information collected, maintained, and disclosed.
The PRA requires that agencies obtain OMB approval, which includes
issuing an OMB number and expiration date, before requesting most types
of information from the public. Regulations at 5 CFR part 1320
implemented the provisions of the PRA and Sec. 1320.3 of this part
defines a ``collection of information,'' ``information,'' and
``burden.'' PRA defines ``information'' as any statement or estimate of
fact or opinion, regardless of form or format, whether numerical,
graphic, or narrative form, and whether oral or maintained on paper,
electronic,
[[Page 41331]]
or other media (5 CFR 1320.3(h)). This includes requests for
information to be sent to the government, such as forms, written
reports and surveys, recordkeeping requirements, and third-party or
public disclosures (5 CFR 1320.3(c)). ``Burden'' means the total time,
effort, or financial resources expended by persons to collect,
maintain, or disclose information.
The existing OMB Control Number for this information collection
request (ICR) is 0970-0583. This final rule will remove the majority of
reporting requirements approved under this OMB Control Number. The only
recordkeeping requirement that will remain is the recordkeeping
requirement that grant recipients update their program policies and
procedures with the evidence-based COVID-19 mitigation policy, which
was required in the final rule published on January 6, 2023 (88 FR
993). There are no new recordkeeping activities associated with this
final rule.
VIII. Regulatory Impact Analysis
I. Introduction and Summary
A. Introduction
We have examined the impacts of this final rule under Executive
Order 12866, Executive Order 13563, and the Regulatory Flexibility Act
(5 U.S.C. 601-612). Executive Orders 12866 and 13563 direct us to
assess all costs and benefits of available regulatory alternatives and,
when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). We believe that this final rule is a significant
regulatory action as defined by Executive Order 12866. Thus, this rule
has been reviewed by the Office of Information and Regulatory Affairs.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the impacts to small entities attributable to the
final rule are cost savings, this analysis concludes, and the Secretary
certifies, that the final rule will not have a significant economic
impact on a substantial number of small entities. These impacts are
discussed in detail in the Final Small Entity Analysis.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $177
million, using the most current (2022) Implicit Price Deflator for the
Gross Domestic Product. This final rule will not result in expenditures
in any year that meet or exceed this amount.
B. Summary of Benefits and Costs
This final rule removes the COVID-19 vaccination and testing
requirements established on November 30, 2021 through an Interim Final
Rule with Comment (IFC), ``Vaccine and Mask Requirements To Mitigate
the Spread of COVID-19 in Head Start Programs.'' \22\ In this analysis,
we evaluate the impacts of the final rule in comparison to a primary
analytic baseline scenario in which these IFC requirements continue
over the time horizon of the analysis. We also discuss the impacts in
comparison to an alternative baseline scenario of no vaccination and
testing requirements.
---------------------------------------------------------------------------
\22\ 86 FR 68052.
---------------------------------------------------------------------------
The final rule will result in fewer COVID-19 tests performed under
the testing requirement for individuals granted an exemption from the
vaccine requirement. This analysis estimates $16.8 million in cost
savings associated with fewer tests performed. The final rule will also
result in reduced vaccine uptake among some individuals hired by Head
Start programs over the time horizon of this analysis, who would become
fully vaccinated under the IFC but who will not become fully vaccinated
without the vaccination requirement. We estimate $1.7 million in cost
savings associated with fewer new hires becoming fully vaccinated. We
also identify foregone benefits in the form of reduced COVID-19
mortality and morbidity risks associated with vaccination. We monetize
these mortality risks using a value per statistic life approach and
report a primary value of these disbenefits of about $0.7 million. Over
a one-year time horizon, we estimate that this final rule will result
in about $18.5 million in total cost savings. Subtracting disbenefits
from the cost savings, we conclude that this final rule will result in
net benefits of about $17.8 million. These estimates are reported in
2022 dollars and do not depend on the choice of 3% or 7% discount rate.
As discussed in greater detail in the full analysis, we acknowledge
some uncertainty in these estimates, including that some Head Start
programs likely adopted evidence-based COVID-19 mitigation policies
that include testing or vaccination strategies.
II. Analysis of the Final Rule
A. Background and Baselines
On November 30, 2021, ACF published an interim final rule with
comment period on ``Vaccine and Mask Requirements To Mitigate the
Spread of COVID-19 in Head Start Programs'' (IFC).\23\ The IFC added
provisions to the Head Start Program Performance Standards to impose
three requirements: \24\
---------------------------------------------------------------------------
\23\ Ibid.
\24\ Ibid.
---------------------------------------------------------------------------
1. Universal masking, with some noted exceptions, for all
individuals two years of age and older when there are two or more
individuals in a vehicle owned, leased, or arranged by the Head Start
program; when they are indoors in a setting where Head Start services
are provided; and, for those not fully vaccinated, outdoors in crowded
settings or during activities that involve close contact with other
people.
2. Vaccination for COVID-19 for Head Start program staff, certain
contractors and volunteers by January 31, 2022.
3. For those granted an exemption to the requirement specified in
(2), at least weekly testing for current SARS-CoV-2 infection.
On January 6, 2023, ACF published a final rule on ``Mitigating the
Spread of COVID-19 in Head Start Programs.'' \25\ That final rule
modified the IFC to remove the requirement for universal masking for
all individuals ages 2 and older, and to require that Head Start
programs have an evidence-based COVID-19 mitigation policy, developed
in consultation with their Health Services Advisory Committee. It did
not address the vaccination and testing requirements of the IFC.
---------------------------------------------------------------------------
\25\ 88 FR 993.
---------------------------------------------------------------------------
In our analysis of this final rule, we adopt a baseline scenario of
the requirements of the November 30, 2021 IFC, as modified by the
January 6, 2023 final rule. This choice of baseline includes ongoing
impacts associated with the testing requirements. It also includes
impacts associated with the vaccination requirement; however, these
impacts are limited to individuals who will be newly hired over the
time horizon of the analysis, since the effective date of the
vaccination requirement for existing staff has passed. As discussed in
greater detail in the Preamble, the requirements addressed in this
final rule are not in effect as a result of a ruling by the
[[Page 41332]]
United States District Court for the Northern District of Texas. Under
an alternative baseline that accounts for this ruling or that compares
against a hypothetical future in which the IFC had never been issued,
the final rule would result in no benefits or costs.
B. Cost Savings Associated With the Testing Requirement
To estimate the cost savings of removing the testing requirement,
we first estimate the number of tests required, and the costs of
testing, under our baseline scenario. We follow the general approach of
the IFC RIA, with several revisions to the assumptions identified in
that analysis. First, the IFC RIA's cost estimates covered 273,000 Head
Start staff, consistent with data available at the time that analysis
was published and the time horizon it covered. In this RIA, we adopt a
lower estimate of 245,700 Head Start staff covered under the baseline
scenario. This estimate is consistent with more recent data from Head
Start programs, and projections of a 10% reduction in the Head Start
workforce over the time horizon of this RIA compared to the period
covered in the IFC RIA.\26\ Second, the IFC RIA assumed that 5% of Head
Start staff would receive an exemption from the vaccine requirement.
This likely underestimated the share of staff receiving an exemption,
so we increase this estimate to 8.5%. Third, the IFC RIA presented data
that 83% Head Start centers were operating in-person or hybrid. Based
on that data, the IFC RIA reduced the number of staff requiring testing
by 17%, since screening testing would not impact staff at virtual/
remote or closed centers. Applying updated data, the RIA for the
January 6, 2023 final rule adopted an estimate of 94% of centers
operating in-person or hybrid. In this analysis, we assume that 100% of
centers operate in-person or hybrid over the time horizon of the
analysis.
---------------------------------------------------------------------------
\26\ Note it is difficult to determine what share of recruitment
and retainment challenges are attributable to this requirement as
compared to other causes. ACF is aware that compensation has
significantly affected the early childhood workforce shortage and is
the number one reason for Head Start staff attrition. Research with
the broader early childhood education (ECE) field indicates higher
compensation for ECE professionals can improve employment stability
and reduce turn-over (and vice versa, with lower wages linked to
high turn-over). Additionally, we have no evidence that the
workforce challenges differed between Head Start programs required
to implement the IFC and those that were not (as a result of
litigation that enjoined 25 states).
---------------------------------------------------------------------------
Combining these assumptions, we estimate that 24,570 staff that are
not fully vaccinated would be tested under the baseline scenario. We
maintain the assumption of the IFC RIA that each test costs $10. We
identify a second cost of time spent testing, adopting an assumption
that each test takes 15 minutes to perform. Using a value of time of
$29.82 per hour,\27\ this is $7.46 in time costs per person tested, or
$17.46 in total costs per person tested. Across 24,570 staff tested
weekly, this is a weekly cost of testing of $428,869.
---------------------------------------------------------------------------
\27\ According to the U.S. Bureau of Labor Statistics, the
hourly median wage for Preschool and Kindergarten Teachers in the
Child Day Care Services industry is $14.91 per hour. We assume that
benefits plus indirect costs equal approximately 100 percent of pre-
tax wages, and adjust this hourly rate by multiplying by two, for a
fully loaded hourly wage rate of $29.82. U.S. Bureau of Labor
Statistics. Occupational Employment and Wage Statistics, May 2022
National Industry-Specific Occupational Employment and Wage
Estimates, NAICS 624400--Child Day Care Services. Median hourly
wage. <a href="https://www.bls.gov/oes/current/naics4_624400.htm">https://www.bls.gov/oes/current/naics4_624400.htm</a>.
---------------------------------------------------------------------------
Thus, we estimate that the final rule, which removes the testing
requirement, would result in $428,869 in weekly cost savings. For the
purposes of this analysis, we assume that Head Start programs operate
in-person, on average, 9 months per year, or about 39 weeks per year.
Multiplying the weekly cost savings by the number of weeks results in
$16.8 million in cost savings over one calendar year. We acknowledge
several sources of uncertainty in this estimate, each of which may
contribute to overestimating these cost savings. First, some Head Start
programs likely adopted evidence-based COVID-19 mitigation policies
that include testing, thus reducing the impact of this final rule on
testing. Second, some individuals that will no longer be required to
test weekly will continue to test routinely, or on an ad hoc basis,
unrelated to Head Start policies. Third, our baseline scenario assumes
`full compliance' with the IFC, which may overstate the quantity of
tests that would be performed under the IFC, even absent the ruling by
the United States District Court for the Northern District of Texas.
C. Cost Savings Associated With Removing the Vaccination Requirement
To estimate the cost savings of removing the vaccination
requirement, we first estimate the number of individuals who would be
newly subject to the vaccination requirement under the baseline
scenario over the time horizon of this analysis. Specifically, we
estimate the number of individuals who would be hired under the
baseline scenario that are not fully vaccinated. To generate this
estimate, we adopt an assumption that Head Start programs turnover and
hire about 10% of teachers and staff every year, or 24,570 new hires
per year. We assume that 20.9% of these new hires are not fully
vaccinated, which is consistent with data as of May 10, 2023 that 79.1%
of the U.S. population >=18 years of age have completed a primary
series.\28\ Thus, over the time horizon of our analysis, we estimate
that 5,135 new hires would be subject to the vaccination requirement.
Consistent with our approach to estimating testing, we assume that 8.5%
of these new hires would receive an exemption from the vaccination
requirement. Combining these assumptions, we estimate 4,699 individuals
would become fully vaccinated under the baseline scenario.
---------------------------------------------------------------------------
\28\ <a href="https://covid.cdc.gov/covid-data-tracker/">https://covid.cdc.gov/covid-data-tracker/</a>. Accessed May 17,
2023.
---------------------------------------------------------------------------
To monetize the costs associated with the vaccination requirement,
we follow the general approach of the IFC RIA, with several revisions
to the assumptions identified in that analysis. We retain the IFC RIA's
estimates of $80 per person to account for two vaccine doses and the
costs of administering those doses. The IFC RIA also included an
estimate of 2 hours as the time necessary to receive one COVID-19
vaccine dose, which that analysis describes as intending ``to be
inclusive of scheduling time; commuting time; time receiving a vaccine
dose; waiting time, including after receiving a vaccine dose to watch
for any reactions; and recovery time.'' For this analysis, we identify
an additional cost associated with adverse reactions, adopting an
assumption of 5.76 hours in time losses across two doses from a broader
study of U.S. employer COVID-19 vaccine mandates,\29\ or 2.88 hours per
dose. These assumptions sum to 4.88 hours in time costs per dose, or
9.76 hours in time costs for two doses. We again adopt a value of time
of $29.82 per hour, for $291.04 in time costs per individual across two
doses. Combined with the costs of the vaccine doses and the costs of
administering doses, this is $371.04 per individual. Across all 4,699
individuals who would become fully vaccinated under the baseline
scenario, this is about $1.7 million in costs associated with the
vaccine requirement.
---------------------------------------------------------------------------
\29\ Ferranna M, Robinson LA, Cadarette D, Eber MR, Bloom DE.
2023. ``The benefits and costs of U.S. employer COVID-19 vaccine
mandates.'' Risk Analysis. Published online January 17, 2023.
doi:10.1111/risa.14090.
---------------------------------------------------------------------------
Thus, we estimate that the final rule, which removes the
vaccination requirement, would result in about $1.7 million in cost
savings over one calendar year. We acknowledge several sources of
uncertainty in this estimate.
[[Page 41333]]
First, some Head Start programs likely adopted evidence-based COVID-19
mitigation policies that include vaccination, thus reducing the impact
of this final rule on vaccination. Second, as noted in the IFC RIA,
absent the IFC, Head Start teachers were more likely to be fully
vaccinated than the general adult population. If individuals hired over
the time horizon of this analysis are similarly more likely to be fully
vaccinated than the general adult population, this would also reduce
the impact of the final rule on vaccination.
D. Foregone Benefits Associated With the Final Rule
To estimate the forgone benefits associated with removing the
vaccination requirement, we follow a simplified version of the approach
used in the IFC RIA to estimate the health benefits from reductions in
COVID-19 mortality attributable to the IFC. In that analysis, we
generated forecasts of COVID-19 outcomes for a baseline scenario and an
IFC scenario that were built on projections published by the Institute
for Health Metrics and Evaluation (IHME). IHME has paused its COVID-19
modeling, and we have not identified a comparable replacement. For the
purposes of identifying the magnitude of the forgone benefits from
reduced vaccine uptake under the final rule, we consider a simpler
model that adopts a static forecast of observed weekly death rates that
vary by vaccine status.
CDC data indicate that, at the time the IFC was issued, the weekly
death rate among unvaccinated adults was 18.25 deaths per 100,000
people; and for adults who were vaccinated without an updated booster,
1.02 weekly deaths per 100,000 people.\30\ At the time this analysis
was prepared, the most recent data readily available indicate that the
weekly death rate among unvaccinated adults was 1.07 per 100,000
people; and for adults who were vaccinated without an updated booster,
0.21 weekly deaths per 100,000 people.\31\ These weekly death rates
include adults of all ages, and are largely driven by deaths among
people 65 and older, which represent only a small fraction of the Head
Start workforce. Since the impacts we are studying accrue to new hires,
we focus on weekly death rates for adults between the ages of 30 and
49. For this age group, the weekly death rate among unvaccinated adults
was 0.07 deaths per 100,000 people; and for adults who were vaccinated
without an updated booster, 0.03 deaths per 100,000 people.\32\
---------------------------------------------------------------------------
\30\ <a href="https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status">https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status</a>. Weekly death rates from November 28, 2021.
\31\ <a href="https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status">https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status</a>. Weekly death rates from February 26, 2023.
\32\ <a href="https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status">https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status</a>. Weekly death rates from February 26, 2023.
---------------------------------------------------------------------------
To apply these estimates, we add assumptions such that the 4,699
individuals who would become fully vaccinated under the baseline
scenario will be hired uniformly over the one-year time horizon and
that they would be fully vaccinated for exactly half of the year. Thus,
assuming weekly death rates remain constant, we would expect about 0.12
deaths among new hires over one year.\33\ Under the final rule, these
individuals would not become fully vaccinated, and we would expect
about 0.17 deaths among new hires over one year.\34\ Thus, we estimate
that removing the vaccination requirement would result in mortality
risk increases equal to 0.05 statistical lives. We monetize these
mortality risk increases associated with lower vaccine uptake using a
value per statistical life of $12.4 million \35\ and report an estimate
of forgone benefits of about $0.61 million.\36\
---------------------------------------------------------------------------
\33\ (0.07+0.03)/2/100,000 * 4,699 * 52 [ap] 0.12.
\34\ 0.07/100,000 * 4,699 * 52 [ap] 0.17.
\35\ U.S. Department of Health and Human Services, Office of the
Assistant Secretary for Planning and Evaluation. 2021. ``Updating
Value per Statistical Life (VSL) Estimates for Inflation and Changes
in Real Income.'' <a href="https://aspe.hhs.gov/reports/updating-vsl-estimates">https://aspe.hhs.gov/reports/updating-vsl-estimates</a>.
\36\ As a sensitivity analysis, we adopt a range of VSL
estimates between $5.8 million and $18.9 million to report a range
of estimates for the forgone benefits of between $0.3 million and
$0.9 million.
---------------------------------------------------------------------------
The IFC RIA also contained estimates of morbidity risk reductions
associated with the vaccine requirement. As with the mortality
estimates, these outcome forecasts were built on projections published
by IHME. Lacking comparable projections, we produce an estimate of
these forgone benefits by referencing the ratio of the total value of
health benefits to the value of mortality benefits estimated in the IFC
RIA. Table 25 in the IFC RIA reports a central estimate of the total
value of risk reductions of $236.8 million, and $213.4 million as the
central estimate of the mortality risk reductions. In that analysis,
the total value of the health benefits is about 11% higher than the
value of the mortality benefits alone. Thus, in this simplified
analysis, we report foregone total benefits associated with removing
the vaccination requirement of about $0.67 million, which is about 11%
larger than the $0.61 million in mortality benefits estimated above.
We acknowledge several sources of uncertainty in addition to those
identified in the previous section. First, the source data on weekly
death rates are not adjusted for time since vaccination, which could
result in the population estimates of the weekly death rate for
vaccinated adults overestimating the weekly death rate for newly
vaccinated individuals. If this is the case, then our foregone benefit
estimates may be underestimated, all else equal. Second, the relative
risk of COVID-19 mortality and morbidity by vaccination status has
varied over time and by variant. Moreover, the estimates of the
relative risk of COVID-19 mortality by vaccination status used in this
analysis serve as a proxy for the effects of vaccination. There may be
other factors correlated with vaccination status that also affect
mortality and morbidity. Consequently, our approach may overestimate or
underestimate the incremental effects of vaccination, which would pass
through to our estimates of the forgone benefits of the final rule.
Third, COVID-19 deaths and cases have varied over time.
III. Final Small Entity Analysis
We have examined the economic implications of this Final Rule as
required by the Regulatory Flexibility Act. This analysis, as well as
other sections in this Regulatory Impact Analysis, serves as the Final
Regulatory Flexibility Analysis, as required under the Regulatory
Flexibility Act.
A. Description and Number of Affected Small Entities
The U.S. Small Business Administration (SBA) maintains a Table of
Small Business Size Standards Matched to North American Industry
Classification System Codes (NAICS).\37\ We replicate the SBA's
description of this table:
---------------------------------------------------------------------------
\37\ U.S. Small Business Administration (2023). ``Table of Size
Standards.'' March 17, 2023 <a href="https://www.sba.gov/document/support--table-size-standards">https://www.sba.gov/document/support--table-size-standards</a>.
This table lists small business size standards matched to
industries described in the North American Industry Classification
System (NAICS), as modified by the Office of Management and Budget,
effective January 1, 2022.
The size standards are for the most part expressed in either
millions of dollars (those preceded by ``$'') or number of employees
(those without the ``$''). A size standard is the largest that a
concern can be and still qualify as a small business for Federal
Government programs. For the most part, size standards are the
average annual receipts or the average employment of a firm. How to
calculate average annual receipts and average employment of a firm
can be found in 13 CFR 121.104 and 13 CFR 121.106, respectively.
[[Page 41334]]
This final rule will impact small entities in NAICS category
624410, Child Care Services, which has a size standard of $9.5 million
dollars. We assume that most Head Start programs, if not all, are below
this threshold and are considered small entities.
B. Description of the Impacts of the Rule on Small Entities
Compared to the baseline scenario, this final rule will result in
cost savings for Head Start programs. We estimate that the incremental
impact of the final rule is about $18.5 million in net cost savings,
most of which will accrue to Head Start programs. Across 20,717
centers, we estimate that these cost savings will average $894 in cost
savings per center. This analysis concludes that the final rule is not
likely to result in a significant impact on a substantial number of
small entities.
IX. Tribal Consultation Statement
ACF conducts an average of five tribal consultations each year for
tribes operating Head Start and Early Head Start. The consultations are
held in four geographic areas across the country: Southwest, Northwest,
Midwest (Northern and Southern), and East. The consultations are often
held in conjunction with other tribal meetings or conferences, to
ensure the opportunity for most of the 150 tribes that operate Head
Start and Early Head Start programs to attend and voice their concerns
regarding service delivery. We complete a report after each
consultation, and then we compile a final report that summarizes the
consultations. We submit the report to the Secretary of Health and
Human Services (the Secretary) at the end of the year.
Although this rule does not have implications specific to AIAN
programs, OHS will continue to collaborate with Tribes on all matters
related to the Head Start Program Performance Standards.
January Contreras, Assistant Secretary of the Administration for
Children and Families, approved this document on May 8, 2023.
List of Subjects in 45 CFR Part 1302
COVID-19, Evidence-based COVID-19 mitigation policy, Education of
disadvantaged, Grant programs--social programs, Head Start, Health
care, Monitoring, Safety, Vaccination.
Dated: June 20, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
Accordingly, the final rule amending 45 CFR part 1302, which was
published at 86 FR 68052, is adopted as final with the following
changes:
PART 1302--PROGRAM OPERATIONS
0
1. The authority citation for part 1302 continues to read as:
Authority: 42 U.S.C. 9801 et seq.
Sec. 1302.93 [Amended]
0
2. Amend Sec. 1302.93 by removing paragraphs (a)(1) and (2).
Sec. 1302.94 [Amended]
0
3. Amend Sec. 1302.94 by removing paragraphs (a)(1) and (2).
[FR Doc. 2023-13423 Filed 6-23-23; 8:45 am]
BILLING CODE 4184-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.