Removal of the Vaccine Requirements for Head Start Programs, 41326-41334 [2023-13423]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Administration for Children and Families

[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 [www.gpo.gov]
[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 
[email protected] 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.'' https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
    \3\ CDC. ``Overview of Testing for SARS-CoV-2 (COVID-19)'' 
October 22, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html.
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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.5 6 7 8 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.'' 
https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
    \6\ CDC. ``Delta Variant: What We Know About the Science.'' 
August 26, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html.
    \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\ https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status MMWR Morb Mortal Wkly Rep 2021;70:1255-1260. DOI: https://dx.doi.org/10.15585/mmwr.mm7036e2.
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    As of Jan. 1, 2022,9 10 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.'' https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
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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.12 13 14 15 16 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\ https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status MMWR Morb Mortal Wkly Rep 2021;70:1255-1260. DOI: https://dx.doi.org/10.15585/mmwr.mm7036e2.
    \14\ https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination.
    \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: https://dx.doi.org/10.15585/mmwr.mm7104e2externalicon.
    \16\ Centers for Disease Control and Prevention. ``Science 
Brief: Vaccines and Vaccination.'' https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
    \17\ Centers for Disease Control and Prevention. COVID Data 
Tracker. Atlanta, GA: U.S. Department of Health and Human Services, 
CDC; 2023, May 26. https://covid.cdc.gov/covid-data-tracker.
    \18\ 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/.
    \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. https://doi.org/10.1001/jama.2022.9745 
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. https://www.cdc.gov/coronavirus/2019-ncov/science/data-review/.
    \21\ CDC. ``Child and Adolescent Immunization Schedule by Age.'' 
Recommendations for Ages 18 Year and Younger, United States, 2023. 
Available at: https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html.
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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. https://www.bls.gov/oes/current/naics4_624400.htm.
---------------------------------------------------------------------------

    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\ https://covid.cdc.gov/covid-data-tracker/. 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\ https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status. Weekly death rates from November 28, 2021.
    \31\ https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status. Weekly death rates from February 26, 2023.
    \32\ https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status. 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.'' https://aspe.hhs.gov/reports/updating-vsl-estimates.
    \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 https://www.sba.gov/document/support--table-size-standards.

    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