[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Rules and Regulations]
[Pages 993-1009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28451]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families

45 CFR Part 1302

RIN 0970-AC90


Mitigating the Spread of COVID-19 in 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 requirement for universal masking 
for all individuals ages 2 and older. This final rule requires that 
Head Start programs have an evidence-based COVID-19 mitigation policy, 
developed in consultation with their Health Services Advisory 
Committee. This final rule does not address the vaccination and testing 
requirement, which is still under review. The vaccine requirement 
remains in effect.

DATES: Effective date: This final rule is effective January 6, 2023.
    Compliance date: The compliance date for the evidence-based COVID-
19 mitigation policy specified at Sec.  1302.47(b)(9) is, March 7, 
2023. For more information, see Implementation Timeframe.

FOR FURTHER INFORMATION CONTACT: Kate Troy, OHS, at 
[email protected] or 1-866-763-6481. Deaf and hearing-impaired 
individuals may call the Federal Dual Party Relay Service at 1-800-877-
8339 between 8 a.m. and 7 p.m. Eastern Standard Time.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
II. Background
III. Overview of Public Comments on the Interim Final Rule With 
Comment Period
IV. Public Comments Analysis
V. Implementation Timeframe
VI. Section-by-Section Discussion of Changes in This Final Rule
VII. Regulatory Process Matters
VIII. Regulatory Impact Analysis
IX. Tribal Consultation Statement

I. Executive Summary

(1) Purpose of the Regulatory Action

    (a) The need for the regulatory action and how the action will meet 
that need: The purpose of this regulatory action is to finalize, with 
modification, 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). This 
final rule takes into consideration the more than 1,700 public comments 
received on masking during the comment period, the most up to date data 
available on COVID-19, and knowledge gained through research on the 
transmission and effects of SARS-CoV-2 to establish a policy that 
prioritizes the health and safety of children served by the federal 
Head Start program, their families, and the program's staff while also 
adapting to the realities of evolving COVID-19 conditions. In brief, 
this final rule:

[[Page 994]]

    (1) removes the requirement of universal masking for all 
individuals 2 years of age and older when they are with 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) requires Head Start programs to have an evidence-based COVID-19 
mitigation policy developed in consultation with their Health Services 
Advisory Committee (HSAC).
    During this rulemaking process alone, there have been considerable 
gains in what the scientific, medical, and public health communities 
know and understand about SARS-CoV-2. More tools are available to 
protect against SARS-CoV2 than when the IFC was issued, and the 
conditions around COVID-19 have changed. These new tools include 
improved accessibility to vaccines for adults and children over age 6 
months, treatments, tests, and improved information about other tools 
like ventilation to maximize protection and minimize transmission. For 
these reasons, and those further outlined in the preamble, ACF has 
removed the specific universal masking requirement and replaced it with 
a requirement that programs establish an evidence based COVID-19 
mitigation policy in consultation with their HSAC.
    Throughout the development of the IFC and this final rule, ACF has 
considered the guidance of the U.S. Centers for Disease Control and 
Prevention (CDC) as our lead public health agency to ensure the latest 
science guides our policies. After consideration and review of the 
latest CDC guidance, ACF has concluded that the universal masking 
requirement established in the IFC no longer is warranted.
    The IFC was published at a point in time when the CDC recommended 
universal masking for individuals 2 years and older. At that time, 
vaccines were not yet available for children between the ages of two 
and five. Additionally, citing CDC data, ACF noted that ``although 
COVID-19 cases had begun to decline in parts of the country,'' ``data 
indicate[d] cases are beginning to rise in other parts,'' and ``the 
future trajectory of the pandemic [was] unclear.'' 86 FR 68053. ACF 
also highlighted the acute risks of the highly transmissible Delta 
variant, which at the time was ``the predominant variant in the United 
States and ha[d] resulted in greater rates of cases and 
hospitalizations among children than from other variants.'' Ibid. At 
this stage of the COVID-19 response, CDC recommends universal masking 
based on COVID-19 Community Level.
    This final rule instead requires Head Start programs to have an 
evidence-based COVID-19 mitigation policy developed in consultation 
with their HSAC. The HSAC is an advisory group usually composed of 
local health providers; they may include pediatricians, nurses, nurse 
practitioners, dentists, nutritionists, and mental health providers. 
Head Start staff and parents also serve on the HSAC. All Head Start and 
Early Head Start programs are required to establish and maintain a HSAC 
(45 CFR 1302.40(b)).
    Removing the universal mask requirement and replacing it with the 
requirement of an evidence-based COVID-19 mitigation policy allows Head 
Start programs to adapt to changing circumstances, to consider the 
unique challenges and needs faced by individual programs, and still 
supports the safest environments for the workforce, and the children 
and families Head Start serves.
    (b) Legal authority for the final rule: ACF publishes this final 
rule under the authority granted to the Secretary by sections 
641A(a)(1)(C), (D) and (E) of the Head Start Act, 42 U.S.C. 
9836a(a)(1)(C), (D) and (E), as amended by the Improving Head Start for 
School Readiness Act of 2007 (Pub. L. 110-134). Specifically, section 
641A of the Head Start Act allows the Secretary to ``modify, as 
necessary, program performance standards by regulation applicable to 
Head Start agencies and programs.'' In developing this modification, 
the Secretary included relevant considerations pursuant to section 
641A(a)(2) of the Head Start Act, 42 U.S.C. 9836a(a)(2). The Secretary 
finds it necessary and appropriate to set health and safety standards 
for Head Start programs to ensure they respond to the evolving COVID-19 
pandemic to keep the environment where Head Start services are provided 
safe.

(2) Summary of the Major Provisions of the Regulatory Action

Head Start Program Performance Standards
Masking
    This final rule removes the universal masking requirement for all 
individuals 2 years of age and older, which had applied universally 
subject to some exceptions.\1\ While this final rule removes the 
universal masking requirement, programs may opt to include such 
requirements in their COVID-19 mitigation policy.
    The universal masking requirement in the IFC mirrored CDC's 
recommendations in fall 2021 and was predicated on then-current data 
about COVID-19 and expectations about the future trajectory of the 
disease. The CDC has moved away from a recommendation for universal 
indoor masking in schools and early care and education facilities. On 
February 25, 2022, the CDC issued new COVID-19 mitigation 
recommendations to help individuals and communities make choices on 
what precautions to take, based on the level of disease burden in their 
community and the capacity of their nearby hospitals. CDC calls these 
``COVID-19 Community Levels,'' which include low, medium, and high 
Community Level classifications. At present, CDC only recommends 
universal masking indoors at the high COVID-19 Community Level. As a 
result, Head Start programs may be operating with a more stringent 
masking requirement than the CDC indicates is warranted currently, and 
specifically, a requirement that reflects a different stage of the 
COVID-19 response when the CDC recommended universal masking for 
individuals ages 2 and older.
    To clarify, programs may still promote, encourage, and even require 
universal masking as part of their COVID-19 evidence-based policy given 
the proven benefits of masking as an effective layered mitigation 
strategy against COVID-19, particularly when communities are 
experiencing a high level of disease burden or are serving high-risk 
populations (e.g., when COVID-19 Community Levels are high).\2\ The 
effectiveness of masking is discussed further in Section III and 
programs may find the responses helpful when developing their COVID-19 
mitigation policies.
    The removal of the universal masking requirement and replacement 
with the evidence-based COVID-19 mitigation policy gives Head Start 
programs more flexibility to adapt to the changing circumstances of 
COVID-19 while still protecting the health of children and consequently 
will reduce burden on programs.
Evidence-Based COVID-19 Mitigation Strategy
    This final rule requires Head Start programs to have an evidence-
based COVID-19 mitigation policy developed in consultation with the 
program's HSAC. This modification allows the rule to continue to be 
relevant and up to date as the level of COVID-19 impact in communities 
changes.

[[Page 995]]

    The evidence-based COVID-19 mitigation policy should consider 
multiple mitigation strategies such as access to vaccination, masking, 
ventilation, and testing. Per the CDC, Head Start programs should 
consider local conditions, including transmission levels as well as 
program characteristics such as the population of children and families 
served, when selecting mitigation strategies to prioritize for 
implementation.
    Although the national vaccination requirement remains in place 
while the vaccination portion of the IFC is under review, Head Start 
programs may include additional considerations beyond the original IFC 
requirement to support vaccination efforts, including for example, 
requiring staff remain up to date on COVID-19 boosters, sharing 
information on COVID-19 vaccination with staff and families, and/or 
partnering with local agencies to increase vaccination access.
    OHS will issue supplementary information at the time of publication 
of this rule to Head Start programs to provide information that may 
assist programs in developing an evidence-based policy. Specifically, 
this supplementary information will reference the latest research and 
science on layered mitigation strategies, including information from 
the CDC guidance for Early Childhood Education settings, CDC COVID-19 
Community Levels guidance, and state and local guidance. OHS will 
update this guidance as appropriate.
    This final rule requires programs to have established an evidence-
based COVID-19 mitigation policy in consultation with their HSAC by 
March 7, 2023.

(3) Costs and Benefits

    This final rule revises 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.'' \3\ In our main analysis, we evaluate the likely impacts of 
the final rule in comparison to a baseline scenario of the IFC without 
modifications.
    The final rule requires that Head Start programs have an evidence-
based COVID-19 mitigation policy, developed in consultation with their 
HSAC. This requirement will result in a one-time cost for each program 
to develop its mitigation policy. Although the final rule is not 
prescriptive with respect to the elements of these mitigation policies, 
we identify and estimate ongoing costs to Head Start programs by 
modeling elements of a mitigation policy that are intended to be 
representative of a range of potential options.
    This final rule also removes the requirement for universal masking 
for all individuals two years of age and older. While some programs may 
maintain masking for certain groups or under certain circumstances, 
removing this requirement will likely result in fewer masks worn. All 
else equal, if fewer masks are worn as a result of the rule, this may 
result in increased transmission risk of SARS-CoV-2; however, this 
could be offset by other elements of evidence based COVID-19 mitigation 
policies developed by Head Start programs.
    Overall, we anticipate that the cost savings associated with 
removing the universal masking requirement will exceed the incremental 
costs of the mitigation policies. Thus, the final rule will result in 
net cost savings, which accrue primarily to Head Start programs. Over a 
3-month time horizon, we estimate that the final rule may result in 
about $9.2 million in net benefits; in other words, this amount is our 
estimate of the net cost savings attributable to the final rule.

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) and1302.42(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.
    All Head Start and Early Head Start programs are required to 
establish and maintain a HSAC (45 CFR 1302.40(b)). The HSAC is an 
advisory group usually composed of local health providers; they may 
include pediatricians, nurses, nurse practitioners, dentists, 
nutritionists, and mental health providers, among others. Head Start 
staff and parents also serve on the HSAC. As HSACs are usually 
comprised of local health care providers, they provide an existing 
framework that supports Head Start programs in accessing and leveraging 
expertise to promote child health. The HSPPS specifically requires the 
HSAC to provide expertise in determining whether children are up to 
date on age-appropriate preventive and primary medical and oral health 
care; support the program in identifying children's nutritional health 
needs; and consult on appropriate screenings for communicable diseases 
for regular volunteers in cases where there is an absence of state, 
tribal or local laws.
    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 ACF's highest priority. While this is always important, 
COVID-19 has highlighted the need to ensure staff and young children 
are also protected.
    ACF published an 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 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 the U.S. Food and Drug 
Administration (FDA).\5\ \6\ \7\ \8\ The Secretary considered OHS's 
past experience with the longstanding health and safety requirements of 
the HSPPS 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

[[Page 996]]

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 address the 
transmission of the SARS-CoV-2 and avoid severe illness, 
hospitalization, and death among program participants.
    As of January 1, 2022,\9\ \10\ following decisions by the United 
States District Courts for the Northern District of Texas and the 
Western District of Louisiana, implementation and enforcement of the 
IFC was 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. In this final rule, discussion of the 
states not implementing the requirement relative to states that are 
implementing the requirements is in reference to these injunctions.
    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 FDA 
authorized the emergency use of the Moderna and Pfizer-BioNTech COVID-
19 vaccines to include children 6 months through 5 years of age. Due to 
the extension of this mitigation strategy to this age cohort, Head 
Start children who are vaccinated are now less vulnerable to the 
effects of COVID-19. COVID-19 vaccines continue to provide crucial 
protections against severe disease, hospitalization, and death in 
children and adolescents.
    The IFC generated many comments. We analyze and discuss those 
comments in Part IV, Public Comments Analysis.

III. 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 more than 1,700 comments that expressed 
concerns with masking generally, and most of those comments focused on 
masking children. As noted, this final rule does not address the 
vaccination or testing requirements in the IFC and, therefore, does not 
include a summary of the comments that pertain to that requirement.
    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.
    The comments expressing concerns with masking, and particularly the 
masking policy for children, include, but are not limited to, concerns 
regarding the physical health of children, the potential impact on 
their social-emotional and speech development, the safety and efficacy 
of masks, and the violation of parental rights. Other areas of concern 
included: difficulties sustaining partnerships, mostly related to 
conflicting requirements with school districts; the requirements being 
a violation of individual rights and an overreach of the federal 
government; and the sentiment that a national versus local approach to 
COVID-19 results in what commenters often referred to as a ``one-size-
fits-all'' approach. Other comments cited disagreement with the mask 
requirement due to factually inaccurate information, such as the 
masking of children leading to carbon dioxide poisoning. A small 
minority of the submissions expressed support for the IFC. Supportive 
commenters commended ACF for its efforts to ensure the safety of Head 
Start children, families, and staff, noted that the mandate made them 
feel safer about Head Start services and viewed the requirements as a 
prioritization of the needs of children and staff, using evidence-based 
practices. Many of the supportive commenters acknowledged the 
challenges associated with the mask requirement but agreed that the 
dynamic nature of SARS-CoV-2 warranted this requirement.

IV. Public Comments Analysis

    We respond to the comments we received on masking in response to 
the IFC in this section-by-section discussion. We also address public 
comments in more detail in Section V where we discuss how we have made 
changes to the IFC. Before discussing the requirements in the final 
rule, we respond to the general comments we received in response to the 
IFC related to the burden of the masking requirement, challenges around 
full enrollment, the implementation timeline, and the lack of a 
termination date of the masking requirement. Many comments we received 
reiterated the same or similar information that fell into these broad 
categories, and we believe it is clearer for us to respond to similarly 
grouped comments in this way.

Burden of Requirements

    Comment: Commenters shared concerns that it is too burdensome to 
implement and enforce the new policies and procedures related to the 
mask requirement given the day-to-day complexities that come with 
navigating the ongoing pandemic. A majority of commenters raised 
concerns about the increased burden and stress imposed on staff and 
families due to the mask mandate.
    Response: ACF is aware that programs have universally experienced 
increased burden related to operating amidst SARS-CoV-2 transmission. 
The masking requirement outlined in the IFC necessitated additional 
effort to implement, and these efforts were warranted at an earlier 
time to address COVID-19, given the age of children served and the 
disproportionate impact of the pandemic on children and staff in Head 
Start programs. Thus, while the requirement required increased effort, 
it was a critical part of a layered mitigation strategy to provide the 
maximum possible protection against COVID-19 infection to Head Start 
children, staff, and families.
    Head Start programs implementing this requirement were able to do 
so successfully while continuing to operate their programs. That said, 
the requirement in this final rule of a COVID-19 mitigation policy 
gives Head Start programs more flexibility to adapt to the changing 
circumstances of COVID-19 and to benefit from prevailing public health 
recommendations concerning the most effective COVID-19 mitigation 
strategies while still protecting the health of children and being 
responsive to the needs of their communities.

Challenges to Enrollment

    Comment: Comments highlighted that many programs are already 
struggling to meet full enrollment and suggested that the mask 
requirement is further hindering their efforts to enroll families, 
especially when the requirement contradicts local school district 
policies. Commenters discussed the consequence of families removing 
their children from the program due to the mask requirement because 
they disagree with the requirement, believed it should be the decision 
of parents, or are concerned about inappropriate developmental 
consequences.

[[Page 997]]

    Response: ACF recognizes that enrollment has been challenging for 
some Head Start programs, particularly as they work to reach more 
families and be fully enrolled. However, ACF has no evidence that the 
mask requirement specifically hindered enrollment efforts nationally. 
OHS center status data suggests that enrollment of children increased 
in the months following the publication of the IFC, and the ability to 
provide children with in-person services remained steady after the 
issuance of the IFC. In the 4 months after the rule was implemented 
(February 2022-May 2022 \11\), programs reported a percent change 
increase of 7 percent in the total average actual enrollment, as 
compared to the 4 months leading up to effective date of the final rule 
(September-December 2021). Additionally, in the 4 months leading up to 
the effective date of the IFC, programs reported an average of 91.25 
percent of enrolled children who received full in-person services. 
Again 4 months after the rule was implemented, programs reported an 
average of 92.6 percent of enrolled children were receiving full in-
person services. Notably, in May 2022, the data show our highest 
percentage of reported enrolled children receiving full in-person 
services since the start of the pandemic (93.4 percent). If we examine 
the 25 states not implementing the requirements, as compared to the 
states and territories that were implementing the requirements, both 
groups increased their reported percentage of children served fully in-
person after publication of the IFC. From November 2021 to March 2022, 
both groups of states increased their reported percentage of children 
served fully in-person by 2 percent.
    In sum, the data does not show an indication that the requirement 
hindered programs' ability to operate in-person services.\12\ While 
center status data has limitations and cannot be used to prove 
causation from any provisions in the IFC, based on the data available, 
OHS has not seen significant impact on slot-level operating status at 
the regional or national level. OHS has not seen a decrease in actual 
enrollment levels in the months following the publication of the IFC. 
Despite many commenters' speculation that these requirements would 
result in families removing their children from Head Start programs on 
a large scale, and ultimately, leading to extensive classroom closures, 
there has been no indication that these predictions occurred.
    While some individual families may have removed their children from 
Head Start, we have not seen a large-scale exodus from Head Start 
programs.
    Compared to the provisions in the IFC, ACF anticipates the shift to 
an evidence based COVID-19 mitigation policy will result in families 
being less inclined to disenroll their children.

Implementation Timeline

    Comment: Commenters reported various concerns broadly related to 
the timeline for the implementation of this requirement. Commenters 
raised concerns about the immediate effective date of the masking 
requirement, stating they did not have enough notice to properly inform 
their staff and families and set up policies and procedures. Commenters 
also raised concerns about the IFC's publication relative to the 
pandemic. Comments included doubt that a required mitigation strategy 
for masking is necessary and effective if it was put into place almost 
two years into the pandemic.
    Response: ACF understands that the effective date for the masking 
requirement was challenging. We value this input and have taken these 
comments into consideration in the development of the implementation 
timeline for this final rule. IFCs, or provisions within IFCs, are used 
when an agency has good cause to issue a final rule without first 
publishing a proposed rule. ACF issued an IFC to protect Head Start 
staff, children, and families in response to alarming trends in the 
data and inadequate vaccination coverage. The lengthier process 
associated with a notice of proposed rulemaking (NPRM) process would 
have impeded ACF's ability to put the necessary mitigation strategies 
in place to create the safest possible environment for staff, children, 
and families based on the information available at the time. The 
Secretary found it necessary and appropriate to set health and safety 
standards for the condition of Head Start facilities to ensure the 
reduction in transmission of the SARS-CoV-2, based on the science at 
the time, and to avoid severe illness, hospitalization, and death among 
program participants.
    In this final rule, in consideration of public comment concerns 
relative to the implementation timeline, the requirement to have 
established an evidence-based COVID-19 mitigation policy in 
consultation with their HSAC is effective 60 days following publication 
of the final rule, March 7, 2023. This compliance date will allow 
programs to develop and implement the required policy.

Indefinite Requirements

    Comment: Commenters raised concerns with the lack of the 
termination date for the universal mask requirement. 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.
    Response: ACF's final rule addresses these concerns in two 
respects:
    (1) ACF has removed the universal masking requirement in this final 
rule, which means that all individuals ages 2 and older no longer need 
to wear a mask indoors, when there are two or more individuals on 
transportation, and, if unvaccinated, when outside in crowded spaces 
and during activities that involve sustained close contact with others, 
unless their program opts to include such requirements under its COVID 
mitigation policy.
    (2) ACF is now requiring Head Start programs to have an evidence-
based COVID-19 mitigation policy developed in consultation with the 
HSAC. ACF believes this change will address concerns with the lack of a 
termination date that existed in the IFC for the universal masking 
requirement. A fuller discussion of this change is included in Section 
VI.

Comments About Section 1302.47(b)(5)(vi) Masking

    The majority of commenters expressed concerns regarding the 
universal mask requirement for children 2 years of age and older in 
Head Start programs. There were several topics raised within this 
broader area of concern.
    Comment: Some commenters raised the concern that having staff 
masked might be particularly difficult for young children who lip-read. 
There was also concern that staff will have difficulty hearing children 
who are masked. More prevalent, many commenters raised concerns 
regarding the potential for children to experience delays due to mask 
use, including social and emotional delays and developmental delays. 
Specifically, commenters expressed concern that the prolonged use of 
masks among young children would result in social and emotional delays 
due to the lack of facial recognition of emotional cues. Other 
commenters feared masks may hinder

[[Page 998]]

children's acquisition of speech and language and consequently children 
will experience developmental delays.
    Response: While studies show masks may reduce decibels, attenuate 
frequencies, and remove visual cues which is a risk for young children 
who are developing speech, language, and pre-reading/reading skills, no 
serious adverse events have been reported.\13\ \14\ Guidance from the 
American Academy of Pediatrics notes that teachers and staff may need 
to use clear paneled masks to adequately serve students who are deaf or 
hard of hearing, students receiving speech/language services, young 
students in early education programs, and English language 
learners.\15\ Further, staff use of clear paneled masks when 
communicating with students who are deaf or hard of hearing may also be 
required by federal disability rights laws, which mandate that such 
students have equal opportunity to participate in the program.
    With respect to the more prevalent concern about social-emotional 
or developmental delays due to mask use, although there have been 
numerous opinion pieces, there are few scientific studies published on 
the risk/benefit of adults wearing masks on young children's social-
emotional and language development. While some of the comments will not 
be applicable to the final rule, given the revised requirements, 
programs may find the responses helpful as they consider the 
appropriateness of various alternatives to the universal masking 
requirement for their COVID-19 mitigation policies.
    ACF identified relevant studies, and in sum, there is not 
sufficient evidence of an impact on social-emotional development when 
adults are wearing masks.\16\ \17\ \18\ \19\ \20\
    There is only one study that suggests that wearing a mask impairs 
children's ability to read emotions, but there are more studies, as 
noted above, that show no impact. There are no published studies on the 
long-term effects of young children's development when adults wear 
masks. The CDC currently recommends universal mask use when the COVID-
19 Community Level \21\ is high and ACF recommends that Head Start 
programs develop a policy on masking that aligns with state, local, and 
national public health guidance.
    Comment: Many of the same commenters were worried about the safety 
of children wearing masks and their efficacy in mitigating the spread 
of COVID-19, some of whom cited conflicting guidance on mask use among 
young children in World Health Organization (WHO) and United Nations 
International Children's Emergency Fund (UNICEF) reports. Commenters 
reported concerns that face masks can reduce oxygen intake, leading to 
carbon dioxide poisoning from re-breathing the air we normally breathe 
out. Some commenters were concerned specifically about the impact of 
mask wearing for children with special health care needs. Other 
concerns included: that masks quickly become unhygienic with young 
children and themselves spread germs, that wearing a face mask weakens 
one's immune system, or that mask use increases one's chances of 
getting sick if exposed to the COVID-19 virus.
    Response: To be clear, there has been no evidence to substantiate 
the claim that mask use leads to reduced oxygen intake or carbon 
dioxide poisoning, weakens one's immune system, or increases one's 
chances of getting sick. The CDC Science Brief: Community Use of Masks 
to Control the Spread of SARS-CoV-2 (last updated December 2021 at the 
time of this publication) provides clear information on SARS-CoV-2 
transmission and the efficacy of masks. SARS-CoV-2 infection is 
transmitted predominantly by inhalation of respiratory droplets 
generated when people cough, sneeze, sing, talk, or breathe. Well-
fitting masks are primarily intended to reduce the emission of virus-
laden droplets by the wearer (``source control''), which is especially 
relevant for asymptomatic or pre-symptomatic infected wearers who feel 
well and may be unaware of their infectiousness to others.\22\ \23\ 
Studies demonstrate that wearing well-fitting masks also provides 
protection to the wearer by reducing wearers' exposure to infectious 
droplets through filtration, including filtration of fine droplets and 
particles less than 10 microns.\24\ Improving fit and filtration--for 
example, through strategies such as using mask fitters or layering a 
cloth mask over a medical procedure mask--can improve wearer 
protection. The community benefit of wearing well-fitting masks for 
SARS-CoV-2 control is due to the combination of source control and 
filtration protection for the wearer; the individual prevention benefit 
of wearing masks increases with increasing numbers of people using 
masks consistently and correctly in a given setting.\25\
    With respect to the safety of children wearing masks and their 
efficacy in mitigating the spread of COVID-19, ACF points to several 
studies. First, in terms of safety, there is no evidence to suggest 
that wearing a mask makes it harder for individuals to breathe, impacts 
their lung development, or traps carbon dioxide.\26\ \27\ \28\
    Second, in terms of the efficacy of children wearing masks as a 
mitigation strategy, there have been a few studies about mask use in K-
12 settings since 2020, as well as one study conducted in early 
childhood settings. In sum, the available research suggests that the 
required use of masks for children in schools and early childhood 
education settings results in lower incidence of SARS-CoV-2 
transmission and fewer school closures.\29\ \30\ \31\ \32\
    Additionally, commenters have cited a joint UNICEF and WHO report 
\33\ that recommended children aged up to 5 years should not wear masks 
as a general preventive strategy. This recommendation conflicts with 
the most current CDC guidance and ACF is choosing to rely on the lead 
U.S. public health agency over other organizations. The report also 
acknowledges that evidence is limited around the use of masks in 
children for COVID-19 and countries may ultimately choose to recommend 
a lower age cut-off for mask use. Having access to the same data, 
countries have come to different conclusions on the benefits and harms 
of children wearing masks, with the U.S. and Canada recommending 
masking for children ages 2 and up.
    Additionally, ACF acknowledges that commenters had valid concerns 
regarding the hygienics of masking children and agree that children may 
need extra masks should theirs become soiled. ACF encourages programs 
to consider the use of COVID-19 response funds and ongoing operational 
funds to purchase extra masks for children in response to this concern.
    In sum, consistent with the CDC recommendations and available 
research, masking children is an appropriate policy option and is 
recommended as one layered mitigation strategy against COVID-19 when 
local conditions necessitate. Despite commenters' concerns, ACF has not 
received reports following the publication of the IFC indicating that 
masks caused Head Start children significant health and safety 
consequences.
    Comment: Parents and stakeholders reported concern that the mask 
requirement for children does not respect parental choice. They 
expressed an overarching concern that the universal mask requirement 
for young children is contrary to the belief that parents know what is 
best for their child--a pillar of the philosophy of Head Start. 
Comments suggested that some parents have elected to remove

[[Page 999]]

their child from Head Start because of this requirement.
    Response Much like the HSPPS requirement that children remain up to 
date on age-appropriate immunizations, there are public health issues 
that warrant prioritizing the health of the broader Head Start 
community--particularly as early childhood education occurs in 
congregate settings--and ACF believes the mask requirement is one such 
example. However, the CDC's recommendations have changed as the 
circumstances of COVID-19 have evolved and the local context and 
disease burden in the local community are key considerations for the 
use of masks and other mitigation strategies, ACF's final rule reflects 
this change.
    Comment: There was also a concern among commenters that the 
requirement for children to mask outdoors is unnecessary, especially in 
rural areas and/or settings where playgrounds are often used just by 
one classroom. Commenters were also concerned that masks are too 
difficult for young children to wear, and staff will have a challenging 
time continuously reminding children to wear them correctly. Commenters 
expressed concern that the time spent reminding children to wear masks 
would ultimately come at the expense of teaching and supporting 
children in other ways.
    Response: ACF has modified the requirement in response to the 
evolving circumstances of COVID-19 and to points raised during the 
public comment period. We discuss the changes to this requirement fully 
in Section V, but in summary, the requirement that Head Start programs 
have an evidence-based COVID-19 mitigation policy supports programs in 
scaling up or down mask use in response to the prevalence of COVID-19 
epidemiology in their community and determining, in consultation with 
the program's HSAC, what circumstances necessitate mask use.
    We think this change will, in part, address concerns related to 
outdoor masking, as programs will have the ability to create their own 
individual evidence-based COVID-19 mitigation policy, including with 
respect to outdoor masking.
    Comment: Many comments raised the issue of workforce attrition and 
loss of volunteers due to unwillingness to comply with the masking 
requirements. Commenters explained that the impact of staff attrition 
in the classroom will lead to classroom closure and the loss of 
services to children and families. Commenters reported that this 
requirement imposes yet another barrier to already difficult hiring 
conditions and exacerbates staff shortages. They also noted that this 
requirement will ultimately lead potential staff to choose to work at 
other local child care centers that do not have such COVID-related 
requirements.
    Response: ACF acknowledges programs are facing unprecedented 
challenges recruiting and retaining qualified staff that existed before 
the onset of the pandemic. We also acknowledge that some commenters 
were concerned that the mask requirement in the IFC may exacerbate 
these challenges. At the same time, 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 care and education (ECE) field indicates higher 
compensation for ECE professionals can improve employment stability and 
reduce turnover (and vice versa, with lower wages linked to higher 
turnover).'' \34\
    Additionally, while there are workforce challenges nationally that 
exist both in those states implementing the requirements and in those 
that are not, we have no evidence that the workforce challenges among 
Head Start programs are more pervasive in those states implementing the 
mask requirement.
    As noted in the Background of this final rule in Section II, Head 
Start regulations have always prioritized the health and safety of the 
children and families we enroll. At the time of the IFC's publication 
the evidence of the efficacy of the use of masks in reducing 
transmission of SARS-CoV-2 was substantial. Masks are effective at 
reducing transmission of SARS-CoV-2, the virus that causes COVID-19, 
when worn consistently and correctly. ACF affirms in this final rule 
the importance of mask use as a key mitigation strategy and believes 
requiring programs to have an evidence-based COVID-19 policy that 
includes mask use in appropriate circumstances will support the safest 
environment possible for Head Start staff, children, and families.
    OHS continues to support Head Start programs and provide training 
and technical assistance as programs navigate this workforce shortage.

V. Implementation Timeframe

    For adoption of the COVID-19 mitigation policy, the compliance date 
is March 7, 2023, 60 days following the publication of the final rule. 
This means that Head Start programs must have established an evidence-
based COVID-19 mitigation policy developed in consultation with their 
HSAC 60 days after the publication of the final rule. This requirement 
applies to all Head Start grant recipients, including those that have 
been under a court injunction and not subject to the vaccination and 
masking requirements in the IFC issued on November 30, 2021. The 
removal of the universal masking requirement occurs immediately upon 
publication.

VI. Section-by-Section Discussion of Changes in This Final Rule

    In this section, we discuss two changes made in this final rule. 
The two changes include:
    (1) removing the requirement of universal masking for all 
individuals 2 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) requiring Head Start programs to have an evidence-based COVID-
19 mitigation policy developed in consultation with their HSAC.
    The modifications are based on current public health data and best 
practices, input from numerous stakeholders, and the continually 
evolving landscape of COVID-19 conditions. We specifically relied on 
the guidance from and consultation with the country's leading public 
health agency, the CDC. Additionally, ACF received letters from state 
and national Head Start associations, outlining their feedback and 
perspectives on the implications on these requirements. We also 
received input from the grant recipient community, some of whom 
contributed their feedback as part of the nearly 2,700 comments we 
received during the public comment period. OHS also hosted two webinars 
following the publication of the IFC, which provided another 
opportunity for grant recipients to provide input and raise questions 
from their respective vantage points as executive directors, program 
directors, fiscal officers, staff members, and parents. Finally, OHS 
regularly consulted experts internal to OHS, ACF, HHS, and OHS's 
National Center advisers, all of whom bring expertise in diverse areas 
of program operations, including administrative and fiscal, health and 
safety, infectious disease management, and child development.

[[Page 1000]]

As such, the Secretary satisfied the relevant considerations pursuant 
to section 641A(a)(2)(A) of the Head Start Act, 42 U.S.C. 
9836a(a)(2)(A). We believe the changes we make below ensure these 
sections are clear, updated, streamlined, and transparent to the 
public.

1. Masking Requirement

    The masking requirement in the IFC mirrored the CDC's 
recommendations issued in the fall of 2021 that all individuals ages 2 
and older wear a mask indoors, wear a mask when there are two or more 
individuals on transportation, and, if unvaccinated, wear a mask when 
outside in crowded spaces and during activities that involve sustained 
close contact with others. In this final rule, ACF is removing the 
masking requirement and requiring Head Start programs to have an 
evidence-based COVID-19 mitigation policy developed in consultation 
with their HSAC.
    The rationale for this change is twofold. First, the CDC's 
guidance, and the science and data that established the basis for that 
guidance, has changed as the conditions surrounding COVID-19 have 
evolved. The IFC was published at a point in time when the CDC 
recommended universal masking for individuals 2 years and older. At 
that time, citing CDC data, ACF noted that ``although COVID-19 cases 
had begun to decline in parts of the country,'' ``data indicate[d] 
cases are beginning to rise in other parts,'' and ``the future 
trajectory of the pandemic [was] unclear.'' 86 FR 68053. ACF also 
highlighted the acute risks of the highly transmissible Delta variant, 
which at the time was ``the predominant variant in the United States 
and ha[d] resulted in greater rates of cases and hospitalizations among 
children than from other variants.'' Ibid. At this stage of COVID-19 
response, the science and data point to an approach that takes into 
account the impact of COVID-19 in the community, as demonstrated by the 
CDC's COVID-19 Community Levels. On February 25, 2022, the CDC issued 
these new recommendations to help individuals and communities make 
choices on what precautions to take, based on the level of disease 
burden in their community. As a result, Head Start programs may be 
operating with a more stringent masking requirement than the CDC 
indicates is warranted currently, and specifically a requirement that 
reflects a different stage of the response to COVID-19 when the CDC 
recommended universal masking for individuals ages 2 and older.
    Second, the public comments on the IFC emphasized that the masking 
requirement prescribed a ``one-size-fits-all'' approach and did not 
consider the variation in locations and local conditions. Many cited 
low transmission rates within their communities, mainly in rural parts 
of the country that are particularly struggling with other issues which 
were only compounded by the circumstances of COVID-19. The shift away 
from universal masking for individuals 2 years and older allows 
programs to adapt more quickly to changing circumstances. The focus on 
a COVID-19 mitigation policy, is consistent with the comments and more 
reflective of the CDC's emphasis on layered prevention strategies--like 
staying up to date on vaccines, staying home when sick, ventilation, 
wearing masks, and hand washing--all of which have a key role in 
minimizing the spread of COVID-19.
    As mentioned, throughout the development of the IFC and the final 
rule, ACF has leaned on the CDC as our lead public health agency to 
guide our policies. The CDC's new recommendations shift their focus to 
mask use depending upon the COVID-19 Community Levels. For that reason, 
and those further outlined in the preamble, ACF has removed the 
universal masking requirement.

2. Evidence-Based COVID-19 Mitigation Policy Requirement

    In place of the universal masking requirement, ACF is requiring 
Head Start programs to have an evidence-based COVID-19 mitigation 
policy developed in consultation with their HSAC. Evidence-based is an 
umbrella term that refers to using the best research evidence (e.g., 
found in health sciences literature) and clinical expertise (e.g., what 
health care providers know) in content development.\35\ Integrating the 
best available science with the knowledge and considered judgements 
from stakeholders and experts benefits Head Start children, families, 
and staff. \36\ In the context of COVID-19, mitigation refers to 
measures taken to reduce or lower SARS-CoV-2 transmission, infection, 
or disease severity. Other terms used for this same concept are ``risk 
reduction strategies'' or ``prevention strategies.''
    The evidence-based COVID-19 mitigation policy should consider 
multiple mitigation strategies such as vaccination, masking, 
ventilation, and testing. Note, the national vaccination requirement 
remains in place while under review for those Head Start programs in 
states that are not subject to the court injunctions. However, Head 
Start programs may include additional considerations beyond the 
original IFC requirement in their approach to vaccination as part of 
their COVID-19 mitigation policy, including for example, requiring 
staff remain up to date on COVID-19 boosters, sharing information on 
COVID-19 vaccination with staff and families, and/or partnering with 
local agencies to increase vaccination uptake. Where appropriate, 
policies should acknowledge that staff may request reasonable 
accommodations based on Federal law because of a disability, medical 
condition, or sincerely-held religious belief, practice, or observance 
regarding elements of the mitigation policy. When developing an COVID-
19 mitigation policy Head Start programs should consider the risk 
factors for their staff and the families served, the available 
strategies, or combination of strategies, to be used when the impact of 
COVID-19 changes in the community (such as testing, improving indoor 
air quality, staying home when sick, etc.);.); and how the risk of 
exposure could change depending on the Head Start services provided. 
Head Start programs may also want to consider additional precautions 
regardless of the prevalence of impact from COVID-19 at that time. As 
noted in the CDC's guidance to K-12 schools and ECE settings, ECE 
program administrators should work with local health officials to 
consider other local conditions and factors when deciding to implement 
prevention measures. For example, ECE-specific indicators--such as 
vaccination rates among children, pediatric-specific healthcare 
capacity, pediatric hospitalizations, and pediatric emergency visits--
can help with decision-making. Head Start programs may consider the 
extent to which children or staff are at increased risk for severe 
disease from COVID-19 or have family members at increased risk for 
severe disease. ECE programs may choose to implement universal indoor 
mask use to meet the needs of the families they serve, which could 
include people at risk for getting very sick with COVID-19.\37\
    Note that the universal masking requirement was included at Sec.  
1302.47(b)(5)(vi) in the IFC. The requirement that Head Start programs 
have a COVID-19 mitigation policy is included in this final rule at 
Sec.  1302.47(b)(9).

3. Severability

    To the extent a court may stay or enjoin any part of this final 
rule or the IFC, ACF intends that other provisions

[[Page 1001]]

or parts of provisions of this final rule and the IFC should remain in 
effect. In particular, ACF intends this final rule to take effect 
notwithstanding any stay or injunction of the separate vaccine 
requirement imposed by the IFC, which remains under agency review, and 
vice versa. Any provision held to be invalid or unenforceable by its 
terms, or as applied to any person or circumstance, shall be construed 
so as to continue to give maximum effect to the provision permitted by 
law, unless such holding shall be one of utter invalidity or 
unenforceability, in which event the provision shall be severable and 
shall not affect the remainder thereof or the application of the 
provision to other persons or circumstances.

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 ``major'' rules issued by federal agencies before 
the rules take effect, see 5 U.S.C. 801(a). The CRA defines a major 
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). Based on our estimates of the impact of this rule, 
the Office of Information and Regulatory Affairs (OIRA) in the Office 
of Management and Budget (OMB) has designated this rule as ``not 
major'' under the CRA.

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, 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 IFC established new recordkeeping requirements and as required 
under the PRA, ACF submitted a request for approval of these 
recordkeeping requirements. The initial request was approved through an 
emergency clearance process, allowing for 6 months of approval under 
the PRA. This was followed by a full request, including two public 
comment periods, to extend approval of the recordkeeping requirements 
without changes. The OMB Control Number for this information collection 
request (ICR) is 0970-0583.
    Under this final rule, Head Start grant recipients are required to 
update their program policies and procedures to include an evidence-
based COVID-19 mitigation policy developed in consultation with their 
Health Services Advisory Committee. ACF will request a revision to OMB 
number 0970-0583 to add this recordkeeping requirement through an 
emergency clearance process. This will allow for 6 months of approval 
under the PRA to support the requirement going into effect 60 days 
following the publication of this rule. We will follow the initial 
emergency approval with a full request to extend approval of the 
recordkeeping requirement. The full request will include two public 
comment periods inviting comments on this new recordkeeping requirement 
and related burden. These public comment periods will be announced 
through separate notices published in the Federal Register. The first 
notice will invite comments within 60-days of publication and is 
expected to publish soon after the publication of this final rule. The 
second notice will publish when ACF submits the full extension request 
to OMB and will invite comments to be submitted to OMB within 30-days 
of publication.
    The burden of updating program policies and procedures is estimated 
at a total of 8 hours per grant recipient. To promote flexibility for 
local programs, there is no standardized instrument associated with the 
recordkeeping requirement under this final rule. See the Regulatory 
Impact Analysis section for related cost estimations.

[[Page 1002]]



----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
             Information collection                  Number of     responses per     hours per    Annual  burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Grant Recipient Updating Program Policies and              1,604               1               8          12,832
 Procedures.....................................
                                                 ---------------------------------------------------------------
    Total Burden Hours..........................  ..............  ..............  ..............          12,832
----------------------------------------------------------------------------------------------------------------

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, and OIRA has determined, 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 we certify 
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 $165 
million, using the most current (2021) 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 revises 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.'' \38\ In our main analysis, we evaluate the likely impacts 
of the final rule in comparison to a baseline scenario of the IFC 
without modifications.
    The final rule requires that Head Start programs have an evidence-
based COVID-19 mitigation policy, developed in consultation with their 
Health Services Advisory Committee. This requirement will result in a 
one-time cost for each program to develop its policy. Although the 
final rule is not prescriptive with respect to the elements of these 
mitigation policies, we identify and estimate ongoing costs to Head 
Start programs by modeling elements of a policy that are intended to be 
representative of a range of potential options. We address uncertainty 
in the representativeness of this mitigation policy in a scenario 
analysis that considers a range of more stringent and less stringent 
approaches to mitigation in the main analysis; and we address 
uncertainty in projecting COVID-19 over the time horizon of the 
analysis by considering a range of observed historic COVID-19 metrics 
in Section E. Uncertainty and Sensitivity Analyses. For our primary 
analysis, we adopt a baseline scenario of the IFC, and perform a 
sensitivity analysis to consider an alternative baseline that 
incorporates the impact of federal court injunctions affecting the IFC 
and a second alternative baseline of no IFC requirements.
    This final rule also removes the requirement for universal masking 
for all individuals two years of age and older. Removing this 
requirement will likely result in fewer masks worn. All else equal, if 
fewer masks are worn as a result of the rule, this may result in 
increased transmission risk of SARS-CoV-2; however, this could be 
offset by other elements of evidence-based COVID-19 mitigation policies 
developed by Head Start programs.
    Overall, we anticipate that the cost savings associated with 
removing the universal masking requirement will exceed the incremental 
costs of the mitigation policies. Thus, the final rule will result in 
net cost savings, which accrue primarily to Head Start programs. Over a 
3-month time horizon, we estimate that the final rule may result in 
about $9.2 million in net benefits, which matches our estimate of the 
quantified net cost savings attributable to the final rule. Table 1 
reports a range of estimates of the incremental impacts of the final 
rule that account for uncertainty in projecting COVID-19 over the time 
horizon of the analysis.
    ACF considered many policy alternatives beyond the regulatory 
option of the final rule. In addition to assessing the impact of the 
final rule, this RIA analyzes and quantifies the impacts of several 
alternatives related to the masking requirement.

          Table 1--Summary of Cost Savings, Costs, and Net Benefits, 2021 Dollars, 3-Month Time Horizon
----------------------------------------------------------------------------------------------------------------
                                                                      Primary
                            Category                                 estimate      Low  estimate  High  estimate
----------------------------------------------------------------------------------------------------------------
Cost Savings....................................................     $11,516,589     $10,820,796     $12,212,383
Costs...........................................................       2,271,134       2,271,134       2,271,134
Quantified Net Benefits.........................................       9,245,455       8,549,662       9,941,249
----------------------------------------------------------------------------------------------------------------
Note: Estimates do not depend on the choice of 3% or 7% discount rate.


[[Page 1003]]

C. Comments on the Final Regulatory Impact Analysis and Our Responses
    On November 30, 2021, we published a regulatory impact analysis of 
the IFC.\39\ In the following paragraphs, we describe and respond to 
comments we received on our analysis of the impacts of the IFC 
(hereafter, ``IFC RIA''). We have numbered each comment to help 
distinguish between the different comment themes. The number assigned 
to each comment is purely for organizational purposes and does not 
signify the comment's value, or the order in which it was discussed by 
the commenter(s). We received additional comments on the IFC that are 
discussed elsewhere in the Preamble. Note that this section does not 
address comments received on the vaccination requirement since it is 
under review and not part of this final rule.
    (Comment 1) We received several comments related to the IFC RIA 
assumptions related to masking. At least one commenter noted that many 
children require more than one mask per day, indicating that we 
underestimated the number of masks required. At least one commenter 
suggested that the total costs associated with masking that are 
attributable to the IFC are overstated because many parents would 
provide masks for their children without the masking requirement.
    (Response 1) We agree with the comment that the assumption of one 
mask per day per child may underestimate the number of masks needed. In 
this RIA, we double this estimate to two masks per day per child in 
Head Start settings. This revised assumption is intended to represent 
the average number of masks per day across all children masking at Head 
Start programs under the final rule, recognizing that some children 
only require 1 mask per day and some children require more than 2 masks 
per day. We agree with the comment that the total cost of masking 
should account for masks that would be worn without the IFC; however, 
we disagree that the IFC RIA made no adjustment for this. Specifically, 
the IFC RIA included the following explicit adjustment for mask usage 
under the Baseline Scenario of no regulatory action: ``We anticipate 
that a substantial portion of these individuals would wear masks when 
in-person at Head Start programs without this requirement, and adopt an 
estimate of 25% for the share of these costs that are attributable to 
the Interim Final Rule.'' \40\ In this RIA, we adopt a higher estimate 
of the share of masking costs attributable to the final rule, which 
reflects lower levels of voluntary masking and less masking 
attributable to state and local mask requirements.
    (Comment 2) At least one commenter suggested our assumption that 
the average price per mask of $0.14 was lower than their experience.
    (Response 2) We acknowledge that the price per mask varies over 
time, by region, and by retail channel. We also acknowledge that the 
average price will vary by the type of mask, as well as the quantity of 
masks purchased at one time. In developing the RIA of the final rule, 
we further explored this assumption by performing additional market 
research to identify current prices for disposable masks. Through this 
process, we identified an online vendor selling 100 disposable masks 
for $6.99,\41\ and another vendor selling 100 disposable children's 
sized masks for $7.99,\42\ which correspond to about $0.07 per mask and 
$0.08 per mask, respectively. We note that the per-mask prices may be 
higher for some customers after accounting for shipping costs. 
Ultimately, we disagree with the commenter that the RIA's assumption of 
average price per mask of $0.14 is too low and maintain this cost-per-
mask assumption in this RIA. In addition to variation in the price per 
disposable masks, we know that some individuals comply with the masking 
requirements through the use of other face coverings, including 
reusable cloth masks. Accounting for reusable cloth masks would likely 
lower our estimate of the total cost associated with masking.
    (Comment 3) We received many comments related to the potential 
staff turnover attributable to the IFC. Most of these comments 
indicated their opposition to the policy based on the potential staff 
turnover, which included some comments that were specific to a 
particular program or individual. Several comments expressed a view 
that the IFC RIA's estimates of the potential staff turnover were too 
low; however, these comments generally did not include alternative 
estimates and did not include recommendations for alternative analytic 
approach that would produce different estimates. One commenter, 
however, estimated that the IFC ``could lead to Head Start programs 
losing between 46,614 and 72,422 employees, or 18% to 26% of all 
staff,'' \43\ deriving these results from a survey fielded after the 
IFC was published. We also received at least one comment that estimated 
one third of all Head Start staff would turnover. Several other 
comments gave turnover estimates that were specific to a particular 
program but did not provide comparable estimates of the turnover across 
all Head Start programs.
    (Response 3) We note that the IFC RIA gave significant attention to 
the potential staff turnover attributable to the IFC. In that analysis, 
we analyzed a range of vaccine coverage scenarios and estimated the 
potential staff turnover for each of those scenarios. The IFC RIA 
reported a primary estimate of 11,517 Head Start staff potentially 
turning over as a result of the IFC and presented a range of turnover 
estimates between 0 staff to 23,035 staff, or between 0% and 8% of the 
total staff. In actuality, the turnover attributable to the IFC was 
much lower than the primary estimate in the IFC RIA. ACF currently 
believes the turnover attributable to the IFC was less than 1% of 
staff. The actual turnover was therefore also significantly below the 
turnover estimates of between 46,614 and 72,422 staff suggested in one 
comment, and less than the turnover estimate suggested by one commenter 
that one-third of staff turnover, which would amount to 91,000 staff.
    (Comment 4) We received at least one comment that indicated the IFC 
RIA overestimated the number of Head Start volunteers.
    (Response 4) We agree with the comment. The IFC RIA reported an 
estimate of the number of volunteers that predated the COVID-19 
pandemic. In this analysis, we adopt a more recent estimate of 464,161 
volunteers for the 2021-2022 program year, which covers Fall 2021 to 
Spring 2022.

II. Analysis of the Revisions to the Interim Final Rule

A. Baseline of the Interim Final Rule
    For our primary analysis of the final rule, we adopt a baseline 
scenario of the requirements of the IFC in effect nationally over the 
time horizon of our analysis. The IFC added provisions to the Head 
Start Program Performance Standards to impose three requirements: \44\
    (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. This requirement is effective immediately.
    (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

[[Page 1004]]

weekly testing for current SARS-CoV-2 infection.
    The baseline scenario accounts for the ongoing impacts associated 
with the IFC, including the benefits and costs of each of these 
provisions. This final rule does not address the vaccination 
requirement, which is still under review. Thus, we focus our 
quantitative assessment of the baseline scenario on the ongoing costs 
of the masking requirements of the IFC. In our scenario analysis below, 
the baseline scenario corresponds to the Universal Scenario, indicating 
that, without further regulatory action, the masking requirements will 
always be in effect for all Head Start programs in all counties.
    We also considered two alternative baseline scenarios. The first 
alternative baseline scenario incorporates the impact of federal court 
injunctions affecting the IFC. The second alternative baseline scenario 
assumes no IFC requirements are in effect. This analysis appears in 
Section E. Uncertainty and Sensitivity Analyses.
B. Scenario Analysis Approach
    The final rule requires that Head Start programs have an evidence-
based masking policy for COVID-19 mitigation, developed in consultation 
with their Health Services Advisory Committee. We are uncertain over 
the elements of the policies that Head Start programs will adopt under 
the final rule; however, we anticipate that elements of the policies 
will either be in effect at all times or closely tied to local COVID-19 
conditions. As the first step in quantifying the impacts for a range of 
potential mitigation policies that could be adopted by Head Start 
programs, we consider five discrete scenarios:
     Scenario 1, ``Universal'': Requirement will always be in 
effect.
     Scenario 2, ``High Level'': Requirement will be in effect 
in counties with a High COVID-19 Community Level.
     Scenario 3, ``High or Medium Level'': Requirement will be 
in effect in counties with a High or Medium COVID-19 Community Level.
     Scenario 4, ``Community Transmission'': Requirement will 
be in effect in counties with a High or Substantial COVID-19 County 
Level of Community Transmission.
     Scenario 5, ``Voluntary'': Requirement will never be in 
effect.
    We analyzed historic data at the county level on COVID-19 Community 
Level \45\ covering the 37-week period ending on November 3, 2022 for 
which data are currently available, and COVID-19 County Level of 
Community Transmission \46\ data covering 237 days (about 34 weeks) 
ending on October 18, 2022. For each observation in the historic data, 
we calculate the share of the U.S. population living in counties with a 
High Community Level, the share of the U.S. population living in 
counties with a High or Medium Community Level, and the share of the 
U.S. population living in counties with High or Substantial Community 
Transmission. As one example calculation, on September 29, 2022, 107 
counties had a High Community Level, or about 3.3% of counties. 
5,239,101 people live in those 107 counties, which is about 1.6% of the 
total U.S. population. If all Head Start programs had adopted a masking 
requirement at centers in counties with a High COVID-19 Community 
Level, the requirement would have covered 1.6% of all staff, children, 
and volunteers for that week. This metric has fluctuated over time, 
reaching a maximum share of 60.9% of the U.S. population living in a 
county with High COVID-19 Community Level on July 28, 2022.
    To quantify the impact of the final rule, we average these 
population shares over the time period of the historic data and adopt 
these as our primary estimates of the share of the population covered 
by the requirements for scenarios 2, 3, and 4 over the time horizon of 
the analysis. Table 2 presents estimates of the average population 
shares, which we multiply with the total number of Head Start staff, 
children, and volunteers for our primary estimates of the average 
number of staff and children covered by the requirements for each of 
the Scenarios. As one example calculation, under the ``High Level'' 
Scenario, we estimate that an average of 46,594 staff [= 17.1% x 
273,000] would be required to mask each week over the time horizon of 
the analysis. Table 2 summarizes these estimates, which correspond to 
our primary estimates for each scenario. In Section E. Uncertainty and 
Sensitivity Analyses, we address uncertainty in our estimate of the 
average weekly population shares.

     Table 2--Estimates of the Average Number of Head Start Staff, Children, and Volunteers in Counties With
                                              Requirement in Effect
----------------------------------------------------------------------------------------------------------------
                    Scenario                        Share  (%)         Staff         Children       Volunteers
----------------------------------------------------------------------------------------------------------------
1: Universal....................................           100.0         273,000         864,289         464,161
2: High Level...................................            17.1          46,594         147,513          79,221
3: High or Medium Level.........................            43.5         118,673         375,707         201,771
4: Community Transmission.......................            86.3         235,504         745,582         400,410
5: Voluntary....................................             0.0               0               0               0
----------------------------------------------------------------------------------------------------------------

C. Impacts of the Revisions to the Interim Final Rule
Masking
    We estimate the number of masks required, and the costs of masking, 
under each of the five scenarios. As an intermediate step to 
calculating the number of masks required, we estimate the total in-
person days per week for staff, children, and volunteers. Table 3 
reports data on the operating status of Head Start Centers and presents 
estimates of the in-person days per week by center status. These 
figures come from May 2022 administrative data, the last month of data 
before summer break. For these estimates, we adopt several assumptions: 
(1) the average number of staff and children served by each center does 
not vary by center status; (2) that centers in hybrid operating status 
meet in person 2.5 days per week, on average; (3) that centers in fully 
in-person status meet in person 5.0 days per week, on average; (4) that 
staff and children attend 100% of in-person days; and (5) that 
volunteers attend 20% of in-person days. For the purposes of this 
analysis, we also assume that the centers with unknown operating status 
are distributed evenly across each center status category. For our 
estimate of the total number of children, we use ``funded enrollment,'' 
which refers to the number of children and pregnant people that are 
supported by Federal Head Start funds in a program at any one time 
during the program year but reduce this estimate by 1% to account for 
pregnant people enrolled in Early Head Start.\47\

[[Page 1005]]



                             Table 3--Head Start Center Operating Status and In-Person Days per Week for Staff and Children
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Count                                  In-person days per week
              Center status                   Centers    -----------------------------------------------------------------------------------------------
                                                               Staff         Children       Volunteers         Staff         Children       Volunteers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Closed..................................             501           6,814          21,573          11,586               0               0               0
Virtual/Remote..........................             424           5,758          18,229           9,790               0               0               0
Hybrid..................................           2,474          33,622         106,444          57,165          84,056         266,111          28,583
Fully In-Person.........................          16,686         226,806         718,042         385,620       1,134,028       3,590,211         385,620
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................          20,085         273,000         864,289         464,161       1,218,083       3,856,322         414,203
--------------------------------------------------------------------------------------------------------------------------------------------------------

    To calculate the costs of masking under each scenario, we replicate 
the in-person days per week for staff and children using the estimates 
reported in Table 3. We reduce the estimate for children by 14% to 
account for children younger than age 2 that were not subject to the 
requirement of the IFC. We assume that staff and volunteers will use an 
average of one mask per day, that children will use an average of two 
masks per day and adopt an estimate of the cost per disposable surgical 
mask of $0.14. Under the Universal Scenario, we anticipate that staff, 
children, and volunteers will combine for a total of about 8.3 million 
masks per week, with the total weekly cost of these masks of about $1.2 
million. We anticipate that some individuals would wear masks when in-
person at Head Start programs without this requirement and adopt an 
estimate of 92% for the share of these costs attributable to the 
revised masking requirement under this scenario.
    This assumption is intended to be consistent with a current 
projection of the mask use of 8%, representing ``the percentage of the 
population who say they always wear a mask in public.'' \48\ This 
parameter should be interpreted as the average share of staff, 
children, and volunteers at in-person Head Start settings who would 
mask over the time period of the analysis, covering a range of masking 
outcomes that will vary over time; however, the actual share of 
individuals wearing a mask on any particular day will likely vary on a 
number of factors, including local COVID-19 conditions. We analyze the 
total costs over a 3-month time horizon and report an estimate of the 
total masking costs attributable to the final rule under Scenario 1 of 
about $13.9 million. We replicate this analysis for each of the other 
scenarios and report total masking costs for each. Finally, we report 
cost savings of the final rule for each scenario compared to the IFC.

           Table 4--Cost Associated With Masking, and Cost Savings Compared to IFC, for Each Scenario
----------------------------------------------------------------------------------------------------------------
                                                                     High and        Community
          Cost element               Universal      High level     medium level    transmission      Voluntary
----------------------------------------------------------------------------------------------------------------
In Person Days per Week:
    Staff.......................       1,218,083       1,218,083       1,218,083       1,218,083       1,218,083
    All Children................       3,856,322       3,856,322       3,856,322       3,856,322       3,856,322
    Children (2+)...............       3,316,437       3,316,437       3,316,437       3,316,437       3,316,437
    Volunteers..................         414,203         414,203         414,203         414,203         414,203
Masks per Staff per Day.........               1               1               1               1               1
Masks per Child per Day.........               2               2               2               2               2
Masks per Volunteer per Day.....               1               1               1               1               1
Centers Requiring Masking.......            100%           17.1%           43.5%           86.3%            0.0%
Total Masks per Week............       8,265,160       1,410,660       3,592,871       7,129,967               0
Cost per Mask...................           $0.14           $0.14           $0.14           $0.14           $0.14
Cost of Masks per Week..........      $1,157,122        $197,492        $503,002        $998,195              $0
Attributable Share..............             92%             92%             92%             92%             92%
Weekly Attributable Cost........      $1,064,553        $181,693        $462,762        $918,340              $0
Weeks Included in This Analysis.              13              13              13              13              13
                                 -------------------------------------------------------------------------------
Total Masking Costs.............     $13,886,709      $2,370,120      $6,036,562     $11,979,414              $0
Cost Savings....................              $0     $11,516,589      $7,850,147      $1,907,295     $13,886,709
----------------------------------------------------------------------------------------------------------------

    We adopt the Universal Scenario as our baseline scenario, which 
corresponds to the IFC approach of requiring masking at 100% of 
centers. We assume that the representative mitigation policy will 
follow the current CDC Guidelines on masking, and therefore adopt the 
High Level Scenario for our primary estimate of the costs of masking 
under the final rule. Thus, we conclude that the final rule will result 
in about $11.5 million in cost savings from fewer masks.
Costs of Communicating and Learning Current Masking Requirements
    While the modifications to the IFC result in overall cost savings, 
we anticipate an additional cost to Head Start centers to communicate 
the current masking requirements. For each of the 19,160 centers 
operating fully in-person or in a hybrid status, we assume that one 
supervisor will spend five minutes each week to learn and communicate 
the current county Community Level and communicate the current 
requirements. Across these centers, this is about 1,597 hours per week. 
To monetize this impact, we apply an estimate of the value of time for 
on-the-job activities of supervisors, described in the Appendix, of 
$45.50 per hour. Multiplying this hourly value of time by the number of 
hours results in $72,649 per week, or $947,674 over a 3-month time 
horizon.
    We also identify a cost to other staff to receive this information. 
Each of the approximately 226,806 staff at fully in-person centers and 
33,622 staff at centers in hybrid operating status will

[[Page 1006]]

need to be aware of the current requirements. Subtracting the 19,160 
staff responsible for learning and communicating the current county 
Community Level, we assume that 241,268 staff will receive this 
information. We assume that receiving this information will take 30 
seconds per week and calculate that it will take a total of 2,011 hours 
per week across all staff. To monetize this impact, we apply an 
estimate of the value of time for on-the-job activities for non-
supervisory staff, described in the Appendix, of $28.20 per hour. 
Multiplying this hourly value of time by the number of hours results in 
$56,698 per week, or $739,604 over a 3-month time horizon.
    We report a total weekly cost of communicating and learning current 
masking requirements of $129,346. Over a 3-month time horizon, the 
total cost of communicating and learning these requirements is 
$1,687,278.
Costs of Establishing an Evidence-Based COVID-19 Mitigation Policy
    We also identify a cost to Head Start programs to develop an 
evidence-based COVID-19 mitigation policy in consultation with their 
Health Services Advisory Committee. For each of the 1,604 grant 
recipients, we assume that developing an evidence-based COVID-19 
mitigation policy will take an average of 8 hours. We Across all 
programs, we estimate that developing these mitigation policies will 
take a total of 12,832 hours. To monetize this impact, we apply an 
estimate of the value of time for on-the-job activities of supervisors, 
described in the Appendix, of $45.50 per hour. Multiplying this hourly 
value of time by the number of hours results in a one-time cost of 
$583,856.
Net Impact on Costs
    Table 6 summarizes the costs under our Baseline of the IFC, and 
costs under the final rule and reports the net impact on costs of the 
revisions to the IFC. All estimates are reported over a 3-month time 
horizon in year-2021 dollars. In total, we estimate that the final rule 
will result in about $9.2 million in cost savings. Table 6 also reports 
the net impacts over an alternative time horizon of a year.

   Table 6--Primary Estimates of the Net Impact on Costs of the Final Rule, 2021 Dollars, 3-Month Time Horizon
----------------------------------------------------------------------------------------------------------------
                                                                    Cost under                      Net impact
                  Cost element                    Cost under IFC    final rule      Net impact        (year)
----------------------------------------------------------------------------------------------------------------
Masking Requirement.............................     $13,886,709      $2,370,120    -$11,516,589     -46,066,357
Communicating and Learning......................               0       1,687,278       1,687,278       6,749,112
Establishing a Policy...........................               0         583,856         583,856         583,856
                                                 ---------------------------------------------------------------
    Total.......................................      13,886,709       4,641,254      -9,245,455     -38,733,389
----------------------------------------------------------------------------------------------------------------
Note that negative net impacts in this table correspond to cost savings attributable to the revisions of the
  final rule.

D. Analysis of Policy Alternatives to the Final Rule
    ACF considered many policy alternatives beyond the regulatory 
option of the final rule. We analyzed and quantified the impacts of 
five policy alternatives related to the masking requirements. 
Specifically, we considered the following alternative masking 
requirements:
    (1) Adopting the approach of the IFC, which required mask wearing 
for all adults and children two years of age and older in certain in-
person Head Start settings.
    (2) Adopting a policy alternative to require masks for all adults 
and children two years of age and older, in certain in-person Head 
Start settings in counties with a High COVID-19 Community Level.
    (3) Adopting a policy alternative to require masks for all adults 
and children two years of age and older in certain in-person Head Start 
settings in counties with a Medium or High COVID-19 Community Level.
    (4) Adopting a policy alternative to require masks for all adults 
and children two years of age and older in certain in-person Head Start 
settings in counties with High or Substantial Community Transmission.
    (5) Adopting a policy alternative to rescind the masking 
requirement, without adopting the requirement for an evidence-based 
COVID-19 mitigation policy.
    We anticipate that Head Start centers will incur costs of 
communicating and learning current masking requirements, except for the 
two masking alternatives that do not depend on the COVID-19 Community 
Level or COVID-19 County Level of Community Transmission. Table 7 
reports the net cost savings of each policy alternative over a 3-month 
time horizon.

      Table 7--Cost Savings for Masking Policy Alternatives, Millions of 2021 Dollars, 3-Month Time Horizon
----------------------------------------------------------------------------------------------------------------
                                                      Cost of         Cost of
       Masking alternative            Cost of      communicating  establishing a    Total costs    Cost savings
                                      masking      and learning       policy
----------------------------------------------------------------------------------------------------------------
Baseline........................     $13,886,709              $0              $0     $13,886,709              $0
Final Rule......................       2,370,120       1,687,278         583,856       4,641,254       9,245,455
Universal.......................      13,886,709               0               0      13,886,709               0
High Level......................       2,370,120       1,687,278               0       4,057,398       9,829,311
High or Medium Level............       6,036,562       1,687,278               0       7,723,840       6,162,869
Community Transmission..........      11,979,414       1,687,278               0      13,666,692         220,017
Voluntary.......................               0               0               0               0     $13,886,709
----------------------------------------------------------------------------------------------------------------
Note that negative net impacts in this table correspond to cost savings attributable to the revisions of the
  final rule.


[[Page 1007]]

E. Uncertainty and Sensitivity Analyses
Uncertainty Over COVID-19 Projections
    Our primary estimates of the cost savings of the final rule 
incorporate estimates of the share of the population covered by the 
requirements, based on historic averages of the observed share of the 
population in counties with a High COVID-19 Community Level for 
masking. Projecting this metric is inherently uncertain. To address 
this uncertainty, we use a bootstrap estimator of the mean share, 
sampling with replacement weekly observations of the share of the 
population from the historic data. We use this process to generate a 
90% confidence interval around our estimated means. Table 8 reports our 
primary estimate and a 5% (Low) and 95% (High) confidence bounds of 
this mean. For this analysis, we used Stata/MP 17.0 and 100,000 
replications.

                       Table 8--Share of Population in Counties With Requirement in Effect
----------------------------------------------------------------------------------------------------------------
                                                                                     Share
                           Scenario                           --------------------------------------------------
                                                                   Primary            Low              High
----------------------------------------------------------------------------------------------------------------
1: Universal.................................................           100.0%           100.0%           100.0%
2: High Level................................................            17.1%            12.1%            22.1%
3: High or Medium Level......................................            43.5%            35.9%            51.0%
4: Community Transmission....................................            86.3%            84.2%            88.3%
5: Voluntary.................................................             0.0%             0.0%             0.0%
----------------------------------------------------------------------------------------------------------------
                           Scenario                                         Impact on Costs, Masking
----------------------------------------------------------------------------------------------------------------
1: Universal.................................................               $0               $0               $0
2: High Level................................................     -$11,516,589     -$12,212,383     -$10,820,796
3: High or Medium Level......................................      -$7,850,147      -$8,898,821      -$6,801,473
4: Community Transmission....................................      -$1,907,295      -$2,190,078      -$1,624,510
5: Voluntary.................................................     -$13,886,709     -$13,886,709     -$13,886,709
----------------------------------------------------------------------------------------------------------------

Analysis of Alternative Baseline Scenarios
    In our primary analysis of the final rule, we adopt a baseline 
scenario of the requirements of the IFC in effect nationally over the 
time horizon of our analysis (``IFC'' in Table 9 below). We also 
performed a sensitivity analysis that adopts two alternative baseline 
scenarios. Our first alternative baseline scenario (``Injunction'') 
accounts for two federal court injunctions.\49\ We estimate that these 
injunctions jointly cover about 45.5% of Head Start staff. Thus, under 
our alternative baseline that accounts for the federal court 
injunctions, we reduce the costs of masking by 45.5% compared to our 
primary baseline. We also assess the impact of the final rule under a 
second alternative baseline of ``No IFC.'' Table 9 reports the costs 
under each of these baselines, the costs under the final rule, and 
presents the impact on costs under each of the baselines. For this 
analysis, we assume that the final rule will be in effect at all Head 
Start programs.

                                                   Table 9--Cost Analysis Under Alternative Baselines
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Baseline costs                                                  Impact on costs
              Cost element               ------------------------------------------------   Costs under  -----------------------------------------------
                                                IFC         Injunction        No IFC        final rule          IFC         Injunction        No IFC
--------------------------------------------------------------------------------------------------------------------------------------------------------
Masking Requirement.....................           $13.9            $7.6            $0.0            $2.4          -$11.5           -$5.2            $2.4
Communicating and Learning..............             0.0             0.0             0.0             1.7             1.7             1.7             1.7
Establishing a Policy...................             0.0             0.0             0.0             0.6             0.6             0.6             0.6
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................            13.9             7.6             0.0             4.6            -9.2            -2.9             4.6
--------------------------------------------------------------------------------------------------------------------------------------------------------

III. Final Small Entity Analysis

    We have examined the economic implications of this Interim Final 
Rule as required by the Regulatory Flexibility Act. This analysis, as 
well as other sections in this Regulatory Impact Analysis, serves as 
the Initial 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).\50\ We replicate the SBA's 
description of this table:

    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, 2017. The latest NAICS codes are referred to as 
NAICS 2017.
    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.

    This final rule will impact small entities in NAICS category 
624410, Child Day Care Services, which has a size standard of $8.5 
million dollars. We assume that all 20,085 Head Start centers are below 
this threshold and are considered small entities.
B. Description of the Impacts of the Rule on Small Entities
    Compared to our Baseline Scenario of the IFC, this final rule will 
result in cost savings for Head Start programs associated with 
modifications to the masking requirement, costs associated with 
communicating current requirements, and costs associated with

[[Page 1008]]

revisions to policies and procedures. As outlined in Table 6, we 
estimate that the incremental impact of the final rule is about $9.2 
million in net cost savings for Head Start programs. Across 20,085 
centers, we estimate that these cost savings will average $460.32 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.

IV. Appendix

A. Value of Time Calculations
On-the-Job Activities for Supervisors
    For changes in time use for on-the-job activities for supervisors, 
we adopt an hourly value of time based on the cost of labor, including 
wages and benefits, and also indirect costs, which ``reflect resources 
necessary for the administrative oversight of employees and generally 
include time spent on administrative personnel issues (e.g., human 
resources activities such as hiring, performance reviews, personnel 
transfers, affirmative action programs), writing administrative 
guidance documents, office expenses (e.g., space rental, utilities, 
equipment costs), and outreach and general training (e.g., employee 
development).'' \51\
    For supervisors, we identify a pre-tax hourly wage of Education and 
Childcare Administrators, Preschool and Daycare, in the Child Day Care 
Services industry. According to the U.S. Bureau of Labor Statistics, 
the hourly median wage for these individuals is $22.75 per hour.\52\ 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 $45.50. We adopt this as 
our estimate of the hourly value of time for changes in time use for 
on-the-job activities for supervisors.
On-the-Job Activities for Non-Supervisory Staff
    For non-supervisory staff, we identify a pre-tax hourly wage of 
Preschool and Kindergarten Teachers in the Child Day Care Services 
industry. According to the U.S. Bureau of Labor Statistics, the hourly 
median wage for these individuals is $14.10 per hour.\53\ 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 $28.20. We adopt this as our estimate 
of the hourly value of time for changes in time use for on-the-job 
activities for non-supervisory staff.

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.
    January Contreras, Assistant Secretary of the Administration for 
Children and Families, approved this document on December 7, 2022.

List of Subjects in 45 CFR Part 1302

    COVID-19, Education of disadvantaged, Grant programs--social 
programs, Head Start, Health care, Mask use, Monitoring, Safety.

    Dated: December 27, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.

    For reasons discussed in the preamble, 45 CFR part 1302 is amended 
as follows:

PART 1302--PROGRAM OPERATIONS

0
1. The authority citation for part 1302 continues to read as:

    Authority:  42 U.S.C. 9801 et seq.


0
2. AmendSec.  1302.47 by:
0
a. Adding the word ``and'' at the end of (b)(5)(iv).
0
b. Removing the word ``and'' from paragraph (b)(5)(v).
0
c. Removing paragraph (b)(5)(vi).
0
d. Adding paragraph (b)(9).
    The addition reads as follows:


Sec.  1302.47  Safety practices.

* * * * *
    (b) * * *
    (9) COVID-19 mitigation policy. The program has an evidence-based 
COVID-19 mitigation policy developed in consultation with their Health 
Services Advisory Committee (HSAC) that can be scaled up or down based 
on the impact of COVID-19 in the community to protect staff, children, 
and families from COVID-19 infection.
* * * * *

Endnotes

    \1\ Exceptions were noted for when individuals are eating or 
drinking; for children when they are napping; for the narrow subset 
of persons who cannot wear a mask, or cannot safely wear a mask, 
because of a disability as defined by the Americans with 
Disabilities Act (ADA), consistent with CDC guidance on disability 
exemptions; and for children with special health care needs, for 
whom programs should work together with parents and follow the 
advice of the child's health care provider for the best type of face 
covering.
    \2\ https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/k-12-childcare-guidance.html.
    \3\ 86 FR 68052.
    \4 \ Not all the listed considerations are included because they 
are only relevant to certain standards, such as curriculum.
    \5\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
    \6\ Centers for Disease Control and Prevention. ``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: http://dx.doi.org/10.15585/mmwr.mm7036e2.
    \9\ Texas et al. v. Becerra, et al., 577 F. Supp. 3d 527 (N.D. 
Tex. 2021)
    \10\ Louisiana, et al. v. Becerra, et al., No. 21-cv-04370, 2022 
WL 4370448,--F. Supp. 3d--(W.D. La. Sept. 21, 2022); Louisiana, et 
al. v. Becerra, et al., No. 21-cv-04370, 577 F. Supp. 3d 483 (W.D. 
La. 2022).)
    \11\ Note: January 2022 center status is not included due to a 
system error with the Head Start Enterprise System, causing 
unusually high unreported values.
    \12\ OHS acknowledges that we do not know what impacts on 
enrollment would have been in states that did not implement the 
requirements.
    \13\ Nobrega M, Opice R, Lauletta M, Nobrega C. How face masks 
can affect school performance. Int J Pediatr Otorhinolaryngol. 
2020;138:110328.
    \14\ Goldin A, Weinstein BE, Shiman N. How do medical masks 
degrade speech perception? Hearing Review. 2020;27(5):8-9.
    \15\ American Academy of Pediatric. ``COVID-19 Guidance for Safe 
Schools and Promotion of In-Person Learning.'' Retrieved in July 
2022: https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/covid-19-planning-considerations-return-to-in-person-education-in-schools/.
    \16\ Schneider, J., Sandoz, V., Equey, L., Williams-Smith, J., 
Horsch, A., & Graz, M.B. (2022). The role of face masks in the 
recognition of emotions by preschool children. JAMA pediatrics, 
176(1), 96-98.
    \17\ Ruba AL, Pollak SD (2020) Children's emotion inferences 
from masked faces:

[[Page 1009]]

Implications for social interactions during COVID-19. PLoS ONE 
15(12): e0243708. https://doi.org/10.1371/journal.pone.0243708.
    \18\ Gori M, Schiatti L and Amadeo MB (2021) Masking Emotions: 
Face Masks Impair How We Read Emotions. Front. Psychol. 12:669432. 
doi: 10.3389/fpsyg.2021.669432
    \19\ Singh, L., Tan, A., & Quinn, P. C. (2021). Infants 
recognize words spoken through opaque masks but not through clear 
masks. Developmental science, 24(6), e13117. https://doi.org/10.1111/desc.13117.
    \20\ Classroom language during COVID-19: Associations between 
mask-wearing and objectively measured teacher and preschooler 
vocalizations
    \21\ Mitsven, S.G., Perry, L.K., Jerry, C.M., & Messinger, D.S. 
Classroom language during COVID-19: Associations between mask 
wearing and objectively measured teacher and preschooler 
vocalizations. Frontiers in Psychology, 6793.
    \22\ Moghadas SM, Fitzpatrick MC, Sah P, et al. The implications 
of silent transmission for the control of COVID-19 outbreaks. Proc 
Natl Acad Sci U S A. 2020;117(30):17513-17515.
    \23\ Johansson MA, Quandelacy TM, Kada S, et al. SARS-CoV-2 
transmission from people without COVID-19 symptoms. JAMA Netw Open. 
2021;4(1):e2035057.
    \24\ CDC. Science Brief: Community Use of Masks to Control the 
Spread of SARS-CoV-2. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/masking-science-sars-cov2.html.
    \25\ Kwon S, Joshi AD, Lo CH, et al. Association of social 
distancing and face mask use with risk of COVID-19. Nat Commun 
2021;12:3737. https://doi.org/10.1038/s41467-021-24115-7external 
icon PMID:34145289.
    \26\ CDC. Science Brief: Community Use of Masks to Control the 
Spread of SARS-CoV-2. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/masking-science-sars-cov2.html.
    \27\ Smith J, Culler A, Scanlon K. Impacts of blood gas 
concentration, heart rate, emotional state, and memory in 
school[hyphen]age children with and without the use of facial 
coverings in school during the COVID-19 pandemic. FASEB J. 
2021;35(Suppl 1) doi:10.1096/fasebj.2021.35.S1.04955.
    \28\ Lubrano R, Bloise S, Testa A, et al. Assessment of 
respiratory function in infants and young children wearing face 
masks during the COVID-19 pandemic. JAMA Netw Open. 
2021;4(3):e210414.
    \29\ Murray TS, Malik AA, Shafiq M, et al. Association of Child 
Masking With COVID-19-Related Closures in US Childcare Programs. 
JAMA Netw Open. 2022;5(1):e2141227. doi:10.1001/
jamanetwork.2021.41227
    \30\ Gettings J, Czarnik M, Morris E, et al. Mask Use and 
Ventilation Improvements to Reduce COVID-19 Incidence in Elementary 
Schools--Georgia, November 16-December 11, 2020. MMWR Morb Mortal 
Wkly Rep 2021;70:779-784. DOI: http://dx.doi.org/10.15585/mmwr.mm7021e1external icon.
    \31\ Boutzoukas, A.E., Zimmerman, K.O., Inkelas, M., Brookhart, 
M.A., Benjamin Sr, D.K., Butteris, S., . . . & Benjamin Jr, D.K. 
(2022). School Masking Policies and Secondary SARS-CoV-2 
Transmission. Pediatrics.
    \32\ Jehn, M., Mac McCullough, J., Dale, A.P., Gue, M., Eller, 
B., Cullen, T., & Scott, S.E. (2021). Association between K-12 
school mask policies and school-associated COVID-19 outbreaks--
Maricopa and Pima Counties, Arizona, July-August 2021. Morbidity and 
Mortality Weekly Report, 70(39), 1372.
    \33\ WHO, &; UNICEF. (2020). Advice on the use of masks for 
children in the community in the context of COVID-19. Annex to the 
Advice on the Use of Masks in the Context of COVID-19. Retrieved 
July 2022.
    \34\ Bassok, D., Doromal, J., Michie, M., & Wong, V. (2021). The 
Effects of Financial Incentives on Teacher Turnover in Early 
Childhood Settings: Experimental Evidence from Virginia. 
EdPolicyWorks at the University of Virginia.; Caven, M., Khanani, 
N., Zhang, X., & Parker, C.E. (2021). Center-and program-level 
factors associated with turnover in the early childhood education 
workforce (REL 2021-069). U.S. Department of Education, Institute of 
Education Sciences, National Center for Education Evaluation and 
Regional Assistance, Regional Educational Laboratory Northeast & 
Islands.
    \35\ Adapted from Office of Disease Prevention. Evidence-based 
practices and programs. National Institutes of Health https://prevention.nih.gov/research-priorities/dissemination-implementation//evidence-based-practices-programs.
    \36\ Adapted from European Centre for Disease Control and 
Prevention. European Centre for Disease Prevention and Control. 
Evidence-based methodologies for public health--How to assess the 
best available evidence when time is limited and there is lack of 
sound evidence. Stockholm: ECDC; 2011. https://www.ecdc.europa.eu/sites/default/files/media/en/publications//Publications/1109_TER_evidence_based_methods_for_public_health.pdf.
    \37\ Centers for Disease Control and Prevention. ``Operational 
Guidance for K-12 Schools and Early Care and Education Programs to 
Support Safe In-Person Learning.'' May, 27, 2022. Available at: 
https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/k-12-childcare-guidance.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2/
Fcoronavirus%2F2019-ncov%2Fcommunity%2Fschools-childcare%2Fchild-
care-guidance.html.
    \38\ 86 FR 68052.
    \39\ Ibid.
    \40\ Ibid.
    \41\ https://www.amazon.com/WRAPCOTT-Disposable-Layer-Breathable-Lightweight/dp/B08L6JGJM3/. $6.99 price per 100 masks 
observed when accessing this online vendor on November 9, 2022.
    \42\ https://www.amazon.com/Disposable-Elastic-Earloops-Childcare-Colorful/dp//B09JYL9C6K/ref=sr_1_4. $7.99 price per 100 
masks observed when accessing this online vendor on November 9, 
2022.
    \43\ https://www.regulations.gov/comment/ACF-2021-0003-2410.
    \44\ 86 FR 68053.
    \45\ Centers for Disease Control and Prevention. United States 
COVID-19 Community Levels by County https://data.cdc.gov/Public-Health-Surveillance//United-States-COVID-19-Community-Levels-by-County/3nnm-4jni. Accessed November 4, 2022.
    \46\ Centers for Disease Control and Prevention. United States 
COVID-19 County Level of Community Transmission. https://data.cdc.gov/Public-Health-Surveillance/United-States-COVID-19-County-Level-of-Community-T/nra9-vzzn/data. CDC notes that this data 
series will no longer be updated as of October 20, 2022. Accessed 
November 4, 2022.
    \47\ https://eclkc.ohs.acf.hhs.gov/sites/default/files/pdf/no-search/hs-program-fact-sheet-2019.pdf.
    \48\ https://covid19.healthdata.org/united-states-of-america?view=mask-use&tab=trend. Accessed November 9, 2022.
    \49\ As of December 31, 2021, following a decision by the United 
States District Court for the Northern District of Texas, 
implementation and enforcement of the IFC is preliminarily enjoined 
in Texas. As of January 1, 2022, following a decision by the United 
States District Court for the Western District of Louisiana, 
implementation and enforcement of the IFC is preliminarily enjoined 
in the following 24 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, Utah, West 
Virginia, and Wyoming. Head Start, Early Head Start, and Early Head 
Start-Child Care Partnership grant recipients in those 25 states are 
not required to comply with the IFC pending future developments in 
the litigation.
    \50\ U.S. Small Business Administration (2022). ``Table of Size 
Standards.'' May 2, 2022. https://www.sba.gov/document/support-table-size-standards.
    \51\ U.S. Department of Health and Human Services, Office of the 
Assistant Secretary for Planning and Evaluation. 2017. ``Valuing 
Time in U.S. Department of Health and Human Services Regulatory 
Impact Analyses: Conceptual Framework and Best Practices.'' https://aspe.hhs.gov/reports/valuing-time-us-department-health-/human-services-regulatory-impact-analyses-conceptual-framework. Page v.
    \52\ U.S. Bureau of Labor Statistics. Occupational Employment 
and Wages, May 2021. 11-9031 Education and Childcare Administrators, 
Preschool and Daycare. Median hourly wage. https://www.bls.gov/oes/current/oes119031.htm.
    \53\ U.S. Bureau of Labor Statistics. Occupational Employment 
and Wage Statistics, May 2021 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.

[FR Doc. 2022-28451 Filed 1-5-23; 8:45 a.m.]
BILLING CODE 4184-01-P