[Federal Register Volume 86, Number 227 (Tuesday, November 30, 2021)]
[Rules and Regulations]
[Pages 68052-68101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25869]
[[Page 68051]]
Vol. 86
Tuesday,
No. 227
November 30, 2021
Part II
Department of Health and Human Services
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Administration for Children and Families
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45 CFR Part 1302
Vaccine and Mask Requirements To Mitigate the Spread of COVID-19 in
Head Start Programs; Interim Final Rule
Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 /
Rules and Regulations
[[Page 68052]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
45 CFR Part 1302
RIN 0970-AC90
Vaccine and Mask Requirements To Mitigate 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: Interim final rule with comment period.
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SUMMARY: This interim final rule with comment (IFC) adds new provisions
to the Head Start Program Performance Standards to mitigate the spread
of the coronavirus disease 2019 (COVID-19) in Head Start programs. This
IFC requires effective upon publication, universal masking for all
individuals two years of age and older, with some noted exceptions, and
all Head Start staff, contractors whose activities involve contact with
or providing direct services to children and families, and volunteers
working in classrooms or directly with children to be vaccinated for
COVID-19 by January 31, 2022.
DATES:
Effective date: This IFC is effective on November 30, 2021.
Compliance date: The compliance date for the mask requirement is
the date of publication of the rule, November 30, 2021. The compliance
date for the vaccine requirement is January 31, 2022. For more
information, see SUPPLEMENTARY INFORMATION.
Comment date: To be assured consideration, comments on this interim
final rule must be received on or before December 30, 2021.
ADDRESSES: You may submit comments, identified by [docket number and/or
RIN number], by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Office of Head Start, Attention: Director of Policy
and Planning, 330 C Street SW, 4th Floor, Washington, DC 20201.
Instructions: All submissions received must include the agency name
and docket number or RIN for this rulemaking. All comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided.
FOR FURTHER INFORMATION CONTACT: Colleen Rathgeb, 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: The compliance date for the vaccine
requirement is January 31, 2022. This means staff, certain contractors
and volunteers must have their second dose in a two-dose series, or
first dose in a single-dose by January 31, 2022. Full vaccination
requires 14 days after a two-dose series such as Pfizer or Moderna or
14 days after a single-dose series like Johnson & Johnson, but for
purposes of this regulation, staff, certain contracts and volunteers
will meet the requirement even if they have not yet completed the 14-
day waiting period required for full vaccination. This timing
flexibility applies only to the initial implementation of this IFC and
has no bearing on ongoing compliance.
Table of Contents
I. Tribal Consultation Statement
II. Statutory Authority
III. Executive Summary
A. Purpose of the Interim Final Rule
B. Interim Final Rule Justification
C. Waiver of Proposed Rulemaking
IV. Background
V. Provisions of the Interim Final Rule
VI. Regulatory Process Matters
Treasury and General Government Appropriations Act of 1999
Federalism Assessment Executive Order 13132
Congressional Review
Paperwork Reduction Act of 1995
VII. Economic Analysis of Impacts
VIII. Alternatives Considered
I. 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. We invite public
comment on this IFC if there are concerns specific to Native
communities and programs.
II. Statutory Authority
ACF publishes this interim 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)-(E)), (D) and (,), as amended by
the Improving Head Start for School Readiness Act of 2007 (Pub. L. 110-
134).
III. Executive Summary
A. Purpose of the Interim Final Rule
SARS-CoV-2, the infectious agent that causes COVID-19, is
considered to be mainly transmissible through exposure to respiratory
droplets when a person is in close contact with someone who has COVID-
19. Correct and consistent facemask use has been critical in reducing
the risk of droplet transmission of SARS-CoV-2.1
2 Vaccination is the most important measure for reducing
risk for SARS-CoV-2 transmission and in avoiding severe illness,
hospitalization, and death.\3\
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\1\ https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/diy-cloth-face-coverings.html.
\2\ https://www.osha.gov/coronavirus/safework.
\3\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
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Four primary variants of SARS-CoV-2 have emerged to date. Of these,
the Delta variant has been of particular concern as it causes more
infections and spreads faster than other variants.\4\ While the Delta
variant has increased levels of transmissibility, COVID-19 vaccination
remains highly effective against hospitalization and death. Although
there are cases of SARS-CoV-2 infections among vaccinated
individuals,\5\ fully vaccinated adults were six times less likely to
become infected, twelve times less likely to be hospitalized and eleven
times less likely to die from COVID-19 compared to unvaccinated adults
according to data from August 2021.6 7 While
studies are still ongoing, preliminary data suggest that vaccinated
persons infected with the Delta variant are potentially less
infectious, and infectious for shorter
[[Page 68053]]
periods of time compared to infected unvaccinated persons.8
9 10 11 12 13
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\4\ 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.
\5\ 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 [bond] MMWR.
\6\ 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.
\7\ https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination.
\8\ Chia PY, Ong SWX, Chiew C, et al. Virological and
serological kinetics of SARS-CoV-2 Delta variant vaccine-
breakthrough infections: a multi-center cohort study. medRxiv.
2021;https://www.medrxiv.org/content/10.1101/2021.07.28.21261295v1.
\9\ Shamier MC, Tostmann A, Bogers S. Virological
characteristics of SARS-CoV-2 vaccine breakthrough infections in
health care workers. medRxiv. 2021;https://www.medrxiv.org/content/10.1101/2021.08.20.21262158v1.
\10\ Kang M, Xin H, Yuan J. Transmission dynamics and
epidemiological characteristics of Delta variant infections in
China. medRxiv. 2021;https://www.medrxiv.org/content/10.1101/2021.08.12.21261991v1.
\11\ Ong SWX, Chiew CJ, Ang LW, et al. Clinical and Virological
Features of SARS-CoV-2 Variants of Concern: A Retrospective Cohort
Study Comparing B.1.1.7 (Alpha), B.1.315 (Beta), and B.1.617.2
(Delta). Preprints with The Lancet. 2021;https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3861566.
\12\ Mlcochova P KS, Dhar MS, et al. . SARS-CoV-2 B.1.617.2
Delta variant emergence and vaccine breakthrough. Research Square.
2021 https://www.researchsquare.com/article/rs-637724/v1.
\13\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
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The purpose of this IFC is to protect the health and safety of Head
Start staff, children, and families and to mitigate the spread of SARS-
CoV-2 in Head Start programs. It requires: (1) Universal masking for
all individuals two years of age and older, with some noted exceptions,
effective immediately upon publication of this rule), (2) vaccination
for COVID-19 by January 31, 2022, with some noted exemptions, for all
Head Start program staff, inclusive of Head Start, Early Head Start,
and Early Head Start-Child Care Partnerships, certain contractors, and
volunteers in classrooms or working directly with children (hereafter
referred to as ``Head Start staff''), and (3) for those granted an
exemption to the requirement specified in (2), at least weekly testing
for current SARS-CoV-2 infection. The requirements in this IFC will
reduce the risk of transmission of SARS-CoV-2 in classrooms, which will
protect the health and safety of children, reduce closures of Head
Start programs, which can cause hardship for families, and support the
Administration's priority of sustained in-person early care and
education that is safe for children--with all of its known benefits to
children and families.\14\
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\14\ Barr, A.C., & Gibbs, C. (2019). Breaking the Cycle?
Intergenerational Effects of an Anti-Poverty Program in Early
Childhood. EdWorkingPaper: 19-141. Retrieved from Annenberg
Institute at Brown University, https://edworkingpapers.com/sites/default/files/ai19-141.pdf.; Bauer, L., & Schanzenbach, D.W. (2016).
The Long-Term Impact of the Head Start Program. Washington, DC: The
Brookings Institute. Retrieved from: https://www.hamiltonproject.org/assets/files/long_term_impact_of_head_start_program.pdf.; Ludwig, J., & Phillips,
D. (2007). The Benefits and Costs of Head Start. Social Policy
Report, Vol. 21(3), Society for Research in Child Development.
Retrieved from: https://files.eric.ed.gov/fulltext/ED521701.pdf.;
Garcia, J.L., Heckman, J.J., Leaf, D.E., & Prados M.J. (2019).
Quantifying the Life-cycle Benefits of a Prototypical Early
Childhood Program. National Bureau of Economic Research Working
Paper No. 23479. Cambridge, MA: NBER. Retrieved from: https://heckmanequation.org/www/assets/2017/01/w23479.pdf.; Yoshikawa, H.,
Weiland, C., Brooks-Gunn, J., Burchinal, M.R., Espinosa, L.M.,
Gormley, W.T., Ludwig, J., Magnuson, K.A., Phillips, D., & Zaslow,
M. (2013). Investing in Our Future: The Evidence Base on Preschool
Education. Society for Research in Child Development and Foundation
for Child Development. Retrieved from: http://www.fcd-us.org/assets/2013/10/Evidence20Base20on20Preschool20Education20FINAL.pdf.
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Greater understanding about the spread of SARS-CoV-2, the increased
risk to certain populations, the benefits of masking, and the safety
and efficacy of vaccines demonstrates the need for widespread masking
and vaccination to reduce COVID-19 and its impacts. Although COVID-19
cases had begun to decline in parts of the country following the most
recent COVID-19 surge, data indicate cases are beginning to rise in
other parts--particular northern states where the weather has begun to
turn colder,\15\ and the future trajectory of the pandemic is unclear.
The Delta variant is currently the predominant variant in the United
States and has resulted in greater rates of cases and hospitalizations
among children than from other variants.16 17
18 Furthermore, there is potential for the rapid and
unexpected development and spread of additional new and more
transmissible variants. Experience with the Delta variant suggests that
we must take adequate steps to prevent transmission and protect the
workforce and children to avoid serious harm.\19\ It is critical that
all Head Start staff get fully vaccinated for COVID-19 and consistently
wear masks to protect children, staff, and families from exposure to
SARS-CoV-2 and to reduce the risk of transmission to families of Head
Start children and staff who may be at risk for increased morbidity and
mortality from COVID-19.
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\15\ https://covid.cdc.gov/covid-data-tracker/#trends_dailycases.
\16\ Delahoy, M., et al. Hospitalizations Associated with COVID-
19 Among Children and Adolescents--COVID-Net, 14 States, March 1,
2020--August 14, 2021, https://www.cdc.gov/mmwr/volumes/70/wr/mm7036e2.htm.
\17\ Siegel DA, Reses HE, Cool AJ, et al. 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.
\18\ https://covid.cdc.gov/covid-data-tracker/#demographicsovertime.
\19\ 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.
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This IFC adds provisions to the Head Start Program Performance
Standards to impose three requirements:
(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, 2021.
(3) For those granted an exemption to the requirement specified
in (2), at least weekly testing for current SARS-CoV-2 infection.
Being fully vaccinated for COVID-19 and using a mask are two of the
most effective mitigation strategies available to reduce transmission
of SARS-CoV-2.\20\ Additionally, including a regular SARS-CoV-2 testing
requirement for those approved for an exemption from the vaccination
requirement is necessary to identify infected employees and separate
them from the workplace to prevent transmission and to facilitate early
medical intervention, when appropriate. Fully vaccinated staff are at
much lower risk of infection and therefore, pose lower transmission
risk to the young unvaccinated children in their care. The CDC
recommends screening testing for current infection of unvaccinated
asymptomatic workers as a useful tool to detect SARS-CoV-2 and stop
transmission quickly.\21\
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\20\ Centers for Disease Control and Prevention. ``Science
Brief: COVID-19 Vaccines and Vaccination.'' September 15, 2021.
Available at: https://www.cdc.gov/coronavirus/2019-ncov/science/
science-briefs/fully-vaccinated-
people.html#:~:text=Evidence%20suggests%20the%20US%20COVID,interrupti
ng%20chains%20of%20transmission.
\21\ Centers for Disease Control. ``Overview of Testing for
SARS-CoV-2 (COVID-19)'' October 22, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html.
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B. Interim Final Rule Justification
Section 641A of the Head Start Act authorizes 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. 9836aSec. 9836a(a)(1)(C),(D), (E). In
developing these modifications, the
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Secretary included relevant considerations pursuant to section
641A(a)(2) of the Head Start Act, 42 U.S.C. 9836a(a)(2). The Secretary
consulted with experts in child health, including pediatricians, a
pediatric infectious disease specialist, and the recommendations of the
CDC and FDA. The Secretary considered the Office of Head Start's past
experience with the longstanding health and safety Head Start Program
Performance Standards that have sought to protect Head Start staff and
participants from communicable and contagious diseases. The Secretary
also considered the circumstances and challenges typically facing
children and families served by Head Start agencies including the
disproportionate effect of COVID-19 on low-income communities served by
Head Start agencies and the potential for devastating consequences for
children and families of program closures and service interruptions due
to SARS-CoV-2 exposures. The Secretary finds it necessary and
appropriate to set health and safety standards for the condition of
Head Start facilities that ensure the reduction in transmission of the
SARS-CoV-2 and to avoid severe illness, hospitalization, and death
among program participants.
ACF initially chose, among other actions, to allow Head Start
programs to decide whether or not to require staff vaccination rather
than require vaccination, to provide information on the COVID-19
vaccine through its Early Childhood Learning and Knowledge Center,\22\
the website used to share guidance and information with Head Start
grant recipients, and to emphasize that grant recipients can use COVID-
19 response funds and American Rescue Plan funds to support staff in
getting the COVID-19 vaccine. However, despite all of these efforts,
uptake of vaccination among Head Start staff has not been as robust as
hoped for and has been insufficient to create a safe environment for
children and families. This is particularly true given the advent of
the Delta variant and the potential for new variants and as programs
continue to return to fully in-person services as the Office of Head
Start expects in January 2022. The Office of Head Start (OHS) issued
guidance to programs on May 20, 2021 outlining its expectations for
programs in the 2021-2022 program year. This guidance prepared programs
for the resumption of in-person services and informed programs that
they should build toward full enrollment and provide comprehensive
services for all enrolled children as soon as possible. It noted that
beginning January 2022, OHS intends to reinstate pre-pandemic practices
for tracking and monitoring enrollment. OHS will also resume evaluating
which programs enter into the Full Enrollment Initiative in January
2022, which is a process by which OHS identifies programs that are not
serving their full funded enrollment. This guidance followed a period
since the onset of the pandemic of greater flexibility for programs
with requirements related to enrollment, service duration, virtual/
remote delivery of services, among others. These flexibilities were
critical to programs' ability to continue providing services to
children and families and to adapt services based on the changing
health conditions in their communities during unprecedented times. As
programs prepare for fully in-person services, it is imperative that we
create conditions that support the health and safety of children and
reduce program closures and service interruptions. The universal
masking and vaccination requirements outlined in this IFC are critical
to this effort.
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\22\ Office of Head Start. ``OHS COVID-19 Updates.'' Available
at: https://eclkc.ohs.acf.hhs.gov/about-us/coronavirus/ohs-covid-19-updates.
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The U.S. Centers for Disease Control and Prevention (CDC) issued
guidance July 27, 2021.\23\ The CDC stated that the rationale for this
guidance was twofold: (1) An alarming rise in COVID-19 cases and
hospitalization rates around the country--a reversal in what had been a
steady decline since January 2021 \24\ and (2) new data showing the
Delta variant to be highly transmissible.\25\ A study covering the
period from June to mid-August 2021 showed that weekly COVID-19
associated hospitalization rates among children and adolescents rose
nearly five-fold during the late June to mid-August 2021 period, which
coincided with increased circulation of the Delta variant.\26\ In this
same study, hospitalization rates were 10 times higher among
unvaccinated than fully vaccinated adolescents. A separate study
conducted in the United Kingdom showed that vaccination effectively
reduces the risk of Delta variant infection \27\ but that ``vaccination
alone is not sufficient to prevent all transmission of the delta
variant in the household setting, where exposure is close and
prolonged.'' The authors recommended nonpharmaceutical interventions,
such as mask wearing, as an important complementary approach alongside
vaccination to minimize spread of the Delta variant.
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\23\ Centers for Disease Control and Prevention. ``Science
Brief: COVID-19 Vaccines and Vaccination.'' September 15, 2021.
Available at: https://www.cdc.gov/coronavirus/2019-ncov/science/
science-briefs/fully-vaccinated-
people.html#:~:text=Evidence%20suggests%20the%20US%20COVID,interrupti
ng%20chains%20of%20transmission.
\24\ Centers for Disease Control and Prevention. ``COVID Data
Tracker.'' Available at: https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network.
\25\ Brown CM, Vostok J, Johnson H, et al. Outbreak of SARS-CoV-
2 Infections, Including COVID-19 Vaccine Breakthrough Infections,
Associated with Large Public Gatherings--Barnstable County,
Massachusetts, July 2021. MMWR Morb Mortal Wkly Rep. ePub: 30 July
2021; https://www.cdc.gov/mmwr/volumes/70/wr/mm7031e2.htm.
\26\ Delahoy MJ, Ujamaa D, Whitaker M, et al. Hospitalizations
Associated with COVID-19 Among Children and Adolescents--COVID-NET,
14 States, March 1, 2020-August 14, 2021. MMWR Morb Mortal Wkly Rep
2021;70:1255-1260. DOI: http://dx.doi.org/10.15585/mmwr.mm7036e2.
\27\ Singanayagam, AnikaBadhan, Anjna et al. Community
transmission and viral load kinetics of the SARS-CoV-2 delta
(B.1.617.2) variant in vaccinated and unvaccinated individuals in
the UK: a prospective, longitudinal, cohort study. https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00648-4/
fulltext.
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On November 10, 2021, the CDC issued updated guidance to early
childhood education and child care (ECE) programs.\28\ One of the key
changes in the guidance is the recommendation for universal indoor
masking for ECE programs for everyone aged 2 years and older regardless
of vaccination status, with limited exceptions, see section V
Provisions of the Interim Final Rule. It also notes that ECE program
staff can model consistent and correct use for children aged 2 years or
older in their care. Vaccinations and masks are key strategies for
reducing the transmission of SARS-CoV-2 along with other risk reduction
strategies, including staying home if sick; handwashing; improving
ventilation; screening and diagnostic testing, cleaning, and
disinfecting; keeping physical distance; and cohorting,\29\ especially
because physical distancing is not always feasible in early childhood
settings.\30\
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\28\ Centers for Disease Control. ``COVID-19 Guidance for
Operating Early Care and Education/Child Care Programs.'' November
10, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/child-care-guidance.html.
\29\ Cohorting refers to placing children and child care
providers into distinct groups who stay together throughout an
entire day.
\30\ Centers for Disease Control and Prevention. ``COVID-19
Guidance for Operating Early Care and Education/Child Care
Programs.'' August 25, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/child-care-guidance.html; https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/transmission_k_12_schools.html.
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The COVID-19 vaccines are the safest and most effective way to
protect individuals and the people with whom they live and work from
infection and
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from severe illness and hospitalization if they contract the virus.
Data from August 2021 indicate that when compared with vaccinated
adults, those who were not fully vaccinated were 6 times more likely to
become infected, 12 times more likely to be hospitalized, and 11 times
more likely to die of COVID-19.\31\ \32\ In addition to preventing
morbidity and mortality associated with COVID-19, currently available
vaccines also demonstrate effectiveness against asymptomatic SARS-CoV-2
infection. A study of the period from December 14, 2020 to August 14,
2021, found that full vaccination for COVID-19 was 80 percent effective
in preventing SARS-CoV-2 infection among health care workers.\33\ While
the scientific evidence for transmissibility of breakthrough cases
(i.e., cases in fully vaccinated individuals) is still developing,
fully vaccinated individuals are less likely to spread COVID-19 because
they are less likely to become infected in the first place. Studies
have shown that vaccinations reduce the risk of COVID-19 among
unvaccinated close contacts, including children. For example, one study
found that vaccination of health care workers was associated with
decreased COVID-19 cases among members of their household.\34\
Additionally, a study during the early months of the COVID-19 vaccine
rollout in Israel found that community vaccination rates were
associated with declines in infections among unvaccinated children.\35\
Vaccination was also shown to be effective in lowering the risk of
severe disease if infected with the Delta variant, which has emerged as
a more contagious strain of the SARS-CoV-2 with a higher impact on
children than previous variants.\36\
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\31\ Monitoring Incidence of COVID-19 Cases, Hospitalizations,
and Deaths, by Vaccination Status--13 U.S. Jurisdictions, April 4-
July 17, 2021 Early Release/September 10, 2021/70.
\32\ Center for Disease Control and Prevention. ``COVID Data
Tracker.'' Available at: https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination.
\33\ Fowles, A., Gaglani, M., Groover, K., et al. Effectiveness
of COVID-19 Vaccines in Preventing SARS-CoV-2 Infection among
Frontline Workers Before and During B.1.617.2 (Delta) Variant
Predominance--Eight U.S. Locations, December 2020-August 2021,
Morbidity and Mortality Weekly Report, August 27, 2021, Available
at: https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
\34\ Effect of Vaccination on Transmission of SARS-CoV-2. N Engl
J Med 2021; 385:1718-1720 DOI: 10.1056/NEJMc2106757.
\35\ Milman, O., Yelin, I., Aharony, N. et al. Community-level
evidence for SARS-CoV-2 vaccine protection of unvaccinated
individuals. Nat Med 27, 1367-1369 (2021). https://doi.org/10.1038/s41591-021-01407-5.
\36\ Centers for Disease Control and Prevention. ``COVID Data
Tracker. Pediatric Data.'' Available at: https://covid.cdc.gov/covid-data-tracker/#pediatric-data; Centers for Disease Control and
Prevention. ``Delta Variant: What We Know About the Science.''
Available at: https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html; Centers for Disease Control and Prevention.
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. Available at: https://www.cdc.gov/mmwr/volumes/70/wr/mm7036e1.htm?s_cid=mm7036e1_w.
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Given that children under age 5 years are too young to be
vaccinated at this time, requiring masking and vaccination among
everyone who is eligible are the best defenses against COVID-19,
especially cases arising from the more infectious Delta variant. These
measures will also reduce program closures due to SARS-CoV-2 infection.
When children or staff test positive for SARS-CoV-2 or have exposure to
someone else who has tested positive for SARS-CoV-2, classrooms or
entire programs close for a period of days or weeks to allow for test
results and quarantining per local health department guidance.
Additionally, as discussed later in this IFC, closures impose hardship
on Head Start children and families by diminishing the ability to
attend Head Start in person. The result is harm to early learning and
development. Closures also diminish the ability of parents to work or
participate in schooling.
Health and Safety
The Delta variant, which in the summer of 2021 became the
predominant SARS-CoV-2 strain in the United States, is more
contagious--spreading twice as fast--and results in more cases and
hospitalizations for children.\37\ The increase in hospitalization is
more acute in states with lower vaccination rates. Studies released by
CDC found that the rate of hospitalization for children was nearly four
times higher in states with the lowest vaccination rates when compared
to states with high vaccination rates.\38\ Furthermore, hospitalization
rates for children in September and October 2021, while lower than
other age groups, were elevated relative to other periods during the
pandemic.\39\ Vaccination remains the best line of defense against
COVID-19. Data show fully vaccinated persons are less likely than
unvaccinated persons to become infected with SARS-CoV-2, and infections
with the Delta variant in fully vaccinated persons are associated with
less severe clinical outcomes.\40\ Being fully vaccinated reduces risk
of the transmission of SARS-COV-2 from staff to children who are not
yet eligible for the vaccine and must be protected to minimize their
exposure. Reducing transmission from staff to children and between
staff also reduces transmission from children and staff to their family
members. Transmission of SARS-CoV-2 in child care settings has been
linked to infections and hospitalizations in family members,\41\ and
some children and staff may return home to family members who are older
or have underlying medical conditions that put them at greater risk for
COVID-19-related morbidity and mortality. Studies have shown that
COVID-19 has disproportionately affected some racial and ethnic
minority groups such as Hispanic or Latino, Black or African American,
American Indian or Alaskan Native (AIAN), and Native Hawaiian and other
Pacific Islander people.\42\ It is also estimated that these
disparities may have long term implications for these populations: for
example, it is estimated that COVID-19 morbidity and mortality impacts
can reverse over 10 years of progress in reducing the gaps in life
expectancy between Black and White populations.\43\ Many families of
Head
[[Page 68056]]
Start children and staff are members of minority communities; 71
percent of families, and 69 percent of staff, self-identify as
Hispanic/Latino, Black/African American, American Indian, or Alaska
Native,\44\ who have been shown to be at increased risk of exposure to
SARS-CoV-2. Given the disproportionate burden of COVID-19 deaths and
lower vaccination rates among racial and ethnic minority groups,
requiring vaccination among Head Start staff is not only an issue of
personal health, but also promotes public and community health and
health equity for children and staff in Head Start programs.\45\A
recent CDC study showed that during the period from May 23 to June 12,
2021, 50 percent of the children in a classroom tested positive for
SARS-COV-2 infection in a Marin County, California elementary school
following exposure to one unvaccinated teacher.\46\ This outbreak,
which began with an unvaccinated teacher who attended school for two
days with symptoms and took off her mask when reading to the class,
demonstrates the importance of vaccinating staff members who work
closely with young children. The rate of SARS-CoV-2 positivity in the
two rows closest to the teacher's desk was 80 percent (8 of 10); in the
three back rows, it was 29 percent (4 of 14). Four days after the
teacher reported being symptomatic, when the teacher received a
positive test, additional cases of COVID-19 were reported among other
staff members, students, parents, and siblings connected to the school.
In addition to highlighting the importance of vaccination and masking,
this study points to the Delta variant's increased transmissibility and
potential for rapid spread, especially in unvaccinated populations such
as children too young for vaccination.\47\
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\37\ 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; https://covid.cdc.gov/covid-data-tracker/#pediatric-data.
\38\ Siegel DA, Reses HE, Cool AJ, et al. 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. MMWR Morb Mortal Wkly Rep 2021; 70:1249-1254. DOI:
https://www.cdc.gov/mmwr/volumes/70/wr/mm7036e1.htm.
\39\ Centers for Disease Control and Prevention. ``COVID Tracker
Weekly Review.'' Available at: https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html.
\40\ Centers for Disease Control and Prevention. ``Science
Brief: COVID-19 Vaccines and Vaccination.'' September 15, 2021.
Available at: https://www.cdc.gov/coronavirus/2019-ncov/science/
science-briefs/fully-vaccinated-
people.html#:~:text=Evidence%20suggests%20the%20US%20COVID,interrupti
ng%20chains%20of%20transmission.
\41\ Lopez AS, Hill M, Antezano J, et al. Transmission Dynamics
of COVID-19 Outbreaks Associated with Child Care Facilities -- Salt
Lake City, Utah, April-July 2020. MMWR Morb Mortal Wkly Rep
2020;69:1319-1323. DOI: http://dx.doi.org/10.15585/mmwr.mm6937e3.
\42\ Centers for Disease Control and Prevention. ``Introduction
to COVID-19 Racial and Ethnic Health Disparities.'' December 10,
2020. Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/index.html.
\43\ Andrasfay, T., & Goldman, N. (2021). Reductions in 2020 US
life expectancy due to COVID-19 and the disproportionate impact on
the Black and Latino populations. Proceedings of the National
Academy of Sciences of the United States of America, 118(5),
e2014746118. https://doi.org/10.1073/pnas.2014746118.
\44\ United States Department of Health and Human Services.
``Head Start Program Information Report.'' Available at: https://eclkc.ohs.acf.hhs.gov/data-ongoing-monitoring/article/program-information-report-pir.
\45\ Patel KM, Malik AA, Lee A, et al. COVID-19 vaccine uptake
among US child care providers. Pediatrics. 2021; doi: https://pubmed.ncbi.nlm.nih.gov/34452977/.
\46\ Lam-Hine T, McCurdy SA, Santora L, et al. Outbreak
Associated with SARS-CoV-2 B.1.617.2 (Delta) Variant in an
Elementary School--Marin County, California, May-June 2021. MMWR
Morb Mortal Wkly Rep 2021; 70:1214-1219. DOI: http://dx.doi.org/10.15585/mmwr.mm7035e2.
\47\ Lam-Hine T, McCurdy SA, Santora L, et al. Outbreak
Associated with SARS-CoV-2 B.1.617.2 (Delta) Variant in an
Elementary School--Marin County, California, May-June 2021. MMWR
Morb Mortal Wkly Rep 2021; 70:1214-1219. DOI: http://dx.doi.org/10.15585/mmwr.mm7035e2.
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Additionally, a study covering the period from July 15 to August
31, 2021, that included public K-12 schools in Maricopa and Pima
Counties, Arizona, found that schools without mask requirements were
3.5 times more likely to have COVID-19 outbreaks compared with schools
that started the year with mask requirements.\48\ This finding is
consistent with another study that included 520 counties across the
United States during the period July 1 to September 4, 2021, reporting
that counties without school mask requirements experienced larger
increases in pediatric COVID-19 case rates after the start of school
compared to counties that had school mask requirements.\49\
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\48\ Jehn M, McCullough JM, Dale AP, et al. Association Between
K-12 School Mask Policies and School-Associated COVID-19 Outbreaks--
Maricopa and Pima Counties, Arizona, July-August 2021. MMWR Morb
Mortal Wkly Rep 2021;70:1372-1373. DOI: http://dx.doi.org/10.15585/mmwr.mm7039e1.
\49\ Budzyn SE, Panaggio MJ, Parks SE, et al. Pediatric COVID-19
Cases in Counties With and Without School Mask Requirements--United
States, July 1-September 4, 2021. MMWR Morb Mortal Wkly Rep
2021;70:1377-1378. DOI: http://dx.doi.org/10.15585/mmwr.mm7039e3.
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Prior to the availability of COVID-19 vaccines in the United
States, during the period from September to October 2020, ACF
collaborated with CDC to conduct a mixed-methods study in Head Start
programs in eight states (Alaska, Georgia, Idaho, Maine, Missouri,
Texas, Washington, and Wisconsin). The study found that implementing
and monitoring adherence to recommended mitigation strategies, such as
mask use, can reduce risk for SARS-COV-2 transmission in Head Start
settings. It also showed that Head Start and Early Head Start programs
that successfully implemented CDC-recommended guidance for childcare
programs were able to continue offering safe in-person learning.\50\
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\50\ Coronado F, Blough S, Bergeron D, et al. Implementing
Mitigation Strategies in Early Care and Education Settings for
Prevention of SARS-CoV-2 Transmission--Eight States, September-
October 2020. MMWR Morb Mortal Wkly Rep 2020; 69:1868-1872. DOI:
http://dx.doi.org/10.15585/mmwr.mm6949e3.
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A survey of the U.S. child care workforce conducted between May 26
and June 23, 2021, found that the overall COVID-19 vaccine uptake among
child care providers was 78.2 percent, which was higher than the
general U.S. adult population (65 percent).\51\ The rate among Head
Start and Early Head Start staff in center-based settings specifically
was 73 percent, though lower in home-based programs. That 73 percent is
a nationwide figure. It could be much less in certain areas. Also, it
is 73 percent of adults, but none of the children in the programs can
be vaccinated. While other teachers and staff members might be
protected from an unvaccinated staff, the concern remains the
protection of children and families. Depending on the role in the
program of the 27 percent of Head Start staff that are unvaccinated, it
could result in roughly 250,000 children who are in the care of an
unvaccinated adult. This IFC is critical in order to increase that
percentage, given the importance of protecting young children from
exposure to SARS-CoV-2, including more transmissible variants.
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\51\ Patel KM, Malik AA, Lee A, et al. COVID-19 vaccine uptake
among US child care providers. Pediatrics. 2021; doi: https://www.cdc.gov/mmwr/volumes/70/wr/mm7036e1.htm.
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Data show COVID-19 vaccination requirements are effective in
increasing vaccination rates among employees. Other industries that
have implemented vaccine requirements have seen substantial increases
in the percent of their workforce receiving the vaccine.\52\ \53\ Two
weeks following the Governor of Washington's vaccine requirement for
State workers, according to the Washington State Department of Health,
the weekly vaccination rate increased 34 percent.\54\
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\52\ Hirsch, L. (2021, September 30). After mandate, 91% of
Tyson workers are vaccinated. The New York Times. Retrieved November
3, 2021, from https://www.nytimes.com/2021/09/30/business/tyson-foods-vaccination-mandate-rate.html; Josephs, L. (2021, September
29). Nearly 600 United Airlines employees face termination for
failing to comply with Vaccine Mandate. CNBC. Retrieved November 3,
2021, from https://www.cnbc.com/2021/09/28/unvaccinated-united-airlines-staff-faces-termination-as-early-as-today.html.
\53\ White House. ``WHITE HOUSE REPORT: Vaccination Requirements
Are Helping Vaccinate More People, Protect Americans from COVID-19,
and Strengthen the Economy.'' Available at: https://www.whitehouse.gov/wp-content/uploads/2021/10/Vaccination-Requirements-Report.pdf.
\54\ White House. ``Path Out of the Pandemic.'' Available at:
https://www.whitehouse.gov/covidplan/#schools; Mikkelsen, D. (2021,
August 27). Covid-19 vaccinations increase in Washington following
mandates, Spike in cases. king5.com. Retrieved November 3, 2021,
from https://www.king5.com/article/news/local/covid-19-vaccinations-increase-in-washington/281-1af4cc43-2d7f-4e77-a2fd-0fad28d0c4f3.
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Reduced Program Closures
Requiring staff to get fully vaccinated for COVID-19 is critical to
reduce program closures due to SARS-CoV-2 exposures. Such closures may
impose multiple hardships on Head Start children and families. The
children and families served by Head Start are largely comprised of
individuals who experience economic hardship and have been historically
underserved and marginalized. In 2019, 80 percent of children served by
Head Start were
[[Page 68057]]
Black, Indigenous, or persons of color.\55\ Thirty-eight percent of
children were dual language learners, with a language other than
English spoken in the home (sometimes in addition to English). The mean
annual household income for families was $26,000. Fifty-nine percent of
children had a mother with a high school diploma or less, and the
majority (77 percent) had a mother who was either working full-time,
working part-time, or looking for work. Fifty-seven percent and 52
percent of children's families received SNAP benefits and WIC benefits,
respectively. Thirty-one percent of children lived in a household where
parents reported household food would often or sometimes run out and
they did not have money to purchase more. Twenty-four percent of
children's mothers had moderate or severe depressive symptoms, as
measured by a clinical depression screening tool.
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\55\ All descriptive statistics in this paragraph are from:
Kopack Klein, A., Aikens, N., Li, A., Bernstein, S. Reid, N., Dang,
M., Blesson, E. . . . Tarullo, L. (2021). Descriptive Data on Head
Start Children and Families from FACES 2019: Fall 2019 Data Tables
and Study Design, OPRE Report 2021-77, Washington, DC: U.S.
Department of Health and Human Services.
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Head Start programs provide critical services to meet the health,
nutrition, and early learning needs of these children and families.
Programs provide healthy nutritious meals to children and provide
diapers for babies and toddlers, every day they are at the program.
Programs ensure children are brushing their teeth and provide critical
mental health services. Programs also provide high-quality early
education services to promote the overall learning and development of
children and prepare them for entry into kindergarten. If a program
must close its facilities for a designated period of time due to an
outbreak of SARS-CoV-2 infections, children at-risk will not receive
these critical in-person services. Further, program closures limit the
ability of Head Start families to work or seek educational
opportunities. As summarized previously, Head Start families earning
low wages and very likely do not have sick leave to care for children
while they are in quarantine. Staying home for intermittent closures,
rather than working, imposes significant financial costs on Head Start
families. It also places the families at risk of losing their
employment if they must take unpaid leave to care for children in
quarantine. Families rely on Head Start programs to provide stable and
reliable early care and education services to their children, and the
effects of intermittent closures are significant.
As alluded to previously, program closures also create instability
and stress for children and families. They disrupt children's
opportunities for learning, socialization, nutrition, and continuity
and routine. In June 2020, the Defending the Early Years organization
released a survey to better understand the impact COVID-19 has had on
young children, their families, and their teachers. Balancing working
from home and supporting children was the number one challenge for
parents. This challenge was especially acute for families with multiple
children in different grade levels or with one child under the age of
four years. Fifty-five percent of parents of young children reported
they were somewhat-to-very concerned about financial issues (e.g., job
loss) due to the COVID-19 pandemic.\56\ Other issues of concern related
to early childhood education program and school closures and/or virtual
or remote learning have compounded to create uniquely difficult
challenges for families. These compounding issues include missed
opportunities for academic instruction, children falling behind,
children missing out on social interaction and play with peers,
challenges to safe reopening, and increase in children's stress.
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\56\ Jones, Denisha. Education Resources Information Center.
``The Impact of COVID-19 on Young Children, Families, and
Teachers.'' Defending the Early Years (2020). Available at: https://eric.ed.gov/?id=ED609168.
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Survey data from February 2021 indicates that a diminished ability
to attend early childhood programs like Head Start in-person, is
related to an increase in social and emotional difficulties for
children, a decrease in support for children with disabilities, and an
increase in parental stress due to lack of affordable child care
including loss of jobs and wages.\57\ The RAPID-EC Survey describes
this as a ``chain of hardship'' where families loss of jobs results in
difficulty paying for basic needs such as food and housing further
negatively impacting family well-being including a rise in emotional
distress for parents and children.\58\ These disruptions can be
particularly difficult for children and families experiencing
homelessness, a population Head Start programs are required to
prioritize (45 CFR 1302.15(c)). Of all families enrolled in Head Start
programs, about 6.2 percent or 42,334 families experienced homelessness
during the 2020-2021 program year.\59\ Given the greater risks to the
health and development of young children experiencing homelessness,
stable Head Start services are critically important for these
families.\60\
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\57\ Barnett, W.S & Jung, K. Seven Impacts of the Pandemic on
Young Children and their Parents: Initial Findings from NIEER's
December 2020 Preschool Learning Activities Survey. February 2021.
Available at:
NIEER_Seven_Impacts_of_the_Pandemic_on_Young_Children_and_their_Paren
ts.pdf.
\58\ Fisher, P, Lombardi, J. & Kendall Taylor, N. A day in the
life of a pandemic/ https://medium.com/rapid-ec-project/a-year-in-the-life-of-a-pandemic-4c8324dda56b.
\59\ United States Department of Health and Human Services.
``Head Start Program Information Report.'' Available at: https://eclkc.ohs.acf.hhs.gov/data-ongoing-monitoring/article/program-information-report-pir.
\60\ Kiersten: Coughlin, C.G., Sandel, M., & Stewart, A.M.
(2020). Homelessness, Children, and COVID-19: A Looming Crisis.
Pediatrics, 146(2). Available at: https://doi.org/10.1542/peds.2020-1408; Haskett, M.E., Armstrong, J.M., & Tisdale, J. (2016).
Developmental Status and Social-Emotional Functioning of Young
Children Experiencing Homelessness. Early Childhood Education
Journal, 44(2), 119-125. Available at: https://doi.org/10.1007/s10643-015-0691-8; Weinreb; L., Goldberg, R., Bassuk, E., & Perloff,
J. (1998). Determinants of Health and Service Use Patterns in
Homeless and Low-income Housed Children. Pediatrics, 102(3), 554-
562. Available at: https://doi.org/10.1542/peds.102.3.554.
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School closures, heightened stress, loss of income, and social
isolation resulting from the COVID-19 pandemic are all stressors that
have increased the risk for child abuse and neglect.\61\ Head Start
programs are required to prioritize foster children for enrollment, and
there was an increase in the rate of children in foster care served in
Head Start from 3.5 percent in 2019 to 3.8 percent in 2021. Program
closures and remote learning during the pandemic contribute to
disruption of service access for these children, who often experience
trauma and are most in need of the consistent care, education and
comprehensive services that Head Start provides.\62\
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\61\ Rodriguez, C.M, Lee, S.J., Ward, K.P., & Pu, D.F. (2021).
The Perfect Storm: Hidden risk of child maltreatment during the
Covid-19 pandemic. Child Maltreatment, 26(2), 139-151.
\62\ Kiersten: Klain, E.J., & White, A.R. (2013). Implementing
trauma-informed practices in child welfare. CITY: State Policy
Advocacy Reform Center. Retrieved from http://www.centerforchildwelfare.org/kb/TraumaInformedCare/ImplementingTraumaInformedPracticesNov13.pdf.
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Supporting safe and sustained in-person services allows programs to
return to fulfilling the critical functions they serve for children and
families. All Head Start staff are mandated reporters and programs must
have internal procedures in place for staff to report suspected cases
of child abuse and neglect. Procedures also include notification to the
program's Regional Office immediately if a staff member or volunteer
suspects an incident. Agencies must provide training in methods for
identifying and reporting suspected child abuse and neglect (45
[[Page 68058]]
CFR 1304.52(l)(3)(i)).\63\ Research also indicates that Early Head
Start can serve as a child abuse and neglect prevention program.\64\
The work Head Start programs do to strengthen family economic stability
and decrease parental stressors is known to help prevent child abuse.
Many programs also provide supports to families experiencing domestic
violence (2.5 percent or 24,000 families in 2019 OHS data \65\). This
IFC is an important step in decreasing serious risks to very young
children and their families.
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\63\ Office of Head Start Information Memorandum. Mandated
Reporting of Child Abuse and Neglect ACF-IM-HS-15-04. September 18,
2015. Available at: https://eclkc.ohs.acf.hhs.gov/policy/im/acf-im-
hs-
1504#:~:text=Staff%20who%20need%20help%20identifying,800%2D422%2D4453
).&text=All%20Head%20Start%20programs%20must,of%20child%20abuse%20and
%20neglect.
\64\ Child Trends. ``How Early Head Start Prevents Child
Maltreatment.'' November 1, 2018. Available at: https://www.childtrends.org/publications/how-early-head-start-prevents-child-maltreatment.
\65\ United States Department of Health and Human Services.
``Head Start Program Information Report.'' Available at: https://eclkc.ohs.acf.hhs.gov/data-ongoing-monitoring/article/program-information-report-pir.
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OHS has been tracking data on the operating status of programs
since the onset of the pandemic. In March and April of 2020, more than
90 percent of programs closed all in-person operations for varying
lengths of time. By August of 2020, 21 percent of programs had reopened
for in-person services, 26 percent remained closed for in-person
services due to COVID-19, and the remainder of programs were closed for
summer months as regularly scheduled. In December 2020, data show the
highest combined percentage (67 percent) of Head Start centers
operating as solely virtual/remote or as hybrid, with an additional
five percent, or 878, of centers closed. Together, these virtual/
remote, hybrid, and closed centers account for over 13,500 centers
nationwide. Each center represents many families for whom unpredictable
closures and transitions to virtual learning come at a cost, may
present difficult decisions between employment and child care
responsibilities, and could result in major financial impacts on their
household.
July 2021 data show that two percent of centers (393) were closed
due to COVID-19, 14 percent of centers were operating in a virtual/
remote service delivery model (2,861), and 45 percent of centers were
operating in a hybrid service delivery model (9,181). Only 35 percent
of centers (7,240) were operating fully in person.
September 2021 center operating status data shows 73 percent
(14,917) of the centers are open for in-person only services, 14
percent (2,892) are operating in a hybrid model of in-person and
virtual/remote services, and 4 percent (835) are open for virtual/
remote only. Two percent (324) of centers remain entirely closed due to
COVID-19 and the remaining 7 percent of centers are unreported, closed
for the season, or closed due to a natural disaster. The increase in
the number of programs delivering services in-person only is consistent
with the expectations OHS outlined in May 2021 that programs move
toward fully in-person services as soon as possible by January 2022,
factoring in local health conditions.\66\ This data also show that
while closures declined, at least 20 percent of programs are closed,
operating a virtual/remote service delivery model only, or in a hybrid
model. Programs need to be able to resume fully in-person services to
meet the needs of children and families, for all the reasons discussed
in this section of the IFC.
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\66\ Office of Head Start. Office of Head Start (OHS)
Expectations for Head Start Programs in Program Year (PY) 2021-2022.
May 20, 2021. Available at: https://eclkc.ohs.acf.hhs.gov/policy/pi/acf-pi-hs-21-04.
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A vaccination requirement and consistent and correct mask use are
critical in mitigating SARS-CoV-2 transmission and keeping Head Start
programs open. Program closures impede Head Start families from
participating in the workforce, impose financial hardship on low wage
workers who may not have paid time off to care for children who are in
quarantine, create instability for children and families who depend on
the Head Start program, and delay a full economic recovery for the
nation.
HHS Secretary's Extension of Public Health Emergency
On January 31, 2020, Health and Human Services Secretary Alex M.
Azar II determined that a public health emergency (PHE) exists
retroactive to January 27, 2020,\67\ under section 319 of the Public
Health Service Act (42 U.S.C. 247d), in response to COVID-19. This
declaration has been extended every 90 days since then and most
recently on October 18, 2021. The current PHE declaration extends until
mid-January 2022.
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\67\ United States Department of Health and Human Services.
``Public Health Emergency.'' January 31, 2020. Available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVDI-15Oct21.aspx.
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C. Waiver of Proposed Rulemaking
In accordance with the Administrative Procedure Act (APA), 5 U.S.C.
553, ACF ordinarily publishes a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule before
the provisions of the rule take effect. Specifically, 5 U.S.C. 553(b)
generally requires the agency to publish a notice of the proposed rule
in the Federal Register that includes a reference to the legal
authority under which the rule is proposed, and the terms and substance
of the proposed rule or a description of the subjects and issues
involved. Section 553(c) further requires the agency to give interested
parties the opportunity to participate in the rulemaking through public
comment before the provisions of the rule take effect. Section
553(b)(B) authorizes the agency to waive these procedures, however, if
the agency finds good cause that notice and comment procedures are
impracticable, unnecessary, or contrary to the public interest and
incorporates a statement of the finding and its reasons in the rule
issued.
The 2021 outbreaks associated with the SARS-Cov-2 Delta variant
have shown that current levels of COVID-19 vaccination coverage up
until now have been inadequate to protect Head Start staff, children,
and families. The data showing the effectiveness of vaccination
indicate to us that we cannot delay taking this action in order to
protect the health and safety of children and families, and the staff
providing care.
We recognize that newly reported COVID-19 cases, hospitalizations,
and deaths have begun to trend downward at a national level;
nonetheless, they remain substantially elevated relative to numbers
seen in May and June 2021, just before the Delta variant became the
predominant strain circulating in the U.S.\68\ And while cases are
trending downward in some states, there are emerging indications of
potential increases in others--particularly northern states where the
weather has begun to turn colder.\69\ The United States experienced a
large COVID-19 wave in the winter of 2020. As of November 18, 2021,
over 30 percent of people aged 12 years and older in the United States
remain not fully vaccinated--and this situation could pose a threat to
the country's progress on the COVID-19 pandemic, potentially incurring
a fifth wave of COVID-19 cases.\70\
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\68\ https://covid.cdc.gov/covid-data-tracker/#datatracker-home.
\69\ https://www.cdc.gov/flu/professionals/acip/background-epidemiology.htm.
\70\ Centers for Disease Control. ``COVID Data Tracker.''
November 18, 2021. Available at: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total.
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[[Page 68059]]
The efficacy of COVID-19 vaccinations has been demonstrated.\71\ An
ASPE report published on October 5, 2021, found that COVID-19 vaccines
are a key component in controlling the COVID-19 pandemic. Clinical data
show vaccines are highly effective in preventing COVID-19 cases and
severe outcomes including hospitalization and death. Vaccines continue
to be effective in preventing COVID-19 associated with the now-dominant
Delta variant.\72\ \73\
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\71\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
\72\ https://www.nejm.org/doi/full/10.1056/nejmoa2108891.
\73\ https://www.mayoclinic.org/coronavirus-covid-19/covid-variant-vaccine.
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In addition to preventing morbidity and mortality associated with
COVID-19, the vaccines also appear to be effective against asymptomatic
SARS-CoV-2 infection. A recent study of health care workers in 8 states
found that, from December 14, 2020, through August 14, 2021, full
vaccination with COVID-19 vaccines was 80 percent effective in
preventing RT-PCR-confirmed SARS-CoV-2 infection among frontline
workers.\74\ Emerging evidence also suggests that vaccinated people who
become infected with Delta have the potential to be less infectious
than infected unvaccinated people, thus decreasing transmission
risk.\75\ For example, in a study of breakthrough infections among
health care workers in the Netherlands, SARS-CoV-2 infectious virus
shedding was lower among vaccinated individuals with breakthrough
infections than among unvaccinated individuals with primary
infections.\76\
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\74\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm?s_cid=mm7034e4_w.
\75\ https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html#ref43.
\76\ https://www.medrxiv.org/content/10.1101/2021.08.20.21262158v1.full.pdf.
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As noted earlier in this section, a combination of factors,
including but not limited to failure to achieve sufficiently high
levels of vaccination based on voluntary efforts and patchwork
requirements, potential harm to children from unvaccinated staff,
continuing strain on the health care system, and known efficacy and
safety of available vaccines, have persuaded us that a vaccine
requirement for Head Start staff, certain contractors, and volunteers
is an essential component of the nation's COVID-19 response. Further,
it would endanger the health and safety of staff, children and
families, and be contrary to the public interest to delay imposing the
vaccine mandate. Therefore, we believe it would be impracticable and
contrary to the public interest for us to undertake normal notice and
comment procedures and to thereby delay the effective date of this IFC.
We find good cause to waive notice of proposed rulemaking under the
APA, 5 U.S.C. 552(d), 553(b)(B). For those same reasons, as authorized
by subtitle E of the Small Business Regulatory Enforcement Fairness Act
of 1996 (the Congressional Review Act or CRA), 5 U.S.C. 808(2), we find
it is impracticable and contrary to the public interest not to waive
the delay in effective date of this IFC under the CRA. Therefore, we
find there is good cause to waive the CRA's delay in effective date
pursuant to 5 U.S.C. 808(2).
IV. 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 require children to be
up to date on immunizations and their state's Early and Periodic
Screening, Diagnosis, and Treatment (EPSDT) schedule (45 CFR
1302.42(b)(1)(i)). When children are behind on immunizations or other
care, Head Start programs are required to ensure they get on a schedule
to catch up. Additionally, education, family service, nutrition, and
health staff help children learn healthy habits, monitor each child's
growth and development, and help parents access needed health care. It
is vitally important that enrolled pregnant women and children from
birth to five years can access in-person services. When children are
able to participate in their regular, in-person program options, they
form a secure attachment to and relationship with their Head Start
teachers. A large body of research demonstrates that a secure
attachment with caregivers is a critical foundation for children to
learn and explore their environment.\77\ Furthermore, education staff
who see children in person are better able to monitor their progress
and individualize teaching and learning. The youngest children,
children from birth to five years, need physical interaction with
materials and in-person support for optimal learning. Screen based
learning is much less effective and necessarily limited in the number
of hours. Finally, as many parents return to work, they need the
assurance that their children are in a safe and high-quality learning
environment.
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\77\ Bergin, C., & Bergin, D. (2009). Attachment in the
classroom. Educational Psychology Review, 21(2), 141-170.; Rees, C.
(2007). Childhood attachment. British Journal of General Practice,
57(544), 920-922.; Sierra, P. G. (2012). Attachment and preschool
teacher: An opportunity to develop a secure base. International
Journal of Early Childhood Special Education (INT-JECSE), 4(1), 1-
16.
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It is equally important that the Head Start program itself is safe
for all children, families, and staff. For this reason, the Head Start
Program Performance Standards specify that the program must ensure
staff do not pose a significant risk of communicable disease (45 CFR
1302.93(a)). Ensuring that children and families can benefit from
program services as safely as possible is OHS' highest priority. While
this is always important, the COVID-19 pandemic highlights the need to
ensure staff are as protected as possible so that children under age 5
years, who cannot yet be vaccinated, are also protected. Fully
vaccinated staff are at much lower risk of infection and therefore,
pose lower transmission risk to the young unvaccinated children in
their care.\78\ Young children who get the virus can also spread it to
others in their homes and communities. Ensuring Head Start staff are
fully vaccinated significantly reduces the possibility of the program
playing an unwitting part in community spread of SARS-CoV-2.
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\78\ Centers for Disease Control and Prevention. ``COVID-19
Guidance for Operating Early Care and Education/Child Care
Programs.'' November 10, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/child-care-guidance.html.
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On October 29, 2021 the U.S. Food and Drug Administration
authorized the Pfizer-BioNTech mRNA vaccine for COVID-19 for use in
children ages five to 11. On November 2, 2021, CDC adopted the CDC
Advisory Committee on Immunization Practices' (ACIP) recommendation
that children 5 to 11 years old be vaccinated for COVID-19 with the
Pfizer-BioNTech pediatric vaccine. While Head Start does serve some
children who are currently eligible for a vaccine, children five and
older only represented 1.11 percent of children enrolled in Head Start
programs during the 2020-2021 program year (Office of Head Start--
Program Information Report [PIR] Enrollment Statistics Report--2021--
National Level). As of November 11, 2021, there is no pediatric COVID-
19 vaccine available for children younger than age five years in the
United States.
To the extent a court may enjoin any part of the rule, the
Department intends
[[Page 68060]]
that other provisions or parts of provisions should remain in effect.
Any provision of this section 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
from this section and shall not affect the remainder thereof or the
application of the provision to persons not similarly situated or to
dissimilar circumstances.
V. Provisions of the Interim Final Rule
This interim final rule (IFR) adds new provisions to the Head Start
Program Performance Standards to require: (1) Effective immediately,
and with exceptions discussed below, universal masking for all
individuals two years of age and older regardless of program option,
(2) all Head Start staff, certain contractors, and volunteers in
classrooms or working directly with children to be fully vaccinated for
COVID-19, with exemptions discussed below, and (3) for those granted an
exemption to the requirement specified in (2) at least weekly testing
for current SARS-CoV-2 infection.
The definition of staff in Sec. 1305.2 is ``paid adults who have
responsibilities related to children and their families who are
enrolled in programs.'' Consistent with that definition, ``all staff''
as noted in this IFC, refers to all staff who work with enrolled Head
Start children and families in any capacity regardless of funding
source. The term ``Head Start'' is inclusive of Head Start, Early Head
Start, and Early Head Start-Child Care Partnerships.
Consistent with CDC's guidance, in general, fully vaccinated \79\
means
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\79\ Centers for Disease Control and Prevention. ``When You've
Been Fully Vaccinated.'' October 15, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html.
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(i) a person's status 2 weeks after completing primary vaccination
with a COVID-19 vaccine with, if applicable, at least the minimum
recommended interval between doses in accordance with the approval,
authorization, or listing that is:
(A) Approved or authorized for emergency use by the Food and Drug
Administration (FDA);
(B) Listed for emergency use by the World Health Organization
(WHO); or
(C) Administered as part of a clinical trial at a U.S. site, if the
recipient is documented to have primary vaccination with the ``active''
(not placebo) COVID-19 vaccine candidate, for which vaccine efficacy
has been independently confirmed (e.g., by a data and safety monitoring
board) or if the clinical trial participant at U.S. sites had received
a COVID-19 vaccine that is neither approved nor authorized for use by
FDA but is listed for emergency use by WHO; or
(ii) A person's status 2 weeks after receiving the second dose of
any combination of two doses of a COVID-19 vaccine that is approved or
authorized by the FDA, or listed as a two-dose series by WHO (i.e., a
heterologous primary series of such vaccines, receiving doses of
different COVID-19 vaccines as part of one primary series). The second
dose of the series must not be received earlier than 17 days (21 days
with a 4-day grace period) after the first dose.
A. Masking Requirement
This IFC adds a new provision to part1302, subpart D--Health
Program Services in Sec. 1302.47, Safety practices. Section
1302.47(b)(5), Safety practices, specifies the appropriate practices
all staff and consultants follow to keep children safe during all
activities. This IFC creates a new paragraph (vi) that requires
universal masking for all individuals aged 2 years and older when there
are two or more individuals in a vehicle owned, leased, or arranged by
the Head Start program; indoors in a setting when Head Start services
are provided; and for those not fully vaccinated, outdoors in crowded
settings or during activities that involve sustained close contact with
other people. The Office of Head Start notes that being outdoors with
children inherently includes sustained close contact for the purposes
of caring for and supervising children.
There are different types of masks. Head Start staff should choose
a mask that is comfortable to wear and fits snugly. It must cover one's
mouth, nose, and chin. It can fasten around the ears or the back of the
head, as long as it stays in place when one talks and moves. Masks with
vents or exhalation valves are not allowed because they allow
unfiltered breath to escape the mask. For more information on masks,
programs can consult Your Guide to Masks [verbar] CDC.
Purchasing masks needed for staff to fulfill their duties and
responsibilities and for children is considered an allowable use of
Head Start program funds, as well as the COVID-19 response funds and
the American Rescue Plan funds.\80\ Programs should have masks
available to provide to children when they do not have their own mask.
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\80\ Office of Head Start. ``FY 2021 American Rescue Plan
Funding Increase for Head Start Programs.'' May 4, 2021. Available
at: https://eclkc.ohs.acf.hhs.gov/policy/pi/acf-pi-hs-21-03.
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This requirement is effective immediately upon publication of this
IFC. Exceptions are 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; \81\ 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. It should be noted that
like all new skills, children will need to be taught the proper way to
put a mask on and keep a mask on. While children are adaptable, they
are still in the early stages of development and may need reminders and
reinforcements to comply with this new practice. It is imperative that
Head Start staff abide by the Standards of Conduct outlined in 1302.90
Personnel Policies in the Head Start Program Performance Standards
namely that staff, consultants, contractors, and volunteers implement
positive strategies to support children's well-being and do not use
harsh disciplinary practices that could endanger the health or safety
of children.
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\81\ Centers for Disease Control. Order: Wearing of face masks
while on conveyances and at transportation hubs. January 21, 2021.
Available at: Order: Wearing of face masks while on conveyances and
at transportation hubs [verbar] Quarantine [verbar] CDC.
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B. Vaccination Requirement
This IFC adds four new provisions to part 1302, subpart I--Human
Resources Management in Sec. 1302.93, Staff health and wellness, and
Sec. 1302.94, Volunteers. Section 1302.93(a), Staff health and
wellness, states that ``the program must ensure staff do not, because
of communicable diseases, pose a significant risk to the health or
safety of others in the program that cannot be eliminated or reduced by
reasonable accommodation, in accordance with the Americans with
Disabilities Act and section 504 of the Rehabilitation Act.'' This IFC
adds a new paragraph (a)(1) to Sec. 1302.93 requiring all staff, and
those contractors whose activities involve contact with or providing
direct services to children and families, to be fully vaccinated for
COVID-19, except for those (i) for whom a vaccine is medically
contraindicated, (ii) for whom
[[Page 68061]]
medical necessity requires a delay in vaccination,\82\ or (iii) who are
legally entitled to an accommodation with regard to the COVID-19
vaccination requirement based on an applicable Federal law. It also
adds a new paragraph (a)(2) indicating that those who are granted an
exemption outlined in (a)(1)(i) through (iii) must undergo testing at
least weekly for current SARS COV-2 infection.
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\82\ As defined by CDC's informational document, Summary
Document for Interim Clinical Considerations for Use of COVID-19
Vaccines Currently Authorized in the United States (CDC, September
29, 2021).
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The additions made to Sec. 1302.94, Volunteers, mirrors that of
Sec. 1302.93, Staff health and wellness. This IFC also adds a new
paragraph (a)(1) to Sec. 1302.94, Volunteers, that requires all
volunteers who are in classrooms or working directly with children
other than their own must be fully vaccinated for COVID-19, except for
those (i) for whom a vaccine is medically contraindicated, (ii) for
whom medical necessity requires a delay in vaccination,\83\ or (iii)
who are legally entitled to an accommodation with regard to the COVID-
19 vaccination requirement based on an applicable Federal law. It also
adds a new paragraph (a)(2) indicating that those who are granted an
exemption outlined in paragraphs (a)(1)(i) through (iii) must undergo
testing at least weekly for current SARS-CoV-2 infection. The costs
associated with regular testing for those granted an exemption are an
allowable use of Head Start funds so long as it is included in a
program's policies and procedures. While paying for the costs
associated with regular testing is allowable use of Head Start funds,
it is not a requirement. Programs should consider whether they can
sustain continued funding for testing if/when the COVID-19 funds are
exhausted. Finally, we have also revised Sec. 1302.94 to remove the
word ``regular'' from paragraph (a). We believe it is important for all
volunteers to adhere to these requirements not just those who regularly
volunteer in the program.
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\83\ As defined by CDC's informational document, Summary
Document for Interim Clinical Considerations for Use of COVID-19
Vaccines Currently Authorized in the United States (CDC, September
29, 2021).
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Programs may use SARS-CoV-2 testing for all staff, regardless of
vaccination status, as an additional mitigation strategy with the
COVID-19 vaccines, and those granted exemptions are required to undergo
testing, but testing alone is not an alternative to the COVID-19
vaccination requirement specified in Sec. 1302.93 and Sec. 1302.94.
This is a key difference between this IFC and the COVID-19 Vaccination
and Testing; Emergency Temporary Standard, published, by the
Occupational Safety and Health Administration (OSHA) on November 5,
2021, which requires employers with 100 or more employees to develop,
implement, and enforce a mandatory COVID-19 vaccination policy, unless
they adopt a policy requiring employees to choose to either be
vaccinated or undergo regular SARS-Cov-2 testing and wear a face
covering. Whereas OSHA allows employers to offer an option for testing
and face coverings, this IFC does not permit a testing and face
coverings option for individuals without an approved vaccine exemption.
The rationale for the difference is that ACF is acting under statutory
and regulatory standards that are different from OSHA's. In general,
the Head Start Act requires standards for a safe environment for staff,
children, and other participants.
Documentation of Vaccination Status
The Head Start Act at section 647 (42 U.S.C. 9842) has a provision
on record-keeping, which allows the Secretary to require certain
records be kept and to support OHS in conducting its oversight of
programs through monitoring. Pursuant to the statutory recordkeeping
requirement in section 647 of the Head Start Act (42 U.S.C. 9842) and
in order to ensure programs are complying with the vaccination
requirements of this IFC, we are requiring that they track and securely
document the vaccination status of each staff member, including those
for whom there is a temporary delay in vaccination, such as recent
receipt of monoclonal antibodies or convalescent plasma. Vaccination
exemption requests and outcomes must also be documented, discussed
further in section II.A.5. of this IFC. This documentation will be an
ongoing process as new staff are onboarded.
While program staff may not have personal medical records on file
with their employer, all staff COVID-19 vaccines must be appropriately
documented by the provider or supplier. All medical records, including
vaccine documentation, must be kept confidential and stored separately
from an employer's personnel files, pursuant to the ADA and the
Rehabilitation Act.
Examples of acceptable forms of proof of vaccination include:
CDC COVID-19 vaccination record card (or a legible photo
of the card),
Documentation of vaccination from a health care provider
or electronic health record, or
State immunization information system record.
If vaccinated outside of the United States, a reasonable equivalent
of any of the previous examples would suffice.
Programs have the flexibility to use the appropriate tracking tools
of their choice. For those who would like to use it, CDC provides a
staff vaccination tracking tool that is available on the NHSN website
(https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html). This is a
generic Excel-based tool available for free to anyone, not just NHSN
participants, that facilities can use to track COVID-19 vaccinations
for staff members.
Exemption Process
Under Federal law, including the Americans with Disabilities Act
(ADA) and Title VII of the Civil Rights Act of 1964, staff,
contractors, and volunteers who cannot be vaccinated because of a
disability under the ADA, medical condition, or sincerely held
religious beliefs, practice, or observance may in some circumstances be
granted an exemption, as discussed in II.B of this IFC. Head Start
staff included in this IFC must be able to request an exemption from
these COVID-19 vaccination requirements. Additionally, programs
following CDC guidelines and the new requirements in this IFC may also
be required to provide reasonable accommodations, to the extent
required by federal law, for employees who request and receive
exemption from vaccination because of a disability, medical condition,
or sincerely held religious belief, practice, or observance.
In support of the new requirements in Sec. Sec. 1302.93 and
1302.94, it is the responsibility of Head Start programs to establish a
process for reviewing and reaching determinations regarding exemption
requests (e.g., disability, medical conditions, sincerely held
religious beliefs, practices, or observances). Programs must have a
process for collecting and evaluating such requests, including the
tracking and secure documentation of information provided by those
staff who have requested exemption, the program's decision on the
request, and any accommodations that are provided. Requests for
exemptions based on an applicable federal law must be documented and
evaluated in accordance with applicable Federal law and each program's
policies and procedures. As is relevant here, this IFC preempts the
applicability of any state or local law providing for exemptions to the
extent such law provides broader exemptions than provided for by
federal law and are inconsistent with this IFC.
[[Page 68062]]
For staff members, contractors, and volunteers who request a
medical exemption from vaccination, all documentation confirming
recognized clinical contraindications to COVID-19 vaccines or medical
need for delay, and which supports the request, must be signed and
dated by a licensed practitioner, who is not the individual requesting
the exemption, and who is acting within their respective scope of
practice as defined by, and in accordance with, all applicable state
and local laws. Such documentation must contain all information
specifying which of the authorized or approved COVID-19 vaccines are
clinically contraindicated for the staff member to receive and the
recognized clinical reasons for the contraindications or the recognized
clinical reasons necessitating delay in vaccination; and a statement by
the authenticating practitioner recommending that the staff member be
exempted from the program's COVID-19 vaccination requirements based on
the recognized clinical contraindications or allowed to delay
vaccination.
For more information, Head Start programs can refer to a resource
produced by the Equal Employment Opportunity Commission (EEOC), which
is responsible for enforcing federal laws that prohibit employment-
related discrimination based on a person's race, color, religion, sex
(including pregnancy, gender identity, and sexual orientation),
national origin, age (40 or older), disability, or genetic information.
The EEOC resource, What You Should Know About COVID-19 and the ADA, the
Rehabilitation Act, and Other EEO Laws, available at What You Should
Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO
Laws [verbar] U.S. Equal Employment Opportunity Commission (eeoc.gov),
should be helpful in navigating employees' requests for accommodations
(EEOC, October 25, 2021).
In granting such exemptions or accommodations, programs must ensure
that they minimize the risk of transmission of SARS-CoV-2 to at-risk
individuals, in keeping with their obligation to protect the health and
safety of staff, children and families. To that end, it is a reasonable
alternative that staff, contractors, and volunteers granted an
accommodation be required to undergo testing at least weekly for
current SARS-CoV-2 infection. Because unvaccinated employees are at
higher risk of SARS-CoV-2 infection, and SARS-CoV-2 transmission among
individuals without symptoms is a significant driver of COVID-19, ACF
has determined it is necessary to prevent the pre-symptomatic and
asymptomatic transmission of SARS-CoV-2 from unvaccinated staff,
contractors and volunteers, through a requirement for a weekly
screening test.\84\ Although more regular screening testing (e.g.,
twice weekly) may identify even more cases, ACF has decided to require
a minimum testing of only on a weekly basis, which is in line with CDC
recommendations.
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\84\ OSHA. ``COVID-19 Vaccination and Testing; Emergency
Temporary Standard.'' November 5, 2021. Available at: https://www.federalregister.gov/documents/2021/11/05/2021-23643/covid-19-vaccination-and-testing-emergency-temporary-standard.
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In support of this requirement, programs should develop and
implement a written SARS-CoV-2 testing protocol for those staff,
contractors, and volunteers granted vaccine exemptions. Programs should
consult with their Health Services Advisory Committee (HSAC) and local
public health officials, along with recommendations from their agency's
legal counsel and Human Resources department in the development of a
SARS-CoV-2 testing protocol. Programs are encouraged to review guidance
from CDC and FDA about selecting SARS-CoV-2 tests and developing
related protocols. The costs of regular testing for those granted an
exemption are an allowable use of Head Start funds so long as it is
included in a program's policies and procedures. While using Head Start
funds is allowable, it is not a requirement. It is at the program's
discretion to decide if they will pay for the cost of testing,
considering such factors as the number of approved exemptions, whether
they can sustain continued funding for testing if/when the COVID-19
funds are exhausted, any incentives associated with allowing the use of
funds for testing, and whether employees can cover the expenses of
testing.
D. Implementation Dates
Due to the urgent nature of the vaccination requirements
established in this IFC, we have not issued a proposed rule, as
discussed in section C of this IFC. While some IFCs, or provisions
within IFCs, are effective immediately upon publication, such as the
mask requirement, we understand that instantaneous compliance, or
compliance within days, with the vaccine requirement is not possible.
Vaccination requires time, especially vaccines delivered in a series.
Programs' updates to their policies and procedures also take time to
develop. However, in order to provide protection to staff, children,
and families, we believe it is necessary to begin staff vaccinations as
quickly as reasonably possible. Therefore, we have set the January 31,
2022 as the compliance date for staff to be vaccinated. Although an
individual is not considered fully vaccinated until 14 days (2 weeks)
after the final dose, staff, certain contractors and volunteers who
have received the final dose of a primary vaccination series by January
31, 2022 are considered to have met the vaccination requirement, even
if they have not yet completed the 14-day waiting period. This timing
flexibility applies only to the initial implementation of this IFC and
has no bearing on ongoing compliance.
The rationale for a different timeline for compliance with the
vaccine requirement in this rule relative to the CMS or the OSHA rule
is because this timeline in this rule is coordinated with OHS's
expectation, communicated through guidance in May 2021, for programs'
return to full in-person services. Beginning January 2022, Head Start
programs are expected to resume fully in-person services after a period
of increased flexibility with virtual and remote services during the
pandemic. At this time, OHS will reinstate pre-pandemic practices for
tracking and monitoring enrollment as part of the Full Enrollment
Initiative. This means that during the first week of February, OHS will
evaluate reported enrollment on the last day of January for purposes of
the under-enrollment process. Requiring that staff receive their second
dose in a two-dose vaccine series, or a single dose in a one-dose
vaccine series, by January 31 is consistent with this return to fully
in-person services.
VI. 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 interim final rule will not have
any impact on the autonomy or integrity of the family as an
institution. However, ACF invites public comment on whether the actions
set forth in this interim final rule would have a negative effect on
family well-being.
[[Page 68063]]
Federalism Assessment Executive Order 13132
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This rule would preempt some State laws that prohibit
employers from requiring their employees to be vaccinated for COVID-19.
Consistent with the Executive Order, we find that State and local laws
that forbid employers in the State or locality from imposing vaccine
requirements on employees directly conflict with this exercise of our
statutory authority to protect the health and safety of Head Start
participants and their families and ensure the continuation of services
by requiring vaccinations for staff, certain contractors, and
volunteers and universal masking. As is relevant here, this IFC
preempts the applicability of any State or local law providing for
exemptions to the extent such law provides broader grounds for
exemptions than provided for by Federal law and are inconsistent with
this IFC. In these cases, consistent with the Supremacy Clause of the
Constitution, the agency intends that this rule preempts State and
local laws to the extent the State and local laws conflict with this
rule. The agency has considered other alternatives (for example,
relying entirely on measures such as voluntary vaccination, source
control alone, and physical distancing) and has concluded that the
mandate established by this rule is the minimum regulatory action
necessary to achieve the objectives of the statute. Given the
transmission rates of the existing strains of coronavirus and their
disproportionate impacts on low-income communities served by Head Start
programs, we believe that vaccination of almost all staff, certain
contractors, and volunteers is necessary to promote and protect program
participants and ensure program continuity. The agency has examined
case studies from other employers and concludes that vaccine mandates
are vastly more effective than other measures at achieving ideal
vaccination rates and the resulting protections. Given the emergency
situation with respect to the Delta variant detailed more fully above,
time did not permit usual consultation procedures. We are, however,
inviting comments on the substance as well as legal issues presented by
this rule.
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). The Office of Information and Regulatory Affairs
in the Office of Management and Budget has determined that this action
is a major rule because it will have an annual effect on the economy of
$100 million or more.
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.
This IFC establishes new recordkeeping requirements under the PRA.
Head Start grant recipients are required as part of this IFC to
maintain records on staff vaccination rates. Additionally, Head Start
programs are required to develop their own written SARS-CoV-2 testing
protocol for current infection for individuals granted vaccine
exemptions. To promote flexibility for local programs, there is no
standardized instrument associated with the new recordkeeping
requirement. As required under the PRA, ACF will submit a request for
approval of these recordkeeping requirements. We will initially request
approval through an emergency clearance process, allowing for 6 months
of approval under the PRA. We will follow the initial approval with a
full request, including two public comment periods, to extend approval
of the recordkeeping requirement. A separate notice inviting comments
on these new recordkeeping requirements will be published in the
Federal Register.
In addition to these new recordkeeping requirements, Head Start
grant recipients are expected to update their program policies and
procedures to ensure costs associated with regular testing for those
granted an exemption are an allowable use of Head Start funds. The
recordkeeping activity of maintaining program policies and procedures
including the associated burden with updating them on an annual basis
is already approved under an existing OMB information collection
(Control Number 0970-0148). The separate Federal Register notice will
also invite comments on this existing recordkeeping requirement.
VII. Economic Analysis of Impacts
Introduction
We have examined the impacts of this interim 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 determined,
that this interim final rule is an economically 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
[[Page 68064]]
attributable to the interim final rule are limited in nature, we
certify that the interim 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.
Summary of Costs and Benefits
This interim final rule establishes vaccine, record keeping, and
mask requirements to mitigate the spread of SARS-CoV-2 in Head Start
programs. We have evaluated the likely impacts of the interim final
rule in comparison to a baseline scenario of no new regulation that
incorporates projections of COVID-19 vaccine coverage, cases, deaths,
and hospital admissions. We anticipate that the requirement that all
Head Start staff get fully vaccinated for COVID-19 will induce a
substantial portion of unvaccinated staff to get fully vaccinated. We
also estimate that the regulation will induce a similar number, but
smaller share, of unvaccinated Head Start volunteers to get fully
vaccinated in response to the interim final rule. Some Head Start
volunteers are likely also covered by other regulatory actions, which
complicates attributing changes in vaccine coverage to any particular
regulatory action. We discuss this in greater detail in the Baseline
Section and Benefits Section.
The increase in vaccine coverage attributable to the interim final
rule will result in substantial health benefits from reductions in
COVID-19 mortality and morbidity. We monetize these impacts using a
Value per Statistical Life (VSL) for fatal cases, and estimates of the
Value per Statistical Case (VSC) that vary by case severity for non-
fatal cases. We also predict that reductions in COVID-19 cases among
Head Start staff will result in lower absenteeism, including fewer
missed days of work for staff infected with SARS-CoV-2 or recovering
from COVID-19 and unvaccinated staff quarantining after a close contact
tested positive for SARS-CoV-2. We monetize these impacts using a value
of time that accounts for time savings for parents and other caregivers
for children enrolled at Head Start centers. We estimate a range of
total monetized benefits between $200 million and $296 million under a
7% discount rate, and a range between $196 million and $288 million
under a 3% discount rate. These monetized benefits cover a time period
between the publication date of the interim final rule and March 1,
2022, when our underlying COVID-19 projections end. For our main
analysis, we assume that the requirements will be effective for this
time horizon, but also consider a scenario in which the requirements
are lifted at an earlier date, such as by the COVID-19 Public Health
Emergency expiring. The choice of discount rate impacts the benefit
estimates through the VSC, which is based on estimates of the Value per
Quality-Adjusted Life Year that vary by discount rate.
In addition to the impacts that we monetize in this analysis, we
anticipate that the increase in vaccine coverage attributable to the
interim final rule will result in indirect health benefits from reduced
transmission of SARS-COV-2, the virus that causes COVID-19. These
impacts include reductions in secondary infections from Head Start
staff and volunteers to other staff and volunteers, children, and
families. We anticipate that the masking requirement will also reduce
transmission SARS-COV-2 from individuals covered by the requirement.
This impact includes a reduction in transmission from children to Head
Start teachers, staff, and other children. We also discuss a mechanism
and valuation approach for monetizing benefits from Head Start centers
reopening. We discuss these impacts in greater detail in the Benefits
Section, and note that they are embedded in a quantitative approach in
the Net Benefits section.
We have identified several costs that are attributable to the
interim final rule. We monetize the costs of vaccination, which
incorporates a value of time for staff and volunteers, and the cost of
doses and administration; the costs of the masking requirement; the
costs of testing unvaccinated staff and volunteers; and the costs of
recordkeeping associated with the interim final rule. We also consider
a scenario where a share of unvaccinated Head Start staff quit rather
than get fully vaccinated. Under this scenario, these costs would
include training replacement staff, and the costs to parents and other
caregivers for children enrolled at Head Start center resulting from
staff vacancies. We estimate a range of costs between $16 million and
$83 million, which cover a time period between the publication of the
interim final rule and March 1, 2022, which is consistent with the time
horizon adopted for our benefits estimates. These cost estimates do not
vary with the discount rate. We also discuss potential additional costs
of masking and testing associated with Head Start centers reopening as
a result of the interim final rule.
Table 1 presents a summary of the monetized impacts attributable to
the interim final rule. All dollar estimates are presented in millions
of 2020 dollars. We request comments on these benefit and cost
estimates.
BILLING CODE 4184-01-P
[[Page 68065]]
[GRAPHIC] [TIFF OMITTED] TR30NO21.000
BILLING CODE 4184-01-C
[[Page 68066]]
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. [insert
reference number]). We request comments on this analysis.
VIII. Alternatives Considered
In making the decision to require vaccination and mask use, ACF
considered whether to require other mitigation strategies or
combinations of mitigation strategies. The CDC's recently issued
guidance on November 10, 2021 reiterates the importance of using
multiple prevention strategies in ECE programs.\85\ In addition to
vaccinations and masks, other strategies noted in this IFC include
staying home if sick; handwashing; improving ventilation; screening and
diagnostic testing; cleaning and disinfecting; keeping physical
distance; and cohorting.
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\85\ Centers for Disease Control and Prevention. ``COVID-19
Guidance for Operating Early Care and Education/Child Care
Programs.'' November 10, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/child-care-guidance.html.
---------------------------------------------------------------------------
There are two primary reasons that ACF decided to mandate
vaccination and mask use. First, Head Start programs have a broad set
of program performance standards that already include requirements for
infection control, exclusion policies, cleaning, sanitizing and
disinfecting. The requirement for staying home when sick is part of
Sec. 1302.47(b)(4)(i)(A); hand hygiene (handwashing) is included at
Sec. 1302.47(b)(6)(i); cleaning, sanitizing, and disinfecting is at
Sec. 1302.47(b)(2)(i); and physical distancing is part of Sec.
1302.47(b)(4)(i)(A), which OHS sees as a strategy for a program's
infection control practices). In addition, Sec. 1302.47(b)(1)(iii)
states that facilities need to be ``free from pollutants, hazards and
toxins that are accessible to children and could endanger children's
safety,'' though it is difficult be overly prescriptive about
ventilation given the range of facilities and spaces used by center-
based and family child care programs.
Second, as discussed in this IFC, being fully vaccinated for COVID-
19 and using a mask are two of the most effective mitigation strategies
available to reduce transmission of COVID-19.\86\ With this in mind,
ACF determined a federal requirement is necessary. While some agencies
and localities have implemented vaccine and masking requirements, many
have not. Additionally, vaccine uptake among Head Start staff has not
been as robust as hoped for and has been insufficient to protect the
health and safety of children and families receiving Head Start
services. Combined, these factors leave certain children and families
with fewer mitigation strategies in place to protect them than others.
It is ACF's responsibility to make sure the environment is as safe as
possible for Head Start programs uniformly across all 1,600 grant
recipients.
---------------------------------------------------------------------------
\86\ Centers for Disease Control and Prevention. ``Science
Brief: COVID-19 Vaccines and Vaccination.'' September 15, 2021.
Available at: https://www.cdc.gov/coronavirus/2019-ncov/science/
science-briefs/fully-vaccinated-
people.html#:~:text=Evidence%20suggests%20the%20US%20COVID,interrupti
ng%20chains%20of%20transmission.
---------------------------------------------------------------------------
Additionally, although less effective and efficient than
vaccination, the CDC has recognized regularly testing unvaccinated
individuals for SARS-CoV-2 as a useful tool for identifying
asymptomatic and/or pre-symptomatic infected individuals so that they
can be isolated,\87\ which informed the decision to include in this IFC
a testing policy for those granted an exemption. It is also consistent
with the CDC's guidance on November 11, 2021, which added screening
testing information to its prevention strategies. This guidance notes
that in ECE programs, screening testing can help promptly identify and
isolate cases, quarantine those who may have been exposed to SARS-CoV-2
and are not fully vaccinated, and identify clusters to reduce the risk
to in-person education. The inclusion of a requirement for masking,
vaccination and testing, for those staff, contractors and volunteers
granted an exemption, ensures the Head Start Program Performance
Standards reflect the current science with respect to reducing the
spread of SARS-CoV-2 and reducing COVID-19.
---------------------------------------------------------------------------
\87\ Centers for Disease Control and Prevention. ``Overview of
Testing for SARS-CoV-2 (COVID-19). October 22, 2021. Available at:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html.
---------------------------------------------------------------------------
ACF also deliberated on the question of whether to require Head
Start programs to cover the cost of testing for those granted an
exemption or to shift those costs to staff. Head Start staff are not
high wage earners, and we recognize it could create hardship for staff
granted an exemption to absorb the cost of weekly testing. That said,
if programs have many staff who are approved for exemptions, it could
be difficult for the program to bear the cost of weekly testing,
particularly when their COVID-19 response funds are exhausted. Given
these various factors, ACF determined that it is important to make it
allowable to use funds at this time, including both COVID-19 response
funds and ongoing program funds, for the purpose of testing but allow
programs the discretion to make the decision based on budgetary
factors, the number of staff approved for an exemption, incentives or
other factors. We invite comment on this decision.
ACF also considered whether to tie the universal masking
requirement and the testing requirement to SARS-CoV-2 transmission
rates. For example, the requirement could make masking voluntary once
community transmission drops below a certain level, consistent with CDC
guidance. There are more than 1600 Head Start grant recipients, many of
which serve multiple communities, cross state lines or serve an entire
state. Transmission rates could be significantly different across
service areas. For example, one grant recipient in Michigan covers 21
different counties. It would be burdensome for this program to issue
separate guidance across its service area to account for changing
transmission levels across those counties. Another grant recipient,
Alabama Department of Resources, has a partnership that covers the
entire state of Alabama. Again, it would be burdensome for this grant
recipient to change its mask guidance for different centers through the
state as transmission rates change. ACF values CDC guidance that
localities should monitor community transmission in making decisions
and has relied on the importance of local health conditions in issuing
guidance to Head Start programs. However, in the case of mask use, ACF
is prioritizing a clear and transparent policy that is easy for
grantees to follow across their service areas. Additionally, children
benefit from routine and predictability. ACF determined that the best
course of action was not to provide an end date on the universal
masking and testing requirement. ACF invites comment on this decision
to leave an undetermined end date or whether we should set a finite end
date, such as 6 months from the effective date of the rule.
[[Page 68067]]
Appendix to Section VII of Supplementary Information: Economic Analysis
of Impacts
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Vaccine and Mask Requirements To Mitigate the Spread of COVID-19 in
Head Start Programs
Final Regulatory Impact Analysis; Final Regulatory Flexibility
Analysis; Unfunded Mandates Reform Act Analysis; Office of Head Start,
Administration for Children and Families, Department of Health and
Human Services
Prepared by
Office of Science and Data Policy
Office of the Assistant Secretary for Planning and Evaluation
Office of the Secretary
Department of Health and Human Services
I. Introduction and Summary
A. Introduction
We have examined the impacts of this interim 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 interim final rule is an economically
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 interim final rule are limited in nature, we certify that the
interim 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.
B. Summary of Costs and Benefits
This interim final rule establishes vaccine, record keeping, and
mask requirements to mitigate the spread of COVID-19 in Head Start
programs. We have evaluated the likely impacts of the interim final
rule in comparison to a baseline scenario of no new regulation that
incorporates projections of COVID-19 vaccine coverage, cases,
deaths, and hospital admissions. We anticipate that the requirement
that all Head Start staff get fully vaccinated against COVID-19 will
induce a substantial portion of unvaccinated staff to get fully
vaccinated. We also estimate that the regulation will induce a
similar number, but smaller share, of unvaccinated Head Start
volunteers to get fully vaccinated in response to the interim final
rule. Some Head Start volunteers are likely also covered by other
regulatory actions, which complicates attributing changes in vaccine
coverage to any particular regulatory action. We discuss this in
greater detail in the Baseline Section and Benefits Section.
The increase in vaccine coverage attributable to the interim
final rule will result in substantial health benefits from
reductions in COVID-19 mortality and morbidity. We monetize these
impacts using a Value per Statistical Life (VSL) for fatal cases,
and estimates of the Value per Statistical Case (VSC) that vary by
case severity for non-fatal cases. We also predict that reductions
in COVID-19 cases among Head Start staff will result in lower
absenteeism, including fewer missed days of work for staff infected
or recovering from COVID-19 and unvaccinated staff quarantining
after a close contact tested positive for COVID-19. We monetize
these impacts using a value of time that accounts for time savings
for parents and other caregivers for children enrolled at Head Start
centers. We estimate a range of total monetized benefits between
$200 million and $296 million under a 7% discount rate, and a range
between $196 million and $288 million under a 3% discount rate.
These monetized benefits cover a time period between the publication
date of the interim final rule and March 1, 2022, when our
underlying COVID-19 projections end. For our main analysis, we
assume that the requirements will be effective for this time
horizon, but also consider a scenario in which the requirements are
lifted at an earlier date, such as by the COVID-19 Public Health
Emergency expiring. The choice of discount rate impacts the benefit
estimates through the VSC, which is based on estimates of the Value
per Quality-Adjusted Life Year that vary by discount rate.
In addition to the impacts that we monetize in this analysis, we
anticipate that the increase in vaccine coverage attributable to the
interim final rule will result in indirect health benefits from
reduced transmission of SARS-COV-2, the virus that causes COVID-19.
These impacts include reductions in secondary infections from Head
Start staff and volunteers to other staff and volunteers, children,
and families. We anticipate that the masking requirement will also
reduce transmission SARS-COV-2 from individuals covered by the
requirement. This impact includes a reduction in transmission from
children to Head Start teachers, staff, and other children. We also
discuss a mechanism and valuation approach for monetizing benefits
from Head Start centers reopening. We discuss these impacts in
greater detail in the Benefits Section, and note that they are
embedded in a quantitative approach in the Net Benefits section.
We have identified several costs that are attributable to the
interim final rule. We monetize the costs of vaccination, which
incorporates a value of time for staff and volunteers, and the cost
of doses and administration; the costs of the masking requirement;
the costs of testing unvaccinated staff and volunteers; and the
costs of recordkeeping associated with the interim final rule. We
also consider a scenario where a share of unvaccinated Head Start
staff quit rather than get fully vaccinated. Under this scenario,
these costs would include training replacement staff, and the costs
to parents and other caregivers for children enrolled at Head Start
center resulting from staff vacancies. We estimate a range of costs
between $16 million and $83 million, which cover a time period
between the publication of the interim final rule and March 1, 2022,
which is consistent with the time horizon adopted for our benefits
estimates. These cost estimates do not vary with the discount rate.
We also discuss potential additional costs of masking and testing
associated with Head Start centers reopening as a result of the
interim final rule.
Table 1 presents a summary of the monetized impacts attributable
to the interim final rule. All dollar estimates are presented in
millions of 2020 dollars. We request comments on these benefit and
cost estimates.
[[Page 68068]]
[GRAPHIC] [TIFF OMITTED] TR30NO21.001
II. Economic Analysis of Impacts
A. Background
Since its inception in 1965, Head Start has been a leader in
helping children from low-income families reach 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, the Office of Head Start identifies health as the foundation
of school readiness.
The Head Start Program Performance Standards require children to
be up to date on immunizations and their state's Early and Periodic
Screening, Diagnosis, and Treatment (EPSDT) schedule. When children
are behind on immunizations or other care, Head Start programs are
required to ensure they get on a schedule to catch up. Additionally,
education, family service, nutrition, and health staff help children
learn healthy habits, monitor each child's growth and development,
and help parents access needed health care. It is vitally important
that enrolled pregnant women and children from birth to 5 can access
in person services, especially after so many children spent a year
or more away from in-person Head Start services.
It is equally important that the Head Start program itself is
safe for all children, families, and staff. For this reason, the
Head Start Program Performance Standards specify that the program
must ensure staff do not pose a significant risk of communicable
disease that cannot be eliminated or reduced by reasonable
accommodation, in accordance with the Americans with Disabilities
Act and section 504 of the Rehabilitation Act. Ensuring that
children and families can benefit from program services as safely as
possible is the Office of Head Start's highest priority.
COVID-19 has resulted in substantial reductions in in-person
Head Start services available to children and their families. As
described in greater detail in the Baseline Section, a majority of
Head Start centers have moved from fully in-person services to a
virtual/remote or a hybrid operating status, while other centers
remain closed as a result of a COVID-19 case or outbreak in a
program. Without the vaccination and masking requirements of this
regulatory action, there is a higher likelihood of transmission of
SARS-COV-2 at in-person Head Start settings, which would result in
more people at greater risk for COVID-19-related morbidity and
mortality, including children returning home and exposing family
members. This interim final rule is needed to address the health
risks from COVID-19 and to increase the likelihood that Head Start
centers are able to reopen or return to in-person services safely.
C. Purpose of the Rule
This regulatory action requires COVID-19 vaccination among all
staff employed in Head Start programs, as well as for volunteers
that interact with children. The interim final rule also requires
mask wearing for all adults and children aged 2 years and older in
certain in-person Head Start settings. This regulation also requires
recordkeeping of vaccination status for both volunteers and staff.
This regulation is necessary to ensure healthy, safe conditions for
in-person early care and education services to children and their
families enrolled in Head Start programs nationwide. Being fully
vaccinated against COVID-19, combined with wearing a mask, are the
safest and most effective ways for Head Start programs to mitigate
the spread of COVID-19 among the children and families they serve,
as well as among staff and volunteers. This action will help more
early childhood centers safely remain open and provide needed
services to Head Start children and families.
D. Baseline Conditions
This section describes the baseline scenario of no new
regulatory action from which the incremental changes to these
outcomes from the policy options considered are measured. The scope
of this economic analysis is limited to the impacts that are
attributable to this regulatory action, which covers more than
20,000 Head Start Centers. The requirements of this interim final
rule will cover about 273,000 staff, and a share of the 1 million
Head Start volunteers who interact with children in certain in-
person Head Start settings. It will also impact a share
[[Page 68069]]
of the 864,000 children in certain in-person Head Start settings.
On September 9, 2021, President Biden announced the ``Path Out
of the Pandemic'' COVID-19 Action Plan,\88\ which announced the
development of a Head Start vaccination requirement, and other
elements of a national strategy to combat COVID-19. In our primary
analysis, we exclude impacts attributable to other elements of this
comprehensive national strategy. For example, the COVID-19 Action
Plan announced the development of the Emergency Temporary Standard
(ETS) recently issued by the Department of Labor's Occupational
Safety and Health Administration (OSHA). Among other provisions, the
OSHA ETS requires employers with 100 or more employees to develop,
implement, and enforce a mandatory COVID-19 vaccination policy,
unless they adopt a policy requiring employees to choose to either
be vaccinated or undergo regular COVID-19 testing and wear a face
covering. Centers for Medicare & Medicaid Services (CMS) also
recently issued an interim final rule with comment period that
requires COVID-19 vaccinations for workers in most health care
settings that receive Medicare or Medicaid reimbursement.\89\ The
OSHA action covers over 80 million workers, while the CMS action
will apply to approximately 76,000 providers and cover more than 17
million health care workers across the country. Additionally,
through Executive Orders 14042, ``Ensuring Adequate COVID Safety
Protocols for Federal Contractors'' \90\ and 14043, ``Requiring
Coronavirus Disease 2019 Vaccination for Federal Employees,'' \91\
and other actions, all federal executive branch employees, including
the military, and all federal contractors will be required to be
fully vaccinated. In total, the vaccination requirements associated
with the Action Plan apply to about 100 million Americans.
---------------------------------------------------------------------------
\88\ https://www.whitehouse.gov/covidplan/.
\89\ https://www.federalregister.gov/documents/2021/11/05/2021-23831/medicare-and-medicaid-programs-omnibus-covid-19-health-care-staff-vaccination.
\90\ https://www.federalregister.gov/documents/2021/09/14/2021-19924/ensuring-adequate-covid-safety-protocols-for-federal-contractors.
\91\ https://www.federalregister.gov/documents/2021/09/14/2021-19927/requiring-coronavirus-disease-2019-vaccination-for-federal-employees.
---------------------------------------------------------------------------
These actions (if implemented, despite ongoing litigation) would
likely have significant impacts on the measured outcomes described
in this baseline scenario. For example, a recent White House report
\92\ discusses existing vaccination requirements and summarizes
several potential impacts of widespread adoption of such
requirements, such as those envisioned in the Action Plan:
---------------------------------------------------------------------------
\92\ https://www.whitehouse.gov/wp-content/uploads/2021/10/Vaccination-Requirements-Report.pdf.
``[V]accination requirements have repeatedly been shown to increase
vaccination rates among workers by 20 to 25 percentage points, and
in some cases by significantly more. More than three out of four
(75.5%) working-aged adult Americans are currently in the labor
force, so increasing the share of workers who are fully vaccinated
by 20 to 25 percentage points could vaccinate an additional 30 to 38
million working-age Americans, cutting the total share of
unvaccinated Americans roughly in half. This could have a major
effect on case rates, hospitalization rates, and death rates--
preventing future waves of the virus from having as significant an
effect as occurred during the spread of the Delta variant. At an
individual level, unvaccinated people are more than five times as
likely to get a symptomatic case of COVID-19 and more than 10 times
---------------------------------------------------------------------------
as likely to be hospitalized or to die from COVID-19.''
There are challenges in extrapolating from private-sector or
smaller jurisdiction mandates to broader action by the federal
government, especially in regards to the effectiveness of the
mandates; however, the estimates contained in the White House Report
are broadly consistent with DOL's estimate ``that approximately 75.3
million (89.4 percent) of covered employees will be vaccinated when
the ETS is in full effect.'' \93\ We exclude these potential spill-
over impacts in characterizing our baseline, adopting a regulatory
scenario that does not account for other elements of the COVID-19
Action Plan.
---------------------------------------------------------------------------
\93\ https://www.govinfo.gov/content/pkg/FR-2021-11-05/pdf/2021-23643.pdf.
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The scope of the COVID-19 vaccine requirement is limited to
staff at Head Start programs and volunteers that interact with
children at Head Start programs. To characterize the baseline
scenario, we present forecasts that are specific to the 273,000
staff employed or contracted by Head Start programs,\94\ and discuss
volunteers separately. We provide quantitative projections of COVID-
19 vaccine coverage, and for each of the COVID-19 outcomes described
above. Our forecasts are based on COVID-19 Projections maintained by
the Institute for Health Metrics and Evaluation (IHME).\95\ IHME
summarizes its projections in a Data Release Information Sheet:
---------------------------------------------------------------------------
\94\ https://eclkc.ohs.acf.hhs.gov/about-us/article/head-start-program-facts-fiscal-year-2019.
\95\ Institute for Health Metrics and Evaluation (IHME). COVID-
19 Mortality, Infection, Testing, Hospital Resource Use, and Social
Distancing Projections. Seattle, United States of America: Institute
for Health Metrics and Evaluation (IHME), University of Washington,
2020. http://www.healthdata.org/covid/data-downloads. Accessed on
November 10, 2022.
``IHME has developed projections for total and daily deaths,
daily infections and testing, hospital resource use, and social
distancing due to COVID-19 for a number of countries. Forecasts at
the subnational level are included for select countries. The
projections for total deaths, daily deaths, and daily infections and
testing each include a reference scenario: Current projection, which
assumes social distancing mandates are re-imposed for 6 weeks
whenever daily deaths reach 8 per million (0.8 per 100k). They also
include two additional scenarios: Mandates easing, which reflects
continued easing of social distancing mandates, and mandates are not
re-imposed; and Universal Masks, which reflects 95% mask usage in
public in every location. Hospital resource use forecasts are based
on the Current projection scenario. Social distancing forecasts are
based on the Mandates easing scenario. These projections are
produced with a model that incorporates data on observed COVID-19
deaths, hospitalizations, and cases, information about social
distancing and other protective measures, mobility, and other
factors. They include uncertainty intervals and are being updated
daily with new data. These forecasts were developed in order to
provide hospitals, policy makers, and the public with crucial
information about how expected need aligns with existing resources,
so that cities and countries can best prepare.''
We adopt the IHME reference scenario as the source of our
baseline forecasts. Since the IHME estimates are ``produced with a
model that incorporates data on observed COVID-19 deaths,
hospitalizations, and cases, information about social distancing and
other protective measures, mobility, and other factors,'' this
significantly narrows the wide range of analytic choices that would
otherwise be necessary to characterize the baseline scenario. Since
the IHME projections cover the entire United States population, we
adjust these projections to align with data specific to Head Start.
We discuss the specific adjustments in the following narrative.
Vaccine Coverage
A recent study measured ``COVID-19 Vaccine Uptake Among U.S.
Child Care Providers,'' with 21,663 respondents, including 1,456
individuals providing services through Head Start or Early Head
Start. Among Head Start survey respondents, 73.0% reported receiving
a COVID-19 vaccine. We interpret this to mean that respondents had
received at least one dose. This interpretation is consistent with
the study's comparison to the general adult population. The authors
note that ``[t]he survey was active between May 26, 2021 and June
23, 2021,'' and compare the overall findings to vaccine uptake for
the U.S. general adult population of 65%.\96\ Since Head Start staff
are more likely to be vaccinated than the general adult population,
our baseline forecast will reflect this difference. Specifically, we
extend this point-in-time estimate to the vaccine coverage forecasts
by adopting an assumption that Head Start staff are about 12% more
likely to be vaccinated than the general adult population,\97\ and
that this relationship will persist under the time horizon of the
baseline scenario of this analysis. As a sample calculation, if the
general adult population vaccine coverage rate increases to 67.1%,
we would infer a corresponding increase in the Head Start vaccine
coverage rate to 74.6%.\98\
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\96\ Patel KM, Malik AA, Lee A, et al. (2021). ``COVID-19
vaccine uptake among US child care providers.'' Pediatrics; doi:
10.1542/peds.2021-053813.
\97\ 0.73/0.65 [ap] 1.12. We perform calculations in the model
based on the share of individuals who are unvaccinated. The
comparable calculation is 1-[(1-0.73)/(1-0.65)] [ap] 0.23, which
indicates that Head Start staff are about 23% less likely to be
unvaccinated than the general adult population.
\98\ 1-[(1-0.671) * (1-0.23)] [ap] 0.75.
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The Center for Disease Control and Prevention (CDC) maintains a
COVID Data
[[Page 68070]]
Tracker on its website, which includes a summary of COVID-19
vaccinations in the United States. On November 10, 2021, CDC reports
that 58.5% of the total U.S. population are fully vaccinated, and
reports 70.3% for a subset of the population that are 18 years of
age or older (hereafter, ``adults'').\99\ The IHME COVID-19
projections are reported at a population level, and do not contain
separate projections that are limited to the adult population.
Therefore, generating a baseline forecast of vaccine coverage among
Head Start staff from the IHME projections first requires an
intermediate step of estimating vaccine coverage for the adult
population. We follow the same approach for this adjustment as we
discussed to translate adult vaccine coverage estimates to Head
Start staff vaccine coverage estimates. Specifically, we calculate a
point-in-time relationship using November 10, 2021 CDC data, and
assume that this relationship will persist over the time horizon of
the analysis. We assume that adults are about 20.1% more likely to
be vaccinated than the total population.\100\ Combining the
adjustments, a population vaccine coverage rate on November 10, 2021
for the total U.S. population of 58.5% would correspond to a 77.1%
Head Start vaccine coverage rate.\101\
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\99\ https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total.
\100\ 0.703/0.585 [ap] 1.20. Calculated in the model as 1-[(1-
0.703)/(1-0.585)] [ap] 0.284, with the interpretation is adults are
about 28.4% less likely to be unvaccinated than the total
population.
\101\1-[(1-.585) * (1-0.284) * (1-0.23)] [ap] 0.771.
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We assume that vaccination coverage will continue to increase
over time and incorporate this into our baseline. For example, the
IHME projections indicate U.S. vaccine coverage of 60.0% on November
18, 2021. This estimate increases to 63.4% on March 1, 2022, the
last date covered in the most recent IHME projections available at
the time of the analysis. We assume that vaccine coverage for Head
Start will follow a similar trajectory, after accounting for the
adjustments described above, and incorporate this into our baseline.
Figure 1 presents forecasts of vaccine uptake under the baseline
scenario. These forecasts include the unadjusted IHME projections
for the total population, our adjustments to project adult
vaccination coverage, and adult vaccination coverage specific to
Head Start staff. For Head Start, we anticipate the vaccine coverage
rate will increase from 77.9% on November 18, 2021 to 79.8% on March
1, 2022 under the baseline scenario of no further regulatory action.
[GRAPHIC] [TIFF OMITTED] TR30NO21.002
COVID-19 Cases, Deaths, and Hospitalizations Among U.S. Adults
The IHME projections include estimates for infections, new
hospital admissions, and deaths at a population level. Several
adjustments are necessary to convert these population-level
estimates to estimates appropriate for the Head Start staff
population characteristics. Specifically, we adjust for the age
distribution and vaccine coverage rates of Head Start staff. We
discuss these adjustments in the narrative contained in the next two
sections.
We generate projections of daily cases by multiplying IHME's
projections of daily infections with its daily estimates of the
infection detection ratio.\102\ Over the period covering November
19, 2021 to March 1, 2022, the estimated infection detection ratio
varies between 0.4693 and 0.4993, suggesting that, on any particular
day, measured COVID-19 cases likely represent between 47% and 49% of
the total COVID-19 infections. We assume that this measure is
consistent with the CDC's case definition.\103\ We acknowledge the
importance of these additional infections that are not confirmed
cases but focus on the metric of confirmed COVID-19 cases, which is
more comparable with other sources of data used in this analysis.
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\102\ http://www.healthdata.org/special-analysis/covid-19-estimating-historical-infections-time-series.
\103\ https://ndc.services.cdc.gov/case-definitions/coronavirus-disease-2019-2021/.
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We make several initial adjustments of the IHME projections,
which cover the entire U.S. population, to generate forecasts that
are limited to the adult population. Using CDC COVID-19 line-level
case surveillance data that cover July 1-September 30, 2021, we
estimate that 21% of COVID-19 cases were individuals aged <18
years.\104\ We adjust the total population case projections by this
percentage to capture only adult cases. We follow the same procedure
for mortality: CDC case surveillance data indicate that 0.1% of
COVID-19 deaths were individuals aged <18 years. We adjust the total
population death projections by this percentage to capture only
adult deaths.\105\ We follow the same procedure for
hospitalizations: CDC COVID-NET data on laboratory-confirmed COVID-
19 associated hospitalizations indicate that 1.9% of COVID-19
hospitalizations were
[[Page 68071]]
individuals aged <18 years.\106\ We adjust the total population
hospital admission projections by this percentage to capture only
adult hospital admissions. We note that the hospitalization data
provide more limited coverage than data on cases and deaths. This
adjustment assumes that the distribution of hospitalizations by age
nationally are similar to the underlying data. We believe this
assumption is more justified, in the context of this analysis, than
not performing an adjustment.
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\104\ Calculation based on CDC COVID-19 Line level case
surveillance data, HHS Protect. 1,414,206/6,589,127 [ap] 0.21. This
share is somewhat higher in recent months than in earlier periods.
For all documented COVID-19 cases through September 30, 2021, the
share is 14% (4,461,790/31,537,748 [ap] 0.14). Accessed October 8,
2021.
\105\ Calculation based on data extracted from https://covid.cdc.gov/covid-data-tracker/#demographics. 637/567,704 [ap]
0.001. Accessed October 3, 2021.
\106\ Calculation based on COVID-19-Associated Hospitalization
Surveillance Network, Centers for Disease Control and Prevention.
https://gis.cdc.gov/grasp/covidnet/COVID19_5.html. 4,228/220,539
[ap] 0.019. Accessed on October 3, 2021.
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Figure 2 presents the IHME projections of daily infections,
cases, and our estimates of adult cases. Figure 3 presents the IHME
projection of daily excess deaths and reported deaths. This analysis
focuses on the projections of reported deaths, which are more
comparable with other data sources used in this analysis. Figure 4
presents the IHME projections of daily new hospital admissions and
adjusted estimates for adult cases.
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COVID-19 Cases, Deaths, and Hospital Admissions Among Head Start Staff
Head Start staff differ from the general U.S. adult population
level in several ways. First, the size of the population is much
smaller. Using the IHME total population estimate of about 328
million, and a Census estimate of the population share of adults of
about 78%,\107\ we compute a total of 255 million adults. The
273,000 Head Start staff represent about 0.1% of total adults. As an
initial adjustment, we adjust the baseline scenario estimates of
daily cases, deaths, and hospital admissions downward to reflect the
population under the scope of the interim final rule.
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\107\ https://www.census.gov/popclock/data_tables.php?component=pyramid.
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If Head Start staff had a COVID-19 risk profile that matched the
adult population, no further adjustments would be necessary;
however, as described above, a higher share of Head Start staff are
fully vaccinated than the adult population as a whole, and we expect
this trend to continue through the time horizon of the baseline
scenario of this analysis. To properly account for the risk
reductions to Head Start staff attributable to higher vaccination
rates, we perform an adjustment based on published estimates of the
incidence rate ratios (IRRs) that compare outcomes for unvaccinated
and vaccinated persons at a population level, which provide a
measure of vaccine effectiveness.\108\
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\108\ Scobie HM, Johnson AG, Suthar AB, et al. (2021).
``Monitoring Incidence of COVID-19 Cases, Hospitalizations, and
Deaths, by Vaccination Status--13 U.S. Jurisdictions, April 4-July
17, 2021.'' Morbidity and Mortality Weekly Report 2021;70:12841290.
DOI: http://dx.doi.org/10.15585/mmwr.mm7037e1.
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This CDC study reports averaged weekly, age-standardized IRRs
for cases, hospitalizations, and deaths, among persons who were not
fully vaccinated (simplified later by describing these as
``unvaccinated'') compared with those among fully vaccinated
persons. The IRRs suggest that vaccinated individuals experienced a
significantly reduced risk of infection, hospitalization, and death,
including during a period when Delta became the most common variant.
For the June 20-July 17, 2021 period, the point estimates of the
average weekly IRRs for all ages were 4.6 for cases, 10.4 for
hospitalizations, and 11.3 for deaths. For individuals between ages
18 and 49 years, these estimates are 4.5 for cases, 15.2 for
hospitalizations, and 17.2 for deaths. For individuals between ages
50 and 64 years, these estimates are 4.9 for cases, 10.9 for
hospitalizations, and 17.9 for deaths. For individuals aged >=65
years, these estimates are 4.6 for cases, 7.6 for hospitalizations,
and 9.6 for deaths.
The IRR of 4.6 for cases means that vaccination offers strong
protection against COVID-19 and that fully vaccinated people had
about a five-fold reduction in risk of infection compared with
people not fully vaccinated. These IRR estimates cover adults and
are standardized to match the U.S. adult population. They are
calculated by dividing average weekly incidence on a per capita
basis among unvaccinated individuals by the incidence among fully
vaccinated individuals. For example, the study calculates the IRR
for cases by dividing 89.1 cases per 100,000 unvaccinated
individuals by 19.4 cases per 100,000 vaccinated individuals.\109\
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\109\ 89.1/19.4 [ap] 4.6.
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For comparison, the CDC study underlying these estimates also
reports higher measurements of the IRR during an earlier time
period, covering April 4-June 19, 2021. Specifically, the comparable
IRR estimates were 11.1 for cases, 13.3 for hospitalizations, and
16.6 for deaths. The study does not disentangle the changes in the
IRR measurements across these time periods that that are
attributable to the highly transmissible Delta variant or other
factors, such as the potential decline in vaccine effectiveness as
the time since vaccination increases. Although the IRRs are unlikely
to remain constant over time, the estimates corresponding to the
June 20-July 17, 2021 period represent the best available estimates
of the IRR for the time horizon of this analysis.
We also generate IRR estimates specific to the Head Start
teacher population. These estimates reflect differences in the age
distribution of Head Start teachers rather than observational data
on COVID-19 cases, since ACF does not collect this information. To
generate these estimates, we pair the age-specific IRR estimates
with the corresponding age range for Head Start teachers. ACF data
indicates that 10.4% of Head Start teachers are ages 18-29 years;
ages 30-39 years, 29.6%; ages 40-49 years, 26.7%; ages 50-59 years,
21.7%; and ages >60 years, 11.6%.\110\ For the purposes of this
analysis, we assume that half of Head Start teachers 60 years and
older are ages 60-64 years, and half are ages >65 years. Table 2
presents the central estimates of the age-standardized IRRs for
cases, hospitalizations and deaths for the adult population, as
reported in the CDC study, and IRRs for the same outcomes, but
standardized for the age profile of Head Start teachers. We later
apply these estimates, which reflect the Head Start teacher age
[[Page 68073]]
profile, for a broader population of Head Start staff.
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\110\ Doran, Elizabeth, Natalie Reid, Sara Bernstein, Tutrang
Nguyen, Myley Dang, Ann Li, Ashley Kopack Klein, Sharika Rakibullah,
Myah Scott, Judy Cannon, Jeff Harrington, Addison Larson, Louisa
Tarullo, and Lizabeth Malone (2021). A Portrait of Head Start
Classrooms and Programs in Spring 2020: FACES 2019 Descriptive Data
Tables and Study Design, OPRE Report #2021-215, Washington, DC:
Office of Planning, Research, and Evaluation, Administration for
Children and Families, U.S. Department of Health and Human Services.
Pending Publication.
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By adopting the adult age-standardized IRR estimates, we are
able to disaggregate COVID-19 cases among unvaccinated individuals
from cases among vaccinated individuals. Figure 5 presents these
estimates for the adult population.
[GRAPHIC] [TIFF OMITTED] TR30NO21.007
[[Page 68074]]
We combine estimates of the daily adult cases among unvaccinated
individuals and daily estimates of the unvaccinated adult population
to generate daily incidence rates among unvaccinated individuals on
a per capita basis. We perform similar calculations to generate
daily incidence rates among vaccinated individuals on a per capita
basis. Figure 6 reports the daily incidence over time and by
vaccination status. These estimates are reported as cases per
100,000 individuals. For the last week in our projections, covering
February 23, 2022 to March 1, 2022, the weekly incidence rate for
unvaccinated adults is about 446 cases per 100,000, while the weekly
incidence rate for vaccinated adults is about 97 cases per 100,000,
which is consistent with a 4.6 IRR. This time period corresponds to
an adult vaccination rate of 73.8%, for a total adult weekly
incidence rate of about 188 cases per 100,000, and a total weekly
adult case count of 480,523.
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To generate estimates of cases among Head Start staff, we
combine the estimates of vaccine uptake from Figure 1, estimates of
the daily incidence by vaccination status, applying the IRR measure
specific to Head Start staff, with outcomes scaled by the number of
Head Start staff. This approach assumes, for the purpose of
developing quantitative projections, that daily exposure to COVID-19
among Head Start staff is largely driven by interactions with the
public as a whole and that Head Start staff face similar exposure to
these risks as other adults. If Head Start staff face greater
exposure to these risks than the adult population, such as through
routine contact with children who are generally not eligible for a
COVID-19 vaccination, this will cause our baseline estimates of
cases, hospitalizations, and deaths among Head Start staff to be
downward biased. This would similarly result in our estimates of the
health benefits from increases in vaccine coverage to be downward
biased. We project that Head Start staff will experience lower per-
capita case counts than the general adult population due to higher
rates of vaccination, and a higher IRR rate consistent with the age
profile of Head Start staff compared to all adults. Figure 7
presents daily Head Start cases. For the last week in our
projections, covering February 23, 2022 to March 1, 2022, we
estimate about 457 total cases, with 246 cases from unvaccinated,
and 211 cases from vaccinated Head Start staff. These cases
translate to a baseline Head Start weekly incidence rate of about
167 cases per 100,000.
[[Page 68075]]
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We generate estimates of the Head Start deaths and hospital
admissions using the same approach as we describe for cases. We
adopt IRR estimates specific to the Head Start staff population of
17.0 for deaths and an IRR of 13.6 for hospitalizations. These IRRs
indicate that the COVID-19 vaccines provide even stronger protection
against COVID-19 associated hospitalization and death than against
infections. We perform adjustments to the adult incidence rates that
are intended to control for deaths and hospital admissions that are
concentrated in older age groups than we observe among Head Start
staff.
Using CDC surveillance data through October 3, 2021, we observe
that, among the 567,704 COVID-19 deaths in the United States for
which age data are available, 319,311 deaths are among individuals
>=75 years. While the Head Start workforce includes a number of
older individuals, very few are >=75 years. Head Start data indicate
that 11.6% of teachers are age 60 years or older, compared to the
general population share of 22.7%. We anticipate that almost all of
the Head Start teachers age 60 years or older are between age 60 and
74 years, and assume this is also true for the broader Head Start
staff population. Therefore, we adjust the adult death incidence
rate to exclude deaths among individuals >=75 years. This adjustment
reduces the baseline forecast for Head Start deaths downwards by
about 56%.\111\ Older individuals are also hospitalized at higher
rates than younger peers, but this difference is less pronounced
than for deaths. Among laboratory-confirmed COVID-19-associated
hospitalizations for which age data are available, about 43% are
individuals >=65 years,\112\ an age subgroup representing about
16.5% of the total population. Since only 5.8% of Head Start staff
are individuals >=65 years, we reduce the total population baseline
forecasts for hospitalizations by about two thirds \113\ of 43%, or
about 28%,\114\ since we expect a significant share of these
hospitalizations to be among individuals older than most Head Start
staff.
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\111\ 319,311/(567,704-637) [ap] 0.56.
\112\ 92,960/(220,539-4,228) [ap] 0.43.
\113\ 0.058/0.165 [ap] 0.35. 1-0.35 = 0.65.
\114\ 0.43 * 0.65 [ap] 0.28.
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Figure 8 reports daily Head Start deaths attributable to COVID-
19 under the baseline scenario. For the entire period of the
baseline scenario, we anticipate fewer than one COVID-19 related
death per day among Head Start staff. For the last week in our
projections, covering February 23, 2022 to March 1, 2022, we
estimate 2.9 weekly deaths out of the total Head Start staff
population of 273,000. To provide additional context, this is a
weekly incidence rate of 1.06 deaths per 100,000 individuals. The
comparable adult weekly incidence rate is about 3.18 deaths per
100,000 individuals. Figure 9 reports daily Head Start hospital
admissions. For the last week in our projections, we estimate 29
hospital admissions for a weekly incidence rate of 10.8 per 100,000.
[[Page 68076]]
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Head Start Program Operating Status and Staffing
The Office of Head Start has tracked the operating status of
programs since the onset of the pandemic. In March and April of
2020, more than 90% of programs closed all in-person operations. By
August of 2020, 21% of programs had reopened for in-person services,
26% remained closed for in-person services due to COVID-19, and the
remainder of programs were closed for summer months as regularly
scheduled. In December 2020, data show the highest combined
percentage (67%) of Head Start centers operating as solely virtual/
remote or as hybrid, with an additional 5% of centers closed.
Together, these centers account for over 13,500 centers nationwide.
This represents many working parents for whom unpredictable closures
and transitions to virtual learning come at a cost, present
difficult decisions between employment and child care
responsibilities, and major financial impacts on their household.
Most recently, July 2021 data show that 2% of centers were
closed due to COVID-19, 14% of centers were operating virtual/
remote, and 44% of centers were operating in a hybrid status, which
includes programs that are alternating between in-person services,
virtual or remote services, or some combination of the two. Only 35%
of centers were operating fully in-person. We do not have comparable
data for about 5% of centers.\115\ While closures have declined, the
majority of Head Start centers are still operating in virtual/remote
or a hybrid status. We adopt these estimates as providing a
reasonable representation of the operating status of Head Start
centers under the baseline scenario of no regulatory action. These
estimates are intended to represent a steady state of overall
operating status under the baseline scenario rather than indicating
that any particular center will remain in its current status without
regulatory action. Table 3 presents the in-person days per week
[[Page 68077]]
by center status. 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; and (3) that
centers in fully in-person status meet in person 5.0 days per week,
on average. For the purpose 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.\116\
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\115\ We are missing data on about 5% of centers. For the
purposes of this analysis, we assign an operating status to these
centers in proportion with the centers for which we have complete
data.
\116\ https://eclkc.ohs.acf.hhs.gov/sites/default/files/pdf/no-search/hs-program-fact-sheet-2019.pdf.
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Early care and education providers, including Head Start
programs, are currently experiencing significant challenges in
recruiting and retaining staff that are attributable to the COVID-19
pandemic and general trends in early care and education labor
markets. These ongoing challenges, which represent the baseline
scenario and are not attributable to the interim final rule, are
difficult to quantify; however, the section on Costs expands on this
discussion. This discussion includes a range of estimates to inform
how the requirements in this rule could exacerbate this issue for
certain programs, which could include programs not being able to
fully staff their classrooms.
E. Impact on Vaccine Coverage
The key parameter underlying the estimated benefits and costs of
the interim final rule is the incremental impact on vaccine uptake,
which is the difference between the share of individuals who are
unvaccinated under the baseline scenario and who are induced to get
fully vaccinated under the interim final rule. As we discuss further
in the Benefits and Costs sections, higher rates of incremental
vaccine uptake are associated with higher benefit estimates, but
also lower overall costs. Given the importance of this parameter and
its uncertain nature, we perform an analysis of several scenarios
for vaccine uptake, and present estimates of the benefits and costs
of the interim final rule for each scenario. Each of the scenarios
adopt the following timing and simplifying assumptions:
(1) For the purposes of this analysis, we adopt November 22,
2021 as the public announcement date of the interim final rule.
(2) The effective date of the vaccination requirement is January
31, 2022. We anticipate that some Head Start staff will wait until
January 31, 2022 to receive their final vaccination dose.
(3) We do not attribute any impact on the rate of fully
vaccinated Head Start staff until at least December 6, 2021. The
earliest impacts would be among Head Start staff who have received
one COVID-19 dose as part of a two-dose series at the time of the
public announcement of the interim final rule who are induced by the
interim final rule to complete their two-dose series. The latest
impacts would be among Head Start staff who receive their final dose
on January 31, 2022, who will be considered fully vaccinated two
weeks later, on February 14, 2022.
(4) The interim final rule describes exemptions from the
vaccination requirement. For the purposes of this analysis, we
assume that 5% of total Head Start staff will seek and be granted an
exemption from the vaccination requirement.\117\ These individuals
will not be induced to get fully vaccinated under the interim final
rule. This assumption translates to least 13,650 \118\ Head Start
staff who will remain unvaccinated under all vaccine coverage
scenarios.
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\117\ This estimate is consistent with an assumption discussed
in the Preamble of the Emergency Temporary Standard recently issued
by the Department of Labor's Occupational Safety and Health
Administration. ``OSHA estimates that some 5% of employees may have
a medical contraindication or request an accommodation from the
rule's requirements for disability or sincerely held religious
belief reasons.'' https://www.federalregister.gov/documents/2021/11/05/2021-23643/covid-19-vaccination-and-testing-emergency-temporary-standard.
\118\ 0.05 * 273,000 = 13,650.
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Our upper-bound scenario is based on an observation contained in
the HHS Guidelines for Regulatory Impact Analysis, which notes that
``[i]n most cases, the analysis focuses on estimating the
incremental compliance costs incurred by the regulated entities,
assuming full compliance with the regulation, and government
costs.'' \119\ For the purpose of this analysis, we maintain the
assumption that 5% of Head Start staff will seek and be granted an
exemption, while the remaining 95% will be fully vaccinated. These
represent two of the routes that Head Start staff can demonstrate
full compliance with the interim final rule. We note that the HHS
Guidelines for Regulatory Impact Analysis further recommend that
``[a]nalysts should consider the uncertainty associated with an
assumption of full compliance and provide analysis of alternative
assumptions, as appropriate.''
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\119\ https://aspe.hhs.gov/reports/guidelines-regulatory-impact-analysis.
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Our lower-bound scenario adopts an estimate drawn from an Issue
Brief published by the HHS's Office of the Assistant Secretary for
Planning and Evaluation (ASPE), which finds that ``[a]s of August
2021, approximately 30% of U.S. adults are
[[Page 68078]]
unvaccinated; among these, approximately 44% may be willing to get
vaccinated against COVID-19.'' \120\ This published finding is based
on an analysis using survey data for Week 33 of the Household Pulse
Survey (June 23-July 5, 2021). We perform an identical calculation
using Week 39 (September 29-October 11) survey responses, which
results in a lower estimate of 33.4%. We assume that 33.4% of the
unvaccinated individuals will be induced to get fully vaccinated by
this time under the policy scenario. Under this scenario, about
86.6% of Head Start staff are fully vaccinated by February 14, 2022.
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\120\ https://aspe.hhs.gov/reports/unvaccinated-willing-ib.
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These estimates are from a nationally representative survey of
households, but are broadly consistent with responses from another
survey specific to U.S. child care providers.\121\ In this survey,
which informs our baseline forecast of Head Start staff vaccine
coverage, overall vaccine uptake among U.S. child care providers was
78.2%. Among unvaccinated survey respondents, including child care
providers not affiliated with Head Start, the authors note that
``only 5.0% were `absolutely certain' that they would get vaccinated
in the future, 6.9% were `very likely,' 28.2% were `somewhat
likely.' '' These percentages, which sum to 40.1%, suggest
substantial room for additional vaccine uptake among child care
providers, even though rates significantly exceeded the general
population at the time of the survey. As a sample calculation, if
40.1% of the 21.8% of unvaccinated survey respondents get
vaccinated, this would increase the overall vaccine uptake among
U.S. child care providers from 78.2% to 86.9%. This estimate is
slightly above our lower-bound estimate of vaccine coverage for Head
Start staff under the interim final rule.
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\121\ Patel KM, Malik AA, Lee A, et al. (2021). ``COVID-19
vaccine uptake among US child care providers.'' Pediatrics; doi:
10.1542/peds.2021-053813.
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We anticipate that the vaccination requirement will induce more
unvaccinated Head Start staff to get fully vaccinated than the
lower-bound vaccine-uptake estimates suggest. For our primary
scenario, we adopt the midpoint vaccine coverage rate between our
lower- and upper-bound scenarios, and project overall vaccine
coverage of 90.8% among Head Start staff by February 14, 2022.
Figure 10 presents our forecasts of the share of Head Start
staff who are fully vaccinated under the baseline scenario, and our
range of policy scenarios. For our baseline scenario, we estimate
the share who are fully vaccinated of 79.8%, or 217,879 fully
vaccinated Head Start staff out of 273,000 total staff. We estimate
a range of estimates under of our policy scenario between 86.6% and
95.0%, for an incremental vaccine uptake of between 6.8% and 15.2%.
For our primary policy scenario, we estimate overall vaccine
coverage of 90.8%, for an incremental vaccine uptake of 11.0%. Under
the primary scenario, we estimate 247,833 fully vaccinated Head
Start staff, and an incremental 29,953 staff fully vaccinated
attributable to the interim final rule.
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E. Benefits of the Rule
We follow identical procedures outlined in the baseline section
to generate forecasts of COVID-19 cases, deaths, and
hospitalizations that are consistent with a range of vaccine
coverage estimates under the policy scenarios. We estimate the
likely impacts of the interim final rule by calculating the
difference between the measurable COVID-19 outcomes under the policy
scenarios against the baseline scenario described in the previous
section.
Reduction in Cases Among Head Start Staff
Figure 11A presents our estimates of the daily COVID-19 cases
among Head Start Staff under each scenario. The baseline scenario
corresponds to the estimates presented in Figure 7 in the previous
section. Figure 11B presents the cumulative reduction in cases over
time that are attributable to the interim final rule under the
vaccine coverage scenarios. Through March 1, 2022, the impact of the
interim final rule is cumulative COVID-19 case reductions between
510 and 1,198, which correspond to the range of vaccine coverage
scenarios.
[[Page 68079]]
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Reduction in Deaths Among Head Start Staff
Figure 12A presents our estimates of the daily COVID-19 deaths
among Head Start Staff under each scenario. The baseline scenario
corresponds to the estimates presented in Figure 8 in the previous
section. Figure 12B presents the cumulative reduction in deaths over
time that are attributable to the interim final rule under the
vaccine coverage scenarios. Through March 1, 2022, the impact of the
interim final rule is cumulative COVID-19 mortality reductions
between 4.8 and 11.2, which correspond to the range of vaccine
coverage scenarios.
[[Page 68080]]
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Reduction in Hospital Admissions Among Head Start Staff
Figure 13A presents our estimates of the daily COVID-19 hospital
admissions among Head Start Staff under each scenario. The baseline
scenario corresponds to the estimates presented in Figure 9 in the
previous section. Figure 13B presents the cumulative reduction in
hospital admissions over time that are attributable to the interim
final rule under the vaccine coverage scenarios. Through March 1,
2022, the impact of the interim final rule is cumulative COVID-19
hospital admission reductions between 51 and 118, which correspond
to the range of vaccine coverage scenarios.
[[Page 68081]]
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Valuing Health Benefits Among Head Start Staff
Table 3 summarizes several measurable improvements in COVID-19
outcomes for Head Start staff that are attributable to the interim
final rule. For the baseline scenario of no new regulatory action,
and for each of the vaccine coverage scenarios, we report the share
of Head Start staff that are fully vaccinated by March 1, 2022, and
the corresponding cumulative cases, deaths, and hospital admissions
averted over the time horizon of the analysis.
IHME's daily projections for U.S. hospital admissions include
about 35% that result in intensive care unit (ICU) admissions. Head
Start hospital admissions estimates are adjusted downwards to
reflect a lower rate of hospitalization among younger individuals.
We similarly expect the share of hospitalizations that include an
ICU admission to be lower for Head Start staff compared to the
general adult population; however, we are not aware of an estimate
that is directly transferable, and adjust this estimate of the share
of hospital admissions that result in an ICU admission down by half.
We believe this assumption is more justified, in the context of this
analysis, than not performing an adjustment. Assuming about 17.5% of
the cumulative hospital admissions result in an ICU admission, we
estimate 76 ICU admissions under the baseline scenario, and between
55 and 67 ICU admissions under the interim final rule, depending on
the vaccine coverage scenario. Therefore, we measure a reduction of
between 9 and 21 ICU admissions under the interim final rule. We
follow the same approach to calculate non-ICU hospital admissions
for the remaining 82.5% of total hospital admissions.
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Valuing risk reductions associated with regulations that address
the COVID-19 presents major challenges. We adopt an approach to
monetize the cumulative cases, deaths, and hospitalizations averted
under the interim final rule by closely following the methodology
described in an ASPE report on ``Valuing COVID-19 Mortality and
Morbidity Risk Reductions in U.S. Department of Health and Human
Services Regulatory Impact Analyses.'' \122\ This paper addresses
these challenges by summarizing the impacts of COVID-19 on health
and longevity, describing the conceptual framework for valuation,
investigating some of the available valuation research (as of March,
2021), and discussing the implications.\123\ We note that the impact
of the virus is rapidly evolving, and new data are continually
emerging. We have reviewed the assumptions and evidence contained in
this report and conclude that the quantitative estimates remain
useful for assessing the impacts of this interim final rule.
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\122\ https://aspe.hhs.gov/reports/valuing-covid-19-risk-reductions-hhs-rias.
\123\ Additional relevant citations not contained in the report
include Viscusi, W.K. Pricing the global health risks of the COVID-
19 pandemic. J Risk Uncertain 61, 101-128 (2020). https://doi.org/10.1007/s11166-020-09337-2 and Viscusi W.K. Economic lessons for
COVID-19 pandemic policies [published online ahead of print, 2021
Mar 4]. South Econ J. 2021;10.1002/soej.12492. doi:10.1002/
soej.12492.
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Valuing these risk reductions using the estimates contained in
the ASPE report requires assumptions that map the non-fatal risk
reductions quantified in Table 4 into ``mild,'' ``severe,'' and
``critical'' case-severity categories. These categories are
characterized by common symptoms experienced for an acute phase and
post-acute phase. Below, we reference the description of each case-
severity category from Table 3.2 Common Symptoms of Nonfatal COVID-
19 Cases by Severity Level of the ASPE Report.\124\
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\124\ https://aspe.hhs.gov/reports/valuing-covid-19-risk-reductions-hhs-rias. Table 3.2 appears on page 35.
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For the acute phase of a critical case, ``[i]ndividuals will
have early symptoms similar to those of mild and severe disease.
Individuals may quickly progress to respiratory failure and may also
have septic shock, encephalopathy (brain disease), heart disease or
failure, coagulation dysfunction (inability of blood to clot
normally), and acute kidney injury. Organ dysfunction can be life-
threatening. Individuals with critical disease often receive
prolonged mechanical ventilation.'' For the post-acute phase,
``[i]ndividuals are likely to have long-term physical and cognitive
impairment similar to other critical illnesses.'' We initially
assign the 9 to 21 averted ICU admissions to the critical case
category, but we reduce these estimates by the number of deaths
averted. This approach avoids the potential for double counting,
since the underlying VSL estimates likely include the willingness-
to-pay to avoid some morbidity prior to death.
The ASPE Report discusses these considerations in greater
detail, noting that ``COVID-19 deaths are generally preceded by
about two weeks of symptoms, including fever, shortness of breath,
high respiratory rate, and cough. They may also involve being placed
on mechanical ventilation in a medically induced coma.'' This is in
contrast to ``[t]he studies that underlie the HHS VSL estimates,
[which] focus largely on occupational risks that lead to relatively
immediate death from injury.'' Therefore, we explore the sensitivity
of the overall results to this approach. Including the value of a
critical case to the value of the mortality reductions for these
individuals prior to death would increase the total monetized health
benefits by between $8.7 million and $20.3 million, depending on the
vaccine coverage scenario. We do not include these estimates in the
summary of monetized benefits.
For the acute phase of a severe case, ``[i]ndividuals will have
early symptoms similar to those of mild disease, such as fever and
cough, which may be accompanied by gastrointestinal symptoms, such
as diarrhea. The disease continues to progress for over a week.
Dyspnea (shortness of breath), high respiratory rate, and/or blood
oxygen saturation of <=93 percent occur. Individuals typically have
pneumonia and require supplementary oxygen. Individuals with severe
disease should be hospitalized.'' For the post-acute phase,
``[i]ndividuals may have post-acute symptoms, such as cough,
shortness of breath, fatigue, and pain.'' We assign the 42 to 97
non-ICU hospital admissions averted to the severe case category.
For the acute phase of a mild case, ``[i]ndividuals will have
symptoms of acute upper respiratory tract infection, which may
include fever, fatigue, myalgia (muscle aches), cough, and sore
throat. Some cases may have digestive symptoms, such as nausea,
abdominal pain, and diarrhea. Loss of taste and smell are common
symptoms. Individuals may have mild pneumonia (infection of the
lungs), and some may have wheezing or dyspnea (shortness of breath)
but blood oxygen saturation remains above 93 percent.'' For the
post-acute phase, ``[i]ndividuals may have post-acute symptoms, such
as cough, shortness of breath, fatigue, and pain.'' We initially
assign the 510 to 1,198 cumulative cases averted to the mild case
category, but we reduce these estimates by the corresponding
estimates of critical and severe cases to avoid double counting.
This yields an estimate of between 460 to 1,080 mild cases averted.
[[Page 68083]]
We considered a further adjustment to the estimate range for
mild cases to account for the share of cases that are asymptomatic.
As noted above, these estimates are derived from projections of
measured COVID-19 cases, rather than total COVID-19 infections. Over
the period of the analysis, these represent slightly less than half
of the total projected infections, including those not confirmed
through testing. This means that, while our measure of mild cases
likely includes some confirmed cases that are asymptomatic, it does
not include some symptomatic COVID-19 infections that are not
confirmed through testing. The ASPE report also discusses the
potential for ``cases that are initially asymptomatic or mildly
symptomatic may ultimately lead to impaired health over the longer
run,'' suggesting that the VSC estimates for mild cases may
underestimate the full long-run health-related quality of life
consequences of an infection. Given the multiple sources and
potential direction of the bias, we have determined that it is
appropriate to not make an explicit adjustment. However, we have
incorporated uncertainty into the main analysis, which includes a
range of total cases averted. We also perform a sensitivity analysis
for all health benefits monetized in this analysis by applying a
range of VSC and VSL estimates.
The mortality and morbidity risk reductions we identify in this
regulatory impact analysis accrue to a working-age Head Start staff
population. We have taken care to ensure that our estimates of the
cumulative cases, deaths, and hospital admissions averted would not
be biased upwards due to an overrepresentation of deaths and
hospital admissions among individuals older than the typical Head
Start staff. Thus, we adopt the population-average VSL and VSC
estimates contained in the ASPE report, with a minor adjustment of
0.8% to account for real income growth, since the mortality and
morbidity risk reductions occur in 2021 and the underlying estimates
are from a 2020 base year.
Table 5A reports the mortality risk reductions attributable to
the interim final rule, and the morbidity risk reductions,
categorized by case-severity category. We monetize these impacts
using a VSL of about $11.5 million, and VSC estimates that vary by
case severity. We multiply the risk reductions by the appropriate
VSL or VSC estimate to generate estimates of the value of these risk
reductions. We sum these to generate a monetized benefit of the
health benefits to Head Start staff attributable to the interim
final rule under the vaccine coverage scenarios. Using a 3% discount
rate, which affects the underlying value per quality-adjusted life
year estimate used in the ASPE report to generate the VSC estimates,
we report a total value of risk reduction of between $66.0 million
and $154.1 million. Table 5B reports the same estimates using a 7%
discount rate. Under this discount rate, we report a total value of
risk reduction of between $68.2 million and $159.2 million. All
estimates are reported using 2020 dollars. These impacts cover the
period between the publication date of the interim final rule and
March 1, 2022, the last day reported in the IHME projections.
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Valuing Time Savings for Head Start Families From Reductions in
Absenteeism
We also anticipate reductions in time spent by parents or other
caretakers providing needed support for children due to COVID-19
infections among Head Start staff. Several assumptions are necessary
to quantify this impact. Since 273,000 Head Start staff provide
services for 864,289 children, a 1:3.2 ratio, we assume that each
staff missing work due to a COVID-19 infection means that an average
of 3.2 children will need support from parents or other caretakers
during this absence. We assume that a typical COVID-19 case results
in two weeks of missed work, which corresponds to an average of 5
days a week, with 6 hours per day of providing Head Start services.
Combining these assumptions, we estimate that cases of COVID-19
among Head Start staff results in an average of 190 hours of support
for children that will be provided by a parent or other caretaker.
As discussed earlier, the interim final rule is anticipated to
reduce COVID-19 cases among Head Start staff by a cumulative 510 to
1,198 cases over the time horizon of the analysis. Each of these
cases averted corresponds to 190 hours of time saved by parents or
other caregivers.
We also anticipate that a COVID-19 case at a center operating
fully in-person can result in missed work for other Head Start staff
who were in close contact and potentially exposed. This impact is
limited to unvaccinated staff, since CDC guidance indicates that
``[p]eople who are fully vaccinated do not need to quarantine if
they come into close contact with someone diagnosed with COVID-19.''
\125\ We assume that all unvaccinated staff will be considered close
contacts and need to quarantine. For simplicity, we adopt 20.2% as
the share of Head Start staff unvaccinated on the last day of our
baseline projections. We anticipate that Head Start staff at fully
in-person centers represent 37% of the total staff cases, which is
in line with the share of centers that are operating fully in-
person, and that each center has about 13 staff, which is in line
with the average number of staff per center. Among these 13 staff,
about 3 are unvaccinated. To avoid double counting, we reduce this
estimate by 1 to account for the initial COVID-19 case.
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\125\ https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/k-12-contact-tracing/about-quarantine.html.
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To monetize these impacts, we adopt a value of time based on
after-tax wages. Our approach matches the default assumptions for
valuing changes in time use for individuals undertaking
administrative and other tasks on their own time, which are outlined
in an ASPE report on ``Valuing Time in U.S. Department of Health and
Human Services Regulatory Impact Analyses: Conceptual Framework and
Best Practices.'' \126\ We start with a measurement of the usual
weekly earnings of wage and salary workers of $990.\127\ We divide
this weekly rate by 40 hours to calculate an hourly pre-tax wage
rate of $24.75. We adjust this hourly rate downwards by an effective
tax rate of about 17%, resulting in a post-tax hourly wage rate of
$20.55. We report a range for the total value of time saved of
between $3.3 million and $7.5 million, depending on the vaccine
coverage scenario.
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\126\ https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework.
\127\ https://www.bls.gov/news.release/pdf/wkyeng.pdf, second
quarter of 2021.
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[[Page 68085]]
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As a sensitivity analysis, we augmented the post-tax wage rate
to account for non-wage benefits. To capture non-wage benefits, we
apply an estimate of the share of compensation from employer
supplements to wages and salaries of about 18%, or $4.55 per hour
using a pre-tax hourly wage as the base.\128\ This results in a
value of time of $25.10 per hour. Using this alternative value of
time, the value of time savings from reduced absenteeism would range
from $3.9 million to $9.2 million, with a primary estimate of $6.6
million.
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\128\ https://fredblog.stlouisfed.org/2018/10/employer-contributions/.
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Benefits Related to Head Start Program Operating Status
We consider it probable that the substantial reduction in COVID-
19 cases per day among Head Start staff and volunteers will result
in fewer center closures due to COVID-19. For a number of reasons,
the interim final rule will not eliminate the risk of COVID-19 among
Head Start staff, volunteers, and children. Among these reasons, we
do not expect that all staff and volunteers will be fully vaccinated
under the interim final rule. We also do not expect many children to
be fully vaccinated under either the baseline or any of the vaccine
coverage scenarios under the policy for the time horizon of the
analysis. As described in our discussion of the baseline scenario,
being fully vaccinated is associated with a substantial reduction in
the risk of a COVID-19 infection; however, it does not eliminate
this risk. Thus, since the interim final rule will not eliminate the
risk of COVID-19, we cannot reasonably conclude that all currently
closed Head Start centers will reopen and remain open for the time
horizon of the analysis. We do not estimate the reduction in
closures anticipated due to the interim final rule; however, we
present a calculation of how we would value this impact on a per-
center basis.
As discussed in the Baseline section, the most recent data
available at the time of this analysis indicates that 393 Head Start
centers were closed due to COVID-19, representing about 2% of
centers. We also presented an estimate of 17,264 children
potentially unable to access Head Start services due to these
closures, which is about 42 children per center. We restate the
assumption that each child not served by these centers requires 30
hours of support per week from family and caregivers that would
normally be provided by Head Start staff and volunteers. This means
each center closure results in 1,318 hours of support needed per
week that would typically be provided by Head Start staff. Combined
with the approach to valuing time described earlier, this means each
center closure averted by the interim final rule could result in
time saved for parents and caregivers valued at $25,722 per week. If
1% of total Head Start centers reopen as a result of the interim
final rule, we would monetize these benefits at $5.3 million per
week.
We also anticipate that the reduction in COVID-19 infection
risks among Head Start staff, paired with the mask requirement, will
result in a larger share of centers operating fully in person. As
discussed in the Baseline section, 3,013 centers are operating in a
virtual/remote status and 9,667 centers are operating in a hybrid
status. We estimate that 125,679 children are receiving services in
centers operating in a virtual/remote status and that 403,305
children are receiving services in centers operating in a hybrid
status. We anticipate that centers transitioning from virtual/remote
status to hybrid status, or from hybrid status to fully in-person
status could result in time saved for parents and caregivers. We do
not provide an estimate, but we expect the value of time saved for
these impacts would be less than the value of time saved from
reopening closed centers.
The value of time saved for families due to Head Start centers
reopening, centers transitioning from virtual/remote status to
hybrid status, and centers transitioning from hybrid status to fully
in-person status are likely to be substantial. However, these time
savings are only part of the anticipated benefits to children and
families as the result of fewer closures, and more in-person
services. Head Start promotes school readiness for children in low-
income families by offering educational, nutritional, health,
social, and other services. We expect that Head Start centers that
are able to reopen or move towards more in-person services under the
interim final rule will be more effective in meeting these goals and
the needs of Head Start families.
Valuing Health Benefits Among Head Start Volunteers
The interim final rule requires volunteers that interact with
children at Head Start programs to be fully vaccinated. In 2019,
approximately 1,061,000 adults volunteered in their local Head Start
program. Of these, 749,000 were parents of Head Start
[[Page 68086]]
children.\129\ We have less information about these adults than for
Head Start staff. For the purposes of providing estimates under the
baseline and interim final rule, we make the following assumptions:
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\129\ https://eclkc.ohs.acf.hhs.gov/sites/default/files/pdf/no-search/hs-program-fact-sheet-2019.pdf.
1. The baseline vaccine coverage rate for Head Start volunteers
matches the overall adult vaccine coverage rate.
2. The mortality and morbidity risks for adult Head Start
volunteers match the risks for Head Start staff, except through
differences in vaccine coverage.
3. The requirement under the interim final rule will be less
salient to unvaccinated volunteers than for staff since it is not
linked to employment. We start with the lower-bound incremental
vaccine-uptake estimate that, among unvaccinated adults,
approximately 33.4% will be induced to get fully vaccinated. As
discussed earlier, this estimate is based on an analysis of the
Household Pulse Survey. We reduce this estimate by half, which is
similar to excluding adults who are ``unsure about getting a
vaccine,'' and results in an incremental vaccine-uptake estimate of
about 16.7%.
4. The volunteers most likely to be impacted by the policy are
the volunteers associated with centers operating under a hybrid or
fully in-person status. For volunteers at centers that are closed or
in a virtual/remote operating status, we adopt an incremental
vaccine-uptake of 0%.
5. We assume that the requirement will be even less salient for
volunteers associated with centers operating in hybrid status. For
these volunteers, we further reduce the incremental vaccine-uptake
estimate by half, which is similar to excluding adults who ``will
probably get a vaccine.'' This results in an incremental-vaccine
uptake of about 8.4%.
6. We do not estimate a second incremental vaccine-uptake
scenario, such as the upper-bound full-compliance scenario for
staff, since volunteers can comply with the requirement by choosing
to not interact with children in an in-person Head Start setting. We
also note that some of these volunteers may be induced to get
vaccinated due to another COVID-19 vaccination requirement.
7. For the purposes of this analysis, we assume that volunteers
are distributed evenly across Head Start centers, regardless of
operating status.
Table 7 summarizes these assumptions for the number of
volunteers, and the incremental vaccine-uptake assumptions that vary
by center operating status.
[GRAPHIC] [TIFF OMITTED] TR30NO21.024
We follow identical steps for estimating the baseline scenario
and policy scenario for Head Start staff, except to substitute the
number of volunteers and vaccine-uptake assumptions for each center
operating status category. As noted above, we also assume that the
baseline vaccination coverage among volunteers matches the adult
vaccination coverage, rather than the higher Head Start staff
vaccination coverage.
Table 8 summarizes several measurable improvements in COVID-19
outcomes for Head Start volunteers at centers operating fully-in
person that we attribute to the interim final rule. We estimate a
total increase of 28,163 volunteers who are fully vaccinated, or
about 2.7% of the total volunteers. To put this into the context of
other vaccine requirements and to continue the discussion of
attribution of impacts, we consider the Head Start volunteers under
the baseline scenario who are also covered by the DOL ETS as
employees of covered employers. DOL recently estimated 27.0% of
covered employees would be vaccinated under the ETS, not including
the 62.4% of covered employees vaccinated in the baseline, pre-
ETS.\130\ If every Head Start volunteer was covered by this interim
final rule, the DOL ETS as an employee of a covered employer, and no
other vaccine requirements, our 2.6% estimate would attribute about
10% of the incremental vaccine coverage to this interim final rule
and about 90% to the DOL ETS. As a sensitivity analysis on the
appropriate attribution of impacts, we also report the net benefits
of the interim final rule, excluding all benefits and costs
associated with volunteers. These estimates are identical to the
policy alternative of not including volunteers in the scope of the
policy, which appears in Table 26.
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\130\ https://www.govinfo.gov/content/pkg/FR-2021-11-05/pdf/2021-23643.pdf. Table IV.B.8.
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For the baseline scenario of no new regulatory action, and for
interim final rule scenario, we report the share of these volunteers
that are fully vaccinated by March 1, 2022, and the corresponding
cumulative cases, deaths, and hospital admissions averted over the
time horizon of the analysis. Table 9 presents the same estimates
for Head Start volunteers associated with centers in hybrid
operating status. Table 10 presents the same estimates that combine
Head Start volunteers associated with centers in virtual/remote and
closed operating statuses. Table 11 presents the estimates for all
Head Start volunteers.
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[[Page 68088]]
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We value the mortality and morbidity risk reductions experienced
by Head Start volunteers following an identical methodology
described above for Head Start staff. This includes the process for
categorizing morbidity reductions by case-severity category, and the
adjustments to prevent double counting. Table 12 presents the total
value of COVID-19 mortality and morbidity risk reductions for Head
Start volunteers across all centers, for a 3% discount rate, which
affects the value per quality-adjusted life year estimates
underlying the VSC estimates. Table 13 presents the same estimates
for a 7% discount rate.
[[Page 68089]]
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[GRAPHIC] [TIFF OMITTED] TR30NO21.029
Summary of Monetized Benefits
We identify several sources of monetized benefits that are
attributable to the interim final rule. Table 14 reports the
monetized benefits from mortality and morbidity risk reductions to
Head Start staff, mortality and morbidity risk reductions to Head
Start volunteers, and time savings for parents and caregivers. These
estimates cover both Head Start staff vaccination coverage
scenarios, and correspond to VSC estimates using a 3% discount rate.
All estimates cover the time period between the publication of the
interim final rule and March 1, 2022, and are reported in 2020
dollars. Table 15 reports the same estimates using a 7% discount
rate.
[[Page 68090]]
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In addition to the impacts that we monetize in this analysis, we
anticipate that the increase in vaccine coverage attributable to the
interim final rule will result in indirect health benefits from
reduced transmission of SARS-COV-2. These impacts include reductions
in secondary infections from vaccinated Head Start staff and
volunteers to other staff and volunteers, children, and families. We
anticipate that the masking requirement will also reduce
transmission at in-person Head Start settings from individuals
covered by the requirement. This impact includes a reduction in
COVID-19 transmission from children to Head Start teachers, staff,
and other children. The reductions in transmission attributable to
the interim final rule will result in additional, unquantified
reductions in mortality and morbidity risks to Head Start children
and families, and to the general public.
We request comment on potential quantitative estimation of
benefits for Head Start staff who receive exemptions (associated
with ancillary provisions and reduced exposure when colleagues are
vaccinated) using a study by Chen, Glymour, et al. (2021).\131\ In
this paper, estimates of excess mortality among 18- to 65-year-olds
in California during the eight months from March to October, 2020,
are summarized across various industry categories, including teacher
assistants, for whom the estimated ratio is 1.28.\132\ The
``unemployed or missing [employment data]'' category has an excess
mortality risk ratio of 1.23--which may yield a reasonable estimate
of the new risk level in cases of rule-induced staff turnover.
During most of the eight months covered by the Chen et al. study,
California imposed stay-at-home requirements, but these policies
were relaxed somewhat during the early and mid-summer, the result
being an increase in COVID-19 mortality. Visual inspection of Chen
et al.'s Figure 2 allows for estimation analogous to that described
above, using the excess mortality risk ratios for August 1, and
yielding a result that the scope for workplace safety improvements
is lesser in the context of relatively free movement and activity,
as compared with a situation of broader non-workplace mitigation
measures. In other words, whatever the overall effectiveness of Cal/
OSHA's workplace health and safety requirements--presumably similar
to this IFR's ancillary provisions--it should be reduced
substantially when extrapolated to a context without widespread
stay-at-home policies. An additional tendency toward overstatement
in the potential estimation approach exists because it does not
incorporate a netting off of the impacts of other jurisdictions'--
including California's own--mitigation activities. (In other words,
it would be necessary to use the correct baseline before attributing
benefits to this IFR.) By contrast, this suggested quantification
method has a tendency toward underestimation in that it does not
account for reduction in exposure due to exemption-receiving Head
Start staff being surrounded by colleagues who are more widely
vaccinated. In addition to seeking comment on how to address these
challenges in a potential quantitative estimate of benefits for
exemption recipients, we request feedback on the potential to use
literature such as Chen, Glymour et al. to proxy the new risk level
for non-turnover cases.
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\131\ Chen, Yea-Hung, Maria Glymour, Alicia Riley, John Balmes,
Kate Duchowny, Robert Harrison, Ellicott Matthay, Kirsten Bibbins-
Domingo. ``Excess mortality associated with the COVID-19 pandemic
among Californians 18-65 years of age, by occupational sector and
occupation: March through October 2020.'' medRxiv
2021.01.21.21250266; doi: https://doi.org/10.1101/2021.01.21.21250266.
\132\ The list of occupations with specific estimates differs,
omitting teacher assistants, in a subsequent version of the paper.
Chen, Yea-Hung, Maria Glymour, Alicia Riley, John Balmes, Kate
Duchowny, Robert Harrison, Ellicott Matthay, Kirsten Bibbins-
Domingo. ``Excess mortality associated with the COVID-19 pandemic
among Californians 18-65 years of age, by occupational sector and
occupation: March through November 2020.'' PLoS One, June 4, 2021
https://doi.org/10.1371/journal.pone.0252454.
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F. Costs of the Rule
The most significant cost of the interim final rule stems from
the potential for Head Start staff to decline COVID-19 vaccination.
This would result in a number of potential consequences, each of
which is likely to represent a substantial social cost. Table 16
presents the number of Head Start staff anticipated to be fully
vaccinated under the vaccine coverage scenarios, under a shared
assumption that 5% of Head Start staff will seek and receive an
exemption from the vaccination requirement. Under the lower-bound
vaccine coverage scenario, as many as
[[Page 68091]]
23,035 Head Start staff will not meet the vaccination requirement
and also not receive an exemption. The upper-bound vaccine coverage
scenario reflects all Head Start staff that do not meet the
vaccination requirement receiving an exemption. Under our primary
scenario, 11,517 Head Start Staff will not meet the vaccination
requirement and also not receive an exemption from the vaccination
requirement.
[GRAPHIC] [TIFF OMITTED] TR30NO21.032
We anticipate some staff employed by Head Start programs will
choose to leave the program due to vaccination and mask mandates.
There are already significant challenges in recruiting and retaining
staff among early care and education providers including Head Start
and the requirements in this rule could exacerbate this issue for
certain programs, resulting in programs not being able to fully
staff their classrooms. This could also result in costs to programs
to recruit new qualified staff to replace those staff that leave the
program and may result in interruption of services for children and
families.
Costs Associated With Head Start Staff Vacancies
In this section, we describe our approach for valuing the costs
associated with Head Start staff vacancies associated with quitters
that are attributable to the interim final rule. We follow many of
the assumptions contained in the Benefits section that outline the
value of time savings for parents and caretakers of children
attributable to the interim final rule through vaccine coverage and
reduced COVID-19 cases among Head Start teachers. For each COVID-19
case averted, parents and caretakers experienced 190 hours of time
savings, assuming each COVID-19 case lasts two weeks. To value the
countervailing risk of staff vacancies, we adopt an assumption that
each Head Start staff that quits in response to the interim final
rule will leave a vacancy that lasts an average of two weeks. This
assumption is intended to reflect an average duration among
vacancies that are filled faster and vacancies that are filled
slower than two weeks. It is also intended to be inclusive of any
efforts by Head Start centers that anticipate resignations on the
effective date of the policy to identify replacements when the
vaccine requirement takes effect. We also anticipate that Head Start
centers will be able to prepare in advance for these vacancies and
reduce the impact on families through increased caseloads per staff.
This preparation would not be possible for absenteeism due to a
COVID-19 case or outbreak. We reduce the average number of families
affected by half, which results in an overall estimate of about 95
hours of time costs for parents and caretakers of children receiving
Head Start services per vacancy from resignations. We are not aware
of another estimate of how long a typical vacancy of this nature
lasts; however, given that we anticipate this to be a significant
cost attributable to the interim final rule, we have determined that
these assumptions are more justified, in the context of this
analysis, than not monetizing this cost. We acknowledge significant
uncertainty in several of these estimates and discuss the nature of
and implications of each source.
We also include a cost of training the replacement Head Start
staff. We assume that new-employee training takes an average of 40
hours, and we adopt a value of time based on the median wage rage of
preschool and kindergarten teachers of $14.36 per hour.\133\ We
double this wage to generate a fully loaded wage that accounts for
benefits and other indirect costs. Table 17 reports the costs of
vacancies and costs of training under the vaccine coverage
scenarios.
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\133\ https://www.bls.gov/oes/current/naics4_624400.htm.
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[[Page 68092]]
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Table 17 presents cost estimates that vary by the vaccine
coverage scenarios, which directly impact the number of vacancies
that we attribute to the interim final rule. For these calculations,
we adopt a common estimate of two weeks for Head Start centers to
fill these vacancies. As noted in the baseline section, early care
and education providers are currently experiencing significant
challenges in recruiting and retaining staff that are attributable
to the COVID-19 pandemic and general trends in early care and
education labor markets. The general trends in early care and
education labor markets suggest that filling these vacancies could
take longer than two weeks. However, the interim final rule directly
addresses the risk of SARS-COV-2 transmission at Head Start centers.
The vaccination and masking requirements might lead to new hiring of
employees who would not feel safe working in these environments
absent these rules. This effect would reduce the average time to
fill each vacancy. Alternatively, this could represent an additional
source of benefits not captured in the main analysis elsewhere.
These cost estimates reflect one approach to account for the
cost of staff vacancies. Other approaches may be reasonable. For
example, in the context of its interim final rule with comment
period that requires COVID-19 vaccinations for workers in most
health care settings that receive Medicare and Medicaid
reimbursement, CMS calculates the likely magnitude of hiring costs
by applying an analysis of the direct hiring costs for workers in
the long-term care sector.\134\ After updating for inflation, CMS
reports a direct hiring cost of $4,000 per worker.\135\ The total
cost estimates in Table 17 amount to $3,100 per worker. Substituting
CMS's per-worker estimate would result in a range of total cost
estimates from $0 to $92 million, with a central estimate of $46
million.
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\134\ Dorie Seavey, ``The Cost of Frontline Turnover in Long-
Term Care,'' Better Jobs Better Care Report, Washington, DC:
Institute for the Future of Aging Services, American Association of
Homes and Services for the Aging. 2004
\135\ https://www.govinfo.gov/content/pkg/FR-2021-11-05/pdf/2021-23831.pdf.
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The cost of staff vacancies estimates also reflect an estimate
of the value of time of $20.55 per hour, which we also use to
estimate the benefits from reduced absenteeism. In a sensitivity
analysis for those benefits, we applied a higher value of time of
$25.10. Performing an identical sensitivity analysis for these costs
yield a higher central estimate of vacancy costs of $27.5 million,
which is a $5.0 million increase compared to the estimate in Table
17. This value of time would also yield a higher estimate of vacancy
costs under the low-coverage scenario of $54.9 million, which is a
$10.0 million increase compared to the estimate in Table 17.
In addition to the costs we identify and monetize related to
staff vacancies, we also note the potential costs associated with
reduced support from volunteers. However, as with staff, it is also
conceivable that some individuals who do not currently feel safe
volunteering at in-person Head Start settings will feel comfortable
volunteering under the interim final rule. On net, this could
increase the support Head Start centers receive from volunteers.
Cost to Head Start Staff and Volunteers to Get Fully Vaccinated
We identify a second cost related to Head Start staff and
volunteers getting fully vaccinated. We adopt an estimate of 2 hours
as the time necessary to receive one COVID-19 vaccine dose, and
adopt a simplifying assumption that each individual induced to get
fully vaccinated under the interim final rule will receive two
vaccine doses. This estimate is intended to be inclusive of
scheduling time; commuting time; time receiving a vaccine dose;
waiting time, including after receiving a vaccine dose to watch for
any reactions; and recovery time. We value the time spent to get
fully vaccinated using a $20.55 per hour value of time, described
above, for a total value of time per person of about $82. We also
include costs associated with the vaccine doses and costs of
administration. Using an estimated $20 cost per dose of vaccine, $20
as the cost per vaccine administration, we compute the cost of
vaccine doses and administration of $80 per person. Table 18 reports
the total costs related to vaccination.
[[Page 68093]]
[GRAPHIC] [TIFF OMITTED] TR30NO21.034
The costs related to vaccination reflect an estimate of the
value of time, $20.55 per hour, used elsewhere in this analysis. In
other cases where this value of time is applied, we have also
performed a sensitivity analysis that applies a higher value of time
of $25.10. Performing an identical sensitivity analysis for these
costs yields a value of time per person to get vaccinated of about
$100. This higher value of time results in total costs of between
$8.4 million and $12.6 million, with a central estimate of $10.5
million, which is an increase of between $0.8 million and $1.3
million. Regardless of the chosen value of time, the costs in Table
18 may be underestimated, since they do not include costs associated
with adverse events reported after COVID-19 vaccination.\136\
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\136\ https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
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Cost of Masking
This regulation also requires mask wearing for all adults and
children age 2 and older in certain in-person Head Start settings.
As an intermediate step, we estimate the total in-person days per
week for staff, children, and volunteers. We replicate the in-person
days per week for staff and children using the estimates reported in
Table 3, but we reduce the estimate for children by 14% to account
for children younger than age 2 that are not subject to the
requirement. To estimate the in-person days per week for volunteers,
we assume they are evenly distributed across center by operating
status, such that 390,426 are associated with fully in-person
centers, and 495,0975 are associated with centers in hybrid
operating status. For purposes of this calculation, we assume that
volunteers associated with in-person centers will volunteer in
person an average of once per week, and that volunteers at centers
in hybrid operating status will volunteer in person an average of
once every other week. We expect that the 175,476 combined
volunteers associated with closed or virtual/remote centers will not
volunteer in-person. These assumptions and data indicate that Head
Start volunteers will average 637,975 in-person days per week.
We assume that each staff, child, and volunteer will use one
mask per day, and adopt an estimate of the cost per surgical mask of
$0.14.\137\ We anticipate that staff, children, and volunteers will
combine for a total of 3,693,426 masks per week, with the total
weekly cost of these masks of $517,080. 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. Finally, we calculate that the masking
requirement will be effective for the entire time horizon of this
analysis. Table 19 reports the costs of masking that are
attributable to the interim final rule.
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\137\ https://www.regulations.gov/document/OSHA-2020-0004-1033,
Table VI.B.14.
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[GRAPHIC] [TIFF OMITTED] TR30NO21.035
Cost of Testing
We also identified a cost of testing Head Start staff and
volunteers that receive an exemption from the vaccine requirement.
Across all scenarios, we anticipate that 5% of Head Start Staff will
receive an exemption, so 13,650 staff will be unvaccinated under the
interim final rule. We further assume that 5% of Head Start
volunteers, or about 53,050, will also receive an exemption. We
assume that only staff and volunteers associated with Head Start
centers that are fully in-person or in hybrid status will be tested.
We assume that Head Start staff and volunteers will be tested
weekly, and that this requirement will be effective for about 4
weeks of the time horizon of the analysis, from January 31, to March
1, 2022. This effective period is shorter than for the masking
provision, which is effective immediately. We calculate that about
230,627 tests will be performed, and adopt an estimate of $10 per
test. Table 20 presents these estimates and the total cost estimate
of about $2.3 million. For the purpose of this analysis, we assume
that the costs of testing are borne by the Head Start centers.
[[Page 68095]]
[GRAPHIC] [TIFF OMITTED] TR30NO21.036
Recordkeeping Costs
We anticipate that the interim final rule will result in
recordkeeping activities. The Paperwork Reduction Act analysis
estimates the total burden of 6,670 hours. To monetize this impact,
we apply an estimate of the hourly wage of Education and Childcare
Administrators, Preschool and Daycare, for individuals working in
the Child Day Care Services industry. According to the U.S. Bureau
of Labor Statistics, the hourly mean wage for these individuals is
$24.78 per hour.\138\ We adjust this hourly rate to account for
benefits and other indirect costs by multiplying by two, for a fully
loaded hourly wage rate of $49.56. Multiplying the fully loaded wage
rate by the number of hours results in a total cost of $330,565.20.
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\138\ https://www.bls.gov/oes/current/oes119031.htm. Wage rage
for job code 11-9031.
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Total Costs
We identify several sources of costs that are attributable to
the interim final rule. Table 21 reports the monetized costs related
to staff vacancies, costs of vaccination, costs of masking, costs of
testing, and costs of recordkeeping. These estimates cover the Head
Start staff vaccination coverage scenarios, and do not differ by
discount rate. All estimates cover the same time horizon and are
reported in 2020 dollars.
[[Page 68096]]
[GRAPHIC] [TIFF OMITTED] TR30NO21.037
BILLING CODE 4184-01-C
We consider it probable that the substantial reduction in COVID-
19 cases per day among Head Start staff will result in fewer center
closures due to COVID-19. We do not estimate the reduction in
closures anticipated due to the interim final rule; however, we
presented a calculation of how we would value the benefit of
reopening on a per-center basis. For comparison, we also estimate
the additional cost of masking, and additional cost of testing
exempted staff and volunteers for centers that reopen.
If 1% of total Head Start centers reopen as a result of the
interim final rule, this would result in 207 centers reopening. For
the purposes of this cost analysis, we calculate the number of masks
required under for a center operating fully in-person. This would
result in 2,730 staff, 8,643 children, 10,610 volunteers wearing
masks at in-person Head Start settings. They would require 67,474
masks on a weekly basis, 16,869 of which we attribute to the interim
final rule. The total cost of these additional masks would be $2,362
per week. For testing, the same number of centers reopening would
result in 667 additional exempted staff and volunteers requiring
testing every week, which corresponds to $6,670 in testing costs per
week. These costs sum to $9,031 per week. To continue the
comparison, if 1% of closed centers reopen, we would monetize the
benefits in time saved for parents and caregivers at $5.3 million
per week. This comparison only includes impacts we are able to
monetize, and does not account for changes in COVID-19 risks
associated with reopening. As discussed elsewhere, these risks will
be reduced as a result of the vaccination and masking requirements.
G. Net Benefits
We have analyzed the major impacts of the interim final rule
under several scenarios of incremental vaccine-uptake among Head
Start staff that are unvaccinated in the baseline scenario of no new
regulatory action. In previous sections, we have indicated that the
benefits are higher and that the costs are lower under the high
vaccine coverage scenario than the low vaccine coverage scenario. In
this section, we demonstrate the magnitudes. Table 22 presents the
total costs, benefits, and net benefits that are attributable to the
interim final rule under a 3% discount rate. Table 23 presents these
same estimates using a 7% discount rate. Both sets of estimates
cover the same time horizon.
[GRAPHIC] [TIFF OMITTED] TR30NO21.038
[[Page 68097]]
[GRAPHIC] [TIFF OMITTED] TR30NO21.039
An analytic issue not addressed in the assessment underlying
these results is the question of how to interpret individuals'
hesitation or unwillingness, in the absence of regulation, to accept
an intervention that achieves extensive health protection for
themselves, with little or no out-of-pocket cost, and ever-lessening
time or inconvenience cost; a simplistic revealed-preference
monetization of the rule's effect would be that it yields minimal or
negative benefits for such staff members, even the ones for whom it
prevents or reduces severity of COVID-19 infection. Given the
dynamic nature of the pandemic--including scientific innovations and
other human responses--it may be that long-run equilibrium for
COVID-19 vaccines has not been reached, in which case the above use
of VSL-related estimates for staff-member risk valuation may be
appropriate at this time. On the other hand, other valuation
approaches may also be worth exploring.
Toward that end, we use Herzog and Schlottmann (1990) to
estimate a cap on how much the benefits of an employment-based
health or safety regulation could exceed its costs.\139\ Under this
model, benefits accrue partially to workers in the form of health
and longevity improvements (net of lost wage premiums) and partially
to employers in the form of wage reductions, and the sum of worker
and employer portions equals the monetized value of health and
longevity improvements. Herzog and Schlottmann find that the wage
reduction portion of total benefits is somewhere between 42.9%
(=$4.29/$10.01) and 74.3% (=$3.67/$4.94). Put another way, the total
benefits of a rule should be no more than 1.3 (=$4.94/$3.67) to 2.3
(=$10.01/$4.29) times the regulatory costs incurred by employers;
otherwise, the wage reductions experienced by those employers would
make it profit-maximizing (or surplus-maximizing, for non-profit
entities) for them to mandate vaccination or perform the other risk-
abatement activities without a regulation forcing them to do so.
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\139\ Herzog, Henry W. and Alan M. Schlottmann. ``Valuing Risk
in the Workplace: Market Price, Willingness to Pay, and the Optimal
Provision of Safety,'' The Review of Economics and Statistics 72(3):
August 1990, pp. 463-470.
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The first several rows of Table 24 show upper bounds on staff
benefits estimated by applying the Herzog and Schlottmann ratios to
the estimated costs of the IFR (assuming for simplicity, as
elsewhere in this analysis, that employers incur the costs).\140\
Unlike in Tables 22 and 23, and the analysis that feeds into them,
the quantified staff benefits in Table 24 are not necessarily
limited to individuals who are newly vaccinated. Another, even more
fundamental difference, is that Table 24 demonstrates an approach in
which low costs are correlated with low staff benefits and high
costs with high staff benefits.
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\140\ Herzog and Schlottmann use an old data set (1965-1970) and
focus on work settings quite different from child care centers. We
request comment on whether more recent or better-tailored inputs are
available.
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[[Page 68098]]
[GRAPHIC] [TIFF OMITTED] TR30NO21.040
BILLING CODE 4184-01-C
H. Distributional Effects
Executive Order 13985 on Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government includes
consideration of agency policies and actions that create or
exacerbate barriers to full and equal participation by all eligible
individuals. As noted previously, a large share of children served
by Head Start programs are from culturally and linguistically
diverse families. And the majority of Head Start children are also
from families experiencing poverty. In FY 2019, OHS administrative
data indicate that 37% of Head Start children were Hispanic or
Latino and the remaining 63% were of non-Hispanic or Latino origin.
Further, 44% were White, 30% were Black or African American, 10%
were biracial or multi-racial, 4% were American Indian or Alaska
Native, and 2% were Asian.\141\ As is evident with these data, the
indirect beneficiaries of this IFR--the children and families served
by Head Start programs--are disproportionately from diverse racial
and ethnic groups, as well as from low-income families, and they
will benefit greatly from reduced exposure to COVID-19 from teachers
who are newly vaccinated.
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\141\ Source: Head Start Program Information Report; the
remaining 10% of children were reported as ``Other or Unspecified.''
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I. Uncertainty and Sensitivity Analysis
In the main analysis, we report the value of COVID-19 mortality
risk reductions using the central HHS estimate of the VSL of $11.5
million, and value of morbidity risk reductions using estimates of
the VSC that are derived from the central VSL. As a sensitivity
analysis, we recalculate these benefits using the low and high
estimates of the VSL, which range from $5.3 million to $17.5
million. Table 25 reports the value of these risk reductions using
the full range of VSL estimates.
[[Page 68099]]
[GRAPHIC] [TIFF OMITTED] TR30NO21.041
In our main analysis, we assume that the vaccination, masking,
and other requirements will be in effect for the entire time horizon
of the analysis. We also considered a scenario that these
requirements will end at an earlier point in time. Specifically, we
evaluated a scenario that the requirements would be repealed through
subsequent rulemaking or expire on January 16, 2022, which
corresponds to the last day of the most recent renewal of the COVID-
19 public health emergency.\142\ For this scenario, we assume that
Head Start staff are surprised on January 16, 2022 by the
announcement, and that unvaccinated staff discontinue efforts to get
fully vaccinated. This results in a lower vaccine coverage rate of
between 84.9% and 91.5%, compared to a vaccine coverage rate of
between 86.6% and 95.0% under the scenario of the requirement in
effect through at least January 31, 2022. This would result in
smaller reductions in mortality and morbidity risks, and smaller
reductions in absenteeism. It would also eliminate the costs from
staff vacancies and training attributable to the interim final rule,
substantially reduce the costs of masking and testing; and reduce
the total costs of vaccinations.
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\142\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVDI-15Oct21.aspx.
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J. Analysis of Regulatory Alternatives to the Rule
We evaluated several regulatory alternatives to the interim
final rule. First, we assessed the impact of not including
volunteers in the scope of the vaccine requirement of the interim
final rule. Under this regulatory alternative, the reductions in
mortality and morbidity for volunteers induced to get fully
vaccinated outlined in Tables 12 and 13 would not occur. We also
anticipate a reduction in costs attributable to the rule related to
the costs related to vaccination described in in Table 18. Table 26
reports the net benefits of this policy alternative, using a 3%
discount rate. Compared to our analysis of the interim final rule,
this option would result in lower net benefits under the vaccine
coverage scenarios that we analyzed.
[GRAPHIC] [TIFF OMITTED] TR30NO21.042
We also considered two alternatives to the masking requirement.
One alternative includes eliminating the masking requirement
entirely. This policy alternative would reduce the cost estimates of
the interim final rule by $1.7 million in line with the calculations
presented in Table 19. A second alternative would limit the masking
requirement to unvaccinated individuals. Under this policy
alternative, the weekly masks needed for Head Start staff and
volunteers would be reduced significantly, in line with the vaccine
coverage rates. When the vaccination requirement takes effect, only
the 5% of Head Start staff and volunteers who receive an exemption
would be expected to wear a mask. This reduces the weekly masks for
Staff and volunteers
[[Page 68100]]
attributable to the rule by about 95%. This policy alternative would
also result in small reduction in the number of masks needed for
children. About 1% of Head Start children are age 5 years and older,
and some of these children may get vaccinated in response to CDC's
``recommendation that children 5 to 11 years old be vaccinated
against COVID-19 with the Pfizer-BioNTech pediatric vaccine.'' \143\
We estimate that the cost of masking under this policy alternative
would be about $1.0 million, which is about $0.6 million lower than
the masking requirement under the interim final rule.
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\143\ https://www.cdc.gov/media/releases/2021/s1102-PediatricCOVID-19Vaccine.html.
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While we do not include a monetized benefit for the masking
requirement, we anticipate that it will reduce transmission of SARS-
COV-2 at in-person Head Start settings from individuals covered by
the requirement. This impact includes a reduction in transmission
from children to Head Start teachers, staff, and other children. The
reductions in transmission attributable to the interim final rule
will result in additional, unquantified reductions in mortality and
morbidity risks to Head Start children and families, and to the
general public. Compared to the analysis of the interim final rule,
the two masking policy alternatives would result in fewer averted
COVID-19 cases, hospitalizations, and deaths.
Finally, we considered a policy alternative of linking the
vaccination, masking, and other requirements of the interim final
rule to the COVID-19 public health emergency. Evaluating this policy
alternative requires an additional assumption about the duration of
the public health emergency. In the Uncertainty and Sensitivity
Analysis, we explore a scenario in which the requirements would be
repealed through subsequent rulemaking or expire on January 16,
2022, which corresponds to the last day of the most recent renewal
of the COVID-19 public health emergency. That sensitivity analysis
represents one possible outcome for this policy alternative. The
main analysis, which assumes that the requirements will remain in
effect through the time horizon of this analysis, represents another
possible outcome for this policy alternative.
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).\144\ We replicate the SBA's
description of this table:
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\144\ U.S. Small Business Administration (2019). ``Table of Size
Standards.'' August 19, 2019. https://www.sba.gov/document/support-table-size-standards.
This table lists small business size standards matched to
industries described in the North American Industry Classification
System (NAICS), as modified by the Office of Management and Budget,
effective January 1, 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 interim final rule will impact small entities in NAICS
category 624410, Child Day Care Services, which has a size standard
of $8.0 million dollars. We assume that all 20,717 Head Start
centers are below this threshold and are considered small entities.
B. Description of the Impacts of the Rule on Small Entities
We identify three categories of costs of the interim final rule
that could impact small entities. Specifically, we expect that small
entities will need to train Head Start staff to replace those who
resign, and monetize these costs at about $13.2 million. For the
purposes of this calculation, we assume that Head Start centers will
purchase masks sufficient to cover every in-person staff, child, and
volunteer, at a cost of about $1.7 million. We also assume that Head
Start centers will incur the costs of testing for staff, at a cost
of about $2.3 million. Finally, we attribute the costs of
recordkeeping to small entities, at a cost of about $0.3 million.
These combine for a total cost to small entities of $17.5 million.
Dividing by the 20,717 Head Start centers, these costs are about
$847 per small entity. As an alternative calculation, we estimate
these costs are $864 per small entity, excluding closed Head Start
centers.
[GRAPHIC] [TIFF OMITTED] TR30NO21.043
The Department considers a rule to have a significant impact on
a substantial number of small entities if it has at least a 3%
impact on revenue on at least 5% of small entities. Therefore, we
perform a threshold analysis to determine whether these costs are
likely to result in a significant impact on a substantial number of
small entities. For $847 to exceed the impact threshold, a small
entity would need to have revenue below $28,235 over the time
horizon of the analysis, or annual revenue of less than about
$113,000.
The Administration for Children and Families awards about $10
billion in grants to Head Start programs, including Early Head
[[Page 68101]]
Start-Child Care Partnerships.\145\ Across 20,717 centers, this
averages to $466,192, which is well above the $113,000 threshold.
Thus, we conclude that the interim final rule is not likely to
result in a significant impact on a substantial number of small
entities.
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\145\ https://eclkc.ohs.acf.hhs.gov/sites/default/files/pdf/no-search/hs-program-fact-sheet-2019.pdf.
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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,
Vaccination.
JooYeun Chang,
Principal Deputy Assistant Secretary for Children and Families.
Approved:
Xavier Becerra,
Secretary.
For the reasons discussed in the preamble, we amend 45 CFR part
1302 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. In Sec. 1302.47, revise paragraphs (b)(5)(iv) and (v) and add
paragraph (b)(5)(vi) to read as follows:
Sec. 1302.47 Safety practices.
* * * * *
(b) * * *
(5) * * *
(iv) Only releasing children to an authorized adult;
(v) All standards of conduct described in Sec. 1302.90(c); and
(vi) Masking, using masks recommended by CDC, for all individuals 2
years of age or older when there are two or more individuals on a
vehicle owned, leased, or arranged by the Head Start program; indoors
in a setting when Head Start services are provided; and for those not
fully vaccinated, outdoors in crowded settings or during activities
that involve sustained close contact with other people, except:
(A) Children or adults when they are either eating or drinking;
(B) Children when they are napping;
(C) When a person cannot wear a mask, or cannot safely wear a mask,
because of a disability as defined by the Americans with Disabilities
Act; or
(D) When a child's health care provider advises an alternative face
covering to accommodate the child's special health care needs.
* * * * *
0
3. In Sec. 1302.93, add paragraphs (a)(1) and (2) to read as follows:
Subpart I--Human Resources Management
Sec. 1302.93 Staff health and wellness.
(a) * * *
(1) All staff, and those contractors whose activities involve
contact with or providing direct services to children and families,
must be fully vaccinated for COVID-19, other than those employees:
(i) For whom a vaccine is medically contraindicated;
(ii) For whom medical necessity requires a delay in vaccination; or
(iii) Who are legally entitled to an accommodation with regard to
the COVID-19 vaccination requirements based on an applicable Federal
law.
(2) Those granted an accommodation outlined in paragraph (a)(1) of
this section must undergo SARS-COV-2 testing for current infection at
least weekly with those who have negative test results to remain in the
classroom or working directly with children. Those with positive test
results must be immediately excluded from the facility, so they are
away from children and staff until they are determined to no longer be
infectious.
* * * * *
0
4. In Sec. 1302.94, revise paragraph (a) to read as follows:
Sec. 1302.94 Volunteers.
(a) A program must ensure volunteers have been screened for
appropriate communicable diseases in accordance with state, tribal or
local laws. In the absence of state, tribal, or local law, the Health
Services Advisory Committee must be consulted regarding the need for
such screenings.
(1) All volunteers in classrooms or working directly with children
other than their own must be fully vaccinated for COVID-19, other than
those volunteers:
(i) For whom a vaccine is medically contraindicated;
(ii) For whom medical necessity requires a delay in vaccination; or
(iii) Who are legally entitled to an accommodation with regard to
the COVID-19 vaccination requirements based on an applicable Federal
law.
(2) Those granted an accommodation outlined in paragraph (a)(1) of
this section must undergo SARS-CoV-2 testing for current infection at
least weekly with those who have negative test results to remain in the
classroom or work directly with children. Those with positive test
results must be immediately excluded from the facility, so they are
away from children and staff until they are determined to no longer be
infectious.
* * * * *
[FR Doc. 2021-25869 Filed 11-29-21; 8:45 am]
BILLING CODE 4184-01-P