Updates to the Bright Futures Periodicity Schedule, 1762-1763 [2022-00461]
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Federal Register / Vol. 87, No. 8 / Wednesday, January 12, 2022 / Notices
Dun and Bradstreet. It is a nine-digit
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unique identifiers of single business
entities. The D–U–N–S number can be
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iUpdate/viewiUpdateHome.htm.
C. Intergovernmental Review
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grant applications.
IV. Submission Information
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To receive funding, eligible entities
must provide a Letter of Assurance
containing all the information outlined
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addressed to: Jennifer Johnson, Deputy
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2. Submission Dates and Times
To receive consideration, Letters of
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VII. Agency Contacts
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Dated: January 6, 2022.
Alison Barkoff,
Principal Deputy Administrator.
[FR Doc. 2022–00401 Filed 1–11–22; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket Nos. FDA–2020–E–1817, FDA–
2020–E–1818, and FDA–2020–E–1820]
lotter on DSK11XQN23PROD with NOTICES1
ACTION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
Notice; correction.
The Food and Drug
Administration (FDA or the Agency)
published a notice in the Federal
Register of November 1, 2021, for the
determination of a regulatory review
SUMMARY:
VerDate Sep<11>2014
17:04 Jan 11, 2022
Jkt 256001
In the Federal Register of November
1, 2021 (86 FR 60252), in FR Doc. 2021–
23725, appearing on page 60253, in the
third column, in section II.,
‘‘Determination of Regulatory Review
Period,’’ in the first two sentences, the
following correction is made:
FDA has determined that the
applicable regulatory review period for
ENHERTU is 1,395 days. Of this time,
114 days occurred during the testing
phase of the regulatory review period,
while 1,281 days occurred during the
approval phase.
[FR Doc. 2022–00404 Filed 1–11–22; 8:45 am]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ENHERTU; Correction
HHS.
Correction
Dated: January 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
AGENCY:
period for purposes of patent extension
for the human biological product,
ENHERTU. This document corrects that
notice by adjusting the applicable
regulatory review period for the testing
phase and approval phase of the
product, ENHERTU.
DATES: All due dates for submission of
comments, redetermination requests,
and submission of petitions for due
diligence as well as the dates used to
determine the regulatory review periods
for the products noted above remain the
same as originally published.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION: On
November 1, 2021, the Food and Drug
Administration (FDA or the Agency)
published a notice in the Federal
Register determining the regulatory
review period for the human biological
product ENHERTU. This correction to
the notice adjusts the applicable
regulatory review period of the product
with the number of days occurring
during the testing phase and the
approval phase of the product
ENHERTU.
Health Resources and Services
Administration
Updates to the Bright Futures
Periodicity Schedule
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
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ACTION:
Notice.
Effective December 30, 2021,
HRSA accepted recommended updates
to the Bright Futures Periodicity
Schedule, a HRSA-supported guideline
for infants, children and adolescents for
purposes of ensuring that nongrandfathered group and individual
health insurance issuers provide
coverage without cost sharing under the
Public Health Service Act. The updates
to the Bright Futures Periodicity
Schedule are: A new category for
sudden cardiac arrest and sudden
cardiac death risk assessment, a new
category for hepatitis B virus infection
risk assessment, addition of suicide risk
as an element of universal depression
screening for children ages 12–21, and
updated category title from
‘‘Psychosocial/Behavioral Assessment’’
to ‘‘Behavioral/Social/Emotional
Screening,’’ with no revision to the ages
in which the screening occurs (newborn
to 21 years). Finally, two clarifying
references related to dental fluoride
varnish and fluoride supplementation
have been added, with no associated
recommended changes to clinical
practice or health insurance coverage.
Please see https://mchb.hrsa.gov/
maternal-child-health-topics/childhealth/bright-futures.html for additional
information.
FOR FURTHER INFORMATION CONTACT:
Savannah Kidd, M.S. MFT, HRSA/
Maternal and Child Health Bureau by
calling 301–287–2601 or by emailing at
SKidd@hrsa.gov.
SUPPLEMENTARY INFORMATION: The Bright
Futures program has been funded by
HRSA since 1990. A primary focus of
this program is for the funding recipient
to maintain and recommend updates to
the Bright Futures Guidelines for Health
Supervision of Infants, Children and
Adolescents, a set of materials and tools
that provide theory-based and evidencedriven guidance for all preventive care
screenings and well-child visits. One
component of these tools is the Bright
Futures Periodicity Schedule, a chart
that identifies the recommended
screenings, assessments, physical
examinations, and procedures to be
delivered within preventive checkups at
each age milestone. Over the program’s
existence, the Bright Futures Periodicity
Schedule has become the accepted
schedule within the United States for
preventive health services through the
course of a child’s development.
Section 2713 of the Public Health
Service Act (42 U.S.C. 300gg–13), added
by the Patient Protection and Affordable
Care Act (Pub. L. 111–148), requires that
non-grandfathered group health plans
and health insurance issuers offering
SUMMARY:
E:\FR\FM\12JAN1.SGM
12JAN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 8 / Wednesday, January 12, 2022 / Notices
group or individual health insurance
coverage provide coverage without costsharing for certain preventive health
services. Section 2713(a)(3) describes
such services for infants, children, and
adolescents as ‘‘evidence-informed
preventive care and screenings provided
for in the comprehensive guidelines
supported by the Health Resources and
Services Administration.’’ HHS, along
with the Departments of Treasury and
Labor, issued an Interim Final Rule on
July 19, 2010 (75 FR 41726–41760) that
identified two specific resources as the
comprehensive guidelines supported by
HRSA for infants, children, and
adolescents to be covered by insurance
without cost sharing by nongrandfathered group health plans and
health insurance issuers: (1) The Bright
Futures Periodicity Schedule and (2) the
Recommended Uniform Screening Panel
of the Advisory Committee on Heritable
Disorders in Newborns and Children.
The Interim Final Rule provided that a
future change to these comprehensive
guidelines is considered to be issued for
purposes of Section 2713 on the date on
which it is accepted by the HRSA
Administrator or, if applicable, adopted
by the Secretary of HHS.
A public comment period was
announced and occurred from
September 13, 2021, through October
13, 2021 (86 FR 50894, September 13,
2021),1 to allow public comment on the
proposed recommended updates
affecting clinical practice and health
insurance coverage requirements. A
total of 27 respondents gave 57
comments during the public comment
period. The Bright Futures grantee, the
American Academy of Pediatrics,
received and considered the public
comments. The annual report (Tab A)
provides a description of the comments,
including a detailed tabulation of each
comment.
On December 30, 2021, the HRSA
Administrator accepted the American
Academy of Pediatrics’ recommended
several updates to the Bright Futures
Periodicity Schedule. The Bright
Futures recommendations included
recommended clinical practice updates,
along with revisions to the footnotes on
the Bright Futures Periodicity Schedule
that do not require changes to clinical
practice or health insurance coverage.
The updates to the Bright Futures
Periodicity Schedule are: (1) A new
category for sudden cardiac arrest and
sudden cardiac death risk assessment,
(2) a new category for hepatitis B virus
1 See https://www.federalregister.gov/documents/
2021/09/13/2021-19630/opportunity-for-commentson-proposed-updates-to-the-bright-futuresperiodicity-schedule-as-part-of.
VerDate Sep<11>2014
17:04 Jan 11, 2022
Jkt 256001
infection risk assessment, (3) addition of
suicide risk as an element of universal
depression screening for children ages
12–21, and (4) updated category title
from ‘‘Psychosocial/Behavioral
Assessment’’ to ‘‘Behavioral/Social/
Emotional Screening,’’ with no revision
to the ages in which the screening
occurs (newborn to 21 years). Finally,
two clarifying references related to
dental fluoride varnish and fluoride
supplementation have been added with
no associated recommended changes to
clinical practice. In light of these
updates, all non-grandfathered group
health plans and health insurance
issuers offering group or individual
health insurance coverage must cover
without cost-sharing the services and
screenings listed on the updated Bright
Futures Periodicity Schedule for plan
years (in the individual market, policy
years) that begin in 2023, which can be
accessed at the following link: https://
mchb.hrsa.gov/maternal-child-healthtopics/child-health/bright-futures.html.
Diana Espinosa,
Acting Administrator.
[FR Doc. 2022–00461 Filed 1–11–22; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Update to the Women’s Preventive
Services Guidelines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
On December 30, 2021, HRSA
approved updates to the HRSAsupported Women’s Preventive Services
Guidelines (Guidelines) that address
health needs specific to women. The
Guidelines are based on clinical
recommendations from the Women’s
Preventive Services Initiative (WPSI), a
coalition of experts and health
professional organizations convened by
the American College of Obstetricians
and Gynecologist (ACOG) under a
cooperative agreement awarded by
HRSA. Under the Public Health Service
Act and pertinent regulations,
preventive care and screenings for
women provided for in comprehensive
guidelines supported by HRSA are
required to be covered without cost
sharing by group health plans and
health insurance issuers offering nongrandfathered group or individual
health insurance coverage. This 2021
SUMMARY:
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1763
update adds one additional service,
Preventing Obesity in Midlife Women,
and revises five services: Breastfeeding
Services and Supplies, Contraception,
Screening for Human
Immunodeficiency Virus Infection,
Counseling for Sexually Transmitted
Infections, and Well-Woman Preventive
Visits. This notice serves as an
announcement of the decision to update
the Guidelines as further described
below. Please see https://www.hrsa.gov/
womens-guidelines/ for
additional information.
FOR FURTHER INFORMATION CONTACT:
Kimberly Sherman, HRSA, Maternal
and Child Health Bureau, telephone
(301) 443–8283, email: wellwomancare@
hrsa.gov.
SUPPLEMENTARY INFORMATION: The
updated 2021 HRSA-supported
Women’s Preventive Services
Guidelines, along with information
related to their development and
implementation, are available at https://
www.hrsa.gov/womens-guidelines/
index.html. A summary of information
regarding the updates to the
comprehensive guidelines supported by
HRSA on December 30, 2021, is set out
below.
Women’s Preventive Services
Guidelines
The first HRSA-supported Guidelines,
based on recommendations of the
Institute of Medicine, were established
in 2011. The Guidelines were
subsequently updated following review
and recommendations by the ACOG
under the WPSI cooperative agreement,
awarded by HRSA in 2016. The purpose
of WPSI is to improve adult women’s
health across the lifespan by engaging a
coalition of experts and health
professional organizations to
recommend updates to the HRSAsupported Guidelines. Following such
review and recommendations, HRSA
decides whether or not to support, in
whole or in part, the recommended
updates to the Guidelines. In March
2021, HRSA awarded a subsequent
cooperative agreement to ACOG to
provide recommendations as
appropriate over a 5-year period to
update the HRSA-supported Guidelines.
Under the cooperative agreement,
ACOG, through the WPSI, engages in a
process to consider and review new and
existing Guidelines developed by a
multidisciplinary group of women’s
health experts and professional
organizations.
Under section 2713 of the Public
Health Service Act, 42 U.S.C. 300gg–13,
group health plans and issuers of nongrandfathered group and individual
E:\FR\FM\12JAN1.SGM
12JAN1
]]>Agencies
[Federal Register Volume 87, Number 8 (Wednesday, January 12, 2022)]
[Notices]
[Pages 1762-1763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Updates to the Bright Futures Periodicity Schedule
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Effective December 30, 2021, HRSA accepted recommended updates
to the Bright Futures Periodicity Schedule, a HRSA-supported guideline
for infants, children and adolescents for purposes of ensuring that
non-grandfathered group and individual health insurance issuers provide
coverage without cost sharing under the Public Health Service Act. The
updates to the Bright Futures Periodicity Schedule are: A new category
for sudden cardiac arrest and sudden cardiac death risk assessment, a
new category for hepatitis B virus infection risk assessment, addition
of suicide risk as an element of universal depression screening for
children ages 12-21, and updated category title from ``Psychosocial/
Behavioral Assessment'' to ``Behavioral/Social/Emotional Screening,''
with no revision to the ages in which the screening occurs (newborn to
21 years). Finally, two clarifying references related to dental
fluoride varnish and fluoride supplementation have been added, with no
associated recommended changes to clinical practice or health insurance
coverage. Please see https://mchb.hrsa.gov/maternal-child-health-topics/child-health/bright-futures.html for additional information.
FOR FURTHER INFORMATION CONTACT: Savannah Kidd, M.S. MFT, HRSA/Maternal
and Child Health Bureau by calling 301-287-2601 or by emailing at
[email protected].
SUPPLEMENTARY INFORMATION: The Bright Futures program has been funded
by HRSA since 1990. A primary focus of this program is for the funding
recipient to maintain and recommend updates to the Bright Futures
Guidelines for Health Supervision of Infants, Children and Adolescents,
a set of materials and tools that provide theory-based and evidence-
driven guidance for all preventive care screenings and well-child
visits. One component of these tools is the Bright Futures Periodicity
Schedule, a chart that identifies the recommended screenings,
assessments, physical examinations, and procedures to be delivered
within preventive checkups at each age milestone. Over the program's
existence, the Bright Futures Periodicity Schedule has become the
accepted schedule within the United States for preventive health
services through the course of a child's development.
Section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13),
added by the Patient Protection and Affordable Care Act (Pub. L. 111-
148), requires that non-grandfathered group health plans and health
insurance issuers offering
[[Page 1763]]
group or individual health insurance coverage provide coverage without
cost-sharing for certain preventive health services. Section 2713(a)(3)
describes such services for infants, children, and adolescents as
``evidence-informed preventive care and screenings provided for in the
comprehensive guidelines supported by the Health Resources and Services
Administration.'' HHS, along with the Departments of Treasury and
Labor, issued an Interim Final Rule on July 19, 2010 (75 FR 41726-
41760) that identified two specific resources as the comprehensive
guidelines supported by HRSA for infants, children, and adolescents to
be covered by insurance without cost sharing by non-grandfathered group
health plans and health insurance issuers: (1) The Bright Futures
Periodicity Schedule and (2) the Recommended Uniform Screening Panel of
the Advisory Committee on Heritable Disorders in Newborns and Children.
The Interim Final Rule provided that a future change to these
comprehensive guidelines is considered to be issued for purposes of
Section 2713 on the date on which it is accepted by the HRSA
Administrator or, if applicable, adopted by the Secretary of HHS.
A public comment period was announced and occurred from September
13, 2021, through October 13, 2021 (86 FR 50894, September 13,
2021),\1\ to allow public comment on the proposed recommended updates
affecting clinical practice and health insurance coverage requirements.
A total of 27 respondents gave 57 comments during the public comment
period. The Bright Futures grantee, the American Academy of Pediatrics,
received and considered the public comments. The annual report (Tab A)
provides a description of the comments, including a detailed tabulation
of each comment.
---------------------------------------------------------------------------
\1\ See https://www.federalregister.gov/documents/2021/09/13/2021-19630/opportunity-for-comments-on-proposed-updates-to-the-bright-futures-periodicity-schedule-as-part-of.
---------------------------------------------------------------------------
On December 30, 2021, the HRSA Administrator accepted the American
Academy of Pediatrics' recommended several updates to the Bright
Futures Periodicity Schedule. The Bright Futures recommendations
included recommended clinical practice updates, along with revisions to
the footnotes on the Bright Futures Periodicity Schedule that do not
require changes to clinical practice or health insurance coverage. The
updates to the Bright Futures Periodicity Schedule are: (1) A new
category for sudden cardiac arrest and sudden cardiac death risk
assessment, (2) a new category for hepatitis B virus infection risk
assessment, (3) addition of suicide risk as an element of universal
depression screening for children ages 12-21, and (4) updated category
title from ``Psychosocial/Behavioral Assessment'' to ``Behavioral/
Social/Emotional Screening,'' with no revision to the ages in which the
screening occurs (newborn to 21 years). Finally, two clarifying
references related to dental fluoride varnish and fluoride
supplementation have been added with no associated recommended changes
to clinical practice. In light of these updates, all non-grandfathered
group health plans and health insurance issuers offering group or
individual health insurance coverage must cover without cost-sharing
the services and screenings listed on the updated Bright Futures
Periodicity Schedule for plan years (in the individual market, policy
years) that begin in 2023, which can be accessed at the following link:
https://mchb.hrsa.gov/maternal-child-health-topics/child-health/bright-futures.html.
Diana Espinosa,
Acting Administrator.
[FR Doc. 2022-00461 Filed 1-11-22; 8:45 am]
BILLING CODE 4165-15-P
