Updates to the Bright Futures Periodicity Schedule, 86938-86939 [2020-28971]
Download as PDF
<![CDATA[
86938
Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Notices
Questions and Answers.’’ We are
issuing this guidance in accordance
with section 212 of the Small Business
Regulatory Enforcement Fairness Act
(Pub. L. 104–121, as amended by Pub.
L. 110–28) 1 to help small businesses
understand and comply with the
Consumer Antiseptic Rub FR (84 FR
14847, April 12, 2019), which
established that 28 active ingredients
are not eligible for evaluation under
FDA’s OTC Drug Review for use in
consumer antiseptic rubs. Drug products
containing these ineligible active
ingredients will require approval under
a new drug application or abbreviated
new drug application before they can be
marketed. In this final action, FDA also
established that three active ingredients
used in consumer antiseptic rubs are
eligible for evaluation under the OTC
Drug Review and granted requests to
temporarily defer further rulemaking on
these three ingredients to allow
interested parties to complete the
studies necessary to fill the safety and
effectiveness data gaps identified for
these three ingredients.
This guidance reviews the content
and effect of the final action, including
identifying which active ingredients
were found eligible and which were
found not eligible for evaluation under
the OTC Drug Review for use in
consumer antiseptic rubs. In addition,
this guidance explains when and how
manufacturers must comply with the
final action.
This Level 2 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on how small
businesses can better understand and
comply with the Consumer Antiseptic
Rub FR. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
15
U.S.C. 601 (note).
VerDate Sep<11>2014
19:28 Dec 30, 2020
Jkt 253001
Dated: December 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–28929 Filed 12–30–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Updates to the Bright Futures
Periodicity Schedule
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
Effective December 28, 2020,
HRSA accepted a recommended update
to the Bright Futures Periodicity
Schedule, a HRSA-supported guideline
for infants, children and adolescents, for
purposes of health insurance coverage
without cost sharing under the Public
Health Service (PHS) Act. The update
includes screening for Hepatitis C Virus
Infection for individuals ages 18 to 21.
Please see https://mchb.hrsa.gov/
maternal-child-health-topics/childhealth/bright-futures.html for additional
information.
FOR FURTHER INFORMATION CONTACT:
Bethany D. Miller, MSW, M.Ed., HRSA/
Maternal and Child Health Bureau by
calling (301) 495–5156 or by emailing at
BMiller@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 update 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 PHS Act requires
that non-grandfathered group health
plans and health insurance issuers
offering group or individual health
insurance coverage provide coverage
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
without cost sharing for certain
preventive health services in four
identified areas. Section 2713(a)(3)
describes such services for infants,
children, and adolescents as ‘‘evidenceinformed 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.
On December 28, 2020, the HRSA
Administrator accepted the
recommended update to the Bright
Futures Periodicity Schedule. The
Bright Futures recommendation
included both a recommended clinical
practice update and revisions to the
footnotes on the Bright Futures
Periodicity Schedule. The update
includes screening for Hepatitis C Virus
Infection for individuals age 18 to 21.
The footnote revisions are applied to
footnote 11 (Developmental Screening);
footnote 12 (Autism Spectrum Disorder
Screening) to update the title of the
relevant revised policy statements and
the electronic hyperlinks; and a new
footnote referring to the supporting
evidence for the recommendation for
screening for hepatitis C virus infection.
Therefore, 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) beginning on or after December
28, 2021.
The updated Bright Futures
Periodicity schedule can be accessed at
the following link: https://
E:\FR\FM\31DEN1.SGM
31DEN1
Federal Register / Vol. 85, No. 251 / Thursday, December 31, 2020 / Notices
mchb.hrsa.gov/maternal-child-healthtopics/child-health/bright-futures.html.
Thomas J. Engels,
Administrator.
[FR Doc. 2020–28971 Filed 12–30–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Training in Primary Care Medicine and
Dentistry
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Training in Primary Care
Medicine and Dentistry (ACTPCMD)
will hold public meetings for the 2021
calendar year (CY). Information about
ACTPCMD, agendas, and materials for
these meetings can be found on the
ACTPCMD website at https://
www.hrsa.gov/advisory-committees/
primarycare-dentist/.
DATES: ACTPCMD meetings will be held
on
• March 2, 2021, 10:00 a.m.–5:00 p.m.
Eastern Time (ET) and March 3, 2021,
10:00 a.m.–2:00 p.m. ET;
• November 2, 2021, 8:30 a.m.–5:00
p.m. ET and November 3, 2021, 8:30
a.m.–2:00 p.m. ET.
ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe
Connect webinar. For updates on how
the meeting will be held, visit the
ACTPCMD website 30 business days
before the date of the meeting, where
instructions for joining meetings either
in-person or remotely will also be
posted. In-person ACTPCMD meetings
will be held at 5600 Fishers Lane,
Rockville, Maryland 20857. For meeting
information updates, go to the
ACTPCMD website meeting page at
https://www.hrsa.gov/advisorycommittees/interdisciplinarycommunity-linkages/meetings/
index.html.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Shane Rogers, Designated Federal
Official, Division of Medicine and
Dentistry, Bureau of Health Workforce,
HRSA, 5600 Fishers Lane, Room
15N142, Rockville, Maryland 20857;
301–443–5260; or SRogers@hrsa.gov.
VerDate Sep<11>2014
19:28 Dec 30, 2020
Jkt 253001
The
ACTPCMD provides advice and
recommendations to the Secretary of
HHS (Secretary) on policy, program
development, and other matters of
significance concerning the activities
under Section 747 of Title VII of the
Public Health Service (PHS) Act, as it
existed upon the enactment of Section
749 of the PHS Act in 1998. The
ACTPCMD prepares an annual report
describing the activities of the
committee, including findings and
recommendations made by the
committee concerning the activities
under Section 747, as well as training
programs in oral health and dentistry.
The annual report is submitted to the
Secretary as well as the Chairman and
ranking members of the Senate
Committee on Health, Education, Labor
and Pensions and the House of
Representatives Committee on Energy
and Commerce. The ACTPCMD
develops, publishes, and implements
performance measures and guidelines
for longitudinal evaluations of programs
authorized under Title VII, Part C of the
PHS Act, and recommends
appropriation levels for programs under
this Part. Since priorities dictate
meeting times, be advised that start
times, end times, and agenda items are
subject to change. For CY 2021
meetings, agenda items may include,
but are not limited to inter-professional
team-based education, practice, and
retention in underserved rural
communities, as well as matters
pertaining to policy, program
development, and other matters of
significance concerning medicine and
dentistry activities authorized under
Title VII of the PHS Act. Refer to the
ACTPCMD website listed above for all
current and updated information
concerning the CY 2021 ACTPCMD
meetings, including draft agendas and
meeting materials that will be posted 30
calendar days before the meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting(s). Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to the
ACTPCMD should be sent to Shane
Rogers using the contact information
above at least 5 business days before the
meeting date(s).
Individuals who need special
assistance or another reasonable
accommodation should notify Shane
Rogers using the contact information
listed above at least 10 business days
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
86939
before the meeting(s) they wish to
attend.
If a meeting is held in-person, it will
occur in a federal government building
and attendees must go through a
security check to enter. Non-U.S. citizen
attendees must notify HRSA of their
planned attendance at an in-person
meeting at least 20 business days prior
to the meeting in order to facilitate their
entry into the building. All attendees are
required to present government-issued
identification prior to entry.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–28919 Filed 12–30–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Council on Nurse Education and
Practice
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the National
Advisory Council on Nurse Education
and Practice (NACNEP) will hold public
meetings for the 2021 calendar year
(CY). Information about NACNEP,
agendas, and materials for these
meetings can be found on the NACNEP
website at https://www.hrsa.gov/
advisory-committees/nursing/
index.html.
SUMMARY:
NACNEP meetings will be held
on
• March 9, 2021, 8:30 a.m.–5:00 p.m.
Eastern Time (ET) and March 10,
2021, 8:30 a.m.–2:00 p.m. ET;
• July 13, 2021, 8:30 a.m.–5:00 p.m. ET
and July 14, 2021, 8:30 a.m.–5:00 p.m.
ET;
• December 7, 2021, 8:30 a.m.–5:00
p.m. ET and December 8, 2021, 8:30
a.m.–5:00 p.m. ET.
ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe
Connect webinar. For updates on how
the meeting will be held, visit the
NACNEP website 30 business days
before the date of the meeting, where
instructions for joining meetings either
in-person or remotely will also be
posted. In-person NACNEP meetings
will be held at 5600 Fishers Lane,
Rockville, Maryland 20857. For meeting
DATES:
E:\FR\FM\31DEN1.SGM
31DEN1
]]>Agencies
[Federal Register Volume 85, Number 251 (Thursday, December 31, 2020)]
[Notices]
[Pages 86938-86939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28971]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration
Updates to the Bright Futures Periodicity Schedule
AGENCY: Health Resources and Service Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Effective December 28, 2020, HRSA accepted a recommended
update to the Bright Futures Periodicity Schedule, a HRSA-supported
guideline for infants, children and adolescents, for purposes of health
insurance coverage without cost sharing under the Public Health Service
(PHS) Act. The update includes screening for Hepatitis C Virus
Infection for individuals ages 18 to 21. Please see https://mchb.hrsa.gov/maternal-child-health-topics/child-health/bright-futures.html for additional information.
FOR FURTHER INFORMATION CONTACT: Bethany D. Miller, MSW, M.Ed., HRSA/
Maternal and Child Health Bureau by calling (301) 495-5156 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 update 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 PHS Act requires that non-grandfathered group
health plans and health insurance issuers offering group or individual
health insurance coverage provide coverage without cost sharing for
certain preventive health services in four identified areas. 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.
On December 28, 2020, the HRSA Administrator accepted the
recommended update to the Bright Futures Periodicity Schedule. The
Bright Futures recommendation included both a recommended clinical
practice update and revisions to the footnotes on the Bright Futures
Periodicity Schedule. The update includes screening for Hepatitis C
Virus Infection for individuals age 18 to 21. The footnote revisions
are applied to footnote 11 (Developmental Screening); footnote 12
(Autism Spectrum Disorder Screening) to update the title of the
relevant revised policy statements and the electronic hyperlinks; and a
new footnote referring to the supporting evidence for the
recommendation for screening for hepatitis C virus infection.
Therefore, 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) beginning on or after
December 28, 2021.
The updated Bright Futures Periodicity schedule can be accessed at
the following link: https://
[[Page 86939]]
mchb.hrsa.gov/maternal-child-health-topics/child-health/bright-
futures.html.
Thomas J. Engels,
Administrator.
[FR Doc. 2020-28971 Filed 12-30-20; 8:45 am]
BILLING CODE 4165-15-P
