Notice2021-21582
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 5, 2021
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In accordance with the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting. Information about ACHDNC and the agenda for this meeting can be found on ACHDNC website at https:// www.hrsa.gov/advisory-committees/heritable-disorders/index.html.
Full Text
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<title>Federal Register, Volume 86 Issue 190 (Tuesday, October 5, 2021)</title>
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[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54984-54985]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21582]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Advisory Committee on Heritable Disorders in
Newborns and Children
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: In accordance with the Public Health Service Act and the
Federal Advisory Committee Act, this notice announces that the Advisory
Committee on Heritable Disorders in Newborns and Children (ACHDNC or
Committee) has scheduled a public meeting. Information about ACHDNC and
the agenda for this meeting can be found on ACHDNC website at <a href="https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html">https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html</a>.
DATES: Tuesday, November 9, 2021, from 10:00 a.m. to 3:00 p.m. Eastern
Time (ET) and Wednesday, November 10, 2021, from 10:00 a.m. to 3:00
p.m. ET.
ADDRESSES: This meeting will be held via webinar. While this meeting is
open to the public, advance registration is required.
Please register online at <a href="https://www.achdncmeetings.org/registration/">https://www.achdncmeetings.org/registration/</a> by 12:00 p.m. ET on November 8, 2021. Instructions on how
to access the meeting via webcast will be provided upon registration.
FOR FURTHER INFORMATION CONTACT: Alaina Harris, Maternal and Child
Health Bureau, HRSA, 5600 Fishers Lane, Room 18W66, Rockville, Maryland
20857; (301) 443-0721; or <a href="/cdn-cgi/l/email-protection#5b1a18131f15181b3329283a753c342d"><span class="__cf_email__" data-cfemail="f9b8bab1bdb7bab9918b8a98d79e968f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: ACHDNC provides advice and recommendations
to the Secretary of Health and Human Services (Secretary) on the
development of newborn screening activities, technologies, policies,
guidelines, and programs for effectively reducing morbidity and
mortality in newborns and children having, or at risk for, heritable
disorders. ACHDNC reviews and reports regularly on newborn and
childhood screening practices, recommends improvements in the national
newborn and childhood screening programs, and fulfills requirements
stated in the authorizing legislation. In addition, ACHDNC's
recommendations regarding inclusion of additional conditions for
screening on the Recommended Uniform Screening Panel, following
adoption by the Secretary, are evidence-informed preventive health
services provided for in the comprehensive guidelines supported by HRSA
pursuant to section 2713 of the Public Health Service Act (42 U.S.C.
300gg-13). Under this provision, non-grandfathered group health plans
and health insurance issuers offering group or individual health
insurance are required to provide insurance coverage without cost-
sharing (a co-payment, co-insurance, or deductible) for preventive
services for plan years (i.e., policy years) beginning on or after the
date that is 1 year from the Secretary's adoption of the condition for
screening.
During the November 9-10, 2021, meeting, ACHDNC will hear from
experts in the fields of public health, medicine, heritable disorders,
rare disorders, and newborn screening. Agenda items include the
following:
(1) The Committee will vote on whether or not to approve the
following updates to the Committee's evidence-based review and
decision-making process: The condition nomination form, methods for
assessing published and unpublished evidence, and additional guidance
for the Committee's decision matrix.
(2) A presentation on phase two of the Mucopolysaccharidosis type
II evidence review;
(3) A presentation on phase one of the Guanidinoacetate
methyltransferase deficiency evidence review;
(4) A Krabbe disease nomination overview;
(5) A possible Committee vote on whether to move Krabbe disease
forward to a full evidence review; and
(6) Workgroup updates.
The agenda for this meeting does not include any vote or decision
to recommend a condition for inclusion in the Recommended Uniform
Screening Panel. As noted in the agenda items, the Committee may hold a
vote on whether or not to recommend a nominated condition (Krabbe
disease) to full evidence review, and will hear presentations on
evidence review of Mucopolysaccharidosis type II and Guanidinoacetate
methyltransferase deficiency, any of which may lead to such a
recommendation at a future time. Agenda items are subject to change as
priorities dictate. Information about ACHDNC, including a roster of
members and past meeting summaries, is also available on the ACHDNC
website.
Members of the public also will have the opportunity to provide
comments. Public participants providing general oral comments may
submit written statements in advance of the scheduled meeting. Oral
comments will be
[[Page 54985]]
honored in the order they are requested and may be limited as time
allows. Requests to provide a written statement or make oral comments
to ACHDNC must be submitted via the registration website by 12:00 p.m.
ET on Thursday, November 4, 2021. Individuals who need special
assistance or another reasonable accommodation should notify Alaina
Harris at the address and phone number listed above at least 10
business days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-21582 Filed 10-4-21; 8:45 am]
BILLING CODE 4165-15-P
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