Notice2022-00896
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
Primary source
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Published
January 19, 2022
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 to be held on Thursday, February 10, 2022, and Friday, February 11, 2022. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable- disorders/index.html.
Full Text
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<title>Federal Register, Volume 87 Issue 12 (Wednesday, January 19, 2022)</title>
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[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Page 2800]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00896]
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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 to be held on Thursday,
February 10, 2022, and Friday, February 11, 2022. Information about the
ACHDNC and the agenda for this meeting can be found on the 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: Thursday, February 10, 2022, from 10:00 a.m.-3:00 p.m. Eastern
Time (ET) and Friday, February 11, 2022, from 10 a.m.-2:30 p.m. ET.
ADDRESSES: This meeting will be held via webinar. While this meeting is
open to the public, advance registration is required.
Please visit the ACHDNC website for information on registration:
<a href="https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html">https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html</a>. The deadline for registration is 12:00 p.m. ET on February
9, 2022. 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#adeceee5e9e3eeedc5dfdecc83cac2db"><span class="__cf_email__" data-cfemail="0647454e424845466e74756728616970">[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. The 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 (RUSP), 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 non-grandfathered 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 one year from the Secretary's adoption of the
condition for screening.
During the February 10-11, 2022 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) Final evidence-based review report on the Mucopolysaccharidosis
type II (MPS II) condition nomination for possible inclusion on the
RUSP. Following this report, the ACHDNC expects to vote on whether to
recommend to the Secretary adding MPS II to the RUSP.
(2) A presentation on phase two of the evidence-based review for
Guanidinoacetate methyltransferase (GAMT) deficiency.
(3) An update on the Krabbe disease condition nomination.
(4) A possible vote on whether to move Krabbe disease forward to
full evidence-based review.
(5) Overview of ACHDNC consumer-friendly resources.
(6) A presentation on healthy equity in newborn screening.
The agenda for this meeting includes a potential vote which may
lead to a decision to recommend a nominated condition (MPS II) to the
RUSP. 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-based review, and will hear presentations on the
evidence-based review for Guanidinoacetate methyltransferase
deficiency, any of which may lead to a recommendation to add or not add
a condition/conditions to the RUSP at a future time.
Agenda items are subject to change as priorities dictate.
Information about the ACHDNC, including a roster of members and past
meeting summaries, is also available on the ACHDNC website listed
above.
Members of the public also will have the opportunity to provide
comments. Public participants providing oral comments may submit
written statements in advance of the scheduled meeting. Oral comments
will be honored in the order they are requested and may be limited as
time allows. Subject to change: Members of the public registered to
submit oral public comments on MPS II are tentatively scheduled to
provide their statements on Thursday, February 10, 2022. Members of the
public registered to provide statements on all other newborn screening
related topics are tentatively scheduled for Friday, February 11, 2022.
Requests to provide a written statement or make oral comments to the
ACHDNC must be submitted via the registration website by 12:00 p.m. ET
on Friday, February 4, 2022.
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. 2022-00896 Filed 1-18-22; 8:45 am]
BILLING CODE 4165-15-P
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