Notice2023-14957
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
Primary source
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Published
July 14, 2023
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) scheduled a public meeting to be held Thursday, August 10, 2023, and Friday, August 11, 2023. Information about ACHDNC and the agenda for this meeting can be found on ACHDNC's website at https:// www.hrsa.gov/advisory-committees/heritable-disorders/index.html.
Full Text
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<title>Federal Register, Volume 88 Issue 134 (Friday, July 14, 2023)</title>
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[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45229-45230]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14957]
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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) scheduled a public meeting to be held Thursday, August 10,
2023, and Friday, August 11, 2023. Information about ACHDNC and the
agenda for this meeting can be found on ACHDNC's 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, August 10, 2023, from 10:00 a.m. to 3:00 p.m. Eastern
Time (ET) and Friday, August 11, 2023, from 10:00 a.m. to 2:00 p.m. ET.
ADDRESSES: This meeting will be held via webinar. While this meeting is
open to the public, advance registration is required. Persons wishing
to register to attend the meeting can do so via this link: <a href="https://achdncmeetings.org/registration/">https://achdncmeetings.org/registration/</a>. Registration closes at 12:00 p.m. ET
on August 9, 2023. 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#5e1f1d161a101d1e362c2d3f70393128"><span class="__cf_email__" data-cfemail="bcfdfff4f8f2fffcd4cecfdd92dbd3ca">[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 (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 1 year from the Secretary's adoption of the
condition for screening.
During the August 10-11, 2023, 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:
<bullet> A presentation on health equity and newborn screening;
<bullet> An update on the Duchenne muscular dystrophy condition
nomination and a potential vote on whether to move it forward to full
evidence-based review, which, depending on the strength of the
evidence, could lead to a future recommendation to add this condition
to the RUSP;
<bullet> A presentation, discussion, and vote on an ACHDNC
expedited review process for resubmitted condition nomination packages;
and
<bullet> A potential presentation and vote on whether to consider
Krabbe disease through the ACHDNC expedited review process described
above.
The agenda for this meeting includes a potential vote on whether to
recommend a nominated condition (Duchenne muscular dystrophy) to full
evidence-based review. In addition, as noted in the agenda items, the
Committee may hold a vote on whether to recommend a nominated condition
(Krabbe disease) be considered through the ACHDNC expedited review
process described above. Both votes may lead to a recommendation to add
or not add these 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 will have an opportunity to provide comments
on any or all of the above agenda items. Public participants may
request to
[[Page 45230]]
provide general oral comments and 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
are tentatively scheduled to provide their statements on Thursday,
August 10, 2023. 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 Wednesday, July 26, 2023. Written comments will be
shared with the Committee, so that they have an opportunity to consider
them prior to the meeting.
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.
Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2023-14957 Filed 7-13-23; 8:45 am]
BILLING CODE 4165-15-P
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