Notice2023-00964
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
January 19, 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) has scheduled a public meeting. 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 88 Issue 12 (Thursday, January 19, 2023)</title>
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[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3422-3423]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00964]
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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 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 9, 2023, from 9:30 a.m. to 3 p.m. Eastern
Time (ET) and Friday, February 10, 2023, from 9:30 a.m. to 2 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> by the deadline of
12 p.m. ET on February 8, 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#4b0a08030f05080b2339382a652c243d"><span class="__cf_email__" data-cfemail="6425272c202a27240c1617054a030b12">[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 9-10, 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:
(1) Presentation of the final evidence-based review report on the
Krabbe disease condition nomination for possible inclusion on the RUSP.
Following this report presentation, the ACHDNC expects to vote on
whether to recommend to the Secretary adding Krabbe Disease to the
RUSP;
(2) An update by the ACHDNC Prioritization and Capacity workgroup;
(3) A possible presentation from the Center for Disease Control and
Prevention's Enhancing Data Driven Disease Detection in Newborns
Project;
(4) A potential update on the HRSA-funded Newborn Screening
Interoperability Programs;
(5) A presentation on the Blueprint for Change, which outlines an
agenda for advancing the system of services for children and youth with
special health care needs (see <a href="https://mchb.hrsa.gov/programs-impact/focus-areas/children-youth-special-health-care-needs-cyshcn/blueprint-change">https://mchb.hrsa.gov/programs-impact/focus-areas/children-youth-special-health-care-needs-cyshcn/blueprint-change</a>);
(6) Workgroup updates; and
(7) A potential 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.
The agenda for this meeting includes a potential vote to recommend
a nominated condition (Krabbe Disease) be added by the Secretary to the
RUSP. In addition, as noted in the agenda items, the Committee may hold
a vote on whether or not to recommend a nominated condition (Duchenne
muscular dystrophy) to full evidence-based review, which may lead to a
recommendation to add or not add this condition 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.
Members of the public also will have the opportunity to provide
comments on any or all of the above agenda items. Public participants
may request to 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 on Krabbe Disease are tentatively scheduled to
provide their statements on Thursday, February 9, 2023. Members of the
public registered to provide oral public comments on all other newborn
screening related topics are tentatively scheduled to provide their
statements on Friday, February 10, 2023. Requests to provide a written
statement or make oral comments to the ACHDNC must be submitted via the
registration website by 12 p.m. ET on
[[Page 3423]]
Thursday, January 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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-00964 Filed 1-18-23; 8:45 am]
BILLING CODE 4165-15-P
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