Notice2022-08053
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
Primary source
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Published
April 15, 2022
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
This notice announces a public meeting of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee), authorized under section 1111(g) of the Public Health Service Act, and the Federal Advisory Committee Act, on Thursday, May 12, 2022, and Friday, May 13, 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 73 (Friday, April 15, 2022)</title>
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[Federal Register Volume 87, Number 73 (Friday, April 15, 2022)]
[Notices]
[Pages 22539-22540]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08053]
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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: This notice announces a public meeting of the Advisory
Committee on Heritable Disorders in Newborns and Children (ACHDNC or
Committee), authorized under section 1111(g) of the Public Health
Service Act, and the Federal Advisory Committee Act, on Thursday, May
12, 2022, and Friday, May 13, 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, May 12, 2022, from 10:00 a.m. to 3:20 p.m. Eastern
Time (ET) and Friday, May 13, 2022, from 10:00 a.m. to 12:40 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 the deadline of 12:00 p.m. ET on May 11, 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#0445474c404a47446c7677652a636b72"><span class="__cf_email__" data-cfemail="befffdf6faf0fdfed6cccddf90d9d1c8">[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 one year from the Secretary's adoption of the
condition for screening.
During the May 12-13, 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 guanidinoacetate
methyltransferase (GAMT) deficiency condition nomination for possible
inclusion on the RUSP. Following this report, the ACHDNC expects to
vote on whether to recommend the Secretary add GAMT deficiency to the
RUSP;
(2) An update on the Krabbe disease condition nomination;
(3) A possible vote on whether to move Krabbe disease forward to
full evidence-based review;
(4) A presentation on homocystinuria newborn screening status; and
(5) A presentation on the Newborn Screening Family Education
Program.
The agenda for this meeting includes a potential vote which may
lead to a decision to recommend a nominated condition (GAMT deficiency)
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
(Krabbe disease) to full evidence-based review, 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 will have the opportunity to provide
comments. 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
[[Page 22540]]
public comments on GAMT deficiency are tentatively scheduled to provide
their statements on Thursday, May 12, 2022. Members of the public
registered to provide statements on all other newborn screening related
topics are tentatively scheduled for Friday, May 13, 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, May
6, 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. 2022-08053 Filed 4-14-22; 8:45 am]
BILLING CODE 4165-15-P
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