[Federal Register Volume 87, Number 73 (Friday, April 15, 2022)]
[Notices]
[Pages 22539-22540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html.

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 https://www.achdncmeetings.org/registration/ 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#5415171c101a17143c2627357a333b22"><span class="__cf_email__" data-cfemail="8dcccec5c9c3cecde5fffeeca3eae2fb">[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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