[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54984-54985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21582]


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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 ACHDNC and 
the agenda for this meeting can be found on ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html.

DATES: Tuesday, November 9, 2021, from 10:00 a.m. to 3:00 p.m. Eastern 
Time (ET) and Wednesday, November 10, 2021, from 10:00 a.m. to 3:00 
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 12:00 p.m. ET on November 8, 2021. 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 [email protected].

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, 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 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 November 9-10, 2021, 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) The Committee will vote on whether or not to approve the 
following updates to the Committee's evidence-based review and 
decision-making process: The condition nomination form, methods for 
assessing published and unpublished evidence, and additional guidance 
for the Committee's decision matrix.
    (2) A presentation on phase two of the Mucopolysaccharidosis type 
II evidence review;
    (3) A presentation on phase one of the Guanidinoacetate 
methyltransferase deficiency evidence review;
    (4) A Krabbe disease nomination overview;
    (5) A possible Committee vote on whether to move Krabbe disease 
forward to a full evidence review; and
    (6) Workgroup updates.
    The agenda for this meeting does not include any vote or decision 
to recommend a condition for inclusion in the Recommended Uniform 
Screening Panel. 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 review, and will hear presentations on 
evidence review of Mucopolysaccharidosis type II and Guanidinoacetate 
methyltransferase deficiency, any of which may lead to such a 
recommendation at a future time. Agenda items are subject to change as 
priorities dictate. Information about 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. Public participants providing general oral comments may 
submit written statements in advance of the scheduled meeting. Oral 
comments will be

[[Page 54985]]

honored in the order they are requested and may be limited as time 
allows. 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 Thursday, November 4, 2021. 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. 2021-21582 Filed 10-4-21; 8:45 am]
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