Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 2800 [2022-00896]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Health Resources and Services Administration

[Federal Register Volume 87, Number 12 (Wednesday, January 19, 2022)]
[Notices]
[Page 2800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00896]


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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 to be held on Thursday, 
February 10, 2022, and Friday, February 11, 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/.

DATES: Thursday, February 10, 2022, from 10:00 a.m.-3:00 p.m. Eastern 
Time (ET) and Friday, February 11, 2022, from 10 a.m.-2:30 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: 
https://www.hrsa.gov/advisory-committees/heritable-disorders/. The deadline for registration is 12:00 p.m. ET on February 
9, 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 [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. 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 10-11, 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 Mucopolysaccharidosis 
type II (MPS II) condition nomination for possible inclusion on the 
RUSP. Following this report, the ACHDNC expects to vote on whether to 
recommend to the Secretary adding MPS II to the RUSP.
    (2) A presentation on phase two of the evidence-based review for 
Guanidinoacetate methyltransferase (GAMT) deficiency.
    (3) An update on the Krabbe disease condition nomination.
    (4) A possible vote on whether to move Krabbe disease forward to 
full evidence-based review.
    (5) Overview of ACHDNC consumer-friendly resources.
    (6) A presentation on healthy equity in newborn screening.
    The agenda for this meeting includes a potential vote which may 
lead to a decision to recommend a nominated condition (MPS II) to the 
RUSP. 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, and will hear presentations on the 
evidence-based review for Guanidinoacetate methyltransferase 
deficiency, any of 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 also will have the opportunity to provide 
comments. Public participants providing oral comments 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 MPS II are tentatively scheduled to 
provide their statements on Thursday, February 10, 2022. Members of the 
public registered to provide statements on all other newborn screening 
related topics are tentatively scheduled for Friday, February 11, 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, February 4, 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. 2022-00896 Filed 1-18-22; 8:45 am]
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