[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45229-45230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14957]


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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) scheduled a public meeting to be held Thursday, August 10, 
2023, and Friday, August 11, 2023. Information about ACHDNC and the 
agenda for this meeting can be found on ACHDNC's website at https://www.hrsa.gov/advisory-committees/heritable-disorders/index.html.

DATES: Thursday, August 10, 2023, from 10:00 a.m. to 3:00 p.m. Eastern 
Time (ET) and Friday, August 11, 2023, from 10:00 a.m. to 2:00 p.m. ET.

ADDRESSES: This meeting will be held via webinar. While this meeting is 
open to the public, advance registration is required. Persons wishing 
to register to attend the meeting can do so via this link: https://achdncmeetings.org/registration/. Registration closes at 12:00 p.m. ET 
on August 9, 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 [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 (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 1 year from the Secretary's adoption of the 
condition for screening.
    During the August 10-11, 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:
     A presentation on health equity and newborn screening;
     An 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;
     A presentation, discussion, and vote on an ACHDNC 
expedited review process for resubmitted condition nomination packages; 
and
     A potential presentation and vote on whether to consider 
Krabbe disease through the ACHDNC expedited review process described 
above.
    The agenda for this meeting includes a potential vote on whether to 
recommend a nominated condition (Duchenne muscular dystrophy) to full 
evidence-based review. In addition, as noted in the agenda items, the 
Committee may hold a vote on whether to recommend a nominated condition 
(Krabbe disease) be considered through the ACHDNC expedited review 
process described above. Both votes may lead to a recommendation to add 
or not add these 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 an opportunity to provide comments 
on any or all of the above agenda items. Public participants may 
request to

[[Page 45230]]

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 
are tentatively scheduled to provide their statements on Thursday, 
August 10, 2023. 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 Wednesday, July 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.

Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2023-14957 Filed 7-13-23; 8:45 am]
BILLING CODE 4165-15-P