[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3422-3423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00964]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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, February 9, 2023, from 9:30 a.m. to 3 p.m. Eastern 
Time (ET) and Friday, February 10, 2023, from 9:30 a.m. to 2 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/index.html by the deadline of 
12 p.m. ET on February 8, 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. 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 9-10, 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:
    (1) Presentation of the final evidence-based review report on the 
Krabbe disease condition nomination for possible inclusion on the RUSP. 
Following this report presentation, the ACHDNC expects to vote on 
whether to recommend to the Secretary adding Krabbe Disease to the 
RUSP;
    (2) An update by the ACHDNC Prioritization and Capacity workgroup;
    (3) A possible presentation from the Center for Disease Control and 
Prevention's Enhancing Data Driven Disease Detection in Newborns 
Project;
    (4) A potential update on the HRSA-funded Newborn Screening 
Interoperability Programs;
    (5) A presentation on the Blueprint for Change, which outlines an 
agenda for advancing the system of services for children and youth with 
special health care needs (see https://mchb.hrsa.gov/programs-impact/focus-areas/children-youth-special-health-care-needs-cyshcn/blueprint-change);
    (6) Workgroup updates; and
    (7) A potential 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.
    The agenda for this meeting includes a potential vote to recommend 
a nominated condition (Krabbe Disease) be added by the Secretary 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 (Duchenne 
muscular dystrophy) to full evidence-based review, which may lead to a 
recommendation to add or not add this condition 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.
    Members of the public also will have the opportunity to provide 
comments on any or all of the above agenda items. 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 public comments on Krabbe Disease are tentatively scheduled to 
provide their statements on Thursday, February 9, 2023. Members of the 
public registered to provide oral public comments on all other newborn 
screening related topics are tentatively scheduled to provide their 
statements on Friday, February 10, 2023. Requests to provide a written 
statement or make oral comments to the ACHDNC must be submitted via the 
registration website by 12 p.m. ET on

[[Page 3423]]

Thursday, January 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.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-00964 Filed 1-18-23; 8:45 am]
BILLING CODE 4165-15-P