Notice With Request for Comment: Consideration of Adding Metachromatic Leukodystrophy to the Recommended Uniform Screening Panel
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Abstract
HRSA is considering recommending to the Secretary the addition of Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel (RUSP). HRSA is providing notice and requesting comments from the public on this potential recommendation. Conditions listed on the RUSP are part of the evidence-informed preventive health guidelines supported by HRSA for infants and children. Non- grandfathered health plans are required to cover screenings included in the HRSA-supported comprehensive guidelines without cost-sharing (e.g., co-payment, co-insurance, etc.). HRSA is particularly interested in comments that address the potential benefit of early screening of MLD within the newborn period, the ability of state newborn screening programs to screen for MLD, and the availability of effective treatments for MLD. In deciding whether to provide recommendations to the Secretary supporting the addition of MLD to the RUSP, HRSA will consider public comments, including evidence-based reports, obtained through this notice.
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<title>Federal Register, Volume 90 Issue 155 (Thursday, August 14, 2025)</title>
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[Federal Register Volume 90, Number 155 (Thursday, August 14, 2025)]
[Notices]
[Pages 39196-39197]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15432]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice With Request for Comment: Consideration of Adding
Metachromatic Leukodystrophy to the Recommended Uniform Screening Panel
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice with request for public comment.
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SUMMARY: HRSA is considering recommending to the Secretary the addition
of Metachromatic Leukodystrophy (MLD) to the Recommended Uniform
Screening Panel (RUSP). HRSA is providing notice and requesting
comments from the public on this potential recommendation. Conditions
listed on the RUSP are part of the evidence-informed preventive health
guidelines supported by HRSA for infants and children. Non-
grandfathered health plans are required to cover screenings included in
the HRSA-supported comprehensive guidelines without cost-sharing (e.g.,
co-payment, co-insurance, etc.). HRSA is particularly interested in
comments that address the potential benefit of early screening of MLD
within the newborn period, the ability of state newborn screening
programs to screen for MLD, and the availability of effective
treatments for MLD. In deciding whether to provide recommendations to
the Secretary supporting the addition of MLD to the RUSP, HRSA will
consider public comments, including evidence-based reports, obtained
through this notice.
DATES: Submit comments no later than September 15, 2025.
ADDRESSES: Responses must be submitted electronically to CDR Leticia
Manning, MPH, at: <a href="/cdn-cgi/l/email-protection#ffb1bdacaf8d90988d9e928cbf978d8c9ed1989089"><span class="__cf_email__" data-cfemail="1b5559484b69747c697a76685b7369687a357c746d">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: CDR Leticia Manning, MPH, Newborn
Screening Team Lead, Division of Services for Children with Special
Health Needs, Maternal and Child Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, Maryland 20857 or <a href="/cdn-cgi/l/email-protection#e9a7abbab99b868e9b88849aa9819b9a88c78e869f"><span class="__cf_email__" data-cfemail="9ad4d8c9cae8f5fde8fbf7e9daf2e8e9fbb4fdf5ec">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The information obtained through this notice
may help inform HRSA on the benefits of screening for MLD and adding
this condition to the RUSP. Of the 56 newborn screening programs in the
United States, all states and Puerto Rico currently screen for at least
31 of the 37 core conditions on the RUSP. Some states also screen for
additional disorders. Conditions listed on the RUSP are part of the
evidence-informed preventive health guidelines supported by HRSA for
infants and children. Non-grandfathered health plans are required to
cover screenings included in the HRSA-supported comprehensive
guidelines without cost-sharing. The Advisory Committee on Heritable
Disorders in Newborns and Children (ACHDNC), now terminated, was tasked
with reviewing available scientific evidence and then making
recommendations to the Secretary regarding what conditions should be on
the RUSP. When a condition is nominated, ACHDNC determines whether
there is sufficient evidence available for early screening and refers
it to the ACHDNC's Evidence Review Group (ERG). The ERG is responsible
for identifying and assessing all available evidence and summarizing
for ACHDNC the strength and effectiveness of the evidence found on the
net benefit of screening, the ability of states to screen for the
condition, and the availability of effective treatments. The ERG
completed an evidence review for MLD. ACHDNC was terminated following
the completion of the evidence review for MLD, but prior to making a
recommendation on its inclusion in the RUSP or issuing a recommendation
to the Secretary.
When drafting responses, consider the data and other information
described on the ERG's report summary, and provide input on the
suitability of states screening for MLD within the newborn period. The
evidence-based review summary for MLD can be found at <a href="https://www.hrsa.gov/advisory-committees/heritable-disorders">https://www.hrsa.gov/advisory-committees/heritable-disorders</a>.
Special Note to Commenters
This notice is not inviting nominations for other conditions to be
added to the RUSP. HRSA is considering potential ways to continue
supporting the RUSP and the overall system of newborn screening. In
deciding whether to provide a recommendation to the Secretary
supporting the addition of MLD to the RUSP, HRSA will consider
evidence-
[[Page 39197]]
based reports and public comments obtained through this notice.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-15432 Filed 8-13-25; 8:45 am]
BILLING CODE 4165-15-P
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