[Federal Register Volume 86, Number 138 (Thursday, July 22, 2021)]
[Notices]
[Page 38728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15569]
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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 (HHS).
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,
August 12, 2021, and Friday, August 13, 2021. 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, August 12, 2021, from 10:00 a.m. to 2:15 p.m. Eastern
Time (ET) and Friday, August 13, 2021, 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.
Please register online at https://www.achdncmeetings.org/registration/ by the deadline of 12:00 p.m. ET on August 11, 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, Rockville, Maryland 20857; 301-
443-0721; or [email protected].
SUPPLEMENTARY INFORMATION: ACHDNC provides advice and recommendations
to the Secretary of HHS (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, following
adoption by the Secretary, are evidence-informed preventive health
services provided for in the comprehensive guidelines supported by HRSA
through the Recommended Uniform Screening Panel 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 one year from the
Secretary's adoption of the condition for screening.
During the August 12-13, 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) Overview of the Committee's review of its evidence-review
processes and proposed updates,
(2) A presentation on phase one of the mucopolysaccharidosis type
II evidence review,
(3) Guanidinoacetate methyltransferase (GAMT) deficiency nomination
summary,
(4) Possible Committee vote on whether to move GAMT deficiency
forward to a full evidence review,
(5) Committee discussion on emerging issues for newborn screening,
(6) A panel presentation on national registries followed by
Committee discussion,
(7) A panel presentation on emerging issues facing the newborn
screening workforce followed by Committee discussion, and
(8) Public comments on any newborn screening related topic.
The public is also encouraged to provide public comment on the
proposed updates to the Committee's evidence review processes. For
reference, a summary of questions for public consideration is on the
ACHDNC website. We request that public participants providing oral
comments on the review of the Committee's evidence review process also
submit a written version of their remarks.
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 (GAMT
deficiency) to full evidence review, which may lead to such a
recommendation 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 available on the ACHDNC website
listed above.
As previously noted, members of the public 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 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 the ACHDNC must be submitted via the
registration website by 10:00 a.m. ET on Monday, August 9, 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. 2021-15569 Filed 7-21-21; 8:45 am]
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