[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17613-17614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06940]


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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 section 1111(g) of 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, May 13, 2021, and Friday, May 14, 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, May 13, 2021, from 10:00 a.m. to 3:00 p.m. Eastern 
Time (ET) and Friday, May 14, 2021, from 10:00 a.m. to 3:00 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 12:00 p.m. ET on May 12, 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 (RUSP) 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 1 
year from the Secretary's adoption of the condition for screening.
    During the May 13-14, 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) Mucopolysaccharidosis type II (MPS II) nomination summary;
    (2) Possible Committee vote on whether to move MPS II forward to a 
full evidence review;

[[Page 17614]]

    (3) Two oral public comment sessions: One session will be open to 
any newborn screening related topic. The other public comment period 
will specifically address the Committee's review of the evidence review 
process (e.g., nomination form, consumer-friendly guidance materials, 
review of conditions on the RUSP). Please note, if you wish to register 
to submit oral public comments on the review of the Committee's 
evidence review process we request that you also submit a written 
version of your remarks;
    (4) Committee discussion of Continuity of Operations Planning and 
COVID-19; and,
    (5) Newborn screening data sources.
    The agenda for this meeting does not include any plans for 
recommending a condition for inclusion in the RUSP. However, as noted 
in the agenda items, the Committee may hold a vote on whether or not to 
recommend a nominated condition (MPS II) 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 also 
available on the ACHDNC website previously listed.
    As noted above, 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. We 
specifically request that public participants providing oral comment on 
the review of the Committee's evidence review process also submit a 
written version of their remarks. 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, May 
10, 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. 2021-06940 Filed 4-2-21; 8:45 am]
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