Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 38728 [2021-15569]

Download as PDF 38728 2 Up 3 Up Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices to 30 states and/or territories will be asked to complete a follow-up survey. to two conditions may be reviewed per year. HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2021–15598 Filed 7–21–21; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: 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 lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:10 Jul 21, 2021 Jkt 253001 Lane, Rockville, Maryland 20857; 301– 443–0721; or ACHDNC@hrsa.gov. 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 9990 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] BILLING CODE 4165–15–P E:\FR\FM\22JYN1.SGM 22JYN1

Agencies

[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.

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

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]
BILLING CODE 4165-15-P