Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 3422-3423 [2023-00964]

Download as PDF 3422 Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices Our estimate of eight ABs is based on the number of International Laboratory Accreditation Cooperation signatories in the U.S. economy. We estimate that approximately 150 testing labs will seek accreditation. Our estimate of Test Reports is based on the number of premarket submissions we expect per year with testing from an ASCAaccredited testing laboratory. Our estimates for the average burden per response, recordkeeping, and disclosure are based on our experience with the pilot program. Our estimated burden for the information collection reflects an overall decrease of 3,129 hours and an increase of 94 responses/records. We attribute this adjustment to a decrease in the one-time burden for accreditation bodies and testing laboratories training and SOPs because much of this activity was completed during the pilot. In addition, there is an increase in the annual responses/records because there is an increase in renewal requests (Request by AB to continue ASCA Recognition and Request by TL to continue ASCA Accreditation) since the pilot program was initiated. Dated: January 12, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–00973 Filed 1–18–23; 8:45 am] BILLING CODE 4164–01–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. 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. 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/. 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. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:49 Jan 18, 2023 Jkt 259001 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/advisorycommittees/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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Alaina Harris, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane, Room 18W66, Rockville, Maryland 20857; 301–443–0721; or ACHDNC@hrsa.gov. 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, coinsurance, 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 evidencebased 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 HRSAfunded 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/childrenyouth-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 evidencebased 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 E:\FR\FM\19JAN1.SGM 19JAN1 Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Announcement of First Meeting of the 2025 Dietary Guidelines Advisory Committee and Request for Comments Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services (HHS); Food, Nutrition, and Consumer Services (FNCS), U.S. Department of Agriculture (USDA). ACTION: Notice. AGENCY: The U.S. Departments of Health and Human Services and Agriculture announce the first meeting of the newly appointed 2025 Dietary Guidelines Advisory Committee (Committee). This meeting will be open to the public virtually. Additionally, this notice opens a public comment period that will remain open until late 2024, throughout the Committee’s deliberations. SUMMARY: The first meeting will be held February 9–10, 2023. The public comment period opens with the publication of this notice. ADDRESSES: (a) The meeting will be accessible online via livestream and recorded for later viewing. Registrants will receive the livestream information prior to the meeting. (b) You may send comments, identified by Docket OASH–2022–0021, by either of the following methods: • Online (preferred method): Federal eRulemaking Portal: https:// www.regulations.gov. • Mail: Janet M. de Jesus, MS, RD, HHS/OASH Office of Disease Prevention and Health Promotion (ODPHP), 1101 Wootton Parkway, Suite 420, Rockville, MD 20852. Instructions: All submissions received must include the agency name and Docket OASH–2022–0021. For detailed instructions on sending comments, see khammond on DSKJM1Z7X2PROD with NOTICES DATES: VerDate Sep<11>2014 17:49 Jan 18, 2023 Jkt 259001 the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: Designated Federal Officer, 2025 Dietary Guidelines Advisory Committee, Janet M. de Jesus, MS, RD; HHS/OASH/ ODPHP, 1101 Wootton Parkway, Suite 420, Rockville, MD 20852; Phone: 240– 453–8266; Email DietaryGuidelines@ hhs.gov. Additional information is available on the internet at www.DietaryGuidelines.gov. SUPPLEMENTARY INFORMATION: Authority and Purpose: Under section 301 of Public Law 101–445 (7 U.S.C. 5341, the National Nutrition Monitoring and Related Research Act of 1990, title III), the Secretaries of HHS and USDA are directed to publish the Dietary Guidelines for Americans (Dietary Guidelines) jointly at least every five years. The law instructs that this publication shall contain nutritional and dietary information and guidelines for the general public; shall be based on the preponderance of scientific and medical knowledge current at the time of publication; and shall be promoted by each Federal agency in carrying out any Federal food, nutrition, or health program. The current edition of the Dietary Guidelines (2020–2025) provides guidance on the entire lifespan, from birth to older adulthood, including pregnancy and lactation. The Dietary Guidelines for Americans, 2025– 2030 will continue to provide foodbased dietary guidance across the entire lifespan to help meet nutrient needs, promote health, and reduce the risk of chronic disease. HHS and USDA appointed the 2025 Dietary Guidelines Advisory Committee (Committee) to conduct an independent scientific review that will help inform the Departments’ development of the next edition of the Dietary Guidelines. The Committee’s review and advice will focus on the scientific questions prioritized by HHS and USDA, with the potential to inform nutrition guidance for Americans across the lifespan. Information on the 2025 Committee membership and the scientific questions will be available at www.DietaryGuidelines.gov. The 2025 Committee’s formation is governed under the provisions of the Federal Advisory Committee Act (FACA), Public Law 92–463, as amended (5 U.S.C. app), which sets forth standards for the formation and use of advisory committees. Committee’s Task: The work of the Committee will be solely advisory in nature and time limited. The Committee will examine evidence on the scientific questions, using approaches including PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 3423 systematic reviews, food pattern modeling, and data analysis. The Committee will then develop a scientific report to be submitted to the HHS and USDA Secretaries. The scientific report should describe the Committee’s review and conclusions and provide sciencebased advice and rationale to the Departments based on the preponderance of evidence reviewed. HHS and USDA will consider the Committee’s scientific report as they develop the Dietary Guidelines for Americans, 2025–2030. The Committee will hold approximately six meetings, open to the public virtually, to review the evidence and discuss recommendations. Future meeting dates, times, and other relevant information will be announced via Federal Register notice and at www.DietaryGuidelines.gov. As stipulated in the charter, the Committee will disband after delivery of its final report to the Secretaries of HHS and USDA, or two years from the date the charter was filed, whichever comes first. Purpose of the Meeting: In accordance with FACA, and to promote transparency of the process, deliberations of the Committee will occur in a public forum. The purpose of this first meeting is to orient the Committee to the Dietary Guidelines process and mark the beginning of its work. Meeting Agenda: The first meeting agenda will include (a) review of operations for the Committee members, (b) overview of the proposed scientific questions identified by the Departments to be examined by the Committee, (c) presentations on the evidence-based approaches for reviewing the scientific evidence, and (d) plans for future Committee work. Meeting Registration: The meeting is open to the public. The meeting will be accessible online via livestream and recorded for later viewing. Registration is required for the livestream. To register, go to www.DietaryGuidelines.gov and click on the link for ‘‘Meeting Registration.’’ Online registration begins on January 18, 2023 and ends on February 10, 2023. To request a sign language interpreter or other special accommodations, please email dietaryguidelines@hhs.gov by February 5, 2023. All registrants will be asked to provide their name, affiliation, email address, and days attending. After registration, individuals will receive livestream access information via email. Public Comments and Meeting Documents: Written comments from the public will be accepted throughout the Committee’s deliberative process for the next approximately two years. E:\FR\FM\19JAN1.SGM 19JAN1

Agencies

[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]


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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.

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/.

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/ 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
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