Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 54984-54985 [2021-21582]

Download as PDF 54984 Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Notices and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisorycommittees/rural-health/. DATES: • Monday, October 25, 2021, 12:00 p.m.–5:30 p.m. Eastern Time (ET); • Tuesday, October 26, 2021, 12:30 p.m.–4:15 p.m. ET; and • Wednesday, October 27, 2021, 12:30 p.m.–4:30 p.m. ET. FOR FURTHER INFORMATION CONTACT: lotter on DSK11XQN23PROD with NOTICES1 Steven Hirsch, Administrative Coordinator at the Federal Office of Rural Health Policy, HRSA, 5600 Fishers Lane, 17W59D, Rockville, Maryland 20857; (301) 443–7322; or shirsch@hrsa.gov. SUPPLEMENTARY INFORMATION: NACRHHS provides advice and recommendations to the Secretary of HHS (Secretary) on policy, program development, and other matters of significance concerning both rural health and rural human services. At this meeting, NACRHHS will discuss Behavioral Health and Primary Care Integration in Rural America and recommendations to the Secretary on designation of a new type of provider, the Rural Emergency Hospital. Members of the public will have the opportunity to provide comments. Public participants wishing to provide oral comments must submit a written version of their statement at least three business days in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time permits. Public participants wishing to offer a written statement should send it to Steven Hirsch, using the contact information above, at least 3 business days prior to the meeting. Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Steven Hirsch at the address and phone number listed above at least 10 business days prior to the meeting. BILLING CODE 4165–15–P VerDate Sep<11>2014 18:56 Oct 04, 2021 Jkt 256001 Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: 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.surveymonkey.com/r/ WLSYQS5 by the deadline of 12:00 p.m. ET on October, 24, 2021. Instructions on how to access the meeting via Zoom will be provided upon registration. [FR Doc. 2021–21581 Filed 10–4–21; 8:45 am] Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children ADDRESSES: Maria G. Button, Director, Executive Secretariat. DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 ACHDNC and the agenda for this meeting can be found on ACHDNC website at https://www.hrsa.gov/ advisory-committees/heritabledisorders/. DATES: Tuesday, November 9, 2021, from 10:00 a.m. to 3:00 p.m. Eastern Time (ET) and Wednesday, November 10, 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 November 8, 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, Room 18W66, Rockville, Maryland 20857; (301) 443–0721; or ACHDNC@hrsa.gov. 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. 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, following adoption by the SUMMARY: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 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 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 November 9–10, 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) The Committee will vote on whether or not to approve the following updates to the Committee’s evidencebased review and decision-making process: The condition nomination form, methods for assessing published and unpublished evidence, and additional guidance for the Committee’s decision matrix. (2) A presentation on phase two of the Mucopolysaccharidosis type II evidence review; (3) A presentation on phase one of the Guanidinoacetate methyltransferase deficiency evidence review; (4) A Krabbe disease nomination overview; (5) A possible Committee vote on whether to move Krabbe disease forward to a full evidence review; and (6) Workgroup updates. 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 (Krabbe disease) to full evidence review, and will hear presentations on evidence review of Mucopolysaccharidosis type II and Guanidinoacetate methyltransferase deficiency, any of which may lead to such a recommendation at a future time. Agenda items are subject to change as priorities dictate. Information about 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. Public participants providing general oral comments may submit written statements in advance of the scheduled meeting. Oral comments will be E:\FR\FM\05OCN1.SGM 05OCN1 Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Notices 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 ACHDNC must be submitted via the registration website by 12:00 p.m. ET on Thursday, November 4, 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. 2021–21582 Filed 10–4–21; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings lotter on DSK11XQN23PROD with NOTICES1 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Visual and Perception Processes. Date: October 28, 2021. Time: 9:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Karen Elizabeth Seymour, Ph.D., Scientific Review Officer, Center for Scientific Review National Institute of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (240) 762–2729, karen.seymour@ nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Language and Communication Study Section. Date: October 28–29, 2021. Time: 10:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). VerDate Sep<11>2014 18:56 Oct 04, 2021 Jkt 256001 Contact Person: Maribeth Champoux, Ph.D., BA, MS, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3182, MSC 7848, Bethesda, MD 20892 (301) 594–3163, champoum@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Special Topics: Noninvasive Neuromodulation and Neuroimaging Technologies. Date: November 3, 2021. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Pablo M. Blazquez Gamez, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (301) 435–1042, pablo.blazquezgamez@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Endocrinology, Metabolism, Nutrition and Reproductive Sciences. Date: November 3, 2021. Time: 10:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jonathan Michael Peterson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health 6701 Rockledge Drive, Bethesda, MD 20892, (301) 867–5309, jonathan.peterson@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Cancer Therapeutics and Drug Development. Date: November 4–5, 2021. Time: 9:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Maureen Shuh, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892 (301) 480–4097, maureen.shuh@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Mechanisms of Memory and Sound Processing. Date: November 5, 2021. Time: 10:30 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sepandarmaz Aschrafi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040D, Bethesda, MD 20892 (301) 451–4251, Armaz.aschrafi@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Motivated Behavior and Alcohol. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 54985 Date: November 9, 2021. Time: 1:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Michael Selmanoff, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5164, MSC 7844, Bethesda, MD 20892 (301) 435– 1119, selmanom@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–21– 230: Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award. Date: November 10, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Seetha Bhagavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD 20892 (301) 237– 9838, bhagavas@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; R15 AREA and REAP: Musculoskeletal, Oral, Skin, Rheumatology and Rehabilitation Sciences. Date: November 10, 2021. Time: 2:00 p.m. to 8:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Chi-Wing Chow, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4110, Bethesda, MD 20892 (301) 402–3912, chowc2@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: September 30, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–21726 Filed 10–4–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences: Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54984-54985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21582]


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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 ACHDNC and 
the agenda for this meeting can be found on ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable-disorders/.

DATES: Tuesday, November 9, 2021, from 10:00 a.m. to 3:00 p.m. Eastern 
Time (ET) and Wednesday, November 10, 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 November 8, 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, 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. 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, 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 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 November 9-10, 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) The Committee will vote on whether or not to approve the 
following updates to the Committee's evidence-based review and 
decision-making process: The condition nomination form, methods for 
assessing published and unpublished evidence, and additional guidance 
for the Committee's decision matrix.
    (2) A presentation on phase two of the Mucopolysaccharidosis type 
II evidence review;
    (3) A presentation on phase one of the Guanidinoacetate 
methyltransferase deficiency evidence review;
    (4) A Krabbe disease nomination overview;
    (5) A possible Committee vote on whether to move Krabbe disease 
forward to a full evidence review; and
    (6) Workgroup updates.
    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 (Krabbe 
disease) to full evidence review, and will hear presentations on 
evidence review of Mucopolysaccharidosis type II and Guanidinoacetate 
methyltransferase deficiency, any of which may lead to such a 
recommendation at a future time. Agenda items are subject to change as 
priorities dictate. Information about 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. Public participants providing general oral comments may 
submit written statements in advance of the scheduled meeting. Oral 
comments will be

[[Page 54985]]

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 ACHDNC must be submitted via the registration website by 12:00 p.m. 
ET on Thursday, November 4, 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. 2021-21582 Filed 10-4-21; 8:45 am]
BILLING CODE 4165-15-P