Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 73490 [2020-25461]

Download as PDF 73490 Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices designation annually and assume that an average of 70 hours is needed to prepare such a request. We estimate 205 respondents will submit 261 requests for fast track designation requests annually and assume that an average of 60 hours is needed to prepare such a request. Of the requests for fast track designation made per year, we granted approximately 224 requests from 392 respondents, and for each of these granted requests, a premeeting package was submitted. We therefore assume an average burden of 100 hours per respondent for preparing a premeeting package. Finally, we estimate 33 respondents will submit 38 requests for RMAT designation and assume that an average of 60 hours is needed to prepare such a request. Dated: November 12, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–25414 Filed 11–17–20; 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 (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 Tuesday, December 1, 2020. 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: Tuesday, December 1, 2020, 2020, from 10:00 a.m. to 2:45 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.cvent.com/d/17qsxn by the deadline of 12:00 p.m. ET on Monday, November 30, 2020. Instructions on how to access the meeting via webcast will be provided upon registration. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:59 Nov 17, 2020 Jkt 253001 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 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, nongrandfathered 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, 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 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) Presentations on the decision making criteria and matrix used to evaluate conditions nominated to the RUSP; (2) review of newborn screening implementation for the following RUSP conditions: Severe combined immunodeficiency (SCID), critical congenital heart disease (CCHD), Pompe disease, mucopolysaccharidosis type I (MPS I), X-linked adrenoleukodystrophy (XALD); and (3) overview of the Review of Newborn Screening for Spinal Muscular Atrophy (SMA) report and vote on whether to submit this review to the Secretary. In July 2018, SMA was added to the RUSP, and the Secretary requested a follow-up report that assesses the PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 impact of implementing screening for SMA. Following the overview of the Review of Newborn Screening for Spinal Muscular Atrophy report, the Committee is expected to vote on whether to submit this review to the Secretary or whether further action is warranted prior to its submission. The agenda for this meeting does not include any plans for recommending a condition for inclusion in the RUSP. Agenda items are subject to changes as priorities dictate. Information about the ACHDNC, including a roster of members and past meeting summaries, are also available on the ACHDNC website. Members of the public also will have the opportunity to provide comments. Public participants 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 Friday, November 27, 2020, by 10:00 a.m. ET. 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. This meeting is being announced less than 15 days prior to the scheduled meeting due to an administrative issue that has now been resolved. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2020–25461 Filed 11–17–20; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Treatment and Prevention of Neuropathic Pain With P2Y14 Antagonists AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Saint Louis University, (‘‘SLU’’), a non-profit university located in Missouri, in its rights to the inventions and patents listed in the SUMMARY: E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Page 73490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25461]


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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 Tuesday, 
December 1, 2020. 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: Tuesday, December 1, 2020, 2020, from 10:00 a.m. to 2:45 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.cvent.com/d/17qsxn by the deadline of 12:00 p.m. 
ET on Monday, November 30, 2020. 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 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 one 
year from the Secretary's adoption of the condition for screening.
    During the 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) Presentations on the decision making criteria and matrix used 
to evaluate conditions nominated to the RUSP;
    (2) review of newborn screening implementation for the following 
RUSP conditions: Severe combined immunodeficiency (SCID), critical 
congenital heart disease (CCHD), Pompe disease, mucopolysaccharidosis 
type I (MPS I), X-linked adrenoleukodystrophy (XALD); and
    (3) overview of the Review of Newborn Screening for Spinal Muscular 
Atrophy (SMA) report and vote on whether to submit this review to the 
Secretary.
    In July 2018, SMA was added to the RUSP, and the Secretary 
requested a follow-up report that assesses the impact of implementing 
screening for SMA. Following the overview of the Review of Newborn 
Screening for Spinal Muscular Atrophy report, the Committee is expected 
to vote on whether to submit this review to the Secretary or whether 
further action is warranted prior to its submission.
    The agenda for this meeting does not include any plans for 
recommending a condition for inclusion in the RUSP. Agenda items are 
subject to changes as priorities dictate. Information about the ACHDNC, 
including a roster of members and past meeting summaries, are also 
available on the ACHDNC website.
    Members of the public also will have the opportunity to provide 
comments. Public participants 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 Friday, November 27, 2020, by 
10:00 a.m. ET.
    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.
    This meeting is being announced less than 15 days prior to the 
scheduled meeting due to an administrative issue that has now been 
resolved.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-25461 Filed 11-17-20; 8:45 am]
BILLING CODE 4165-15-P