Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 17613-17614 [2021-06940]

Download as PDF 17613 Federal Register / Vol. 86, No. 63 / Monday, April 5, 2021 / Notices topic areas of interest to the Federal Office of Rural Health Policy, including: (a) Access to care; (b) population demographics; (c) staffing; (d) consortium/network; (e) sustainability; and (f) project specific domains. All measures will evaluate HRSA’s progress toward achieving its goals. The proposed changes of RHND measures are a result of the accumulation of grantee feedback, peerreviewed research, and information gathered from the previously approved RHND program measures. The proposed changes include additional questions surrounding the network’s components of sustainability. Questions surrounding Health Information Technology and Telehealth have been modified to reflect updated knowledge on the use of both and to improve understanding of how these important technologies are affecting HRSA grantees. Additional National Quality Forum measures were also included in an effort to allow uniform collection efforts throughout the Federal Office of Rural Health Policy. Likely Respondents: Respondents will be awardees of the Rural Health Network Development Program. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Form name Total responses Average burden per response (in hours) Total burden hours Performance Improvement and Measurement System Database .......................................................................... 44 1 44 6 264 Total .............................................................................. 44 ........................ 44 ........................ 264 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. 2021–06880 Filed 4–2–21; 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: jbell on DSKJLSW7X2PROD with NOTICES Number of responses per respondent 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 SUMMARY: VerDate Sep<11>2014 17:23 Apr 02, 2021 Jkt 253001 (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/heritabledisorders/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 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 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 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; E:\FR\FM\05APN1.SGM 05APN1 17614 Federal Register / Vol. 86, No. 63 / Monday, April 5, 2021 / Notices jbell on DSKJLSW7X2PROD with NOTICES (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, consumerfriendly 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] BILLING CODE 4165–15–P VerDate Sep<11>2014 17:23 Apr 02, 2021 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; 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. 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 purpose of this meeting is to evaluate requests for preclinical development resources for potential new therapeutics for the treatment of cancer. The outcome of the evaluation will provide information to internal NCI committees that will decide whether NCI should support requests and make available contract resources for development of the potential therapeutic to improve the treatment of various forms of cancer. The research proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the proposed research projects, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; FEB2021 Cycle 37 NExT SEP Committee Meeting. Date: April 21, 2021. Time: 9:00 a.m. to 3:00 p.m. Agenda: To evaluate the NCI Experimental Therapeutics Program Portfolio. Place: National Institutes of Health, 9000 Rockville Pike, Building 31, Room 3A44, Bethesda, Maryland 20892 (WebEx Meeting). Contact Persons: Barbara Mroczkowski, Ph.D. Executive Secretary, Discovery Experimental Therapeutics Program, National Cancer Institute, NIH, 31 Center Drive, Room 3A44, Bethesda, MD 20817, (301) 496–4291, mroczkoskib@mail.nih.gov. Toby Hecht, Ph.D., Executive Secretary, Development Experimental Therapeutics Program, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 3W110, Rockville, MD 20850, (240) 276–5683, toby.hecht2@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 Dated: March 30, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–06890 Filed 4–2–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276– 0361. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: 2022 National Survey on Drug Use and Health (OMB No. 0930–0110) The National Survey on Drug Use and Health (NSDUH) is a survey of the U.S. civilian, non-institutionalized population aged 12 years old or older. The data are used to determine the prevalence of use of tobacco products, alcohol, illicit substances, and illicit use of prescription drugs. The results are used by SAMHSA, the Office of National Drug Control Policy (ONDCP), federal government agencies, and other organizations and researchers to establish policy, direct program activities, and better allocate resources. As certain parts of the United States reduce COVID–19 restrictions, NSDUH in-person data collection will proceed where possible. However, to ensure E:\FR\FM\05APN1.SGM 05APN1

Agencies

[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.

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

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]
BILLING CODE 4165-15-P