Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 1105-1106 [2024-00264]
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1105
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Direct Financial Support Program .......................................
Infrastructure Program .........................................................
Multipurpose or Hybrid Program ..........................................
619
219
1,044
1
1
1
619
219
1,044
2.7
4.8
3.1
1,671.3
1,051.2
3,236.4
Total ..............................................................................
1,882
........................
1,882
........................
5,958.9
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. 2024–00210 Filed 1–8–24; 8:45 am]
BILLING CODE 4165–15–P
registration, https://www.hrsa.gov/
advisory-committees/heritabledisorders/, by the deadline of
12 p.m. ET on Friday, January 26, 2024.
Instructions on how to access the
meeting via webcast will be provided
upon registration. If you are a nonUnited States citizen who would like to
attend the January meeting in-person,
please contact ACHDNC@hrsa.gov by
January 11, 2024.
Kim
Morrison, Maternal and Child Health
Bureau, HRSA, 5600 Fishers Lane,
Room, Rockville, Maryland 20857; 301–
822–4978; or ACHDNC@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
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 (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.
SUPPLEMENTARY INFORMATION:
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 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. 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/.
DATES: Monday, January 29, 2024, from
10 a.m. to 5 p.m. Eastern Time (ET) and
Tuesday, January 30, 2024, from 10 a.m.
to 3 p.m. ET.
ADDRESSES: This meeting will be held in
person with webcast options. While this
meeting is open to the public, advance
registration is required. Please visit the
ACHDNC website for information on
SUMMARY:
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Total
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During the January 29–30, 2024,
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
topics:
(1) A possible presentation on
qualitative research that focuses on
family perspectives;
(2) Updates from Committee ad hoc
topic groups. Potential topics include:
the nomination process and revisions to
the decision matrix;
(3) An update on the evidence review
of Duchenne muscular dystrophy
nomination; and
(4) 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 the second
meeting day, on January 30, 2024,
whether to recommend to the Secretary
adding Krabbe disease to the RUSP
(with potential implications under
section 2713 of the Public Health
Service Act, as noted above).
The agenda for this meeting includes
a potential vote to recommend a
nominated condition (Krabbe disease)
be added by the Secretary to the RUSP.
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 Tuesday, January 30,
2024. Members of the public registered
to provide oral public comments on all
other newborn screening related topics
are tentatively scheduled to provide
E:\FR\FM\09JAN1.SGM
09JAN1
1106
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
their statements on Monday, January 29,
2024. Requests to provide a written
statement or make oral comments to
ACHDNC must be submitted via the
registration website by 12 p.m. ET on
Tuesday, January 17, 2024. Written
comments will be shared with the
Committee prior to the meeting so that
they have an opportunity to consider
them in advance of the meeting.
Individuals who need special assistance
or another reasonable accommodation
should notify Kim Morrison at the
address and phone number listed above
at least 10 business days prior to the
meeting.
Since this meeting occurs in a federal
government building, attendees must go
through a security check to enter the
building. Non-United States Citizen
attendees must notify HRSA of their
planned attendance at least 15 business
days prior to the meeting in order to
facilitate their entry into the building.
All attendees are required to present
government-issued identification prior
to entry.
Extramural Research, National Eye Institute,
National Institutes of Health, 6700 B
Rockledge Dr., Rockville, MD 20892, 301–
451–2020, hoshawb@mail.nih.gov.
Name of Committee: National Eye Institute
Special Emphasis Panel; Clinical
Applications.
Date: February 27, 2024.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Eye Institute, 6700
Rockledge Drive, Bethesda, MD 20817
(Virtual Meeting).
Contact Person: Ashley Fortress, Ph.D.,
Designated Federal Official, Division of
Extramural Activities, National Eye Institute,
National Institutes of Health, 6700 B
Rockledge Dr., Bethesda, MD 20817, (301)
451–2020 ashley.fortress@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.867, Vision Research,
National Institutes of Health, HHS)
Dated: January 4, 2024.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–00212 Filed 1–8–24; 8:45 am]
BILLING CODE 4140–01–P
Maria G. Button,
Director, Executive Secretariat.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2024–00264 Filed 1–8–24; 8:45 am]
BILLING CODE 4165–15–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Mental Health;
Notice of Closed Meetings
National Institutes of Health
National Eye Institute; Notice of Closed
Meetings
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 1009 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: National Eye Institute
Special Emphasis Panel; Center Core Grant
for Vision Research (P30).
Date: February 20, 2024.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Eye Institute, 6700B
Rockledge Drive, Bethesda, MD 20817
(Virtual Meeting).
Contact Person: Brian Hoshaw, Ph.D.,
Designated Federal Official, Division of
VerDate Sep<11>2014
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Jkt 262001
Pursuant to section 1009 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: National Institute of
Mental Health Special Emphasis Panel;
Measures to Advance Quality in Mental
Health Services.
Date: February 6, 2024.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
PO 00000
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Fmt 4703
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Neuroscience Center, 6001 Executive Blvd.
Bethesda, MD 20852, 301–500–5829,
serena.chu@nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; NonPharmacological Clinical Trials.
Date: February 8, 2024.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Bethesda, MD 20852, 301–500–5829,
serena.chu@nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
BRAIN Initiative: Research on the Ethical
Implications of Advancements in
Neurotechnology and Brain Science (R01).
Date: February 9, 2024.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Rebecca Steiner Garcia,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Bethesda, MD 20892–9608, 301–443–4525,
steinerr@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; Early
Phase Clinical Trials: Pharma/Device and K
Awards.
Date: February 22, 2024.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Regina Dolan-Sewell,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Bethesda, MD 20852, (240) 796–6785,
regina.dolan-sewell@nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
BRAIN R01.
Date: February 28, 2024.
Time: 11:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard Rockville, MD 20852, (Virtual
Meeting).
Contact Person: EMMA Perez-Costas,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
E:\FR\FM\09JAN1.SGM
09JAN1
Agencies
[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1105-1106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00264]
-----------------------------------------------------------------------
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 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. 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: Monday, January 29, 2024, from 10 a.m. to 5 p.m. Eastern Time
(ET) and Tuesday, January 30, 2024, from 10 a.m. to 3 p.m. ET.
ADDRESSES: This meeting will be held in person with webcast options.
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 Friday, January
26, 2024. Instructions on how to access the meeting via webcast will be
provided upon registration. If you are a non-United States citizen who
would like to attend the January meeting in-person, please contact
[email protected] by January 11, 2024.
FOR FURTHER INFORMATION CONTACT: Kim Morrison, Maternal and Child
Health Bureau, HRSA, 5600 Fishers Lane, Room, Rockville, Maryland
20857; 301-822-4978; 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 (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 January 29-30, 2024, 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 topics:
(1) A possible presentation on qualitative research that focuses on
family perspectives;
(2) Updates from Committee ad hoc topic groups. Potential topics
include: the nomination process and revisions to the decision matrix;
(3) An update on the evidence review of Duchenne muscular dystrophy
nomination; and
(4) 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 the
second meeting day, on January 30, 2024, whether to recommend to the
Secretary adding Krabbe disease to the RUSP (with potential
implications under section 2713 of the Public Health Service Act, as
noted above).
The agenda for this meeting includes a potential vote to recommend
a nominated condition (Krabbe disease) be added by the Secretary to the
RUSP. 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 Tuesday, January 30, 2024. Members of the
public registered to provide oral public comments on all other newborn
screening related topics are tentatively scheduled to provide
[[Page 1106]]
their statements on Monday, January 29, 2024. Requests to provide a
written statement or make oral comments to ACHDNC must be submitted via
the registration website by 12 p.m. ET on Tuesday, January 17, 2024.
Written comments will be shared with the Committee prior to the meeting
so that they have an opportunity to consider them in advance of the
meeting. Individuals who need special assistance or another reasonable
accommodation should notify Kim Morrison at the address and phone
number listed above at least 10 business days prior to the meeting.
Since this meeting occurs in a federal government building,
attendees must go through a security check to enter the building. Non-
United States Citizen attendees must notify HRSA of their planned
attendance at least 15 business days prior to the meeting in order to
facilitate their entry into the building. All attendees are required to
present government-issued identification prior to entry.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-00264 Filed 1-8-24; 8:45 am]
BILLING CODE 4165-15-P