Meeting of the Advisory Commission on Childhood Vaccines, 70680-70681 [2023-22584]
Download as PDF
<![CDATA[
ddrumheller on DSK120RN23PROD with NOTICES1
70680
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of digital
health, such as AI/ML, augmented
reality, virtual reality, digital
therapeutics, wearables, remote patient
monitoring, software development, user
experience, real-world data, real-world
evidence, patient-generated health data,
interoperability, personalized medicine/
genetics, decentralized clinical trials,
cybersecurity, and implementation in
clinical practice of and patient
experience with digital health, as well
as other relevant areas. Members will be
invited to serve for overlapping terms of
up to 4 years. Non-Federal members of
this committee will serve either as
special government employees or nonvoting representatives. Federal members
will serve as regular government
employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who serves as an
individual, but who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons.
The Commissioner or designee shall
also have the authority to select from a
group of individuals nominated by
industry to serve temporarily as nonvoting members who are identified with
and represent industry interests. The
number of temporary members selected
for a particular meeting will depend on
the meeting topic.
In announcing the establishment of
this Advisory Committee under the
Federal Advisory Committee Act (5
U.S.C. 1001 et seq.), FDA is also
soliciting public feedback on potential
topics for this committee to discuss and
upon which to advise the Agency. The
following topics may include, but are
not limited to:
• Transparency and bias management
considerations, including promoting
health equity in DHTs
• Augmented reality and virtual reality
technical and clinical questions
• Transparency and labeling
considerations for ‘‘opaque box’’
algorithms
• Digital therapeutics
• AI/ML
• Input on regulation of AI/ML-enabled
devices
• Real-world data and real-world
evidence
• Patient-generated health data
• Postmarket monitoring considerations
for a total product lifecycle approach
to DHTs
• Interoperability
• Personalized medicine/genetics
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
• Wearables, remote patient monitoring,
and internet of things
• Postmarket monitoring of DHTs
• Technologies to enable decentralized
clinical trials
• Cybersecurity best practices in
software development for cloud-based
software
Elsewhere in this issue of the Federal
Register, FDA is publishing separate
documents regarding: (1) Digital Health
Advisory Committee: Request for
Nominations for Voting Members on a
Public Advisory Committee: Digital
Health Advisory Committee; (2) Request
for Nomination of Individuals and
Consumer Organizations for the Digital
Health Advisory Committee; and (3)
Request for Nomination of Individuals
and Industry Organizations for the
Digital Health Advisory Committee.
FDA intends to publish in the Federal
Register a final rule adding the Digital
Health Advisory Committee to 21 CFR
14.100.
Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22566 Filed 10–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Commission
on Childhood Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Commission on Childhood Vaccines
(ACCV) will hold public meetings for
the 2024 calendar year (CY).
Information about ACCV, agendas, and
materials for these meetings can be
found on the ACCV website at https://
www.hrsa.gov/advisory-committees/
vaccines/.
DATES: ACCV meetings will be held on
March 7, 2024, 10:00 a.m.–4:00 p.m.
Eastern Time (ET); March 8, 2024, 10:00
a.m.–4:00 p.m. ET; September 5, 2024,
10:00 a.m.–4:00 p.m. ET; September 6,
2024, 10:00 a.m.–4:00 p.m. ET.
ADDRESSES: Meetings may be held inperson or by Zoom webinar. For updates
on how the meeting will be held, visit
the ACCV website meeting page
included below 30 business days before
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
the date of the meeting, where
instructions for joining meetings either
in-person or remotely will be posted. Inperson ACCV meetings will be held at
5600 Fishers Lane, Rockville, MD
20857. For meeting information
updates, go to the ACCV website
meeting page at https://www.hrsa.gov/
advisory-committees/vaccines/
meetings.html.
FOR FURTHER INFORMATION CONTACT: Pita
Gomez, Principal Staff Liaison, Division
of Injury Compensation Programs,
HRSA, 5600 Fishers Lane, 8W–25A,
Rockville, MD 20857; 800–338–2382; or
ACCV@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACCV
provides advice and recommendations
to the Secretary of HHS (Secretary) on
policy, program development, and other
issues related to implementation of the
National Vaccine Injury Compensation
Program and concerning other matters
as described under section 2119 of the
Public Health Service Act (42 U.S.C.
300aa–19).
Since priorities dictate meeting times,
be advised that start times, end times,
and agenda items are subject to change.
For CY 2024 meetings, agenda items
may include, but are not limited to:
updates from the Division of Injury
Compensation Programs, Department of
Justice, Office of Infectious Disease and
HIV/AIDS Policy (HHS), Immunization
Safety Office (Centers for Disease
Control and Prevention), National
Institute of Allergy and Infectious
Diseases (National Institutes of Health)
and Center for Biologics Evaluation and
Research (Food and Drug
Administration). Refer to the ACCV
website listed above for all current and
updated information concerning the CY
2024 ACCV meetings, including draft
agendas and meeting materials that will
be posted 5 calendar days before the
meeting.
These meetings are open to the
public. Meetings held by Zoom webinar
will require registration. Registration
details will be provided on our ACCV
website at https://www.hrsa.gov/
advisory-committees/vaccines/
meetings.html. All registrants will be
asked to provide their name, affiliation,
and email address. After registration,
individuals will receive personalized
Zoom information via email.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting(s). Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to ACCV should
E:\FR\FM\12OCN1.SGM
12OCN1
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
be sent to Pita Gomez using the contact
information listed above at least 5
business days before the meeting
date(s).
Individuals who need special
assistance or another reasonable
accommodation should notify Pita
Gomez using the contact information
listed above at least 10 business days
before the meeting(s) they wish to
attend. Since all in-person meetings will
occur in a federal government building,
attendees must go through a security
check to enter the building. Non-U.S.
Citizen attendees must notify HRSA of
their planned attendance at least 20
business days prior to the meeting 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. 2023–22584 Filed 10–11–23; 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.
ACTION: Notice.
AGENCY:
In accordance with 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,
November 2, 2023, and Friday,
November 3, 2023. 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: Thursday, November 2, 2023,
from 10:00 a.m. to 4:00 p.m. Eastern
Time (ET) and Friday, November 3,
2023, from 10:00 a.m. to 2:00 p.m. ET.
ADDRESSES: This meeting will be held
via webinar. While this meeting is open
to the public, advance registration is
required.
Please visit the ACHDNC website for
information on registration: https://
www.hrsa.gov/advisory-committees/
heritable-disorders/ by the
deadline of 12:00 p.m. ET on November
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
1, 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
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
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 1
year from the Secretary’s adoption of the
condition for screening.
During the November 2–3, 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) An update on the Krabbe disease
expedited evidence review update;
(2) An update on the Duchenne
Muscular Dystrophy evidence review
update;
(3) An update by the ACHDNC
Decision Matrix ad hoc topic group and
potential vote on revisions to the
ACHDNC Decision Matrix;
(4) A presentation and discussion on
the ACHDNC’s conflict of interest
procedures;
(5) Ad hoc topic group updates; and
(6) A possible presentation on the
National Academies of Sciences,
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
70681
Engineering, and Medicine Workshop
on Next Generation Screening.
ACHDNC will not vote on
recommending conditions for inclusion
in the Recommended Uniform
Screening Panel during this meeting;
however, Krabbe disease and Duchenne
Muscular Dystrophy evidence review
updates along with a discussion and a
potential vote on revisions to the
ACHDNC Decision Matrix may inform
such potential future recommendations.
Agenda items are subject to change as
priorities dictate. Information about
ACHDNC, including a roster of members
and past meeting summaries, is
available on the ACHDNC website.
Members of the public 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. 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 Thursday,
November 2, 2023. 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 Friday, October 20,
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. 2023–22493 Filed 10–11–23; 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
Infant and Maternal Mortality
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
SUMMARY:
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70680-70681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22584]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Advisory Commission on Childhood Vaccines
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, this
notice announces that the Advisory Commission on Childhood Vaccines
(ACCV) will hold public meetings for the 2024 calendar year (CY).
Information about ACCV, agendas, and materials for these meetings can
be found on the ACCV website at https://www.hrsa.gov/advisory-committees/vaccines/.
DATES: ACCV meetings will be held on March 7, 2024, 10:00 a.m.-4:00
p.m. Eastern Time (ET); March 8, 2024, 10:00 a.m.-4:00 p.m. ET;
September 5, 2024, 10:00 a.m.-4:00 p.m. ET; September 6, 2024, 10:00
a.m.-4:00 p.m. ET.
ADDRESSES: Meetings may be held in-person or by Zoom webinar. For
updates on how the meeting will be held, visit the ACCV website meeting
page included below 30 business days before the date of the meeting,
where instructions for joining meetings either in-person or remotely
will be posted. In-person ACCV meetings will be held at 5600 Fishers
Lane, Rockville, MD 20857. For meeting information updates, go to the
ACCV website meeting page at https://www.hrsa.gov/advisory-committees/vaccines/meetings.html.
FOR FURTHER INFORMATION CONTACT: Pita Gomez, Principal Staff Liaison,
Division of Injury Compensation Programs, HRSA, 5600 Fishers Lane, 8W-
25A, Rockville, MD 20857; 800-338-2382; or [email protected].
SUPPLEMENTARY INFORMATION: ACCV provides advice and recommendations to
the Secretary of HHS (Secretary) on policy, program development, and
other issues related to implementation of the National Vaccine Injury
Compensation Program and concerning other matters as described under
section 2119 of the Public Health Service Act (42 U.S.C. 300aa-19).
Since priorities dictate meeting times, be advised that start
times, end times, and agenda items are subject to change. For CY 2024
meetings, agenda items may include, but are not limited to: updates
from the Division of Injury Compensation Programs, Department of
Justice, Office of Infectious Disease and HIV/AIDS Policy (HHS),
Immunization Safety Office (Centers for Disease Control and
Prevention), National Institute of Allergy and Infectious Diseases
(National Institutes of Health) and Center for Biologics Evaluation and
Research (Food and Drug Administration). Refer to the ACCV website
listed above for all current and updated information concerning the CY
2024 ACCV meetings, including draft agendas and meeting materials that
will be posted 5 calendar days before the meeting.
These meetings are open to the public. Meetings held by Zoom
webinar will require registration. Registration details will be
provided on our ACCV website at https://www.hrsa.gov/advisory-committees/vaccines/meetings.html. All registrants will be asked to
provide their name, affiliation, and email address. After registration,
individuals will receive personalized Zoom information via email.
Members of the public will have the opportunity to provide
comments. Public participants may submit written statements in advance
of the scheduled meeting(s). Oral comments will be honored in the order
they are requested and may be limited as time allows. Requests to
submit a written statement or make oral comments to ACCV should
[[Page 70681]]
be sent to Pita Gomez using the contact information listed above at
least 5 business days before the meeting date(s).
Individuals who need special assistance or another reasonable
accommodation should notify Pita Gomez using the contact information
listed above at least 10 business days before the meeting(s) they wish
to attend. Since all in-person meetings will occur in a federal
government building, attendees must go through a security check to
enter the building. Non-U.S. Citizen attendees must notify HRSA of
their planned attendance at least 20 business days prior to the meeting
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. 2023-22584 Filed 10-11-23; 8:45 am]
BILLING CODE 4165-15-P
