Workshop To Consider Artificial Intelligence in Drug and Biological Product Development; Public Workshop, 56757-56758 [2024-15125]
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Federal Register / Vol. 89, No. 132 / Wednesday, July 10, 2024 / Notices
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Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Moon Choi, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–2894, email:
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SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing and/or video
conferencing platform.
The Committee will discuss new drug
application 214927, for arimoclomol,
submitted by Zevra Denmark A/S, for
the treatment of adults and pediatric
patients 2 years of age and older with
Niemann-Pick disease type C.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
meeting link. For online participants the
meeting will include slide presentations
with audio and video components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. All electronic and
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ADDRESSES) on or before July 25, 2024,
will be provided to the Committee. Oral
presentations from the public will be
scheduled between approximately
between 2:25 p.m. and 3:25 p.m. Eastern
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Time. Those individuals interested in
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or before July 17, 2024. Time allotted for
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
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also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place both in-person
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This waiver is in the interest of allowing
greater transparency and opportunities
for public participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
The conditions for issuance of a waiver
under 21 CFR 10.19 are met.
Dated: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15127 Filed 7–9–24; 8:45 am]
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56757
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0001]
Workshop To Consider Artificial
Intelligence in Drug and Biological
Product Development; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop titled ‘‘Artificial Intelligence
(AI) in Drug & Biological Product
Development.’’ Convened and
supported by a cooperative agreement
between FDA and the Clinical Trials
Transformation Initiative (CTTI), the
purpose of the public workshop is to
bring drug developers and AI experts
together to discuss guiding principles
for the responsible use of AI in the
development of safe and effective drugs
and biological products. The workshop
format will include presentations and
panel discussions.
SUMMARY:
The public workshop will be
held virtually and in-person on August
6, 2024, from 10 a.m. to 5:30 p.m.
Eastern Time. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
DATES:
Participants can join the
public workshop either virtually using
the Zoom platform or in person at the
FDA Great Room, located at 10903 New
Hampshire Ave., Silver Spring, MD,
20993. The link for the public workshop
will be sent to registrants upon
registration.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Marsha Samson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6330,
Silver Spring, MD 20993–0002, 301–
837–7407, Marsha.Samson@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
This public workshop will convene
experts in AI including drug sponsors,
academia, and technology organizations
to discuss guiding principles that are
being applied by innovators to promote
the responsible use of AI in the
development of safe and effective drugs.
E:\FR\FM\10JYN1.SGM
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56758
Federal Register / Vol. 89, No. 132 / Wednesday, July 10, 2024 / Notices
II. Topics for Discussion at the Public
Workshop
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
At the public workshop, FDA plans to
convene experts in AI to discuss topics,
including but not limited to:
1. Optimizing model design through
multidisciplinary expertise.
Specifically, discussants will explore
the importance of integrating experts
from diverse fields, such as medicine,
statistics, pharmacology, data science,
and engineering to ensure the
development of optimal AI models.
2. Exploring strategies for overcoming
common data-related challenges,
namely, the availability of fit-for-use
data that can be used in drug
development. Topics will include data
availability and access via federated
learning, data quality issues (i.e.,
representativeness of data, bias, etc.),
and the use of synthetic data.
3. Balancing model performance,
explainability, and transparency of AI
models. Additionally, discussants will
share strategies for assessing the need to
integrate humans into the decisionmaking process (human-in-the-loop
and/or human-on-the-loop).
4. Identifying key gaps and challenges
hindering the use of AI in drug and
biological product development and
exploring potential strategies,
collaborations, and initiatives to address
these challenges. Considering actionable
next steps to advance the responsible
use of AI in developing safe, effective,
and quality drugs.
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://duke.zoom.us/meeting/
register/tJcrcuqrTMiHdayh1J3JhkCi6XkvmAIFey6.
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Registration is free and people
interested in attending this public
workshop must register to receive a link
to the meeting. Registrants will receive
confirmation email after they register.
If you need special accommodations
due to a disability, please contact
Kelly.Franzetti@duke.edu no later than
July 30, 2024. Please note, closed
captioning will be available
automatically.
Dated: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15125 Filed 7–9–24; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:33 Jul 09, 2024
Jkt 262001
Center for Scientific Review; Notice of
Closed Meetings
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: Center for Scientific
Review Special Emphasis Panel; Small
Business Metabolism.
Date: August 2, 2024.
Time: 12:00 p.m. to 2:30 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: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, dianne.hardy@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics on HIV Comorbidities,
Coinfections and Associated Cancers.
Date: August 5, 2024.
Time: 10:00 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: Raul Rojas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6185,
Bethesda, MD 20892, (301) 451–6319, rojasr@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Respiratory Sciences.
Date: August 6–7, 2024.
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: Michael L. Bloom, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6187,
MSC 7804, Bethesda, MD 20892, 301–451–
0132, bloomm2@mail.nih.gov.
PO 00000
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(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: July 5, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–15112 Filed 7–9–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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: Center for Scientific
Review Special Emphasis Panel; Small
Business Metabolism.
Date: July 26, 2024.
Time: 1:00 p.m. to 3:30 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: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, dianne.hardy@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Hypersensitivity,
Autoimmunity and Immune-mediated
Diseases.
Date: August 2, 2024.
Time: 11:00 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: Alok Mulky, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4203,
Bethesda, MD 20892, (301) 435–3566,
mulkya@mail.nih.gov.
E:\FR\FM\10JYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 132 (Wednesday, July 10, 2024)]
[Notices]
[Pages 56757-56758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15125]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0001]
Workshop To Consider Artificial Intelligence in Drug and
Biological Product Development; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop titled ``Artificial
Intelligence (AI) in Drug & Biological Product Development.'' Convened
and supported by a cooperative agreement between FDA and the Clinical
Trials Transformation Initiative (CTTI), the purpose of the public
workshop is to bring drug developers and AI experts together to discuss
guiding principles for the responsible use of AI in the development of
safe and effective drugs and biological products. The workshop format
will include presentations and panel discussions.
DATES: The public workshop will be held virtually and in-person on
August 6, 2024, from 10 a.m. to 5:30 p.m. Eastern Time. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: Participants can join the public workshop either virtually
using the Zoom platform or in person at the FDA Great Room, located at
10903 New Hampshire Ave., Silver Spring, MD, 20993. The link for the
public workshop will be sent to registrants upon registration.
FOR FURTHER INFORMATION CONTACT: Marsha Samson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6330, Silver Spring, MD 20993-0002, 301-
837-7407, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
This public workshop will convene experts in AI including drug
sponsors, academia, and technology organizations to discuss guiding
principles that are being applied by innovators to promote the
responsible use of AI in the development of safe and effective drugs.
[[Page 56758]]
II. Topics for Discussion at the Public Workshop
At the public workshop, FDA plans to convene experts in AI to
discuss topics, including but not limited to:
1. Optimizing model design through multidisciplinary expertise.
Specifically, discussants will explore the importance of integrating
experts from diverse fields, such as medicine, statistics,
pharmacology, data science, and engineering to ensure the development
of optimal AI models.
2. Exploring strategies for overcoming common data-related
challenges, namely, the availability of fit-for-use data that can be
used in drug development. Topics will include data availability and
access via federated learning, data quality issues (i.e.,
representativeness of data, bias, etc.), and the use of synthetic data.
3. Balancing model performance, explainability, and transparency of
AI models. Additionally, discussants will share strategies for
assessing the need to integrate humans into the decision-making process
(human-in-the-loop and/or human-on-the-loop).
4. Identifying key gaps and challenges hindering the use of AI in
drug and biological product development and exploring potential
strategies, collaborations, and initiatives to address these
challenges. Considering actionable next steps to advance the
responsible use of AI in developing safe, effective, and quality drugs.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: https://duke.zoom.us/meeting/register/tJcrcu-qrTMiHdayh1J3JhkCi6XkvmAIFey6. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone.
Registration is free and people interested in attending this public
workshop must register to receive a link to the meeting. Registrants
will receive confirmation email after they register.
If you need special accommodations due to a disability, please
contact [email protected] no later than July 30, 2024. Please
note, closed captioning will be available automatically.
Dated: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15125 Filed 7-9-24; 8:45 am]
BILLING CODE 4164-01-P
