Notice2024-16365
Enhancing Diversity in Therapeutics Development for Pediatric Patients; Public Workshop
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 7, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Enhancing Diversity in Therapeutics Development for Pediatric Patients." The aim of the public workshop is to explore strategies to increase the enrollment of historically underrepresented populations in pediatric clinical trials and to help improve the strength and generalizability of the evidence for the intended use population.
Full Text
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<title>Federal Register, Volume 89 Issue 152 (Wednesday, August 7, 2024)</title>
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[Federal Register Volume 89, Number 152 (Wednesday, August 7, 2024)]
[Notices]
[Page 64467]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16365]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0001]
Enhancing Diversity in Therapeutics Development for Pediatric
Patients; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Enhancing Diversity
in Therapeutics Development for Pediatric Patients.'' The aim of the
public workshop is to explore strategies to increase the enrollment of
historically underrepresented populations in pediatric clinical trials
and to help improve the strength and generalizability of the evidence
for the intended use population.
DATES: The public workshop will be held on September 6, 2024, from 9
a.m. to 5 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the registered
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>. The workshop will also be streamed online.
FOR FURTHER INFORMATION CONTACT: Julie Levin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6481, Silver Spring, MD 20993, 202-567-
7565, or <a href="/cdn-cgi/l/email-protection#efa0a1abbf9a8d83868ca2bba8bc9a9f9f809d9baf898b8ec187879cc1888099"><span class="__cf_email__" data-cfemail="9ad5d4decaeff8f6f3f9d7ceddc9efeaeaf5e8eedafcfefbb4f2f2e9b4fdf5ec">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Clinical trials in children are essential for obtaining data on the
safety and effectiveness of medical products in children and to protect
children from the risks associated with exposure to medical products
that may be unsafe or ineffective for their intended uses in children.
In some therapeutic areas, participation in clinical trials may be an
important component of a participant's clinical care. Pediatric drug
development programs should consider the clinical and demographic
factors that impact the generalizability of study results with respect
to the patient population that will use the product once it is
approved.
II. Topics for Discussion at the Public Workshop
FDA, in collaboration with the University of Maryland Center of
Excellence in Regulatory Science and Innovation, is convening a 1-day
workshop to explore strategies for enrolling historically
underrepresented populations in pediatric clinical trials. The specific
topics to be covered include, but are not limited to, the following:
<bullet> Understanding the current state and challenges of
pediatric clinical trial participation;
<bullet> Understanding metrics for assessing representative
clinical study enrollment, including considerations of disease
prevalence and incidence across subgroups of the pediatric population;
and
<bullet> Discussing key elements of a strategy to include a more
representative population, including trial design and methodological
considerations, community engagement, recruitment and retention
practices, and other related topics.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: <a href="https://www.fda.gov/drugs/news-events-human-drugs/adept-9-public-workshop-enhancing-diversity-therapeutics-development-pediatric-patients-09062024">https://www.fda.gov/drugs/news-events-human-drugs/adept-9-public-workshop-enhancing-diversity-therapeutics-development-pediatric-patients-09062024</a>. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop in person must register by August 23, 2024, at 5 p.m. Eastern
Time; virtual attendees may register by September 6, 2024, at 9 a.m.
Eastern Time. Early registration is recommended because seating is
limited; therefore, FDA may limit the number of participants from each
organization. Registrants will receive confirmation when they have been
accepted. If time and space permit, onsite registration on the day of
the public workshop will be provided beginning at 8:15 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
If you need special accommodations due to a disability, please
contact Julie Levin at 202-567-7565 or <a href="/cdn-cgi/l/email-protection#7d3233392d081f11141e30293a2e080d0d120f093d1b191c5315150e531a120b"><span class="__cf_email__" data-cfemail="1857565c486d7a74717b554c5f4b6d6868776a6c587e7c793670706b367f776e">[email protected]</span></a>
no later than August 16, 2024.
Streaming Webcast of the Public Workshop: This public workshop will
also be streamed virtually via Zoom. A link will be provided via email
to registered participants. If you have never attended a Zoom event
before, test your connection at <a href="https://zoom.us/test">https://zoom.us/test</a>. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible on the workshop
website.
(Notice of this meeting is given pursuant to 21 CFR 10.65.)
Dated: July 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16365 Filed 8-6-24; 8:45 am]
BILLING CODE 4164-01-P
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