Enhancing Diversity in Therapeutics Development for Pediatric Patients; Public Workshop, 64467 [2024-16365]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 89, Number 152 (Wednesday, August 7, 2024)]
[Notices]
[Page 64467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.fda.gov/about-fda/visitor-information. 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 [email protected].

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:
     Understanding the current state and challenges of 
pediatric clinical trial participation;
     Understanding metrics for assessing representative 
clinical study enrollment, including considerations of disease 
prevalence and incidence across subgroups of the pediatric population; 
and
     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: https://www.fda.gov/drugs/news-events-human-drugs/adept-9-public-workshop-enhancing-diversity-therapeutics-development-pediatric-patients-09062024. 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 [email protected] 
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 https://zoom.us/test. 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