[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Page 42849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16709]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0771]


Advancing the Development of Pediatric Therapeutics Complex 
Innovative Trial Design; Public Workshop

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Advancing the Development of 
Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.'' The 
purpose of the public workshop is to discuss applications of complex 
and innovative trial designs in pediatric clinical trials.

DATES: The public workshop will be held virtually on September 1, 2021 
(Day 1), from 10 a.m. to 3 p.m. Eastern Time and September 2, 2021 (Day 
2), from 10 a.m. to 3 p.m. Eastern Time. See the SUPPLEMENTARY 
INFORMATION section for registration information.

ADDRESSES: The public workshop will be held in virtual format only. 
Please note that due to the impact of this COVID-19 pandemic, all 
meeting participants will be joining this public meeting via an online 
teleconferencing platform and will not be held at a specific location.

FOR FURTHER INFORMATION CONTACT: Evangela Covert, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5234, Silver Spring, MD 20993, 301-796-
4075, <a href="/cdn-cgi/l/email-protection#aaefdccbc4cdcfc6cb84e9c5dccfd8deeacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="c287b4a3aca5a7aea3ec81adb4a7b0b682a4a6a3ecaaaab1eca5adb4">[email protected]</span></a>; or Denise Pica-Branco, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6402, Silver Spring, MD 20993, 301-796-
4075, <a href="/cdn-cgi/l/email-protection#eeaa8b80879d8bc0be878d8f8c9c8f808d81ae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="266243484f554308764f454744544748454966404247084e4e5508414950">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Over the last two decades, great advances have been made in 
pediatric drug development. In addition, there is a growing recognition 
that complex and innovative trial designs have the potential to 
optimize drug development in small populations. Innovations that have 
been proposed include Bayesian and other methods of utilizing external 
historical information from previous pediatric trials or other 
populations (such as adults), adaptive designs, bridging biomarkers, 
etc. These designs tend to require more extensive discussion and 
collaboration between drug developers and regulators to implement 
effectively.
    The Complex Innovative Trial Design Pilot Meeting Program (CID 
Program) facilitates and advances the use of these types of designs by 
providing for increased interactions between staff in the Center for 
Drug Evaluation and Research and the Center for Biologics Evaluation 
and Research and sponsors accepted into the program. Several pediatric 
study designs have been accepted into the CID Program. This workshop is 
being organized in collaboration with the CID Program.

II. Topics for Discussion at the Public Workshop

    The main objective of the ``Advancing the Development of Pediatric 
Therapeutics (ADEPT 7) Complex Innovative Trial Design'' workshop is to 
discuss opportunities for leveraging complex and innovative trial 
designs, understand the challenges with their applications, and develop 
solutions on how challenges in the designs can be overcome. The 
workshop will specifically focus on two topics of interest: Bridging 
biomarkers in pediatric extrapolation and Bayesian techniques in 
pediatric studies. In addition, the workshop will allow for an open 
dialogue around the use of these approaches among regulators, industry, 
academia, and patient organizations.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://go.umd.edu/ADEPT7. 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. Early registration is recommended because 
space is limited; therefore, FDA may limit the number of participants 
from each organization.
    If you need special accommodations due to a disability, please 
contact
    Evangela Covert or Denise Pica-Branco (see FOR FURTHER INFORMATION 
CONTACT) no later than August 18, 2021, by 5 p.m. Eastern Time.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast at the following site: https://collaboration.fda.gov/adept7.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

    Dated: August 2, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-16709 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-P


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