Document ID: FDA-2021-N-0031-0012
Agency: fda
Document Type: Notice
Title: Best Practices for Development and Application of Disease Progression
Models; Public Workshop
Posted Date: 2021-10-05T04:00Z

[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 54981-54982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21758]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0031]

Best Practices for Development and Application of Disease 
Progression Models; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) Center for Drug 
Evaluation and Research, and Center for Biologics Evaluation and 
Research, are announcing a public workshop entitled ``Best Practices 
for Development and Application of Disease Progression Models.'' The 
purpose of this public workshop is to discuss the best practices for 
developing disease progression models and their application to support 
drug development decisions, share experiences and case studies that 
highlight the opportunities and limitations in the development and 
application of disease progression models including models for natural 
history of disease and clinical trial simulations, and discuss the 
knowledge gaps and research needed to advance the development and use 
of disease progression models.

DATES: The public workshop will be held on November 19, 2021, from 9:30 
a.m. to 2:30 p.m., Eastern Time. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: This workshop will be virtual only.

FOR FURTHER INFORMATION CONTACT: Maryanne Dingman, Office of Clinical 
Pharmacology, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-8777; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the FDA Reauthorization Act of 2017 (Pub. L. 115-52), FDA 
agreed, in accordance with section I of the Prescription Drug User Fee 
Act (PDUFA) VI Performance Goals, ``Ensuring the Effectiveness of the 
Human Drug Review, part J, Enhancing Regulatory Decision Tools to 
Support Drug Development and Review,'' to hold several workshops to 
identify best practices for model-informed drug development. This 
workshop, ``Best Practices for Development and Application of Disease 
Progression Models,'' fulfills FDA's performance commitment under PDUFA 
VI.

II. Topics for Discussion at the Public Workshop

    The following topics will be discussed at the public workshop:
     Role of disease models in drug development and regulatory 
review;
     Lessons learned from past experiences of applying disease 
models in drug development;
     Best practice considerations for disease modeling to 
support drug development and regulatory decisions; and
     Best practice considerations for clinical trial 
simulations based on disease progression/natural history models to 
support drug development and regulatory decisions.

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register by November 9, 2021, at https://go.usa.gov/xMxPZ.
    If you need special accommodations due to a disability, please 
contact

[[Page 54982]]

Maryanne Dingman (see FOR FURTHER INFORMATION CONTACT) no later than 
November 9, 2021.
    Streaming Webcast of the Public Workshop: This public workshop will 
be webcast. A live webcast of this workshop will be available at 
https://go.usa.gov/xMxPZ on the day of the workshop.
    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.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. It will also be accessible at https://go.usa.gov/xMxPZ.

    Dated: September 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21758 Filed 10-4-21; 8:45 am]
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