Document ID: FDA-2021-N-0001-0001
Agency: fda
Document Type: Notice
Title: Model Informed Drug Development Approaches for Immunogenicity 
Assessments; Public Workshop
Posted Date: 2021-04-23T04:00Z

[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21753-21754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08487]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0001]

Model Informed Drug Development Approaches for Immunogenicity 
Assessments; 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 Biologics 
Evaluation and Research, in collaboration with the Center for Drug 
Evaluation and Research, is announcing the following public workshop 
entitled ``Model Informed Drug Development Approaches for 
Immunogenicity Assessments.'' The purpose of this public workshop is to 
discuss the best practices and future directions of quantitative 
methods for predicting immunogenicity of biological products. This 
public workshop is also being conducted to satisfy one of FDA's 
performance goals included in the sixth reauthorization of the 
Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA 
Reauthorization Act of 2017 (FDARA), to hold a series of workshops 
related to model-informed drug development (MIDD).

DATES: The public workshop will be held virtually on June 9, 2021, from 
8 a.m. to 5 p.m., Eastern Time. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all participants will be joining this public workshop via an online 
teleconferencing platform. The public workshop will be held virtually 
via Adobe Connect. Webcast information will be provided upon completion 
of registration.

FOR FURTHER INFORMATION CONTACT: Loni Warren Henderson or Sherri 
Revell, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1118, Silver 
Spring, MD 20993, 240-402-8010, CBERPublicEvents@fda.hhs.gov (subject 
line: MIDD Workshop).

SUPPLEMENTARY INFORMATION:

I. Background

    Under FDARA, and in accordance with section I, part J of the PDUFA 
VI Performance Goals, FDA agreed to convene a series of workshops to 
identify best practices for MIDD (https://www.fda.gov/media/99140/download, see page 27). Each workshop focuses on current and emerging 
scientific approaches, including methodological limitations. The 
workshop announced in this notice fulfills FDA's performance commitment 
under PDUFA VI, specifically for modeling immunogenicity and correlates 
of protection for evaluating biological products, including vaccines 
and blood products.

II. Topics for Discussion at the Public Workshop

    Topics for discussion include the following:
    1. Current in silico methodologies used to assess drug 
immunogenicity;
    2. Available data resources and data needs for MIDD approaches to 
evaluate immunogenicity at various stages of drug development;
    3. Possible applications and limitations of MIDD approaches for 
desired immunogenicity of vaccine/allergenic products; and
    4. Insight into the possible future applications of MIDD and good 
modeling practices.
    A detailed agenda will be posted in advance of the workshop at 
https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/workshops-meetings-conferences-biologics.

[[Page 21754]]

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online by May 26, 2021, at https://www.eventbrite.com/e/model-informed-drug-development-approaches-for-immunogenicity-assessments-tickets-138618787525. 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.
    If you need special accommodations due to a disability, please 
contact Loni Warren Henderson or Sherri Revell (see FOR FURTHER 
INFORMATION CONTACT) no later than May 26, 2021. Please note, Computer 
Aided Realtime Translation/captioning will be available.
    Streaming Webcast of the Public Workshop: This public workshop will 
be streamed via webcast only.
    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 workshop 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, 240-402-7500. A link to the transcript will also 
be available on the internet at https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/workshops-meetings-conferences-biologics.

    Dated: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08487 Filed 4-22-21; 8:45 am]
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