Document ID: FDA-2019-N-0001-0006
Agency: fda
Document Type: Notice
Title: Implementing the Food and Drug Administration’s Predictive Toxicology
Roadmap: An Update of the Food and Drug Administration’s Activities;
Public Workshop
Posted Date: 2019-08-20T04:00Z

[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Page 43144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17876]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0001]

Implementing the Food and Drug Administration's Predictive 
Toxicology Roadmap: An Update of the Food and Drug Administration's 
Activities; 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 ``Implementing FDA's 
Predictive Toxicology Roadmap: An Update of FDA's Activities.'' The 
purpose of the public workshop is to highlight the work FDA has been 
doing to support and implement FDA's Predictive Toxicology Roadmap.

DATES: The public workshop will be held on September 18, 2019, from 8 
a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503A), Silver Spring, MD 20993. Entrance for the 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/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Laurie-Anne Sayles, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4355, Silver Spring, MD 20993, 301-796-
0621 x4353, Laurie-Anne.Sayles@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In December 2017, FDA launched its Predictive Toxicology Roadmap, a 
six-part framework for integrating predictive toxicology methods into 
safety and risk assessments. Among other recommendations, the Roadmap 
calls for FDA research to identify data gaps and to support intramural 
and extramural research to ensure that the most promising technologies 
are developed, validated, and integrated into regulatory review, if 
applicable.
    FDA held its initial public hearing on the Roadmap, sponsored by 
FDA's cross-agency Toxicology Working Group, on September 12, 2018. 
More information about the Roadmap as well as the initial public 
hearing can be found on the following website: https://www.fda.gov/predictivetoxroadmap.

II. Topics for Discussion at the Public Workshop

    On Wednesday, September 18, 2019, FDA will highlight the work it 
has been doing to support and implement FDA's Predictive Toxicology 
Roadmap.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://www.fda.gov/predictivetoxroadmap.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by Monday, September 16, 2019, 5 p.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 you need special accommodations due to a disability, please 
contact Laurie-Anne Sayles (see FOR FURTHER INFORMATION CONTACT) no 
later than September 11, 2019, 5 p.m. Eastern Time.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. To register for the webcast, please visit the 
following website: https://www.fda.gov/predictivetoxroadmap.
    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.fda.gov/predictivetoxroadmap.

    Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17876 Filed 8-19-19; 8:45 am]
 BILLING CODE 4164-01-P