[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, [email protected].
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]
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