
[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Notices]
[Page 17169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06889]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Seventh Annual Predictive Safety Testing Consortium/Food and Drug 
Administration Scientific Workshop; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug 
Evaluation and Research (CDER), in cosponsorship with the Critical Path 
Institute (C-Path), is announcing a public scientific workshop to 
discuss the impact of safety biomarkers on drug development. The 
purpose of the workshop is to discuss the following issues: Application 
of toxicometrics as a translational safety strategy that integrates 
nonclinical and clinical safety approaches; uses of rodent and non-
rodent nonclinical species in biomarker qualification; and assay 
validation aspects during biomarker development and qualification.

DATES: The public workshop will be held on April 25, 2016, from 8:30 
a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503 A/B), Silver Spring, MD 20993-0002.
    The FDA Conference Center is a federal facility and is located on 
the White Oak campus and like all federal facilities employs security 
procedures. Entrance for scientific 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Jacqueline Brooks-Leighton, Food and 
Drug Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 4521, Silver Spring, MD 20993, 240-402-
5292, FAX: 301-796-9907, email: jacqueline.brooks-
leighton,@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA and C-Path have expressed a willingness to leverage their 
combined strengths to develop and apply predictive safety testing 
biomarkers in drug development. This annual public workshop is intended 
to bring together leading academic experts, interested pharmaceutical 
companies, regulatory agencies, patient advocacy groups, and non-profit 
organizations.
    This meeting will offer the opportunity to provide updates on the 
progress made in various biomarker development areas by the Predictive 
Safety Testing Consortium, and to discuss issues related to the 
regulatory aspects of qualification and uptake of biomarkers in drug 
development, as well as roadblocks to the sharing of biomarker data by 
the scientific community.

II. Attendance, Registration, and Accommodations

    There is no fee to attend the meeting, but attendees must register 
in advance. Space is limited, and registration will be on a first-come, 
first-served basis. Onsite registration on the day of the workshop is 
not guaranteed but may be possible if space is available. For questions 
regarding registration, please contact Stephanie Codd Anderson, 520-
647-8376, email: scanderson@gmail.com, at the Critical Path Institute.
    Persons interested in attending this meeting in person must 
register online by April 11, 2016 at http://www.cvent.com/d/2fqzl2/4W.
    FDA has verified the Web address, but is not responsible for 
subsequent changes to the Web site after this document publishes in the 
Federal Register. Interested persons without Internet access should 
contact Stephanie Codd Anderson at 520-647-8376 to register.
    The public workshop will also be available to be viewed online via 
webcast at https://collaboration.fda.gov/pstc0416/.
    Workshop attendees with special needs due to a disability should 
contact Stephanie Codd Anderson, 520-647-8376, email: 
scanderson@gmail.com, at the Critical Path Institute at least 7 days 
before the scientific workshop.
    Attendees are responsible for their own hotel accommodations.
    There will not be a transcript for this meeting.

    Dated: March 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06889 Filed 3-25-16; 8:45 am]
 BILLING CODE 4164-01-P


