81_FR_17228 81 FR 17169 - Seventh Annual Predictive Safety Testing Consortium/Food and Drug Administration Scientific Workshop; Public Workshop

81 FR 17169 - Seventh Annual Predictive Safety Testing Consortium/Food and Drug Administration Scientific Workshop; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 59 (March 28, 2016)

Page Range17169-17169
FR Document2016-06889

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.

Federal Register, Volume 81 Issue 59 (Monday, March 28, 2016) 
[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Notices]
[Page 17169]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected], 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: 
[email protected], 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

Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Notices 17169 Number of Average Number of Total burden Instrument responses per burden hours respondents hours respondent per response Administrative data request ............................................................................. 49 1 24 1,176 Estimated Total Annual Burden issues: Application of toxicometrics as a well as roadblocks to the sharing of Hours: 1,176. translational safety strategy that biomarker data by the scientific integrates nonclinical and clinical safety community. Additional Information approaches; uses of rodent and non- Copies of the proposed collection may rodent nonclinical species in biomarker II. Attendance, Registration, and be obtained by writing to the qualification; and assay validation Accommodations Administration for Children and aspects during biomarker development Families, Office of Planning, Research There is no fee to attend the meeting, and qualification. and Evaluation, 330 C Street SW., but attendees must register in advance. DATES: The public workshop will be Washington, DC 20201. Attention Space is limited, and registration will be held on April 25, 2016, from 8:30 a.m. Reports Clearance Officer. All requests on a first-come, first-served basis. Onsite to 5 p.m. should be identified by the title of the registration on the day of the workshop ADDRESSES: The public workshop will information collection. Email address: is not guaranteed but may be possible if be held at the FDA White Oak Campus, infocollection@acf.hhs.gov. space is available. For questions 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. regarding registration, please contact OMB Comment 1503 A/B), Silver Spring, MD 20993– Stephanie Codd Anderson, 520–647– OMB is required to make a decision 8376, email: scanderson@gmail.com, at 0002. concerning the collection of information the Critical Path Institute. The FDA Conference Center is a between 30 and 60 days after federal facility and is located on the Persons interested in attending this publication of this document in the White Oak campus and like all federal meeting in person must register online Federal Register. Therefore, a comment facilities employs security procedures. by April 11, 2016 at http:// is best assured of having its full effect Entrance for scientific workshop www.cvent.com/d/2fqzl2/4W. if OMB receives it within 30 days of participants (non-FDA employees) is publication. Written comments and FDA has verified the Web address, but through Building 1, where routine recommendations for the proposed is not responsible for subsequent security check procedures will be information collection should be sent changes to the Web site after this performed. For parking and security directly to the following: Office of document publishes in the Federal information, please refer to http:// Management and Budget, Paperwork Register. Interested persons without www.fda.gov/AboutFDA/ Reduction Project, Email: OIRA_ Internet access should contact WorkingatFDA/BuildingsandFacilities/ SUBMISSION@OMB.EOP.GOV, Attn: Stephanie Codd Anderson at 520–647– WhiteOakCampusInformation/ Desk Officer for the Administration for 8376 to register. ucm241740.htm. Children and Families. FOR FURTHER INFORMATION CONTACT: The public workshop will also be Robert Sargis, Jacqueline Brooks-Leighton, Food and available to be viewed online via Reports Clearance Officer. Drug Administration, Center for Drug webcast at https://collaboration.fda.gov/ [FR Doc. 2016–06915 Filed 3–25–16; 8:45 am] Evaluation and Research, 10903 New pstc0416/. BILLING CODE 4184–01–P Hampshire Ave., Bldg. 21, Rm. 4521, Workshop attendees with special Silver Spring, MD 20993, 240–402– needs due to a disability should contact 5292, FAX: 301–796–9907, email: Stephanie Codd Anderson, 520–647– DEPARTMENT OF HEALTH AND jacqueline.brooks-leighton,@ HUMAN SERVICES 8376, email: scanderson@gmail.com, at fda.hhs.gov. the Critical Path Institute at least 7 days Food and Drug Administration SUPPLEMENTARY INFORMATION: before the scientific workshop. [Docket No. FDA–2016–N–0001] I. Background Attendees are responsible for their FDA and C-Path have expressed a own hotel accommodations. Seventh Annual Predictive Safety willingness to leverage their combined There will not be a transcript for this Testing Consortium/Food and Drug strengths to develop and apply meeting. Administration Scientific Workshop; predictive safety testing biomarkers in Public Workshop Dated: March 22, 2016. drug development. This annual public workshop is intended to bring together Leslie Kux, AGENCY: Food and Drug Administration, HHS. leading academic experts, interested Associate Commissioner for Policy. ACTION: Notice of public workshop. pharmaceutical companies, regulatory [FR Doc. 2016–06889 Filed 3–25–16; 8:45 am] agencies, patient advocacy groups, and BILLING CODE 4164–01–P SUMMARY: The Food and Drug non-profit organizations. Administration’s (FDA’s) Center for This meeting will offer the Lhorne on DSK5TPTVN1PROD with NOTICES Drug Evaluation and Research (CDER), opportunity to provide updates on the in cosponsorship with the Critical Path progress made in various biomarker Institute (C-Path), is announcing a development areas by the Predictive public scientific workshop to discuss Safety Testing Consortium, and to the impact of safety biomarkers on drug discuss issues related to the regulatory development. The purpose of the aspects of qualification and uptake of workshop is to discuss the following biomarkers in drug development, as VerDate Sep<11>2014 14:52 Mar 25, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 9990 E:\FR\FM\28MRN1.SGM 28MRN1


Document Created: 2016-03-26 00:12:56
Document Modified: 2016-03-26 00:12:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop.
DatesThe public workshop will be held on April 25, 2016, from 8:30 a.m. to 5 p.m.
ContactJacqueline 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.
FR Citation81 FR 17169 
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