Document ID: FDA-2013-N-0001-0052
Agency: fda
Document Type: Notice
Title: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study; Public Workshop
Posted Date: 2013-06-19T04:00Z

[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Notices]
[Pages 36787-36788]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14580]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk 
Assessment During Drug Development Without the Thorough QT Study; 
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 Cardiac Safety 
Research Consortium, and the International Life Sciences Institute's 
Health and Environmental Sciences Institute (HESI) will cosponsor a 
public workshop entitled ``Rechanneling the Current Cardiac Risk 
Paradigm: Arrhythmia Risk Assessment During Drug Development Without 
the Thorough QT Study.'' The workshop will introduce for discussion a 
new

[[Page 36788]]

nonclinical paradigm for assessing Torsade de Pointes (TdP) risk and 
explore the parameters for an appropriate, strong, nonclinical 
proarrthymia screening method as an alternative to clinical Thorough QT 
studies. The workshop, which will seek input from all attendees, is 
intended to provide a forum for stakeholders, including experts and 
opinion leaders from academia, industry, and regulatory agencies in the 
United States, the European Union, Canada, and Asian countries, to 
discuss what a new framework might look like, the benefits and 
limitations of the current guidelines, and the importance of a uniform 
assay schema.
    Date and Time: The public workshop will be held on July 23, 2013, 
from 8 a.m. to 6 p.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (rm. 1503), Silver Spring, MD 20993.
    Contact Person: Devi Kozeli, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
22, rm. 4183, Silver Spring, MD 20993, 301-796-1128, email: 
devi.kozeli@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
    This workshop will introduce for discussion a new nonclinical 
paradigm for assessing TdP risk and explore the parameters for an 
appropriate, strong, nonclinical proarrthymia screening method as an 
alternative to clinical Thorough QT studies. The workshop, which will 
seek input from all attendees, is intended to provide a forum for 
stakeholders, including experts and opinion leaders from academia, 
industry, and regulatory agencies in the United States, the European 
Union, Canada, and Asian countries, to discuss what a new framework 
might look like, the benefits and limitations of the current 
guidelines, and the importance of a uniform assay schema.
    A description of the planned activities for the workshop can be 
found at: http://www.hesiglobal.org/i4a/pages/index.cfm?pageID=3620 
(FDA has verified this online address but is not responsible for 
subsequent changes to the Web site where it is located after this 
document publishes in the Federal Register.)
    Registration and Accommodations: Registration for non-FDA attendees 
should be performed online at the following address: https://evm.auxserv.duke.edu/iebms/reg/reg_p1_form.aspx?oc=10&ct=DCRIHBD09&eventid=50715. (FDA has verified this 
online address but is not responsible for subsequent changes to the Web 
site where it is located after this document publishes in the Federal 
Register.)
    Registration for FDA attendees is also online, at the following 
address: https://duke.qualtrics.com/SE/?SID=SV_bmv7T8GPm4IAPd3.
    The registration deadline for paying attendees is July 15, 2013. 
With the exception of FDA employees and a limited number of speakers or 
organizers, registrants must pay a registration fee covering the cost 
of facilities, materials, and food. The registration fees for different 
categories of attendee are as follows:

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                            Category                               Cost
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Commercial Entity or Industry, Not Members of HESI..............    $950
Commercial Entity or Industry, HESI Members.....................     600
Academia, Professional Society, or Nonprofit Organization.......     250
Government (non-FDA)............................................     150
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    Seats are limited, and conference space will be filled in the order 
in which registrations are received. Attendees are responsible for 
their own accommodations.
    If you need special accommodations due to a disability, please 
contact Devi Kozeli (see Contact Person) at least 7 days in advance.

    Dated: June 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14580 Filed 6-18-13; 8:45 am]
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