[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Notices]
[Pages 36787-36788]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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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