United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-06-20 article Notices D09002ee1c7fb58b1 D09002ee1c7fb5936 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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 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: 78 FR 36787 https://www.govinfo.gov/app/details/FR-2013-06-19/2013-14580 2013-14580 fr19jn13-88 4160-01-P Docket No. FDA-2013-N-0001 https://www.govinfo.gov/app/details/FR-2013-06-19/2013-14580 https://www.govinfo.gov/content/pkg/FR-2013-06-19/html/2013-14580.htm https://www.govinfo.gov/content/pkg/FR-2013-06-19/pdf/2013-14580.pdf 2 p. 36787 36788 78 FR 36787 Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study; Public Workshop; Federal Register Vol. 78, Issue NOTICE 2013-14580 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-N-0001 4160-01-P 2013-14580 Notice of public workshop.

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 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:

Meetings: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study , devi.kozeli@fda.hhs.gov http://www.hesiglobal.org/i4a/pages/index.cfm?pageID=3620 https://duke.qualtrics.com/SE/?SID=SV_bmv7T8GPm4IAPd3 https://evm.auxserv.duke.edu/iebms/reg/reg_p1_form.aspx?oc=10&ct=DCRIHBD09&eventid=50715 Vol. 78, no. 118 Office of the Federal Register, National Archives and Records Administration 2013-06-19 continuing daily deposited born digital 464 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-06-19 P0b002ee18501a822 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19jn13 https://www.govinfo.gov/app/details/FR-2013-06-19 https://www.govinfo.gov/content/pkg/FR-2013-06-19/pdf/FR-2013-06-19.pdf https://www.govinfo.gov/content/pkg/FR-2013-06-19/xml/FR-2013-06-19.xml fdlp 36645 37099 DGPO 2013-06-20 2024-06-03 FR-2013-06-19 machine generated eng FR FR-2013-06-19 78 118