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U.S. Department of Health and Human Services

Medical Devices

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Public Meeting - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices, September 27-28, 2012

The Food and Drug Administration (FDA) is announcing a public meeting entitled "Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices." The purpose of this meeting is to obtain input from academia, Government, industry and other stakeholders on the clinical application and scientific and technological challenges for performance validation of radiation biodosimetry devices.

Date, Time and Location

This meeting will be held September 27-28, 2012 from 8:00 a.m. - 5:00 p.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Room 1503)
Silver Spring, MD 20993

The meeting will be webcasted.

Webcast

The webcast will be available at:

Transcript

Agenda

September 27, 2012

8:00am-8:15amWelcome and Announcements
Maria Chan
8:15am-8:30amIntroduction and Purpose of the Meeting
Jennifer Dickey
Topic: Development Challenges for Radiation Biodosimetry
Moderator: Shyam Kalavar
8:30am-9:00am"Radiation Biodosimetry Research: Academic Perspective"
David Brenner
9:00am-9:30am"BARDA Biodosimetry Program and Shared Regulatory Challenges"
Rodney Wallace
9:30am-10:00am"Department of Defense/AFRRI Subject Matter Expert Perspective"
William Blakely
10:00am-10:30amBreak
10:30am-11:30amPublic Presentations
11:30am-12:00pmPanel Discussion, Moderator: Marcy Beth Grace
David Brenner, Rodney Wallace, William Blakely, Bert Maidment
12:00am-1:00pmLunch
Topic: FDA Regulatory Process for Radiation Biodosimetry
Moderator: Lea Carrington
1:00pm-1:45pm"FDA’s Medical Countermeasures Initiative (MCMi)"
Alan Liss
1:45pm-2:15pm“Regulation of Biodosimetry Tools”
Michael O’Hara
2:15pm-2:45pmBreak
2:45pm-3:45pmPanel Discussion, Moderator: Brenda Brooks
Alan Liss, Michael O’Hara, Carmen Maher, Jennifer Dickey
3:45pm-4:15pm

Wrap-up and Summary
Tremel Faison

September 28, 2012

Topic: The Use of Animal Models in Radiation Biodosimetry Efficacy Testing
Moderator: William Dickerson
8:15am-8:30amIntroduction and Summary of Yesterday
Tremel Faison
8:30am-9:00am"The Nuclear Event: What do We Need in Order to Treat Lethally Irradiated Personnel? - Do We Need a Number or a Set of Signs/Symptoms?"
Thomas MacVittie
9:00am-9:30am

"The Use of Mouse Models in Medical Countermeasure Development"
Christie Orschell

9:30am-9:45am"Group to Link nonhuman Primate and Human radiation effects"
Thomas MacVittie
9:45am-10:00am“Radiation Heatlh Threats: What We Know about Ionizing Radiation and Specific Radionuclides”
Alla Shapiro
10:00am-10:30amBreak
10:30am-10:50amPublic Presentations
10:50am-11:20pmPanel Session Discussion, Moderator: Lynne Wathen
Thomas MacVittie, Christie Orschell, Alla Shapiro, Joel Beren
11:20pm-12:20pmLunch
Topic: Clinical Application and Public Health Need of Radiation Biodosimetry
Moderator: Raquel Peat
12:20pm-12:50pm”Use of Biodosimetry and Clinical Algorithms for Medical Management During Large Mass Casualty Radiation Incidents”
Judith Bader
12:50pm-1:20pm"Biodosimetry and Public Health Decision-making"
Charles Miller
1:20pm-1:50pm“Day to Day Emergency Care as the Foundation of Preparedness”
John Koerner
1:50pm-2:20pmBreak
2:20pm-3:20pmPublic Presentations
3:20pm-3:50pmPanel Discussion, Moderator: Norberto Pantoja-Galicia
Judith Bader, Charles Miller, John Koerner, Tom Heaton
3:50pm-4:20pmWrap-up and Lessons Learned
Kevin Lorick & Jennifer Dickey

Registration to Attend the Workshop

Online registration is closed as of September 13, 2012.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you wish to make an oral presentation during an open comment session at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Joyce Raines, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, WO-66 Room 4319, Silver Spring, MD 20993, 301-796-5709, FAX: 301-847-8142, email: joyce.raines@fda.hhs.gov.

Contact Us

For questions regarding workshop content please contact:

Jennifer Dickey
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, WO-66 Room 4254
Silver Spring, MD 20993
301-796-5028
email: Jennifer.dickey@fda.hhs.gov