Tobacco Products

November: Risk Assessment - A Public Workshop

Risk Assessment: A Public Workshop

November 15-16, 2016
8:30 a.m. to 5:00 p.m.

The Marriott Inn and Conference Center
University of Maryland University College (UMUC)
3501 University Blvd. East
Hyattsville, Maryland 20783


Workshop Objectives:

FDA/CTP is hosting a workshop designed to open the discussion regarding available data and approaches to inform the risk assessment of tobacco products and to support tobacco regulatory science.  The objectives of the workshop are to identify:

  • Available data to characterize tobacco product users
  • Available data and risk assessment methods to characterize exposures and health risks associated with different types of tobacco products as well as tobacco product constituents
  • Areas of research and method development which may further strengthen knowledge and approaches regarding tobacco product risk assessment. 

Who Should Attend this Workshop?

Scientific and medical experts or other interested participants from academia, public health organizations, federal, state and local government agencies, the tobacco industry, and other interested stakeholders.


Registration to Attend the Workshop:

If you wish to attend the workshop in person or by webcast, you must register by submitting either an electronic or written request no later than October 21, 2016.
 
Please submit electronic requests at https://www.surveymonkey.com/r/RiskNov2016.  Persons without Internet access may send written requests for registration to Caryn Cohen (see Contact for Questions, below).  Requests for registration must include the prospective attendee’s name, title, affiliation, address, email address if available, and telephone number.  Registration is free and you may register to either attend in-person or view the live webcast.  Both seating and viewership are limited, so early registration is recommended.  FDA may limit the number of registrants from a single organization, as well as the total number of participants, if registration reaches full capacity. 
 
For registrants with Internet access, confirmation of registration will be emailed to you no later than October 25, 2016. 
 
Onsite registration may be allowed if space is available.  If registration reaches maximum capacity, FDA will post a notice closing registration.   

FDA will post the webcast along with complete transcripts on this website as soon as they are available.


Presenters and Panelists:

FDA is interested in discussing scientific information with individuals with a broad range of backgrounds on the scientific topics identified below.  We are inviting presenters and panelists to address the pertinent information and provide insight into methods to better address information pertaining to the following topics related to risk assessment:  

Hazard Characterization:

  1.  What toxicological or epidemiological data and methods are available to characterize the hazards associated with constituents that are present in or produced by different types of tobacco products?
  2. What toxicological information and other studies would provide scientifically valid means to characterize hazard and risk differences between tobacco products, which are complex mixtures? 

Exposure:

  1. What data are available to characterize the populations that use different types of tobacco products?  
  2. What data are available to characterize tobacco product use (e.g. consumption data, topography information, exposure duration, biomarkers)?   
  3. What methods are available to characterize exposures to constituents associated with use of different types of tobacco products?   

Population Susceptibility:

  1. What data are available on susceptibility factors (e.g. genetic variability, age, sex, co-morbidities) and what methods are available that can be used to characterize susceptibility to tobacco product exposure and risk?

Risk:

  1. What data and methods are available to evaluate if the hazards identified represent the total risk from exposure to a tobacco product?
  2. What data and methods are available to evaluate the cancer risks from exposures to individual constituents from different types of tobacco products?
  3. What data and methods are available to evaluate the non-cancer health risks from exposures to individual constituents from different types of tobacco products?
  4. What data and methods are available to evaluate the cancer and non-cancer health risks from exposures to complex mixtures from different types of tobacco products?
  5. What are the sources of uncertainty and variability in each step of the risk assessment when evaluating risks from the different types of tobacco products?  What are primary contributors to risk variability?
  6. What approaches are available to quantify and incorporate sources of variability and uncertainty to generate risk distributions?

If you are interested in serving as a presenter or panelist, please submit the following information, along with the topic on which you would like to speak, to workshop.CTPOS@fda.hhs.gov by September 30, 2016.

To be considered to serve as a presenter, please provide the following:

  • A brief abstract for each presentation.  The abstract should identify the specific topic(s) to be addressed and the amount of time requested.
  • A one-page biosketch that describes and supports the speaker’s scientific expertise on the specific topic(s) being presented, nature of the individual’s experience and research in the scientific field, positions held, and any program development activities.

Panelists will discuss the scientific presentations and questions listed above.  To be considered as a panelist, please provide the following:

  • A one-page biosketch that describes and supports the speaker’s scientific expertise on the specific topic(s) being presented, nature of the individual’s experience and research in the scientific field, positions held, and any program development activities.

FDA Invites Public Comments on Risk Assessment

To present oral comments at the workshop:

For those attending the workshop in person, FDA will hold a public comment session on the above listed topics on November 16, 2016, during which comments from the public will be accepted.  If you would like to present during the public comment session, please indicate this at the time of registration https://www.surveymonkey.com/r/RiskNov2016 and provide the specific topic of your presentation.  FDA will do its best to accommodate requests to speak.  Individuals and organizations with common interests are urged to consolidate or coordinate their remarks and request time for a joint presentation.  FDA will determine the amount of time allotted to each speaker and provide instructions to speakers ahead of the meeting.

Requesters with Internet access will receive an email regarding your request to speak during the public comment period by October 25, 2016.


Key Dates:

  • Deadline for Requests to Serve as a Presenter or Panelist: September 30, 2016
  • Registration Deadline: October 21, 2016
  • Deadline for Requests to Speak During Public Comment Session: October 21, 2016
  • Date successful registrants will receive registration confirmation: October 25, 2016
  • Date requests to present oral comments will be acknowledged: October 25, 2016

Special Accommodations:

If you need special accommodations because of disability, please contact Caryn Cohen (see Contact for Questions) at least seven days before the meeting.


Contact for Questions:

Caryn Cohen, MS
Office of Science
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone: 1-877-287-1373 (choose Option 5)
FAX: 301-595-1138
e-mail:  Workshop.CTPOS@fda.hhs.gov
 

Page Last Updated: 11/14/2016
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