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U.S. Department of Health and Human Services

Tobacco Products

Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop

March 19, 2013, 8:30 a.m. to 5 p.m.
March 20, 2013, 8:30 a.m. to 1 p.m.
Center for Tobacco Products
9200 Corporate Blvd.
Rockville, MD   20850
Room 020B

 

Registration to attend the workshop in person is now closed.  There will be no on-site registration.  The workshop will be webcast for no charge (no pre-registration necessary).  The archived webcast and transcripts will be available after the meeting.

 

Agenda:

Agenda for the Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop

 

Workshop Objective:

The purpose of the workshop is to discuss the recommendation in the Institute of Medicine’s report, “Scientific Standards for Studies on Modified Risk Tobacco Products,” that sponsors of Modified Risk Tobacco Product (MRTP) applications use independent third parties to undertake one or more key functions in tobacco product research (third party governance).  FDA is also considering third party governance as it relates more generally to tobacco research.  Our goal is to receive input from interested stakeholders regarding features from existing third party governance models that may be applicable to tobacco product research.

 

Who Should Attend this Workshop?

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

 

Registration to Attend the Workshop: 

Registration to attend the workshop in person is now closed. On-site registration will not be permitted. We encourage interested parties to view the workshop via webcast. 

 

Webcast: 

 

Read Transcripts from the Workshop

 

FDA Invites Public Comments on Third Party Governance of Industry-Sponsored Tobacco Product Research

To present oral comments at the workshop:

For those attending the workshop, FDA will hold an open comment session on March 20, 2013 at 9 a.m., during which comments from the public will be accepted.  Registration for presenting during the public comment session has now closed.

Persons registered to give public comments must check in at the registration table by 8:30 a.m. on March 20, 2013, in order to keep their time to speak. 
 

Docket for submitting public written comments:

A docket had been established for the submission of comments on the topic of third party governance of industry-sponsored tobacco product research. Regardless of attendance at the public workshop, interested persons are invited to submit comments to the docket.

 

 

Key Dates:

Registration:  

Open until maximum capacity is reached, at which time a notice will be posted on this website.
 

Deadline for Requests to Speak During Open Comment Session:  

January 31, 2013 

 

 

Special Accommodations:

If you need special accommodations because of disability, please contact Caryn Cohen (see Contact for Questions) at least 7 days before the workshop.
Contact for Questions:

Caryn Cohen
Office of Science
Center for Tobacco Products
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
Telephone: 1-877-287-1373 (choose Option 5),
FAX: 240-276-3655
e-mail:  Workshop.CTPOS@fda.hhs.gov