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Advisory Committee Meeting

Event Title
February 14, 2020: Tobacco Products Scientific Advisory Committee Meeting
February 14, 2020


Date:
February 14, 2020
Time:
8:00 AM - 5:00 PM ET
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States



Agenda

On February 14, 2020, the Center for Tobacco Products (CTP) Tobacco Products Scientific Advisory Committee (TPSAC) will meet in open session to discuss the modified risk tobacco product applications, submitted by 22nd Century Group Inc. for the following combusted filtered cigarette tobacco products:


Meeting Materials

FDA intends to make the background material available to the public on its website no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting and will be posted on FDA’s website after the meeting.


Webcast 


Attending a Public Meeting at FDA

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. 

If you require special accommodations due to a disability, please contact Serina Hunter-Thomas at least 7 days in advance of the meeting.

Information regarding ground transportation, airport information, lodging, driving directions; visitor parking and security can be accessed at the Public meetings at White Oak main page.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site for procedures on public conduct during advisory committee meetings.

Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

Please check this page or call the FDA Advisory Committee Information Line for the latest meeting information, including any last-minute changes.


Contact Information

  • CAPT Serina Hunter-Thomas, 240-402-5771, e-mail: serina.hunter-thomas@fda.hhs.gov 
  • FDA Advisory Committee Information Line (for latest information about this meeting):
    1-800-741-8138 (301-443-0572 in the Washington, DC area) 

Additional Resources


A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).


Event Materials

Title File Type/Size Source Organization
TPSAC Meeting – 21420 – Agenda – Draft pdf (61.25 KB) Center for Tobacco Products
TPSAC Meeting – 21420 – Agenda – Final pdf (60.85 KB) Center for Tobacco Products
TPSAC Meeting – 21420 – FDA Briefing Document pdf (1,003.19 KB) Center for Tobacco Products
TPSAC Meeting – 21420 – Roster pdf (67.33 KB) Center for Tobacco Products
TPSAC Meeting – 21420 – Public Submission 1 pdf (221.18 KB)
TPSAC Meeting – 21420 – Public Submission 2 pdf (584.65 KB)
TPSAC Meeting – 21420 – Public Submission 3 pdf (893.64 KB)
TPSAC Meeting – 21420 – Public Submission 4 pdf (1.24 MB)
TPSAC Meeting – 21420 – Public Submission 5 pdf (1.01 MB)
TPSAC Meeting – 21420 – Public Law 111 - Sec 911 pdf (48.61 KB) Center for Tobacco Products
Modified Risk Tobacco Product Applications: Draft Guidance for Industry pdf (977.02 KB) Center for Tobacco Products
TPSAC Meeting – 21420 – Discussion Questions pdf (25.10 KB) Center for Tobacco Products
TPSAC Meeting – 21420 – 22nd Century Briefing Document pdf (867.17 KB)
TPSAC Meeting – 21420 – FDA Errata pdf (81.42 KB) Center for Tobacco Products
TPSAC Meeting – 21420 – Presentation - 22nd Century pdf (2.39 MB)
TPSAC Meeting – 21420 – Presentation - Justin Byron pdf (1.04 MB)
TPSAC Meeting – 21420 – Presentation - Mollie Miller pdf (407.53 KB) Center for Tobacco Products
TPSAC Meeting – 21420 – Presentation - Alexander Persoskie pdf (511.89 KB) Center for Tobacco Products
TPSAC Meeting – 21420 – Presentation - Cindy Tworek pdf (296.55 KB) Center for Tobacco Products
TPSAC Meeting 21420 - Transcript pdf (1.05 MB)
TPSAC Meeting – 21420 – Summary Minutes pdf (258.28 KB)