Attendance:

• In-person
  Registration is not required for audience members to attend advisory committee meetings. Rather, audience seating is available on a first come, first served basis.
• Webcast
  
  • Day 1:
    • Part 1: https://collaboration.fda.gov/p7u5wfqhla8/
    • Part 2: https://collaboration.fda.gov/p8sjpme378w/
    • Part 3: https://collaboration.fda.gov/p5kznafcrm8/
    • Part 4: https://collaboration.fda.gov/p8n8aptmopc/
  • Day 2:
    • Part 1: https://collaboration.fda.gov/p1nwsm7l01i/
    • Part 2: https://collaboration.fda.gov/p9qkrezw24r/ 

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Agenda:

On September 13-14, 2018, the Committee will discuss modified risk tobacco product applications (MRTPAs), submitted by R.J. Reynolds Tobacco Company for six products:

• MR0000068: Camel Snus Frost
• MR0000069: Camel Snus Frost Large
• MR0000070: Camel Snus Mellow
• MR0000071: Camel Snus Mint
• MR0000072: Camel Snus Robust
• MR0000073: Camel Snus Winterchill

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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.

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Public Participation Information:

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Oral presentations

Oral presentations from the public will be scheduled between approximately 8 a.m. and 9 a.m. on September 14, 2018. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 16, 2018.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 17, 2018.

Written submissions

Written submissions may be made to the contact person on or before August 29, 2018. Please send 20 paper copies, and one electronic copy, of your submission to:

Caryn Cohen
Office of Science
Center for Tobacco Products
Food and Drug Administration
Document Control Center
Bldg. 71, Rm. G335
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

Copies must be received by 4 p.m. (Eastern) on August 29, 2018.

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Contact Information

Caryn Cohen
Office of Science
Center for Tobacco Products
Food and Drug Administration
Document Control Center, Bldg. 71, Rm. G335
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

Phone: 1-877-287-1373 (choose Option 5)
Email: [email protected]

FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)

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 and call the appropriate advisory committee hot line/phone line 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caryn Cohen at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings.

Please visit our website 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).