February 6, 2019 - 8:30 a.m. to 5:00 p.m.
February 7, 2019 - 8:00 a.m. to 1:00 p.m.
White Oak Conference Center
Registration is not required for audience members to attend advisory committee meetings. Rather, audience seating is available on a first come, first served basis.
- Recorded Webcast
- Day 1
Part 1: https://collaboration.fda.gov/pk2dfga6w5em/
Part 2: https://collaboration.fda.gov/ptiwlu542dn5/
Part 3: https://collaboration.fda.gov/pyepb7snyp5r/
Part 4: https://collaboration.fda.gov/pr0o74j01xpf/
- Day 2:
Part 1: https://collaboration.fda.gov/p135od55hpvi/
Part 2: https://collaboration.fda.gov/p75yajc7b98c/
- Day 1
On February 6-7, 2019, the Committee will convene for two sessions. The first session will convene at 8:30 a.m. on February 6, 2019, during which the Committee will discuss an amendment to the modified risk tobacco product applications (MRTPAs), submitted by Swedish Match North America for the following snus smokeless tobacco products:
- MR0000020: General Loose;
- MR0000021: General Dry Mint Portion Original Mini;
- MR0000022: General Portion Original Large;
- MR0000024: General Classic Blend Portion White Large-12ct;
- MR0000025: General Mint Portion White Large;
- MR0000027: General Nordic Mint Portion White Large-12ct;
- MR0000028: General Portion White Large; and
- MR0000029: General Wintergreen Portion White Large.
The second session will convene, after the first session has concluded, on February 6, 2019 and continue beginning at 8:00 a.m. on February 7, 2019. During the second session the Committee will discuss the modified risk tobacco product application (MRTPA), submitted by Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company LLC for the following smokeless tobacco product:
- MR0000108 Copenhagen Snuff Fine Cut.
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.
Public Participation Information:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Oral presentations from the public will be scheduled between approximately 10:00 a.m. and 10:30 a.m. on February 6, 2019 and for the second session between approximately 8:00 a.m. and 8:30 a.m. on February 7, 2019. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement describing the general nature of the evidence or arguments they wish to present, the names and email addresses of proposed participants, and the session during which they would like to speak, on or before January 14, 2019.
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 January 15, 2019.
Written submissions may be made to the contact person on or before January 22, 2019. Please send your submission by email to Caryn Cohen at TPSAC@fda.hhs.gov.
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 (see “Contact Information” below) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings.
Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee meetings.
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)
FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).