Advisory Committees

April 9-10, 2015 – Tobacco Products Scientific Advisory Committee Meeting Announcement

CenterDate Time Location 
CTPApril 9-10, 20158:30 a.m. to 5 p.mFood and Drug Administration
FDA White Oak Conference Center
Building 31, Room 1503
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

Please note that there will be no closed session on April 9, 2015 and that the Open Public Hearing portion of the meeting has been moved from April 10 to April 9, 2015.

Webcast
You may view the archived webcast for this meeting at: 
April 9, 2015:
https://collaboration.fda.gov/p9moalpegw9/
https://collaboration.fda.gov/p6x71chqg54/
https://collaboration.fda.gov/p35flkqm8je/ 

April 10, 2015
https://collaboration.fda.gov/p1tkvfkzlbr/
https://collaboration.fda.gov/p6f489rgyy7/
https://collaboration.fda.gov/p6nz9422i0c/
 

Agenda 

On April 9-10, 2015, the Committee will discuss modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products:

  • MR0000020: General Loose, smokeless tobacco, loose snus, 1.59 oz (45g), cardboard can (SKU 4852);
  • MR0000021: General Dry Mint Portion Original Mini, smokeless tobacco, snus portions, 0.21 oz (6g), 20—0.3g portions, plastic can (SKU 4800);
  • MR0000022: General Portion Original Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4880);
  • MR0000023: General Classic Blend Portion White Large, smokeless tobacco, snus portions, 0.48 oz (13.5g), 15—0.9g portions, plastic can (SKU 4877);
  • MR0000024: General Classic Blend Portion White Large, smokeless tobacco, snus portions, 0.38 oz (10.8g), 12—0.9g portions, plastic can (SKU 4878);
  • MR0000025: General Mint Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4352);
  • MR0000026: General Nordic Mint Portion White Large, smokeless tobacco, snus portions, 0.48 oz (13.5g), 15—0.9g portions, plastic can (SKU 4876);
  • MR0000027: General Nordic Mint Portion White Large, smokeless tobacco, snus portions, 0.38 oz (10.8g), 12—0.9g portions, plastic can (SKU 4875);
  • MR0000028: General Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4881); and
  • MR0000029: General Wintergreen Portion White Large, smokeless tobacco, snus portions, 0.9 oz (24g), 24—1g portions, plastic can (SKU 4882).

Meeting Materials 

Links to meeting materials will be added as they become available.  FDA intends to make the background material available to the public 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.

Written submissions may be made to the contact person on or before March 20, 2015.  Please send 20 paper copies, and one electronic copy,  of your submission to:

Caryn Cohen, M.S.
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 

Copies must be received by 4 p.m. (Eastern) on March 20, 2015.

Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 p.m. on April 10, 2015.  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 March 12, 2015.

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 March 13, 2015.

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) FAX: 240-276-3655 Email: TPSAC@fda.hhs.gov

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 Web site at http://www.fda.gov/oc/advisory/default.htm 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).
 

Page Last Updated: 04/27/2015
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