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U.S. Department of Health and Human Services

Tobacco Products

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Stakeholder Letter on Listening Sessions about the Listing and Registration of Tobacco Products

October 20, 2009

Dear Sir or Madam:

Beginning October 26, 2009, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will initiate a series of listening session conference calls to provide industry additional opportunities to make comments on and raise questions and concerns about the guidance documents entitled "Listing of Ingredients in Tobacco Products" and "Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments". The guidance documents provide FDA’s interpretations of, and recommendations for complying with, the requirements of sections 904(a)(1), 904(a)(4), and 905 of the Family Smoking Prevention and Tobacco Control Act relating to:

1. Tobacco establishment registration and product listing,
2. Ingredient submission, and
3. Submission of certain research documents.

The sessions will be operator-moderated and recorded. Transcripts will be posted on-line. Although individual questions will not be answered, FDA may respond to selected topics, themes, and areas of concern in the opening remarks of each call. FDA encourages industry representatives to submit questions and concerns in advance of each call to CTPQuestions@fda.hhs.gov. After the opening remarks, there will be an opportunity to provide up to two minutes of feedback to CTP leadership.

FDA also encourages industry to continually monitor www.fda.gov/tobacco for updates on implementation of the requirements of sections 904(a)(1), 904(a)(4), and 905 of the law. These updates will provide background for questions to be submitted to FDA.

The dates for the listening sessions are as follows:

Monday, October 26, 2:00 p.m. – 3:00 p.m. EST

Monday, November 09, 2:00 p.m. – 3:00 p.m. EST  DATE CHANGE

Should comments received from industry indicate a need for additional sessions, FDA will communicate planned dates and times in advance of each additional session.
Please submit questions/issues at least three days prior to each call to CTPQuestions@fda.hhs.gov.

The phone number and pass code for each listening session is 800.857.3437, pass code 54148

Please note there are additional opportunities to provide comment and/or receive updates on implementation of the Family Smoking Prevention and Tobacco Control Act, including:

(1) A public docket (FDA-2009-N- 0294), available at www.regulations.gov EXTENDED through December 28, for the public to provide general comments on implementing the legislation and creating the Center for Tobacco Products; and
(2) A free tobacco e-mail subscription service https://service.govdelivery.com/service/subscribe.html?code=USFDA_131.  When you subscribe to this service, you will receive an e-mail message each time there is an update to the FDA page(s) you select.

We look forward to hearing from you.

Sincerely,

/S/

Lawrence R. Deyton, M.S.P.H., M.D.
Director, Center for Tobacco Products
U.S. Food and Drug Administration