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Total number of product submissions received or filed in the month (1)

Dictionary: The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain a market authorization order before they market their products. To introduce a new or modified tobacco product, an applicant must submit an application to FDA providing information on the product sufficient to allow the agency to determine that an order authorizing the product’s introduction is appropriate for the protection of the public health.

Alternately, a manufacturer may submit a substantial equivalence report demonstrating that its new tobacco product is substantially equivalent to a predicate tobacco product, as defined in the Tobacco Control Act. The Substantial Equivalence provision of the Tobacco Control Act requires nothing of manufacturers of unaltered tobacco products which were commercially available on February 15, 2007.

Additional information about premarket review requirements for tobacco products can be found on the CTP website.

Information is current as of November 30, 2012

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Footnotes

• (1) As submissions are reviewed, data may need to be updated to account for duplicates and multiple products on one submission.

Number of Regular Substantial Equivalence Submissions (SE) received in the month

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	0
Nov 2010	N/A	0
Dec 2010	N/A	0
Jan 2011	N/A	0
Feb 2011	N/A	0
Mar 2011	N/A	25
Apr 2011	N/A	9
May 2011	N/A	2
Jun 2011	N/A	9
Jul 2011	N/A	36
Aug 2011	N/A	24
Sep 2011	N/A	16

FY 2011 Total: 121

Number of Provisional SE Reports received in the month

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	0
Nov 2010	N/A	10
Dec 2010	N/A	16
Jan 2011	N/A	0
Feb 2011	N/A	0
Mar 2011	N/A	3,136
Apr 2011	N/A	0
May 2011	N/A	0
Jun 2011	N/A	0
Jul 2011	N/A	0
Aug 2011	N/A	0
Sep 2011	N/A	0

FY 2011 Total: 3,162

Number of SE Exemption Submissions received in the month

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	0
Nov 2010	N/A	0
Dec 2010	N/A	0
Jan 2011	N/A	0
Feb 2011	N/A	0
Mar 2011	N/A	0
Apr 2011	N/A	0
May 2011	N/A	0
Jun 2011	N/A	0
Jul 2011	N/A	0
Aug 2011	N/A	0
Sep 2011	N/A	10

FY 2011 Total: 10

Number of New Products Submissions (PMTA) filed in the month

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	0
Nov 2010	N/A	0
Dec 2010	N/A	0
Jan 2011	N/A	0
Feb 2011	N/A	0
Mar 2011	N/A	0
Apr 2011	N/A	0
May 2011	N/A	0
Jun 2011	N/A	0
Jul 2011	N/A	0
Aug 2011	N/A	0
Sep 2011	N/A	0

FY 2011 Total: 0

Number of Modified Risk Products (MR) filed in the month (1)

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	0
Nov 2010	N/A	0
Dec 2010	N/A	0
Jan 2011	N/A	0
Feb 2011	N/A	1
Mar 2011	N/A	0
Apr 2011	N/A	0
May 2011	N/A	0
Jun 2011	N/A	0
Jul 2011	N/A	0
Aug 2011	N/A	0
Sep 2011	N/A	0

FY 2011 Total: 1

Footnotes

• (1) Oct 2010 and Nov 2010 counts are amendments to previous submissions.