83C Memo - User Fee TOC

0910-0749 user fee TOC update.docx

Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products

83C Memo - User Fee TOC

OMB: 0910-0749

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Tobacco User Fees

(OMB Control Number 0910-0749)


Change Request (83-C)


March 24, 2016


The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to request a revision to the current Terms of Clearance for OMB Control Number 0910-0749. OMB has concurred that the current terms of clearance have been satisfied and can be removed.


FDA recommends revising the current Terms of Clearance to:


The terms of condition for this ICR data are being revised. The information collected under FDA’s Center for Tobacco Products (OMB Control No. 0910-0749) have led to the identification of certain legal restrictions that are outlined in the Internal Revenue Code law(s), specifically section 6103, that does not allow for the complete utilization of data received from the TTB and CBP to implement FDA’s Tobacco User Fee Program. FDA will continue to communicate with the TTB and CBP to obtain certain information from each organization that will allow the CTP to verify and validate our records received from industry to ensure accurate tobacco user fee assessments.


For reference, please see the attached document entitled “User fee report FY16 Q1”, dated December 31, 2015.


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