View ICR - OIRA Conclusion



0910-0749 201605-0910-003
Historical Active 201603-0910-014
HHS/FDA CTP
Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
Revision of a currently approved collection   No
Regular
Approved without change 06/24/2016
Retrieve Notice of Action (NOA) 05/10/2016
For reference, the data to be collected under this ICR overlaps with collections of excise tax and import information by Alcohol and Tobacco Tax and Trade Bureau (TTB) and Customs and Border Protection (CBP). However, the TTB and CBP data cannot currently be used by FDA for calculating user fees due to both logistical reasons and restrictions on the use of excise tax information that could be provided to FDA directly by TTB. FDA has had meetings with TTB about establishing a memorandum of understanding (MOU) with TTB to receive information directly from TTB regarding tobacco permit holders and excise tax payments and has fulfilled quarterly reporting requirements to notify OMB of outcomes of these interagency discussions. These meetings 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. This ICR extension is approved with the understanding that quarterly reporting to OMB on interagency communications between TTB and FDA will no longer be required, and 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 their records received from industry to ensure accurate tobacco user fee assessments.
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved 07/31/2017
8,729 0 5,215
16,922 0 10,150
0 0 0