View ICR - OIRA Conclusion



0910-0749 201603-0910-014
Historical Active 201509-0910-010
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
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 03/25/2016
Retrieve Notice of Action (NOA) 03/24/2016
Previous terms of clearance are being revised as follows: 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 Nonsubstantive Change request 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 our records received from industry to ensure accurate tobacco user fee assessments.
  Inventory as of this Action Requested Previously Approved
07/31/2017 07/31/2017 07/31/2017
5,215 0 5,215
10,150 0 10,150
0 0 0