Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
ICR 201603-0910-014 · OMB 0910-0749 · Historical Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0749 can be found here:
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
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 FDAâs 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
The Food and Drug Administration (FDA) is issuing a proposed rule that would require domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The United States Department of Agriculture (USDA) has been collecting this information and providing FDA with the data FDA needs to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA intends to cease collecting this information in fiscal year 2015 (October 2014). Consistent with the requirements of the FD&C Act, FDA is proposing to require the submission of this information to FDA instead of USDA. FDA is taking this action to ensure that FDA continues to have the information FDA needs to calculate, assess, and collect user fees.
PL:
Pub.L. 111 - 31 31
Name of Law: Family Smoking Prevention and Tobacco Control Act
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form FDA 3852 FDA 3852 Report of Tobacco Product Removals Subject to Tax
0910-0749 user fee TOC update.docx
User Fees Final Rule Supporting Statement 6.23.doc
Submission of Requests for further review of disputes of User Fees