Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
ICR 201605-0910-003 · 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⚠️ Notice: This information collection may be outdated.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
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
The Food and Drug Administration (FDA) is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA recently expanded its authority by issuing a final rule, “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products” (Deeming rule), deeming all products that meet the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act’s user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, this final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA.
PL:
Pub.L. 111 - 31 31
Name of Law: Family Smoking Prevention and Tobacco Control Act
The burden for this collection of information is expected to increase by 6,772 reporting hours due to an expected increase in the number of Tobacco respondents. This adjustment is a result is FDA issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Additionally, FDA is extending the Agency's "tobacco product" authorities in the FD&C Act to all other categories of products that meet the statutory definition of "tobacco product" in the FD&C Act, except accessories of such newly deemed tobacco products.
The estimated number of respondents will increase by 954 (from 515 to 1,469 respondents) and the annual responses will increase by 3,514 (from 5,215 to 8,729). The currently OMB approved burden estimate of 10,150 hours will increase by 6,772 hours to equal a total of 16,922 total burden hours.
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 General identifying information provided by manufacturers and importers of FDA regulated tobacco products and Identification and removal information (monthly); Form FDA 3852
0749 User Fees Second Final Rule Supporting Statement Final.docx
Section 1150_15_d.doc
Annual submission of request for further review of dispute of user fee