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

ICR 201403-0910-003

OMB: 0910-0749

Federal Form Document

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ICR Details
0910-0749 201403-0910-003
Historical Inactive 201306-0910-002
HHS/FDA 19734
Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
New collection (Request for a new OMB Control Number)   No
Preapproved 06/23/2014
Retrieve Notice of Action (NOA) 03/10/2014
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. FDA will work with TTB and CBP to further develop means for the sharing of information that FDA could use to calculate and assess tobacco product user fees. This purpose of FDA’s collaboration with TTB and CBP is to explore whether it would be possible, in light of current legal restrictions on the use of individual taxpayer information, for FDA to rely solely on data received from TTB and CBP and thus eliminate the need for this information collection. FDA will report to OIRA on a quarterly basis beginning October 1, 2014, regarding the progress of these meetings until a resolution is reached, which shall be accomplished no later than July 1, 2016.
  Inventory as of this Action Requested Previously Approved
06/30/2017 36 Months From Approved
5,215 0 0
10,150 0 0
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

0910-AG81 Final or interim final rulemaking


  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 5,215 0 0 5,215 0 0
Annual Time Burden (Hours) 10,150 0 0 10,150 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Changing Regulations
This is a new information collection.

Jonna Capezzuto 301 796-3794 [email protected]


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.

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