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
Federal Form Document
⚠️ Notice: This information collection may be outdated.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 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
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