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
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⚠️ Notice: This information collection may be outdated.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
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