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
⚠️ Notice: This information collection may be outdated.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
New
collection (Request for a new OMB Control Number)
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
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.
Submission of Requests for further review of disputes of User Fees