[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Pages 42487-42488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3031]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Tobacco Products, 
User Fees, Requirements for the Submission of Data Needed To Calculate 
User Fees for Domestic Manufacturers and Importers of Tobacco Products

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by August 15, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0749. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
<a href="/cdn-cgi/l/email-protection#f5a5a7b4a681949393b5939194db9d9d86db929a83"><span class="__cf_email__" data-cfemail="fcacaebdaf889d9a9abc9a989dd294948fd29b938a">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

OMB Control Number 0910-0749--Extension

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (the Tobacco Control Act) (Pub. L. 111-31) was signed into law. The 
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) and granted FDA authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect public 
health generally and to reduce tobacco use by minors.
    FDA issued a final rule on May 10, 2016 (81 FR 28707) 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 FD&C Act (https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10688.pdf). FDA expanded its authority over tobacco products 
by issuing another final rule entitled ``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; May 10, 2016, 81 FR 
28974), 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 (https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10685.pdf). 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, the user 
fee 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.
    As noted, FDA issued a final rule that requires domestic tobacco 
product manufacturers and importers to submit information needed to 
calculate the amount of user fees assessed under the FD&C Act. The U.S. 
Department of Agriculture (USDA) had been collecting this information 
and provided FDA with the data the Agency needed to calculate the 
amount of user fees assessed to tobacco product manufacturers and 
importers. USDA ceased collecting this information in fiscal year 2015 
(October 2014). USDA's information collection did not require OMB 
approval, per an exemption by Public Law 108-357, section 642(b)(3). 
Consistent with the requirements of the FD&C Act, FDA requires the 
submission of this information to FDA. FDA took this action to ensure 
that the Agency continues to have the information needed to calculate, 
assess, and collect

[[Page 42488]]

user fees from domestic manufacturers and importers of tobacco 
products.
    Section 919(a) of the FD&C Act (21 U.S.C. 387s(a)) requires FDA to 
``assess user fees on, and collect such fees from, each manufacturer 
and importer of tobacco products'' subject to the tobacco product 
provisions of the FD&C Act (chapter IX of the FD&C Act). The total 
amount of user fees to be collected for each fiscal year is specified 
in section 919(b)(1) of the FD&C Act and, under section 919(a), FDA is 
to assess and collect a proportionate amount each quarter of the fiscal 
year. The FD&C Act provides for the total assessment to be allocated 
among the classes of tobacco products. The class allocation is based on 
each tobacco product class's volume of tobacco product removed into 
commerce. Within each class of tobacco products, an individual domestic 
manufacturer or importer is assessed a user fee based on its share of 
the market for that tobacco product class.
    To make reporting requirements for this collection easier for 
respondents, FDA offers respondents the ability to provide their user 
fee submission information via an electronic form (Form FDA 3852). To 
learn more about the electronic submission process and download Form 
FDA 3852 respondents may go to: https://www.fda.gov/tobacco-products/manufacturing/electronic-submissions-tobacco-products.
    In the Federal Register of November 19, 2021 (86 FR 64948), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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1150.5(a), (b)(1), and (2), and              700              12           8,400               3          25,200
 Form FDA 3852; General
 identifying information
 provided by manufacturers and
 importers of FDA regulated
 tobacco products and
 identification and removal
 information (monthly)..........
1150.5(b)(3); Certified copies               700              12           8,400               1           8,400
 (monthly)......................
1150.13; Submission of user fee              376               4           1,504               1           1,504
 information (identifying
 information, fee amount, etc.)
 (quarterly)....................
1150.15(a); Submission of user                 5               1               5              10              50
 fee dispute (annually).........
1150.15(d); Submission of                      3               1               3              10              30
 request for further review of
 dispute of user fee (annually).
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          35,184
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Recordkeeping burden hours for Sec.  1150.5(a) and (b), Form FDA 
3852, and Sec.  1150.13 appearing in the notice published in the 
Federal Register on November 19, 2021, are obsolete due to fiscal year 
(FY) 2021 data. Table 1 of this document contains the updated 
estimates.
    FDA estimates that entities will submit tobacco product user fee 
reports for approximately 700 Alcohol and Tobacco Tax and Trade Bureau 
(TTB) permits in a given month. The permit count was derived from 
aggregate data of active permit holders provided by the TTB and 
reflects that in FY21, there was an average of 234 total permitted 
manufacturers and 466 permitted importers reporting tobacco user fees 
over all tobacco product types for which TTB assesses excise taxes 
(including cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, 
and roll-your-own tobacco).
    FDA estimates it will take 3 hours for each of these submission 
types for a total of 25,200 hours annually. Under Sec.  1150.5(b)(3), 
these respondents are also expected to provide monthly certified copies 
of the returns and forms that relate to the removal of tobacco products 
into domestic commerce and the payment of Federal excise taxes imposed 
under chapter 52 of the Internal Revenue Code of 1986 to FDA. We 
estimate that each monthly report will take 1 hour for a total of 8,400 
hours annually.
    The estimate of 376 respondents required to submit payment of user 
fee information under Sec.  1150.13 reflects an average across the 4 
quarters for FY21 assessments issued to entities. FDA estimates the 
quarterly submission will take approximately 1 hour for a total of 
1,504 hours annually.
    FDA estimates that five of those respondents assessed user fees 
will dispute the amounts under Sec.  1150.15(a), for a total amount of 
50 hours. FDA also estimates that three respondents who dispute their 
user fees will ask for further review by FDA under Sec.  1150.15(d), 
for a total amount of 30 hours. FDA has received nine dispute 
submissions since fiscal year 2015. Based on this data, the Agency does 
not believe we will receive more than five disputes and three requests 
for further reviews in the next 3 years.
    FDA estimates the total annual burden for this collection of 
information is 35,184 hours. The estimated burden for the information 
collection reflects an overall decrease of 444 hours. We attribute this 
adjustment to a slight decrease in the number of entities submitting 
tobacco user fee information to FDA.

    Dated: July 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15157 Filed 7-14-22; 8:45 am]
BILLING CODE 4164-01-P


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