Notice2022-15157
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 15, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 135 (Friday, July 15, 2022)</title>
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[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Pages 42487-42488]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 (<a href="https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10688.pdf">https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10688.pdf</a>). 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 (<a href="https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10685.pdf">https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10685.pdf</a>). 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: <a href="https://www.fda.gov/tobacco-products/manufacturing/electronic-submissions-tobacco-products">https://www.fda.gov/tobacco-products/manufacturing/electronic-submissions-tobacco-products</a>.
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).
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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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