Notice2021-25306
Agency Information Collection Activities; Proposed Collection; 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
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Published
November 19, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products.
Full Text
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<title>Federal Register, Volume 86 Issue 221 (Friday, November 19, 2021)</title>
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[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Notices]
[Pages 64948-64950]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-25306]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3031]
Agency Information Collection Activities; Proposed Collection;
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, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Tobacco Products, User Fees, Requirements
for the Submission of Data Needed to Calculate User Fees for Domestic
Manufacturers and Importers of Tobacco Products.
DATES: Submit either electronic or written comments on the collection
of information by January 18, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 18, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 18, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the
[[Page 64949]]
instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3031 for ``Agency Information Collection Activities;
Proposed Collection; 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.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#dd8d8f9c8ea9bcbbbb9dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="4c1c1e0d1f382d2a2a0c2a282d6224243f622b233a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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,
[[Page 64950]]
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 now instead of USDA. FDA took
this action to ensure that the Agency continues to have the information
needed to calculate, assess, and collect 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' 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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1150.5(a), (b)(1), and (b)(2), 711 12 8,532 3 25,596
and 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 711 12 8,532 1 8,532
(monthly)......................
1150.13; Submission of user fee 355 4 1,420 1 1,420
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....................... .............. .............. .............. .............. 35,628
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 711 entities will submit tobacco product user
fees. The entity count was derived from aggregate data provided by the
Alcohol and Tobacco Tax and Trade Bureau (TTB) and reflects that in
2021 there were 233 total permitted manufacturers and 478 permitted
importers over all tobacco product types for which TTB assesses excise
taxes (including cigarettes, cigars, snuff, chewing tobacco, pipe
tobacco, and roll-your-own tobacco).
The estimate of 711 respondents to provide the information
requested from Sec. 1150.5(a), (b)(1), and (b)(2) (21 CFR 1150.5(a),
(b)(1), and (b)(2)), and Form FDA 3852 reflects both reports of no
removal of tobacco products into domestic commerce and reports of
removal of tobacco product into domestic commerce. FDA estimates it
will take 3 hours for each of these submission types for a total of
25,596 hours. 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 8,532 hours. The estimate of 355
respondents to submit payment of user fee information under Sec.
1150.13 (21 CFR 1150.13) reflects an average of half the number of
domestic manufacturers and importers who may be subject to fees each
fiscal quarter. FDA estimates the quarterly submission will take
approximately 1 hour for a total of 1,420 hours.
FDA estimates that five of those respondents assessed user fees
will dispute the amounts under Sec. 1150.15(a) (21 CFR 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 35,628 hours. The estimated burden for the information
collection reflects an overall increase of 2,648 hours. We attribute
this adjustment to an increase in the number of entities submitting
tobacco user fee information to FDA.
Dated: November 12, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25306 Filed 11-18-21; 8:45 am]
BILLING CODE 4164-01-P
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