Notice2021-26651
Tobacco Product User Fees: Responses to Frequently Asked Questions; Guidance for Industry; Availability
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
December 9, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Tobacco Product User Fees: Responses to Frequently Asked Questions." This guidance provides information in response to frequently asked questions related to tobacco product user fees assessed and collected under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 86 Issue 234 (Thursday, December 9, 2021)</title>
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[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70129-70131]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26651]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0373]
Tobacco Product User Fees: Responses to Frequently Asked
Questions; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Tobacco Product User Fees: Responses to Frequently Asked Questions.''
This guidance provides information in response to frequently asked
questions related to tobacco product user fees assessed and collected
under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: The announcement of the guidance is published in the Federal
Register on December 9, 2021.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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 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.
[[Page 70130]]
<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-2021-D-0373 for ``Tobacco Product User Fees: Responses to
Frequently Asked Questions.'' Received comments 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
1-877-287-1373, email: <a href="/cdn-cgi/l/email-protection#46051216142321332a27322f29283506202227682e2e3568212930"><span class="__cf_email__" data-cfemail="da998e8a88bfbdafb6bbaeb3b5b4a99abcbebbf4b2b2a9f4bdb5ac">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Tobacco Product User Fees: Responses to Frequently Asked
Questions.'' This guidance provides information in response to
frequently asked questions related to tobacco product user fees
assessed and collected under section 919 of the FD&C Act (21 U.S.C.
387s). In particular, this guidance provides information regarding the
submission of information needed to assess user fees owed by each
domestic manufacturer or importer of tobacco products and how FDA
determines whether a company owes user fees in each quarterly
assessment.
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) was enacted on June 22, 2009 (Pub. L. 111-31), amending
the FD&C Act and providing FDA with the authority to regulate tobacco
products. Included in the Tobacco Control Act is the requirement that
FDA assess and collect user fees. Section 919(a) of the FD&C Act
requires FDA, in accordance with that section, 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). Under the calculations required
by section 919 of the FD&C Act, the tobacco products that are subject
to user fee assessments are cigarettes, snuff, chewing tobacco, roll-
your-own tobacco, cigars, and pipe tobacco. The total amount of user
fees 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 one-fourth
of that total each quarter of the fiscal year. The FD&C Act provides
for the total quarterly assessment to be allocated among specified
classes of tobacco products. The class allocation is based on each
tobacco product class' volume of tobacco products removed into
commerce. Within each class of tobacco products, an individual domestic
manufacturer or importer is assessed a user fee based on its market
share for that tobacco product class.
In the Federal Register of May 31, 2013 (78 FR 32581), FDA issued a
notice of proposed rulemaking to add 21 CFR part 1150 to require
domestic tobacco product manufacturers and importers to submit to FDA
information needed to calculate the amount of user fees to assess each
domestic manufacturer and importer under the FD&C Act. In the Federal
Register of July 10, 2014 (79 FR 39302), FDA finalized portions of the
User Fee proposed rule related to cigarettes, snuff, chewing tobacco,
and roll-your-own tobacco, which is codified at 21 CFR part 1150. In
the Federal Register of May 10, 2016 (81 FR 28707), FDA finalized a
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 FD&C Act. In the Federal Register of May
27, 2021 (86 FR 28604), we published the notice of availability for the
draft guidance ``Tobacco Product User Fees: Responses to Frequently
Asked Questions.'' On July 26, 2021, the comment period closed with no
comments having been received. We are now finalizing the guidance with
no substantive changes.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on frequently asked questions about tobacco
product user fees set forth in the guidance. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 1150 have been approved under 0910-0749.
[[Page 70131]]
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the guidance at either <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm">https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26651 Filed 12-8-21; 8:45 am]
BILLING CODE 4164-01-P
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