[Federal Register Volume 86, Number 101 (Thursday, May 27, 2021)]
[Notices]
[Pages 28604-28605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11222]
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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Questions; Draft Guidance for Industry; Availability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 or Agency) is announcing
the availability of a draft guidance for industry entitled ``Tobacco
Product User Fees: Responses to Frequently Asked Questions.'' This
draft guidance provides information in response to frequently asked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DATES: Submit either electronic or written comments on the draft
guidance by July 26, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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:
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.
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 https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
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 https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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 draft 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 draft guidance may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the draft guidance.
[[Page 28605]]
FOR FURTHER INFORMATION CONTACT: Eric C. Mandle, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
email: [email protected], 1-877-287-1373.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Tobacco Product User Fees: Responses to Frequently Asked
Questions.'' This draft 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 draft 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 current Form FDA 3852, ``Report of Tobacco Produce
Removals Subject to Tax for Tobacco Product User Fee Assessments,''
discussed in this draft guidance, is available at https://www.fda.gov/media/88957/download.
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act) was enacted on June 22, 2009, 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
proposed rule to add part 1150 (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 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.
FDA is issuing this draft guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the responses
to the frequently asked questions 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
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 part 1150 have been approved under 0910-0749.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the draft guidance at https://www.regulations.gov, https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
Dated: May 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11222 Filed 5-26-21; 8:45 am]
BILLING CODE 4164-01-P