[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70129-70131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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.

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     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 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: [email protected].

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.

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III. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the guidance at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm, or 
https://www.regulations.gov.

    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