[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Notices]
[Pages 45937-45940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19664]


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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 the information collection for tobacco 
product user fees.

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DATES: Submit either electronic or written comments on the collection 
of information by November 13, 2018.

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 November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 13, 2018. 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:
     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-2018-N-3031 for ``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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 
111-31) 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 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

[[Page 45939]]

FD&C Act. FDA expanded its authority over tobacco products by issuing 
another final rule, ``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), 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. 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 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      Hours per      Total hours
                                    respondents     respondent       responses       response
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1150.5(a), (b)(1) and (2), and               658              12           7,896               3          23,688
 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               658              12           7,896               1           7,896
 (monthly)......................
1150.13; Submission of user fee              329               4           1,316               1           1,316
 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.......................  ..............  ..............  ..............  ..............          32,980
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that 658 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 
2017 there were 192 total permitted manufacturers and 466 permitted 
importers over all tobacco product types for which TTB collects excise 
taxes (including cigarettes, cigars, snuff, chewing tobacco, pipe 
tobacco, and roll-your-own tobacco, excluding electronic nicotine 
delivery systems).
    The estimate of 658 respondents to provide the information 
requested from Sec.  1150.5(a), (b)(1) and (2) (21 CFR 1150.5(a), 
(b)(1) and (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 23,688 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 7,896 hours. The estimate of 329 
respondents to submit payment of user fee information under Sec.  
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 1,316 hours.
    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 only received one dispute 
submission 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 32,980 hours. The estimated burden for the information 
collection reflects an overall increase of 16,058 hours. We

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attribute this adjustment to an increase in the number of entities 
submitting tobacco user fee information to FDA.

    Dated: September 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19664 Filed 9-10-18; 8:45 am]
 BILLING CODE 4164-01-P