[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Notices]
[Pages 22498-22499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10287]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3031]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 
17, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0749. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 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 (https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10688.pdf). 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 (https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10685.pdf). 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,

[[Page 22499]]

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.
    In the Federal Register of September 11, 2018 (83 FR 45937), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received that was not PRA 
related.
    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 (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 attribute 
this adjustment to an increase in the number of entities submitting 
tobacco user fee information to FDA.

    Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10287 Filed 5-16-19; 8:45 am]
BILLING CODE 4164-01-P


