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, 22498-22499 [2019-10287]
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22498
Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
1140.30—Scope of permissible forms of labeling and advertising ............................................................................
25
1
25
1
25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden hour estimates for this
collection of information were based on
industry-prepared data and information
regarding cigarette and smokeless
tobacco product advertising
expenditures.
FDA estimates that approximately 25
respondents will submit an annual
notice of alternative advertising, and the
Agency has estimated it should take 1
hour to provide such notice. Therefore,
FDA estimates that the total time
required for this collection of
information is 25 hours.
We have adjusted our burden estimate
to approximately 25 notifications
annually, which more accurately
reflects the current number of
submissions under this regulation. This
is a decrease to the currently approved
burden. The decrease in notifications is
not unexpected given that the regulation
applies to cigarettes and smokeless
tobacco and many of the alternative
media notifications have been made in
previous years.
(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.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2019–10291 Filed 5–16–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3031]
OMB Control Number 0910–0749—
Extension
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
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-
AGENCY:
Food and Drug Administration,
HHS.
jbell on DSK3GLQ082PROD with NOTICES
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.
ADDRESSES:
ACTION:
Notice.
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
SUMMARY:
VerDate Sep<11>2014
17:05 May 16, 2019
Jkt 247001
PO 00000
Frm 00069
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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/201610685.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,
E:\FR\FM\17MYN1.SGM
17MYN1
22499
Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
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
1150.5(a), (b)(1) and (2), and 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 (monthly) ..............................
1150.13; Submission of user fee information (identifying
information, fee amount, etc.) (quarterly) .........................
1150.15(a); Submission of user fee dispute (annually) .......
1150.15(d); Submission of request for further review of
dispute of user fee (annually) ..........................................
Total ..............................................................................
jbell on DSK3GLQ082PROD with NOTICES
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
658
658
12
12
7,896
7,896
3
1
23,688
7,896
329
5
4
1
1,316
5
1
10
1,316
50
3
1
3
10
30
........................
........................
........................
........................
32,980
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
§ 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
§ 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 § 1150.13 reflects an
average of half the number of domestic
VerDate Sep<11>2014
17:05 May 16, 2019
Jkt 247001
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 § 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
§ 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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0717]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Evaluation of the
Food and Drug Administration’s
General Market Youth Tobacco
Prevention Campaigns
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 evaluation of
FDA’s General Market Youth Tobacco
Prevention Campaigns.
DATES: Submit either electronic or
written comments on the collection of
information by July 16, 2019.
SUMMARY:
E:\FR\FM\17MYN1.SGM
17MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected]. 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,
[email protected].
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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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).
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 32,980
----------------------------------------------------------------------------------------------------------------
\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
