Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products, 49593-49596 [2022-17248]
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Federal Register / Vol. 87, No. 154 / Thursday, August 11, 2022 / Notices
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Jkt 256001
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Registration and
Product Listing for Owners and
Operators of Domestic Tobacco
Product Establishments and Listing of
Ingredients in Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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
(PRA).
DATES: Submit written comments
(including recommendations) on the
collection of information by September
12, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
SUMMARY:
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49593
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0650. 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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products
OMB Control Number 0910–0650—
Extension
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (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) by adding, among other
things, a chapter granting FDA
important authority to regulate the
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors. The
Tobacco Control Act created new
requirements for the tobacco industry.
Section 101 of the Tobacco Control Act
amended the FD&C Act by adding,
among others, sections 905 and 904 (21
U.S.C. 387e and 387d).
Section 905 of the FD&C Act requires
the annual registration of any
‘‘establishment in any State engaged in
the manufacture, preparation,
compounding, or processing of a
tobacco product or tobacco products.’’
Section 905 of the FD&C Act requires
this registration be completed by
December 31 of each year. The Secretary
of Health and Human Services
(Secretary) has delegated to the
Commissioner of Food and Drugs the
responsibility for administering the
FD&C Act, including section 905.
Section 905 of the FD&C Act requires
owners or operators of each
establishment to register: (1) their name;
(2) places of business; (3) a list of all
tobacco products which are
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Federal Register / Vol. 87, No. 154 / Thursday, August 11, 2022 / Notices
manufactured by that person; (4) a copy
of all labeling and a reference to the
authority for the marketing of any
tobacco product subject to a tobacco
product standard under section 907 of
the FD&C Act (21 U.S.C. 387g) or to
premarket review under section 910 of
the FD&C Act (21 U.S.C. 387j); (5) a
copy of all consumer information and
other labeling; (6) a representative
sampling of advertisements; (7) upon
request made by the Secretary for good
cause, a copy of all advertisements for
a particular tobacco product; and (8)
upon request made by the Secretary, if
the registrant has determined that a
tobacco product contained in the
product list is not subject to a tobacco
product standard established under
section 907 of the FD&C Act, a brief
statement of the basis upon which the
registrant made such determination.
FDA collects the information
submitted pursuant to section 905 of the
FD&C Act through an electronic portal,
and through paper forms (Forms FDA
3741 https://www.fda.gov/media/77915/
download and 3741a https://
www.fda.gov/media/99863/download)
for those individuals who choose not to
use the electronic portal.
FDA has also published a guidance
for industry entitled ‘‘Registration and
Product Listing for Owners and
Operators of Domestic Tobacco Product
Establishments’’ (https://www.fda.gov/
downloads/TobaccoProducts/Labeling/
RulesRegulationsGuidance/
UCM191940.pdf). This guidance is
intended to assist persons making
tobacco product establishment
registration and product listing
submissions to FDA.
Section 904(a)(1) of the FD&C Act
requires that each tobacco product
manufacturer or importer submit ‘‘a
listing of all ingredients, including
tobacco, substances, compounds, and
additives that are, as of such date, added
by the manufacturer to the tobacco,
paper, filter, or other part of each
tobacco product by brand and by
quantity in each brand and subbrand’’
by December 22, 2009. This section
applies only to those tobacco products
manufactured and distributed before
June 22, 2009, and which are still
manufactured as of the date of the
ingredient listing submission.
Section 904(c) of the FD&C Act
requires that a tobacco product
manufacturer: (1) provide all
information required under section
904(a) of the FD&C Act to FDA ‘‘at least
90 days prior to the delivery for
introduction into interstate commerce of
a tobacco product not on the market on
the date of enactment’’ of the Tobacco
Control Act; (2) advise FDA in writing
at least 90 days prior to adding any new
tobacco additive or increasing in
quantity an existing tobacco additive,
except for those additives that have
been designated by FDA through
regulation as not a human or animal
carcinogen, or otherwise harmful to
health under intended conditions of
use; and (3) advise FDA in writing at
least 60 days of such action of
eliminating or decreasing an existing
additive, or adding or increasing an
additive that has been designated by
FDA through regulation as not a human
or animal carcinogen, or otherwise
harmful to health under intended
conditions of use.
FDA collects the information
submitted pursuant to section 904(a)(1)
and 904(c) of the FD&C Act through an
electronic portal, and through a paper
form (Form FDA 3742 https://
www.fda.gov/media/77661/download)
for those individuals who choose not to
use the electronic portal.
In addition to the development of the
electronic portal and paper form, FDA
published a guidance entitled ‘‘Listing
of Ingredients in Tobacco Products’’
(https://www.fda.gov/media/101162/
download). This guidance is intended to
assist persons making tobacco product
ingredient listing submissions. FDA also
provides a technical guide, embedded
hints, and a web tutorial to the
electronic portal.
The Tobacco Control Act also gave
FDA the authority to issue a regulation
deeming all other products that meet the
statutory definition of a tobacco product
to be subject to Chapter 9 of the FD&C
Act (section 901(b) of the FD&C Act (21
U.S.C. 387a(b))). On May 10, 2016, FDA
issued that rule, extending FDA’s
tobacco product authority to all
products that meet the definition of
tobacco product in the law (except for
accessories of newly regulated tobacco
products), including electronic nicotine
delivery systems, cigars, hookah
tobacco, pipe tobacco, nicotine gels, and
dissolvables that were not already
subject to the FD&C Act, and other
tobacco products that may be developed
in the future (81 FR 28974 at 28976)
(‘‘the final deeming rule’’).
In the Federal Register of January 28,
2022 (87 FR 4622), FDA published a 60day 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
respondents
FDA form; activity; Tobacco Control Act section
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Tobacco Product Establishment Initial Registration and Listing; Form
FDA 3741 Registration and Product Listing for Owners and Operators of Domestic Establishments (Electronic and Paper submissions);
sections 905(b)–(d), 905(h), or 905(i).
Tobacco Product Establishment Renewal Registration and Listing;
Form FDA 3741 Registration and Product Listing for Owners and
Operators of Domestic Establishments (Electronic and Paper submissions); sections 905(b)–(d), 905(h), or 905(i).
Tobacco Product Listing; Form FDA 3742 Listing of Ingredients (Electronic and Paper submissions); section 904(a)(1).
Tobacco Product Listing; Form FDA 3742 Listing of Ingredients (Electronic and Paper submissions); section 904(c).
Obtaining a Dun and Bradstreet (D–U–N–S) Number ............................
Total ..................................................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average burden per
recordkeeping
Total hours
200
1
200
1.6 ...............................
320
2,572
1
2,572
0.16 (10 minutes) .......
412
16
1
16
2 ..................................
32
37
10
370
0.40 (24 minutes) .......
148
100
1
100
0.5 (30 minutes) .........
50
........................
........................
........................
.....................................
962
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the publishing of the 60-day
notice, the Consolidated Appropriations
Act of 2022 (the Appropriations Act,
VerDate Sep<11>2014
17:49 Aug 10, 2022
Jkt 256001
Pub. L. 117–103), enacted on March 15,
2022, amended the definition of the
term ‘‘tobacco product’’ in section
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201(rr) of the FD&C Act (21 U.S.C.
321(rr)) to include products that contain
nicotine from any source. As a result,
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Federal Register / Vol. 87, No. 154 / Thursday, August 11, 2022 / Notices
non-tobacco nicotine (NTN) products
that were not previously subject to the
FD&C Act (e.g., products containing
synthetic nicotine) are now subject to all
of the tobacco product provisions in the
FD&C Act beginning on April 14, 2022.
Based on this new authority the owners
and operators of establishments engaged
in the manufacture, preparation,
compounding, or processing of tobacco
products containing NTN must register
with the FDA and list all these tobacco
products that they manufacture,
prepare, compound, or process for
commercial distribution. As such we
have revised the estimates in the burden
chart to account for products containing
NTN.
The PRA burden estimates have been
updated to fully incorporate the use of
an electronic system known as Tobacco
Registration and Product Listing Module
Next Generation (TRLM NG) for
submitting registration and product
listing information to FDA. With the
TRLM NG, manufacturers can enter
information quickly and easily. For
example, product label pictures can be
uploaded directly. We anticipate that
most, if not all companies, already have
electronic versions of their labels for
printing, sales, or marketing purposes.
Product listing information is
provided at the time of registration.
Currently, registration and listing
requirements only apply to domestic
establishments engaged in the
manufacture, preparation,
compounding, or processing of a
tobacco product. This includes
importers to the extent that they engage
in the manufacture, preparation,
compounding, or processing of a
tobacco product, including repackaging
or otherwise changing the container,
wrapper, or labeling of any tobacco
product package. Foreign
establishments are not required to
register and list until FDA issues
regulations establishing such
requirements in accordance with section
905(h) of the FD&C Act. To account for
the foregoing, we include both domestic
manufacturing establishments and
importers in our estimates.
The deadline for initial establishment
registration and product listing for both
statutorily regulated and deemed
products has passed. However, pursuant
to the new authority provided by the
Appropriations Act, the FD&C Act now
includes specific language that makes
clear FDA has the authority the owners
and operators of establishments engaged
in the manufacture, preparation,
compounding, or processing of tobacco
products containing NTN must register
with the FDA and list all these tobacco
products that they manufacture,
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17:49 Aug 10, 2022
Jkt 256001
prepare, compound, or process for
commercial distribution.
FDA estimates up to 200 new
establishments will submit one initial
establishment registration and product
listing report each year. Such new
establishments potentially include
manufacturers of NTN products, new
vape shop locations that mix or
assemble tobacco products on the
market as of the final deeming rule
effective date. The Agency estimates
that up to 200 tobacco establishments
will each submit 1 initial establishment
registration and product listing report
each year, which is expected to take 1.6
hours, for a total 320 burden hours.
FDA estimates that the confirmation
or updating of establishment registration
and product listing information as
required by section 905 of the FD&C Act
will take 10 minutes annually per
confirmation or update per
establishment. Based on FDA’s
experience with current establishment
registration and product listings
submitted to the Agency, the Agency
estimates that on average 2,572
establishments will each submit one
confirmation or updated report each
year, which is expected to take 0.16
hour (10 minutes) for a total 412 burden
hours.
FDA estimates that the submission of
ingredient listings required by section
904(a)(1) of the FD&C Act for each
establishment will take 2 hours initially.
Ingredients may be submitted
electronically through the Center for
Tobacco Products portal or if unable to
submit ingredients electronically then
by mail using Form FDA 3742. We
expect all 904(a)(1) tobacco ingredient
submissions to have been received prior
to November 8, 2018, for small
manufacturers and large manufacturers,
May 8, 2018, for cigarettes, cigarette
tobacco, roll-your-own, smokeless
tobacco, and deemed tobacco products.
While all manufacturers have been
expected to submit 904(a)(1) tobacco
ingredient submissions, there may be a
small number of firms that have missed
this deadline. We are estimating
approximately three manufacturers may
have missed their deadline. This is
based on estimates of how many late
submissions FDA has received after the
deadline. Because this burden estimate
covers 3 years, we are dividing by 3, to
yield 1 respondent as a yearly average
for this estimate. Additionally,
manufacturers for tobacco products
containing nicotine that is not made or
derived from tobacco must complete
initial tobacco ingredient submissions
for such products per section 904(a)(1)
of the FD&C Act. Therefore, FDA
estimates that 16 establishments will
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49595
initially submit one report annually at 2
hours per report, for a total of 32 hours.
Submissions under section 904(c) of
the FD&C Act are for any new product
that is not yet on the market (e.g., if on
the market due to deeming compliance
period, deemed product manufacturers
should have submitted under section
904(a)(1) of the FD&C Act). This
includes any statutorily regulated
product that would receive a marketing
authorization, any new deemed product
not subject to the deeming compliance
period, and any new NTN products not
on the market as of April 14, 2022. For
deemed product categories and NTN
products, there is a portion of these
applicants who will have reported their
ingredients under section 904(a)(1) of
the FD&C Act as most of these
submissions are expected to be for
products subject to section 904(a)(1)
requirements.
Based on FDA’s experience and the
number of new products authorized to
be introduced or delivered for
introduction into interstate commerce
submitted over the past 3 years, FDA
estimates that 37 establishments will
each submit 10 reports (1 every 6
months). FDA also estimates that the
confirmation or updating of product
(ingredient) listing information required
by section 904(c) of the FD&C Act is
expected to take 0.40 hour (24 minutes)
for a total 148 burden hours. FDA
estimates that obtaining a DUNS (data
universal numbering system) number
will take 30 minutes. FDA assumes that
all new establishment facilities that will
be required to initially register under
section 905 of the FD&C Act would
obtain a DUNS number. FDA estimates
that up to 100 establishments that
would need to obtain this number each
year. The total industry burden to obtain
a DUNS number is 50 hours.
FDA estimates the total burden for
this collection to be 962 hours. We have
adjusted our burden estimate, which has
resulted in an increase of 132 hours to
the currently approved burden. As a
result, NTN products that were not
previously subject to the FD&C Act (e.g.,
products containing synthetic nicotine)
are now subject to all of the tobacco
product provisions in the FD&C Act
beginning on April 14, 2022. Based on
this new authority the owners and
operators of establishments engaged in
the manufacture, preparation,
compounding, or processing of tobacco
products containing NTN must register
with the FDA and list all these tobacco
products that they manufacture,
prepare, compound, or process for
commercial distribution. As such we
have revised the estimates in the burden
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49596
Federal Register / Vol. 87, No. 154 / Thursday, August 11, 2022 / Notices
chart to account for products containing
NTN.
Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
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.
[FR Doc. 2022–17248 Filed 8–10–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2013–N–0520]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Substances
Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in
Ruminant Feed
Food and Drug Administration,
HHS.
ACTION:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
the FDA docket number found in
brackets in the heading of this
document.
Notice.
The Food and Drug
Administration (FDA) 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: Submit written comments
(including recommendations) on the
collection of information by September
12, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0339. Also include
SUMMARY:
Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed—21 CFR
589.2000(e)(1)(iv)
OMB Control Number 0910–0339—
Extension
Section 701(a) (21 U.S.C. 371(a)) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) gives us the authority to
issue regulations for the efficient
enforcement of the FD&C Act. Our
regulation at 21 CFR 589.2000 provides
that animal protein derived from
mammalian tissue (with some
exclusions) is not generally recognized
as safe (GRAS) for use in ruminant feed
and is a food additive subject to certain
provisions of the FD&C Act (62 FR
30936, June 5, 1997).
This information collection was
established because epidemiological
evidence gathered in the United
Kingdom suggested that bovine
spongiform encephalopathy (BSE), a
progressively degenerative central
nervous system disease, is spread to
ruminant animals by feeding protein
derived from ruminants infected with
BSE. This regulation places general
requirements on persons that
manufacture, blend, process, and
distribute products that contain, or may
contain, protein derived from
mammalian tissue, and feeds made from
such products.
Specifically, this regulation requires
renderers, feed manufacturers, and
others involved in feed and feed
ingredient manufacturing and
distribution to maintain written
procedures specifying the cleanout
procedures or other means and
specifying the procedures for separating
products that contain or may contain
protein derived from mammalian tissue
from all other protein products from the
time of receipt until the time of
shipment. These written procedures are
intended to help the firm formalize
consistent processes, and then to help
inspection personnel confirm that the
firm is conducting these processes in
compliance with the regulation.
Inspection personnel will evaluate the
written procedure and confirm it is
being followed when they are
conducting an inspection.
These written procedures must be
maintained if the facility is operating in
a manner that necessitates the record,
and if the facility makes changes to an
applicable procedure or process the
record must be updated. Written
procedures required by this section
shall be made available for inspection
and copying by FDA.
Description of Respondents:
Respondents include renderers, feed
manufacturers, and others involved in
feed and feed ingredient manufacturing
and distribution.
In the Federal Register of January 28,
2022 (87 FR 4626), FDA published a 60day notice requesting public comment
on the proposed collection of
information. Although one comment
was received it was not responsive to
the four collection of information topics
solicited.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part
Number of
recordkeepers
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Written procedures; 589.2000(e)(1)(iv) ..
225
1
225
14
3,150
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number
of recordkeepers on inspectional data.
Based on a review of the information
collection since our last request for
OMB approval we have adjusted our
burden estimate, which has resulted in
a decrease of 1,330 hours. Review of our
inspection data suggests that the
number of facilities that need to conduct
VerDate Sep<11>2014
17:49 Aug 10, 2022
Jkt 256001
these separation practices is gradually
decreasing, therefore we have decreased
the number of facilities who must
comply, as well as the total number of
hours needed to comply with this
burden.
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Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17274 Filed 8–10–22; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 87, Number 154 (Thursday, August 11, 2022)]
[Notices]
[Pages 49593-49596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17248]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0386]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration and
Product Listing for Owners and Operators of Domestic Tobacco Product
Establishments and Listing of Ingredients in Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by September 12, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0650. 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.
Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments and Listing of Ingredients in Tobacco
Products
OMB Control Number 0910-0650--Extension
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (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) by adding, among other things, a chapter granting FDA
important authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors. The Tobacco Control Act created
new requirements for the tobacco industry. Section 101 of the Tobacco
Control Act amended the FD&C Act by adding, among others, sections 905
and 904 (21 U.S.C. 387e and 387d).
Section 905 of the FD&C Act requires the annual registration of any
``establishment in any State engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products.''
Section 905 of the FD&C Act requires this registration be completed by
December 31 of each year. The Secretary of Health and Human Services
(Secretary) has delegated to the Commissioner of Food and Drugs the
responsibility for administering the FD&C Act, including section 905.
Section 905 of the FD&C Act requires owners or operators of each
establishment to register: (1) their name; (2) places of business; (3)
a list of all tobacco products which are
[[Page 49594]]
manufactured by that person; (4) a copy of all labeling and a reference
to the authority for the marketing of any tobacco product subject to a
tobacco product standard under section 907 of the FD&C Act (21 U.S.C.
387g) or to premarket review under section 910 of the FD&C Act (21
U.S.C. 387j); (5) a copy of all consumer information and other
labeling; (6) a representative sampling of advertisements; (7) upon
request made by the Secretary for good cause, a copy of all
advertisements for a particular tobacco product; and (8) upon request
made by the Secretary, if the registrant has determined that a tobacco
product contained in the product list is not subject to a tobacco
product standard established under section 907 of the FD&C Act, a brief
statement of the basis upon which the registrant made such
determination.
FDA collects the information submitted pursuant to section 905 of
the FD&C Act through an electronic portal, and through paper forms
(Forms FDA 3741 https://www.fda.gov/media/77915/download and 3741a
https://www.fda.gov/media/99863/download) for those individuals who
choose not to use the electronic portal.
FDA has also published a guidance for industry entitled
``Registration and Product Listing for Owners and Operators of Domestic
Tobacco Product Establishments'' (https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf). This
guidance is intended to assist persons making tobacco product
establishment registration and product listing submissions to FDA.
Section 904(a)(1) of the FD&C Act requires that each tobacco
product manufacturer or importer submit ``a listing of all ingredients,
including tobacco, substances, compounds, and additives that are, as of
such date, added by the manufacturer to the tobacco, paper, filter, or
other part of each tobacco product by brand and by quantity in each
brand and subbrand'' by December 22, 2009. This section applies only to
those tobacco products manufactured and distributed before June 22,
2009, and which are still manufactured as of the date of the ingredient
listing submission.
Section 904(c) of the FD&C Act requires that a tobacco product
manufacturer: (1) provide all information required under section 904(a)
of the FD&C Act to FDA ``at least 90 days prior to the delivery for
introduction into interstate commerce of a tobacco product not on the
market on the date of enactment'' of the Tobacco Control Act; (2)
advise FDA in writing at least 90 days prior to adding any new tobacco
additive or increasing in quantity an existing tobacco additive, except
for those additives that have been designated by FDA through regulation
as not a human or animal carcinogen, or otherwise harmful to health
under intended conditions of use; and (3) advise FDA in writing at
least 60 days of such action of eliminating or decreasing an existing
additive, or adding or increasing an additive that has been designated
by FDA through regulation as not a human or animal carcinogen, or
otherwise harmful to health under intended conditions of use.
FDA collects the information submitted pursuant to section
904(a)(1) and 904(c) of the FD&C Act through an electronic portal, and
through a paper form (Form FDA 3742 https://www.fda.gov/media/77661/download) for those individuals who choose not to use the electronic
portal.
In addition to the development of the electronic portal and paper
form, FDA published a guidance entitled ``Listing of Ingredients in
Tobacco Products'' (https://www.fda.gov/media/101162/download). This
guidance is intended to assist persons making tobacco product
ingredient listing submissions. FDA also provides a technical guide,
embedded hints, and a web tutorial to the electronic portal.
The Tobacco Control Act also gave FDA the authority to issue a
regulation deeming all other products that meet the statutory
definition of a tobacco product to be subject to Chapter 9 of the FD&C
Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))). On May 10,
2016, FDA issued that rule, extending FDA's tobacco product authority
to all products that meet the definition of tobacco product in the law
(except for accessories of newly regulated tobacco products), including
electronic nicotine delivery systems, cigars, hookah tobacco, pipe
tobacco, nicotine gels, and dissolvables that were not already subject
to the FD&C Act, and other tobacco products that may be developed in
the future (81 FR 28974 at 28976) (``the final deeming rule'').
In the Federal Register of January 28, 2022 (87 FR 4622), 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
FDA form; activity; Tobacco Control Act Number of responses per Total annual Average burden per recordkeeping Total hours
section respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Product Establishment Initial 200 1 200 1.6...................................... 320
Registration and Listing; Form FDA 3741
Registration and Product Listing for Owners
and Operators of Domestic Establishments
(Electronic and Paper submissions); sections
905(b)-(d), 905(h), or 905(i).
Tobacco Product Establishment Renewal 2,572 1 2,572 0.16 (10 minutes)........................ 412
Registration and Listing; Form FDA 3741
Registration and Product Listing for Owners
and Operators of Domestic Establishments
(Electronic and Paper submissions); sections
905(b)-(d), 905(h), or 905(i).
Tobacco Product Listing; Form FDA 3742 16 1 16 2........................................ 32
Listing of Ingredients (Electronic and Paper
submissions); section 904(a)(1).
Tobacco Product Listing; Form FDA 3742 37 10 370 0.40 (24 minutes)........................ 148
Listing of Ingredients (Electronic and Paper
submissions); section 904(c).
Obtaining a Dun and Bradstreet (D-U-N-S) 100 1 100 0.5 (30 minutes)......................... 50
Number.
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Total.................................... .............. .............. .............. ......................................... 962
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Since the publishing of the 60-day notice, the Consolidated
Appropriations Act of 2022 (the Appropriations Act, Pub. L. 117-103),
enacted on March 15, 2022, amended the definition of the term ``tobacco
product'' in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) to
include products that contain nicotine from any source. As a result,
[[Page 49595]]
non-tobacco nicotine (NTN) products that were not previously subject to
the FD&C Act (e.g., products containing synthetic nicotine) are now
subject to all of the tobacco product provisions in the FD&C Act
beginning on April 14, 2022. Based on this new authority the owners and
operators of establishments engaged in the manufacture, preparation,
compounding, or processing of tobacco products containing NTN must
register with the FDA and list all these tobacco products that they
manufacture, prepare, compound, or process for commercial distribution.
As such we have revised the estimates in the burden chart to account
for products containing NTN.
The PRA burden estimates have been updated to fully incorporate the
use of an electronic system known as Tobacco Registration and Product
Listing Module Next Generation (TRLM NG) for submitting registration
and product listing information to FDA. With the TRLM NG, manufacturers
can enter information quickly and easily. For example, product label
pictures can be uploaded directly. We anticipate that most, if not all
companies, already have electronic versions of their labels for
printing, sales, or marketing purposes.
Product listing information is provided at the time of
registration. Currently, registration and listing requirements only
apply to domestic establishments engaged in the manufacture,
preparation, compounding, or processing of a tobacco product. This
includes importers to the extent that they engage in the manufacture,
preparation, compounding, or processing of a tobacco product, including
repackaging or otherwise changing the container, wrapper, or labeling
of any tobacco product package. Foreign establishments are not required
to register and list until FDA issues regulations establishing such
requirements in accordance with section 905(h) of the FD&C Act. To
account for the foregoing, we include both domestic manufacturing
establishments and importers in our estimates.
The deadline for initial establishment registration and product
listing for both statutorily regulated and deemed products has passed.
However, pursuant to the new authority provided by the Appropriations
Act, the FD&C Act now includes specific language that makes clear FDA
has the authority the owners and operators of establishments engaged in
the manufacture, preparation, compounding, or processing of tobacco
products containing NTN must register with the FDA and list all these
tobacco products that they manufacture, prepare, compound, or process
for commercial distribution.
FDA estimates up to 200 new establishments will submit one initial
establishment registration and product listing report each year. Such
new establishments potentially include manufacturers of NTN products,
new vape shop locations that mix or assemble tobacco products on the
market as of the final deeming rule effective date. The Agency
estimates that up to 200 tobacco establishments will each submit 1
initial establishment registration and product listing report each
year, which is expected to take 1.6 hours, for a total 320 burden
hours.
FDA estimates that the confirmation or updating of establishment
registration and product listing information as required by section 905
of the FD&C Act will take 10 minutes annually per confirmation or
update per establishment. Based on FDA's experience with current
establishment registration and product listings submitted to the
Agency, the Agency estimates that on average 2,572 establishments will
each submit one confirmation or updated report each year, which is
expected to take 0.16 hour (10 minutes) for a total 412 burden hours.
FDA estimates that the submission of ingredient listings required
by section 904(a)(1) of the FD&C Act for each establishment will take 2
hours initially. Ingredients may be submitted electronically through
the Center for Tobacco Products portal or if unable to submit
ingredients electronically then by mail using Form FDA 3742. We expect
all 904(a)(1) tobacco ingredient submissions to have been received
prior to November 8, 2018, for small manufacturers and large
manufacturers, May 8, 2018, for cigarettes, cigarette tobacco, roll-
your-own, smokeless tobacco, and deemed tobacco products. While all
manufacturers have been expected to submit 904(a)(1) tobacco ingredient
submissions, there may be a small number of firms that have missed this
deadline. We are estimating approximately three manufacturers may have
missed their deadline. This is based on estimates of how many late
submissions FDA has received after the deadline. Because this burden
estimate covers 3 years, we are dividing by 3, to yield 1 respondent as
a yearly average for this estimate. Additionally, manufacturers for
tobacco products containing nicotine that is not made or derived from
tobacco must complete initial tobacco ingredient submissions for such
products per section 904(a)(1) of the FD&C Act. Therefore, FDA
estimates that 16 establishments will initially submit one report
annually at 2 hours per report, for a total of 32 hours.
Submissions under section 904(c) of the FD&C Act are for any new
product that is not yet on the market (e.g., if on the market due to
deeming compliance period, deemed product manufacturers should have
submitted under section 904(a)(1) of the FD&C Act). This includes any
statutorily regulated product that would receive a marketing
authorization, any new deemed product not subject to the deeming
compliance period, and any new NTN products not on the market as of
April 14, 2022. For deemed product categories and NTN products, there
is a portion of these applicants who will have reported their
ingredients under section 904(a)(1) of the FD&C Act as most of these
submissions are expected to be for products subject to section
904(a)(1) requirements.
Based on FDA's experience and the number of new products authorized
to be introduced or delivered for introduction into interstate commerce
submitted over the past 3 years, FDA estimates that 37 establishments
will each submit 10 reports (1 every 6 months). FDA also estimates that
the confirmation or updating of product (ingredient) listing
information required by section 904(c) of the FD&C Act is expected to
take 0.40 hour (24 minutes) for a total 148 burden hours. FDA estimates
that obtaining a DUNS (data universal numbering system) number will
take 30 minutes. FDA assumes that all new establishment facilities that
will be required to initially register under section 905 of the FD&C
Act would obtain a DUNS number. FDA estimates that up to 100
establishments that would need to obtain this number each year. The
total industry burden to obtain a DUNS number is 50 hours.
FDA estimates the total burden for this collection to be 962 hours.
We have adjusted our burden estimate, which has resulted in an increase
of 132 hours to the currently approved burden. As a result, NTN
products that were not previously subject to the FD&C Act (e.g.,
products containing synthetic nicotine) are now subject to all of the
tobacco product provisions in the FD&C Act beginning on April 14, 2022.
Based on this new authority the owners and operators of establishments
engaged in the manufacture, preparation, compounding, or processing of
tobacco products containing NTN must register with the FDA and list all
these tobacco products that they manufacture, prepare, compound, or
process for commercial distribution. As such we have revised the
estimates in the burden
[[Page 49596]]
chart to account for products containing NTN.
Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17248 Filed 8-10-22; 8:45 am]
BILLING CODE 4164-01-P
