Section II of the revised form now allows information for
``bundled'' or grouped PMTAs to be submitted. Section II now allows
submitters to submit updated tobacco product information for all new
tobacco products including co-packaged products. Additionally, section
II of the revised form enables submitters to describe the subject of
their correspondence and provide a submission summary describing the
intended use of the submitted contents.
    Where appropriate, FDA has harmonized the terminology in the form
with other FDA forms and has harmonized the layout of the Amendment and
General Correspondence submission form with the layout of the PMTA
submission form. For example, section I of the revised PMTA form is
used to describe the applicant, the authorized representative, the
alternate point of contact and other applicant information.
Correspondingly, section I of the revised Amendment and General
Correspondence submission form is used to update applicant information.
Similarly, section II of the revised PMTA form is used to set out
tobacco product information. Correspondingly, section II of the revised
Amendment and General Correspondence submission form is used to update
tobacco product information.
    FDA received generally supportive comments regarding proposed Form
FDA 4057b. Comments agreed the form was a positive step towards
streamlining the current PMTA submission process, as well as promoting
efficient processing and review of bundled PMTAs.
    (Comment 144) One comment noted that Form FDA 4057b failed to
include an ``oral tobacco-derived nicotine (OTDN)'' category or
subcategory designation. The comment argued that OTDN products are both
distinct, being tobacco-free and non-dissolvable, and one of the
fastest growing tobacco product segments in the U.S. market. Including
an OTDN product subcategory would provide clarity for applicants and
streamline FDA review of these products. The comment also noted that
Form FDA 4057b requires applicants to include characterizing flavor
information but does not define this term in Form FDA 4057b or within
the proposed rule.
    (Response 144) Providing unique identifying information, such as
product category or subcategory, ensures FDA can identify the new
tobacco product and distinguish it from other tobacco products,
including additional new tobacco products in a bundled submission
submitted using Form FDA 4057b, and assists FDA in performing its
acceptance and filing reviews. At this

time, FDA does not yet have the experience necessary to create
requirements for OTDN as a standalone product category or subcategory.
Review of OTDN products will be handled on a case-by-case basis and any
future decision to update or change the requirements of the rule and
form to include OTDN products will follow appropriate notice and
comment procedures. While the rule does not specifically include OTDN
as a category or subcategory, where an applicant believes its new
tobacco product, such as OTDN, does not fit within a product category
set forth in the rule, it should identify the product category as
``other''. Applicants are encouraged to include any properties in
addition to those required by the ``other'' category or subcategory to
fully identify the tobacco product, if applicable.
    In addition, the requirement for applicants to include product-
specific information, such as characterizing flavor(s), corresponds to
the general information requirements of Sec.  1114.7.(c)(3)(iii) that
will allow FDA to quickly check whether the product is within CTP's
purview and identify the specific product that is the subject of the
submission. For the characterizing flavor item, FDA is looking to see
how the applicant identifies the tobacco product as having no
characterizing flavor or having a particular characterizing flavor. If
applicants do not consider the product to have a characterizing flavor,
applicants must state ``none''. As discussed in the proposed rule,
applicants that have questions regarding how to describe their
product's characterizing flavor are encouraged to contact FDA prior to
submission.
    (Comment 145) Another comment noted that while the use of Form FDA
4057b would be a positive step, the current PMTA process is
prohibitively expensive for most individual manufacturers of nicotine
e-liquids.
    (Response 145) As discussed in the proposed RIA, FDA has considered
the costs and benefits associated with the rule, if finalized. While
there are costs associated with the rule, the analysis also noted that
the rule, would create cost savings for firms and for FDA by reducing
the number of follow-on submission for PMTAs (i.e., additional PMTAs
submitted for the same product(s) after FDA refuses to accept or file,
or issues a marketing denial order in response to, an initial PMTA).
The analysis also noted small manufacturers who submit ENDS PMTA
bundles would benefit from the proposed rule, if finalized. Submitted
bundles, such as those submitted via Form FDA 4057b, would receive
marketing orders through the PMTA pathway earlier with rulemaking than
without rulemaking, increasing lifetime profits for the ENDS products
included in the submitted ENDS bundles.
    FDA is finalizing requirements for the content, format, submission,
and review of PMTAs, as well as other requirements related to PMTAs,
including recordkeeping requirements, and postmarket reporting. FDA is
also finalizing recordkeeping requirements regarding the legal
marketing of Pre-Existing Tobacco Products and products that are exempt
from the requirements of demonstrating substantial equivalence.
    Section 910(a)(2) of the FD&C Act generally requires that a new
tobacco product be the subject of a PMTA marketing order unless FDA has
issued an order finding it to be substantially equivalent to a
predicate product or it is exempt from the requirements of
demonstrating substantial equivalence. A manufacturer may choose to
submit a PMTA under section 910(b) of the FD&C Act in an attempt to
satisfy the requirements of premarket review. Section 910(b)(1)
describes the required contents of a PMTA, which in addition to
specific items, allows FDA to require applicants to submit other
information relevant to the subject matter of the application.
    Under Sec.  1114.5 an applicant may submit a PMTA to demonstrate
that a new tobacco product meets the requirements to receive a
marketing order. A new tobacco product may not be introduced or
delivered for introduction into interstate commerce under this part
until FDA has issued a marketing order for the product. Section Sec.
1114.7 describes the required content and format of the PMTA. The PMTA
must contain sufficient information for FDA to determine whether any of
the grounds for denial specified in section 910(c)(2) of the FD&C Act
apply. The application must contain the following sections: general
information, descriptive information, product samples as required by
FDA, a statement of compliance with part 25, a summary, product
formulation, manufacturing, health risk investigations, and a
certification statement.
    Section Sec.  1114.9 provides that FDA may request, and an
applicant may submit, an amendment to a pending PMTA. FDA generally
expects that when an applicant submits a PMTA, the submission will
include all information required by section 910(b)(1) of the FD&C Act
and part 1114 to enable FDA to determine whether it should authorize
the marketing of a new tobacco product. However, FDA recognizes that
additional information may be needed to complete the review of a PMTA
and, therefore, section Sec.  1114.9 allows the submission of
amendments to a pending application.
    Section Sec.  1114.13 describes the steps that requires an
applicant to take when it changes ownership of a PMTA. This section is
intended to facilitate transfers of ownership and help ensure that FDA
has current information regarding the ownership of a PMTA. An applicant
may transfer ownership of its PMTA at any time, including when FDA has
yet to act on it.
    Section Sec.  1114.15 discusses supplemental PMTAs, which are an
alternative format for submitting a PMTA. Specifically, supplemental
PMTAs are a standardized cross-referencing format that FDA would
implement under its authority of section 701(a) of the FD&C Act to
efficiently enforce section 910 for submissions that are based on a
PMTA that FDA has previously reviewed. Applicants that have received a
marketing order are able to submit a supplemental PMTA to seek
marketing authorization for a new tobacco product that results from a
modification or modifications to the original tobacco product that
received the marketing order. FDA is restricting the use of
supplemental PMTAs to only changes that require the submission of
limited information or revisions to ensure that FDA is able to
efficiently review the application. An applicant is also be able to
submit a supplemental PMTA for modifications made to comply with a
product standard issued under section 907 of the FD&C Act where FDA
specifies that the submission of supplemental PMTAs would be
appropriate.
    Section Sec.  1114.17 describes resubmissions, which are an
alternative format for submitting an application that meets the
requirements of Sec.  1114.7(b) or Sec.  1114.15 to seek a marketing
order for a tobacco product by responding to the deficiencies outlined
in a marketing denial order. An applicant may submit a resubmission for
the same tobacco product that received a marketing denial order or for
a different new tobacco product that results from changes necessary to
address the deficiencies outlined in a marketing denial order. This
application format allows an applicant to address the deficiencies
described in a marketing denial order without having to submit a
standard PMTA. The resubmission format is not available for PMTAs that
FDA refused to accept, refused to file, cancelled, or administratively
closed, or that the

applicant withdrew because FDA has not previously completed reviews of
such applications upon which it can rely, and such applications may
need significant changes to be successfully resubmitted.
    Section Sec.  1114.41 requires applicants that receive a marketing
order to submit postmarket reports. FDA requires such reports as
necessary to determine or facilitate a determination of whether there
may be grounds to withdraw or temporarily suspend a marketing order.
Section Sec.  1114.41 describes the reports that FDA would require
through this regulation; however, FDA may require additional reporting
in an individual applicant's marketing order. Applicants would be
required under Sec.  1114.41 to submit two types of reports after
receiving a marketing order: periodic reports and adverse experience
reports.
    Applicants need to submit periodic reports within 60 calendar days
of the reporting date specified in the marketing order. FDA requires
the submission of these reports on an annual basis, but FDA may require
in a specific order that reports be made more or less frequently
depending upon a number of factors. Applicants are also required to
report all serious and unexpected adverse experiences associated with
the tobacco product that have been reported to the applicant or of
which the applicant is aware under section Sec.  1114.41(a)(2). The
serious and unexpected adverse experience reports must be submitted to
CTP's Office of Science through the HHS Safety Reporting Portal within
15 calendar days after receiving or becoming aware of a serious and
unexpected adverse experience.
    Section Sec.  1114.45 requires applicants receiving a marketing
order to maintain all records necessary to facilitate a determination
of whether there are or may be grounds to withdraw or temporarily
suspend the marketing order, including records related to both the
application and postmarket reports, and ensure that such records remain
readily available to the Agency upon request. Under section Sec.
1114.45(a)(1), an applicant must retain all documents submitted to FDA
as part of an application and postmarket reports. An applicant must
also retain any additional documentation supporting the application and
postmarket reports that was not submitted to FDA.
    Section Sec.  1100.200 states that subpart C of part 1100
establishes requirements for the maintenance of records by tobacco
product manufacturers who introduce a Pre-Existing Tobacco Product, or
deliver it for introduction, into interstate commerce
    Section Sec.  1107.3 describes that each applicant who submits an
abbreviated report under section 905(j)(1)(A)(ii) of the FD&C Act and
receives a letter acknowledging the receipt of an abbreviated report
from FDA must maintain all records to support a determination that
their exemption request meets the requirements of section
905(j)(3)(A)(i) of the FD&C Act that the modification to a product
additive described in the exemption request was a minor modification
made to a tobacco product that can be sold under the FD&C Act.
    Section Sec.  1114.49 requires an applicant to submit a PMTA and
all supporting and related documents to FDA in electronic format. Under
section Sec.  1114.49(c), an applicant that has a waiver would submit a
paper submission to the address that FDA provides in the letter
granting the waiver. FDA's section Sec.  1114.49 is based on FDA's
general experience with electronic submissions, which FDA has found
help facilitate premarket reviews because electronic submissions
typically enable FDA to receive, access, search, and review a
submission more quickly than a submission submitted on paper through
postal mail.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMTA Submission (ENDS).............................................             200             3.75              750            1,713    1,284,750 \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ This total will not be added to the total burden for this rule as its currently approved under a separate OMB control number 0910-0768.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
    21 CFR part; activity         Number of     responses per   Total annual     Average burden     Total hours
                                 respondents     respondent       responses       per response
----------------------------------------------------------------------------------------------------------------
1114.5--Submission of                       1               1               1              1,713           1,713
 Standard Bundled PMTAs \2\..
1114.7--Premarket Tobacco                  24               1              24  0.75 (45 minutes)              18
 Product Application (PMTA)
 Submission (Form FDA 4057)..
Premarket FDA Tobacco Product              24              14             336  0.16 (10 minutes)              54
 Application Amendment and
 General Correspondence
 Submission (Form FDA 4057a).
Premarket Tobacco Product                  24               1              24  0.75 (45 minutes)              18
 Unique Identifying
 Information for New Tobacco
 Products Submission (Form
 FDA 4057b)..................
1114.41--Reporting                          3               1               3                 50             150
 Requirements (periodic
 reports)....................
1114.9--Amendments...........              24               2              48                188           9,024
1114.13--Change in Ownership.               1               1               1                  1               1
1114.15--Supplemental                       2               1               2                428             856
 applications................
1114.17--Resubmissions.......               3               1               3                565           1,695
1114.41(a)(2)--Adverse                      3               6              18   0.6 (36 minutes)              11
 Experience Reports..........
1114.49(b) and (c)--Waiver                  1               1               1  0.25 (15 minutes)            0.25
 from Electronic Submission..
                              ----------------------------------------------------------------------------------

    Total....................  ..............  ..............  ..............  .................          13,540
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ FDA anticipates that applicants will submit bundled PMTAs, which are single submissions containing PMTAs for
  a number of similar or related products. We estimate that a bundle will contain on average (between 6 and 11)
  with most submitting 9 distinct products.

    FDA has based these estimates on the full analysis of economic
impacts and experience with current PMTA submissions. Table 1 describes
the current estimates for OMB control number 0910-0768 which covers the
burden for ENDS products PMTA submissions. These estimates were
originally published in the deeming final rule and recently in the
Federal Register of April 22, 2019 (84 FR 16673). FDA estimates that it
will take each respondent approximately 1,500 hours to prepare a PMTA
seeking an order from FDA allowing the marketing of a new tobacco
product. FDA also estimates that it would on average take an additional
213 hours to prepare an EA in accordance with the requirements of Sec.
25.40, for a total of 1,713 hours per PMTA application.
    Table 1 describes the estimated annual reporting burden per the
requirements that the rule would create beyond what is covered in the
existing information collection. For this analysis, FDA assumes that
firms will submit all applications as PMTA bundles. We also considered
updated data on market consolidation that has occurred since the
deeming final rule was published. For originally regulated products we
expect to receive one full PMTA submission for a total of 1,713 hours.
    FDA conducted a thorough analysis of the current paperwork burden
associated with the PMTA program and other similar forms and applied
the most accurate burden to the forms; however, upon further review and
certain updates made to the form based on comments received and product
categorization changes, FDA has revised the burden associated with
entering the data into the form (which includes searching existing data
sources and gathering and maintaining the data needed) to be 45 minutes
per individual product (rather than 30 minutes per product) on Form FDA
4057. For Form FDA 4057a, FDA has revised the burden for this form to
10 minutes (from 5 minutes). This form serves several purposes from
changing a point of contact (minimal burden) to providing additional
substantive information for the purpose of the review of the PMTA
application (more burdensome).
    FDA developed Form FDA 4057 for use when submitting PMTA single and
bundled submissions. FDA estimates that 24 respondents will submit PMTA
bundles using this form at 0.75 (45 minutes) per response. The number
24 is accounting for the bundles of ENDS products and the 1 bundle we
expect to receive yearly for originally regulated products. (200 + 1 =
201/8.5 products on average in a bundle) for a total of 12 hours.
    FDA developed Form FDA 4057a for use when firms are submitting
amendments and other general correspondence. Our estimate is 0.16 (10
minutes) per response to fill out this form. We estimate there will be
at least one amendment per application for a total of 28 hours. With
most applications being submitted toward the end of our 3-year range,
we expect fewer amendments during this period. However, FDA expects
correspondence from earlier applications to be submitted during this
period.
    FDA developed an additional form (Form FDA 4057b) that will assist
industry and FDA in identifying the products that are the subject of a
submission where an applicant groups multiple PMTAs into a single
submission (referred to as a bundled submission or a grouped
submission). FDA has previously stated that one approach to submitting
PMTAs could be to group applications for products that are both from
the same manufacturer or domestic importer and in the same product
category and subcategory into a single submission. FDA discussed
bundled submissions in the proposed rule (84 FR 50566 at 50578) and
noted that FDA intends to consider information on each tobacco product
as a separate, individual PMTA. The form will assist applicants in
providing the unique identifying information for each product in a
grouped submission of PMTAs that are required Sec.  1114.7(c)(3)(iii).
By having the identifying information for products contained in a
submission be more clearly organized, FDA will be able to more
efficiently process and review the applications contained in a grouped
submission.
    Based on the Form FDA 4057 for use when submitting PMTA single and
bundled submissions, a respondent would utilize Form FDA 4057b once for
each submission containing more than one PMTA. We assume the submitter
could include from 2 to 2,000 products in each Form FDA 4057b. Entering
data for up to 2,000 rows can take approximately 4 hours on average per
Form FDA 4057b for manual data entry. However, FDA's original estimate
that Form 4057b would estimate 4 hours per response was a high-end
estimate and not an average. We now reflect the average time of 45
minutes per response based on the assumption that we expect to receive
an average of nine bundled products per submission. Assuming 45 minutes
per Form FDA 4057b for 24 applications, we estimate a total burden of
18 hours for this activity.
    FDA estimates under Sec.  1114.41 that three respondents will
submit a periodic report. This number is based on the average number of
periodic report submissions expected between 2020-2022. The RIA
estimates that periodic reports will take between 20 and 80 hours per
submission. For this estimate, we use the average of 50 per response
for a total of 150 hours.
    Under Sec.  1114.9 firms will prepare amendments to PMTA bundles in
response to deficiency letters. These amendments contain additional
information that we need to complete substantive review. In the RIA we
state in our limited history reviewing PMTAs, we on average issue two
deficiency letters. Based on this, we would anticipate two responses
back per bundle. Therefore, we estimate that 24 respondents will submit
48 amendments (24 x 2). Assuming 1,500 hours as the time to prepare and
submit a full PMTA and amendments may on average take 10 percent to 15
percent of that time (150-225). We averaged this time out (12.5 percent
of a full submission preparation time) and arrived at 188 hours per
response. FDA estimates the total burden hours for preparing amendments
is 9,024 hours.

    Section Sec.  1114.13 would allow an applicant to transfer
ownership of a PMTA to a new owner. FDA believes this will be
infrequent, so we have assigned 1 token hour acknowledging the
requirement.
    Section Sec.  1114.15 is an alternative format of submitting a PMTA
that meets the requirements of Sec.  1114.7 that would reduce the
burden associated with the submission and review of an application. Our
estimated number of 2 respondents is based on the number estimated for
postmarket reports, which is 3 bundles (which is approximately 26
products). Not all applicants will resubmit modifications to previously
authorized products, so we estimate 2 bundles (which is approximately
17 products). FDA estimates further that a supplemental PMTA will take
25 percent of the time it takes to do an original submission (including
EA hours) for 428 hours per response. We estimate a total of 856 burden
hours for this activity.
    Under Sec.  1114.17 an applicant may submit a resubmission for the
same tobacco product that received a marketing denial order or for a
different new tobacco product that results from changes necessary to
address the deficiencies outlined in a marketing denial order. Based on
the preliminary RIA, we are estimating that out of all bundles received
in 2020, 2021, and 2022, that an average of three bundles are
authorized. If we receive 24 bundles yearly, and based on historical
data, 58 percent fail at acceptance (down to 8 bundles remaining), 17
percent fail at filing (down to 7 bundles remaining), and 25 percent
receive marketing orders (5 left). We estimate that 50 percent will try
to resubmit in a year. Thus, this number of respondents is three
(rounded up). FDA estimates that a resubmission will take 33 percent of
the time it takes to complete an original submission (including EA
hours) at 565 hours per response for a total of 1,695 hours.
    Under Sec.  1114.41(a)(2), firms would also submit adverse
experience reports for tobacco products with marketing orders. We
assume the same number of firms submitting periodic reports will submit
adverse experience reports. Currently, firms may voluntarily submit
adverse experience reports using Form FDA 3800 under OMB control number
0910-0645. We have based our estimates on this information collection
which estimates that it takes 1 hour (for mandatory reporting) to
complete this form for tobacco products for a total of 18 hours.
    Section Sec.  1114.49 would require an applicant to submit a PMTA
and all supporting and related documents to FDA in electronic format
that FDA can process, review, and archive unless an applicant requests,
and FDA grants, a waiver from this requirement. FDA does not believe we
will receive many waivers, so we have assigned one respondent to
acknowledge the option to submit a waiver. Consistent with our other
application estimates for waivers, we believe it would take .25 hours
(15 minutes) per waiver for a total of .25 hours.

                               Table 3--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
      21 CFR part; activity          Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
1114.45--PMTA Records...........              24               1              24               2              48
1100.204--Pre-Existing Tobacco                 1               1               1               2               2
 Product Records................
1107.3--Exemptions from                        1               1               1               2               2
 Substantial Equivalence Records
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              52
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 3 describes the annual recordkeeping burden per the
requirements in this rule. FDA estimates that 26 recordkeepers will
maintain records at 2 hours per record. Additionally, the rule requires
that firms establish and maintain records related to SE Exemption
Requests and Pre-Existing Tobacco Products. We expect the burden hours
of this rule to be negligible for SE Exemption Requests. Firms would
have already established the required records when submitting the SE
Exemption Request. Similarly, we expect the hours of this rule to be
negligible for any Pre-Existing Tobacco Products that have already
submitted Standalone Pre-Existing Tobacco Product Submissions, because
firms would have established the required records when submitting the
Standalone Pre-Existing Tobacco Product Submissions. We believe this
time is usual and customary for these firms. We estimate that it would
take 2 hours per record to establish the required records for a total
of 4 hours. Therefore, the total recordkeeping burden hours is
estimated to be 52 hours.
    The total burden for these new collections of information in this
rulemaking is 13,540 reporting hours and 52 recordkeeping hours for a
total of 13,592 hours.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

XIII. Federalism: Executive Order 13132

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13132. Section 4(a) of the Executive Order
requires Agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.''
    Section 916(a)(2) of the FD&C Act is an express preemption
provision. Section 916(a)(2) provides that ``no State or political
subdivision of a State may establish or continue in effect with respect
to a tobacco product any requirement which is different from, or in
addition to, any requirement under the provisions of this chapter
relating to . . . premarket review.'' Thus, the final

rule creates requirements that fall within the scope of section
916(a)(2) of the FD&C Act.

XIV. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a ``major rule,'' as defined by 5 U.S.C. 804(2).

XV. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

XVI. Analysis of Environmental Impact

    The Agency has determined under Sec.  25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. No extraordinary circumstances exist
to indicate that the specific proposed action may significantly affect
the quality of the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

XVII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
This final rule is a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We expect that the final rule will generate net benefits or
negligible net costs for most affected small entities. Therefore, we
certify that the final rule will not have a significant economic impact
on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This final rule will not
result in an expenditure in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    The final rule will require manufacturers of Pre-Existing Tobacco
Products and manufacturers of products that are exempt from the
requirements of demonstrating SE to maintain records to demonstrate
that they can legally market their products. For products that receive
a PMTA marketing granted order, the final rule will require certain
postmarket reporting, including periodic reporting and adverse
experience reporting. The final rule will also implement and set forth
requirements for the content and format of PMTAs and the general
procedures we intend to follow in reviewing and communicating with
applicants.
    The final rule will make the review of PMTAs more efficient. As a
result, the final rule will create cost savings for FDA related to the
review of some PMTAs. The final rule will also create cost savings for
FDA and for PMTA applicants by reducing the number of PMTAs submitted.
In table 4, we present the annualized benefits of the final rule. We
estimate that annualized benefits over 20 years will equal $2.04
million at a 7 percent discount rate, with a low estimate of $1.36
million and a high estimate of $2.85 million. We estimate that
annualized benefits over 20 years will equal $2.08 million at a 3
percent discount rate, with a low estimate of $1.43 million and a high
estimate of $2.84 million.
    This is the first regulation to address the costs of PMTA
requirements for new, originally regulated tobacco products. While we
already included the costs to submit and review PMTAs for deemed
tobacco products in the final RIA for the deeming final rule, no RIA
includes the costs to submit and review PMTAs for originally regulated
tobacco products. Therefore, we include the costs to prepare and review
PMTAs for these tobacco products in this analysis.
    The final rule will increase the cost for applicants to prepare a
PMTA. As a result, the final rule will generate incremental costs
related to the preparation of PMTAs for ENDS products. Firms will incur
costs to maintain and submit postmarket reports and we will incur costs
to review these reports. Finally, firms will incur costs to read and
understand the rule and costs to maintain records for some Pre-Existing
Tobacco Products. In table 4, we present the annualized costs of the
final rule. We estimate that annualized costs over 20 years will equal
$4.73 million at a 7 percent discount rate, with a low estimate of
$2.63 million and a high estimate of $7.45 million. We estimate that
annualized costs over 20 years will equal $4.86 million at a 3 percent
discount rate, with a low estimate of $2.50 million and a high estimate
of $7.95 million.

                                    Table 4--Summary of Benefits, Costs, and Distributional Effects of the Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                                ------------------------------------
                   Category                       Primary       Low        High                               Period                  Notes
                                                 estimate    estimate    estimate      Year      Discount     covered
                                                                                dollars     rate  %     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized ($m/year)............       $2.04       $1.36       $2.85        2019           7          20  All quantified benefits are cost
                                                      2.08        1.43        2.84        2019           3          20   savings.

    Annualized Quantified.....................
                                               ---------------------------------------------------------------------------------------------------------
    Qualitative...............................  Benefits from postmarket surveillance.
-----------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized ($m/year)............        4.73        2.63        7.45        2019           7          20
                                                      4.86        2.50        7.95        2019           3          20
    Annualized Quantified.....................
    Qualitative...............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:

    Federal Annualized Monetized ($m/year)....  From:
                                                To:
                                               ---------------------------------------------------------------------------------------------------------
    Other Annualized Monetized ($m/year)......  From: Currently marketed tobacco
                                                products.
                                                To: New tobacco products with PMTA
                                                marketing orders.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local, or Tribal Government: None............................................................................................................
    Small Business: None................................................................................................................................
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

XVIII. Effective Date

    This rule will become effective 30 days after it publishes in the
Federal Register.
    (Comment 146) One comment stated that FDA must not apply any
requirements from the final rule retroactively to applications that
have already been submitted because doing so would be fundamentally
unfair. The comment further stated, for instance, that FDA should not
discount the results of a study on the basis that it does not contain
the newly required statements or documentation regarding financial
conflicts of interest.
    (Response 146) FDA agrees with this comment insofar as it applies
to the acceptance and filing criteria. FDA does not intend to
retroactively apply any new acceptance and filing criteria added by
Sec.  1114.27 to applications that have been submitted before the final
rule is effective. If an applicant has submitted an application before
this rule is effective, FDA will not refuse to accept or refuse to file
the PMTA unless the FD&C Act or other existing regulations require
information that the application is missing. It is important to note
that while FDA will not apply acceptance and filing criteria required
by this rule retroactively, the information required for acceptance and
filing under this rule remains important to FDA's substantive review of
an application. The comment's example of information regarding
financial conflicts of interest is particularly relevant because
determining the reliability of a study's results is an important part
of FDA's substantive review of an application, regardless of whether
it's applied as a filing criteria. Other provisions in this rule, such
as those regarding application amendments, temporary suspension and
withdrawal, postmarket changes, postmarket reporting, and
recordkeeping, will take effect for all PMTAs, as applicable, once the
rule is effective. In addition, all the requirements in section 910 of
FD&C Act are in effect.

XIX. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they also are available electronically at https://www.regulations.gov.
References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may
be available at the website address, if listed. References without
asterisks are available for viewing only at the Dockets Management
Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852,<PHONE_NUMBER>. FDA has verified the website
addresses, as of the date this document publishes in the Federal
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List of Subjects

21 CFR Part 1100

    Administrative practice and procedure, Smoke, Smoking, Tobacco,
Tobacco products.

21 CFR Part 1107

    Administrative practice and procedure, Smoke, Smoking, Tobacco,
Tobacco products.

21 CFR Part 1114

    Administrative practice and procedure, Smoke, Smoking, Tobacco,
Tobacco products.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs,
chapter I of title 21 of the Code of Federal Regulations will be
amended as follows:

PART 1100--GENERAL

0
1. The authority citation for part 1100 is revised to read as follows:

    Authority: 21 U.S.C. 371, 374, 387a(b), 387e, and 387i; Pub. L.
111-31.

0
2. Revise the part heading to read as set forth above.

Subpart A--Tobacco Products Subject to FDA Authority

0
3. Add subpart A consisting of Sec. Sec.  1100.1, 1100.2, 1100.3, and
1100.5 to read as set forth above:

Subpart B [Reserved]

0
4. Add and reserve subpart B.

0
5. Add subpart C, consisting of Sec. Sec.  1100.200, 1100.202, and
1100.204, to read as follows:
Subpart C--Maintenance of Records Demonstrating That a Tobacco Product
Was Commercially Marketed in the United States as of February 15, 2007
Sec.
1100.200 Purpose and scope.
1100.202 Definitions.
1100.204 Recordkeeping requirements.

Subpart C--Maintenance of Records Demonstrating That a Tobacco
Product Was Commercially Marketed in the United States as of
February 15, 2007.

Sec.  1100.200  Purpose and scope.

    This subpart sets out requirements under the Federal Food, Drug,
and Cosmetic Act for the maintenance of records by tobacco product
manufacturers that introduce a Pre-Existing Tobacco Product, or deliver
it for introduction, into interstate commerce.

Sec.  1100.202  Definitions.

    For the purposes of this subpart:
    Commercially marketed means selling or offering for sale a tobacco
product in the United States to consumers or to any person for the
eventual purchase by consumers in the United States.
    Pre-Existing Tobacco Product means a tobacco product (including
those products in test markets) that was commercially marketed in the
United States as of February 15, 2007. A Pre-Existing Tobacco Product
is not subject to the premarket requirements of section 910 of the
Federal Food, Drug, and Cosmetic Act.
    Tobacco product means any product made or derived from tobacco that
is intended for human consumption, including any component, part, or
accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). The term ``tobacco product'' does not mean an article
that under the Federal Food, Drug, and Cosmetic Act is a drug (section
201(g)(1)), a device (section 201(h)), or a combination product
(section 503(g)).
    Tobacco product manufacturer means any person, including any
repacker or relabeler, who--
    (1) Manufactures, fabricates, assembles, processes, or labels a
tobacco product; or
    (2) Imports a finished tobacco product for sale or distribution in
the United States.

Sec.  1100.204  Recordkeeping requirements.

    (i) Any tobacco product manufacturer that introduces a Pre-Existing
Tobacco Product, or delivers it for introduction, into interstate
commerce must maintain records that demonstrate that the tobacco
product was commercially marketed in the United States as of February
15, 2007, as described in this subpart. These records may include items
such as:

    (A) Dated copies of advertisements;
    (B) Dated catalog pages;
    (C) Dated promotional material;
    (D) Dated trade publications;
    (E) Dated bills of lading;
    (F) Dated freight bills;
    (G) Dated waybills;
    (H) Dated invoices;
    (I) Dated purchase orders;
    (J) Dated customer receipts;
    (K) Dated manufacturing documents;
    (L) Dated distributor or retailer inventory lists; or
    (M) Any other dated document that demonstrates that the tobacco
product was commercially marketed in the United States as of February
15, 2007.
    (ii) All records must be legible, in the English language, and
available for inspection and copying by officers or employees duly
designated by the Secretary. Documents that have been translated from
another language into English (e.g., advertisements written in a
language other than English) must be accompanied by the original
language version of the document, a signed statement by an authorized
representative of the manufacturer certifying that the English language
translation is complete and accurate, and a brief statement of the
qualifications of the person that made the translation.
    (iii) All records required by this subpart must be retained for a
period of not less than 4 years after the date either FDA makes a
determination that the product is a Pre-Existing Tobacco Product, or
the tobacco product manufacturer permanently ceases the introduction or
delivery for introduction into interstate commerce of the tobacco
product, whichever occurs sooner.

PART 1107--EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS

0
6. The authority citation for part 1107 is revised to read as follows:

    Authority:  21 U.S.C. 371, 374, 387e(j), 387i, 387j.

0
7. Revise the part heading as set forth above.

0
8. Add Sec.  1107.3 to subpart A to read as follows:

Sec.  1107.3  Recordkeeping.

    (a) Definition. The term ``Pre-Existing Tobacco Product'' means a
tobacco product (including those products in test markets) that was
commercially marketed in the United States as of February 15, 2007. A
Pre-Existing Tobacco Product is not subject to the premarket
requirements of section 910 of the Federal Food, Drug, and Cosmetic
Act.
    (b) Record maintenance. (1) Each applicant who submits an
abbreviated report under section 905(j)(1)(A)(ii) of the Federal Food,
Drug, and Cosmetic Act and receives a letter acknowledging the receipt
of an abbreviated report from FDA must maintain all records (including
those created by third parties on the applicant's behalf) that support
the submission. Such records may include, but are not limited to:
    (i) A copy of the abbreviated report and, if applicable, the
exemption request and all amendments thereto.
    (ii) A copy of the acknowledgement letter issued in response to an
abbreviated report and, if applicable, the exemption order issued by
FDA.
    (iii) Documents related to formulation of product, design
specifications, packaging, and related items.
    (iv) Documents showing design specifications are consistently met.
    (v) Documents related to product packing and storage conditions.
    (vi) Analytical test method records, including:
    (A) Performance criteria.
    (B) Validation or verification documentation; and
    (C) Reports/results from these test methods.
    (vii) Source data and related summaries.
    (2) An applicant that submits an abbreviated report for a
modification to a Pre-Existing Tobacco Product must also maintain
records demonstrating that the Pre-Existing Tobacco Product was
commercially marketed in the United States as of February 15, 2007,
such as the records described in Sec.  1100.204 of this chapter.
    (3) An applicant that submits an abbreviated report for a
modification to a tobacco product that previously received premarket
authorization (i.e., an exemption (and for which the applicant has
submitted an abbreviated report under section 905(j)(1)(A)(ii) of the
Federal Food, Drug, and Cosmetic Act, a substantially equivalent order
under section 910(a), or a marketing granted order under section
910(c)) must maintain a copy of the exemption order, substantially
equivalent order, or marketing granted order.
    (4) An applicant that submits an abbreviated report for a
modification to a tobacco product that is the subject of a pending SE
report and is marketed pursuant to section 910(a)(2)(B) of the Federal
Food, Drug, and Cosmetic Act must maintain all communications to and
from FDA relating to the pending SE Report (e.g., acknowledgement
letter, deficiency letters), including the SE Report.
    (c) Record quality. All records must be legible, in the English
language, and available for inspection and copying by officers or
employees duly designated by the Secretary. Documents that have been
translated from another language into English (e.g., advertisements
written in a language other than English) must be accompanied by the
original language version of the document, a signed statement by an
authorized representative of the manufacturer certifying that the
English language translation is complete and accurate, and a brief
statement of the qualifications of the person that made the
translation.
    (d) Record retention. All records required by this subpart must be
retained for a period of 4 years from the date that an acknowledgement
letter is issued by FDA.

0
9. Add part 1114 to subchapter K to read as follows:

PART 1114--PREMARKET TOBACCO PRODUCT APPLICATIONS

Subpart A--General Provisions
Sec.
1114.1 Scope.
1114.3 Definitions.
Subpart B--Premarket Tobacco Product Applications
1114.5 Application submission.
1114.7 Required content and format.
1114.9 Amendments.
1114.11 Withdrawal by applicant.
1114.13 Change in ownership of an application.
1114.15 Supplemental applications.
1114.17 Resubmissions.
Subpart C--FDA Review
1114.25 Communication between FDA and applicants.
1114.27 Review procedure.
1114.29 FDA action on an application.
1114.31 Issuance of a marketing granted order.
1114.33 Issuance of a marketing denial order.
1114.35 Withdrawal of a marketing granted order.
1114.37 Temporary suspension of a marketing granted order.
Subpart D--Postmarket Requirements
1114.39 Postmarket changes.
1114.41 Reporting requirements.
Subpart E--Miscellaneous
1114.45 Record retention.
1114.47 Confidentiality.
1114.49 Electronic submission.

    Authority:  21 U.S.C. 371, 374, 387a, 387i, and 387j.

Subpart A--General Provisions

Sec.  1114.1  Scope.

    (a) This part sets forth the procedures and requirements for
submitting a premarket tobacco product application (PMTA), the general
procedures FDA will follow when evaluating a PMTA, and postmarket
reporting requirements.
    (b) This part does not apply to modified risk tobacco product
applications, except that single applications seeking both a marketing
granted order under section 910(c) of the Federal Food, Drug, and
Cosmetic Act and an order under section 911(g) of the Federal Food,
Drug, and Cosmetic Act must satisfy the requirements of this part in
addition to the requirements of section 911 of the Federal Food, Drug,
and Cosmetic Act.
    (c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
    (d) This part does not apply to ``premium'' cigars as defined in
Sec.  1114.3.

Sec.  1114.3  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or
    (2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product, but:
    (i) Solely controls moisture and/or temperature of a stored tobacco
product; or
    (ii) Solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
    Additive means any substance the intended use of which results or
may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristic of any
tobacco product (including any substances intended for use as a
flavoring or coloring or in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding),
except that such term does not include tobacco, or a pesticide chemical
residue in or on raw tobacco or a pesticide chemical.
    Adverse experience means any unfavorable physical or psychological
effect in a person that is temporally associated with the use of or
exposure to a tobacco product, whether or not the person uses the
tobacco product, and whether or not the effect is considered to be
related to the use of or exposure to the tobacco product.
    Applicant means any person that submits a premarket tobacco product
application to receive a marketing granted order for a new tobacco
product.
    Brand means a variety of tobacco product distinguished by the
tobacco used, tar content, nicotine content, flavoring used, size,
filtration, packaging, logo, registered trademark, brand name(s),
identifiable pattern of colors, or any combination of such attributes.
    Characteristics means the materials, ingredients, design,
composition, heating source, or other features of a tobacco product.
    Commercially marketed means selling or offering for sale a tobacco
product in the United States to consumers or to any person for the
eventual purchase by consumers in the United States.
    Component or part means any software or assembly of materials
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance,
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco
product. Component or part excludes anything that is an accessory of a
tobacco product.
    Composition means the materials in a tobacco product, including
ingredients, additives, and biological organisms. The term includes the
manner in which the materials, for example, ingredients, additives, and
biological organisms, are arranged and integrated to produce a tobacco
product.
    Constituent means any chemical or chemical compound in a tobacco
product that is or potentially is inhaled, ingested, or absorbed into
the body, any chemical or chemical compound in an emission (e.g.,
smoke, aerosol, droplets) from a tobacco product, that either transfers
from any component or part of the tobacco product to the emission or
that is formed by the product, including through combustion or heating
of tobacco, additives, or other components of the tobacco product.
    Container closure system means any packaging materials that are a
component or part of a tobacco product.
    Design means the form and structure concerning, and the manner in
which components or parts, ingredients, software, and materials are
integrated to produce a tobacco product.
    Finished tobacco product means a tobacco product, including all
components and parts, sealed in final packaging (e.g., filters or
filter tubes sold to consumers separately or as part of kits, or e-
liquids sealed in final packaging sold to consumers either separately
or as part of kits) or in the final form in which it is intended to be
sold to consumers.
    Harmful or potentially harmful constituent or HPHC means any
chemical or chemical compound in a tobacco product or tobacco smoke or
emission that:
    (1) Is or potentially is inhaled, ingested, or absorbed into the
body, including as an aerosol or any other emission; and
    (2) Causes or has the potential to cause direct or indirect harm to
users or nonusers of tobacco products.
    Heating source means the source of energy used to burn or heat the
tobacco product.
    Ingredient means tobacco, substances, compounds, or additives
contained within or added to the tobacco, paper, filter, or any other
component or part of a tobacco product, including substances and
compounds reasonably expected to be formed through a chemical reaction
during tobacco product manufacturing.
    Label means a display of written, printed, or graphic matter upon
the immediate container of any article.
    Labeling means all labels and other written, printed, or graphic
matter upon any article or any of its containers or wrappers, or
accompanying such article.
    Line data means an analyzable dataset of observations for each
individual study participant, laboratory animal, or test replicate.
    Marketing denial order means the order described in section
910(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act stating
that the product may not be introduced or delivered for introduction
into interstate commerce.
    Marketing granted order means the order described in section
910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act stating
that the new tobacco product may be introduced or delivered for
introduction into interstate commerce.
    Material means an assembly of ingredients. Materials are assembled
to form a tobacco product or components or parts of a tobacco product.
    New tobacco product means:
    (1) Any tobacco product (including those products in test markets)
that was not commercially marketed in the United States as of February
15, 2007; or

    (2) Any modification (including a change in design, any component,
any part, or any constituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or any other additive or
ingredient) of a tobacco product where the modified product was
commercially marketed in the United States after February 15, 2007.
    Other features means any distinguishing qualities of a tobacco
product similar to those specifically enumerated in section
910(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. Such other
features include harmful and potentially harmful constituents and any
other product characteristics that relate to the chemical, biological,
and physical properties of the tobacco product.
    Package or packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
    Premarket tobacco product application or PMTA means the application
described in section 910(b) of the Federal Food, Drug, and Cosmetic
Act. This term includes the initial premarket tobacco product
application and all subsequent amendments.
    ``Premium'' cigar means a type of cigar that:
    (1) Is wrapped in whole tobacco leaf;
    (2) Contains a 100 percent leaf tobacco binder;
    (3) Contains at least 50 percent (of the filler by weight) long
filler tobacco (i.e., whole tobacco leaves that run the length of the
cigar);
    (4) Is handmade or hand rolled (i.e., no machinery was used apart
from simple tools, such as scissors to cut the tobacco prior to
rolling);
    (5) Has no filter, nontobacco tip, or nontobacco mouthpiece;
    (6) Does not have a characterizing flavor other than tobacco;
    (7) Contains only tobacco, water, and vegetable gum with no other
ingredients or additives; and
    (8) Weighs more than 6 pounds per 1,000 units.
    Serious adverse experience means an adverse experience that results
in any of the following outcomes:
    (1) Death;
    (2) A life-threatening condition or illness;
    (3) Inpatient hospitalization or prolongation of existing
hospitalization;
    (4) A persistent or significant incapacity or substantial
disruption of the ability to conduct normal life functions;
    (5) A congenital anomaly/birth defect; or
    (6) Any other adverse experience that, based upon appropriate
medical judgment, may jeopardize the health of a person and may require
medical or surgical intervention to prevent one of the other outcomes
listed in this definition.
    Submission tracking number or STN means the number that FDA assigns
to submissions that are received from an applicant, such as a PMTA and
a supplemental PMTA.
    Tobacco product means any product made or derived from tobacco that
is intended for human consumption, including any component, part, or
accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). The term ``tobacco product'' does not mean an article
that under the Federal Food, Drug, and Cosmetic Act is a drug (section
201(g)(1)), a device (section 201(h)), or a combination product
(section 503(g)).
    Tobacco product manufacturer means any person, including a repacker
or relabeler, who:
    (1) Manufactures, fabricates, assembles, processes, or labels a
tobacco product, or
    (2) Imports a finished tobacco product for sale or distribution in
the United States.
    Unexpected adverse experience means an adverse experience occurring
in one or more persons in which the nature, severity, or frequency of
the experience is not consistent with:
    (1) The known or foreseeable risks of adverse experiences
associated with the use or exposure to the tobacco product as described
in the PMTA and other relevant sources of information, such as the
product labeling and postmarket reports;
    (2) The expected natural progression of any underlying disease,
disorder, or condition of the persons(s) experiencing the adverse
experience and the person's predisposing risk factor profile for the
adverse experience; or
    (3) The results of nonclinical investigations.
    Vulnerable populations means groups that are susceptible to tobacco
product risk and harm due to disproportionate rates of tobacco product
initiation, use, burden of tobacco-related diseases, or decreased
cessation. Vulnerable populations can include, but are not limited to,
youth and young adults, those with lower socioeconomic status, certain
races or ethnicities, sexual or gender minorities, underserved rural
populations, those pregnant or trying to become pregnant, those in the
military or veterans, and those with mental health conditions or
substance use disorders.

Subpart B--Premarket Tobacco Product Applications

Sec.  1114.5  Application submission.

    An applicant may submit a PMTA to demonstrate that a new tobacco
product meets the requirements to receive a marketing granted order. A
new tobacco product may not be introduced or delivered for introduction
into interstate commerce under this part until FDA has issued a
marketing granted order for the product.

Sec.  1114.7  Required content and format.

    (a) General. The PMTA must contain sufficient information for FDA
to determine whether any of the grounds for marketing denial order
specified in section 910(c)(2) of the Federal Food, Drug, and Cosmetic
Act apply. The application must contain the following sections:
    (1) General information (as described in paragraph (c) of this
section);
    (2) Descriptive information (as described in paragraph (d) of this
section);
    (3) Product samples (as described in paragraph (e) of this
section);
    (4) Labeling and description of marketing plans (as described in
paragraph (f) of this section);
    (5) Statement of compliance with 21 CFR part 25 (as described in
paragraph (g) of this section);
    (6) Summary (as described in paragraph (h) of this section);
    (7) Product formulation (as described in paragraph (i) of this
section);
    (8) Manufacturing (as described in paragraph (j) of this section);
    (9) Health risk investigations (as described in paragraph (k) of
this section); and
    (10) The effect on the population as a whole (as described in
paragraph (l) of this section);
    (11) Certification statement (as described in paragraph (m) of this
section).
    (b) Format. (1) The application must be submitted using the form(s)
that FDA provides, contain a comprehensive index (i.e., a listing of
files and data associated with those files) and table of contents, be
well-organized and legible, and be written in English. Documents that
have been translated from another language into English (e.g., original
study documents written in a language other than English) must be
accompanied by: The original language version of the document, signed a
statement by an authorized representative of the manufacturer

certifying that the English language translation is complete and
accurate, and a brief statement of the qualifications of the person
that made the translation. As described in Sec.  1114.49, the applicant
must submit the application and all information supporting the
application in an electronic format that FDA can process, read, review,
and archive, unless FDA has granted a waiver.
    (2) An applicant may include content in a submission by cross-
reference to a tobacco product master file or a pending modified risk
tobacco product application for the same tobacco product. Applicants
using a master file must provide documentation of their right of
reference for the master file and clearly identify the specific content
being incorporated into the PMTA submission. Except as provided for in
Sec. Sec.  1114.15 and 1114.17, FDA will not consider content included
by cross-reference to other sources of information outside of the
submission.
    (c) General information. The applicant must, by using the form(s)
FDA provides, specify the following general information:
    (1) Applicant name, address, and contact information;
    (2) Authorized representative or U.S. agent (for a foreign
applicant), including the name, address, and contact information;
    (3) The following information to uniquely identify the product:
    (i) Manufacturer;
    (ii) Product name(s), including brand and subbrand (or other
commercial name(s) used in commercial distribution); and
    (iii) The product category, product subcategory, and product
properties as provided in the following table. If the product does not
have a listed product property, such as ventilation or characterizing
flavor, the application must state ``none'' for that property.

                                        Table 1 to Paragraph (c)(3)(iii)
----------------------------------------------------------------------------------------------------------------
                                           Tobacco product
       Tobacco product category              subcategory                       Product properties
----------------------------------------------------------------------------------------------------------------
(A) Cigarettes.......................  (1) Filtered...........  --Package type (e.g., hard pack, soft pack, clam
                                                                 shell).
                                                                --Product quantity (e.g., 20 cigarettes, 25
                                                                 cigarettes).
                                                                --Length (e.g., 89.1 millimeters (mm), 100.0
                                                                 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 10.0%, 25.0%).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Non-filtered.......  --Package type (e.g., hard pack, soft pack, clam
                                                                 shell).
                                                                --Product quantity (e.g., 20 cigarettes, 25
                                                                 cigarettes).
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                -- Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Other..............  --Package type (e.g., hard pack, soft pack, clam
                                                                 shell).
                                                                --Product quantity (e.g., 20 cigarettes, 25
                                                                 cigarettes).
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 10.0%, 25.0%).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
(B) Roll-Your-Own Tobacco Products...  (1) Roll-Your-Own        --Package type (e.g., bag, pouch).
                                        Tobacco Filler.
                                                                --Product quantity (e.g., 20.1 grams [g], 16.0
                                                                 ounces [oz.]).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Rolling Paper......  --Package type (e.g., box, booklet).
                                                                --Product quantity (e.g., 50 sheets, 200
                                                                 papers).
                                                                --Length (e.g., 79.1 mm, 100.0 mm, 110.2 mm).
                                                                --Width (e.g., 28.1 mm, 33.0 mm, 45.2 mm).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Cigarette Tube,      --Package type (e.g., bag, box).
                                        Filtered.
                                                                --Product quantity (e.g., 100 tubes, 200 tubes).
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 10.0%, 25.0%).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) Cigarette Tube, Non- --Package type (e.g., bag, box).
                                        filtered.
                                                                --Product quantity (e.g., 100 tubes, 200 tubes).
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Filter.............  --Package type (e.g., bag, box).
                                                                --Product quantity (e.g., 100 filters, 200
                                                                 filters).
                                                                --Length (e.g., 8.0 mm, 12.1 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).

                                       (6) Paper Tip..........  --Package type (e.g., bag, box).
                                                                --Product quantity (e.g., 200 tips, 275 tips).
                                                                --Length (e.g., 12.0 mm, 15.1 mm).
                                                                --Width (e.g., 27.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (7) Other..............  --Package type (e.g., bag, box).
                                                                --Product quantity (e.g., 200 tips, 100 filters,
                                                                 200 tubes.
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
(C) Smokeless Tobacco Products.......  (1) Moist Snuff, Loose.  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 20.0 g, 2.1 oz.).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable,
                                                                 e.g., fine cut, long cut, straight cut).
                                       (2) Moist Snuff,         --Package type (e.g., plastic can with metal
                                        Portioned.               lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 22.5 g, 20.0 g).
                                                                --Portion count (e.g., 15 pouches, 20 pieces).
                                                                --Portion mass (e.g., 1.5 g/pouch, 1.0 g/piece).
                                                                --Portion length (e.g., 15.0 mm, 20.1 mm).
                                                                --Portion width (e.g., 10.0 mm, 15.1 mm).
                                                                --Portion thickness (e.g., 5.0 mm, 7.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Snus, Loose........  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 20.0 g, 2.1 oz.).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) Snus, Portioned....  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 22.5 g, 20.0 g).
                                                                --Portion count (e.g., 15 pouches, 20 pieces).
                                                                --Portion mass (e.g., 1.5 g/pouch, 1.0 g/piece).
                                                                --Portion length (e.g., 15.0 mm, 20.1 mm).
                                                                --Portion width (e.g., 10.0 mm, 15.1 mm).
                                                                --Portion thickness (e.g., 5.0 mm, 7.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Dry Snuff, Loose...  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 20.0 g, 2.1 oz.).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (6) Dissolvable........  --Package type (e.g., plastic can with metal
                                                                 lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 22.5 g, 20.0 g)
                                                                --Portion count (e.g., 15 sticks, 20 pieces).
                                                                --Portion mass (e.g., 1.5 g/strip, 1.0 g/piece).
                                                                --Portion length (e.g., 10.0 mm, 15.1 mm).
                                                                --Portion width (e.g., 5.0 mm, 8.1 mm).
                                                                --Portion thickness (e.g., 3.0 mm, 4.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (7) Chewing Tobacco,     --Package type (e.g., bag, pouch, wrapped).
                                        Loose.
                                                                --Product quantity (e.g., 20.0 g, 3.1 oz).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (8) Chewing Tobacco,     --Package type (e.g., plastic can with metal
                                        Portioned.               lid, plastic can with plastic lid).
                                                                --Product quantity (e.g., 22.5 g, 20.0 g)
                                                                --Portion count (e.g., 10 bits).
                                                                --Portion mass (e.g., 2.1 g/bit).
                                                                --Portion length (e.g., 8.0 mm, 10.1 mm).
                                                                --Portion width (e.g., 6.0 mm, 8.1 mm).
                                                                --Portion thickness (e.g., 5.1 mm, 7.0 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (9) Other..............  --Package type (e.g., bag, box, can).
                                                                --Product quantity (e.g., 20.1 g, 22.5 g, 3.0
                                                                 oz.).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry, wintergreen, tobacco).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.

(D) Electronic Nicotine Delivery       (1) E-Liquid, Open.....  --Package type (e.g., bottle, box, pod).
 System (ENDS) (Also referred to as
 vapes).
                                                                --Product quantity (e.g., 1 bottle, 5 bottles).
                                                                --E-liquid volume (e.g., 0.5 milliliters [ml]),
                                                                 2.0 ml, 5.1 ml).
                                                                --Nicotine concentration (e.g., 0 milligrams/
                                                                 milliliter [mg/ml], 0.2 mg/ml, 0.4 mg/ml, 1%,
                                                                 0.2 mg/bottle).
                                                                --Propylene glycol (PG)/vegetable glycerin (VG)
                                                                 ratio (e.g., not applicable [N/A], 0/100, 50/
                                                                 50, 100/0).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) E-Liquid, Closed...  --Package type (e.g., cartridge, pod).
                                                                --Product quantity (e.g., 1 cartridge, 5
                                                                 cartridges).
                                                                --E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1
                                                                 ml).