PDU safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 55 and 63). Similarly for HTPs
the battery current range gives an indication of the safe zone for the
battery to charge and what is considered its normal operating region;
if the battery levels go beyond the safe zone while charging, the
battery could be damaged, which could cause harm to the user.
    [cir] For ENDS, the battery and PDU voltage impacts the amount of
e-liquid consumed, the vapor temperature, and the total emissions of
volatile aldehydes

(Ref. 65) Similarly for HTPs, the battery voltage indicates how much
current the battery can send out to the heating element. For the same
resistance, a higher voltage will send more current (and more watts) to
the heating element and it will produce more vapor. There is a link
between voltage and capacity because vaping at a higher wattage will
produce a higher current and that will reduce the amount of time you
can vape between charges. In addition, the voltage will influence the
vapor temperature, and in, turn smoke yields.
    [cir] For ENDS, an increase in battery capacity (mAh rating) can
increase the number of puffs the e-cigarette can deliver per vaping
session. Longer vaping sessions may lead to greater exposure to
toxicant emissions (Ref. 58). Similarly for HTPs, the battery capacity
rating is a measure of the average amount of current the battery
releases over time under normal use. Current may influence the heating
element temperature, which in turn affects toxicant emissions and
nicotine delivery. In addition, battery mAh rating provides an
understanding of how long a battery will last and thus the product
stability.
    [cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU current operating range are necessary for evaluating battery and
PDU safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 55 and 63). Similarly for HTPs,
the battery charging temperature limits give insight on the safe range
for battery charging temperatures and testing will show if the software
of the battery can keep the battery in the safe zone.
    [cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU current operating range are necessary for evaluating battery and
PDU safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 55 and 63). Similarly for HTPs,
the battery discharge temperature limits give insight on the safe range
for battery discharging temperatures and testing will show if the
software of the battery can keep the battery in the safe zone.
    [cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU and battery current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 55 and 63).
Similarly for HTPs, the end of discharge voltage is the level to which
the battery voltage or cell voltage can fall before affecting the load.
This helps to establish the life cycle of the battery.
    [cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU and battery current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 55 and 63).
Similarly for HTPs, the maximum current at which the battery can be
charged continuously is usually defined by the battery manufacturer in
order to prevent excessive charge rates that would damage the battery
or reduce its capacity. Damage to batteries is a hazard to users.
    [cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU and battery current operating range are necessary for evaluating
battery and PDU safety. Risks of e-cigarette battery explosion,
leakage, fire, or overheating are a safety concern (Refs. 55 and 63).
Similarly for HTPs, the maximum current at which the battery can be
discharged continuously is usually defined by the battery manufacturer
in order to prevent excessive discharge rates that would damage the
battery or reduce its capacity. Damage to batteries is a hazard to
users.
    [cir] For ENDS, the battery type, battery current operating range,
battery failure safety features, battery conformance to standards, and
PDU current operating range are necessary for evaluating battery and
PDU safety. Risks of e-cigarette battery explosion, leakage, fire, or
overheating are a safety concern (Refs. 55 and 63). Similarly for HTPs,
the battery upper limit charging voltage is important to limit the
maximum battery voltage during charging to prevent damage to the
battery, which is a hazard to users.
    [cir] For ENDS, the battery and PDU voltage range may influence
volatile aldehydes emissions (Ref. 65). Similarly for HTPs, the battery
and PDU voltage impact the amount of e-liquid consumed, the vapor
temperature, and the total emissions of volatile aldehydes.
    [cir] For ENDS, the Battery and PDU current operating range and
wattage range may influence the toxicant emissions (Refs. 57 and 59).
Similarly for HTPs, the PDU current operating range and wattage
operating range may influence the heating element temperature thereby
affecting toxicant emissions.
    [cir] For ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 55 and 63). Similarly for
HTPs, the PDU temperature cutoff is an electrical safety product that
interrupts electric current when heated to a specific temperature to
protect the user.
    [cir] For ENDS, the battery type, failure safety features, and
battery conformance to standards are necessary for evaluating battery
and PDU safety. Risks of e-cigarette battery explosion, leakage, fire,
or overheating are a safety concern (Refs. 55 and 63). Similarly for
HTPs, the current cutoff is an electrical cutoff, which is an
electrical safety product that interrupts electric current when a
specific condition is met (temperature, current, etc.) to protect the
user.
    [cir] For ENDS, the battery and PDU current operating range may
influence the toxicant emissions (Refs. 57 and 59). Similarly for HTPs,
the batteries should have a normal operating current range so as to not
overheat the product and cause it to become a hazard to the user. In
addition, this current range has a direct impact on the heating
element, which in turn affects the smoke constituent yields.
    [cir] Inhaled aerosol temperatures can be damaging or uncomfortable
to users who inhale aerosol above a certain temperature (Ref. 67).
    [cir] For e-liquids, aerosol parameters such as particle number
concentration, count median diameter, and PM2.5 are used to
characterize the amount and size of particles to which the user is
exposed (Refs. 68 and 69). Similarly for HTPs, the aerosol parameters
such as particle number concentration, count median diameter, and
PM2.5 are used to characterize the amount and size of
particles to which the user is exposed. Clinical studies have shown
that exposure to large amounts of small particles can impair lung
function and is correlated with cardiovascular disease.
    [cir] For cigarettes, filter pressure drop may affect smoke
constituent yields (Ref. 46). Similarly for HTPs, the filter pressure
drop may affect smoke constituent yields.
    [cir] For cigarettes, filter diameter, denier per filament, total
denier, filter density, and filter length may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 33). Similarly for the
HTPs, the filter diameter, denier per filament, total denier, filter
density, and filter length may affect filter efficiency and, in turn,
smoke constituent yields.

    (Comment 61). Some comments provide information in response to the
proposed rule's request for comment on the appropriate design
parameters for cigars and pipe tobacco. These comments suggest the
following list as appropriate design parameters to be addressed for
cigars: Cigar length; ring gauge; total tobacco mass (including wrapper
mass, binder mass, and filler mass); and filter ventilation (if
applicable). One comment provided this list of appropriate design
parameters for pipe tobacco: Tobacco filler mass (mg); tobacco cut size
(mm); and tobacco moisture (%). One comment suggests that without
design parameters or testing information related to cigar, hookah, pipe
tobacco and other comments, the rule is deficient and further states
that the final rule must include content requirements for each product
category and subcategory.
    (Response 61) As discussed earlier in this section, following
consideration of these comments, FDA has added design parameters for
cigars, pipes, waterpipes, and other tobacco products to this section.
Note that FDA does not consider a tobacco product to be ``new'' if
there are variations that fall within the product's specifications. So
long as the product is manufactured within specified parameters, FDA
would not consider variations within these parameters to be a design
change that would result in a new tobacco product. It is also important
to note that at this time, FDA does not intend to enforce the premarket
requirements of sections 910 and 905(j) for tobacco blending changes
required to address the natural variation of tobacco (e.g., blending
changes due to variation in growing conditions) in order to maintain a
consistent product. FDA agrees with the commenter's suggested list of
appropriate design parameters for pipe tobacco.
 Comparison of Heating Sources (Sec.  1107.19(b))
    In the following paragraphs, we describe the comments and our
responses on Sec.  1107.19(b). We are finalizing this subsection
without change.
    (Comment 62) One comment states that the information required by
proposed Sec.  1107.19(b), which states that the SE Report must include
a description of the heating source for the new and predicate tobacco
products and identify any differences, or the report must state that
there is no heating source in the product, is similar to the previously
submitted ingredient listing information. The comment asserts that
requiring manufacturers to submit this information a second time is
unnecessary and would lengthen FDA's review of the SE Report.
    (Response 62) Section 910(a)(3)(B) of the FD&C Act specifically
identifies the heating source as one of the characteristics of a
tobacco product that FDA must consider in determining whether a new
tobacco product is substantially equivalent to a predicate tobacco
product. We disagree that information describing the heat source of the
products being compared in an SE Report is similar to or duplicative of
previously submitted ingredient listing information. Although there
will likely be some overlap, the ingredient listing requirement under
section 904 of the FD&C Act (21 U.S.C. 387d) is a separate requirement
from the requirement to submit ingredient information in a premarket
application. It is necessary to receive ingredient information in an SE
Report because a finding of substantial equivalence is based on a side-
by-side listing of quantitative and qualitative comparisons of all
product characteristics that differ between a new and predicate tobacco
product.
 Comparison of Product Composition (Sec.  1107.19(c))
    In the following paragraphs, we describe the comments and our
responses on Sec.  1107.19(c). As discussed in the introductory
paragraphs to Sec.  1107.19, we are finalizing this subsection with
minor clarifying changes.
    (Comment 63) Two comments took issue with the requirement in Sec.
1107.19(c) that information on ``[t]he type of tobacco, including grade
and variety'' be submitted in an SE Report. These comments assert that
the Department of Agriculture grading system would not be useful
because they claim that it is not uniformly used by farmers and
manufacturers. Instead, they noted that each farmer and manufacturer
has its own unique grading system and that a written record may not
exist for such system.
    (Response 63) FDA has decided to remove the requirement in Sec.
1107.19(c) that applicants provide information regarding the grade and
variety of tobacco type in their SE Reports. FDA agrees with the
comments that tobacco grading is not uniform throughout the industry,
which reduces the utility of this information in application review. In
addition, FDA does not need to characterize the tobacco type to the
level of detail of tobacco variety for the purposes of an SE
evaluation. Instead, information regarding the tobacco curing process
is more useful to FDA to characterize and analyze the tobacco used in
the tobacco products and tobacco products in general. FDA is still
requiring that the tobacco type (e.g., Bright, Burley, Oriental) and
curing process (e.g., fire-cured, flue-cured, air-cured) be provided in
SE Reports. As described in the proposed rule, the tobacco type impacts
the characteristics of the products as different types have different
smoke constituent profiles, including potentially different HPHC
profiles (Refs. 71 and 72). The curing process also can impact HPHC
profiles (Ref. 73).
 Comparison of Other Features (Sec.  1107.19(d))
    In the following paragraphs, we describe the comments and our
responses Sec.  1107.19(d). We are finalizing this subsection with the
minor clarifying changes as described in the introductory paragraphs to
Sec.  1107.19.
    (Comment 64) Section 1107.19(d) lists the other features that must
be included in an SE Report. One such other feature listed in Sec.
1107.19(d) are HPHCs. Several comments express concern with the
proposed requirement that data from two smoking regimens be submitted
for combusted tobacco products. They state that this requirement would
lead to an unnecessary and significant increase in testing burden with
no corresponding benefit. However, one comment contends that, if
constituent yields were reported from a single smoking regimen only,
FDA would have limited and potentially misleading information about
constituent yields produced by a given product.
    (Response 64) We disagree that mainstream smoke data from two
smoking regimens (non-intense and intense) should not be required. Each
of these regimens provides unique information on the HPHCs generated by
the tobacco product under different pyrolysis conditions (i.e., varying
amounts of oxygen due to smoker use). Studies have shown identical
tobacco products smoked using a non-intense smoking regimen differ in
the formation of volatile organic compounds (VOCs) and aldehydes than
when smoked using an intense smoking regimen. A non-intense smoking
regimen can provide the upper range of aldehydes generated from smoking
while an intense smoking regimen can provide the upper range of VOCs
generated from smoking. Exposure to VOCs and aldehydes results in an
increased risk of cancer and respiratory disease, and for some of these
VOCs and aldehydes tobacco smoke is the primary source of non-
occupational exposure in the U.S. population (Ref. 74). Aldehydes, such
as

formaldehyde, have been classified as class 1 carcinogens by the
International Agency for Research on Cancer. A 2018 study (Ref. 75)
shows aldehyde (formaldehyde, acrolein, acetaldehyde, and
crotonaldehyde) formation may increase nonlinearly, up to six times
more in a non-intense smoking regimen than in an intense smoking
regimen. Another study showed there is a disproportionate increase in
monoaromatic VOCs under a smoking regimen where the filter ventilation
is blocked (i.e., intense smoking regimen) compared to a non-intense
smoking regimen (Ref. 76). Thus, the current state of science
indicates: (1) There is a nonlinear correlation between the smoke data
obtained by a non-intense compared to an intense smoking regimen and
(2) due to variations in the oxygen environment during pyrolysis,
different VOCs and aldehydes are formed in a non-intense smoking
regimen than those formed in an intense smoking regimen.
    Finally, considering smoke data from only one smoking regimen would
result in an incomplete assessment of smoker exposure. A non-intense
and intense smoking regimen provides an upper and lower range of HPHCs
that are generated during the use of a combusted tobacco product;
consequently, it is necessary that FDA evaluate smoke data obtained by
both intense and non-intense smoking regimens.
    (Comment 65) Several comments expressed concern regarding the
requirement in proposed Sec.  1107.19(d) that HPHC data be submitted,
particularly as it relates to cigars, given the variety of cigars and
the variability of several smoke HPHCs in filler HPHC data, the lack of
smoke testing methodologies, for example, for pipes and cigars, costs
of HPHC testing, and insufficient laboratory capacity. One comment also
notes that FDA has not clarified which HPHCs will be required to be
reported for any cigars. A few comments also maintain that FDA has not
provided substantial evidence that the testing will yield meaningful
results. In addition, one comment claims that FDA should not require
that HPHC testing be included in an SE Report because the FD&C Act does
not require it be included. One comment encourages FDA to ensure that
analytical methods are appropriately validated.
    (Response 65) We disagree that HPHC data should not be required in
an SE Report. In determining whether a new tobacco product is
substantially equivalent, it is important for FDA to understand what is
placed into the product (e.g., ingredients), as well as what comes out
of the product and what is, or potentially is, inhaled, ingested, or
absorbed in the body (e.g., HPHCs). HPHCs are of particular importance,
as they may be carcinogens and/or respiratory, cardiovascular, and/or
reproductive or developmental toxicants.
    With respect to the comments on the lack of smoke testing
methodologies, we note that there are some cigar smoking methods that
are applicable to many commercially available products, including
larger cigars.\19\ The cost of testing will be dependent upon a variety
of factors related to the new tobacco product, including the product
characteristics and proposed modifications (e.g., minor changes to
ingredients may need no or limited testing information while more
significant changes to tobacco blend or ingredient changes in higher
quantities may require a higher number of HPHCs tested or more
voluminous data). In general, the cost of testing information necessary
to submit with an SE Report to determine substantial equivalence is not
disproportionate for any product category. FDA acknowledges that
applicants may rely on third party laboratories, the SE program has
been in existence for many years, and FDA has received thousands of SE
Reports, including SE reports containing information obtained from
third party laboratories. Additionally, we anticipate laboratory
capability and capacity will continue to expand over time to meet the
needs of future applicants.
---------------------------------------------------------------------------

    \19\ See, e.g., the following CORESTA standards: CORESTA
Reference Method (CRM) 65: Determination of Total and Nicotine-Free
Dry Particulate Matter using a Routine Analytical Cigar-Smoking
Machine--Determination of Total Particulate Matter and Preparation
for Water and Nicotine Measurements; CRM 66: Determination of
Nicotine in the Mainstream Smoke of Cigars by Gas Chromatographic
Analysis; CRM 67: Determination of Water in the Mainstream Smoke of
Cigars by Gas Chromatographic Analysis; CRM 68: Determination of
Carbon Monoxide in the Mainstream Smoke of Cigars by Non-Dispersive
Infrared Analysis.
---------------------------------------------------------------------------

 Shelf Life and Stability Information (Sec.  1107.19(f))
    In the following paragraphs, we describe the comments and our
responses on Sec.  1107.19(f) (in the proposed rule, this was proposed
as Sec.  1107.19(e), stability information). We are finalizing
subsection (f) with the changes described in the introductory
paragraphs to Sec.  1107.19.
    (Comment 66) Proposed Sec.  1107.19(e) (now subsection (f))
requires the submission of stability information for smokeless tobacco
products and any other tobacco product that contains fermented tobacco.
Several comments dispute that stability information is a relevant
testing parameter. The comments also claim that FDA cannot require
stability testing without substantial evidence regarding its necessity,
and that FDA has not met this requirement.
    (Response 66) We disagree. TSNAs are carcinogenic compounds that
are present at very low levels in freshly harvested tobacco leaves but
can increase dramatically during tobacco processing and storage (Refs.
10, 19-21, 77, 78). TSNA production is critically influenced by the
microbial communities associated with the tobacco. Microbial-mediated
reduction of nitrate results in production of nitrite, which further
reacts with alkaloids present in tobacco to produce the carcinogenic
TSNAs (Refs. 17, 18, 20, 79-82). Therefore, TSNA content in the
finished tobacco products is greatly affected by a variety of factors
such as tobacco processing method(s) (e.g., curing, aging, sweating,
fermentation, heat treatment), product composition (e.g., humectants,
preservatives), container closure system, and product storage
conditions (e.g., temperature, humidity), all of which could
potentially alter microbial activity and, in turn, affect the stability
of the tobacco product over the shelf life. Since bacterial communities
and constituents in tobacco products can potentially change over the
shelf life (Refs. 17, 83, 84), information obtained through stability
testing is important for FDA to consider during its review to ensure
that the tobacco products are microbiologically and chemically stable
during storage and do not result in an increased risk to public health
as the product sits in storage as compared to the predicate tobacco
product.
 Comparison to Original Predicate Tobacco Product (Sec.
1107.19(h))
    In the following paragraphs, we describe the comments and our
responses on Sec.  1107.19(h) (proposed Sec.  1107.19(g)). We are
finalizing this subsection with the changes described in the
introductory paragraphs to Sec.  1107.19, including changes for
consistency with the updated definition of predicate tobacco product.
    We received several comments related to this proposed subsection.
In the proposed rule, we explained that FDA may request that the
applicant include information related to the ``original'' predicate
tobacco product (a tobacco product that was commercially marketed
(other than for test marketing) in the United States as of February 15,
2007), even if the original predicate tobacco product is back several

predicate tobacco products. Due to the removal of the definition of
``grandfathered,'' we are no longer using the term grandfathered
tobacco product in this section. We describe the comments and responses
on this subsection in the following paragraphs.
    (Comment 67) One comment states that FDA has underestimated the
burden that would be imposed by the proposed requirement that a new
tobacco product be compared to the original predicate tobacco product.
Other comments object to the proposed requirement arguing that it could
foster anti-competitive competition and create an imbalance in the
industry in favor of large manufacturers that can afford to maintain a
large pool of tobacco products. In addition, they assert that smaller
companies will risk non-compliance given the costs associated with
complying with the rule and that the cost of compliance may cause
companies to raise prices on their goods. Instead of requiring this
information, the comments suggest FDA should instead rely on data the
Agency currently has including data from previously submitted SE
Reports. Another comment suggests that this interpretation also is
inconsistent with FDA's position that only a single predicate can be
used as the basis for an SE determination because the interpretation
suggests that applicants that use as a predicate a tobacco product that
was previously found SE ``must demonstrate multiple levels of
substantial equivalence and support multiple comparisons in a single
application.''
    (Response 67) We disagree that this requirement should or even
could be deleted. This is because, as explained in the proposed rule,
although an applicant can support a showing of SE by comparing the new
tobacco product to a predicate tobacco product that was commercially
marketed (other than for test marketing) in the United States as of
February 15, 2007, or that FDA has previously found SE, in order to
issue an SE order, FDA must find that the new tobacco product is
substantially equivalent to a tobacco product commercially marketed
(other than for test marketing) in the United States as of February 15,
2007 (see section 910(a)(2)(A)(i)(I) of the FD&C Act). This statutory
provision helps FDA ensure that new tobacco products using the
substantial equivalence pathway and relying on predicate tobacco
products previously found SE do not vary so much from the original
predicate tobacco product that the new product would actually raise
different questions of public health compared to the original predicate
tobacco product. New products with differences that may appear only
incremental when a new tobacco product is compared to a predicate
tobacco product previously found SE can lead to product ``creep,''
which could result in the new tobacco product actually having
significant changes when compared to the original predicate tobacco
product. Issuance of an order under section 910(a)(2)(A)(i)(I) of the
FD&C Act would undermine the public health purposes of the Tobacco
Control Act (section 3) by permitting significant product evolution
over time that raises different questions of public health. Such
products should be submitted for premarket authorization through the
PMTA pathway, which requires an applicant to demonstrate that their
product is ``appropriate for the protection of the public health.'' FDA
would only request the information described in Sec.  1107.19(h) when
necessary to ensure that any order issued by the Agency complies with
section 910(a)(2)(A)(i)(I) of the FD&C Act. Before requesting this
information from the applicant, FDA would review other relevant SE
Reports in the chain, for example, the first SE Report that received an
SE order using the original predicate tobacco product as a predicate
product, to make this finding. If FDA is unable to make the finding
required by section 910(a)(2)(A)(i)(I) of the FD&C Act based on the
information in its files, and the applicant does not provide the needed
information when requested, FDA would not be able to issue an order
authorizing the new tobacco product. We disagree with the comments
suggesting this requirement favors large companies or would lead to
anti-competitive behavior as we expect that companies, regardless of
size, maintain records such as these as part of their business
practices. We note that FDA expects to be able to make the finding
required by section 910(a)(2)(A)(i)(I) of the FD&C Act based on the
information in its files in the vast majority of circumstances, and
thus only expects applicants to need to provide additional information
in unusual circumstances. In response to the comment that suggests that
FDA's ``look-back'' approach effectively implements an SE process
relying on multiple predicates, we note that where FDA must compare the
new product to the original predicate tobacco product in addition to
the selected predicate, each of those comparisons involves an
evaluation comparing a singular new product to a singular predicate.
    (Comment 68) One comment states that FDA's proposed requirement
means that specifications and measurements for the original predicate
tobacco products be submitted, and because those data were not required
at the time the original predicate tobacco product was originally
manufactured, would essentially be requiring the manufacturer to
retroactively adopt certain design and manufacturing requirements for
products. Other comments state that applicants would have to
manufacture the original predicate tobacco products in order to comply
with the proposed requirements. One comment added that the requirement
would decrease clarity, efficiency, and predictability during the SE
review process. Some comments state that while it is appropriate to
``compare key design parameters'' to determine whether a new product
has the same or different characteristics as a predicate tobacco
product, the FD&C Act does not give FDA the authority to retroactively
impose design requirements on tobacco products, especially for
provisional tobacco products that were designed, manufactured, and
marketed before the Act required submission of SE Reports. Instead, the
comments assert that FDA must issue a regulation under section 906(e)
to impose design criteria and that such regulation must be independent
of the SE framework. One comment instead proposes a framework that
would require the manufacturer to provide the specifications employed
in designing the new and predicate product, confirm that those
specifications were met in manufacturing the product for HPHC testing,
and then compare the output to determine whether there is a difference
in disease risk posed.
    (Response 68) We disagree that this section requires applicants to
retroactively adopt or impose certain design and manufacturing
requirements for original predicate tobacco products. FDA is not
imposing design parameters on original predicate tobacco products and
section 906(e) of the FD&C Act does not apply here. Rather, this
section is intended to make applicants aware that in certain cases FDA
may need to request information related to the original predicate
tobacco product when necessary to ensure that any order issued by the
Agency complies with section 910(a)(2)(A)(i)(I) of the FD&C Act. As
explained in a preceding response, before requesting this information
from the applicant, FDA would review its own files for other relevant
SE Reports in the chain, for example, the first SE Report that received
an SE order using the original

predicate tobacco product as a predicate product to make this finding.
    (Comment 69) Some comments object to the proposed requirement that,
if an applicant is using as a predicate a tobacco product found SE by
FDA, and not one that is considered the original predicate tobacco
product, FDA may request information related to the original predicate
tobacco product. The comments dispute that applicants should have to
comply with FDA's ``look back'' approach because under section 905(j)
of the FD&C Act, an applicant may compare a new tobacco product to
either a tobacco product commercially marketed (other than for test
marketing) in the United States as of February 15, 2007, or a product
previously found to be substantially equivalent. The comments also
claim that the proposed requirement allowing FDA to request this
information is in conflict with Congressional intent, and presents
other issues, including preventing tobacco products from evolving by
locking products into their 2007 composition, difficulty for applicants
in obtaining data on the 2007 product, and inconsistency with FDA's
proposed requirement that applicants maintain records for four years
since this provision would require records in perpetuity if FDA could
reach back to the 2007 product.
    (Response 69) We disagree with these objections as manufacturers
have been on notice since the passage of the Tobacco Control Act that
FDA is required to make the comparison between the new tobacco product
and the original predicate tobacco product, and, in doing so, may need
to rely on previously submitted SE Reports, including those submitted
by a different manufacturer. As discussed in the proposed rule, the
statute permits an applicant to compare its new tobacco product to
either a tobacco product commercially marketed (other than for test
marketing) in the United States as of February 15, 2007, or one that
FDA has previously found SE (section 905(j)(1)(A)(i) of the FD&C Act).
However, the statute also requires FDA to make an SE determination by
comparing the new tobacco product to a tobacco product commercially
marketed (other than for test marketing) in the United States as of
February 15, 2007 (section 910(a)(2)(A)(i)(I) of the FD&C Act).
Therefore, to meet its statutory obligation, FDA may need to look back
to previously submitted SE Reports in the SE chain that relied on the
original predicate tobacco product in order to issue an SE order. This
statutory provision helps FDA ensure that new tobacco products using
the substantial equivalence pathway and relying on predicate tobacco
products previously found SE do not vary so much from the original
predicate tobacco product that the new product would actually raise
different questions of public health compared to the original predicate
tobacco product. New products with differences that may appear only
incremental when a new tobacco product is compared to a predicate
product previously found SE may actually have had significant changes
when compared to the original predicate tobacco product. Should this be
the case, such that FDA cannot issue the determination required under
section 910(a)(2)(A)(i)(I), the statute also provides alternative
premarket pathways.
    (Comment 70) Another comment supports the proposed requirement to
include the information regarding the original predicate tobacco
product in the SE Report. The comment states that successive iterations
of SE Reports, each referencing a predicate product that is not itself
the original predicate tobacco product, would attenuate the
relationship between the new tobacco product and the original predicate
tobacco product, thereby introducing products that are not
substantially equivalent to any product actually commercially marketed
(other than for test marketing) on February 15, 2007.
    (Response 70) We agree with this comment and have maintained this
requirement without change from the proposed rule.
 Other Comments on Comparison Information
    (Comment 71) A few comments request that we provide further clarity
on the comparison information required to be submitted for cigars and
ENDS, and particularly more clarity with respect to required HPHC
information. Some comments suggest specific cigar design parameter
information that should be included, such as cigar length,
circumference, wrapper mass, binder mass and filter ventilation.
Another comment states that is inappropriate for FDA to require cigar
manufacturers to include wrapper material as part of the product
properties information to be submitted since whole leaf tobacco is the
wrapper material.
    (Response 71) FDA is providing additional clarity related to
comparison information for deemed tobacco products in this final rule.
Following our consideration of the comments and based on our
experience, FDA has added information to Sec.  1107.19 to address these
concerns, including as suggested by at least one comment, cigar
parameter information (cigar length, circumference, wrapper mass,
binder mass, and filter ventilation) as well as additional product
parameters that vary based on cigar construction (e.g., unfiltered,
hand rolled). We disagree that it is inappropriate to require
information on wrapper material as part of the reported cigar product
properties, as the composition of the wrapper will contribute to
changes in smoke constituent delivery to the user.
    With respect to HPHC information, as defined in this rule and
discussed in the proposed rule, HPHCs are a subset of the chemical and
chemical compounds in the tobacco product, including cigars, or its
tobacco smoke or emission and, accordingly, the SE Report for a cigar
must include the HPHC information necessary to provide a complete
comparison between the new and predicate tobacco products. CORESTA \20\
has established and published methods on how to generate cigar smoke in
order to quantitatively compare HPHCs found in cigar smoke. We also
recommend that applicants that wish to submit a premarket application
for a new ENDS, cigar, or other tobacco product consider the final
guidance entitled ``Harmful and Potentially Harmful Constituents' in
Tobacco Products as Used in Section 904(e) of the Federal Food, Drug,
and Cosmetic Act'' (76 FR 5387, January 31, 2011; revised guidance
issued August 2016, see https://www.fda.gov/media/80109/download),
which FDA intends to update in the future. Although this guidance
document does not break out the information for those specific tobacco
product categories, this guidance document may still provide useful
information for these products; additionally, applicants may request a
meeting to discuss these and other issues and, as noted in the proposed
rule, FDA will make every attempt to grant requests for meetings to
resolve important issues (see, e.g., the guidance entitled ``Meetings
with Industry and

Investigators on the Research and Development of Tobacco Products''
(May 25, 2012, 77 FR 31368; revised guidance issued July 2016, see
https://www.fda.gov/media/83420/download)).
---------------------------------------------------------------------------

    \20\ CORESTA standards that applicants might consider include
CORESTA Reference Method (CRM) 46: Atmosphere for Conditioning and
Testing Cigars of all Sizes and Shapes; CRM 47: Cigars--Sampling;
CRM 64: Routine Analytical Cigar-Smoking Machine--Specifications,
Definitions and Standard Conditions; CRM 65: Determination of Total
and Nicotine-Free Dry Particulate Matter using a Routine Analytical
Cigar-Smoking Machine--Determination of Total Particulate Matter and
Preparation for Water and Nicotine Measurements; CRM 66:
Determination of Nicotine in the Mainstream Smoke of Cigars by Gas
Chromatographic Analysis; CRM 67: Determination of Water in the
Mainstream Smoke of Cigars by Gas Chromatographic Analysis; CRM 68:
Determination of Carbon Monoxide in the Mainstream Smoke of Cigars
by Non-Dispersive Infrared Analysis.
---------------------------------------------------------------------------

4. Amendments (Sec.  1107.20)
    We proposed in Sec.  1107.20 to establish how and when applicants
may submit amendments to an SE Report, including information on when a
redacted copy of the amendment might need to be submitted. The proposed
section provided that an applicant could not amend an SE Report to
change the predicate tobacco product and that an applicant could not
amend an SE Report after FDA closed the report under proposed Sec.
1107.44 or the report was withdrawn under proposed Sec.  1107.22. The
proposed provision also stated that amendments would generally be
reviewed in the next review cycle as described in proposed Sec.
1107.42. Following our review of comments on this section, we are
finalizing the section without change. We describe the comments on this
section in the following paragraphs.
    (Comment 72) One comment disagrees with the proposed requirement
that an applicant could not amend an SE Report to change the predicate
after the report is accepted for review. This comment states that
permitting applicants to change a predicate prior to the initiation of
scientific review is important for products covered by FDA's current
compliance policy for deemed new tobacco products that were on the
market on August 8, 2016, as withdrawal of a timely submitted SE Report
would impact the marketing status of the product.
    (Response 72) We disagree that applicants should be permitted to
change the predicate tobacco product identified in an SE Report that
FDA has accepted for review. As stated in the proposed rule, changing
the predicate product changes the fundamental basis of the analysis, as
the comparison between the new and predicate tobacco products is the
crux of the SE determination. Unless FDA refuses to accept the SE
Report (Sec.  1107.40), FDA intends to issue an acceptance for review
letter and then begin to review the SE Report . Therefore, there is no
time to change the predicate tobacco product between FDA's acceptance
of an SE Report for review and FDA's initiation of the review. If an
applicant determines that a predicate change is necessary, they should
withdraw the initial SE Report and resubmit it as a new SE Report with
the information related to the new predicate tobacco product.
5. Withdrawal by Applicant (Sec.  1107.22) and Change in Ownership of
an SE Report (Sec.  1107.24)
    Proposed Sec.  1107.22 would establish when and how an applicant
may withdraw an SE Report. We received no comments on this proposed
section, and we are finalizing the section with one substitute of
``part 20'' for Sec.  20.45. Proposed Sec.  1107.24 would establish the
procedures for transferring ownership of an SE Report. We received no
comments on this proposed section, and we are finalizing the section
without change.

E. Comments on Subpart D--FDA Review and FDA Responses

    In this subpart, FDA proposed requirements related to FDA review of
an SE Report, including how FDA would communicate with an applicant,
review cycles, and FDA's actions on an SE Report, including issuance of
orders and rescission of orders. Following our review of the comments,
we are finalizing Sec.  1107.40 with a minor change to reflect that,
after receiving an SE Report, FDA will either refuse to accept the
report for review or issue an ``acceptance for review'' letter rather
than an ``acknowledgement'' letter, as proposed. We revised Sec.
1107.44(a) to add a reference to Sec.  1105.10 (refuse to accept). We
revised Sec. Sec.  1107.42, 1107.44, 1107.46, and 1107.48 for
consistency with the updates to the definition of predicate tobacco
product. We also revised Sec.  1107.42(c) to replace a ``will'' with
``generally intends to'' to provide the Agency with some discretion
following receipt of a deficient SE Report. We also revised Sec.
1107.50 pertaining to the opportunity for a hearing in a rescission
action, and we describe those revisions in more detail in the
paragraphs related to that section.
    We note that in addition to the general comments we received on
this subpart, in the proposed rule, FDA invited comment on two issues:
The appropriate amount of time to allow applicants to respond to a
deficiency letter and when extensions of time should be granted. In
response, some comments discuss FDA's review process generally, and
many of these comments recommend that FDA change the timeframes for
review and response.
    In the following paragraphs, we describe the comments we received
on this proposed subpart and our responses.
1. Comments on Communications Between FDA and Applicants (Sec.
1107.40)
    Proposed Sec.  1107.40(a) provided for general principles regarding
communications between applicants and FDA and the form of these
communications, e.g., phone conversations, letters, email. Proposed
Sec.  1107.40(b) addressed the purpose of meetings and that FDA would
make every attempt to grant meeting requests for important issues.
Proposed Sec.  1107.40(c) described how FDA would acknowledge an SE
Report, and proposed Sec.  1107.40(d) stated that FDA would make
reasonable efforts to communicate to applicants the deficiencies found
in an SE report and any additional information needed for FDA's review.
This section also stated that applicants must provide additional
comparison information under proposed Sec.  1107.19 if requested by
FDA. Following our review of comments to this proposed section, we are
finalizing the section by replacing ``acknowledgement'' with
``acceptance for review'' in paragraph (c).
    (Comment 73) Some comments state that FDA should grant meetings
with industry while an SE Report is pending and when FDA requests
scientific information or testing in the pending SE Report. The
comments reason that meetings during the review process serve to
clarify and improve the quality of information required, and improve
the timelines for future actions. Another comment notes that a phone
conversation could help advance the review process for a request for a
determination that a product was commercially marketed in the United
States as of February 15, 2007 (Pre-Existing tobacco product).
    (Response 73) FDA agrees that opportunities can be helpful to
clarify the information being requested, e.g., in a deficiency letter
with an applicant. In addition, FDA intends to use a variety of methods
to communicate with applicants depending on the circumstances and
issues, including but not limited to, telephone conversations, letters,
and/or emails, and, therefore, in many cases a formal meeting may not
be necessary. If there are complex scientific issues that require
discussion, an applicant may request a meeting to discuss these and
other issues and, as noted in the proposed rule, FDA will make every
attempt to grant requests for meetings to resolve important issues.
However, fundamental scientific issues should be the subject of meeting
requests prior to submitting an SE Report (see, e.g., the guidance
entitled

``Meetings with Industry and Investigators on the Research and
Development of Tobacco Products'').
    (Comment 74) One comment argues that FDA should communicate
deficiencies in SE Reports to applicants prior to issuing an NSE order.
A comment requests that FDA establish dispute resolution procedures
that include a mechanism for stay of an NSE order for a provisional
tobacco product, and that during this period of time, FDA should be
barred from making it known that the product was found to be NSE given
the potentially serious business consequences of such a disclosure.
    (Response 74) We note that Sec.  1107.42(b) provides for the use of
multiple review cycles allowing FDA to communicate procedural,
administrative, or scientific deficiencies found during a review,
rather than issuing an NSE order. There may be cases where it is in
FDA's and/or the applicant's interest to not issue deficiency letters
but rather issue an NSE order, and, as customary, FDA generally intends
to outline the deficiencies that are the basis for the decision. This
will allow applicants to consider the deficiencies and consider the
best course to address the deficiencies identified in their NSE order
letter. An applicant has the option to request a meeting with FDA, if
they choose, and FDA intends to make every effort to grant pre-
submission meetings with applicants to discuss the scientific
principles in their NSE determination and how best to prepare a
subsequent premarket application. In addition, the scope of this rule
is SE Reports for new, non-provisional products, which should not be on
the market during FDA's review. FDA intends to comply with the
requirements related to disclosure of information in 21 CFR part 20 and
Sec.  1107.60. If an applicant wishes to dispute the issuance of an NSE
order, they may request supervisory review of FDA decisions under Sec.
10.75 (21 CFR 10.75).
2. Comments on Review Cycles (Sec.  1107.42)
    Proposed Sec.  1107.42 addressed review cycles and explained what
an initial review cycle is, as well as when additional review cycles
would occur and what would happen if FDA issued a deficiency
notification. Following our review of comments, we are finalizing this
section with a minor change to add ``(other than for test marketing)''
following commercially marketed in paragraph (a).
    (Comment 75) Several comments state that FDA should set clear
deadlines for the review process. One comment suggests that FDA's rule
should establish a 90-day review timeline noting that Congress directed
that FDA review ``the more rigorous PMTA applications for new and novel
products'' ``no later than 180 days after receiving the application.''
    (Response 75) FDA agrees that review timeframes are important for
both FDA and industry. Thus, in general, FDA intends to review SE
Reports and either issue a deficiency letter or make a final
determination within 90 calendar days of receipt of the SE Report or
amendment as proposed in Sec.  1107.42(a).
    (Comment 76) One comment disagrees with the review cycles set out
in the proposed rule (initial review, at least one scientific Advice/
Information request, and one preliminary finding letter), which could
mean that review could take 270 days. Some comments support the
proposed review process of three review-cycles, noting it provides
appropriate time and resources for industry and FDA.
    (Response 76) We agree with those comments that support the three
review-cycle process as providing appropriate timeframes. Although the
FD&C Act does not require FDA to provide multiple review cycles, FDA
has provided this framework to help applicants. This final rule
provides additional predictability to this review process by
establishing timeframes for both FDA's review and the applicant's
response. As the proposed rule explained, FDA's intent is to complete
review of an SE Report submitted under Sec.  1107.18 within a maximum
of 270 review days (i.e., three 90-day review cycles). Based on FDA's
review experience, an SE Report should be resolved within three review
cycles, sometimes fewer. If fewer review cycles are needed, FDA intends
to decide in a shorter time period, and we expect that this rule will
result in a decrease in the average number of review cycles needed to
issue an order. As the tobacco industry and we continue to gain
experience with submitting and reviewing, respectively, our goal would
be to complete SE reviews in shorter timeframes.
    It is ultimately the applicant's responsibility to provide a
complete SE Report that supports a scientific finding of substantial
equivalence. If the applicant receives a deficiency letter and cannot
respond within the specified timeframe, they have the option to
withdraw and resubmit the SE Report with the required content.
    (Comment 77) Some comments propose that FDA issue a notice of
refusal to accept an SE Report for review within five business days of
receipt of the report. Other comments propose that an acknowledgement
or refusal to accept letter should be issued within 10 business days,
and that applicants have a reasonable period of time to respond, such
as 30 or 60 days, with a request that for the first five deficiencies,
FDA provide 60 days to respond. The comments also assert that the time
permitted to respond to a deficiency letter should be based on factors
such as the size of the company submitting the SE report and the type
or number of deficiencies identified by FDA. Some comments state that
FDA should provide 180 days for applicants to respond to deficiency
letters without regard to the type or number of deficiencies. The
comments propose a similar approach to extension requests, noting that
the extensions should be given on a case-by-case basis, with
consideration given to the nature of the request.
    (Response 77) The rule will provide predictability to the review
process with timeframes for both FDA review and applicant response. As
already stated, it is the applicant's responsibility to provide a
complete SE Report that supports a scientific finding of substantial
equivalence. With respect to issuance of a refuse to accept letter, FDA
has established performance goals of 21 calendar days. This action
closes the SE Report; therefore, an applicant would need to submit a
new SE Report in order to obtain premarket authorization through the SE
pathway. For an SE Report that is accepted for review, and for which
the applicant receives a deficiency letter to which it cannot respond
within the specified timeframe, the applicant has the option to
withdraw and resubmit the SE Report with the required information. With
respect to deficiency timeframes being based on the size of the
manufacturer or the number of deficiencies involved, FDA is committed
to following a consistent and transparent process for all submitters of
SE Reports. As an SE Report should be complete upon submission to the
Agency, if an applicant is unable to respond to the number of
deficiencies in the timeframe provided in the letter, the applicant has
the option to withdraw and resubmit the SE Report with the required
information. FDA will review all subsequent applications without
prejudice.
3. FDA Action on an SE Report (Sec.  1107.44) and Issuance of an Order
Finding a New Tobacco Product Substantially Equivalent
    Proposed Sec.  1107.44 listed the actions FDA could take after
receipt of an SE

Report. We received no comments on this proposed section, and we are
finalizing the section with a minor change to add ``for review'' and a
reference to Sec.  1105.10 (to ensure applicants are aware of that
provision). Proposed Sec.  1107.46 explained when FDA would issue an
order finding a new tobacco product substantially equivalent. We
received no comments on this proposed section, and we are finalizing
the section without change.
4. Issuance of an Order Denying Marketing Authorization (Sec.  1107.48)
    Proposed Sec.  1107.48 explained when FDA would issue an order that
the new tobacco product cannot be marketed. After considering the
comment on this proposed section, we are finalizing the section without
change. We describe the comment and our response in the following
paragraphs.
    (Comment 78) One comment requests that FDA include a dispute
resolution mechanism for those applicants that seek to challenge an
adverse decision by FDA. The comment asserts that manufacturers whose
products are removed from the market while NSE orders are pending
appeal are harmed when the Agency does not have a formal mechanism to
challenge the decision beyond 21 CFR part 10.
    (Response 78) As discussed in previous paragraphs, this rule
applies to new, non-provisional SE Reports, not provisional SE Reports.
In general, tobacco products that are the subject of non-provisional SE
reports should not be on the market prior to FDA making an SE or NSE
determination. Therefore, no products would need to be removed from the
market during supervisory review of an NSE determination. Applicants
who wish to dispute an NSE finding can use Sec.  10.75.
5. Rescission of an Order and FDA Response (Sec.  1107.50)
    Proposed Sec.  1107.50 set out the grounds for rescinding an SE
order and providing notice of the opportunity for a hearing related to
the Agency's intention to rescind. We are finalizing this section with
some clarifications to reflect the updated definition of predicate
tobacco product, as well as additions related to when notice of an
opportunity for a hearing will be offered. As described in the proposed
rule, FDA will generally rescind an order only after notice of an
opportunity for a hearing under 21 CFR part 16 (hereinafter a Part 16
hearing). However, also as described in the proposed rule, FDA may
rescind an order prior to notice of an opportunity for a hearing if it
finds that there is a reasonable probability that continued marketing
of the tobacco product presents a serious risk to public health. In
that case, FDA will provide the manufacturer a notice of an opportunity
for a hearing as soon as possible after the rescission. In addition,
FDA has revised Sec.  1107.50(b) to add paragraphs (i)-(iii) as a means
of more clearly explaining that FDA may rescind an order without notice
of an opportunity for a Part 16 hearing where an entity that has, on
its own initiative, identified a mistake, notified the Agency of the
mistake, and agreed to a rescission of the marketing order of the
tobacco product without the need for a Part 16 hearing. In this narrow
circumstance, providing notice of an opportunity for a hearing is an
unnecessary procedural step as the applicant has already informed the
Agency that they would not request a Part 16 hearing. Other than these
two circumstances, FDA will offer notice of an opportunity for a Part
16 hearing prior to rescission, as described in Sec.  1107.50(b). We
received comments on this proposed section, and we respond to those in
the following paragraphs.
    (Comment 79) Some comments object to Sec.  1107.50 of the proposed
regulation which provides the grounds for rescinding an SE order. The
comments state that FDA was not granted authority to rescind an SE
order, in contrast to FDA's express authority to withdraw a PMTA or
modified risk tobacco product order. One comment objects to FDA's
reliance in the proposed rule on Ivy Sports Med. LLC v. Burwell, 767
F.3d 81, 86 (D.C. Cir. 2014) (hereinafter Ivy Sports) as misplaced
because Congress did not confer rescission authority for SE orders.
This comment notes that Congress ``plainly intended to displace any
[rescission] authority here'' as it provided misbranding, adulteration,
and recall authorities to address SE orders based on false information
or unanticipated safety issues. Other comments state that if the
rescission provision is maintained, FDA should include clear
definitions and specific time limits.
    (Response 79) We disagree with the comments that suggest FDA cannot
or should not rescind SE orders when the grounds set out in Sec.
1107.50 exist. As explained in the proposed rule, this provision is
based on our authority to issue an order when we can make the findings
in section 910(a)(2)(A)(i) of the FD&C Act, as well as our authority in
section 701 (related to issuing regulations for the efficient
enforcement of the FD&C Act). Moreover, as explained in the proposed
rule, this section is also based on FDA's inherent authority to timely
revisit and reconsider prior decisions, as discussed in Ivy Sports.
Although misbranding, adulteration, and recall authorities are
important authorities that can be used to address safety and other
issues related to a tobacco product, Sec.  1107.50 will work in tandem
with those authorities to protect the public health. For example, under
Sec.  1107.50, FDA may rescind a substantially equivalent order if the
applicant has removed the new tobacco product from the market for a
safety concern. If the applicant continued to market such a product
without premarket authorization, that product would then be adulterated
under section 902 of the FD&C Act and misbranded under section 903 of
the FD&C Act. However, without rescission of an SE order, there is no
adulteration, misbranding, or other provision in the statute to address
products found SE based on false information.
    As discussed in the proposed rule, FDA's initiation of rescission
will occur only when the grounds described in Sec.  1107.50 exist. We
agree with comments that suggest FDA should exercise this authority in
a timely and judicious way; while we are declining to set specific time
limits, FDA intends to initiate a rescission action within a reasonable
period of time, which will depend on the circumstances of each order.
For example, we note that, in the absence of applicant malfeasance, 10
months has been held to be ``comfortably within the reasonableness
standard'' in light of the particular facts. Ivy Sports Medicine, LLC
v. Sebelius, 938 F. Supp. 2d 47, 63 (D.D.C. 2013) (upholding FDA
rescission of medical device clearance), rev'd on other grounds 767 F.
3d 81 (D.C. Cir. 2014). In the presence of applicant malfeasance, more
than six years has been held to be reasonable. Ranbaxy Labs., Ltd. v.
Burwell, 82 F. Supp. 3d 159, 196 (D.D.C. 2015) (upholding FDA
rescission of tentative approval of abbreviated new drug applications).

F. Comments on Subpart E--Miscellaneous Provisions and FDA Responses

1. Record Retention (Sec.  1107.58)
    Proposed Sec.  1107.58 described record retention requirements. The
proposed provision would require that records supporting an SE order be
maintained for a period of not less than 4 years from the date of an SE
order. After considering comments on this proposed section, we are
finalizing the section without change. We describe the comments to this
section and our responses in the following paragraphs.

    (Comment 80) A few comments state that by requiring manufacturers
to trace their products back to the original predicate product (Sec.
1107.19(h)), a record retention requirement of 4 years has no effect
since they would have to maintain records in ``perpetuity'' if the
manufacturer wanted to use the original predicate tobacco product at a
later date.
    (Response 80) Section 1107.58 states that each applicant that
receives an order under Sec.  1107.46 authorizing the marketing of a
new tobacco product must maintain all records required by this subpart
and records that support the SE Report for a substantial equivalence
order. These records must be legible, in the English language, and
available for inspection and copying by officers or employees duly
designated by the Secretary. All records must be retained for a period
of not less than 4 years from the date of the order even if such
product is discontinued. If an applicant believes that they will want
to rely on the data in the future, they may choose to retain records
longer than this time period. For example, manufacturers who elect to
use a predicate that is a product that has been previously found SE may
need to be able to produce records relating to the original predicate
tobacco product where FDA is unable to make the finding required by
section 910(a)(2)(A)(i)(I) of the FD&C Act based on the information in
its files.
2. Confidentiality (Sec.  1107.60)
    Proposed Sec.  1107.60 described how FDA would determine the public
availability of any part of an SE Report and other content related to
such an SE Report under this proposed section and part 20 of this
chapter. After considering comments on this proposed section, we are
finalizing the section without change. We describe the comments to this
section and our responses in the following paragraphs.
    (Comment 81) One comment objects to the level of confidentiality
afforded to SE Reports noting that this has ``prevented the public from
having any significant information about FDA's review of such
applications or the standards FDA is applying.'' The comment states
that to obtain information about SE Reports, Freedom of Information Act
(FOIA) requests must be submitted and the Agency's responses to those
FOIA requests are too slow. This comment also notes that because FDA
does not disclose the existence of SE Reports the public cannot
participate in the consideration of such reports. Another comment
disagrees with limiting disclosure of information to only the summary
review or the final cycle primary discipline reviews for SE Reports
found NSE (without the need for FOIA requests). This comment urges FDA
to release reviewer notes from each cycle of review to the manufacturer
(or applicant), as well as information related to the measures FDA
takes to ensure consistency among reviewers.
    (Response 81) We decline to make any changes to the codified
provisions. Although we agree with the goals of transparency, the
confidentiality provisions in this section align with the requirements
of FOIA, other statutory provisions governing disclosure of pending SE
Reports and the information contained in such SE Reports, and 21 CFR
part 20. As FDA explained in the proposed rule, the intent to market a
tobacco product that is not currently marketed is often considered
confidential commercial information. Consistent with this rule, FDA
will continue to make available to the public information related to
tobacco product premarket review and marketing orders at https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-product-marketing-orders.
3. Electronic Submissions (Sec.  1107.62)
    Proposed Sec.  1107.62 describes the requirement for the electronic
submission of an SE Report, unless the applicant requested and FDA
granted a waiver request. After considering comments on this proposed
section, we are finalizing this section with one minor change that the
applicant include their email address to help ensure we have complete
contact information. We note that we intend to periodically issue
specifications and guidance pertaining to electronic submission format
and organization to provide updated information related to electronic
submission, e.g., as technology evolves. We describe the comments to
this section and our responses in the following paragraphs.
    (Comment 82) One comment believes submitting the SE Report
electronically should be optional and the applicant should be permitted
to submit paper reports without requesting a waiver.
    (Response 82) As stated in Sec.  1107.62, FDA requires the SE
Report and supporting information to be submitted electronically,
unless the applicant requested and FDA granted a waiver request. In
addition, Sec.  1107.18 requires applicants to submit the SE Report
using the forms that FDA provides (i.e., Forms FDA 3964 and 3965) (FDA
forms may be found at https://www.fda.gov/about-fda/reports-manuals-forms/forms). This approach is consistent with Sec.  1105.10, which
states that FDA generally intends to refuse to accept for review an SE
Report if required forms are not included with the SE Report. Also,
requiring electronic submission is consistent with the requirements for
other FDA regulated products, e.g., new drug applications (NDAs) and
investigational new drug applications (INDs). FDA provides tools, such
as eSubmitter, to facilitate the creation of an electronic submission.
This is available for voluntary use by sponsors, manufacturers, and
importers to create a variety of submission types within the drug,
device, radiological health, tobacco, animal drug and animal food
regulated industries.
    Without the mandatory information from the forms and electronic
submission, the processing and review of each submission would be
slower and more burdensome. The use of a form also helps avoid the
submission of incomplete information, which can hinder decision-making
and prolong the review process. Electronic data and electronic
submission enable automation in the review process, which in turn
increases data quality by eliminating human error from manual data
entry.

G. Comments on Other Issues for Consideration and FDA Response

    FDA requested comment on whether some modifications to tobacco
products that result in a new tobacco product, beyond those eligible
for an exemption from substantial equivalence, might be handled through
a ``categorical'' approach to substantial equivalence. For example,
under such an approach, FDA could establish categories of
modifications, and if a modification is within a category, the
applicant could then submit a streamlined SE Report that identifies the
modification and demonstrates substantial equivalence. We solicited
comment on concerns or benefits of this type of approach, along with
information on the types of modifications or categories that might be
handled in this way, or should not be handled this way.
    (Comment 83) Several comments support consideration of categories
of modifications that could be subject to streamlined SE reviews or
excluded from review, and provided specific examples. For example, one
comment presents suggestions for categories of modifications for which
no SE Report should be required, such as changes based on operation of
law (e.g., change made to comply with a product standard); supplier/
commodity changes, modifications to ensure tobacco product consistency
(e.g., blending changes and

similar changes to maintain consistency); packaging changes, including
changes to CCS; product quantity changes.
    (Response 83) After considering these comments, FDA has determined
that further consideration is needed on whether and, if so, what,
categories should be created for a ``categorical'' approach to
substantial equivalence, particularly once FDA has gained more
experience and is able to identify potential categories. We note that
some of the changes included as suggestions for exclusion may not
require a premarket submission, i.e., a change in supplier that does
not result in a new product (there is no modification to the product as
a result in the change in supplier).
    (Comment 84) Some comments note that there are categories of minor
changes which would not raise different questions of public health. One
such comment includes several modifications that the commenter states
does not raise different questions of public health. The comment notes
that modifications that: (1) Reduce HPHC yield; (2) change quantity;
(3) change product design; (4) change from loose to portioned tobacco;
(5) change the packaging or container; (6) reduce ingredients; (7)
change an ingredient supplier; (8) change a manufacturing process; or
(9) respond to other FDA requirements should not require SE Reports
because they do not raise different questions of public health.
    (Response 84) We disagree that changes that result in a
modification of the tobacco product should not require premarket
authorization. The FD&C Act generally requires that before a new
tobacco product may be introduced into interstate commerce for
commercial distribution in the United States, the new tobacco product
must undergo premarket review by FDA. However, depending on the
modification, an applicant could proceed through the same
characteristics SE pathway (which does not require a showing that any
changes do not cause the product to raise different questions of public
health) or the SE exemption pathway. In addition, as with some of the
previous examples, some of the changes highlighted in this comment may
not result in a new tobacco product, and therefore would not require
premarket review (e.g., changes to packaging that are not part of a
container closure system, a change in supplier that does not result in
a modification of the tobacco product, or a change in manufacturing
process that does not affect the characteristics of the tobacco
product).
    (Comment 85) Similarly, a comment requests FDA to remove
``aesthetic'' changes, supplier changes, changes performed to ensure
consistency of the product, and packaging changes from those
modifications that would require applicants to submit an SE submission.
This comment expresses concern that the rule as proposed would require
a manufacturer to submit a report on a change that it may not even know
took place.
    (Response 85) An application is only required if the change renders
a product a new tobacco product. ``Aesthetic'' changes that alter the
name or labeling, changes to packaging that are not part of a container
closure system, or other modifications that do not impact the
characteristics of a tobacco product do not require submission of an SE
Report. However, any modifications that create a new tobacco product
must receive authorization through the submission of an application
(e.g., PMTA, SE Report, or Exemption Request). Otherwise, if the new
tobacco product enters into interstate commerce for commercial
distribution, it would be adulterated under section 902 of the FD&C Act
and misbranded under section 903 of the FD&C Act and subject to
enforcement action.
    (Comment 86) One comment opposes the creation of categories of
products eligible for a streamlined substantial equivalence process
stating that the FD&C Act contemplates product-by-product review. This
comment refers to FDA's experience with SE reviews and notes that the
majority of SE Reports do not result in SE orders and that this shows
``that manufacturers, if not required to produce specific evidence in
support of substantial equivalence, will make claims of substantial
equivalence that cannot be supported.'' Other comments request further
clarification on the issue. The comments request that if FDA were to
adopt a categorical approach, FDA publish the list of categorical
modifications appropriate under the approach.
    (Response 86) Given the wide range of suggested categories and
other feedback on this topic, FDA agrees with the comments that
indicate further consideration is needed on whether and, if so, what,
categories should be created. FDA intends to continue to consider this
issue and how we might best proceed in providing additional clarity and
recommendations on the premarket approach that may work best for any
``category'' of change.

VI. Effective Date

    As stated in the proposed rule, this final rule will become
effective 30 days after the final rule publishes in the Federal
Register. FDA responds to the comments on the effective date in the
following paragraphs.
    (Comment 87) More than one comment requests that FDA delay or
stagger the effective date of the final regulation or the submission
dates for premarket applications.
    (Response 87) We decline to change the effective date for the rule,
or add compliance dates at this time. We note that premarket
requirements already apply to new tobacco products as described in the
statute and the deeming final rule (sections 905 and 910 of the FD&C
Act and 81 FR 28974, May 10, 2016, see https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10685.pdf, codified at 21 CFR 1101.) This
rule supports those existing requirements by, among other things,
providing content and format requirements related to SE Reports for new
tobacco products that will help applicants prepare SE Reports and
enable FDA to make SE determinations for new tobacco products.

VII. Economic Analysis of Impacts

    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. Because we have determined that the compliance costs are less
than 0.2 percent of revenues, we certify that the 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
would not result in an expenditure in any year that meets or exceeds
this amount.
    This analysis uses the state of the world where manufacturers
routinely submit SE Reports as the baseline. This final rule will
impose compliance costs on affected entities to read and understand the
rule, establish or revise internal procedures, keep records, and fill
out a form for SE Reports. We estimate that the present value of
industry compliance costs ranges from $0.4 million to $3.4 million,
with a primary estimate of $1.9 million at a 3 percent discount rate,
and from $0.4 million to $2.9 million, with a primary estimate of $1.6
million at a 7 percent discount rate over 10 years. Annualized industry
compliance costs over 10 years range from $0.05 million to $0.39
million, with a primary estimate of $0.22 million at a 3 percent
discount rate and from $0.06 million to $0.42 million, with a primary
estimate of $0.23 million at a 7 percent discount rate. The costs to
industry range from around $200 to around $1,400 per affected entity
per year, with a primary estimate of around $800 per entity per year.
    The incremental benefits of this final rule are potential time-
savings to industry and cost-savings to FDA. The final rule clarifies
when applicants may certify that certain characteristics are identical
in the new tobacco product and the predicate tobacco product.
Certifying may save applicants time in preparing their SE Reports. We
anticipate shorter review times for SE Reports as a result of this
final rule. In addition, based on our experience with prior SE Reports,
we believe this final rule will lead to higher quality SE Reports,
saving us time in review and requiring fewer staff to review SE
Reports, which will result in cost-savings. We estimate that the
present value of government cost-savings ranges from $15.1 million to
$150.6 million, with a primary estimate of $50.2 million at a 3 percent
discount rate, and from $12.4 million to $124 million, with a primary
estimate of $41.3 million at a 7 percent discount rate over 10 years.
Annualized government cost-savings over 10 years range from $1.8
million to $17.7 million, with a primary estimate of $5.9 million at
both 3 and 7 percent discount rates. The FDA cost-savings per report
ranges from around $17,700 to around $58,800, with our best estimate at
around $29,400.
    The qualitative benefits of this final rule include additional
clarity to industry about the requirements for the content and format
of SE Reports. The final rule establishes the general procedures we
intend to follow in reviewing and communicating with applicants. In
addition, this final rule will make the SE pathway more predictable.
    Table 1 summarizes the benefits and costs of the final rule.

                                      Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                            Low       Primary      High    ------------------------------------
               Category                  estimate    estimate    estimate                             Period                      Notes
                                         (million)   (million)   (million)     Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/           $1.8        $5.9       $17.7        2018           7          10  Cost-savings to government.
     year.                                     1.8         5.9        17.7        2018           3          10  Cost-savings to government.
    Annualized Quantified.............  ..........  ..........  ..........        2018           7          10
                                        ..........  ..........  ..........        2018           3          10
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........  Greater certainty for SE applicants.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/           0.06        0.23        0.42        2018           7          10
     year.                                    0.05        0.22        0.39        2018           3          10
    Annualized Quantified.............  ..........  ..........  ..........        2018           7          10
                                        ..........  ..........  ..........        2018           3          10
                                       -----------------------------------------------------------------------------------------------------------------
    Qualitative

--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized        ..........  ..........  ..........        2018           7          10
     $millions/year.                    ..........  ..........  ..........        2018           3          10
                                       -----------------------------------------------------------------------------------------------------------------
                                        From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........        2018           7          10
     $millions/year.                    ..........  ..........  ..........        2018           3          10
                                       -----------------------------------------------------------------------------------------------------------------
                                        From:
                                        To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: No
 effect.
    Small Business: No effect.........
    Wages: No effect..................
    Growth: No effect.................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 86) and at
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. 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 action may significantly affect the
quality of the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject

to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title,
description, and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual reporting and recordkeeping burden. Included in the estimate
is the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and
reviewing each collection of information.
    Title: Substantial Equivalence Reports for Tobacco Products.
    Description: Tobacco Products, Substantial Equivalence Reports,
Requirements for Submitting Information Needed to Determine Substantial
Equivalence and Maintaining Records to Support a Substantial
Equivalence Report.
    As required by section 3506(c)(2)(B) of the Paperwork Reduction Act
of 1995 (PRA), FDA provided an opportunity for public comment on the
information collection requirements of the proposed rule that published
in the Federal Register of April 2, 2019. In response to this rule FDA
received the following PRA related comments:
    (Comment 88) Some comments state that FDA underestimated the burden
associated with collecting the information and suggest the proposed
collection of information would have better utility and value if FDA
went by product category. Specifically, the comments take issue with
estimates of 683 SE reports filed and state that FDA failed to consider
foreign manufacturers filing when the Agency used the registration and
listing data to estimate the associated burden with the requirements.
The comments also state that FDA has underestimated the burden of the
proposed collection of information on FDA and does not reflect the
level of agency resources needed to review the thousands of SE reports.
    (Response 88) We disagree. The rule reflects estimates of the
burden for the submission and review of SE Reports beginning when the
rule becomes effective, which will be 30 days after the final rule
publishes. These estimates reflect what we expect will be the level of
submissions and burden at that time, based on our experience with SE
Reports since the inception of the program. We disagree that we did not
account for foreign firms. For SE purposes foreign firms are handled
the same way as domestic firms. Although foreign firms are currently
not required to register and list, they must still provide a U.S. agent
to export a tobacco product.
    (Comment 89) Several comments stated that our estimate of 87 to 300
hours to prepare and submit an SE Report is too low and that this must
not account for the burden associated with HPHC testing. Several
comments suggest that, based on the commenters' experience, it will
take approximately 900-1,000 hours to prepare an SE Report for one
product, and other comments estimate that it may take 15-28 months to
prepare an SE Report depending on the scientific testing required. One
comment asserts that this estimate is too low because the Agency is
assuming a single submission, when the commenter's experience is that
multiple submissions may be made with an SE Report including the
original report. In addition, the comment states that this estimate
does not include the time associated with amending the SE Report or an
environmental assessment. The comment states that FDA may need multiple
years to review and process SE Reports for tobacco products subject to
the deeming final rule (``deemed tobacco products''), such as cigars,
and that FDA will likely make multiple requests to applicants for
additional information. One comment states that SE Reports require
extensive data that could take thousands of hours per application to
prepare and submit.
    (Response 89) Because the estimates are based on our experience
with SE Reports, we are maintaining the estimates as proposed. The SE
program was originally approved by OMB in 2010. Since then, FDA has
reassessed the program burden each time the collection was up for
extension and other related programmatic changes in between.
Additionally, we have further analysis on our reporting and
recordkeeping requirements that was provided in the preamble to the
proposed rule and the proposed regulatory impact analysis. We note that
the final rule provides more clarity on both design parameters for
cigars, pipes, and other deemed tobacco products, and also when
scientific testing may be needed. This information will assist
applicants in understanding the content and format of an SE report
which will accelerate the process of submitting a report.
    (Comment 90) A comment states that our estimated burden of
``bundled'' SE Reports is significantly lower than our estimate for a
single product. The comments believe that this is wrong because the
bundled applications cover multiple products and should therefore be
greater than the burden associated with preparing a report for a single
product.
    (Response 90) We agree that the total time to submit a bundled SE
Report is greater than the time to submit a report for a single
product. Our estimates for ``bundled'' SE Reports were the time
associated with submitting for each additional product in the bundle.
Therefore, the total cost for submitting a bundle of 3 products would
be the full SE burden for the first product, plus two times the burden
to submit a bundled report. We have clarified this in the final
analysis.
    (Comment 91) Several commenters provided estimates for the hours
needed for preparing and submitting SE Reports of between 900 hours and
28 months. Based on these hours, the commenters estimate that the cost
per SE Report could be between $250,000 and $2,000,000, although they
state there may be some economies of scale in submitting multiple
reports.
    (Response 91) We believe some commenters have confused cost
estimates from the regulatory impact analysis (RIA) and burden hours
from the PRA. Although these concepts are similar and account for some
corresponding items, they ultimately serve different purposes and
separate functions. The PRA estimates burden in hours on an annual
basis generally for three years; while the regulatory impact analysis
uses these estimated burden hours on an annual basis, along with an
estimate of wage per hour, to estimate a cost in terms of dollars over
a long-term horizon. See comment 4 of the RIA and comment 1 in the
appendix of the RIA for a further discussion regarding costs and see
comments 2 and 3 of the RIA for discussion on burden hours.
    (Comment 92) A comment states that they believe our estimated
burden for an environmental assessment is too high as a proportion of
the time to prepare and submit an SE Report. They state that our
estimate of 52 to 80 hours for an EA is potentially more than our
estimated burden for an SE Report at 35 to 220 hours. Other comments
suggest that the burden associated with EAs is too low.
    (Response 92) FDA has estimated 80 hours for an environmental
assessment for the SE program for many years. Based on experience with
SE Reports,

interactions with the industry, and information related to other
regulated products we do not have evidence suggesting a different
estimate and note that the range given for EAs is intended to reflect
the variation that might exist depending on the specific tobacco
product.
    (Comment 93) Several comments believe that FDA has substantially
underestimated the number of SE Reports it will receive annually. The
comments state that FDA should expect tens of thousands of SE Reports--
much higher than the proposed rule estimate of 683 standalone SE
Reports and 456 bundled SE Reports each year. Additionally, the
commenter also notes that it expects to submit well over 100 reports
per year as opposed to the FDA estimate of one application per year.
    (Response 93) FDA believes our PRA estimates are accurate as we
have had years of experience with the SE pathway. The SE program was
originally approved by OMB in 2010. Since then FDA has reassessed the
program burden each time the collection was up for extension and other
related programmatic changes in between. Additionally, we have further
analysis that was provided in the preamble to the proposed rule and the
proposed regulatory impact analysis. As referenced in the proposed
rule, many of our estimates were based on submissions being bundled. As
is currently the practice, applicants may continue to bundle groups of
SE Reports submitted under Sec.  [thinsp]1107.18 that have the same
proposed modifications (e.g., a change in ingredient supplier that
results in a new tobacco product). Co-packaging two or more tobacco
products may result in a new tobacco product. When groups of full or
product quantity change SE Reports have identical content, they may be
submitted together (bundled); when a group of similar reports are
bundled, the subsequent bundled reports are expected to take less time
to prepare than the initial report. Additionally, manufacturers may
bundle groups of SE Reports for their new products in the same product
category and subcategory where the proposed modifications are the same;
when a group of similar SE Reports are bundled, the reporting burden
for the initial SE Report is expected to take the same amount of time
as a stand-alone SE Report. However, the reporting burden for
subsequent bundled SE Reports is expected to be lower than the initial
SE Report.
    Section 1107.18, paragraphs (b) and (c) include requirements that
the applicant use the forms that FDA provides when submitting an SE
Report. Following our consideration of the comments related to the
forms, we are finalizing these requirements without change. We describe
the comments to these sections and our responses next.
    (Comment 94) At least one comment states that use of the FDA forms
should be optional rather than mandatory.
    (Response 94) We disagree. As explained in the proposed rule, the
requirements in this rule, including use of these forms, are intended
to provide clarity to applicants with respect to what they should
submit in an SE Report and to help ensure that an SE Report provides
information necessary for FDA to determine whether the new tobacco
product is substantially equivalent to a tobacco product commercially
marketed (other than for test marketing) in the United States as of
February 15, 2007. Additionally, use of a standardized form allows FDA
to receive information in a way that allows for faster processing and
uploading of the SE Report and its contents, thereby increasing
efficiency of the review process.
    (Comment 95) Another comment notes that although FDA appears to
recognize that the evidence required in an SE Report depends on whether
new tobacco product has ``same'' characteristics as the predicate
product or if the new tobacco product has ``different'' characteristics
than the predicate product, this distinction is not reflected in either
the draft of Form FDA 3965 or the rule itself.
    (Response 95) We disagree. The form and the rule are structured to
clarify both the common elements (``same'' characteristics) and
distinct elements (``different'' characteristics) of SE Reports for
both new tobacco products with the ``same'' characteristics as the
predicate product and for new tobacco products with ``different''
characteristics than the predicate product. This includes reference to
and discussion of these elements in the forms and throughout the rule.
Applicants should indicate that their report is a ``same
characteristics'' report where no data is necessary to demonstrate that
the new tobacco product is substantially equivalent to its predicate.
The form has been revised to include a section where the applicant
would distinguish whether they are submitting a ``same
characteristics'' SE Report, or a ``different characteristics'' SE
Report. For a ``same characteristics'' SE Report, an applicant must
describe the modification and certify that is the only change between
the new and predicate tobacco product.
    (Comment 96) One comment believes FDA has underestimated the time
needed to complete the forms and did not explain how it arrived at
these estimates.
    (Response 96) FDA conducted a thorough analysis of the current
paperwork burden associated with the SE program and other similar forms
and applied the most accurate burden to the forms; however, upon
consideration of this comment and certain updates made to the form
based on comments received and product categorization changes FDA is
revising 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 3965. For Form FDA
3964, FDA is revising 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 SE Report (more
burdensome). FDA notes that the comment did not provide a
recommendation for the alternative estimates FDA might consider.
    Description of Respondents: Manufacturers of tobacco products who
submit SE Reports.
    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.
    This establishes requirements for the content and format of SE
Reports (Sec. Sec.  1107.18 and 1107.19). Most of the requirements
mirror current practices and recommendations related to the submission
of SE Reports, including information related to part 25 (environmental
considerations), but the rule provides both applicants and FDA more
certainty regarding the content and format for the SE Reports. A health
information summary or statement would continue to be required (section
910(a)(4) of the FD&C Act) and the health summary or response to a
request would be required to be in the format of a redacted SE Report,
along with any additional health information about the new tobacco
product, including any information, research, or data about adverse
health effects, that the applicant has or knows about and that is not
contained in the SE Report.
    As is currently the practice, the rule continues to permit
amendments for SE Reports submitted under Sec.  1107.18, e.g., to
address deficiencies (Sec.  1107.20). Also, in accordance with current
practice, the rule continues to permit withdrawals (Sec.  1107.22) of
pending SE Reports. The rule also describes requirements for

when the ownership of an SE Report changes to ensure that FDA has
information related to the current applicant (Sec.  1107.24).
    The rule establishes a recordkeeping requirement, under which
applicants are required to maintain records supporting the SE Report
for an authorized new tobacco product for 4 years from the date of an
order finding substantial equivalence, even if such product is
discontinued (Sec.  1107.58).
    The rule requires that respondents submit an SE Report in an
electronic format, unless a waiver from this requirement is requested
by the applicant and granted by FDA (Sec.  1107.62). FDA created two
new forms for submission; Form FDA 3964, Tobacco Amendment and General
Correspondence; and Form FDA 3965, Tobacco Substantial Equivalence
Report Submission.
    FDA estimates the burden as the following:

        Table 2--Existing Burden for OMB Control Number 0910-0673, Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    Activity; 21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and                  683               1             683             300         204,900
 910(a).........................
Full SE 905(j)(1)(A)(i) and                  456               1             456              90          41,040
 910(a) Bundled.................
Product Quantity Change SE                   239               1             239              87          20,793
 Report.........................
Product Quantity Change Bundled              192               1             192              62          11,904
 SE Report......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         278,637
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This chart represents the currently OMB approved burden for the SE program.

                                      Table 3--New Burden per the Final Rule, Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
      Activity; FDA form; 21 CFR section          Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3965--Tobacco Substantial Equivalence               1,570               1           1,570  .75 (45 minutes).........................           1,178
 Report Submission.
FDA 3964--Tobacco Amendment and General                   628               1             628  .16 (10 minutes).........................             100
 Correspondence.
Waiver from Electronic submission 1107.62(b).             240               1             240  .25 (15 minutes).........................              60
                                              ----------------------------------------------------------------------------------------------------------
    Totals...................................  ..............  ..............  ..............  .........................................           1,338
--------------------------------------------------------------------------------------------------------------------------------------------------------

                              Table 4--Final Reporting Table 2 + 3 Reporting Burden, Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
      Activity; FDA form; 21 CFR section          Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
SE Report--1107.18...........................             683               1             683  300......................................         204,900
Bundled SE--1107.18..........................             456               1             456  90.......................................          41,040
SE Report where applicant provides                        239               1             239  87.......................................          20,793
 certification for identical characteristics--
 1107.18(g) and 1107.18(l)(2).
SE Report where applicant provides                        192               1             192  62.......................................          11,904
 certification for some identical
 characteristics (bundled)--1107.18(g) and
 1107.18(l)(2).
FDA 3965--Tobacco Substantial Equivalence               1,570               1           1,570  .75 (45 minutes).........................           1,178
 Report Submission.
FDA 3964--Tobacco Amendment and General                   628               1             628  .16 (10 minutes).........................             100
 Correspondence Report.
Waiver from Electronic submission--1107.62(b)             240               1             240  .25 (15 minutes).........................              60
                                              ----------------------------------------------------------------------------------------------------------
    Totals...................................  ..............  ..............  ..............  .........................................         279,975
--------------------------------------------------------------------------------------------------------------------------------------------------------

                             Table 5--New Recordkeeping Burden per the Final Rule, Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                    Activity; 21 CFR section                          Number of        records per      Total annual          per          Total hours
                                                                    recordkeepers     recordkeeper        records        recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping SE Report under 1107.18-1107.58...................              471                 1              471                 5            2,355
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA's estimates are based on experience with SE Reports,
registration and listing data, interactions with the industry, and
information related to other regulated products. Utilizing registration
and listing data for deemed

tobacco products, the estimated annual number of SE Reports is expected
to be 1,570. The expected number of reports has not changed since the
proposed rule. As discussed earlier in this rule, FDA is not finalizing
the proposed SE rule with respect to ``premium'' cigars. As such, the
estimate of the number of reports expected is likely an overestimate as
it includes ``premium'' cigars, which are excluded from the scope of
this final rule.
    When groups of full SE Reports or SE Reports that each contain a
certification that some characteristics have identical content, they
may be bundled; when a group of similar reports are bundled, the
subsequent bundled reports are expected to take less time to prepare
than the initial report.
    FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA expectations regarding the tobacco
industry's use of the substantial equivalence pathway to market their
products. Table 2 describes the annual reporting burden for compliance
with the requirements to demonstrate substantial equivalence under the
FD&C Act. We do not expect a large burden increase for this program,
as, without the rule, manufacturers would routinely submit SE Reports
for new tobacco products, and the Agency believes most respondents are
currently practicing most of the requirements. FDA will revise this
collection with the new burden.
    Table 3 describes the annual reporting burden as a result of the
requirements in Sec. Sec.  1107.18 and 1107.19, implementing the
substantial equivalence requirements of sections 905(j)(1)(A)(i) and
910(a) of the FD&C Act. This rule requires manufacturers to submit SE
Reports electronically (Sec.  1107.62). We estimate that it would
initially take about 45 minutes per product to fill out the Form FDA
3965. However, for amendments we estimate that filling out the Form FDA
3964 will take 10 minutes as applicants can copy and paste from the
first submission. Section 1107.62(b) also allows for waivers from the
electronic format requirement. FDA estimates that 240 respondents or 15
percent of SE Reports (1,570) will submit a waiver.
    Based on updated information, FDA estimates that it will receive
683 full initial SE Reports for a new tobacco product each year under
Sec.  1107.18 that take a manufacturer approximately 300 hours to
prepare. Additionally, manufacturers may bundle groups of SE Reports
for their new products in the same product category and subcategory
where the proposed modifications are the same; when a group of similar
SE Reports are bundled, the reporting burden for the initial SE Report
is expected to take the same amount of time as a stand-alone SE Report.
However, the reporting burden for subsequent bundled SE Reports is
expected to be lower than the initial SE Report. We expect to receive
456 bundled SE Reports under Sec.  1107.18 (other than the initial SE
Report in the bundle) at approximately 90 hours per response for a
total of 41,040 hours.
    In the absence of more specific information concerning SE Reports
where applicants provide a certification for some identical
characteristics under Sec. Sec.  1107.18(g) and 1107.18(l)(2), FDA
estimates receiving 239 such SE Reports at 87 hours per response for a
total of 20,973 hours. We also estimate receiving 192 bundled SE
Reports where applicants provide a certification for some identical
characteristics under Sec. Sec.  1107.18(g) and 1107.18(l)(2) (other
than the initial SE Report in the bundle) at 62 hours per response for
a total of 11,904 hours. Although we believe that the number of SE
Reports that include a certification will increase because the rule
clarifies when applicants may certify that certain characteristics are
identical in the new tobacco product and the predicate tobacco product,
in the absence of specific information on how many more applicants
might choose to certify, we are maintaining our previous estimates at
this time.
    FDA has based these estimates on the full analysis of economic
impacts and experience with the recently-revised existing information
collection (OMB Control Number 0910-0673) that applies to tobacco
products. In addition, anyone submitting an SE Report is required to
submit an environmental assessment prepared in accordance with Sec.
25.40 under Sec.  1107.18(k). The burden for environmental reports has
been included in the burden per response for each type of SE Report.
    Based on FDA's experience with EAs for currently regulated tobacco
products, we expect industry to spend 80 hours preparing an
environmental assessment for a full SE Report under Sec.  1107.18.
    Generally, an applicant may withdraw its SE Report after submission
(Sec.  1107.22), change the ownership of its SE Report (Sec.  1107.24),
and amend its SE Report (Sec.  1107.20). Currently, FDA has an OMB
approved information collection for SE. The information required to
grant these applications is already being collected under the OMB
approval, so we do not expect a change in burden to these sections.
    FDA estimates that 30 percent of SE Reports or 471 respondents will
maintain required records related to their SE Reports at 5 hours per
record for a total of 2,355 recordkeeping hours. FDA has revised the
estimated burden for recordkeeping per hour from 2.5 hours per record
to 5 hours. As discussed in the RIA, the first SE Report in a chain
must use a tobacco product commercially marketed (other than for test
marketing) in the United States as of February 15, 2007, as a predicate
product for the SE Report. Therefore, we believe that manufacturers
will have records on those ``original'' predicate tobacco products from
their initial SE Reports. Based on this assumption, this requirement
could lead to manufacturers keeping records for a longer time. The
final regulatory impact analysis estimates zero to 10 hours per entity
each year for recordkeeping, and the PRA estimate has assumed a mid-
point of that estimate.
    FDA estimates that the burden for new requirements will increase
this collection by 3,693 hours (1,338 reporting + 2,355 recordkeeping).
The burden for the submission of substantial equivalence information is
estimated to total 282,330 hours (279,975 reporting and 2,355
recordkeeping). This rule also refers to previously approved
collections of information found in FDA regulations.
    Section 1107.40 references meetings that may be held with
applicants who want to meet with FDA to discuss scientific and other
issues. Additional information about how to request meetings with FDA's
CTP can be found in FDA's guidance entitled ``Meetings with Industry
and Investigators on the Research and Development of Tobacco
Products.'' The collections of information in the guidance referenced
have been approved under OMB control number 0910-0731. In addition to
the premarket application under section 910(b) and a report under
905(j)(1)(A)(i) of the FD&C Act, certain new tobacco products may use
the exemption premarket pathway (see Sec.  1107.1). The collections of
information found in Sec.  1107.1 have been approved under OMB control
number 0910-0684.
    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.

X. Federalism

    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.

XI. 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).

XII. 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. We received one
comment related to tribal consultation and we respond to this comment
in the following paragraphs.
    (Comment 97) A comment disagrees with the Agency's tentative
determination that the rule does not contain policies that would have a
substantial direct effect 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. The comment notes that FDA's decisions
regarding substantial equivalence have had profound effects on the
tribe's ability to raise revenue for government services and have
required significant expenditures for compliance costs over the last 3
years.
    The comment also states the tribe's representatives were unable to
participate in an All Tribes' Call on the proposed rule due to late
notice of the call. The tribe notes that, although FDA provided them
with another opportunity for a call on the proposed rule, late notice
of the All Tribes' Call may have caused other tribes to miss the
opportunity for consultation and recommends a second All Tribes' Call
with at least 30 days' notice, or an in-person consultation with a
phone-in option, prior to completing the next phase of rulemaking.
    (Response 97) The impact and costs of the proposed rule on tribal
manufacturers were considered as part of the Preliminary Regulatory
Impact Statement. FDA agrees that collaboration and consultation with
Federally recognized tribal governments, per the FDA Tribal
Consultation Policy and Executive Order 13175, is important. FDA
engages with tribal stakeholders, including tribal government leaders,
tribal health leaders, and public health professionals, about the
implementation and enforcement of the Tobacco Control Act and related
regulations by various methods (e.g., ``Dear Tribal Leader'' letters,
All Tribes' Calls, formal and informal consultations as well as face-
to-face meetings). We also encourage tribes to stay informed about
developments related to tobacco products through our website (https://www.fda.gov/TobaccoProducts).
    There were several opportunities for tribes to engage with FDA
about the proposed rule, including the impact and costs of the proposed
rule on tribal manufacturers, which was considered as part of the
Preliminary Regulatory Impact Statement (https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm). In a ``Dear
Tribal Leader'' letter dated April 4, 2019, FDA initiated consultation
with federally recognized Indian tribes on the proposed rule and
invited tribes to participate in an All Tribes' Call. The purpose of
the call was to provide an overview of the proposed rule, answer
questions, and hear tribal comments on the proposed rule. We provided
contact information in the letter and during the call to help ensure
that there was a mechanism to address any further questions. To help
ensure accessibility to the call, we recorded the call and made that
recording available on FDA's website for 30-days following the call,
and we added a transcript of the call to the docket for the rulemaking.
We also encouraged tribes to submit written comments on the proposed
rule and supporting documents such as the Preliminary Regulatory Impact
Statement. We note that no other tribe has requested additional
consultation on the proposed rule.

XIII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) 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. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
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8. * FDA, Form FDA 3964 (Amendment).
9. * FDA, Form FDA 3965 (Substantial Equivalence Submission).
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12. Belluzzi, J., R. Wang, and F. Leslie, ``Acetaldehyde Enhances
Acquisition of Nicotine Self-Administration in Adolescent Rats.''
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13. Andersen, R.A., M.J. Kasperbauer, H. Burton, et al., ``Changes
in Chemical Composition of Homogenized Leaf-Cured and Air-Cured
Burley Tobacco Stored in Controlled Environments.'' Journal of
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During Tobacco Storage and the Effect of Temperature and Nitrate
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Yields and Human Exposure: A Comparison of Alternative Testing
Regimens,'' Cancer Epidemiology, Biomarkers & Prevention,
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16. Rees, V.W., G.F. Wayne, B.F. Thomas, et al., ``Physical Design
Analysis and Mainstream Smoke Constituent Yields of the New
Potential Reduced Exposure Product, Marlboro UltraSmooth,'' Nicotine
& Tobacco Research, 9(11):1197-1206, 2007.
17. Fisher, M.T., C.B. Bennett, A. Hayes, et al., ``Sources of and
Technical Approaches for the Abatement of Tobacco Specific
Nitrosamine Formation in Moist Smokeless Tobacco Products.'' Food
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18. * Rutqvist, L. E., M. Curvall, T. Hassler, et al., ``Swedish
Snus and the GothiaTek[supreg] Standard.'' Harm Reduction Journal,
8:11, 2011. Available at https://doi.org/10.1186/1477-7517-8-11.
19. Law, A.D., C. Fischer, A. Jack, et al., ``Tobacco, Microbes, and
Carcinogens: Correlation Between Tobacco Cure Conditions, Tobacco-
Specific Nitrosamine Content, and Cured Leaf Microbial Community.''
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20. Di Giacomo, M., M. Paolino, D. Silvestro, et al., ``Microbial
Community Structure and Dynamics of Dark Fire-Cured Tobacco
Fermentation.'' Applied and Environmental Microbiology, 73(3):825-
837, 2007. Available at https://doi.org/10.1128/AEM.02378-06.
21. Jensen, C.O. and H.B. Parmele, ``Fermentation of Cigar-Type
Tobacco,'' Industrial and Engineering Chemistry, 43(3):519-522,
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22. Smith, T.E., ``A Literature Review of Aging and Fermentation of
Tobacco,'' Brown & Williamson Records, 1964, available at https://www.industrydocumentslibrary.ucsf.edu/tobacco/docs/fpgv0147.
23. Cornell, A., W.F. Cartwright, and T.A. Bertinuson, ``Influence
of Microorganisms (Fermentation) on the Chemistry of Tobacco,
1979,'' Food and Agriculture Organization of the United Nations,
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24. Schulthess, D., ``Project Clover Marlboro--Roll Your Own Report
on the Microbial Analysis,'' Philip Morris Records, 1984, available
at: https://www.industrydocuments.ucsf.edu/docs/#id=zzwl0112.
25. Mutasa, E.S., K.J. Seal, and N. Magan, ``The Water Content/Water
Activity Relationship of Cured Tobacco and Water Relations of
Associated Spoilage Fungi,'' International Biodeterioration, 26:6
381-396, 1990. Available at: https://doi.org/10.1016/0265-3036(90)90003-P.
26. CORESTA Recommended Method No 77, ``Determination of Diffusion
Capacity by Measurement of CO2 Transfer Rate Through
Materials Used as Cigarette Papers and Cigarette Papers Having an
Oriented Zone of Reduced Diffusion Capacity,'' 2012. Available at
https://www.coresta.org/sites/default/files/technical_documents/main/CRM_77-June2019.pdf.
27. ISO 3308:2012. Routine analytical cigarette-smoking machine--
Definitions and standard conditions.
28. ISO 20778:2018. Cigarettes--Routine analytical cigarette smoking
machine--Definitions and standard conditions with an intense smoking
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29. * HHS, ``The Health Consequences of Smoking--The Changing