identified above.
                                Other............  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
Pipe Tobacco Products.........  Pipe.............  --Package type (e.g.,
                                                    box, none).
                                                   --Product quantity
                                                    (e.g., 1 pipe).
                                                   --Length (e.g., 200
                                                    mm, 300 mm).
                                                   --Diameter (e.g., 25
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Pipe Tobacco       --Package type (e.g.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16
                                                    ounces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    Cavendish, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Pipe Component...  --Package type (e.g.,
                                                    bowl, shank, stem,
                                                    screen, filter).
                                                   --Product quantity
                                                    (e.g., 1 bowl, 1
                                                    stem, 100 filters).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Pipe Co-Package..  --For a new co-
                                                    packaged tobacco
                                                    product composed of
                                                    multiple pipe
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified above.
                                Other............  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
Waterpipe Tobacco Products....  Waterpipe........  --Package type (e.g.,
                                                    box, none).
                                                   --Product quantity
                                                    (e.g., 1 waterpipe).
                                                   --Length (e.g., 200
                                                    mm, 500 mm).
                                                   --Width (e.g., 100
                                                    mm, 300 mm).
                                                   --Number of hoses
                                                    (e.g., 1, 2, 4).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Waterpipe Tobacco  --Package type (e.g.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16
                                                    ounces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, apple).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Waterpipe Heat     --Package type (e.g.,
                                 Source.            box, film sleeve,
                                                    bag, none).
                                                   --Product quantity
                                                    (e.g., 150 g, 680
                                                    g).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    apple).
                                                   --Portion count
                                                    (e.g., 20 fingers,
                                                    10 discs, 1 base).
                                                   --Portion mass (e.g.,
                                                    15 g/finger).
                                                   --Portion length
                                                    (e.g., 40 mm, 100
                                                    mm).
                                                   --Portion width
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Source of energy
                                                    (e.g., charcoal,
                                                    battery,
                                                    electrical).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).

                                Waterpipe          --Package type (e.g.,
                                 Component.         bag, box, none).
                                                   --Product quantity
                                                    (e.g., 1 base, 1
                                                    bowl, 1 hose, 10
                                                    mouthpieces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    apple).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Waterpipe Co-      --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple waterpipe
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified above.
                                Waterpipe Other..  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
Other.........................  Other............  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
------------------------------------------------------------------------
\7\ Characterizing flavors may include those added to certain components
  or parts (e.g., paper) of the tobacco product. If there is no
  characterizing flavor, the application must state ``none.''

    The applicant would be required to include any additional
properties needed to uniquely identify the tobacco product, if
applicable (e.g., use of product descriptors such as ``premium'' would
be required to be identified). Proposed Sec.  1107.18(c)(8) would also
require the address of the facilities involved in the manufacture of
the tobacco products and any Facility Establishment Identifier number.
This information would assist the Agency in making environmental impact
considerations and determinations under part 25 by helping FDA
understand the scale of products that would be manufactured.
    d. Summary. Proposed Sec.  1107.18(d) would require a summary at
the beginning of the SE Report. This summary portion of the SE Report
would act as an abstract designed to orient reviewers to the contents
of the SE Report. Under proposed Sec.  1107.18(d), the summary would be
required to include three elements. First, the summary would be
required to include a concise description of the characteristics of the
new tobacco product. As stated in section 910(a)(3)(B) of the FD&C Act,
characteristics means ``the materials, ingredients, design,
composition, heating source, or other features of a tobacco product,''
all of which are defined in proposed Sec.  1107.12. Second, the summary
would also be required to include the applicant's basis for whether the
new tobacco product has the same characteristics as the predicate
tobacco product or has different characteristics from the predicate
tobacco product which the applicant believes do not cause the new
tobacco product to raise different questions of public health. Third,
with respect to those characteristics, the summary would be required to
include a description of the similarities and differences between the
new tobacco product and the predicate tobacco product.
    e. New tobacco product description. Proposed Sec.  1107.18(e) sets
forth the information that would be required in the description of the
new tobacco product. Based on our experience reviewing SE Reports, FDA
has found that, to have a meaningful scientific comparison, a new
tobacco product should be compared to a single predicate product (this
is discussed in more detail at proposed Sec.  1107.18(f), the section
of this document describing the predicate tobacco description).
Accordingly, proposed Sec.  1107.18(e) would require the applicant to
identify the new tobacco product in the SE Report for comparison to one
predicate tobacco product. As is currently the practice, applicants may
continue to bundle groups of SE Reports submitted under proposed Sec.
1107.18 that have the same proposed modifications (e.g., a change in
ingredient supplier that results in a new tobacco product). As
discussed previously, co-packaging two or more tobacco products may
result in a new tobacco product.
    Proposed Sec.  1107.18(e) would require that the SE Report describe
the new tobacco product in sufficient detail to enable FDA to
understand and evaluate the characteristics of the new tobacco product
in comparison to the predicate. Specifically, the Agency proposes that
this section of the SE Report include the following information:
     A narrative description of the new tobacco product, as
well as detailed drawings or schematics. The drawings would be required
to identify the container closure system and illustrate all of the
product's components. As defined in proposed Sec.  1107.12, a
``component or part'' of a tobacco product is any software or assembly
of materials intended or reasonably expected: (1) To alter or affect
the tobacco product's performance, composition, constituents, or
characteristics or (2) to be used with or for the human consumption of
a tobacco product. The definition excludes anything that is an
accessory of a tobacco product. For example, an applicant submitting an
SE Report for a pouched snus product would illustrate all the
components and parts of the product, including the pouch material and
tobacco filler. The narrative description would identify all the
components, e.g., for a cigarette, the applicant would identify the
rod, and the rod's paper and filler, and so on.
     A description of and the function for each component or
part of the new tobacco product as well as an explanation of how each
component or part is integrated into the product design.
     If the manufacturing process for the new tobacco product
could affect the characteristics of the new product, an applicant would
be required to provide an overview of the manufacturing process. This
overview would not need to be an exhaustive discussion but enough
information to enable FDA to fully understand and compare the
characteristics that can be affected by the manufacturing process of
the new

tobacco product and the predicate tobacco product. FDA has found during
reviews of SE Reports that changes in manufacturing, including
fermentation, may impact the characteristics of the tobacco product,
e.g., the quantities of nicotine (total and free), as well as HPHCs
such as tobacco-specific N-nitrosamines (TSNAs). Such changes could
cause the new product to raise different questions of public health,
e.g., fermentation can increase the levels of nicotine, which impacts
dependence and cessation (Refs. 36 and 37), and an increase in TSNAs
may increase the risk for certain types of cancer (Ref. 38). Thus, if
fermentation is used in the manufacturing process for the new tobacco
product, then the SE Report would be required to describe the process,
including the type and quantity of the microbial inoculum and/or
fermentation solutions (fermentation is typically used in smokeless
tobacco products, and the hot and sticky environment associated with
fermentation may contribute to bacteria and growth of contaminants,
which is a major health and safety concern). If the manufacturing
process for the new tobacco product does not affect the characteristics
of the new product beyond what is described elsewhere in the SE Report,
an applicant would be required to state that to satisfy this provision.
    f. Description of the predicate tobacco product. Under proposed
Sec.  1107.18(f), the SE Report would be required to include a section
describing the predicate tobacco product. Under proposed Sec.
1107.18(f)(1), the applicant would be required to identify one
predicate tobacco product that is either a grandfathered tobacco
product or a tobacco product that FDA previously found to be
substantially equivalent to a predicate tobacco product. The applicant
may reference the STN if FDA has already made a grandfathered
determination, or provide specific information sufficient to support a
grandfathered determination (see the final guidance entitled
``Establishing That a Tobacco Product Was Commercially Marketed in the
United States as of February 15, 2007'' (79 FR 58358, September 29,
2014)). If the SE Report includes information to demonstrate the
grandfathered status of the predicate product, FDA intends to make the
grandfathered determination on that predicate tobacco product before
beginning substantive scientific review of the SE Report.
    As with any new tobacco product, applicants who wish to use the SE
pathway to obtain marketing authorization for new co-packaged products
would have to identify a single predicate tobacco product for each new
tobacco product. An applicant could use a co-packaged product as a
predicate so long as it is a valid predicate; however, an applicant
would not be required to use a co-packaged product as its predicate
tobacco product.
    FDA invites comments on this approach or any recommended
alternative approaches for co-packaged products.
    Proposed Sec.  1107.18(f)(2)(i) would require that the predicate
tobacco product chosen by the applicant be in the same category (e.g.,
cigarette, smokeless) and subcategory (e.g., filtered, non-filtered) as
the new tobacco product to provide a meaningful starting point for our
substantial equivalence review. This proposed requirement reflects
FDA's experience, which has been that if the predicate and new tobacco
products differ on these points, it is highly unlikely that we would be
able to find that the SE Report demonstrates the substantial
equivalence of the new tobacco product to the predicate tobacco
product. For example, when an SE Report includes a predicate and new
tobacco product that are in different categories (e.g., a comparison of
a combusted tobacco product to a smokeless product), the considerable
differences between the products in almost every characteristic will
raise different questions of public health (e.g., an applicant
attempting to compare a smokeless moist snuff predicate to a new
combusted filtered cigarette would likely not be able to demonstrate
that the cigarette does not raise different questions of public health
as compared to the smokeless moist snuff, as the properties and
characteristics of the two products are so vastly different. For
example, an applicant would not be able to show that a ventilation of
25 percent would not cause the cigarette to raise different questions
of public health given that the smokeless moist snuff has no
ventilation characteristic with which to compare). These drastic
differences in characteristics make it very hard for applicants to
provide the evidence necessary to show that these differences do not
cause the new product to raise different questions of public health
because addressing the uncertainty in the influence on adverse health
impact on the user, product use, initiation, and cessation would often
require complex clinical studies.
    In addition, under proposed Sec.  1107.18(f)(2)(ii), the predicate
must have been either commercially marketed (not exclusively in a test
market) in the United States as of February 15, 2007 (a grandfathered
predicate tobacco product), or have been previously determined to be
substantially equivalent by FDA. If the SE Report is using a
grandfathered predicate tobacco product, the SE Report must include a
statement that ``I, (name of responsible official), confirm that the
predicate tobacco product, (insert name of predicate tobacco product),
was commercially marketed other than for test marketing as of February
15, 2007'' or reference the STN for a previous determination by FDA
that the predicate tobacco product is grandfathered. The statement
would be a means of ensuring that the applicant understands that the
product must have been commercially marketed on February 15, 2007, to
be considered grandfathered, and supports the information provided in
proposed Sec.  1107.18(f)(1).
    Under proposed Sec.  1107.18(f)(2)(iii), the applicant would be
required to identify a predicate tobacco product that is an individual
product. As previously discussed, an applicant could use a co-packaged
product as a predicate so long as it is a valid predicate (e.g., on the
market as of February 15, 2007, or one that was previously found SE).
However, a predicate could not be a fictional product made up by
combining characteristics of two or more products that are
grandfathered or have been found SE. In addition, under proposed Sec.
1107.18(f)(2)(iv) and (v), the predicate tobacco product could not be
the subject of a rescission order by FDA as described in proposed Sec.
1107.50 and could not have been removed from the market at the
initiative of FDA or have been determined by judicial order to be
adulterated or misbranded. These proposed requirements are intended to
minimize some of the problems with predicate tobacco products that FDA
has identified during SE Report reviews which prevent us from
proceeding with an SE review.
    g. Comparison information. Proposed Sec.  1107.18(g) states that
the SE Report would be required to include a comparison of the
characteristics of the new tobacco product and the predicate tobacco
product, as described in proposed Sec.  1107.19. FDA expects this
comparison to be a significant part of an SE Report as it would be
expected to describe in detail how the product characteristics of the
new tobacco product compare to the product characteristics of the
predicate tobacco product.\8\ If the new tobacco product

has some characteristics that are not identical to the predicate, but
some characteristics that are identical, the applicant must provide
comparison information related to the characteristics that are not
identical, but may certify that the other characteristics are identical
under proposed Sec.  1107.18(l)(2).
---------------------------------------------------------------------------

    \8\ FDA notes that some applications may use surrogate tobacco
products for discrete parts of an SE application. A surrogate is a
tobacco product for which an applicant provides data it would like
to extrapolate to the new, predicate tobacco product or both new and
predicate tobacco products. However, the surrogate tobacco product
is neither the new or predicate tobacco product (a grandfathered
determination is not necessary for surrogate tobacco products as it
is not a predicate tobacco product). Data for a surrogate tobacco
product is provided in place of data or to provide a bridge between
data for the new or predicate tobacco product. A surrogate tobacco
product is used when there is inadequate data available for the new
or predicate tobacco product; data for a surrogate tobacco product
supplement the data for a new or predicate tobacco product. Unlike
predicate tobacco products, surrogate tobacco product data may be in
place at the start of substantive scientific review or may be
provided in response to a deficiency letter. FDA invites comments on
the use of surrogate tobacco products.
---------------------------------------------------------------------------

    For example, if the modification between the new and predicate
product is a change to fire standard compliant (FSC) paper, the SE
Report would state and provide comparison information on the difference
of the non-FSC to FSC paper, the change in filtration (e.g., if there
is a change in filtration due to the change made to the paper), and the
change in tobacco blend (e.g., if there is a change in blend made with
the change to the paper), but the SE Report could then include a
certification that all other characteristics of the new and predicate
product, other than the modified paper, filtration, and blend, are
identical. Another example is a change in product quantity (e.g., an
increase from 20 grams to 35 grams of loose moist snuff). In this
scenario, if the per weight composition has not changed, the applicant
could provide comparison information on only the characteristics that
differ between the new and predicate product, and include a
certification under proposed Sec.  1107.18(l)(2) that all other
characteristics are identical. A third example would be a container
closure system (CCS) substitution of a bag for a box. In this case, the
SE Report would provide comparison information on the change in CCS and
the SE Report could then include a certification under proposed Sec.
1107.18(l)(2) that the characteristics of all non-CCS items have not
changed (e.g., rolling papers are identical between the new and
predicate product). The applicant would be required to maintain records
supporting the certification consistent with proposed Sec.  1107.58.
    h. Comparative testing information. Other than for characteristics
that are identical (and for which the applicant has certified that the
characteristics are identical under paragraph (l)(2)), proposed Sec.
1107.18(h) would require the SE Report to include testing information
on the characteristics of the new and predicate tobacco products as
described in section Sec.  1107.19, except where the applicant
adequately justifies that such comparative testing information is not
necessary to demonstrate that the new product: (1) Has the same
characteristics as the predicate or (2) does not raise different
questions of public health. For example, it may not always be necessary
to provide comparative testing information on the heating source.
    Comparative testing supports the SE Report by showing the
information contained in the SE Report is meaningful and accurate and,
where applicable, helps demonstrate that the different
characteristic(s) in a new tobacco product does not raise different
questions of public health. FDA's experience has been that the summary
data provided in some SE Reports has been miscalculated, and thus, a
substantial equivalence determination was not supportable. To ensure
the accuracy of the data provided, FDA has needed to review the
experimental data.
    Accordingly, proposed Sec.  1107.18(h)(1) would require that the SE
Report include test protocols, quantitative acceptance criteria, and
test results (including means and variances, data sets, and a summary
of the results). Under proposed Sec.  1107.18(h)(2), the testing would
be required to be conducted on a sufficient sample size and on samples
that reflect the final tobacco product composition and design. Proposed
Sec.  1107.18(h)(3) would require the SE Report to state whether the
testing method for the new and predicate products are the same and, if
they differ, to explain how the results of the different test methods
can be compared. Under proposed Sec.  1107.18(h)(4), the SE Report also
must identify any national and international standards used to test the
new and predicate tobacco products and explain any deviations.\9\ If no
standards were used for testing, the SE Report would be required to
state so. There are multiple ways to satisfy this comparative testing
requirement that may not require comparative testing on the specific
characteristic that is different between the new and predicate tobacco
product. For example, if an applicant is proposing to modify the
container closure system of a smokeless tobacco product for loose moist
snuff, rather than supply testing information on the container closure
system, the applicant could demonstrate that the ingredients,
constituents, moisture, and stability of the loose tobacco within the
container closure system are not affected by the change in container
closure system in a way that would cause the new product to raise
different questions of public health. As testing information on the
ingredients, constituents, moisture, and stability information would
already be required for the smokeless tobacco product, additional
comparative testing information on differences in the container closure
system would not be required. Instead the applicant would state that
this information is already covered by the submission of the
ingredients, constituents, moisture, and stability information within
the SE Report.
---------------------------------------------------------------------------

    \9\ In the guidance document entitled, ``Section 905(j) Reports:
Demonstrating Substantial Equivalence for Tobacco Products''
(January 2011), FDA provided some examples of standards that might
be used to support an SE application.
---------------------------------------------------------------------------

    i. Statement of compliance with applicable tobacco product
standards. As required by section 905(j)(1)(B) of the FD&C Act, under
proposed Sec.  1107.18(i), the SE Report must list and describe the
action(s) that the applicant has taken to comply with the requirements
under section 907 of the FD&C Act (tobacco product standards) that are
applicable to the tobacco product. In the alternative, the SE Report
must state that there are no requirements under section 907 that are
applicable to the new tobacco product. For SE Reports that are
submitted after the finalization of this rule, but still pending after
issuance of any future tobacco product standards, FDA invites public
comments on how such pending SE Reports should be considered or handled
in relation to the satisfaction of the requirement for a statement of
compliance with applicable tobacco product standards.
    j. Health information summary or statement regarding availability
of such information. As required by section 910(a)(4) of the FD&C Act,
the SE Report must include either an adequate summary of any health
information related to the new tobacco product or a statement that such
information would be made available upon request by any person.
Proposed Sec.  1107.18(j) would codify this statutory requirement and
ensure that applicants provide adequate information as required by
section 910(a)(4). Under proposed Sec.  1107.18(j)(1), if the applicant
chooses to provide a health information summary, the applicant would be
required to provide a redacted version of the full SE Report that
excludes research subject identifiers and trade secret and confidential
commercial information as defined in Sec. Sec.  20.61 and

20.63 (21 CFR 20.61 and 20.63). FDA believes that an SE Report redacted
in the manner described would generally provide an adequate summary of
any health information related to the new tobacco product, as well as
detailed information regarding data concerning adverse health effects
of the new tobacco product. The redacted SE Report would be required to
be submitted with the original submission, and a redacted copy of an
amendment would be required with the submission of any amendment to the
SE Report.
    In addition, to the extent that there is additional health
information about the new tobacco product, including any information,
research (e.g., published or unpublished research, internal reports or
analyses), or data about adverse health effects, that the applicant has
or knows about and that is not contained in the SE Report, the
applicant would be required to provide such accurate and complete, and
not false or misleading, information in the health information summary.
If there is no such additional health information, the SE Report would
be required to include a statement that the company does not have and
does not know of any such additional health information. FDA would post
the health information summary, including the redacted SE Report, and
any additional health information provided by the applicant on FDA's
website.
    Under proposed Sec.  1107.18(j)(2), if the applicant chooses to
make the health information available upon request, the SE Report would
be required to include a certification statement made by an authorized
representative of the applicant that an adequate summary of any health
information related to the new tobacco product, including detailed
information regarding data concerning adverse health effects of the new
tobacco product, would be made available to a requestor within 30
calendar days of a request. The certification is intended to ensure
that applicants understand that they are responsible for providing this
information upon request.
    Under proposed Sec.  1107.18(j)(3), the health information the
applicant would need to make available would be a copy of the full SE
Report (which includes any amendments), excluding research subject
identifiers and trade secret and confidential commercial information as
defined in Sec. Sec.  20.61 and 20.63. To the extent that the applicant
has or knows of any additional health information, including any
information, research, or data regarding adverse health effects that is
not contained in the SE Report, the applicant would also provide the
requester such accurate and complete, and not false or misleading,
information. If there is no such additional health information, the
applicant would provide the requester with a statement that the company
does not have and does not know of any such additional health
information.
    Proposed Sec.  1107.18(j)(4) would provide that requests for health
information be made to the authorized representative of the applicant,
whose contact information the applicant would provide to FDA. FDA
intends to make this contact information available on FDA's website.
The applicant would be required to update this contact information with
FDA whenever necessary (e.g., the identified authorized representative
is no longer with the company or the address or telephone information
changes). If an applicant elects to include the statement in their SE
Report, the applicant would be required to provide the information to
persons who request it. Applicants would not be permitted to later
amend SE Reports on which FDA has issued a marketing order to choose
instead to submit a health information summary. Therefore, applicants
that provide the statement instead of providing the summary to FDA as
part of the SE Report must be prepared to provide the information
required under section 910(a)(4) of the FD&C Act, as implemented
through proposed Sec.  1107.18(j).
    Under proposed Sec.  1107.18(j)(5), to the extent information is
included in the health information summary or the health information
provided upon request under paragraphs (j)(1) and (2) of this section
that is not required by section 910(a)(4) of the Federal Food, Drug,
and Cosmetic Act or paragraph (j) of this section, that information
cannot contain a statement that would cause the proposed new tobacco
product to be in violation of section 911 of the FD&C Act (21 U.S.C.
387k) upon the introduction or delivery for introduction of the
proposed new product into interstate commerce. If an applicant includes
such a statement in its health information summary or in the health
information the applicant provides upon request, the review of the
applicant's SE Report may be delayed.
    FDA would generally not consider a statement of relative risk to be
required by section 910(a)(4) of the FD&C Act or paragraph (j) of this
section if the risk being conveyed is unrelated to the applicant's
demonstration that the new product is substantially equivalent and
FDA's review of the SE Report. For example, if an applicant submitted
an SE Report for a new smokeless tobacco product and identified a
smokeless tobacco product as the predicate product, a statement
comparing the tar in the new smokeless tobacco product to the tar in a
cigarette would generally be unrelated to the applicant's demonstration
that the new product is substantially equivalent and FDA's review of
the SE Report.
    For the purposes of Sec.  1107.18(j), any statement an applicant is
required to include in a health information summary or the health
information provided in response to a request--including statements
made in an SE Report (e.g., comparisons of HPHCs between the new and
predicate tobacco products)--typically would not cause the proposed new
tobacco product to be in violation of section 911 of the FD&C Act upon
introduction or delivery for introduction of the proposed new product
into interstate commerce. Congress required applicants to submit health
information summaries with their SE Reports or to provide such
information upon request. Nothing in section 911 of the FD&C Act
suggests that Congress intended for that provision to impede an
applicant's ability to fulfill its obligations under section 910(a)(4)
of the FD&C Act.
    k. Compliance with part 25. An applicant must include an
environmental assessment (EA) prepared in accordance with Sec.  25.40
or a valid claim of a categorical exclusion, if applicable. (Under
Sec.  25.15(a), all submissions requesting FDA action require the
submission of either a claim of categorical exclusion or an EA.) In
accordance with Sec.  25.40(a), an environmental assessment must
include, at a minimum, brief discussions of the need for the proposed
action, of alternatives as required by section 102(2)(E) of the
National Environmental Policy Act (NEPA), of the environmental impacts
of the proposed action and alternatives, a listing of the agencies and
persons consulted, and the relevant environmental issues relating to
the use and disposal from use. Although applicants may wish to review
the categorical exclusions specific to tobacco product applications at
Sec.  25.35, the only categorical exclusion currently available for an
order authorizing the marketing of a new tobacco product is found at
Sec.  25.35(a), and applies only to orders finding provisional products
substantially equivalent. If the applicant believes the action would
qualify for an available categorical exclusion, the applicant would be
required to state under Sec.  25.15(a) and (d) that the action
qualifies for a categorical exclusion, cite to the claimed exclusion,
and state that to the applicant's knowledge no

extraordinary circumstances exist under Sec.  25.21.
    To evaluate the environmental impact (as described in Sec.
25.40(a)), information that addresses the status of the new tobacco
product relative to the predicate tobacco product would be required.
Accordingly, the environmental assessment would be required to include
a statement indicating whether the new tobacco product is intended to:
(1) Replace the predicate tobacco product once the new tobacco product
receives market authorization and is commercially marketed; (2) be a
line extension of the predicate tobacco product; (3) be marketed along
with the predicate product by the same manufacturer; and/or (4) be
marketed along with the predicate tobacco product by a different
manufacturer (e.g., by a manufacturer other than the manufacturer of
the predicate tobacco product). This statement would be included in the
section on the need for the proposed action and would help FDA
understand the environmental impact of an SE order by understanding the
marketing intention for the new and predicate tobacco products. The
marketing authorization of a new tobacco product may have a different
impact if the new tobacco product is intended to be marketed along with
the predicate tobacco product than if the new tobacco product is
intended to replace a predicate tobacco product.
    l. Certification statement. Proposed Sec.  1107.18(l)(1) would
require that an applicant include in the SE Report a specific statement
certifying that the applicant would maintain all records to
substantiate the accuracy of the report consistent with the record
retention requirements in proposed Sec.  1107.58, that, to the best of
their knowledge, the information and accompanying submission are true
and correct, no material fact has been omitted, the signer is
authorized to submit the information on the applicant's behalf, and
that the signer understands that anyone who knowingly and willfully
makes a materially false, fictitious, or fraudulent statement or
representation in any matter within the jurisdiction of the executive,
legislative, or judicial branch of the Government of the United States
is subject to criminal penalties (under 18 U.S.C. 1001). The
certification is intended to provide FDA with additional assurance that
the applicant has fully considered the SE Report and its contents, that
the applicant believes there is a basis for making the findings
required by section 910(a)(2) of the FD&C Act, and that the applicant
understands the potential consequences of submitting false information
to the U.S. Government.
    In addition, under proposed Sec.  1107.18(l)(2), if an SE Report
states that the new tobacco product has certain characteristics that
are identical to the predicate tobacco product (though not all
characteristics, such that the product would not be ``new''), an
applicant can choose to submit a certification in lieu of providing
information for each characteristic of the new and predicate tobacco
products. FDA would permit the applicant to certify that the other
characteristics are identical as long as the applicant maintains
supporting documentation, including the records demonstrating the
comparison information detailed in proposed Sec.  1107.19. The records
would be required to be maintained consistent with proposed Sec.
1107.58. The certification must be signed by an authorized
representative of the applicant.
3. Comparison Information (Proposed Sec.  1107.19)
    This proposed section describes the comparison information that
would be required in the SE Report. Comparative testing supports the SE
Report by showing the information contained in the SE Report is
meaningful and accurate; where applicable, the testing also helps
demonstrate that the different characteristic(s) in a new tobacco
product does not raise different questions of public health. FDA
requests public comments on the quantitative and qualitative
differences in each of the design parameters for each of the tobacco
product categories identified below as well as data to support such
values or characteristics.
    a. Product design. Proposed Sec.  1107.19(a) would require the SE
Report to include descriptions of the product designs of the new and
predicate tobacco products and identify any differences. This proposed
section would require that the information be in a tabular format with
a side-by-side comparison of each design parameter of the new and
predicate tobacco products. The SE report would also be required to
include for each design parameter a target value and range of
acceptable values, actual measured value (if applicable), and ranges of
measured values (if applicable) with units of measure. The report would
also be required to include test data for each applicable design
parameter. Proposed Sec.  1107.19(a)(1)-(6) would establish the
required design parameter information for the tobacco product category,
as follows:
    For cigarettes, the required design parameter information to be
provided for each predicate and new tobacco product would be:

      Table 3--Required Design Parameter Information for Cigarettes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Cigarette length (mm)                     --Puff count.
--Cigarette circumference (mm)              --Cigarette draw resistance
                                             (mm H2O).
--Cigarette draw resistance (mm H2O)        --Tobacco filler mass (mg).
--Tobacco filler mass (mg)                  --Tobacco moisture (%).
--Tobacco rod density (g/cubic centimeter   --Filter ventilation (%).
 (cm3))
--Tobacco moisture (%)                      --Cigarette paper base paper
                                             basis weight (g/m2).
--Filter ventilation (%)                    --Cigarette paper base paper
                                             porosity (CU).
--Tipping paper length (mm)                 --Cigarette paper band
                                             porosity (CU).
--Cigarette paper base paper basis weight   --Filter efficiency (%) [If
 (g/meter squared(m2))                       no filter efficiency data
                                             is available for the
                                             products, include
                                             information sufficient to
                                             show that the cigarette
                                             filter is unchanged (e.g.,
                                             denier per filament, total
                                             denier, and filter
                                             density)].
                                            --Filter pressure drop (mm
                                             H2O).
--Cigarette paper base paper porosity (CU)
--Cigarette paper band porosity (CU)
--Cigarette paper band width (mm)
--Cigarette paper band space (mm)

--Filter efficiency (%) (If no filter
 efficiency data is available for the
 products, include information sufficient
 to show that the cigarette filter is
 unchanged (e.g., denier per filament,
 total denier, and filter density))
--Filter length (mm)
--Filter pressure drop (mm H2O)
------------------------------------------------------------------------

    FDA is proposing to require that these parameters be included for
cigarettes because variations in these parameters may cause the new
tobacco product to raise different questions of public health, as
described below:
     A difference in cigarette length may alter tobacco
biomarker levels (Ref. 5).
     A difference in cigarette circumference may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 6).
     A difference in puff count can directly affect smoke
constituent yields (Ref. 7).
     A difference in cigarette draw resistance may result in
differences in the difficulty of pulling air through the tobacco rod
and, in turn, affect smoke constituent yields (Ref. 8).
     A difference in tobacco filler mass may affect smoke
constituent yields (Refs. 9 and 10).
     A difference in tobacco rod density may modify burn
properties and smoke constituent yields (Refs. 11 and 12).
     A difference in tobacco moisture may affect puff count
(Refs. 13-15).
     A difference in cigarette paper base paper basis weight
may affect puff count and smoke constituent yields (Ref. 16).
     A difference in cigarette paper base paper porosity may
affect smoke constituent yields (Ref. 16).
     A difference in cigarette paper band porosity may affect
smoke constituent yields since band porosity allows for the overall
assessment of the weighted change in air flow through the cigarette
paper during active puffing (Refs. 18, 19, and 38).
     A difference in cigarette paper band width may affect
ventilation and, in turn, smoke constituent yields (Ref. 20).
     A difference in cigarette paper band space may affect
ignition propensity and, in turn, puff count (Ref. 21).
     A difference in filter efficiency may affect smoke
constituent yields (Refs. 18 and 20).
     A difference in denier per filament may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 22).
     A difference in total denier may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 22).
     A difference in filter density may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 22).
     A difference in filter pressure drop may affect smoke
constituent yields (Ref. 23, slide 40).
     A difference in filter length may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 22).
     A difference in filter ventilation may affect smoke
constituent yields (Ref. 6).
     A difference in tipping paper length may affect smoke
constituent yields (Ref. 24).
    For portioned and non-portioned smokeless tobacco products, the
required design parameter information to be provided for each predicate
and new tobacco product would be:

  Table 4--Required Design Parameter Information for Portioned and Non-
                  Portioned Smokeless Tobacco Products
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
                  Portioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm)                     --Tobacco cut size (mm).
--Tobacco moisture (%)                      --Tobacco moisture (%).
--Portion length (mm) (if applicable)       --Portion mass (mg) (if
                                             applicable).
--Portion width (mm) (if applicable)        --Pouch paper porosity (CU).
--Portion mass (mg) (if applicable)         --Pouch paper basis weight
                                             (g/m2).
--Portion thickness (mm) (if applicable).
--Pouch paper wicking.
--Pouch paper porosity (CU).
--Pouch paper basis weight (g/m2).
------------------------------------------------------------------------
                Non-portioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm).                    --Tobacco cut size (mm).
--Tobacco moisture (%).                     --Tobacco moisture (%).
------------------------------------------------------------------------

    FDA is proposing to require that these parameters be included for
smokeless tobacco products because variations in these parameters may
cause the new tobacco product to raise different questions of public
health, as described below:
     A difference in tobacco cut size may alter the surface
area and accessibility of saliva to get to the surfaces of the tobacco,
thereby affecting the amount and rate of constituents released from the
product (Ref. 25).
     A difference in tobacco moisture may affect microbial
growth in the product, extraction efficiency, and total exposure to
nicotine, NNN, and NNK (Ref. 26).

     A difference in portion mass may affect user exposure to
the tobacco product and, in turn, exposure to the HPHCs contained in
each portion (Ref. 27).
     A difference in portion length as it relates to portion
size may affect the amount of constituents in each portion (Ref. 27).
     A difference in portion width may result in a surface area
difference, which is proportional to the amount and rate of
constituents released from the product (Ref. 28).
     A difference in portion thickness may result in a surface
area difference, which is directly proportional to the amount and rate
of constituents released from the product (Ref. 28).
     A difference in pouch paper basis weight may alter the
interactions between the tobacco and oral cavity, thereby affecting the
amount and rate of constituents released from the product (Ref. 29).
     A difference in pouch paper porosity may alter the
interactions between the tobacco and oral cavity, thereby affecting the
amount and rate of constituents released from the product (Ref. 29).
    For RYO tobacco rolling papers, the required design parameter
information to be provided for each predicate and new tobacco product
would be:

 Table 5--Required Design Parameter Information for RYO Tobacco Rolling
                                 Papers
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Paper length (mm).                        --Mass per paper (mg).
--Paper width (mm).                         --Cigarette paper base paper
                                             basis weight (g/m2).
--Mass per paper (mg).                      --Cigarette paper base paper
                                             porosity (CU).
--Cigarette paper base paper basis weight   --Cigarette paper band
 (g/m)2.                                     porosity (CU) (if
                                             applicable).
--Cigarette paper base paper porosity
 (CU).
--Cigarette paper band porosity (CU) (if
 applicable).
--Cigarette paper band width (mm) (if
 applicable).
--Cigarette paper band space (mm)
 (applicable).
------------------------------------------------------------------------

    FDA is proposing to require that these parameters be included for
rolling papers because variations in these parameters may cause the new
tobacco product to raise different questions of public health, as
described below:
     A difference in overall length may alter the surface area
that is available for tobacco packing, thereby affecting the smoke
constituent yields (Ref. 23, slide 46).
     A difference in overall width may alter the surface area
that is available for tobacco packing, thereby affecting the smoke
constituent yields (Ref. 23, slide 46).
     A difference in total mass per pack may be a result of a
surface area or basis weight difference and, in turn, may affect puff
count and smoke constituent yields (Refs. 16 and 23 (slide 46)).
     A difference in RYO paper base paper basis weight may
affect puff count and smoke constituent yields (Ref. 16).
     A difference in RYO paper base paper porosity may affect
smoke constituent yields (Ref. 16).
     A difference in RYO paper band porosity may affect smoke
constituent yields because band porosity allows for the overall
assessment of the weighted change in air flow through the cigarette
paper during active puffing (Refs. 17 and 37).
     A difference in RYO paper band width may affect
ventilation and, in turn, smoke constituent yields (Ref. 20).
     A difference in RYO paper band space may affect ignition
propensity and, in turn, puff count (Ref. 21).
    For RYO tobacco tubes, the required design parameter information to
be provided for each predicate and new tobacco product is as follows:

  Table 6--Required Design Parameter Information for RYO Tobacco Tubes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Tube length (mm).                         --Total mass (mg).
--Tube circumference (mm).                  --Cigarette paper base paper
                                             basis weight (g/m2).
--Total mass (mg).                          --Cigarette paper base paper
                                             porosity (CU).
--Cigarette paper base paper basis weight   --Cigarette paper band
 (g/m2).                                     porosity (CU).
--Cigarette paper base paper porosity
 (CU).
--Cigarette paper band porosity (CU).
--Cigarette paper band width (mm).
--Cigarette paper band space (mm).
------------------------------------------------------------------------

    For RYO tobacco filtered tubes, the required design parameter
information to be provided for each new predicate and new tobacco
product would be:

 Table 7--Required Design Parameter Information for RYO Tobacco Filtered
                                  Tubes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Tube length (mm).                         --Total mass (mg).
--Tube circumference (mm).                  --Filter ventilation (%).
--Total mass (mg).                          --Cigarette paper base paper
                                             basis weight (g/m2).
--Tipping paper length (mm).                --Cigarette paper base paper
                                             porosity (CU).

--Filter ventilation (%).                   --Cigarette paper band
                                             porosity (CU).
--Cigarette paper base paper basis weight   --Filter denier per filament
 (g/m2).                                     (DPF).
--Cigarette paper base paper porosity       --Filter total denier (g/
 (CU).                                       9000m).
--Cigarette paper band porosity (CU).       --Filter density (g/cm3).
--Cigarette paper band width (mm).          --Filter pressure drop (mm
                                             H2O).
--Cigarette paper band space (mm).
--Filter length (mm).
--Filter denier per filament (DPF).
--Filter total denier (g/9000m).
--Filter density (g/cm3).
--Filter pressure drop (mm H2O).
------------------------------------------------------------------------

    FDA is proposing to require that these parameters be included for
RYO tobacco tubes because variations in these parameters may cause the
new tobacco product to raise different questions of public health, as
described below:
     A difference in tube length may alter tobacco biomarker
levels (Ref. 5).
     A difference in tube circumference may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 6).
     A difference in total mass per pack may be a result of a
surface area or basis weight difference and, in turn, may affect puff
count and smoke constituent yields (Refs. 16 and 23 (slide 46)).
     A difference in tube paper base paper basis weight may
affect puff count and smoke constituent yields (Ref. 16).
     A difference in tube paper base paper porosity may affect
smoke constituent yields (Ref. 16).
     A difference in tube paper band porosity may affect smoke
constituent yields since band porosity allows for the overall
assessment of the weighted change in air flow through the cigarette
paper during active puffing (Refs. 17 and 37).
     A difference in tube paper band width may affect
ventilation and, in turn, smoke constituent yields (Ref. 20).
     A difference in tube paper band space may affect ignition
propensity and, in turn, puff count (Ref. 21).
     A difference in filter efficiency may affect smoke
constituent yields (Ref. 13).
     A difference in denier per filament may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 22).
     A difference in total denier may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 33).
     A difference in filter density may affect filter
efficiency and, in turn, smoke constituent yields (Ref. 32).
     A difference in filter pressure drop may affect smoke
constituent yields (Ref. 23, slide 40).
     A difference in filter length may affect filter efficiency
and, in turn, smoke constituent yields (Ref. 32).
     A difference in ventilation may affect smoke constituent
yields (Ref. 24).
     A difference in tipping paper length may affect smoke
constituent yields (Ref. 24).
    For RYO tobacco, the required design parameter information to be
provided for each predicate and new tobacco product would be:

     Table 8--Required Design Parameter Information for RYO Tobacco
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Tobacco filler mass (mg).                 --Tobacco filler mass (mg).
--Tobacco cut size (mm).                    --Tobacco cut size (mm).
--Tobacco moisture (%).                     --Tobacco moisture (%).
------------------------------------------------------------------------

    FDA is proposing to require that these RYO tobacco parameters be
included for RYO tobacco because variations in these parameters may
cause the new tobacco products to raise different questions of public
health, as described below:
     A difference in tobacco filler mass may affect smoke
constituent yields when used with rolling paper (Ref. 9).
     A difference in tobacco cut width alters the size of the
tobacco pieces, which may result in more particulate matter (Ref. 30).
     A difference in moisture may affect smoke composition
(Ref. 13).
    For tobacco products not specifically identified (e.g., ENDS,
cigars) FDA invites comments and information on the parameters that may
be needed to support an SE Report.
    b. Heating source. Proposed Sec.  1107.19(b) would require that the
SE Report include a description of any heating source for both the new
and predicate tobacco products (e.g., burning coal, electric, chemical
reaction, carbon tip) and identify any differences. If there is no
heating source for the new and predicate tobacco products, the SE
Report would be required to state that.
    c. Product composition. Proposed Sec.  1107.19(c) would require
that the SE Report include descriptions of the product composition of
the new and predicate tobacco products and identify any differences.
The information would be required to be in tabular format with a side-
by-side comparison of the materials and ingredients for each component
or part of the new and predicate tobacco products. Under the proposed
rule, the SE Report would be required to provide for each material and
ingredient the following information: The quantity, the target value
and range of acceptable values, actual measured value (where
applicable), and range of measured values (where applicable) reported
as mass per component or part.
    Proposed Sec.  1107.19(c)(1) would require that the SE Report
include the following information for each material in the product:
     The material name and common name (if applicable);
     The component or part where it is located;

     The subcomponent or subpart where it is located (if
applicable);
     The function of the material;
     Quantities (including ranges or means and acceptance
limits) with identification of any specification variation between the
new tobacco product and predicate tobacco product;
     Specifications (including quality, grades, and suppliers)
used for the new tobacco product and the predicate (including any
specification variations, if applicable); and
     Any other material properties necessary to characterize
the new and predicate tobacco products.
    Proposed Sec.  1107.19(c)(2) would require that the SE Report
include information on ingredients other than tobacco (information on
tobacco ingredients is addressed in proposed Sec.  1107.19(c)(3)).
Required information would include:
     International Union of Pure and Applied Chemistry chemical
name and common name (if applicable);
     Chemical Abstracts Service (CAS) number(s) or FDA Unique
Ingredients Identifier;
     The function of the ingredient;
     The quantity with the unit of measure (including ranges or
means, and acceptance limits) of the materials in the new tobacco
product and predicate tobacco product (with any specification
variation, if applicable);
     The specifications (including purity or grade and
supplier);
     For complex purchased ingredients, each single chemical
substance reported separately; and
     Any other ingredient information necessary to characterize
the new and predicate tobacco products.
    Proposed Sec.  1107.19(c)(3) would require information on tobacco
ingredients. This information would include the following:
     The type of tobacco, including grade and variety. This
impacts the characteristics of the products because different grades
have different constituent profiles (the SE Report would need to
include information on the applicant's grading system so that FDA
understands the grade);
     The quantity, with the unit of measure (including ranges
or means, and acceptance limits), of tobacco in the new and predicate
tobacco products (with a specification variation, if applicable);
     The specification of tobacco used for the new tobacco
product and predicate tobacco product (with any specific variation, if
applicable);
     A description of any genetic engineering that impacts
characteristics, because genetic engineering affects the constituent
profile; and
     Any other information about tobacco ingredients necessary
to characterize the new and predicate tobacco products.
    If the new tobacco product does not contain tobacco (e.g., rolling
paper or tipping paper), this section of the report would be required
to state that.
    FDA is proposing that ingredient quantities under proposed Sec.
1107.19(c)(2) and (3) be reported as mass per gram of tobacco for non-
portioned tobacco products and as mass per portion for portioned
tobacco products. These specific measurements provide consistent,
complete information that would allow FDA to understand the ingredient
quantities. In contrast, if ingredient quantities were reported as
percentages, FDA would have to make assumptions about the denominator
used to calculate the percentage. For example, if xylitol were reported
as 10 percent of a portioned moist snuff, FDA would not able to
determine if xylitol was 10 percent of the mass of the tobacco filler
or of the entire product (containing filler, paper, etc.).
    Proposed Sec.  1107.19(c)(4) would require that the SE Report
include a description of the container closure system for the new and
predicate tobacco products, including a side-by-side quantitative
comparison of the subcomponents or subparts and materials and annotated
illustrations.
    d. Other features. Proposed Sec.  1107.19(d) would require that the
SE Report include descriptions of any other applicable features of the
new and predicate tobacco products and identify any differences that
exist. If a specific feature described in proposed Sec.  1107.19(d) is
not applicable to the new tobacco product, the SE Report would be
required to state as such. In response, FDA may request a scientific
explanation for why a particular feature is not applicable, and under
proposed Sec.  1107.19(d) the applicant would be required to provide
that information to FDA. The SE Report must also address any other
product characteristics that relate to the chemical, physical or
biological properties of the tobacco product and are necessary for SE
Report review.
    Specifically, proposed Sec.  1107.19(d)(1) would require that the
SE Report include HPHC and other constituent information as appropriate
to demonstrate that: (1) The new tobacco product has the same
characteristics as the predicate tobacco product or (2) any differences
in characteristics between the new and predicate tobacco product do not
cause the new tobacco product to raise different questions of public
health, as follows:
     Constituent names in alphabetical order,
     Common names,
     CAS number,
     Mean quantity and variance with unit of measure,
     Number of samples and measurement replicates for each
sample,
     Analytical methods used, description and associated
reference(s),
     Testing laboratory(ies) and accreditation information,
     Length of time between dates of manufacture and dates of
testing,
     Storage conditions of the tobacco product before it was
tested, and
     Full test data (including test protocols, any deviations
from the test protocols, quantitative acceptance (pass/fail) criteria,
and complete data sets) for all testing performed.
    For combusted tobacco products, constituent smoke yields from the
new and predicate products would need to be determined using intense
and non-intense smoking regimens.\10\ Two smoking regimens are required
in order to understand the way that constituent yields delivered by a
tobacco product can change over a range of different smoking
conditions. If constituent yields were only reported from a single
smoking regimen, FDA would have limited and potentially misleading
information about constituent yields produced by a given tobacco
product. Many studies demonstrate that different smoking regimens
result in different constituent yields from the same product (Refs. 31
and 32). By requiring both an intense and a non-intense smoking
regimen, FDA would have a better understanding of quantities of each
constituent that may be produced by the tobacco product when smoked
under different conditions. If an alternative to these smoking regimens
is used, the applicant would be required to provide an explanation of
why the alternative provides comparable results to the intense and non-
intense smoking regimens.
---------------------------------------------------------------------------

    \10\ These refer to regimens by the International Organization
for Standardization and Health Canada.
---------------------------------------------------------------------------

    FDA is proposing that the HPHC information in an SE Report for a
new cigarette include, at a minimum, a comparison of the quantities of
nicotine-dry particulate matter, total particulate matter, carbon
monoxide, and nicotine (total) in the mainstream smoke of the new
tobacco product with that of the predicate tobacco product, using both
intense and non-intense smoking regimens. Further, additional HPHC

yields may need to be reported in order to demonstrate that: (1) The
new tobacco product has the same characteristics as the predicate
tobacco product or (2) any differences in characteristics do not cause
the new tobacco product to raise different questions of public health.
For example, blend differences may require reporting of HPHC yields
specific to the differences in tobacco blends. Studies show that the
mainstream smoke of burley and reconstituted tobaccos contains much
higher TSNA levels than the mainstream smoke of bright and oriental
tobacco, whereas the mainstream smoke of bright tobacco contains higher
benzo[a]pyrene levels than other tobacco types (Refs. 33 and 34).
Reconstituted tobacco can produce high levels of carbon monoxide,
nitrogen oxides, and TSNAs during combustion (Ref. 8). Smoke from
cigarettes made from expanded stems is higher in carbon monoxide,
nitrous oxides, formaldehyde, tar, benzo[a]anthracene, and
benzo[a]pyrene than smoke from cigarettes made of puffed tobacco,
expanded tobacco, or freeze-dried tobacco (Ref. 30). Similarly,
addition of sugar or corn syrup to a tobacco product may increase HPHCs
such as formaldehyde and may therefore require additional HPHC
measurements (Ref. 35). Or, if the new tobacco product contains
significantly more guar gum (a binder in rod paper and tobacco blends)
than the predicate product, additional HPHC yields may be required to
be reported because pyrolysis of guar gum may form formaldehyde,
acetaldehyde, acetone, benzene, cresol, and toluene (Refs. 39-41).
    Based on its experience reviewing new tobacco products, FDA has
found significant increases in HPHCs (e.g., TSNAs and polycyclic
aromatic hydrocarbons (PAHs)) in cigarettes due to changes in types of
tobacco when compared to a predicate tobacco product. For all new
cigarettes that have a substantial increase in other types of tobacco,
to support a finding of SE the applicant should include a comparison of
TSNAs and PAHs in the mainstream smoke of the new tobacco product with
that of the predicate tobacco product using both intense and non-
intense smoking regimens. Depending on the specific differences between
the new and predicate products, quantities of additional HPHCs in
mainstream smoke may be required to be reported.
    For a smokeless tobacco product, the HPHC information in an SE
Report would need to include a comparison of the quantities of total
and free nicotine, total TSNAs, NNN, and NNK in the tobacco of the
products. Depending on the specific differences between the new and
predicate products, the applicant may be required to report quantities
of additional HPHCs in the product.
    Proposed Sec.  1107.19(d)(2) would require that the SE Report
include a description and comparison of any other features of the new
and predicate tobacco products.
    Proposed Sec.  1107.19(e) would require stability information for
smokeless tobacco products and any tobacco product that contains
fermented tobacco. As described in more detail in the following
paragraphs, stability information is a particular concern with
smokeless tobacco products and other tobacco products that contain
fermented tobacco because the characteristics of these products can be
affected by the manufacturing process, storage conditions, and length
of time on a shelf. Accordingly, proposed Sec.  1107.19(e) would
require stability information for the new and predicate tobacco
products, including:
     A description of how stability is indicated and whether
stability testing is identical for the predicate and new tobacco
products (proposed Sec.  1107.19(e)(i));
     Any known or expected impacts on product stability due to
differences between the new and predicate products (if there are none,
the SE Report would state that) (proposed Sec.  1107.19(e)(ii)). For
example, for products that contain fermented tobacco, the SE Report
would be required to provide information on the fermentation processing
steps, including the following:

[cir] Composition of the inoculum including species name(s) and
concentration(s)
[cir] pH
[cir] Temperature
[cir] Moisture content
[cir] Water activity
[cir] Duration
[cir] Ingredients added.

    FDA is proposing to require that this information be submitted in
the SE Report because these parameters of the fermentation process can
result in different degrees of change in the chemical constituents of
the tobacco (Refs. 42 and 43) and affect the type and amount of
microorganisms in the final product (Ref. 44), thereby affecting the
stability of the product, which could change the characteristics of the
tobacco product, which may cause the new tobacco product to raise
different questions of public health. In addition, the type and amount
of the fermentation inoculum can be used to control or affect the
fermentation process and thus, can change the product as a result of
directed fermentation, which could cause the new tobacco product to
raise different questions of public health (Ref. 45).
     Detailed stability testing information, including test
protocols, quantitative acceptance criteria, data sets, and a summary
of the results for all stability testing performed (proposed Sec.
1107.19(e)(iii)). Stability testing would be required to be performed
at the beginning (zero time), middle, and end of the expected storage
time for the following chemical and microbial endpoints:

[cir] Microbial content data, including total aerobic microbial count
and total yeast and mold count, along with identification of detected
microbiological organisms by genus and species names (if applicable)
[cir] pH
[cir] Moisture content
[cir] Water activity
[cir] Tobacco-specific nitrosamines (TSNAs, including total, NNN, and
NNK)
[cir] Nitrate and nitrite levels
[cir] Preservatives and microbial metabolic inhibitors, if any
[cir] Method of heat treatment or pasteurization used to reduce
microbial loads.

    The proposed rule would require this information because product
stability is affected by factors such as the fermentation and
stabilization processes (if applicable), addition of chemical additives
to control microbial activity (e.g., preservatives, metabolic
inhibitors, humectants), and water activity (aw) of the
product (Refs. 42, 46-48). Additionally, factors such as nitrate/
nitrite concentrations, moisture content, microbial content, storage
temperature, and pH are reported to influence the microbial stability
and TSNA formation during storage of tobacco products (Refs. 49-53).
     Storage conditions for samples retained for testing,
identifying the test methods used, along with testing of the tobacco
product in the same container closure system as that in which the
tobacco product is intended to be marketed, and testing supporting the
expiration date (proposed Sec.  1107.19(e)(iv)). Accelerated studies,
combined with basic stability information, could be used to support
tentative expiration dates provided full shelf life studies are not yet
available but are being conducted. Where data from accelerated studies
are used to project a tentative expiration date that is beyond a date
supported by actual shelf-life studies, stability studies would need to
be conducted to support the SE

Report, including tobacco product testing at appropriate intervals,
until the tentative expiration date could be verified or the
appropriate expiration date could be determined.
    Proposed Sec.  1107.19(e)(v) and (vi) would require information on
the stability testing laboratory and identification of the
microbiological organisms by genus and species names, where applicable,
along with the culture collection number either used during the
manufacturing process and/or detected through stability testing.
    Proposed Sec.  1107.19(f) would require applicants to state that
the new tobacco product has either: (1) The same characteristics as the
predicate tobacco product and the basis for this determination or (2)
different characteristics than the predicate tobacco product. Where an
applicant states that its new tobacco product has different
characteristics than the predicate tobacco product, the applicant must
also include an explanation as to why a difference in any of the
following characteristics do not cause the new product to raise
different questions of public health: Product design (see Sec.
1107.19(a)); heating source (see Sec.  1107.19(b)); materials and
ingredients (see Sec.  1107.19(c)); and other features (see Sec.
1107.19(d)). In addition, in order to demonstrate that a new tobacco
product with different characteristics is substantially equivalent, an
applicant must also explain why any differences in the manufacturing
process that could affect the characteristics of the new product do not
cause the new product to raise different questions of public health
(see Sec.  1107.18(e)). Similarly, for smokeless tobacco products, an
applicant must explain why any difference in stability between the new
tobacco product and the predicate tobacco product does not raise
different questions of public health (see Sec.  1107.19(e)).
    Proposed Sec.  1107.19(g) would explain that, if the applicant is
comparing the new tobacco product to a predicate product that FDA has
previously found to be substantially equivalent to another product, FDA
may request that the applicant include information related to the
original grandfathered tobacco product. Although an applicant can
support a showing of SE by comparing the new tobacco product to a
tobacco product that is grandfathered 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 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 grandfathered tobacco product
that the new product would actually raise different questions of public
health compared to the originally grandfathered 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
grandfathered tobacco product.
    Because the statute permits applicants to compare to either a
grandfathered tobacco product or one that FDA has previously found SE
(section 905(j)(1)(A)(i)) but also requires FDA to make an SE
determination by comparing the new tobacco product to the grandfathered
tobacco product (section 910(a)(2)(A)(i)(I)), FDA is proposing the
approach in Sec.  1107.19(g). To meet its statutory obligation, FDA may
need to look back to previously submitted SE Reports in the SE chain
that rely on the original grandfathered product in order to issue an SE
order. Manufacturers have been on notice since the passage of the
Tobacco Control Act that FDA must make the comparison between the new
tobacco product and the original grandfathered tobacco product, and in
doing so, may need to rely on previously submitted SE Reports, even if
submitted by a different manufacturer than the applicant at hand.
    Accordingly, for SE Reports that compare the new tobacco product to
a predicate tobacco product that FDA previously found substantially
equivalent, proposed Sec.  1107.19(g) states that, if requested by FDA,
the applicant would be required to provide information related to the
original grandfathered tobacco product, even if the grandfathered
tobacco product is several tobacco products removed from the predicate
identified by the applicant. FDA would request this information 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 grandfathered product as a predicate product to make
this finding. If FDA is unable to look back to data provided to the
Agency regarding the grandfathered product and the applicant does not
provide the information, FDA would be unable to make the finding
required by section 910(a)(2)(A)(i)(I) of the FD&C Act. FDA encourages
applicants to provide this information with the initial SE Report to
support an efficient review of the SE Report, although FDA acknowledges
this may be more difficult if the applicant is not the manufacturer or
owner of the predicate tobacco product. FDA requests specific public
comment on this proposed provision and any challenges it may present.
4. Amendments (Proposed Sec.  1107.20)
    Proposed Sec.  1107.20(a) would permit an applicant to submit an
amendment to an SE Report. Proposed Sec.  1107.20(a) would require any
applicant who chose to submit a health information summary with its SE
Report under proposed Sec.  1107.18(j)(1) to submit with the amendment
a redacted copy of the amendment that excludes research subject
identifiers and trade secret and confidential and commercial
information as defined in Sec. Sec.  20.61 and 20.63 (21 CFR 20.61 and
20.63).
    An applicant may not amend an SE Report to change the predicate
tobacco product (proposed Sec.  1107.20(b)). Because the comparison
between the new and predicate tobacco products is the crux of the
substantial equivalence determination, changing the predicate product
changes the fundamental basis of the analysis. An applicant that
determines that a predicate change is necessary should withdraw the
initial SE Report and resubmit the SE Report with the information
related to the new predicate tobacco product as described in proposed
Sec.  1107.18.
    In addition, under proposed Sec.  1107.20(c), an applicant may not
amend a closed SE Report, e.g., one that FDA has refused to accept,
closed, canceled, or issued an order for under proposed Sec.  1107.44,
or one that has been withdrawn under proposed Sec.  1107.22. Proposed
Sec.  1107.20(d) also explains that FDA would review the additional
information in the next review cycle (proposed Sec.  1107.42 discusses
review cycles). As explained in proposed Sec.  1107.62, SE Reports,
including amendments, would be submitted to CTP's Document Control
Center. Phone calls and emails to FDA staff would not be considered
amendments to an SE Report.
5. Withdrawal by Applicant (Proposed Sec.  1107.22)
    Proposed Sec.  1107.22 would permit an applicant to make a request
to withdraw an SE Report unless FDA has closed the SE Report through an
action in proposed Sec.  1107.44 (all FDA actions in proposed Sec.
1107.44 would close the SE

Report except for a request for additional information in proposed
Sec.  1107.44(b)). FDA has determined that withdrawal of an SE Report
would benefit both the Agency and the applicant by potentially saving
time and resources if the original SE Report might otherwise be
insufficient or marketing authorization is no longer desired. The
withdrawal request would state: (1) If the withdrawal is due to a
health or safety concern related to the tobacco product; (2) the STN;
and (3) the name of the new tobacco product that is the subject of the
SE Report. This information would assist FDA in correctly identifying
the SE Report to be withdrawn and also help inform FDA as to whether
there were any concerns under section 909 of the FD&C Act (e.g.,
relating to serious unexpected adverse experiences). Under proposed
Sec.  1107.22(b), an SE Report would be considered withdrawn when FDA
issues a notice stating the SE Report has been withdrawn (see also
proposed Sec.  1107.40(e)).
    The SE Report is an Agency record even if withdrawn. Thus, under
proposed Sec.  1107.22(c), FDA would retain the withdrawn SE Report
consistent with Agency record retention schedules and policies and,
under the Agency's public information regulations in part 20, would
provide a copy to the applicant upon request subject to Sec.  20.45. If
the withdrawal request is made at the final review stage and FDA has
identified unresolved deficiencies in the SE Report, FDA may provide a
list of deficiencies in the communication that the Agency sends to the
applicant acknowledging withdrawal. Under proposed Sec.  1107.40(e), an
SE Report would be considered withdrawn when FDA issues a notice
stating that it is withdrawn.
6. Change in Ownership of an SE Report (Proposed Sec.  1107.24)
    Proposed Sec.  1107.24 would reflect that transfers in ownership of
SE Reports occur. This proposed section is intended to facilitate
transfers of ownership and help ensure that FDA has current information
regarding the ownership of an SE Report. Proposed Sec.  1107.24 applies
to both pending SE Reports and SE Reports that are the subject of an SE
order. Under proposed Sec.  1107.24, at the time of the transfer, the
new and former applicants (or owners) of the SE Report would be
required to submit certain information to the Agency. First, the former
applicant would be required to submit a notice to FDA identifying the
new applicant and stating that all of the former applicant's rights and
responsibilities relating to the SE Report have been transferred to the
new applicant. Second, the new applicant would be required to submit a
signed notice to FDA containing the following information:
     To the extent applicable, the new applicant's commitment
to agreements, promises, and conditions made by the former applicant
and contained in the SE Report (e.g., this could be an agreement by the
new applicant to conduct studies the former applicant had agreed to
conduct in support of a request for an extension of time to respond to
a deficiency);
     The date that the change in ownership is effective;
     Either a statement that the new applicant has a complete
copy of the SE Report that FDA determined was substantially equivalent
(including any amendments, or any records required to be kept under
proposed Sec.  1107.58); or a statement of intent to request a copy of
the SE Report under the Freedom of Information Act (FDA's implementing
regulations are in part 20); and
     A certification that no modifications have been made to
the new tobacco product since the SE Report was submitted to FDA.
    Although FDA expects that the new applicant would have a copy of
the SE Report from the former applicant, if the new applicant requests
a copy of the SE Report from FDA, FDA would provide a copy to the new
applicant, subject to the Freedom of Information Act requirements as
implemented by FDA at part 20 and under the fee schedule in Sec.
20.45.
    The new applicant also would be required to make available all
required records upon inspection by FDA (proposed Sec.  1107.58 would
impose a recordkeeping requirement). The information required to be
made available for inspection would include raw data and other
information necessary to substantiate the SE Report.

C. FDA Review (Proposed Subpart D)

1. Communications Between FDA and Applicants (Proposed Sec.  1107.40)
    Proposed Sec.  1107.40 would establish general principles and
provide clarity regarding communications between FDA and applicants
during review of an SE Report. Proposed Sec.  1107.40(a) explains that,
during the course of FDA's review of an SE Report, FDA may seek to
communicate with applicants about relevant matters, including
scientific and procedural issues that arise during the review process.
Communications regarding medical issues may arise if adverse events
reports exist for the tobacco product. FDA may use a variety of methods
to communicate with applicants, such as telephone conversations,
letters, or emails, depending on the circumstances and issues. FDA
would document any communications regarding an SE Report in accordance
with 21 CFR 10.65.
    Proposed Sec.  1107.40(b) would provide that applicants and
representatives of the Agency may have meetings to discuss scientific
and other issues. Applicants interested in requesting meetings would
direct their requests to the Office of Science through the Document
Control Center. For further information, applicants may review 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). As discussed in this
guidance, FDA does not intend to grant meetings in most circumstances
to discuss an applicant's questions related to a pending SE Report
because the timing is frequently inappropriate (e.g., premature or
late, depending on stage of review) and such meetings are generally an
inefficient or duplicative use of resources. For example, the applicant
may be seeking substantive information while FDA's review is underway
but before FDA has issued a deficiency letter or other response. Please
note that each SE Report has a specific CTP contact to whom an
applicant may ask clarifying questions, which helps ensure faster and
more direct responses. FDA specifically requests public comment on the
proposed decision to not grant meetings to discuss an applicant's
questions related to a pending SE Report. Specifically, FDA seeks to
understand if there are reasons why such meetings may be necessary for
an applicant to respond to a deficiency letter or if the absence of
such meetings present obstacles to the applicant in responding to
deficiency letters.
    Proposed Sec.  1107.40(c) would provide that, upon receipt of an SE
Report under proposed Sec.  1107.18, FDA would either refuse to accept
the SE Report or issue an acknowledgement letter. FDA requests comment
on what a reasonable period of time would be within which such refusal
to accept or acknowledgement of receipt letters should be issued.
    Proposed Sec.  1107.40(d) addresses FDA's notification of
deficiencies in an SE Report submitted under proposed Sec.  1107.18.
FDA reviewers would make reasonable efforts to communicate to
applicants the procedural, administrative, or scientific deficiencies
found in an SE Report and, if appropriate, the data needed to enable

the Agency's review. For example, a reviewer might inform the applicant
that a signature is needed for a certification, that provided test
results have last values cutoff or appear to have a typographical
error, or that the SE Report is missing a reference for support. This
communication is intended to give applicants an opportunity to correct
deficiencies in the SE Report and to submit an amendment if needed.
    Proposed Sec.  1107.40(e) explains that an SE Report would be
considered withdrawn when FDA issues a notice stating that it is
withdrawn, which would ensure that FDA has received the withdrawal
notification and that both FDA and the applicant now consider the SE
Report as withdrawn.
    FDA invites public comments on the following topics related to
reasonable time periods to respond to a deficiency letter:
     Appropriate timelines for responding to a deficiency
letter identifying missing information that is described in the final
rule;
     Appropriate timelines for responding to a deficiency
letter identifying missing information that requests additional
information not described in the final rule;
     When requests for extensions of time to respond to a
deficiency letter should be granted, and
     Whether or not deadlines to respond to deficiency letters
should be tailored to the relative burden of the request.
2. Review Cycles (Proposed Sec.  1107.42)
    Proposed Sec.  1107.42(a) would set forth the timeframe for FDA's
initial review cycle. The ``initial review cycle'' would consist of the
90 calendar days following: (1) FDA's receipt of the SE Report and
determination that a predicate product is grandfathered (for SE Reports
that claim the predicate product was commercially marketed in the
United States as of February 15, 2007, and FDA has not already
determined the tobacco product is grandfathered) or (2) FDA's receipt
of an SE Report (for SE Reports that contain a predicate product that
was previously found substantially equivalent or for which FDA has
previously determined that the predicate product is grandfathered). As
described in more detail in proposed Sec.  1107.44, FDA intends to
review the SE Report and communicate with the applicant or take an
action on an SE Report during this time period. At any time before FDA
issues an order on the SE Report, the applicant would be allowed to
withdraw it under proposed Sec.  1107.22.
    Proposed Sec.  1107.42(b) would provide for the use of additional
review cycles to complete FDA's review of an SE Report. If FDA issues a
deficiency letter for an SE Report under proposed Sec.  1107.40(d), FDA
would stop reviewing the SE Report until it received a response to the
notification of deficiencies (or deficiency letter) or the timeframe
specified in the letter has elapsed. If the applicant fails to provide
a response within the time period provided, FDA would issue an order
denying marketing authorization for the new tobacco product under the
criteria set forth in Sec.  1107.48. If the applicant provides a
response within the allotted timeframe, but FDA identifies the need for
additional information as a result of this response, FDA could issue an
additional deficiency notification. Each response would begin a new 90
calendar day review cycle for FDA to review the response.
    FDA's intent is to complete review of an SE Report submitted under
proposed 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. If fewer review cycles
are needed, FDA intends to decide in a shorter time period. Section
1107.40 would not obligate FDA to notify applicants of deficiencies in
all circumstances before taking an action on an SE Report per proposed
Sec.  1107.44 or proposed Sec.  1107.48. In any case where the SE
Report has significant deficiencies, FDA might issue an order denying
marketing authorization without providing additional opportunities to
provide the missing information. Examples of significant deficiencies
include when an SE Report provides no scientific evidence to
substantiate a statement from the applicant that the new tobacco
product does not raise different questions of public health or when an
SE Report has multiple deficiencies but the applicant does not provide
responses to all of the deficiencies. FDA requests public comment on
whether FDA should provide specific timeframes within which applicants
would need to respond to deficiency letters, along with an explanation
as to why the proposed timeframes may be suitable for addressing the
concerns commonly cited in the letters and why.
    Proposed Sec.  1107.42(c) states that, in the event that an
applicant's response to FDA's deficiency notification(s) does not
provide adequate information or the applicant provides information but
the SE Report remains deficient, FDA intends to issue an order denying
market authorization under the criteria set forth in proposed Sec.
1107.48. The applicant also could make a written request to withdraw
the SE Report under proposed Sec.  1107.22 at any time before FDA
issues an order regarding the SE Report.
3. FDA Action on an SE Report (Proposed Sec.  1107.44)
    Proposed Sec.  1107.44 lists six actions FDA may take after
completing review of an SE Report:
     First, FDA could refuse to accept the SE Report and not
begin substantive scientific review if the SE Report does not comply
with the requirements of proposed Sec.  1107.18 (this action would stop
the review clock and end the review cycle). For example, FDA could
refuse to accept an SE Report that was not written in English as
required under Sec.  1107.18(b), or did not provide the information on
product composition as required under Sec.  1107.19(c)(1). Or, FDA
could advise the applicant that the SE Report is not appropriate under
chapter IX of the FD&C Act because the product does not meet the
definition of a tobacco product under section 201(rr) of the FD&C Act.
     Second, FDA could request additional information as
provided in proposed Sec.  1107.40(d).
     Third, FDA could issue a letter closing the SE Report if
it not possible to make a determination on an SE Report (sometimes
referred to as an administrative closure, for example, which we might
do when there is no way to determine if a new product is SE or NSE and
additional information is unavailable);
     Fourth, FDA could issue a letter canceling the SE Report
if FDA finds it mistakenly acknowledged the SE Report, e.g., the SE
Report does not pertain to a new tobacco product;
     Fifth, FDA could issue an order finding the new tobacco
product to be substantially equivalent and in compliance with the
requirements of the FD&C Act under proposed Sec.  1107.46.
     Sixth, FDA could issue an order denying marketing
authorization under proposed Sec.  1107.48 (NSE order) because:
    [cir] The applicant has failed to provide the information needed
for FDA to find that the new tobacco product is substantially
equivalent to a tobacco product that was commercially marketed in the
United States on February 15, 2007;
    [cir] The new tobacco product is not substantially equivalent to a
tobacco product that was commercially marketed in the United States on
February 15, 2007; or

    [cir] The new tobacco product is not in compliance with the
requirements of the FD&C Act. For example, a new tobacco product is not
in compliance with the requirements of the FD&C Act if the manufacturer
of such product is in arrears with respect to its user fees; therefore,
FDA would issue an NSE order.
4. Issuance of an Order Finding a New Tobacco Product Substantially
Equivalent (Proposed Sec.  1107.46)
    Proposed Sec.  1107.46 would explain that if, after review, FDA
determines that the new tobacco product is substantially equivalent to
a predicate tobacco product that was commercially marketed in the
United States on February 15, 2007, and in compliance with the FD&C
Act, the Agency would send the applicant an order authorizing the
marketing of the product. The marketing authorization would be
effective on the date the order is issued, which would typically be
noted on the first page of the order.
5. Issuance of an Order Denying Marketing Authorization (Proposed Sec.
1107.48)
    Proposed Sec.  1107.48(a) would provide that, in general, if FDA:
(1) Is unable to determine that the new tobacco product is
substantially equivalent to a predicate tobacco product that was
commercially marketed in the United States on February 15, 2007, or (2)
determines that the new tobacco product is not in compliance with the
FD&C Act, the Agency would issue an NSE order indicating that the
manufacturer cannot market the new tobacco product. FDA would
communicate this decision to the applicant in writing. Proposed Sec.
1107.48(b) provides that the NSE order would describe the basis for
denying marketing authorization. FDA intends to describe any
deficiencies that FDA has identified in an SE Report.
6. Rescission of Order (Proposed Sec.  1107.50)
    Proposed Sec.  1107.50 would provide the procedural mechanism for
FDA to rescind an SE order and describes the grounds for when an SE
order may be rescinded. FDA intends to exercise this authority in a
judicious and timely way in specific circumstances. FDA is proposing
this provision based on our authority to issue an order only when it
can make the findings provided in section 910(a)(2)(A)(i) of the FD&C
Act and our authority to promulgate regulations for the efficient
enforcement of the FD&C Act (section 701 of the FD&C Act). FDA's
inherent authority to timely revisit and reconsider prior decisions is
also supported by case law, with the inherent authority for timely
administrative reconsideration premised on the notion that the ``
`power to reconsider is inherent in the power to decide.' '' See Ivy
Sports Med. LLC, v. Burwell, 767 F.3d 81, 86 (D.C. Cir. 2014) (quoting
Albertson v. FCC, 182 F.2d 397, 399 (D.C. Cir. 1950)). Where, as here,
nothing in the Tobacco Control Act suggests that Congress intended to
displace this inherent authority in the context of SE determinations,
FDA may rescind an SE order based on its inherent authority. If, after
issuing an SE order, FDA later determines, for example, that the order
was based on false information or there was an error in information
upon which the SE order is based, FDA would rescind the SE order. This
proposed section would provide that--
     First, FDA may rescind an SE order if, after an order has
issued, FDA becomes aware that the tobacco product for which the order
has been issued:
    [cir] Does not have the same characteristics as the predicate
tobacco product or
    [cir] has different characteristics and there is insufficient
information demonstrating that it was not appropriate to require a
premarket tobacco product application under section 910(b) of the FD&C
Act because the product does not raise different questions of public
health.
     Second, FDA may rescind an SE order if, after an order has
issued, FDA becomes aware that the SE Report (including any submitted
amendments) contains an untrue statement of material fact.
     Third, FDA may rescind an SE order if the SE Report
compared the new tobacco product to a tobacco product that FDA
previously found substantially equivalent, and the predicate tobacco
product relied on in the SE Report has been found ineligible because
its SE Report (including any submitted amendments) contains an untrue
statement of material fact, and/or a predicate product on which any of
the previous substantial equivalence determinations was based, going
back to the original grandfathered product, has been found ineligible
because its SE Report (including any amendments) contained an untrue
statement of material fact.
     Fourth, FDA may rescind an SE order if FDA or the
applicant has removed from the market due to a health or safety concern
related to the tobacco product:
    [cir] The predicate product on which the substantial equivalence
determination is based and/or
    [cir] a predicate product on which any of the previous substantial
equivalence determinations is based, going back to the original
grandfathered product, if the SE Report compared the new tobacco
product to a tobacco product that FDA previously found substantially
equivalent. FDA may rescind in this scenario because the new tobacco
product is SE to, or is in the same generational line as a predicate
tobacco product with safety issues, and, therefore, may present similar
safety concerns.
    Proposed Sec.  1107.50(b) states that, generally, FDA would rescind
an SE order only after it has provided notice to the applicant and an
opportunity for a hearing under part 16. FDA is proposing to amend
Sec.  16.1 to add a reference Sec.  1107.50. FDA encourages applicants
to bring errors to the Agency's attention that may necessitate
rescission, and FDA intends to work with applicants in such scenarios.
    In addition, FDA may need to rescind an order without providing
notice and a prior opportunity for a hearing if FDA finds that the
continued marketing of the tobacco product presents a serious risk to
public health, e.g., if the applicant represented that the new tobacco
product conformed to a tobacco product standard, but FDA later
determined that the new tobacco product did not conform to a tobacco
product standard in a way that presents a serious risk to public
health. Another example would be if FDA identifies data integrity
issues during an inspection that would lead FDA to believe that the
tobacco product presents a serious risk to public health. In these
cases, FDA would provide the applicant an opportunity for a hearing as
soon as possible after the rescission.

D. Miscellaneous (Proposed Subpart E)

    Subpart E describes other procedures and requirements related to SE
Reports, including record retention, electronic submission
requirements, foreign data, and confidentiality considerations.
1. Record Retention (Proposed Sec.  1107.58)
    Consistent with the authority to require recordkeeping under
section 909 of the FD&C Act, proposed Sec.  1107.58, would require
applicants receiving an order under proposed Sec.  1107.46 authorizing
the marketing of a new tobacco product to maintain all records
supporting that SE Report for at least 4 years from the date of the
order even if such product is discontinued. FDA has selected 4 years as
a means to help ensure that the records would be available for at least
one biennial FDA

inspection under section 704 and 905(g) of the FD&C Act. The records
would be required to be legible, written in English or an English
translation provided, and available for inspection and copying by
officers or employees designated by the Secretary of Health and Human
Services. Applicants that have stopped marketing a tobacco product may
want to retain the records for a longer period, if the product might be
reintroduced in order to avoid the time and expense of having to
generate the information again.
2. Confidentiality (Proposed Sec.  1107.60)
    Proposed Sec.  1107.60(a) states that FDA would determine the
public availability of any part of any SE Report and other content
related to an SE Report as provided under this proposed section and
part 20 (Public Information). The Freedom of Information Act (FOIA) (5
U.S.C. 552), as well as certain provisions of the FD&C Act, e.g.,
section 301(j) (21 U.S.C. 331(j)) and section 906(c) (21 U.S.C.
387f(c)), govern the disclosure of the existence of a pending SE Report
and the information contained in such an SE Report. Under FOIA, the
public has broad access to government documents. However, FOIA provides
certain exemptions from mandatory public disclosure. One such
provision, 5 U.S.C. 552(b)(4), exempts records that are ``trade secrets
and commercial or financial information obtained from a person and
privileged or confidential'' from the requirement of mandatory
disclosure. Part 20 of FDA's regulations sets forth FDA's general
regulations concerning public availability of FDA records.
    Like with drugs and devices, the intent to market a tobacco product
is often considered confidential commercial information, as premature
disclosure could result in a competitive advantage to competitors.
Therefore, FDA is proposing Sec.  1107.60(b)(1), which would address
the confidentiality of an SE Report prior to the issuance of an order
under either proposed Sec.  1107.46 or proposed Sec.  1107.48. Under
the proposed regulation and consistent with part 20, FDA would not
publicly disclose the existence of an SE Report unless the applicant
has publicly disclosed or acknowledged the existence (as such
disclosure is defined in Sec.  20.81), or has authorized FDA in writing
to publicly disclose or acknowledge, that the applicant has submitted
the SE Report to FDA.
    Proposed Sec.  1107.60(b)(2) provides that FDA would not disclose
the existence or contents of an FDA communication with an applicant
regarding its SE Report except to the extent that the applicant has
publicly disclosed or acknowledged, or authorized FDA in writing to
publicly disclose or acknowledge, the existence of or contents of that
particular FDA communication. Proposed Sec.  1107.60(b)(3) provides
that FDA would not disclose information contained in an SE Report
unless the applicant has publicly disclosed or acknowledged, or
authorized FDA in writing to publicly disclose or acknowledge, that
particular information. If the applicant has publicly disclosed or
acknowledged, or authorized FDA in writing to publicly disclose or
acknowledge, that particular information contained in an SE Report, FDA
may disclose that particular information.
    Proposed Sec.  1107.60(c) would address the disclosure of data and
information after an order is issued under proposed Sec.  1107.46. This
proposed section would provide that, after an order under Sec.  1107.46
(finding a new tobacco product substantially equivalent), FDA would
make the following information related to the SE Report and order
available for public disclosure upon request or at FDA's own
initiative, including information from amendments to the SE Report and
FDA's reviews of the SE Report: (1) All data previously disclosed to
the public, as such disclosure is defined in Sec.  20.81; (2) any
protocol for a test or study, except to the extent it is shown to fall
within the exemption established for trade secrets and confidential
commercial information in Sec.  20.61; (3) information and data
submitted to demonstrate that the new tobacco product does not raise
different questions of public health, except to the extent it is shown
to fall within the exemptions established in Sec.  20.61 for trade
secrets and confidential commercial information, or in Sec.  20.63 for
personal privacy; (4) correspondence between FDA and the applicant,
including any requests FDA made for additional information and
responses to such requests, and all written summaries of oral
discussions between FDA and the applicant, except to the extent it is
shown to fall within the exemptions in Sec.  20.61 for trade secrets
and confidential commercial information, or in Sec.  20.63 for personal
privacy; and (5) the environmental assessment or, if applicable, the
claim of categorical exclusion from the requirement to submit an
environmental assessment under part 25 of this chapter.
    Even after issuance of an order under Sec.  1107.48 (Denying
marketing authorization), the applicant's intent to market may still
constitute confidential commercial information, as the applicant may
still be planning to market the new tobacco product that is the subject
of the SE Report (e.g., by submitting a new SE Report, a PMTA, or a
request for exemption from substantial equivalence, or by seeking
further review of the denial). Therefore, proposed Sec.  1107.60(d)
addresses the disclosure of data and information after FDA issues an
order under Sec.  1107.48 (Denying marketing authorization). Under this
proposed subsection, FDA may make certain information related to the SE
Report and the order available for public disclosure upon request or at
FDA's own initiative except to the extent the information is otherwise
exempt from disclosure under part 20. Information FDA may disclose
includes the tobacco product category (e.g., cigarette), tobacco
product subcategory (e.g., filtered), package size, and the basis for
the order denying marketing authorization.
    Proposed Sec.  1107.60(e) addresses disclosure of the health
information summary or statement and would provide that health
information required by section 910(a)(4) of the FD&C Act, if submitted
as part of the SE Report (which includes any amendments), would be
disclosed within 30 calendar days of issuing a substantially equivalent
order. If the applicant has instead submitted a 910(a)(4) statement as
provided in Sec.  1107.18(j)(2), FDA would make publicly available on
FDA's website the responsible official to whom a request for health
information may be made. FDA intends to include this information on our
website to ensure that the information is easily accessible to
requestors.
3. Electronic Submission (Proposed Sec.  1107.62)
    Based on our authority in section 905 of the FD&C Act to prescribe
the format of SE Reports, proposed Sec.  1107.62(a) and (b) would
require the applicant to submit the SE Report and supporting and other
related documents in an electronic format that FDA can process, read,
review, and archive unless a waiver from this requirement is requested
by the applicant and FDA grants the waiver. Reasons that an applicant
might request a waiver would include that the applicant has no access
to email or a computer. Under proposed Sec.  1107.62(c), an applicant
that has a waiver would submit a paper submission to the address that
FDA provides in the letter granting the waiver. FDA is proposing Sec.
1107.62 based on FDA's general experiences with electronic submission,
which FDA

has found helps facilitate premarket reviews because electronic
submission typically has enabled FDA to receive, open, and read a
submission more quickly than a submission submitted on paper through
postal mail. If this rule is finalized, FDA intends to provide
information on submitting information in an electronic format that FDA
can process, read, review and archive (e.g., method of transmission,
media, file formats, preparation, organization of files, accompanying
metadata) (https://www.fda.gov/TobaccoProducts/default.htm). FDA
intends to update this information as needed (e.g., to accommodate
changes in technology).

IV. Other Issues for Consideration

    In addition to comments and information on the proposed
requirements described in section III, FDA is also seeking comments and
information 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. Under such an
approach, FDA would 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. FDA is soliciting 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.

V. Paperwork Reduction Act of 1995

    This proposed 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. 3501-3520). A
description of these provisions is given in the Description section of
this document with an estimate of the annual reporting and
recordkeeping. 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.
    FDA invites comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    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.
    This proposed rule would establish requirements for the content and
format of substantial equivalence (SE) Reports (proposed Sec. Sec.
1107.18 and 1107.19). Most of the proposed requirements would mirror
current practices and recommendations related to the submission of SE
Reports, including information related to part 25 (environmental
considerations), but the rule would provide both applicants and FDA
more certainty regarding the content and format 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 proposed rule would continue to
permit amendments for SE Reports submitted under proposed Sec.
1107.18, e.g., to address deficiencies (proposed Sec.  1107.20). Also
in accordance with current practice, the proposed rule would continue
to permit withdrawals (proposed Sec.  1107.22) of pending SE Reports.
The proposed rule would also propose requirements for when the
ownership of an SE Report changes to ensure that FDA has information
related to the current applicant (proposed Sec.  1107.24).
    The proposed rule would establish a recordkeeping requirement,
under which applicants would be 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 (proposed Sec.  1107.58).
    The proposed rule would require 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 (proposed 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.
    Description of Respondents: Manufacturers of tobacco products who
submit SE Reports.

Existing Burden OMB Control Number 0910-0673

                                 Table 9--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and                  410               1             410             300         123,000
 910(a).........................
Full SE 905(j)(1)(A)(i) and                  250               1             250              90          22,500
 910(a) Bundled.................
Product Quantity Change SE                   264               1             264              87          22,968
 Report.........................
Product Quantity Change Bundled               55               1              55              62           3,410
 SE Report......................
                                 -------------------------------------------------------------------------------
    Totals......................  ..............  ..............  ..............  ..............         171,878
----------------------------------------------------------------------------------------------------------------
\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.

Reporting Burden Updated Estimates

                                 Table 10--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours