--Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/
                                                                 ml, 0.4 mg/ml, 1%, 2.0 mg/bottle).
                                                                --PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) E-Cigarette, Closed  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 e-cigarette, 5 e-
                                                                 cigarettes).
                                                                --Length (e.g., 100.0 mm, 120.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.0 mm).
                                                                --Wattage (e.g., 100 watts [W], 200 W).
                                                                --Battery capacity (e.g., 100 milliampere hours
                                                                 [mAh], 200 mAh).
                                                                --E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1
                                                                 ml).
                                                                --Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/
                                                                 ml, 0.4 mg/ml, 1%, 0.2 mg/e-cigarette).
                                                                --PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
                                       (4) E-Cigarette, Open..  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 e-cigarette, 5 e-
                                                                 cigarettes).
                                                                --Length (e.g., 100.0 mm, 120.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.0 mm).
                                                                --E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1
                                                                 ml).
                                                                --Wattage (e.g., 100 W, 200 W).
                                                                --Battery capacity (e.g., 100 mAh, 200 mAh).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) ENDS Component.....  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g.,1 coil).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry, wintergreen).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (6) ENDS Other.........  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 e-cigarette, 5
                                                                 bottles).
                                                                --Characterizing flavor(s) (e.g., none, cherry,
                                                                 wintergreen, tobacco, menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
(E) Cigars...........................  (1) Cigar, Filtered      --Package type (e.g., hard pack, soft pack, clam
                                        Sheet-Wrapped.           shell).
                                                                --Product quantity (e.g., 20 filtered cigars, 25
                                                                 filtered cigars).
                                                                --Length (e.g., 89.1 mm, 100.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 0%, 10.0%, 25.0%).
                                                                --Characterizing flavor (e.g., none, menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Cigar, Unfiltered    --Package type (e.g., box, film sleeve).
                                        Sheet-Wrapped.
                                                                --Product quantity (e.g., 1 cigar, 5
                                                                 cigarillos).
                                                                --Length (e.g., 100.1 mm, 140.0 mm).
                                                                --Diameter (e.g., 8.0 mm, 10.1 mm).
                                                                --Tip (e.g., none, wood tips, plastic tips).
                                                                --Characterizing flavor (e.g., none, menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Cigar, Unfiltered    --Package type (e.g., box, film, sleeve, none).
                                        Leaf-Wrapped.
                                                                --Product quantity (e.g., 1 cigar, 5 cigars).
                                                                --Length (e.g., 150.1 mm, 200.0 mm).
                                                                --Diameter (e.g., 8.0 mm, 10.1 mm).
                                                                --Wrapper material (e.g., burley tobacco leaf,
                                                                 Connecticut shade grown tobacco leaf).
                                                                --Characterizing flavor (e.g., none, whiskey).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).

                                       (4) Cigar Component....  --Package type (e.g., box, booklet).
                                                                --Product quantity (e.g., 10 wrappers, 20
                                                                 leaves).
                                                                --Characterizing flavor (e.g., none, menthol,
                                                                 cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Cigar Tobacco        --Package type (e.g., bag, pouch).
                                        Filler.
                                                                --Product quantity (e.g., 20.0 g, 16.1 oz.).
                                                                --Characterizing flavor (e.g., none, menthol,
                                                                 cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (6) Other..............  --Package type (e.g., box, booklet).
                                                                --Product quantity (e.g., 1 cigar, 5 cigars, 20
                                                                 leaves, 16 g).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
(F) Pipe Tobacco Products............  (1) Pipe...............  --Package type (e.g., box, none).
                                                                --Product quantity (e.g., 1 pipe).
                                                                --Length (e.g., 200.0 mm, 300.1 mm).
                                                                --Diameter (e.g., 25.1 mm).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cavendish, cherry).
                                                                 --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Pipe Tobacco Filler  --Package type (e.g., bag, none).
                                                                --Product quantity (e.g., 20.0 g, 16.1 oz).
                                                                --Tobacco cut style (e.g., standard cut, such as
                                                                 shag cut, bugler cut, loose cut, etc., or a
                                                                 pressed cut, such as flake, cube cut, roll
                                                                 cake, etc., or a mixture).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cavendish, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Pipe Component.....  --Package type (e.g., box, bag, none).
                                                                --Product quantity (e.g., 1 bowl, 1 stem, 100
                                                                 filters).
                                                                --Characterizing flavor(s) (e.g., none, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) Other..............  --Package type (e.g., bag, box, none).
                                                                --Product quantity (e.g., 1 pipe, 1 bowl, 1
                                                                 stem, 100 filters).
                                                                --Characterizing flavor(s) (e.g., none, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product.
(G) Waterpipe Tobacco Products.......  (1) Waterpipe..........  --Package type (e.g., box, none).
                                                                --Product quantity (e.g., 1 waterpipe).
                                                                --Height (e.g., 200.0 mm, 500.1 mm).
                                                                --Width (e.g., 100.1 mm, 300.0 mm).
                                                                --Diameter (e.g., 100.1 mm, 300.0 mm)--Number of
                                                                 hoses (e.g., 1, 2, 4).
                                                                --Characterizing flavor(s) (e.g., none).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Waterpipe Tobacco    --Package type (e.g., bag, pouch).
                                        Filler.
                                                                --Product quantity (e.g., 20.0 g, 16.1 oz.).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, apple).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) Waterpipe Heat       --Package type (e.g., box, film sleeve, bag,
                                        Source.                  none).
                                                                --Product quantity (e.g., 150.0 g, 680.0 g).
                                                                --Portion count (e.g., 20 fingers, 10 discs, 1
                                                                 base).
                                                                --Portion mass (e.g., 15.0 g/finger, 10.0g/
                                                                 brick).
                                                                --Portion length (e.g., 40.0 mm, 100.0 mm).
                                                                --Portion width (e.g., 10.0 mm, 40.0 mm).
                                                                --Portion thickness (e.g., 10.0 mm, 40.0 mm).
                                                                --Source of energy (e.g., charcoal, battery,
                                                                 electrical).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 apple).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) Waterpipe Component  --Package type (e.g., bag, box, none).
                                                                --Product quantity (e.g., 1 base, 1 bowl, 1
                                                                 hose, 10 mouthpieces).
                                                                --Characterizing flavor(s) (e.g., none, menthol,
                                                                 cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Waterpipe Other....  --Package type (e.g., bag, box, none).
                                                                --Product quantity (e.g., 1 base, 1 bowl, 1
                                                                 hose, 10 mouthpieces).
                                                                --Characterizing flavor(s) (e.g., none, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
(H) Heated Tobacco Products (HTP)....  (1) Closed HTP.........  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 device, 1 HTP).
                                                                --Length (e.g., 100.0 mm, 120.0 mm).

                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Wattage (e.g., 100 W, 200 W).
                                                                --Battery capacity (e.g., 100 mAh, 200 mAh).
                                                                --Characterizing flavor(s) (e.g., none).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (2) Open HTP...........  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 device, 1 HTP).
                                                                --Length (e.g., 100.0 mm, 120.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Wattage (e.g., 100 W, 200 W).
                                                                --Battery capacity (e.g., 100 mAh, 200 mAh).
                                                                --Characterizing flavor(s) (e.g., none).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (3) HTP Consumable.....  --Package type (e.g., hard pack, soft pack,
                                                                 plastic clamshell).
                                                                --Product quantity (e.g., 20 sticks, 25
                                                                 cartridges).
                                                                --Length (e.g., 60.0 mm, 82.0 mm).
                                                                --Diameter (e.g., 6.0 mm, 8.1 mm).
                                                                --Ventilation (e.g., none, 10.0%, 25.0%).
                                                                --Characterizing flavor(s) (e.g., none,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (4) HTP Component......  --Package type (e.g., box, none, plastic
                                                                 clamshell).
                                                                --Product quantity (e.g., 1 mouthpiece, 1
                                                                 spacer).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
                                       (5) Other..............  --Package type (e.g., box, bag, plastic
                                                                 clamshell, none).
                                                                --Product quantity (e.g., 1 base, 5 capsules).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
(I) Other............................  (1) Other..............  --Package type (e.g., box, bag, plastic
                                                                 clamshell, none).
                                                                --Product quantity (e.g., 1 base, 5 capsules).
                                                                --Characterizing flavor(s) (e.g., none, tobacco,
                                                                 menthol, cherry).
                                                                --Additional properties needed to uniquely
                                                                 identify the tobacco product (if applicable).
----------------------------------------------------------------------------------------------------------------

    (4) The type of PMTA (i.e., PMTA, supplemental PMTA, or
resubmission);
    (5) Whether the applicant requests that FDA refer the PMTA to the
Tobacco Products Scientific Advisory Committee (TPSAC);
    (6) Identifying information regarding any prior submissions
regarding the tobacco product (e.g., submissions related to
investigational tobacco products, substantial equivalence reports,
PMTAs), including submission tracking numbers (STNs) where applicable;
    (7) Dates and purpose of any prior meetings with FDA regarding the
new tobacco product;
    (8) If applicable, the dates when the tobacco product was
commercially marketed in the United States;
    (9) Address and the Facility Establishment Identifier (FEI)
number(s), if available, of the establishment(s) involved in the
manufacture of the new tobacco product;
    (10) A brief statement regarding how the PMTA satisfies the content
requirements of section 910(b)(1) of the Federal Food, Drug, and
Cosmetic Act;
    (11) A brief description of how marketing of the new tobacco
product would be appropriate for the protection of the public health;
and
    (12) A list identifying all enclosures, labels, and labeling being
submitted with the application.
    (d) Descriptive information. The application must contain
descriptive information in this section that outlines the major aspects
of the new tobacco product, including the following items:
    (1) A concise description of the new tobacco product;
    (2) A statement identifying all tobacco product standards issued
under section 907 of the Federal Food, Drug, and Cosmetic Act that are
applicable to the new tobacco product and a brief description of how
the new tobacco product fully meets any identified tobacco product
standard, or if the new tobacco product deviates from a product
standard, if applicable, the application must include adequate
information to identify and justify those deviations;
    (3) The name(s) of the product as designated on the product's
label;
    (4) A description of problems that were identified in prototypes
that are the subject of studies in the application and previous or
similar versions of the new tobacco product that were marketed, if any.
If there are previous or similar versions that are the subject of
studies in the application or were marketed, the application must
contain a bibliography of all reports regarding the previous or similar
version of the product, whether adverse or supportive; and
    (5) Any restrictions on the sale, distribution, advertising, or
promotion of the new tobacco product that the applicant proposes to be
included as part of a marketing granted order under section
910(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act to help
support a showing that the marketing of the product is appropriate for
the protection of the public health. If there are no proposed
restrictions, the application must contain a statement to that effect.
    (e) Samples of new tobacco products. After FDA accepts a PMTA for
review, it may require the submission of samples of the new tobacco
product, including its components and parts. If required, the applicant
must submit samples of the finished tobacco product or its components
or parts in accordance with instructions provided by FDA. FDA may also
require the submission of additional samples to further aid in its
review.
    (f) Labeling and description of marketing plans--(1) Labeling. The
application must contain specimens of

all proposed labeling for the new tobacco product, including labels,
inserts, onserts, instructions, and other accompanying information. The
specimens of labeling must include all panels, reflect the actual size
and color proposed to be used for the tobacco product, and include any
warning label statements and other information required by regulation
or statute, as applicable.
    (2) Description of Marketing Plans. A PMTA must contain a
description of the applicant's plans to market the new tobacco product,
for at least the first year the product would be marketed after
receiving a marketing granted order, in way that is both consistent
with the applicant's discussion of the increased or decreased
likelihood of changes in tobacco product use behavior, including
switching, initiation, cessation, and polyuse, under Sec.  1114.7(l),
and permits FDA to determine permitting the new tobacco product to be
marketed would be appropriate for the protection of public health. The
description must include actions to market the product that would be
taken by the applicant, on behalf of the applicant, or at the
applicant's direction, and also discuss any restrictions on the sales
and distribution the applicant proposes to be included in a marketing
order under section 910(c)(1)(B) of the Federal Food Drug and Cosmetic
Act. The description of marketing plans must contain, at minimum:
    (i) A description of the specific group(s) to which the labeling,
advertising, marketing, promotion, and other consumer-directed
activities for the new tobacco product would be targeted (i.e., the
intended audience(s));
    (ii) A discussion of how the labeling, advertising, marketing,
promotion, and other consumer-directed activities for the new tobacco
product would be targeted to reach the intended audience(s) identified
in paragraph (i) and what other group(s) would foreseeably be exposed
to those materials and activities as a result;
    (iii) A discussion of, for individuals below the minimum age of
sale, how access to the new tobacco product would be restricted and
exposure to the labeling, advertising, marketing, promotion, and other
consumer-directed activities would be limited; and
    (iv) A concluding summary describing how the applicant's plans for
marketing the new tobacco product are consistent with the applicant's
discussion of the increased or decreased likelihood of changes in
tobacco product use behavior, including switching, initiation,
cessation, and polyuse, under Sec.  1114.7(l) and permits FDA to
determine permitting the new tobacco product to be marketed would be
appropriate for the protection of public health.
    (g) Statement of compliance with 21 CFR part 25. (1) The
application must contain an environmental assessment prepared in
accordance with Sec.  25.40 of this chapter, or a valid claim of
categorical exclusion, if applicable. If the applicant believes that
the action qualifies for an available categorical exclusion, the
applicant must state under Sec.  25.15(a) and (d) of this chapter that
the action requested qualifies for a categorical exclusion, citing the
particular exclusion that is claimed, and that to the applicant's
knowledge, no extraordinary circumstances exist under Sec.  25.21 of
this chapter.
    (h) Summary. The application must include a summary of all
information contained in the application. The summary must include the
following items, highlighting the effects on youth, young adults, and
other relevant vulnerable populations:
    (1) A summary of the product formulation section of the
application;
    (2) A summary of the manufacturing section of the application;
    (3) A summary of the health risk investigations section of the
application, including all information regarding the following items,
and identify areas in which there is a lack of information, where
applicable:
    (i) The health risks of the tobacco product to both users and
nonusers of the product and whether the tobacco product may present
less health risk than other tobacco products;
    (ii) The impact the product and its marketing will have on the
likelihood of changes in tobacco use behavior, including cessation,
switching, and polyuse, of tobacco product users;
    (iii) The impact the product and its marketing will have on the
likelihood of tobacco use initiation by tobacco product nonusers;
    (iv) How users and nonusers perceive the risk of the tobacco
product based upon its label, labeling, and advertising, to the extent
that advertising has been studied;
    (v) Whether users are able to understand the labeling and
instructions for use, and use the product in accordance with those
instructions; and
    (vi) The impact of human factors on the health risks to product
users and nonusers (as described in paragraph (k)(1)(v) of this
section);
    (4) A concluding discussion describing how the data and information
contained in the PMTA both constitute valid scientific evidence and
establish that permitting marketing of the new tobacco product is
appropriate for the protection of the public health, as determined with
respect to the risks and benefits to the population as a whole,
including users and nonusers of the tobacco product. This discussion
must specifically describe the effects on youth, young adults, and
other relevant vulnerable populations with an emphasis on populations
that are most likely to use the new tobacco product. The summary must
also identify any key or pivotal studies on which an applicant is
relying to establish that permitting the marketing of the new tobacco
product would be APPH.
    (i) Product formulation. The application must contain a full
statement of the components or parts, materials, ingredients,
additives, constituents, properties, and the principle or principles of
operation, of the tobacco product, including the following information:
    (1) Components or parts, materials, ingredients, additives, and
constituents. The applicant must provide a full statement of:
    (i) Components or parts. The quantity, function, and purpose of,
and, where applicable, target specification(s) of, each component or
part in the product. Where the tobacco product contains software
components, the applicant must provide:
    (A) A description of the software or technology (e.g., Bluetooth);
    (B) The purpose of the software or technology, such as monitoring
where tobacco products are located, activated, or used;
    (C) A description of the data collected by the software and how it
will be used.
    (ii) Materials. For each material in the product, include:
    (A) The material name and common name(s), if applicable;
    (B) The component or part of the tobacco product where the material
is located;
    (C) The subcomponent or subpart where the material is located, if
applicable;
    (D) The function of the material;
    (E) The quantities (including ranges or means and acceptance
limits) of the material(s) in the new tobacco product (with any
specification variation, if applicable);
    (F) The specification(s) (including quality/grades and suppliers)
used for the new tobacco product (including any specification
variations, if applicable); and
    (G) Any other material properties to fully characterize the new
tobacco product.

    (iii) Ingredients other than tobacco. For ingredients other than
tobacco in each component or part of the product, include:
    (A) The International Union of Pure and Applied Chemistry (IUPAC)
chemical name and common name, if applicable;
    (B) The Chemical Abstracts Service (CAS) number or FDA Unique
Ingredient Identifier (UNII), if applicable;
    (C) The function of the ingredient;
    (D) The quantity of the ingredient in the tobacco product, with the
unit of measure (including ranges or means and acceptance limits)
reported as mass per gram of tobacco for nonportioned tobacco products
and as mass per portion for portioned tobacco products (with any
specification variation, if applicable);
    (E) The specification(s) (including purity or grade and supplier);
and
    (F) For complex purchased ingredients, each single chemical
substance reported separately.
    (iv) Tobacco ingredients. For tobacco ingredients in each component
or part, include the following information or, if applicable, a
statement that the product does not contain tobacco ingredients:
    (A) The type(s) (e.g., Bright, Burley, reconstituted);
    (B) The quantity with the unit of measure (including ranges or
means, acceptance limits) of each tobacco ingredient in the tobacco
product reported as mass per gram of tobacco for nonportioned tobacco
products and as mass per portion for portioned tobacco products (with
any specification variation, if applicable);
    (C) The specification of tobacco used for the new tobacco product
(with any specification variation, if applicable); and
    (D) A description of any genetic engineering of the tobacco that
impacts product characteristics.
    (v) Constituents. Constituents, including HPHCs and other
constituents, contained within, or emitted from (including its smoke or
aerosol), the product, including any reaction product from leaching or
aging, by providing:
    (A) The constituent names in alphabetical order;
    (B) The common name(s);
    (C) The Chemical Abstract Services number;
    (D) The mean quantity and variance with unit of measure;
    (E) The number of samples and measurement replicates for each
sample;
    (F) A description of method procedure, method validation
information and rationale for selecting each test method;
    (G) The name and location of the testing laboratory or laboratories
and documentation showing that the laboratory or laboratories is (or
are) accredited by a nationally or internationally recognized external
accreditation organization;
    (H) Length of time between dates of manufacture and date(s) of
testing;
    (I) Storage conditions of the tobacco product before it was tested;
    (J) Test data including test protocols, any deviation(s) from the
test protocols, quantitative acceptance (pass/fail) criteria, and line
data for all testing performed. Test data for combusted or inhaled
products must reflect testing conducted using both intense and
nonintense smoking or aerosol-generating regimens, where established;
and
    (K) Complete descriptions of any smoking or aerosol-generating
regimens used for analytical testing that are not standardized or
widely accepted by the scientific community, if applicable.
    (vi) Container closure system. A description of the container
closure system, including:
    (A) Information describing how the container closure system
protects and preserves the product from damage during transport,
environmental contaminants, and potential leaching and migration of
packaging constituents into the new tobacco product; and
    (B) Information describing design features developed to prevent the
risk of accidental exposure, if any.
    (vii) Statement of tobacco blending, reconstitution, or
manipulation. Information regarding tobacco blending, reconstitution,
or manipulation, where applicable.
    (2) Other properties. The applicant must provide a full description
of the additional properties of the tobacco product that includes:
    (i) Product dimensions and construction. The product dimensions and
the overall construction of the product using a diagram or schematic
drawing that clearly depicts the finished tobacco product and its
components with dimensions, operating parameters, and materials.
    (ii) Design parameters and test data. (A) All final design
parameters of the product, specifying nominal values or the explicit
range of values as well as the design tolerance (where appropriate),
including, but not limited to, the parameters specified in tables 1 to
22 of this paragraph as applicable. If a design parameter specified in
tables 1 to 22 does not apply to the tobacco product, applicants must
explain why the required design parameter does not apply or how an
alternative design parameter would satisfy the required design
parameter. If the product has additional design parameters that are not
specified in tables 1 to 22, the application must contain a description
of the design specifications as well as test data and processes to
demonstrate that the design parameters and their associated processes
are adequately controlled; and
    (B) A quantitative description of the performance criteria,
including test protocols, line data, and a summary of the results, for
each applicable intermediate and final design parameter and
manufacturing step, that includes, but is not limited to the test data
specified in tables 1 to 22 of this paragraph for the product category
as applicable. If the test data specified in the applicable table does
not apply to the tobacco product, applicants must explain why the test
data does not apply or how alternative test data would satisfy this
requirement. Where tobacco cut size or particle size is a required
design parameter for a product category or subcategory and the target
specifications and range limits are not available, the following
alternative information may be submitted in place of this information:
a description of the tobacco cutting process (including a complete
description of the milling, cutting, and sifting process; the control
parameters of the miller or cutter; and any sift specifications), or
the measured particle size distribution;

 Table 2 to Paragraph (i)(2)(ii)--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).              Tobacco filler mass
                                             (mg).
 Cigarette circumference or          Tobacco rod density
 diameter (mm).                              (g/cm\3\).
 Tobacco filler mass (mg).           Tobacco cut size
                                             (mm or CPI).
 Tobacco rod density (g/cm\3\).      Tobacco moisture or
                                             oven volatiles (%).

 Tobacco cut size (mm or CPI).       Cigarette paper
                                             base paper porosity
                                             (permeability) (CU).
 Tobacco moisture or oven            Cigarette paper
 volatiles (%).                              band porosity or
                                             permeability (CU) or
                                             Cigarette paper band
                                             diffusivity (cm\2\/s).
 Cigarette paper length (mm).        Filter pressure
                                             drop (mm H2O).
 Cigarette paper base paper
 porosity (permeability) (CU).
 Cigarette paper band porosity       Filter efficiency
 (permeability) (CU) [alternatively, band    (%) (If no filter
 diffusivity (cm\2\/s)] (if applicable).     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)).
 Cigarette paper band width (mm).    Filter ventilation
                                             (%).
 Cigarette paper band space (mm).
 Filter length (mm).
 Filter pressure drop (mm H2O).
 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)).
 Tipping paper length (mm).
 Filter ventilation (%).
------------------------------------------------------------------------

 Table 3 to Paragraph (i)(2)(ii)--Required Design Parameter Information
        for Portioned and Nonportioned 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 or CPI) or     Tobacco cut size
 tobacco particle size (mm or micron).       (mm or CPI) or tobacco
                                             particle size (mm or
                                             micron).
 Tobacco moisture (%).               Tobacco moisture
                                             (%).
 Portion length (mm).                Portion mass (mg).
 Portion width (mm).                 Pouch material
                                             basis weight (g/m\2\) (if
                                             applicable).
 Portion mass (mg).                  Pouch material
                                             porosity (CU)
                                             (permeability) (L/m\2\/s).
 Portion material thickness (mm)     Nicotine
 (if applicable).                            dissolution rate (%/min).
 Pouch material basis weight (g/
 m\2\) (if applicable).
 Pouch material porosity
 (permeability) (CU or L/m\2\/s) (if
 applicable).
 Nicotine dissolution rate (%/
 min).
------------------------------------------------------------------------
                 Nonportioned Smokeless Tobacco Products
------------------------------------------------------------------------
 Tobacco cut size (mm or CPI) or     Tobacco cut size
 tobacco particle size (mm or micron)        (mm or CPI) or tobacco
                                             particle size (mm or
                                             micron).
 Tobacco moisture (%)                Tobacco moisture
                                             (%).
------------------------------------------------------------------------

 Table 4 to Paragraph (i)(2)(ii)--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:
------------------------------------------------------------------------
 Roll-your-own (RYO) paper length    RYO mass per paper
 (mm).                                       (mg).
 RYO paper width (mm).               RYO paper base
                                             paper basis weight (g/
                                             m\2\).
 RYO mass per paper (mg).            RYO paper base
                                             paper porosity
                                             (permeability) (CU).
 RYO paper base paper basis weight   RYO paper band
 (g/m\2\).                                   porosity (permeability)
                                             (CU) or [alternatively, RYO
                                             paper band diffusivity
                                             (cm\2\/s)] (if applicable).
 RYO paper base paper porosity
 (permeability) (CU).
 RYO paper band porosity
 (permeability) (CU) or [alternatively,
 RYO paper band diffusivity (cm\2\/s)] (if
 applicable).
 RYO paper band width (mm) (if
 applicable).
 RYO paper band space (mm) (if
 applicable).
------------------------------------------------------------------------

 Table 5 to Paragraph (i)(2)(ii)--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 mass (mg).                     Tube mass (mg).
 Tube length (mm).                   Tube paper base
                                             paper basis weight (g/
                                             m\2\).
 Tube circumference or diameter      Tube paper base
 (mm).                                       paper porosity
                                             (permeability) (CU).

 Tube paper width (mm).              Tube paper band
                                             porosity (permeability)
                                             (CU) (if applicable) or
                                             Tube paper band diffusivity
                                             (cm\2\/s) (if applicable).
 Tube paper base paper basis
 weight (g/m\2\).
 Tube paper base paper porosity
 (permeability) (CU).
 Tube paper band porosity
 (permeability) (CU) (if applicable) or
 Tube paper band diffusivity (cm\2\/s) (if
 applicable).
 Tube paper band width (mm) (if
 applicable).
 Tube paper band space (mm) (if
 applicable).
------------------------------------------------------------------------

 Table 6 to Paragraph (i)(2)(ii)--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 mass (mg).                     Tube paper base
                                             paper basis weight (g/
                                             m\2\).
 Tube length (mm).                   Tube paper base
                                             paper porosity
                                             (permeability) (CU).
 Tube circumference or diameter      Tube mass (mg).
 (mm).
 Tube paper length (mm).             Tube paper band
                                             porosity (permeability)
                                             (CU) (if applicable) or
                                             Tube paper band diffusivity
                                             (cm\2\/s) (if applicable).
 Nonfilter tube length (mm).         Filter pressure
                                             drop (mm H2O).
 Tube paper width (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 (DPF), total
                                             denier (g/9000m), and
                                             filter density (g/cm\3\))).
 Tube paper base paper basis         Filter ventilation
 weight (g/m\2\).                            (%).
 Tube paper base paper porosity     ............................
 (permeability) (CU).
 Tube paper band porosity
 (permeability) (CU) (if applicable) or
 Tube paper band diffusivity (cm\2\/s) (if
 applicable).
 Tube paper band width (mm) (if
 applicable).
 Tube paper band space (mm) (if
 applicable).
 Filter length (mm).
 Filter pressure drop (mm H2O).
 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 (DPF), total denier (g/9000m),
 and filter density (g/cm\3\))).
 Tipping paper length (mm).
 Filter ventilation (%).
------------------------------------------------------------------------

 Table 7 to Paragraph (i)(2)(ii)--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 cut size (mm or CPI).       Tobacco cut size
                                             (mm or CPI).
 Tobacco moisture or oven            Tobacco moisture or
 volatiles (%).                              oven volatiles (%).
------------------------------------------------------------------------

 Table 8 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                       for RYO Tobacco Paper Tips
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 RYO paper tip length (mm).          RYO paper base
                                             paper basis weight (g/
                                             m\2\).
 RYO paper tip width (mm).           RYO paper porosity
                                             (permeability) (CU).
 RYO paper tip mass (mg).            RYO paper tip
                                             ventilation (%).
 RYO paper base paper basis weight
 (g/m\2\).
 RYO paper porosity (permeability)
 (CU).
 RYO paper tip ventilation (%).
------------------------------------------------------------------------

 Table 9 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                    for Filtered Sheet-Wrapped Cigars
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Cigar mass (mg).                    Cigar mass (mg).
 Cigar wrapper basis weight (g/      Puff count.
 m\2\).
 Cigar binder length (mm).           Cigar wrapper basis
                                             weight (g/m\2\).
 Cigar binder width (mm).            Cigar wrapper
                                             porosity (permeability)
                                             (CU).

 Cigar binder basis weight (g/       Cigar binder
 m\2\)                                       porosity (permeability)
                                             (CU).
 Cigar length (mm).                  Cigar binder basis
                                             weight (g/m\2\).
 Cigar overall diameter (mm).        Tobacco filler mass
                                             (mg).
 Cigar minimum diameter (mm) if      Tobacco rod density
 applicable.                                 (g/cm\3\).
 Cigar maximum diameter (mm) if      Tobacco cut size
 applicable.                                 (CPI or mm).
 Tobacco filler mass (mg).           Tobacco moisture or
                                             oven volatiles (%).
 Tobacco rod density (g/cm\3\).      Cigar wrapper band
                                             porosity (permeability)
                                             (CU) [alternatively, band
                                             diffusivity (cm\2\/s)](if
                                             applicable).
 Tobacco cut size (CPI or mm).       Cigar binder band
                                             porosity (permeability)
                                             (CU) [alternatively, band
                                             diffusivity (cm\2\/s)] (if
                                             applicable).
 Tobacco moisture or oven            Cigar minimum
 volatiles (%).                              diameter (mm) (if
                                             applicable).
 Cigar wrapper porosity              Cigar maximum
 (permeability) (CU).                        diameter (mm) (if
                                             applicable).
 Cigar wrapper length (mm).          Filter pressure
                                             drop (mm H2O).
 Cigar wrapper width (mm).           Filter efficiency
                                             (%) (if no filter
                                             efficiency data is
                                             available for the products,
                                             include information
                                             sufficient to show that the
                                             cigar filter is unchanged
                                             [e.g., denier per filament
                                             (DPF), total denier (g/
                                             9000m), and filter density
                                             (g/cm\3\)]{time} .
 Cigar wrapper band porosity         Filter ventilation
 (permeability) (CU) (if applicable).        (%).
 Cigar wrapper band width (mm) (if
 applicable).
 Cigar wrapper band space (mm) (if
 applicable).
 Cigar binder porosity
 (permeability) (CU).
 Cigar binder band porosity
 (permeability) (CU) (if applicable).
 Cigar binder band width (mm) (if
 applicable).
 Cigar binder band space (mm) (if
 applicable).
 Filter length (mm).
 Filter diameter (mm).
 Filter pressure drop (mm H2O).
 Filter efficiency (%) {If no
 filter efficiency data is available for
 the products, include information
 sufficient to show that the cigar filter
 is unchanged [e.g., denier per filament
 (DPF), total denier (g/9000m), and filter
 density(g/cm\3\)]{time} .
 Tipping paper length (mm).
 Filter ventilation (%).
------------------------------------------------------------------------

 Table 10 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                   for Unfiltered Sheet-Wrapped Cigars
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Cigar mass (mg).                    Puff count.
 Cigar length (mm).                  Cigar mass (mg).
 Cigar overall diameter (mm).        Tobacco rod density
                                             (g/cm\3\).
 Cigar minimum diameter (mm) (if     Tobacco cut size
 applicable).                                (CPI or mm).
 Cigar maximum diameter (mm) (if     Tobacco moisture or
 applicable).                                oven volatiles (%).
 Tobacco rod density (g/cm\3\).      Tobacco filler mass
                                             (mg).
 Tobacco moisture or oven            Cigar minimum
 volatiles (%).                              diameter (mm) (if
                                             applicable).
 Tobacco cut size (CPI or mm).       Cigar maximum
                                             diameter (mm) (if
                                             applicable).
 Tobacco filler mass (mg).           Cigar wrapper
                                             porosity (permeability)
                                             (CU).
 Cigar wrapper porosity              Cigar wrapper basis
 (permeability) (CU).                        weight (g/m\2\).
 Cigar wrapper length (mm).          Cigar binder basis
                                             weight (g/m\2\).
 Cigar wrapper width (mm).           Cigar binder
                                             porosity (permeability)
                                             (CU).
 Cigar wrapper basis weight (g/      Cigar tip mass (mg)
 m\2\).                                      (if applicable).
 Cigar binder porosity               Cigar wrapper band
 (permeability) (CU).                        porosity (permeability)
                                             (CU) [alternately, band
                                             diffusivity (cm2/s)] (if
                                             applicable).
 Cigar binder width (mm)             Cigar binder band
                                             porosity (permeability)
                                             (CU) [alternately, band
                                             diffusivity (cm2/s)] (if
                                             applicable).
 Cigar binder basis weight (g/
 m\2\).
 Cigar tip length (mm) (if
 applicable).
 Cigar tip inner diameter (mm) (if
 applicable).
 Cigar tip mass (mg) (if
 applicable).
 Cigar wrapper band space (mm) (if
 applicable).
 Cigar wrapper band width (mm) (if
 applicable).
 Cigar binder band width (mm) (if
 applicable).
 Cigar binder band space (mm) (if
 applicable).
 Cigar wrapper band porosity or
 permeability (CU) [alternately, band
 diffusivity (cm2/s)] (if applicable).

 Cigar binder band porosity
 (permeability) (CU) [alternately, band
 diffusivity (cm2/s)] (if applicable).
------------------------------------------------------------------------

 Table 11 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                         for Leaf-Wrapped Cigars
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Cigar mass (mg).                    Puff count.
 Cigar length (mm).                  Cigar mass (mg).
 Overall diameter (mm).              Cigar minimum
                                             diameter (mm).
 Cigar minimum diameter (mm).        Cigar maximum
                                             diameter (mm).
 Cigar maximum diameter (mm).        Cigar wrapper basis
                                             weight (g/m\2\).
 Tobacco moisture or oven            Cigar binder basis
 volatiles (%).                              weight (g/m\2\).
 Tobacco filler mass (mg).           Tobacco filler mass
                                             (mg).
 Tobacco rod density (g/cm\3\).      Tobacco rod density
                                             (g/cm\3\).
 Tobacco cut size (CPI or mm).       Tobacco cut size
                                             (CPI or mm).
 Tobacco moisture or oven            Tobacco moisture or
 volatiles (%).                              oven volatiles (%).
 Cigar wrapper length (mm).
 Cigar wrapper width (mm).
 Cigar wrapper basis weight (g/
 m\2\).
 Cigar binder width (mm).
 Cigar binder basis weight (g/
 m\2\).
------------------------------------------------------------------------

 Table 12 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                            for Cigar 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 cut size (CPI or mm)        Tobacco cut size
                                             (CPI or mm).
 Tobacco moisture or oven            Tobacco moisture or
 volatiles (%)                               oven volatiles (%).
------------------------------------------------------------------------

 Table 13 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                           for Cigar Wrappers
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Cigar wrapper length (mm).          Cigar wrapper
                                             length (mm).
 Cigar wrapper width (mm).           Cigar wrapper width
                                             (mm).
 Cigar wrapper basis weight (g/      Cigar wrapper basis
 cm\2\).                                     weight (g/cm\2\).
------------------------------------------------------------------------

 Table 14 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                             for Waterpipes
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Hose length (mm).                   Hose length (mm).
 Hose materials.                     Hose internal
                                             diameter (mm).
 Hose internal diameter (mm).        Stem length (mm).
 Stem length (mm).                   Stem internal
                                             diameter (mm).
 Stem internal diameter (mm).        Base diameter (mm).
 Base diameter (mm).                 Base volume
                                             (cm\3\).
 Base volume (cm\3\).                Pressure drop (mm
                                             H2O).
 Base shape.                         Water filter
                                             efficiency (%).
 Pressure drop (mm H2O).             Head height (mm).
 Water filter efficiency (%).        Head top diameter
                                             (mm).
 Hose air permeability (CU).         Head bottom
                                             diameter (mm).
 Head height (mm).                   Head volume
                                             (mm\3\).
 Head top diameter (mm).
 Head bottom diameter (mm).
 Number of holes.
 Head volume (mm\3\).
 Heating source type.
 Head materials.
------------------------------------------------------------------------

 Table 15 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                          for Waterpipe 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 cut size (CPI or mm).       Tobacco cut size
                                             (CPI or mm).
 Tobacco moisture or oven            Tobacco moisture or
 volatiles (%).                              oven volatiles (%).
------------------------------------------------------------------------

 Table 16 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                      for Waterpipe Heating Sources
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Heating element temperature range   Heating element
 ([deg]C).                                   temperature range ([deg]C).
 Heating element mass (mg).          Heating element
                                             mass (mg).
 Heating element density (g/         Heating element
 cm\3\).                                     density (g/cm\3\).
 Heating element resistance (ohms)   Heating element
 (if applicable).                            resistance (ohms) (if
                                             applicable).
 Number of heating elements.         Heating element
                                             diameter (gauge).
 Heating element configuration.      Battery current
                                             rating (mA) (if
                                             applicable).
 Heating element diameter (gauge)    Battery capacity
 (if applicable).                            (mAh) (if applicable).
 Battery current rating (mA) (if     Battery voltage
 applicable).                                operating range (volts) (if
                                             applicable).
 Battery capacity (mAh) (if          Battery current
 applicable)                                 operating range (amps) (if
                                             applicable).
 Battery voltage operating range     Power delivery unit
 (volts) (if applicable).                    (PDU) temperature cut-off
                                             ([deg]C) (if applicable).
 Battery current operating range     Power delivery unit
 (amps) (if applicable).                     (PDU) voltage operating
                                             range (volts) (if
                                             applicable).
 Power delivery unit (PDU)           PDU current
 temperature cut-off ([deg]C) (if            operating range (amps) (if
 applicable).                                applicable).
 Power delivery unit (PDU) voltage   PDU wattage
 operating range (volts) (if applicable).    operating range (watts) (if
                                             applicable).
 PDU current operating range        ............................
 (amps) (if applicable).
 PDU wattage operating range        ............................
 (watts) (if applicable).
------------------------------------------------------------------------

 Table 17 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                           for Waterpipe Foil
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Foil length (mm) (for square or     Foil length (mm)
 rectangular shape foil).                    (for square or rectangular
                                             shape foil).
 Foil width (mm) (for square or      Foil width (mm)
 rectangular shape foil).                    (for square or rectangular
                                             shape foil).
 Diameter (mm) (for circular shape   Diameter (mm) (for
 foil).                                      circular shape foil).
 Foil thickness (mm).                Foil thickness
                                             (mm).
 Number of holes.                    Diameter of the
                                             holes (mm).
 Diameter of the holes (mm).        ............................
------------------------------------------------------------------------

 Table 18 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                           for Waterpipe Head
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Head height (mm),                   Head height (mm).
 Head top diameter (mm),             Head top diameter
                                             (mm).
 Head bottom diameter (mm),          Head bottom
                                             diameter (mm).
 Number of holes,                    Head volume
                                             (mm\3\).
 Head volume (mm\3\),               ............................
 Head materials,                    ............................
------------------------------------------------------------------------

 Table 19 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                                for Pipes
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Bowl chamber cover outer diameter   Bowl chamber volume
 (mm).                                       (cm\3\).
 Bowl chamber cover inner diameter   Pipe pressure drop
 (mm).                                       (mm H2O).
 Draught hole diameter (mm).         Air flow through
                                             air valve (cc/min).
 Screen (if applicable).             Airway volume
                                             (cm\3\).
 Draught hole shape.                 Filter pressure
                                             drop (mm H2O).
 Draught hole location.              Filter efficiency
                                             (%) {If no filter
                                             efficiency data is
                                             available for the products,
                                             include information
                                             sufficient to show that the
                                             cigar filter is unchanged
                                             [e.g., denier per filament
                                             (DPF), total denier (g/
                                             9000m), and filter
                                             density(g/cm\3\)]{time} .
 Bowl chamber hole shape.           ............................
 Bowl chamber volume (cm\3\)        ............................
 Airway volume (cm\3\)              ............................
 Stem length (mm).                  ............................

 Stem diameter (mm).                ............................
 Shank length (mm).                 ............................
 Shank diameter (mm).               ............................
 Draught hole dimension.            ............................
 Pressure drop through air valve    ............................
 (mm H2O).
 Air flow through air valve (cc/    ............................
 min).
 Filter efficiency (%) {If no       ............................
 filter efficiency data is available for
 the products, include information
 sufficient to show that the cigar filter
 is unchanged [e.g., denier per filament
 (DPF), total denier (g/9000m), and filter
 density(g/cm\3\)]{time} .
 Filter pressure drop (mm H2O).     ............................
 Filter length (mm).                ............................
------------------------------------------------------------------------

 Table 20 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                            for Pipe 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 cut size (CPI or mm).       Tobacco cut size
                                             (CPI or mm).
 Tobacco moisture or oven            Tobacco moisture or
 volatiles (%).                              oven volatiles (%).
------------------------------------------------------------------------

 Table 21 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                                for ENDS
------------------------------------------------------------------------
                                             Provide test data (include
                                                   test protocols,
  Provide target specification with upper      quantitative acceptance
        and lower range limits for:          criteria, data sets, and a
                                            summary of the results) for:
------------------------------------------------------------------------
 Draw resistance (mm H2O).          ............................
 Puff count (for full tank/          Draw resistance (mm
 cartridge).                                 H2O).
 Atomizer tank/cartridge volume      Puff count (for
 (mL).                                       full tank/cartridge).
 Number of heating elements (e.g.,   Atomizer tank/
 coil).                                      cartridge volume (mL).
 Heating Element diameter (gauge).   Heating Element
                                             diameter (gauge).
 Heating Element length (mm).        Heating Element
                                             resistance (Ohms).
 Heating Element resistance          Heating Element
 (Ohms).                                     temperature range ([deg]C).
 Heating Element temperature range   Battery voltage
 ([deg]C).                                   operating range (V).
 Heating Element configuration       Battery current
 (target only).                              operating range (mA).
 Battery voltage operating range     PDU voltage
 (V).                                        operating range (V).
 Battery current operating range     PDU current
 (mA).                                       operating range (mA).
 Battery Capacity (mAh).             PDU wattage
                                             operating range (watts).
 Battery Nominal Voltage (V).        PDU Current cut-off
                                             (mA) (if applicable).
 Battery Current rating (mA).        PDU temperature cut-
                                             off ([deg]C) (if
                                             applicable).
 Battery charging temperature        Battery Capacity
 limits ([deg]C).                            (mAh).
 Battery discharge temperature       Battery Nominal
 limits ([deg]C).                            Voltage (V).
 Battery end of discharge voltage    Battery Current
 (V).                                        rating (mA).
 Battery maximum charging current    Battery charging
 (mA).                                       temperature limits
                                             ([deg]C).
 Battery maximum discharging         Battery discharge
 current (mA).                               temperature limits
                                             ([deg]C).
 Battery upper limits charging       Battery maximum
 voltage (V).                                charging current (mA).
 Power Delivery Unit (PDU) voltage   Battery maximum
 operating range (V).                        discharging current (mA).
 PDU current operating range (mA).   Battery upper
                                             limits charging voltage
                                             (V).
 PDU wattage operating range         Inhaled aerosol
 (watts).                                    temperature ([deg]C).
 PDU temperature cut-off ([deg]C)    Airflow rate (L/
 (if applicable).                            min) (if applicable).
 Airflow rate (L/min) (if            Ventilation (%).
 applicable).
 PDU Current cut-off (mA) (if       ............................
 applicable).
 PDU Temperature cut-off ([deg]C)   ............................
 (if applicable).
 Inhaled aerosol temperature        ............................
 ([deg]C).
 Ventilation (%).                   ............................
------------------------------------------------------------------------

 Table 22 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                              for E-liquids
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 E-liquid viscosity (at 20[deg]C).   E-liquid viscosity
                                             (at 20[deg]C).
 E-liquid volume (ml).               E-liquid volume
                                             (ml).
 Particle number concentration (#/   Particle number
 cm\3\).                                     concentration (#/cm\3\).
 Count median diameter (nm).         Count median
                                             diameter (nm).
 PM2.5 ([micro]g/m\3\).              PM2.5 ([micro]g/
                                             m\3\).
------------------------------------------------------------------------

 Table 23 to Paragraph (i)(2)(ii)--Required Design Parameter Information
                    for Heated Tobacco Products (HTP)
------------------------------------------------------------------------
                                             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:
------------------------------------------------------------------------
 Overall Product.                    Overall Product.
    [cir] Mass (mg).                         [cir] Draw resistance (mm
                                             H2O).
    [cir] Length (mm).                       [cir] Puff count (for full
                                             tank/cartridge).
    [cir] Width (mm).                        [cir] Product volume (mL).
    [cir] Height (mm).                       [cir] Airflow rate (L/min)
                                             (if applicable).
    [cir] Diameter (mm).                     [cir] Ventilation (%).
    [cir] Draw resistance (mm H20).          [cir] Operational
                                             Temperature ([deg]C).
    [cir] Puff Count (for full tank/         [cir] Temperature sensor
     cartridge).                             (if applicable).
    [cir] Puff volume (mL).                  [cir] Material wrapper
                                             length (mm) (if
                                             applicable).
    [cir] Product volume (mL).               [cir] Material wrapper
                                             width (mm) (if applicable).
    [cir] Airflow rate (L/min) (if           [cir] Material wrapper
     applicable).                            basis weight (g/m\2\) (if
                                             applicable).
    [cir] Ventilation (%).                   [cir] Material porosity
                                             (permeability) (CU) (if
                                             applicable).
    [cir] Operational Temperature            Heating element.
     ([deg]C).
    [cir] Temperature sensor (if             [cir] Heating Element
     applicable).                            diameter (gauge).
    [cir] Material wrapper length (mm) (if   [cir] Heating Element
     applicable).                            resistance (Ohms).
    [cir] Material wrapper width (mm) (if    [cir] Heating Element
     applicable).                            temperature range ([deg]C).
    [cir] Material wrapper basis weight (g/  E-liquid.
     m\2\) (if applicable).
    [cir] Material porosity (permeability)   [cir] E-liquid viscosity
     (CU) (if applicable).                   (at 20[deg]C).
 Heating element.                    [cir] E-liquid volume (ml).
    [cir] Heating element source/type/       Tobacco (if
     approach (electrical, carbon,           applicable).
     aerosol, etc.).
    [cir] Heating element temperature        [cir] Tobacco moisture (%).
     range ([deg]C).
    [cir] Heating element operational        [cir] Tobacco cut size (CPI
     temperature ([deg]C).                   or mm).
    [cir] Heating element maximum            [cir] Tobacco density (g/
     temperature (boost temperature)         cm\3\)
     ([deg]C).
    [cir] Heating element material.          Battery.
    [cir] Heating element Configuration     ............................
     (i.e., the shape and design of the
     heating element. If the heating
     element is a coil, it is the shape
     and arrangement of the coil. If the
     heating element is a novel design,
     provide the configuration and its
     design targets.).
    [cir] Heating element length (mm).
    [cir] Heating element mass (mg).
    [cir] Heating element location.         ............................
    [cir] Number of heating elements         [cir] Battery voltage
     (e.g., coil) (dimensionless).           operating range (V).
    [cir] Heating Element diameter (gauge)   [cir] Battery current
     (if applicable).                        operating range (mA).
    [cir] Heating Element resistance         [cir] PDU voltage operating
     (Ohms) (if applicable).                 range (V).
 Tobacco/E-liquid.                   [cir] PDU current operating
                                             range (mA) PCO wattage
                                             operating range (W).
    [cir] Tobacco mass (mg) (if             ............................
     applicable).
    [cir] Tobacco density (g/cm\3\) (if      [cir] PDU Current cut-off
     applicable).                            (mA) (if applicable).
    [cir] Tobacco moisture or oven           [cir] PDU temperature cut-
     volatiles (%) (if applicable).          off ([deg]C).
    [cir] Tobacco cut size (CPI or mm) (if   [cir] Battery Capacity
     applicable).                            (mAh).
    [cir] E-liquid volume (mL) (if           [cir] Battery Nominal
     applicable).                            Voltage (V).
    [cir] E-liquid viscosity (at 20[deg]C)   [cir] Battery Current
     (if applicable).                        rating (mA).
 Battery (if applicable).            [cir] Battery charging
                                             temperature limits
                                             ([deg]C).
    [cir] Battery capacity (mA).             [cir] Battery discharge
                                             temperature limits
                                             ([deg]C).
    [cir] Battery Voltage Operating Range    [cir] Battery maximum
     (V) or Wattage (W).                     charging current (mA).
    [cir] Battery Current Charging range     [cir] Battery maximum
     (amps).                                 discharging current (mA).
    [cir] Battery Nominal Voltage (V).       [cir] Battery upper limits
                                             charging voltage (V).
    [cir] Battery Current rating (mA).       Aerosol.
    [cir] Battery charging temperature
     limits ([deg]C).
    [cir] Battery discharge temperature
     limits ([deg]C).
    [cir] Battery end of discharge voltage   [cir] Inhaled aerosol
     (V).                                    temperature ([deg]C).
    [cir] Battery maximum charging current   [cir] Aerosol Particle
     (mA).                                   number concentration (#/
                                             cm\3\).
    [cir] Battery maximum discharging        [cir] Count median diameter
     current (mA).                           (nm).
    [cir] Battery upper limits charging      [cir] PM2.5 ([micro]g/
     voltage (V).                            m\3\).
    [cir] Power Delivery Unit (PDU)          Filter (if
     voltage operating range (V).            applicable).
    [cir] PDU current operating range        [cir] Filter efficiency (%)
     (mA).                                   {If no filter efficiency
                                             data is available for the
                                             products, include
                                             information sufficient to
                                             show that the cigar filter
                                             is unchanged [e.g., denier
                                             per filament (DPF), total
                                             denier (g/9000m), and
                                             filter density(g/
                                             cm\3\)]{time} .
    [cir] PDU wattage operating range        [cir] Filter ventilation
     (watts).                                (%).
    [cir] PDU temperature cut-off ([deg]C)   [cir] Filter pressure drop
     (if applicable)                         (mm H2O).
    [cir] PDU Current cut-off (mA) (if      ............................
     applicable).
 Aerosol.                           ............................
    [cir] Inhaled aerosol temperature       ............................
     ([deg]C).
    [cir] Aerosol Particle number           ............................
     concentration (#/cm\3\).
    [cir] Count median diameter (nm).       ............................
    [cir] PM2.5 ([micro]g/m\3\).            ............................
 Filter (if applicable).            ............................

    [cir] Filter efficiency (%) {If no      ............................
     filter efficiency data is available
     for the products, include information
     sufficient to show that the cigar
     filter is unchanged [e.g., denier per
     filament (DPF), total denier (g/
     9000m), and filter density(g/
     cm\3\)]{time} .
    [cir] Filter pressure drop (mm H2O).    ............................
    [cir] Filter length (mm).               ............................
    [cir] Filter diameter (mm).             ............................
    [cir] Filter ventilation (%).           ............................
------------------------------------------------------------------------

    (iii) Function. How the product is intended to function.
    (iv) Product pH and nicotine formulation. The pH of the product and
the formulation of nicotine in the product, if applicable, including
the form (e.g., unprotonated nicotine, nicotine salts) and quantity.
    (v) Fermentation process. For smokeless tobacco products and
tobacco products that contain fermented tobacco (including naturally
fermented tobacco), information on the fermentation process, including
the following:
    (A) Description of the fermentation process;
    (B) Composition of the inoculum (starter culture) with genus and
species name(s) and concentration(s) (if applicable);
    (C) Any step(s) taken to reduce endogenous microbes (e.g., cleaning
of product contact surfaces);
    (D) Specifications and test data for pH, temperature, moisture
content, and water activity;
    (E) Frequency of aeration or turning (if applicable);
    (F) Duration of fermentation;
    (G) Added ingredients;
    (H) Method used to stabilize or stop fermentation (e.g., heat
treatment) (if applicable), including parameters of the method (e.g.,
length of treatment, temperature) and method validation data; and
    (I) Storage conditions of the fermented tobacco prior to further
processing or packaging and duration of storage (if applicable).
    (vi) Heat treatment process. For tobacco products that are heat
treated, the application must contain the following information
regarding the heat treatment process:
    (A) Description of the heat treatment process;
    (B) Type of heat treatment;
    (C) Conditions of heat treatment, including time, temperature, and
moisture; and
    (D) Method validation data, including microbial loads (including
bacteria, spores, yeast, and fungi) and TSNAs before and after heat
treatment.
    (vii) Shelf life and stability information. With the exception of
applications for roll-your-own tobacco products and cigarettes that are
not HTPs, the application must contain information on the stability of
the tobacco product over the shelf life and including the following:
    (A) The length of the shelf life, a description of how the shelf
life is determined, and a description of how shelf life is indicated on
the tobacco product, if applicable;
    (B) Stability data assessed at the beginning (zero time), middle,
and end of the expected shelf life. If a tobacco product does not have
a defined shelf life, provide stability data over a specified amount of
time and a justification for why that time period is appropriate.
Stability testing must be performed for the microbial and chemical
endpoints as follows: Microbial content data, including total aerobic
microbial count and total yeast and mold count; water activity;
tobacco-specific nitrosamines (TSNAs) yields (total TSNAs, N'-
nitrosonor-nicotine (NNN), 4-(methylnitrosamino)-1-(3-pyridyl)-1-
butanone) (NNK)); and preservatives content.
    (C) Stability testing details for each microbial and chemical
endpoint, including: The mean quantity and variance with unit of
measures; the number of samples and measurement replicates for each
sample; the methods used, including any deviation(s) from the methods,
associated reference(s), and full validations reports for each method;
the testing laboratory or laboratories and documentation showing that
the laboratory or laboratories is (or are) accredited by a nationally
or internationally recognized external accreditation organization;
length of time between date of tobacco product manufacture and date(s)
of testing; storage conditions of the tobacco product before it was
tested; a statement that the testing was performed on a tobacco product
in the same container closure system in which the tobacco product is
intended to be marketed; and full test data (including quantitative
acceptance (pass/fail) criteria, complete data sets, and a summary for
the results) for all stability testing performed.
    (viii) Product and packaging design risks and misuse hazards. A
review and assessment of reasonably foreseeable risks associated with
the design of the tobacco product and its package that may occur during
normal use of the tobacco product or during any foreseeable misuse of
the product, including user error, which may cause illness, injury, or
death not normally associated with the use of the tobacco product. The
review and assessment must identify the measures taken to reduce or
eliminate each risk associated with the design of the tobacco product
and package.
    (3) Principles of operation. The applicant must provide a full
statement of the principle or principles of operation of the tobacco
product, including full narrative descriptions of:
    (i) The way in which a typical consumer will use the new tobacco
product, including a description of how a consumer operates the
product, how long a single unit of product is expected to last (e.g.,
total length of time of use to consume a unit, number of use sessions
expected per unit), and, where applicable, how a consumer can change
the product design and add or subtract ingredients;
    (ii) A justification for an applicant's determination of what
constitutes a single unit of product as described in the PMTA; and
    (iii) Whether the product incorporates a heating source, and if so,
a description of the heating source.
    (4) Product testing and analysis information. Each analysis
required in this paragraph must be performed on test samples that
reflect the finished tobacco product composition and design, and must
be conducted using a sufficient sample size and number of

replicates to substantiate the results of the type of testing
conducted. Additionally, the applicant must provide the following
information:
    (i) The name and location of the testing laboratory or laboratories
and documentation showing that the laboratory or laboratories is (or
are) accredited by a nationally or internationally recognized external
accreditation organization;
    (ii) The length of time between dates of manufacture and date(s) of
testing;
    (iii) The storage conditions of the tobacco product before it was
tested;
    (iv) The number of samples and measurement replicates for each
sample;
    (v) A description of method procedure, method validation
information and rationale for selecting each test method, including
relevant voluntary testing standards, test protocols, quantitative
acceptance criteria, line data, and a summary of the results;
    (vi) Reports of product formulation testing that include test
protocols, quantitative acceptance criteria, line data, and a summary
of the results, for each applicable design parameter; and
    (vii) Complete descriptions of any smoking or aerosol-generating
regimens used for analytical testing that are not standardized or
widely accepted by the scientific community, if applicable.
    (j) Manufacturing. The application must contain a full description
of the methods used in, and the facilities and controls used for, the
design (including design validation and design verification, to assess
whether the tobacco product, as manufactured, performs in accordance
with design specifications), manufacture, packing, and storage of the
tobacco product in sufficient detail to demonstrate whether the product
meets manufacturing specifications, can be manufactured in a manner
consistent with the information submitted in the application, and
conforms to the requirements of any regulations issued under section
906(e) of the Federal Food, Drug, and Cosmetic Act, including:
    (1) A list of all manufacturing, packaging, storage, and control
facilities for the product, including the facility name, address, and
FEI number, if applicable, and a contact name and telephone number for
a representative from each facility;
    (2) A narrative description, accompanied by a list and summary, of
all standard operating procedures (SOPs) and examples of relevant forms
and records for the following categories of information for all
manufacturing, design controls, packing, and storage for the tobacco
product:
    (i) Manufacturing and production process activities at each
establishment, including a description of each establishment, all
production steps, and process controls, process specifications with
relevant acceptance criteria, and monitoring and acceptance activities;
    (ii) Managerial oversight and employee training related to the
manufacture, processing, packing, and installation of the tobacco
product, as applicable;
    (iii) Monitoring procedures and manufacturing controls for product
design, product characteristics, and changes in products,
specifications, methods, processes, or procedures, including a hazard
analysis that details the correlation of the product design attributes
with public health risk, as well as any mitigation strategies
implemented;
    (iv) Activities related to identifying and monitoring suppliers and
the products supplied (including, for example, purchase controls and
product acceptance activities);
    (v) Handling of complaints, nonconforming products and processes,
and corrective and preventative actions;
    (vi) Testing procedures carried out before the product is released
to market, including:
    (A) A list and summary of any standards used for all testing
methods;
    (B) Validation and verification activities for all test methods
used to ensure that the tobacco product meets specifications;
    (C) Documentation of accreditation information for all testing
laboratories;
    (D) Complete description of smoking or aerosol-generating regimes
used for analytical testing, if any; and
    (E) Tobacco product specifications (including any physical,
chemical, and biological specifications) and acceptance criteria for
those specifications;
    (F) Reports of release testing performed on finished products to
demonstrate conformity with established specifications, including test
protocols, line data, and a summary of the results for each applicable
testing.
    (k) Health risk investigations--(1) Study types. The application
must contain full reports of all information, both favorable and
unfavorable, published or known to, or which should reasonably be known
to, the applicant concerning investigations, including nonclinical and
human subject studies regarding the following topics. If no substantive
information exists regarding the topics specified in Sec.
1114.27(b)(1)(ii), including information from published literature or
that may be bridged from an investigation of another tobacco product,
an applicant may need to conduct its own investigation(s) to ensure
substantive information is included in the PMTA to meet the application
filing requirements.
    (i) Health risks of the product. The potential health risks of the
tobacco product to users and nonusers, including potential exposures
and information regarding risks to youth, young adults, and other
relevant vulnerable populations, and whether the product may present
different risks than other tobacco products, including:
    (A) The health effects of the constituents, including HPHCs, at the
quantitative levels delivered to both users and nonusers under the
range of conditions under which the product might be used;
    (B) The toxicological profile of the new tobacco product related to
the route of administration, including the genotoxicity,
carcinogenicity, reproductive toxicity, immunotoxicity, acute toxicity,
and repeat dose (chronic) toxicity of the new tobacco product relative
to other tobacco products. The toxicological profile also includes
information on the toxicity of the ingredients, additives, and HPHCs,
relative to the route of administration and the range of potential
levels of exposure resulting from the use of, or exposure to, the new
tobacco product, including studies which discuss the toxicological
effects of any leachables and extractables that can appear from the
container closure system and the ingredient mixture, such as additive
or synergistic effects;
    (C) The pharmacological profile of the new tobacco product,
including the pharmacokinetics, pharamacodynamics, metabolism, and
elimination profile, of any of the ingredients, additives, and HPHCs
for the range of potential levels of exposure resulting from the use
of, or exposure to, the new tobacco product relative to other tobacco
products. The applicant must specify whether the studies were conducted
in vitro, in vivo, ex vivo, or in silico; and
    (D) The health risks of the tobacco product compared to other
tobacco products on the market, never using tobacco products, quitting
tobacco product use, and using the tobacco product in conjunction with
other tobacco products.
    (ii) Impacts on tobacco use behavior of tobacco product users. How
the product and its label, labeling, and advertising, to the extent
that advertising has been studied, will affect the tobacco use behavior
of tobacco product users, specifically considering

youth, young adults, and other relevant vulnerable populations,
including:
    (A) The abuse liability of the tobacco product;
    (B) How users actually use the product, including use topography,
product use frequency, use trends over time, and how such use affects
the health risks of the product to individual users;
    (C) The likelihood that users will use the product in conjunction
with other tobacco products;
    (D) The likelihood that current tobacco product users will start
using the product;
    (E) The likelihood that current tobacco users who adopt the product
will switch to or switch back to other tobacco products that may
present increased risks to individual health; and
    (F) The likelihood that current tobacco users who may have
otherwise quit using tobacco products will instead start or continue to
use the product.
    (iii) Impacts on tobacco use initiation by nonusers, including
youth, young adults, and other relevant vulnerable populations. The
impact of the tobacco product and its label, labeling, or advertising,
to the extent that advertising has been studied, on tobacco use
initiation by nonusers, including:
    (A) The likelihood that consumers who have never used tobacco
products, particularly youth, young adults, and other relevant
vulnerable populations, will initiate use of the tobacco product;
    (B) The likelihood that nonusers of tobacco products who adopt the
tobacco product will switch to other tobacco products that may present
higher levels of individual health risk; and
    (C) The likelihood that former users of tobacco products will re-
initiate use with the tobacco product.
    (iv) Perceptions and use intentions. The impact of the product and
its label, labeling, and advertising, to the extent that advertising
has been studied, on individuals:
    (A) Perception of the product;
    (B) Use intentions; and
    (C) Ability to understand the labeling and instructions for use and
use the product in accordance with those instructions.
    (v) Human factors. The impact of human factors on product risk,
including discussion of use conditions, use environments, use related
hazards, estimated use error risk, potential unintended uses, risk
controls to ensure that harms and unintended consequences are
minimized, and adverse experiences related to such uses.
    (2) Literature search. The applicant must conduct a literature
search for each type of information described in paragraph (k)(1) of
this section, and the application must contain a description of the
literature search performed, including the databases searched and the
date searched, search terms, reasons for inclusion or exclusion of
documents, and the strategy for study quality assessment. The
application must also contain a bibliography of all published studies
and articles referenced in the application. If a literature search was
performed and resulted in no information found, the application must
contain a statement to that effect.
    (3) Study reports. The full report of each study included in the
application must describe the specific product studied and include the
following items, where applicable and to the extent reasonably
available. For applicable items not contained in the full report of an
investigation, the applicant must contain a description of the actions
taken to obtain the information and why the document is not reasonably
available.
    (i) Full copies of any published articles and other reference
materials;
    (ii) Documentation of all actions taken to ensure the reliability
of the study. For all studies, to the extent reasonably available or
obtainable, the application must contain a certification that
investigators do not have, or documentation fully disclosing, any
financial conflicts of interest, such as the financial arrangements
specified in the Financial Disclosure by Clinical Investigators
regulation in part 54 of this chapter. Additionally, for nonclinical
laboratory studies, the application must contain, for each study,
documentation of all actions taken to ensure the reliability of the
study, e.g., documentation of whether the study was conducted in
accordance with good laboratory practices, such as those specified in
part 58 of this chapter;
    (iii) Copies of all versions of protocols and amendments that were
used in the study;
    (iv) Copies of all versions of investigator instructions, if any
were produced in addition to the protocol;
    (v) The statistical analysis plan, including a detailed description
of the statistical analyses used (including all variables, confounders,
and subgroup analyses), the scientific rationale for the choice of
sample sizes, and any amendments to the plan;
    (vi) Line data, including data definition files that include the
names of the variables, codes, and formats in each dataset, and copies
of programs and any necessary macro-programs used to create derived
datasets, and the results included in the study reports;
    (vii) A list of sites and clinical investigators that conducted the
study, including contact information and physical address(es);
    (viii) The location of all source data. If the site where the study
was conducted has not maintained all of the source data, indicate where
the data are located;
    (ix) The format of the records and data (e.g., electronic or hard
copy);
    (x) A list of all sites that had early termination and the reason
for early termination, if applicable;
    (xi) A list of contractors who participated in the study, the role
of each contractor, and the initiation and termination dates of the
participation of each contractor;
    (xii) A signed full report of all findings;
    (xiii) For human subject studies:
    (A) All versions of study materials (e.g., consent forms,
questionnaires, stimuli) used;
    (B) All versions of case report forms used; and
    (C) Individual case report forms related to participant deaths,
other serious and unexpected adverse experiences, withdrawals, and
participant discontinuation where the study participant was exposed to
the tobacco product that is the subject of the PMTA or similar
products; and
    (xiv) For tobacco product perception and use intention studies that
use advertising as stimuli, a statement describing whether the
advertising used is representative of advertising that the applicant
intends to use in marketing the product. If the advertising is not
representative of the advertising an applicant intends to use in
marketing the product, the applicant must describe whether the study
results are still relevant to the likely impact of the advertising on
tobacco product perceptions and use intentions.
    (l) The effect on the population as a whole. The application must
contain an analysis and discussion of how the data and information
contained in the application establish that permitting the tobacco
product to be marketed would be appropriate for the protection of
public health determined with respect to the population as a whole,
including users and nonusers of the tobacco product. The analysis and
discussion must integrate all of the information in the application
regarding the product and its likely effects on health, and tobacco use
behavior, including tobacco use cessation and initiation, to provide an
overall assessment of the likely effect that the marketing of the
tobacco product may have on overall tobacco-related morbidity and
mortality.

    (m) Certification statement. The application must contain the
following certification, with the appropriate information inserted (as
indicated by parenthetical italicized text), signed by an authorized
representative of the applicant:

    ``I (name of responsible official) on behalf of the applicant,
(applicant name), hereby certify that the applicant will maintain
all records to substantiate the accuracy of this application for the
period of time required in 21 CFR 1114.45 and ensure that such
records remain readily available to FDA upon request. I certify that
this information and the accompanying submission are true and
correct, that no material fact has been omitted, and that I am
authorized to submit this on the applicant's behalf. I understand
that under section 1001 of title 18 of the United States Code 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.''

Sec.  1114.9   Amendments.

    (a) General. FDA may request, or an applicant may submit on its own
initiative, an amendment to a PMTA containing information that is
necessary for FDA complete the review of a pending PMTA. An amendment
must include the appropriate form and specify the STN assigned to the
original submission and, if submitted other than at FDA's request, the
reason for submitting the amendment. An amendment must also include the
certification statement set forth in Sec.  1114.7(m), with the
appropriate information inserted, and signed by an authorized
representative of the applicant.
    (b) Review of an amendment. Submission of an amendment may affect
the timing of review of an amended submission as follows:
    (1) If the amendment is a major amendment (e.g., an amendment that
contains significant new data from a previously unreported study,
detailed new analyses of previously submitted data, or substantial new
manufacturing information), FDA will restart the 180-day review period
after receipt of the amendment.
    (2) If FDA requests a minor amendment (i.e., an amendment that is
not a major amendment) and receives a written response submitting the
requested amendment, FDA may pause the review period for the number of
days elapsed between the date of the request and the date that FDA
receives the written response.
    (c) Failure to respond to amendment request. If FDA requests an
amendment and the applicant does not respond within the time period
specified in FDA's request, FDA may consider the applicant to have
submitted a request to voluntarily withdraw the pending PMTA under
Sec.  1114.11 and issue an acknowledgment letter notifying the
applicant of the withdrawal.
    (d) No amendment to closed or withdrawn application. An applicant
may not amend an application after FDA has closed the application
through an action under Sec.  1114.29 or it has been withdrawn under
Sec.  1114.11.

Sec.  1114.11  Withdrawal by applicant.

    (a) An applicant may at any time make a written request using the
appropriate form to withdraw a PMTA that FDA has not acted on as
described in Sec.  1114.29. The withdrawal request must state:
    (1) Whether the withdrawal is due to a health concern related to
the tobacco product and, if so, a description of those concerns,
including the extent, duration, and frequency of the health effects,
and what gave rise to the concerns, such as reports of adverse
experiences;
    (2) The application STN; and
    (3) The name(s) of the new tobacco product that is the subject of
the application.
    (b) An application will be considered withdrawn when FDA issues an
acknowledgement letter stating that the application has been withdrawn.
    (c) The application is an Agency record, even if withdrawn. FDA
will retain the withdrawn application under Federal Agency records
schedules. The availability of the withdrawn application will be
subject to FDA's public information regulation in Part 20 of this
chapter.

Sec.  1114.13  Change in ownership of an application.

    An applicant may transfer ownership of a PMTA. At or before the
time of transfer, the new owner and the former owner must submit
information to FDA using the appropriate form as follows:
    (a) The new and former owner must sign and submit a notice to FDA
stating that all of the former applicant's rights and responsibilities
relating to the PMTA have been transferred to the new owner. This
notice must identify the name and address of the new owner and the PMTA
transferred by tobacco product name(s) and STN.
    (b) The new owner must sign and submit a notice to FDA containing
the following:
    (1) The new owner's commitment to agreements, promises, and
conditions made by the former owner and contained in the application
and marketing granted order, if applicable;
    (2) The date that the change in ownership is effective;
    (3) Either a statement that the new owner has a complete copy of
the application, including all amendments, the marketing granted order
(if applicable), and any records that are required to be kept under
Sec.  1114.45, or a request for a copy of the application, including
all amendments, and the modified risk order (if applicable) from FDA's
files in accordance with part 20 of this chapter. In accordance with
the Freedom of Information Act, FDA will provide a copy of the
application to the new owner under the fee schedule in FDA's public
information regulations in Sec.  20.45 of this chapter; and
    (4) A certification that no modifications have been made to the
tobacco product since the application, including amendments (if any),
was submitted to FDA.

Sec.  1114.15   Supplemental applications.

    (a) Supplemental PMTA submission. Applicants that have received a
marketing granted order for a tobacco product may, as an alternative
format of submitting an application that meets the content requirements
of Sec.  1114.7, submit a supplemental PMTA to seek marketing
authorization for modifications to such product, which result in a new
tobacco product under section 910(a)(1) of the Federal Food, Drug, and
Cosmetic Act. Supplemental PMTAs must include new information
concerning modifications that create the new tobacco product but allow
the applicant to satisfy the remaining application requirements by
cross-referencing applicable content from the previously submitted PMTA
for the original tobacco product. Applicants may submit supplemental
PMTAs only for modifications that require the submission of limited new
information or where specified in a rule under section 907 of the FD&C
Act. Except as permitted in a rule under section 907 of the Federal
Food, Drug, and Cosmetic Act, an applicant may not submit a
supplemental PMTA where:
    (1) Modifications to the product that result in the new tobacco
product require the submission of new information or revisions to the
PMTA for the original product to the extent that reviewing a
supplemental application for the new tobacco product would be
confusing, cumbersome, or otherwise inefficient and submitting a
standard PMTA under Sec.  1114.7 would better facilitate review.

    (2) The marketing granted order for the original tobacco product
has been withdrawn; or
    (3) The marketing granted order for the original tobacco product
has been temporarily suspended or is subject to temporary suspension or
withdrawal proceedings by FDA, except where authorized in writing by
FDA.
    (b) Required format. The supplemental PMTA must comply with format
requirements of Sec.  1114.7(b), except that an applicant must include
certain content in a supplemental PMTA by cross-referencing a PMTA, or,
where applicable, a supplemental PMTA, for an original tobacco product
that is owned by that applicant, and may include other content by
cross-referencing a tobacco product master file and postmarket reports
for the original tobacco product. FDA will not consider content
included by cross-reference to other sources of information outside of
the submission.
    (c) Required content. The supplemental PMTA must provide sufficient
information for FDA to determine whether any of the grounds for denial
listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act
apply to the application.
    (1) The application must contain the full text of all the
information described in the following sections:
    (i) General information that identifies the submission as a
supplemental PMTA (as described in Sec.  1114.7(c));
    (ii) New product information (as described in paragraph (d) of this
section);
    (iii) Statement of compliance with 21 CFR part 25 (as described in
Sec.  1114.7(g));
    (iv) Labeling (as described in Sec.  1114.7(f)) if the labeling is
not identical to the labeling submitted in the PMTA or postmarket
reports for the original product;
    (v) Postmarket information (as described in paragraph (e) of this
section); and
    (vi) Certification statement (as described in paragraph (f) of this
section);
    (2) The application must include the following sections by cross-
reference to the PMTA for the original tobacco product and contain any
additional information that is necessary to supplement or update the
cross-referenced information:
    (i) Descriptive information (as described in Sec.  1114.7(d));
    (ii) Product samples (as described in Sec.  1114.7(e));
    (iii) Labeling (as described in Sec.  1114.7(f)) if the labeling is
identical to the labeling that was submitted in the PMTA or postmarket
reports for the original tobacco product;
    (iv) Summary of all research findings (as described in Sec.
1114.7(h));
    (v) Product formulation (as described in Sec.  1114.7(i));
    (vi) Manufacturing (as described in Sec.  1114.7(j)); and
    (vii) Health risk investigations (as described in Sec.  1114.7(k)).
    (d) New product information. The application must contain a section
that includes:
    (1) Full descriptions of each modification to the product and
comparisons to the original product version described in the previously
authorized PMTA;
    (2) A statement as to whether the new tobacco product, if it
receives a marketing granted order, will replace the original tobacco
product, will be a line extension of the original tobacco product, or
will be introduced as an additional product by the same manufacturer;
    (3) All data and information relating to each modification to the
product that would be required in an application under Sec.  1114.7;
and
    (4) A concluding summary of how the new tobacco product meets the
requirements to receive a marketing granted order, including how the
data and information contained in both the supplemental PMTA and cross-
referenced from the previously authorized PMTA constitute valid
scientific evidence and establishes that the PMTA meets the
requirements of section 910(c) of the Federal Food, Drug, and Cosmetic
Act to receive a marketing granted order, including that permitting the
new tobacco product to be marketed would be appropriate for the
protection of the public health determined with respect to the risks
and benefits to the population as a whole, including users and nonusers
of the tobacco product.
    (e) Postmarket reports. (1) If an applicant has submitted
postmarket reports for the original tobacco product, the applicant must
include all such reports in the application by cross-reference.
    (2) If an applicant is required to, but has not yet submitted a
postmarket report, the applicant must submit a report as part of its
application that contains all of the information for the original
tobacco product that would otherwise be required in a report under
Sec.  1114.41 covering the period of time from when it received a
marketing granted order for the original tobacco product to when it
submits the supplemental PMTA.
    (f) Certification statement. The application must contain the
following certification, with the appropriate information inserted as
indicated by parenthetical italicized text, signed by an authorized
representative of the applicant:
    ``I, (name of responsible official), on behalf of (name of
applicant), certify that (new tobacco product name) has a different
(describe each modification to the product) than (name of original
tobacco product) described in (STN of the PMTA for the original
product) but is otherwise identical to (name(s) of original tobacco
product). I certify that (name of applicant) understands this means
there is no other modification to the materials, ingredients,
design, composition, heating source, or any other feature of the
original tobacco product. I also certify that (name of applicant)
will maintain all records that substantiate the accuracy of this
application and ensure that such records remain readily available to
FDA upon request for the period of time required in 21 CFR 1114.45.
I certify that this information and the accompanying submission are
true and correct, and that I am authorized to submit this on the
applicant's behalf. I understand that under section 1001 of title 18
of the United States Code, 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.''

Sec.  1114.17  Resubmissions.

    (a) General. An applicant may, as an alternative format of