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List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 1107

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

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

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
1. The authority citation for part 16 continues to read as follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
2. In Sec.  16.1(b)(2) add in numerical sequence an entry for ``Sec.
1107.50'' to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec.  1107.50, relating to rescission of an order finding a tobacco
product substantially equivalent.
* * * * *

PART 1107--EXEMPTIONS AND SUBSTANTIAL EQUIVALENCE REPORTS

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

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

0
4. The heading of part 1107 is revised to read as set forth above.

0
5. Add subparts B through E to read as follows:
Subpart B--General
Sec.
1107.10 Scope.
1107.12 Definitions.
Subpart C--Substantial Equivalence Reports
1107.16 Submission of a substantial equivalence report.
1107.18 Required content and format of an SE Report.
1107.19 Comparison information.
1107.20 Amendments.
1107.22 Withdrawal by applicant.
1107.24 Change in ownership of an SE Report.
Subpart D--FDA Review
1107.40 Communications between FDA and applicants.
1107.42 Review cycles.
1107.44 FDA action on an SE Report.
1107.46 Issuance of an order finding a new tobacco product
substantially equivalent.
1107.48 Issuance of an order denying marketing authorization.
1107.50 Rescission of order.
Subpart E--Miscellaneous
1107.58 Record retention.
1107.60 Confidentiality.
1107.62 Electronic submission.

Subpart B--General

Sec.  1107.10   Scope.

    (a) Subparts B through E of this part apply to a substantial
equivalence report (or an SE Report) for a new tobacco product, other
than ``premium'' cigars as defined in Sec.  1107.12, that has:
    (1) Characteristics different from a predicate tobacco product and
for which information is submitted to demonstrate it is not appropriate
to regulate the product under section 910(b) and (c) of the Federal
Food, Drug, and Cosmetic Act because the new tobacco product does not
raise different questions of public health or
    (2) The same characteristics as a predicate tobacco product.
    (b) These subparts set forth procedures and requirements for the
submission to FDA of an SE Report under sections 905 and 910 of the
Federal, Food, Drug, and Cosmetic Act; the basic criteria for
establishing substantial equivalence; and the general procedures FDA
will follow when evaluating submissions.

Sec.  1107.12   Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or

    (2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product but
    (i) Solely controls moisture and/or temperature of a stored
product; or
    (ii) Solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
    Additive means any substance the intended use of which results or
may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristic of any
tobacco product (including any substances intended for use as a
flavoring or coloring or in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding),
except that the term does not include tobacco or a pesticide chemical
residue in or on raw tobacco, or a pesticide chemical.
    Applicant means any manufacturer of tobacco products who is subject
to chapter IX of the Federal Food, Drug, and Cosmetic Act that submits
a premarket application to receive marketing authorization for a new
tobacco product.
    Brand means a variety of tobacco product distinguished by the
tobacco used, tar content, nicotine content, flavoring used, size,
filtration, packaging, logo, registered trademark, brand name(s),
identifiable pattern of colors, or any combination of such attributes.
    Characteristic means the materials, ingredients, design,
composition, heating source, or other features of a tobacco product.
    Commercial distribution means any distribution of a tobacco
product, whether domestic or imported, to consumers or to any person,
but does not include interplant transfers of a tobacco product between
establishments within the same parent, subsidiary, and/or affiliate
company, nor does it include providing a tobacco product for product
testing where such product is not made available for personal
consumption or resale. ``Commercial distribution'' does not include the
handing or transfer of a tobacco product from one consumer to another
for personal consumption.
    Commercially marketed means selling or offering for sale a tobacco
product in the United States to consumers or to any person for the
eventual purchase by consumers in the United States.
    Component or part means any software or assembly of materials
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance,
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco
product. Component or part excludes anything that is an accessory of a
tobacco product.
    Composition means the materials in a tobacco product, including
ingredients, additives, and biological organisms. The term includes the
manner in which the materials, for example, ingredients, additives, and
biological organisms, are arranged and integrated to produce a tobacco
product.
    Constituent means any chemical or chemical compound in a tobacco
product that is or potentially is inhaled, ingested, or absorbed into
the body, any chemical or chemical compound in an emission (e.g.,
smoke, aerosol, droplets) from a tobacco product, that either transfers
from any component or part of the tobacco product to the emission or
that is formed by the combustion or heating of tobacco, additives, or
other component of the tobacco product.
    Container closure system means any packaging materials that are a
component or part of a tobacco product.
    Design means the form and structure concerning, and the manner in
which, components or parts, ingredients, software, and materials are
integrated to produce a tobacco product.
    Distributor means any person who furthers the distribution of a
tobacco product, whether domestic or imported, at any point from the
original place of manufacture to the person who sells or distributes
the product to individuals for personal consumption. Common carriers
are not considered distributors for the purposes of this part.
    Finished tobacco product means a tobacco product, including all
components and parts, sealed in final packaging (e.g., filters or
filter tubes sold to consumers separately or as part of kits) or in the
final form in which it is intended to be sold to consumers.
    Harmful or potentially harmful constituent (HPHC) means any
chemical or chemical compound in a tobacco product or tobacco smoke or
emission that:
    (1) Is or potentially is inhaled, ingested, or absorbed into the
body, including as an aerosol or any other emission; and
    (2) Causes or has the potential to cause direct or indirect harm to
users or nonusers of tobacco products.
    Health information statement means a statement, made under section
910(a)(4) of the Federal Food, Drug, and Cosmetic Act, that the health
information related to a new tobacco product will be made available
upon request by any person.
    Health information summary means a summary, submitted under section
910(a)(4) of the Federal Food, Drug, and Cosmetic Act, of any health
information related to a new tobacco product.
    Heating source means the source of energy used to burn or heat the
tobacco product.
    Ingredient means tobacco, substances, compounds, or additives
contained within or added to the tobacco, paper, filter, or any other
component or part of a tobacco product, including substances and
compounds reasonably expected to be formed through a chemical reaction
during tobacco product manufacturing.
    Material means an assembly of ingredients. Materials are assembled
to form a tobacco product or components or parts of tobacco products.
    New tobacco product means:
    (1) Any tobacco product (including those products in test markets)
that was not commercially marketed in the United States as of February
15, 2007; or
    (2) Any modification (including a change in design, any component,
any part, or any constituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or any other additive or
ingredient) of a tobacco product where the modified product was
commercially marketed in the United States after February 15, 2007.
    Other features means any distinguishing qualities of a tobacco
product similar to those specifically enumerated in section
910(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. Such other
features include harmful and potentially harmful constituents and any
other product characteristics that relate to the chemical, biological,
and physical properties of the tobacco product.
    Package or packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
    Predicate tobacco product means a tobacco product that was
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007, or a tobacco product that FDA has
previously found substantially equivalent under section 910(a)(2)(A)(i)
of the Federal Food, Drug, and Cosmetic Act.
    Premium cigars means a type of cigar that:
    (1) Is wrapped in whole tobacco leaf;
    (2) Contains a 100 percent leaf tobacco binder;
    (3) Contains at least 50 percent (of the filler by weight) long
filler tobacco (i.e., whole tobacco leaves that run the length of the
cigar);

    (4) Is handmade or hand rolled (i.e., no machinery was used apart
from simple tools, such as scissors to cut the tobacco prior to
rolling);
    (5) Has no filter, nontobacco tip, or nontobacco mouthpiece;
    (6) Does not have a characterizing flavor other than tobacco;
    (7) Contains only tobacco, water, and vegetable gum with no other
ingredients or additives; and
    (8) Weighs more than 6 pounds per 1,000 units.
    Submission tracking number or STN means the number that FDA assigns
to submissions that are received from a manufacturer of tobacco
products, such as SE Reports and voluntary requests for determinations
that a tobacco product was commercially marketed in the United States
as of February 15, 2007.
    Substantial equivalence or substantially equivalent means, with
respect to a new tobacco product being compared to a predicate tobacco
product, that FDA by order has found that the new tobacco product:
    (1) Has the same characteristics as the predicate tobacco product;
or
    (2) Has different characteristics and the information submitted
contains information, including clinical data if deemed necessary by
FDA, that demonstrates that it is not appropriate to require premarket
review under section 910(b) and (c) of the Federal Food, Drug, and
Cosmetic Act because the new tobacco product does not raise different
questions of public health.
    Substantial equivalence report or SE Report means a submission
under section 905(j)(1)(A)(i) of the Federal Food, Drug, and Cosmetic
Act that includes the basis for the applicant's determination that a
new tobacco product is substantially equivalent to a predicate tobacco
product. This term includes the initial substantial equivalence report
and all subsequent amendments.
    Tobacco product means any product made or derived from tobacco that
is intended for human consumption, including any component, part, or
accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). The term ``tobacco product'' does not mean an article
that under the Federal Food, Drug, and Cosmetic Act is a drug (section
201(g)(1)), a device (section 201(h)), or a combination product
(section 503(g)).
    Tobacco product manufacturer means any person, including a repacker
or relabeler, who:
    (1) Manufactures, fabricates, assembles, processes, or labels a
tobacco product, or
    (2) Imports a finished tobacco product for sale or distribution in
the United States.

Subpart C--Substantial Equivalence Reports

Sec.  1107.16   Submission of a substantial equivalence report.

    An applicant may submit an SE Report intended to demonstrate that a
new tobacco product is substantially equivalent to a predicate tobacco
product. The applicant must submit the SE Report at least 90 calendar
days prior to the date the applicant intends to introduce or deliver
for introduction a new tobacco product into interstate commerce for
commercial distribution. The applicant cannot begin commercial
distribution of the new tobacco product until FDA has provided the
applicant an order stating that the Agency has determined that the new
tobacco product is substantially equivalent to a predicate tobacco
product, unless the new tobacco product has received authorization to
be marketed through another premarket pathway.

Sec.  1107.18   Required content and format of an SE Report.

    (a) Overview. The SE Report must provide information uniquely
identifying the new tobacco product and the predicate tobacco product,
and compare the new tobacco product to either a tobacco product
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007, or a tobacco product that FDA
previously found to be substantially equivalent. The SE Report must
provide sufficient information as described in this section to enable
FDA to determine whether the new tobacco product is substantially
equivalent to a tobacco product that was commercially marketed (other
than for test marketing) in the United States as of February 15, 2007.
If FDA cites deficiencies and requests information to support a
statement in the SE Report, the applicant must provide that information
for review to continue, or FDA may issue an order under Sec.  1107.48.
FDA generally intends to refuse to accept an SE Report for review if it
does not comply with Sec.  1105.10 and this section. The SE Report must
contain the following information:
    (1) General information (as described in paragraph (c) of this
section);
    (2) Summary (as described in paragraph (d) of this section);
    (3) New tobacco product description (as described in paragraph (e)
of this section);
    (4) Predicate tobacco product description (as described in
paragraph (f) of this section), including a statement that the
predicate tobacco product has not been removed from the market at the
initiative of FDA and has not been determined by judicial order to be
adulterated or misbranded, and the submission tracking number of the SE
order finding the predicate product SE, or the submission tracking
number of, or information to support, that the predicate tobacco
product was commercially marketed (other than for test marketing) in
the United States as of February 15, 2007;
    (5) Comparison information (as described in paragraph (g) of this
section);
    (6) Comparative testing information (as described in paragraph (h)
of this section);
    (7) Statement of compliance with applicable tobacco product
standards (as described in paragraph (i) of this section);
    (8) Health information summary or statement that such information
will be made available upon request (as described in paragraph (j) of
this section);
    (9) Compliance with part 25 of this chapter (as described in
paragraph (k) of this section); and
    (10) Certification statement (as described in paragraph (l) of this
section).
    (b) Format. The applicant must submit the SE Report using the
form(s) that FDA provides. The SE Report must contain a comprehensive
index and table of contents, be well-organized and legible, and be
written in English. As described in Sec.  1107.62, the applicant must
submit the SE Report and all information supporting the SE Report in an
electronic format that FDA can process, read, review, and archive,
unless FDA has provided a waiver under Sec.  1107.62(b).
    (c) General information. The SE Report must include the following
information, using the form FDA provides:
    (1) The date the SE Report is submitted;
    (2) Type of submission (e.g., the SE Report or amendment to a
report);
    (3) FDA STN, if previously assigned;
    (4) Any other relevant FDA STN, such as a voluntary request for a
determination that a tobacco product was commercially marketed in the
United States as of February 15, 2007, or SE Report previously found
substantially equivalent (if applicable),

and cross-references to meetings with FDA regarding the new tobacco
product;
    (5) Applicant name, address, and contact information (including
email address);
    (6) Authorized representative or U.S. agent (for a foreign
applicant), including the name, address, and contact information
(including email address);
    (7) For both the new and predicate tobacco products, the following
information to uniquely identify the products:
    (i) Manufacturer;
    (ii) Product name, including the brand and sub brand (or other
commercial name used in commercial distribution); and
    (iii) Product category, product subcategory, and product properties
(if the product does not have a listed product property, e.g.,
ventilation or characterizing flavor, the report must state ``none''
for that property) as provided in the following table:

                  Table 1 to Sec.   1107.18(c)(7)(iii)
------------------------------------------------------------------------
                                 Tobacco product
   Tobacco product category        subcategory       Product properties
------------------------------------------------------------------------
(A) Cigarettes................  (1) Filtered.....  --Package type (e.g.,
                                                    hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89.1
                                                    millimeters (mm),
                                                    100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Non-filtered.  --Package type (e.g.,
                                                    hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Other........  --Package type (e.g.,
                                                    hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
(B) Roll-Your-Own Tobacco       (1) Roll-Your-Own  --Package type (e.g.,
 Products.                       Tobacco Filler.    bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20.1 grams
                                                    (g), 16 ounces
                                                    (oz.)).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Rolling Paper  --Package type (e.g.,
                                                    box, booklet).
                                                   --Product quantity
                                                    (e.g., 50 sheets,
                                                    200 papers).
                                                   --Length (e.g., 79.1
                                                    mm, 100 mm, 110.2
                                                    mm).
                                                   --Width (e.g., 28.1
                                                    mm, 33 mm, 45.2 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Filtered       --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 tubes,
                                                    200 tubes).
                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Non-Filtered   --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 tubes,
                                                    200 tubes).
                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) Filter.......  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 filters,
                                                    200 filters).
                                                   --Length (e.g., 8 mm,
                                                    12.1 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (6) Paper Tip....  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity
                                                    (e.g., 200 tips, 275
                                                    tips).
                                                   --Length (e.g., 12
                                                    mm, 15.1 mm).

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

                                                   --Portion thickness
                                                    (e.g., 5.1 mm, 7
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (9) Other........  --Package type (e.g.,
                                                    box, bag, can).
                                                   --Product quantity
                                                    (e.g., 20.1 g, 22.5
                                                    g, 3 oz.).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry, wintergreen,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
(D) Electronic Nicotine         (1) Open E-Liquid  --Package type (e.g.,
 Delivery Systems (ENDS)                            bottle, box, pod).
 (Vapes).
                                                   --Product quantity
                                                    (e.g., 1 bottle, 5
                                                    bottles).
                                                   --E-liquid volume
                                                    (e.g., 0.5
                                                    milliliters (ml)), 2
                                                    ml, 5.1 ml).
                                                   --Nicotine
                                                    concentration (e.g.,
                                                    0 mg/ml), 0.2 mg/ml,
                                                    0.4 mg/ml, 1%, 0.2
                                                    mg/bottle).
                                                   --Propylene Glycol
                                                    (PG)/Vegetable
                                                    Glycerin (VG) ratio
                                                    (e.g., not
                                                    applicable (N/A), 0/
                                                    100, 50/50, 100/0).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Closed E-      --Package type (e.g.,
                                 Liquid.            cartridge, pod).
                                                   --Product quantity
                                                    (e.g., 1 cartridge,
                                                    5 cartridges).
                                                   --E-liquid volume
                                                    (e.g., 0.5 ml, 2 ml,
                                                    5.1 ml).
                                                   --Nicotine
                                                    concentration (e.g.,
                                                    0 mg/ml, 0.2 mg/ml,
                                                    0.4 mg/ml, 1%, 0.2
                                                    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) Closed E-      --Package type (e.g.,
                                 Cigarette.         box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 e-
                                                    cigarette, 5 e-
                                                    cigarettes).
                                                   --Length (e.g., 100
                                                    mm, 120 mm)
                                                   --Diameter (e.g., 6
                                                    mm, 8 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 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
                                                    (if applicable).
                                (4) Open E-        --Package type (e.g.,
                                 Cigarette.         box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 e-
                                                    cigarette, 5 e-
                                                    cigarettes).
                                                   --Length (e.g., 100
                                                    mm, 120 mm)
                                                   --Diameter (e.g., 6
                                                    mm, 8 mm).
                                                   --Wattage (e.g., 100
                                                    W, 200 W).
                                                   --Battery capacity
                                                    (e.g., 100 mAh, 200
                                                    mAh).
                                                   --E-liquid volume
                                                    (e.g., 0.5 ml, 2 ml,
                                                    5.1 ml).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) ENDS           --Package type (e.g.,
                                 Component.         box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 coil).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry, wintergreen,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (6) Other........  --Package type (e.g.,
                                                    box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 e-
                                                    cigarette, 5
                                                    bottles).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cherry, wintergreen,
                                                    tobacco).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
(E) Cigars....................  (1) Filtered,      --Package type (e.g.,
                                 Sheet-Wrapped.     hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20 filtered
                                                    cigars, 25 filtered
                                                    cigars).

                                                   --Length (e.g., 89.1
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 0%, 10%, 25%).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Unfiltered,    --Package type (e.g.,
                                 Sheet-Wrapped.     box, film sleeve).
                                                   --Product quantity
                                                    (e.g., 1 cigar, 5
                                                    cigarillos).
                                                   --Length (e.g., 100.1
                                                    mm, 140 mm).
                                                   --Diameter (e.g., 8
                                                    mm, 10.1 mm).
                                                   --Tip (e.g., none,
                                                    wood tips, plastic
                                                    tips).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    menthol, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Unfiltered,    --Package type (e.g.,
                                 Leaf-Wrapped.      box, film, sleeve,
                                                    none).
                                                   --Product quantity
                                                    (e.g., 1 cigar, 5
                                                    cigars).
                                                   --Length (e.g., 150.1
                                                    mm, 200 mm).
                                                   h;Diameter (e.g., 8
                                                    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          --Package type (e.g.,
                                 Component.         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.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16.1
                                                    oz.).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    tobacco, 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
                                                    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   --Package type (e.g.,
                                 Filler.            box, none).
                                                   --Product quantity
                                                    (e.g., 20 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           --Package type (e.g.,
                                 Component.         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.,
                                                    box, bag, 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
                                                    mm, 500.1 mm).
                                                   --Width (e.g., 100.1
                                                    mm, 300 mm).
                                                   --Diameter (e.g.,
                                                    100.1 mm, 300 mm).
                                                   --No. 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      --Package type (e.g.,
                                 Tobacco Filler.    bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 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      --Package type (e.g.,
                                 Heat Source.       box, film sleeve,
                                                    bag, none).
                                                   --Product quantity
                                                    (e.g., 150 g, 680
                                                    g).
                                                   --Portion count
                                                    (e.g., 20 fingers,
                                                    10 discs, 1 base).
                                                   --Portion mass (e.g.,
                                                    15 g/finger, 10 g/
                                                    brick).
                                                   --Portion length
                                                    (e.g., 40 mm, 100
                                                    mm).
                                                   --Portion width
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Source of energy
                                                    (e.g., charcoal,
                                                    battery,
                                                    electrical).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    apple).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Waterpipe      --Package type (e.g.,
                                 Component.         box, bag, 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).
                                (5) Other........  --Package type (e.g.,
                                                    box, bag, 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     (1) Closed HTP...  --Package type (e.g.,
 (HTP).                                             box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 device, 1
                                                    HTP).
                                                   --Length (e.g., 100
                                                    mm, 120 mm).
                                                   --Diameter (e.g., 6
                                                    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
                                                    mm, 120 mm)
                                                   --Diameter (e.g., 6
                                                    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            --Package type (e.g.,
                                 Consumable.        hard pack, soft
                                                    pack, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 20 sticks, 25
                                                    cartridges).
                                                   --Length (e.g., 60
                                                    mm, 82 mm.)
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --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).
Other.........................  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).
------------------------------------------------------------------------

    (8) Address and the FDA Establishment Identifier number(s) of the
establishments involved in the manufacture and/or importation of the
new and predicate tobacco products.
    (d) Summary. The SE Report must include a summary at the beginning
of the SE Report that includes the following:
    (1) A concise description of the characteristics of the new tobacco
product;
    (2) A statement as to whether the applicant believes the new
tobacco product has the same characteristics as the predicate tobacco
product or has different characteristics but any differences in
characteristics do not cause the new tobacco product to raise different
questions of public health; and
    (3) A concise description of the similarities and differences
between the new tobacco product and the predicate tobacco product with
respect to their characteristics (materials, ingredients, design,
composition, heating source, or other features).
    (e) New tobacco product description. The applicant must identify
one new tobacco product in the SE Report for comparison to one
predicate tobacco product. The SE Report must describe the new tobacco
product in sufficient detail to enable FDA to evaluate its
characteristics. This part of the SE Report must include:
    (1) A narrative description of the new tobacco product and detailed
drawings or schematics of the new tobacco product, including its
container closure system, illustrating all components or parts of the
product. For a portioned tobacco product, the SE Report must also
include a diagram illustrating all components or parts of the
individual unit of use;
    (2) A description and the function of each component or part of the
new tobacco product, and an explanation of how each component or part
is integrated into the design of the new tobacco product; and
    (3) A concise overview of the process used to manufacture the new
tobacco product. If the manufacturing process for the new tobacco
product does not affect the characteristics of the new tobacco product
beyond what is described elsewhere in the SE Report, an applicant must
state that to satisfy this provision.
    (f) Description of predicate tobacco product. (1) The applicant
must identify a predicate tobacco product that is either a tobacco
product commercially marketed (other than for test marketing) as of
February 15, 2007, or a tobacco product that FDA previously found to be
substantially equivalent.
    (2) A tobacco product to which a new tobacco product is compared
must:
    (i) Have been either:
    (A) Commercially marketed (other than for test marketing) in the
United States as of February 15, 2007, as shown by either specific
information sufficient to support this in the SE Report, including a
statement that ``I, (insert name and position title of responsible
official), confirm that the predicate tobacco product associated with
this submission, (insert name of predicate tobacco product), was
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007,'' and, if applicable, reference to an
STN for a previous determination by FDA that the predicate product was
commercially marketed (other than for test marketing) in the United
States as of February 15, 2007; or
    (B) Previously determined to be substantially equivalent by FDA;
    (ii) Be an individual product and not a composite of multiple
products;
    (iii) Not be the subject of a rescission action by FDA, as
described in Sec.  1107.50; and
    (iv) Not have been removed from the market at the initiative of FDA
and not have been determined by judicial order to be adulterated or
misbranded.
    (g) Comparison information. The SE Report must include a comparison
of the characteristics of the new tobacco product and the predicate
tobacco product. If the new tobacco product has limited changes to a
characteristic(s) when compared to the predicate tobacco product, and
all other characteristics are identical (e.g., a change to product
quantity), the applicant must provide comparison information related to
any characteristic(s) that have changed, but may certify that the other
characteristics are identical under paragraph (l)(2) of this section.
The applicant must maintain records supporting the certification
consistent with Sec.  1107.58.
    (h) Comparative testing information. Other than for characteristics
that are identical, and for which the applicant has certified that the
characteristics are identical under paragraph (l)(2) of this section,
the SE Report must provide comparative testing information that has
been demonstrated to be fully validated on the characteristics of the
new and predicate tobacco products except where the applicant
adequately justifies that such comparative testing information is not
necessary to demonstrate that the new product:
    (1) Has the same characteristics as the predicate or
    (2) Does not raise different questions of public health.
    (i) Statement of compliance with applicable tobacco product
standards. The SE Report must either:
    (1) List and describe the action(s) taken by the applicant to
comply with applicable requirements under section 907 of the Federal
Food, Drug, and Cosmetic Act; or
    (2) State there are no applicable requirements under section 907 of
the Federal Food, Drug, and Cosmetic Act.
    (j) Health information summary or statement regarding availability
of such information. The SE Report must include either a health
information summary or a statement that such information will be made
available upon request, as provided in section 910(a)(4) of the Federal
Food, Drug, and Cosmetic Act, in accordance with the following:
    (1) Health information summary. If including a health information
summary with the SE Report, the applicant must provide a copy of the
full SE Report that excludes research subject identifiers and trade
secret and confidential commercial information as defined in Sec. Sec.
20.61 and 20.63 of this chapter; and either
    (i) Provide accurate, complete, and not false or misleading,
additional health information, including information, research, or data
about adverse health effects, that the applicant has or knows about
concerning the new tobacco product that is not contained in the SE
Report; or
    (ii) Provide the following statement, if true, about the new
tobacco product: ``Applicant does not have or know of any additional
health information, including information, research or data regarding
adverse health effects, about the new tobacco product that is the
subject of this SE Report.''
    (2) Statement regarding availability of health information. If the
applicant chooses to make the health information available upon
request, the SE Report must include the following statement, with the
appropriate applicant information inserted as indicated by
parenthetical text, signed by an authorized representative of the
applicant, made on a separate page of the SE Report, and clearly
identified as ``910(a)(4) health information statement'': ``I certify
that, in my capacity as (the position held in company by person
required to submit the SE Report, preferably the responsible official
of the applicant) of (company name), I will make available, upon
request, the information identified in 21 CFR 1107.18(j)(3) within 30
calendar days of a request.''
    (3) Content of health information. The health information the
applicant agrees

to make available in paragraph (j)(2) of this section must be a copy of
the full SE Report, excluding all research subject identifiers, trade
secrets, and confidential commercial information, as defined in
Sec. Sec.  20.61 and 20.63 of this chapter; and either:
    (i) Accurate, complete, and not false or misleading, additional
health information, including information, research, or data about
adverse health effects, that the applicant has or knows about
concerning the new tobacco product and that is not contained in the SE
Report; or
    (ii) The following statement, if true, about the new tobacco
product: ``(Company name) does not have or know of any additional
health information, including information, research or data regarding
adverse health effects about the new tobacco product that is the
subject of the provided SE Report.''
    (4) Requests for information. All requests for information under
paragraph (j)(2) of this section must be made in writing to the
authorized representative of the applicant, whose contact information
will be posted on the FDA website listing substantial equivalence
determinations. The applicant must provide FDA any updated information
if the contact information changes.
    (5) No modified risk violations. To the extent information is
included in the health information summary or health information
provided upon request under paragraphs (j)(1) and (2) of this section
that is not required by section 910(a)(4) of the Federal Food, Drug,
and Cosmetic Act or this paragraph (j), that information must not
contain a statement that would cause the tobacco product to be in
violation of section 911 of the Federal Food, Drug, and Cosmetic Act
upon the introduction or delivery for introduction of the proposed new
product into interstate commerce.
    (k) Compliance with part 25 of this chapter. (1) The SE Report must
include an environmental assessment prepared in accordance with Sec.
25.40 of this chapter, or a valid claim of categorical exclusion. 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.
    (2) The environmental assessment must include a statement
explaining whether the new tobacco product is intended to replace the
predicate tobacco product after the new tobacco product receives market
authorization, is intended to be a line extension of the predicate
tobacco product, is intended to be introduced as an additional product
by the same manufacturer, or if the new tobacco product will be
introduced as an additional product but by a different manufacturer.
    (l) Certification statement. (1) The SE Report must contain the
following certification, with the appropriate information inserted (as
indicated by parenthetical text), and be signed by an authorized
representative of the applicant: ``I (name of responsible official) on
behalf of (applicant), hereby certify that (applicant) will maintain
all records to substantiate the accuracy of this SE Report for the
period of time required in 21 CFR 1107.58 and ensure that such records
remain readily available to the 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.''
    (2) The SE Report must include the following certification, as well
as a justification for the certification, if an applicant chooses to
certify that certain characteristics are identical in lieu of providing
data for each characteristic of the new and predicate tobacco products.
This certification must include the appropriate information inserted
(as indicated by parenthetical text) and be signed by an authorized
representative of the applicant: ``I, (name of responsible official),
on behalf of (name of company), certify that (new tobacco product name)
has the following modification(s) as compared to (name of predicate
tobacco product): (describe modification(s), e.g., change in product
quantity or change in container closure system). Aside from these
modifications, the characteristics of (new tobacco product name) and
(name of predicate tobacco product) are identical. I certify that (name
of company) understands this means there is no other modification to
the materials, ingredients, design features, heating source, or any
other feature. I also certify that (name of company) will maintain
records to support the comparison information in 21 CFR 1107.19 that
substantiate the accuracy of this statement for the period of time
required in 21 CFR 1107.58, and ensure that such records remain readily
available to FDA upon request.''

Sec.  1107.19   Comparison information.

    The SE Report must include a comparison of the characteristics of
the new tobacco product to the predicate tobacco product. Where test
data is submitted, the testing information must include the test
protocols, quantitative acceptance criteria, and test results
(including means and variances, data sets, and a summary of the
results). Comparison testing must be conducted on a sufficient sample
size and on test samples that reflect the finished tobacco product
composition and design. The SE report must state whether the same test
methods were used for the new tobacco product and the predicate
product, and if the methods differed, an explanation as to how the
results of the different test methods can be compared. The SE report
must identify national and international standards used to test the new
and predicate tobacco products and explain any deviations from the
standard, or state that no standards were used for the testing. The SE
report must include the following:
    (a) Comparison of product design. The SE Report must include a
description of the product designs of the new and predicate tobacco
products and an identification of any differences. The SE Report must
include, in a tabular format, a side-by-side comparison of each design
parameter of the new and predicate tobacco products. The target
specification and upper and lower range limits must be provided for
each design parameter. Test data (including test protocols,
quantitative acceptance criteria, data sets (i.e., measured values),
and a summary of the results) must be provided for the new and
predicate tobacco products when the target specification or range
limits of the new tobacco product differ from the predicate tobacco
product. For tobacco cut size or particle size, when 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 for the new and predicate tobacco
products.
    (1) Cigarettes. For cigarettes, the required design parameter
information to be provided for each predicate and new tobacco product
is as follows:

                     Table 1 to Sec.   1107.19(a)(1)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specification With Upper and Lower Range Limits for:
    --Cigarette length (mm).
    --Cigarette circumference or diameter (mm).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (mm or cuts per inch (CPI)).
    --Filter ventilation (%).
    --Tipping paper length (mm).
    --Cigarette paper base paper porosity (CORESTA unit (CU)) or
     permeability.
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigarette paper band width (mm).
    --Cigarette paper band space (mm).
    --Filter efficiency (%) (If no filter efficiency data is available
     for the products, include information sufficient to show that the
     cigarette filter is unchanged (e.g., denier per filament (DPF),
     total denier (g/9000m), and filter density (g/cm\3\))).
    --Filter length (mm).
    --Filter pressure drop (mm H2O).
------------------------------------------------------------------------

                     Table 2 to Sec.   1107.19(a)(1)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco filler mass (mg).
    --Tobacco moisture (%) or oven volatiles (%).
    --Filter ventilation (%).
    --Tobacco cut size (mm or CPI).
    --Cigarette paper base paper porosity (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)).
    --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., DPF, total denier (g/9000m),
     and filter density (g/cm\3\))).
    --Filter pressure drop (mm H2O).
------------------------------------------------------------------------

    (2) Smokeless Tobacco. For portioned and non-portioned smokeless
tobacco products, the required design parameter information to be
provided for each predicate and new tobacco product is as follows:

                     Table 3 to Sec.   1107.19(a)(2)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specification With Upper and Lower Range Limits for:
    Portioned Smokeless Tobacco Products:
        --Tobacco cut size (mm or CPI) or tobacco particle size (mm or
         micron).
        --Tobacco moisture (%).
        --Portion length (mm).
        --Portion width (mm).
        --Portion mass (mg).
        --Pouch material thickness (mm) (if applicable).
        --Pouch material porosity or permeability (CU or L/m\2\/s) (if
         applicable).
        --Pouch material basis weight (g/m\2\). (if applicable).
        --Nicotine dissolution rate (%/min) (if applicable).
    Non-portioned Smokeless Tobacco Products:
        --Tobacco cut size (mm or CPI) or tobacco particle size (mm or
         micron).
        --Tobacco moisture (%).
------------------------------------------------------------------------

                     Table 4 to Sec.   1107.19(a)(2)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    Portioned Smokeless Tobacco Products:
        --Tobacco cut size (mm or CPI) or tobacco particle size (mm or
         micron).
        --Tobacco moisture (%).
        --Portion mass (mg).
        --Pouch material porosity or permeability (CU or L/m\2\/s).
        --Pouch material basis weight (g/m\2\).
        --Nicotine dissolution rate (%/min) (if applicable).
    Non-portioned Smokeless Tobacco Products:
        --Tobacco cut size (mm or CPI) or tobacco particle size (mm or
         micron).
        --Tobacco moisture (%).
------------------------------------------------------------------------

    (3) Roll-your-own tobacco, rolling papers. For roll-your-own
tobacco rolling papers, the required design parameter information to be
provided for each predicate and new tobacco product is as follows:

                     Table 5 to Sec.   1107.19(a)(3)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Paper length (mm).
    --Paper width (mm).
    --Mass per paper (mg).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity or permeability (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigarette paper band width (mm) (if applicable).
    --Cigarette paper band space (mm) (if applicable).
------------------------------------------------------------------------

                     Table 6 to Sec.   1107.19(a)(3)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Mass per paper (mg).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity or permeability (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
------------------------------------------------------------------------

    (4) Roll-your-own tobacco, non-filtered tubes. For roll-your-own
tobacco non-filtered tubes, the required design parameter information
to be provided for each predicate and new tobacco product is as
follows:

                     Table 7 to Sec.   1107.19(a)(4)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tube length (mm).
    --Tube circumference or diameter (mm).
    --Tube mass (mg).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigarette paper band width (mm) (if applicable).
    --Cigarette paper band space (mm) (if applicable).
------------------------------------------------------------------------

                     Table 8 to Sec.   1107.19(a)(4)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tube mass (mg).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)).
------------------------------------------------------------------------

    (5) Roll-your-own tobacco, filtered tubes. For roll-your-own
tobacco filtered tubes, the required design parameter information to be
provided for each predicate and new tobacco product is as follows:

                     Table 9 to Sec.   1107.19(a)(5)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tube length (mm).
    --Tube circumference or diameter (mm).
    --Tube mass (mg).
    --Tipping paper length (mm).
    --Filter ventilation (%).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity or permeability (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigarette paper band width (mm) (if applicable).
    --Cigarette paper band space (mm) (if applicable).
    --Filter length (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., DPF, total denier (g/9000m),
     and filter density (g/cm\3\))).
    --Filter pressure drop (mm H2O).
------------------------------------------------------------------------

                    Table 10 to Sec.   1107.19(a)(5)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tube mass (mg).

    --Filter ventilation (%).
    --Cigarette paper base paper basis weight (g/m\2\).
    --Cigarette paper base paper porosity or permeability (CU).
    --Cigarette paper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --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., DPF, total denier (g/9000m),
     and filter density (g/cm\3\))).
    --Filter pressure drop (mm H2O).
------------------------------------------------------------------------

    (6) Roll-your-own tobacco. For roll-your-own tobacco, the required
design parameter information to be provided for each predicate and new
tobacco product is as follows:

                    Table 11 to Sec.   1107.19(a)(6)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Tobacco cut size (mm or CPI).
    --Tobacco moisture (%) or oven volatiles (%).
------------------------------------------------------------------------

                    Table 12 to Sec.   1107.19(a)(6)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Tobacco cut size (mm or CPI).
    --Tobacco moisture (%) or oven volatiles (%).
------------------------------------------------------------------------

    (7) Filtered, sheet-wrapped cigars. For filtered, sheet-wrapped
cigars, the required design parameter information to be provided for
each predicate and new tobacco product is as follows:

                    Table 13 to Sec.   1107.19(a)(7)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Provide Target Specifications With Upper and Lower Range Limits for:
    --Cigar mass (mg).
    --Cigar wrapper basis weight (g/m\2\).
    --Cigar binder length (mm).
    --Cigar binder width (mm).
    --Cigar binder basis weight (g/m\2\).
    --Cigar length (mm).
    --Cigar overall diameter (mm).
    --Cigar minimum diameter (mm) (if applicable).
    --Cigar maximum diameter (mm) (if applicable).
    --Tobacco filler mass (mg).
    --Tobacco rod density (g/cm\3\).
    --Tobacco moisture or oven volatiles (%).
    --Tobacco cut size (CPI or mm).
    --Cigar wrapper porosity or permeability (CU).
    --Cigar wrapper length (mm).
    --Cigar wrapper width (mm).
    --Cigar wrapper band porosity or permeability (CU) (alternately,
     band diffusivity (cm\2\/s)) (if applicable).
    --Cigar wrapper band width (mm) (if applicable).
    --Cigar wrapper band space (mm) (if applicable).
    --Tipping paper length (mm).
    --Cigar binder porosity or permeability (CU).
    --Cigar binder band porosity or permeability (CU) (alternately, band
     diffusivity (cm\2\/s)) (if applicable).
    --Cigar binder band width (mm) (if applicable).
    --Cigar binder band space (mm) (if applicable).
    --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., DPF, total denier (g/9000m), and
     filter density(g/cm\3\))).
    --Filter pressure drop (mm H2O).
    --Filter length (mm).
    --Filter diameter (mm).
    --Filter ventilation (%).
------------------------------------------------------------------------

                    Table 14 to Sec.   1107.19(a)(7)
------------------------------------------------------------------------

-------------------------------------------------------------------------
Where Test Data Are Necessary, As Explained in Paragraph (a) of This
 Section, Provide This Information for the Following Parameters:
    --Cigar mass (mg).
    --Puff count.
    --Cigar wrapper basis weight (g/m\2\).

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

    (8) Unfiltered, sheet-wrapped cigars. For unfiltered, sheet-wrapped
cigars, the required design parameter information to be provided for
each predicate and new tobacco product is as follows:

                    Table 15 to Sec.   1107.19(a)(8)
------------------------------------------------------------------------