108. Brownson, E.G., C.M. Thompson, S. Goldsberry, et al.,
``Explosion Injuries from E-Cigarettes,'' N. Engl. J. Med.,
375:1400-1402, 2016, available at: https://www.nejm.org/doi/full/10.1056/NEJMc1608478.
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110. Oldendorf, W.H., ``Some Relationships Between Addiction and
Drug Delivery to the Brain,'' 120:13-25, 1992, available at: https://www.ncbi.nlm.nih.gov/pubmed/1501682.
111. Gorelick, D.A., ``The Rate Hypothesis and Agonist Substitution
Approaches to Cocaine Abuse Treatment,'' Advances in Pharmacology,
42:995-997, 1997, available at: https://www.sciencedirect.com/science/article/abs/pii/S105435890860914X.
112. *HHS, ``The Health Consequences of Smoking--50 Years of
Progress,'' A Report of the Surgeon General, 2014, available at:
https://www.hhs.gov/surgeongeneral/reports-and-publications/tobacco/index.html.
113. Kasza, K.A., et al., ``Tobacco-Product by Adults and Youths in
the United States in 2013 and 2014,'' New England Journal of
Medicine, 376(4):342-353, 2017, available at: https://www.nejm.org/doi/full/10.1056/nejmsa1607538.
114. *Jamal, A., et al., ``Tobacco Use Among Middle and High School
Students--United States, 2011-2016,'' Morbidity and Mortality Weekly
Report, 66.23, 2017, available at: https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm.
115. Shahab, L., et al., ``Nicotine, Carcinogen, and Toxin Exposure
in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A
Cross-Sectional Study,'' Annals of Internal Medicine 166(6):390-400,
2017, available at: https://annals.org/aim/fullarticle/2599869/nicotine-carcinogen-toxin-exposure-long-term-e-cigarette-nicotine-replacement.
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118. *Preliminary Regulatory Impact Analysis; Initial Regulatory
Flexibility Analysis; Unfunded Mandates Reform Act Analysis,
Premarket Tobacco Product Applications and Recordkeeping
Requirements; Proposed Rule.

List of Subjects

21 CFR Part 1100

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

21 CFR Part 1107

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

21 CFR Part 1114

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

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

PART 1100--GENERAL

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

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

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

Sec. Sec.  1100.1, 1100.2, 1100.3, and 1100.5   [Desingated as Subpart
A]

0
3. Designate Sec. Sec.  1100.1, 1100.2, 1100.3, and 1100.5 as subpart A
under the following heading:

Subpart A--Tobacco Products Subject to FDA Authority

Subpart B [Reserved]

0
4. Add reserved subpart B.
0
5. Add subpart C, consisting of Sec. Sec.  1100.200, 1100.202, and
1100.204, to read as follows:

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

Sec.
1100.200 Purpose and scope.
1100.202 Definitions.
1100.204 Recordkeeping requirements.

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

Sec.  1100.200  Purpose and scope.

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

Sec.  1100.202   Definitions.

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

Sec.  1100.204  Recordkeeping requirements.

    (a) Any tobacco product manufacturer that introduces a
grandfathered tobacco product, or delivers it for introduction, into
interstate commerce must maintain records that demonstrate that the
tobacco product was commercially marketed in the United States as of
February 15, 2007, as described in this subpart. These records may
include items such as:
    (1) Dated copies of advertisements;
    (2) Dated catalog pages;
    (3) Dated promotional material;
    (4) Dated trade publications;
    (5) Dated bills of lading;
    (6) Dated freight bills;
    (7) Dated waybills;

    (8) Dated invoices;
    (9) Dated purchase orders;
    (10) Dated customer receipts;
    (11) Dated manufacturing documents;
    (12) Dated distributor or retailer inventory lists; or
    (13) Any other dated document that demonstrates that the tobacco
product was commercially marketed (not exclusively in test markets) in
the United States as of February 15, 2007.
    (b) All records must be legible, in the English language, and
available for inspection and copying by officers or employees duly
designated by the Secretary. Documents that have been translated from
another language into English (e.g., advertisements written in a
language other than English) must be accompanied by the original
language version of the document, a signed statement by an authorized
representative of the manufacturer certifying that the English language
translation is complete and accurate, and a brief statement of the
qualifications of the person that made the translation.
    (c) All records required by this subpart must be retained for a
period of not less than 4 years after the date either FDA makes a
determination that the product is a grandfathered tobacco product, or
the tobacco product manufacturer permanently ceases the introduction or
delivery for introduction into interstate commerce of the tobacco
product, whichever occurs sooner.

PART 1107--EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS

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

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

0
7. Revise the part heading as set forth above.
0
8. Add Sec.  1107.3 to subpart A to read as follows:

Sec.  1107.3  Recordkeeping.

    (a) Definition. The term ``grandfathered tobacco product'' means a
tobacco product that was commercially marketed in the United States on
February 15, 2007. The term does not include a tobacco product
exclusively in test markets as of that date. A grandfathered tobacco
product is not subject to the premarket requirements of section 910 of
the Federal Food, Drug, and Cosmetic Act.
    (b) Record maintenance. (1) Each applicant who submits an
abbreviated report under section 905(j)(1)(A)(ii) of the Federal Food,
Drug, and Cosmetic Act and receives a letter acknowledging the receipt
of an abbreviated report from FDA must maintain all records (including
those created by third parties on the applicant's behalf) that support
the submission. Such records may include, but are not limited to:
    (i) A copy of the abbreviated report and, if applicable, the
exemption request and all amendments thereto.
    (ii) A copy of the acknowledgement letter issued in response to an
abbreviated report and, if applicable, the exemption order issued by
FDA.
    (iii) Documents related to formulation of product, design
specifications, packaging, and related items.
    (iv) Documents showing design specifications are consistently met.
    (v) Product labeling.
    (vi) Documents related to product packing and storage conditions.
    (vii) Analytical test method records, including:
    (A) Performance criteria.
    (B) Validation or verification documentation; and
    (C) Reports/results from these test methods.
    (viii) Source data and related summaries.
    (2) An applicant that submits an abbreviated report for a
modification to a grandfathered tobacco product must also maintain
records demonstrating that the grandfathered tobacco product was
commercially marketed in the United States as of February 15, 2007,
such as the records described in Sec.  1100.204 of this chapter.
    (3) An applicant that submits an abbreviated report for a
modification to a tobacco product that received an exemption (and for
which the applicant has submitted an abbreviated report under section
905(j)(1)(A)(ii)) of the Federal Food, Drug, and Cosmetic Act, or a
substantial equivalence (SE) or premarket tobacco product application
marketing order must maintain a copy of the exemption order or
marketing order.
    (4) An applicant that submits an abbreviated report for a
modification to a tobacco product marketed consistent with section
910(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act, but for which
an SE order has not been granted, must maintain all communications to
and from FDA relating to the pending SE Report (e.g., acknowledgement
letter, deficiency letters), including the SE Report.
    (c) Record quality. All records must be legible, in the English
language, and available for inspection and copying by officers or
employees duly designated by the Secretary. Documents that have been
translated from another language into English (e.g., advertisements
written in a language other than English) must be accompanied by the
original language version of the document, a signed statement by an
authorized representative of the manufacturer certifying that the
English language translation is complete and accurate, and a brief
statement of the qualifications of the person that made the
translation.
    (d) Record retention. All records required by this subpart must be
retained for a period of 4 years from the date that an acknowledgement
letter is issued by FDA.
0
9. Add part 1114 to subchapter K to read as follows:

PART 1114--PREMARKET TOBACCO PRODUCT APPLICATIONS

Subpart A--General Provisions

Sec.
1114.1 Scope.
1114.3 Definitions.
Subpart B--Premarket Tobacco Product Applications
1114.5 Application submission.
1114.7 Required content and format.
1114.9 Amendments.
1114.11 Withdrawal by applicant.
1114.13 Change in ownership of an application.
1114.15 Supplemental applications.
1114.17 Resubmissions.
Subpart C--FDA Review
1114.25 Communication between FDA and applicants.
1114.27 Review procedure.
1114.29 FDA action on an application.
1114.31 Issuance of a marketing order.
1114.33 Issuance of a no marketing order.
1114.35 Withdrawal of a marketing order.
1114.37 Temporary suspension of a marketing order.
Subpart D--Postmarket Requirements
1114.39 Postmarket changes.
1114.41 Reporting requirements.
Subpart E--Miscellaneous
1114.45 Record retention.
1114.47 Confidentiality.
1114.49 Electronic submission.

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

Subpart A--General Provisions

Sec.  1114.1   Scope.

    (a) This part sets forth the procedures and requirements for
submitting a premarket tobacco product application (PMTA), the general
procedures FDA will follow when evaluating a PMTA, and postmarket
reporting requirements.
    (b) This part does not apply to modified risk tobacco product
applications, except that single applications under section 911(l)(4)
of

the Federal Food, Drug, and Cosmetic Act seeking both a marketing order
under section 910(c) of the Federal Food, Drug, and Cosmetic Act and an
order under section 911(g) of the Federal Food, Drug, and Cosmetic Act
must satisfy the requirements of this part in addition to the
requirements of section 911 of the Federal Food, Drug, and Cosmetic
Act.
    (c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.

Sec.  1114.3   Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does
not contain tobacco and is not made or derived from tobacco; and meets
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a tobacco
product; or
    (2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a tobacco
product, but:
    (i) Solely controls moisture and/or temperature of a stored tobacco
product; or
    (ii) Solely provides an external heat source to initiate but not
maintain combustion of a tobacco product.
    Additive means any substance the intended use of which results or
may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristic of any
tobacco product (including any substances intended for use as a
flavoring or coloring or in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding),
except that such term does not include tobacco, or a pesticide chemical
residue in or on raw tobacco or a pesticide chemical.
    Adverse experience means any unfavorable physical or psychological
effect in a person that is temporally associated with the use of or
exposure to a tobacco product, whether or not the person uses the
tobacco product, and whether or not the effect is considered to be
related to the use of or exposure to the tobacco product.
    Applicant means any person that submits a premarket tobacco product
application to receive a marketing order for a new tobacco product.
    Brand means a variety of tobacco product distinguished by the
tobacco used, tar content, nicotine content, flavoring used, size,
filtration, packaging, logo, registered trademark, brand name(s),
identifiable pattern of colors, or any combination of such attributes.
    Characteristics means the materials, ingredients, design,
composition, heating source, or other features of a tobacco product.
    Component or part means
    (1) Any software or assembly of materials intended or reasonably
expected:
    (i) To alter or affect the tobacco product's performance,
composition, constituents, or characteristics; or
    (ii) To be used with or for the human consumption of a tobacco
product.
    (2) 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 or in tobacco smoke or emission that is or potentially is
inhaled, ingested, or absorbed into the body.
    Container closure system means any packaging materials that are a
component or part of the tobacco product.
    Design means the form and structure concerning, and the manner in
which components or parts, ingredients, software, and materials are
integrated to produce a tobacco product.
    Finished tobacco product means a tobacco product, including all
components and parts, sealed in final packaging (e.g., filters or
filter tubes sold to consumers separately or as part of kits).
    Harmful or potentially harmful constituent or HPHC means any
chemical or chemical compound in a tobacco product or tobacco smoke or
emission that:
    (1) Is or potentially is inhaled, ingested, or absorbed into the
body, including as an aerosol or any other emission; and
    (2) Causes or has the potential to cause direct or indirect harm to
users or nonusers of tobacco products.
    Heating source means the source of energy used to burn or heat the
tobacco product.
    Ingredient means tobacco, substances, compounds, or additives
contained within or added to the tobacco, paper, filter, or any other
component or part of a tobacco product, including substances and
compounds reasonably expected to be formed through a chemical reaction
during tobacco product manufacturing.
    Label means a display of written, printed, or graphic matter upon
the immediate container of any article.
    Labeling means all labels and other written, printed, or graphic
matter upon any article or any of its containers or wrappers, or
accompanying such article.
    Line data means an analyzable dataset of observations for each
individual study participant, laboratory animal, or test replicate.
    Marketing order means the order described in section
910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act stating
that the new tobacco product may be introduced or delivered for
introduction into interstate commerce.
    Material means an assembly of ingredients. Materials are assembled
to form the tobacco product or components or parts of a tobacco
product.
    New tobacco product means:
    (1) Any tobacco product (including those products in test markets)
that was not commercially marketed in the United States as of February
15, 2007; or
    (2) Any modification (including a change in design, any component,
any part, or any constituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or any other additive or
ingredient) of a tobacco product where the modified product was
commercially marketed in the United States after February 15, 2007.
    No marketing order means the order described in section
910(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act stating
that the product may not be introduced or delivered for introduction
into interstate commerce.
    Other features means any distinguishing qualities of a tobacco
product similar to those specifically enumerated in section
910(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. Such other
features include harmful and potentially harmful constituents and any
other product characteristics that relate to the chemical, biological,
and physical properties of the tobacco product.
    Package or packaging means a pack, box, carton, or container of any
kind or, if no other container, any wrapping (including cellophane), in
which a tobacco product is offered for sale, sold, or otherwise
distributed to consumers.
    Premarket tobacco product application or PMTA means the application
described in section 910(b) of the Federal Food, Drug, and Cosmetic
Act. This term includes the initial

premarket tobacco product application and all subsequent amendments.
    Serious adverse experience means an adverse experience that results
in any of the following outcomes:
    (1) Death;
    (2) A life-threatening condition or illness;
    (3) Inpatient hospitalization or prolongation of existing
hospitalization;
    (4) A persistent or significant incapacity or substantial
disruption of the ability to conduct normal life functions;
    (5) A congenital anomaly/birth defect; or
    (6) Any other adverse experience that, based upon appropriate
medical judgment, may jeopardize the health of a person and may require
medical or surgical intervention to prevent one of the other outcomes
listed in this definition.
    Tobacco product means any product made or derived from tobacco that
is intended for human consumption, including any component, part, or
accessory of a tobacco product (except for raw materials other than
tobacco used in manufacturing a component, part, or accessory of a
tobacco product). The term ``tobacco product'' does not mean an article
that under the Federal Food, Drug, and Cosmetic Act is a drug (section
201(g)(1)), a device (section 201(h)), or a combination product
(section 503(g)).
    Tobacco product manufacturer means any person, including a repacker
or relabeler, who:
    (1) Manufactures, fabricates, assembles, processes, or labels a
tobacco product, or
    (2) Imports a finished tobacco product for sale or distribution in
the United States.
    Unexpected adverse experience means an adverse experience occurring
in one or more persons in which the nature, severity, or frequency of
the experience is not consistent with:
    (1) The known or foreseeable risks of adverse experiences
associated with the use or exposure to the tobacco product as described
in the PMTA and other relevant sources of information, such as the
product labeling and postmarket reports;
    (2) The expected natural progression of any underlying disease,
disorder, or condition of the persons(s) experiencing the adverse
experience and the person's predisposing risk factor profile for the
adverse experience; or
    (3) The results of nonclinical investigations.

Subpart B--Premarket Tobacco Product Applications

Sec.  1114.5  Application submission.

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

Sec.  1114.7  Required content and format.

    (a) General. The PMTA must contain sufficient information for FDA
to determine whether any of the grounds for denial specified in section
910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply. The
application must contain the following sections:
    (1) General information (as described in paragraph (c) of this
section);
    (2) Descriptive information (as described in paragraph (d) of this
section);
    (3) Product samples (as described in paragraph (e) of this
section);
    (4) Labeling (as described in paragraph (f) of this section);
    (5) Statement of compliance with part 25 of this chapter (as
described in paragraph (g) of this section);
    (6) Summary (as described in paragraph (h) of this section);
    (7) Product formulation (as described in paragraph (i) of this
section);
    (8) Manufacturing (as described in paragraph (j) of this section);
    (9) Health risk investigations (as described in paragraph (k) of
this section); and
    (10) The effect on the population as a whole (as described in
paragraph (l) of this section);
    (11) Certification statement (as described in paragraph (m) of this
section).
    (b) Format. (1) The application must be submitted using the form(s)
that FDA provides, contain a comprehensive index (i.e., a listing of
files and data associated with those files) and table of contents, be
well-organized and legible, and be written in English. Documents that
have been translated from another language into English (e.g., original
study documents written in a language other than English) must be
accompanied by: The original language version of the document, signed a
statement by an authorized representative of the manufacturer
certifying that the English language translation is complete and
accurate, and a brief statement of the qualifications of the person
that made the translation. As described in Sec.  1114.49, the applicant
must submit the application and all information supporting the
application in an electronic format that FDA can process, read, review,
and archive, unless FDA has granted a waiver.
    (2) An applicant may include content in a submission by cross-
reference to a tobacco product master file or a pending modified risk
tobacco product application for the same tobacco product. Applicants
using a master file must provide documentation of their right of
reference for the master file and clearly identify the specific content
being incorporated into the PMTA submission. Except as provided for in
Sec. Sec.  1114.15 and 1114.17, FDA will not consider content included
by cross-reference to other sources of information outside of the
submission.
    (c) General information. The applicant must, by using the form FDA
provides, specify the following general information:
    (1) Applicant name, address, and contact information;
    (2) Authorized representative or U.S. agent (for a foreign
applicant), including the name, address, and contact information;
    (3) The following information to uniquely identify the product:
    (i) Manufacturer;
    (ii) Product name(s), including brand and subbrand (or other
commercial name(s) used in commercial distribution); and
    (iii) The product category, product subcategory, and product
properties as provided in the following table. If the product does not
have a listed product property, such as ventilation or characterizing
flavor, the application must state ``none'' for that property.

                                       Table 1 to Sec.   1114.7(c)(3)(iii)
----------------------------------------------------------------------------------------------------------------
                                           Tobacco product
     Tobacco product category:               subcategory:                       Product properties:
----------------------------------------------------------------------------------------------------------------
(A) Cigarettes.....................  (1) Combusted, Filtered....  --Package type (e.g., hard pack, soft pack,
                                                                   clam shell).
                                                                  --Product quantity (e.g., 20 cigarettes).
                                                                  --Length (e.g., 89 millimeters (mm), 100 mm).
                                                                  --Diameter (e.g., 6 mm, 8.1 mm).

                                                                  --Ventilation (e.g., 0%, 10%, 25%).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (2) Combusted, Nonfiltered.  --Package type (e.g., hard pack, soft pack,
                                                                   clam shell).
                                                                  --Product quantity (e.g., 20 cigarettes).
                                                                  --Length (e.g., 89 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) Combusted, Bidi, and     --Package type (e.g., hard pack, soft pack,
                                      Other.                       clam shell).
                                                                  --Product quantity (e.g., 20 cigarettes).
                                                                  --Length (e.g., 89 mm, 100 mm).
                                                                  --Diameter (e.g., 6 mm, 8.1 mm).
                                                                  --Ventilation (e.g., 0%, 10%, 25%) (if
                                                                   applicable).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (4) Noncombusted (e.g.,      --Package type (e.g., hard pack, soft pack,
                                      heated tobacco).             clam shell).
                                                                  --Product quantity (e.g., 20 cigarettes, 25
                                                                   cigarettes).
                                                                  --Length (e.g., 89 mm, 100 mm).
                                                                  --Diameter (e.g., 6 mm, 8.1 mm).
                                                                  --Ventilation (e.g., 0%, 10%, 25%).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Source of energy (e.g., charcoal, electrical
                                                                   heater).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (5) Cigarette, Co-Package..  --For a new co-packaged tobacco product
                                                                   composed of multiple cigarette tobacco
                                                                   products, include, as applicable, all
                                                                   properties for each individual tobacco
                                                                   product, as identified above.
(B) Roll-Your-Own Tobacco Products.  (1) Roll-Your-Own Tobacco    --Package type (e.g., bag, pouch).
                                      Filler.                     --Product quantity (e.g., 20 g, 40 grams (g)).
                                                                  --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., bag, box, booklet).
                                                                  --Product quantity (e.g., 200 papers).
                                                                  --Length (e.g., 79 mm, 100 mm, 110 mm).
                                                                  --Width (e.g., 45 mm, 60 mm, 78 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (3) Cigarette Tube,          --Package type (e.g., bag, box).
                                      Filtered.
                                                                  --Product quantity (e.g., 100 tubes, 200
                                                                   tubes).
                                                                  --Length (e.g., 89 mm, 100 mm).
                                                                  --Diameter (e.g., 6 mm, 8.1 mm).
                                                                  --Ventilation (e.g., 0%, 10%, 25%).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (4) Cigarette Tube,          --Package type (e.g., bag, box).
                                      Nonfiltered.
                                                                  --Product quantity (e.g., 100 tubes, 200
                                                                   tubes).
                                                                  --Length (e.g., 89 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).
                                     (5) Filter.................  --Package type (e.g., bag, box).
                                                                  --Product quantity (e.g., 100 filters, 200
                                                                   filters).
                                                                  --Length (e.g., 8 mm, 12 mm).
                                                                  --Diameter (e.g., 6 mm, 8.1 mm).
                                                                  --Ventilation (e.g., 0%, 10%, 25%).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --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 mm).
                                                                  --Width (e.g., 27 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).

                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (7) Roll-Your-Own, Co-       --For a new tobacco product composed of
                                      Package.                     multiple roll-your-own tobacco products,
                                                                   include all applicable properties for each
                                                                   tobacco product (e.g., roll-your own tobacco,
                                                                   rolling paper, filtered cigarette tube,
                                                                   nonfiltered cigarette tube, filter, paper
                                                                   tip) as identified above.
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (8) Other..................  --Package type (e.g., bag, box).
                                                                  --Product quantity.
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product.
(C) Smokeless Tobacco Products.....  (1) Moist Snuff, Loose.....  --Package type (e.g., plastic can with metal
                                                                   lid, plastic can with plastic lid).
                                                                  --Product quantity (e.g., 20 g, 30 g).
                                                                  --Tobacco cut size (e.g., 5 mm, 7 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cherry, wintergreen).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (2) Moist Snuff, Portioned.  --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 pouches, 20 pieces).
                                                                  --Portion mass (e.g., 1.5 g/pouch, 2 g/piece).
                                                                  --Portion length (e.g., 15 mm, 20 mm).
                                                                  --Portion width (e.g., 10 mm, 15 mm).
                                                                  --Portion thickness (e.g., 5 mm, 7 mm).
                                                                  --Tobacco cut size (e.g., 5 mm, 7 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cherry, wintergreen).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (3) Snus, Loose............  --Package type (e.g., plastic can with metal
                                                                   lid, plastic can with plastic lid).
                                                                  --Product quantity (e.g., 20 g, 2 ounces).
                                                                  --Tobacco cut size (e.g., 5 mm, 7 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cherry, wintergreen).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (4) Snus, Portioned........  --Package type (e.g., plastic can with metal
                                                                   lid, plastic can with plastic lid).
                                                                  --Product quantity (e.g., 22.5 g, 20 g).
                                                                  --Portion count (e.g., 15 pouches, 20 pieces).
                                                                  --Portion mass (e.g., 1.5 g/pouch, 2 g/piece).
                                                                  --Portion length (e.g., 15 mm, 20 mm).
                                                                  --Portion width (e.g., 10 mm, 15 mm).
                                                                  --Portion thickness (e.g., 5 mm, 7 mm).
                                                                  --Tobacco cut size (e.g., 5 mm, 7 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cherry, wintergreen).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (5) Dry Snuff, Loose.......  --Package type (e.g., plastic can with metal
                                                                   lid, plastic can with plastic lid).
                                                                  --Product quantity (e.g., 20 g, 2 ounces).
                                                                  --Tobacco cut size (e.g., 0.05 mm, 0.07 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cherry, wintergreen).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (6) Dry Snuff, Portioned...  --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 pouches, 20 pieces).
                                                                  --Portion mass (e.g., 1.5 g/pouch, 2 g/piece).
                                                                  --Portion length (e.g., 10 mm, 15 mm).
                                                                  --Portion width (e.g., 5 mm, 8 mm).
                                                                  --Portion thickness (e.g., 3 mm, 4 mm).
                                                                  --Tobacco cut size (e.g., 5 mm, 7 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cherry, wintergreen).
                                     (7) Dissolvable............  --Package type (e.g., plastic can with metal
                                                                   lid, plastic can with plastic lid).
                                                                  --Product quantity (e.g., 22.5 g, 20 g).

                                                                  --Product form (e.g., strip, tablet, stick).
                                                                  --Portion count (e.g., 15 sticks, 20 tablets).
                                                                  --Portion mass (e.g., 1.5 g/strip, 1.0 g/
                                                                   piece).
                                                                  --Portion length (e.g., 10 mm, 15 mm).
                                                                  --Portion width (e.g., 5 mm, 8 mm).
                                                                  --Portion thickness (e.g., 3 mm, 4 mm).
                                                                  --Tobacco cut size (e.g., 0.05 mm, 0.07 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cherry, wintergreen).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (8) Chewing Tobacco, Loose.  --Package type (e.g., bag, pouch).
                                                                  --Product quantity (e.g., 20 g, 40 g).
                                                                  --Tobacco cut size (e.g., 0.05 mm, 0.07 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cherry, wintergreen).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (9) Chewing Tobacco,         --Package type (e.g., plastic can with metal
                                      Portioned.                   lid, plastic can with plastic lid).
                                                                  --Product quantity (e.g., 20 g).
                                                                  --Product form (e.g., plug, twist, portioned
                                                                   chewing tobacco).
                                                                  --Portion count (e.g., 1 plug, 3 twists, 10
                                                                   bits).
                                                                  --Portion mass (e.g., 2 g/bit).
                                                                  --Portion length (e.g., 8 mm, 10 mm).
                                                                  --Portion width (e.g., 6 mm, 8 mm).
                                                                  --Portion thickness (e.g., 5 mm, 7 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cherry, wintergreen).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (10) Smokeless Co-Package..  --For a new tobacco product composed of
                                                                   multiple smokeless tobacco products, include
                                                                   all applicable properties for each individual
                                                                   tobacco product as identified above.
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (11) Other.................  --Package type (e.g., bag, box).
                                                                  --Product quantity.
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product.
(D) ENDS (Electronic Nicotine        (1) E-Liquid, Open.........  --Package type (e.g., bottle, box).
 Delivery System).                                                --Product quantity (e.g., 1 bottle, 5
                                                                   bottles).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   tobacco, menthol, cherry, wintergreen).
                                                                  --E-liquid volume (e.g., 10 milliliter (ml)).
                                                                  --Nicotine concentration (e.g., 0, 0.2 mg/ml).
                                                                  --Propylene glycol/vegetable glycerin (PG/VG)
                                                                   ratio (e.g., N/A, 0/100, 50/50).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (2) E-Liquid, Closed.......  --Package type (e.g., cartridge).
                                                                  --Product quantity (e.g., 1 cartridge, 5
                                                                   cartridges).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   tobacco, menthol, cherry, wintergreen).
                                                                  --E-liquid volume (e.g., 10 ml).
                                                                  --Nicotine concentration (e.g., 0, 0.2 mg/ml).
                                                                  --PG/VG ratio (e.g., N/A, 0/100, 50/50).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (3) E-Cigarette, Closed....  --Package type (e.g., box, none, plastic
                                                                   clamshell).
                                                                  --Product quantity (e.g., 1 e-cigarette, 5 e-
                                                                   cigarettes).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   tobacco, menthol, cherry, wintergreen).
                                                                  --Length (e.g., 100 mm, 120 mm).
                                                                  --Diameter (e.g., 6 mm, 8 mm).
                                                                  --E-liquid volume (e.g., 2 ml, 5 ml).
                                                                  --Nicotine concentration (e.g., 0, 0.2 mg/ml).
                                                                  --PG/VG ratio (e.g., N/A, 0/100, 50/50).
                                                                  --Wattage (e.g., 100 W, 200 W).
                                                                  --Battery capacity (e.g., 100 mAh, 200 mAh).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product.
                                     (4) E-Cigarette, Open......  --Package type (e.g., box, none, plastic
                                                                   clamshell).
                                                                  --Product quantity (e.g., 1 e-cigarette, 5 e-
                                                                   cigarettes).

                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   tobacco, menthol, cherry, wintergreen).
                                                                  --Length (e.g., 100 mm, 120 mm).
                                                                  --Diameter (e.g., 8 mm, 14 mm).
                                                                  --E-liquid volume (e.g., 2 ml, 5 ml).
                                                                  --Wattage (e.g., 100 W, 200 W).
                                                                  --Battery capacity (e.g., 100 mAh, 200 mAh).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (5) ENDS Component.........  --Package type (e.g., box, none, plastic
                                                                   clamshell).
                                                                  --Product quantity (e.g., 1 e-cigarette, 5 e-
                                                                   cigarettes).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   tobacco, menthol, cherry, wintergreen).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (6) ENDS Co-Package........  --For a new tobacco product composed of
                                                                   multiple ENDS tobacco products, include all
                                                                   applicable properties for each individual
                                                                   tobacco product as identified above.
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (7) ENDS Other.............  --Package type (e.g., bag, box).
                                                                  --Product quantity.
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   tobacco, menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product.
(E) Cigars.........................  (1) Cigar, Filtered Sheet-   --Package type (e.g., hard pack, soft pack,
                                      Wrapped.                     clam shell).
                                                                  --Product quantity (e.g., 20 filtered cigars,
                                                                   25 filtered cigars).
                                                                  --Characterizing flavor (e.g., none, menthol).
                                                                  --Length (e.g., 89 mm, 100 mm).
                                                                  --Diameter (e.g., 6 mm, 8.1 mm).
                                                                  --Ventilation (e.g., none, 10%, 25%).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (2) Cigar, Unfiltered Sheet- --Package type (e.g., box, film sleeve).
                                      Wrapped.                    --Product quantity (e.g., 1 cigar, 5
                                                                   cigarillos).
                                                                  --Characterizing flavor (e.g., none, menthol).
                                                                  --Length (e.g., 100 mm, 140 mm).
                                                                  --Diameter (e.g., 8 mm, 10 mm).
                                                                  --Tip (e.g., none, wood tips, plastic tips).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (3) Cigar, Leaf-Wrapped....  --Package type (e.g., box, film, sleeve,
                                                                   none).
                                                                  --Product quantity (e.g., 1 cigar, 5 cigars).
                                                                  --Characterizing flavor (e.g., none, whiskey).
                                                                  --Length (e.g., 150 mm, 200 mm).
                                                                  --Diameter (e.g., 8 mm, 10 mm).
                                                                  --Wrapper material (e.g., burley tobacco leaf,
                                                                   Connecticut shade grown tobacco leaf).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (4) Cigar Component........  --Package type (e.g., box, booklet).
                                                                  --Product quantity (e.g., 10 wrappers, 20
                                                                   leaves).
                                                                  --Characterizing flavor (e.g., none, menthol,
                                                                   cherry).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (5) Cigar Tobacco Filler...  --Package type (e.g., bag, pouch).
                                                                  --Product quantity (e.g., 20 g, 16 ounces).
                                                                  --Characterizing flavor (e.g., none, menthol,
                                                                   cherry).
                                                                  --Tobacco cut size (e.g., 15 cuts per inch).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (6) Cigar Co-Package.......  --For a new tobacco product composed of
                                                                   multiple cigar tobacco products, include all
                                                                   applicable properties for each individual
                                                                   tobacco product as identified above.
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (7) Other..................  --Package type (e.g., bag, box).
                                                                  --Product quantity.
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --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 mm).
                                                                  --Diameter (e.g., 25 mm).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (2) Pipe Tobacco Filler....  --Package type (e.g., bag, pouch).
                                                                  --Product quantity (e.g., 20 g, 16 ounces).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, cavendish, cherry).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (3) Pipe Component.........  --Package type (e.g., bowl, shank, stem,
                                                                   screen, filter).
                                                                  --Product quantity (e.g., 1 bowl, 1 stem, 100
                                                                   filters).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (4) Pipe Co-Package........  --For a new tobacco product composed of
                                                                   multiple pipe tobacco products, include all
                                                                   applicable properties for each individual
                                                                   tobacco product as identified above.
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (5) Other..................  --Package type (e.g., bag, box).
                                                                  --Product quantity.
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --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).
                                                                  --Length (e.g., 200 mm, 500 mm).
                                                                  --Width (e.g., 100 mm, 300 mm).
                                                                  --Number of hoses (e.g., 1, 2, 4).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (2) Waterpipe Tobacco        --Package type (e.g., bag, pouch).
                                      Filler.
                                                                  --Product quantity (e.g., 20 g, 16 ounces).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   tobacco, menthol, apple).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (3) Waterpipe Heat Source..  --Package type (e.g., box, film sleeve, bag,
                                                                   none).
                                                                  --Product quantity (e.g., 150 g, 680 g).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, apple).
                                                                  --Portion count (e.g., 20 fingers, 10 discs, 1
                                                                   base).
                                                                  --Portion mass (e.g., 15 g/finger).
                                                                  --Portion length (e.g., 40 mm, 100 mm).
                                                                  --Portion width (e.g., 10 mm, 40 mm).
                                                                  --Portion thickness (e.g., 10 mm, 40 mm).
                                                                  --Source of energy (e.g., charcoal, battery,
                                                                   electrical).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (4) Waterpipe Component....  --Package type (e.g., bag, box, none).
                                                                  --Product quantity (e.g., 1 base, 1 bowl, 1
                                                                   hose, 10 mouthpieces).
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   menthol, apple).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (5) Waterpipe Co-Package...  --For a new tobacco product composed of
                                                                   multiple waterpipe tobacco products, include
                                                                   all applicable properties for each individual
                                                                   tobacco product as identified above.
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
                                     (6) Waterpipe Other........  --Package type (e.g., bag, box).
                                                                  --Product quantity.
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   tobacco, menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
Other..............................  Other......................  --Package type (e.g., bag, box).
                                                                  --Product quantity.
                                                                  --Characterizing flavor(s) (e.g., none,
                                                                   tobacco, menthol).
                                                                  --Additional properties needed to uniquely
                                                                   identify the tobacco product (if applicable).
----------------------------------------------------------------------------------------------------------------

    (4) The type of PMTA (i.e., PMTA, supplemental PMTA, or
resubmission);
    (5) Whether the applicant requests that FDA refer the PMTA to the
Tobacco Products Scientific Advisory Committee (TPSAC);
    (6) Identifying information regarding any prior submissions
regarding the tobacco product (e.g., submissions related to
investigational tobacco products, substantial equivalence reports,
PMTAs), including submission tracking numbers (STNs) where applicable;
    (7) Dates and purpose of any prior meetings with FDA regarding the
new tobacco product;
    (8) Address and the Facility Establishment Identifier (FEI)
number(s), if available, of the establishment(s) involved in the
manufacture of the new tobacco product;
    (9) A brief statement regarding how the PMTA satisfies the content
requirements of section 910(b)(1) of the Federal Food, Drug, and
Cosmetic Act;
    (10) A brief description of how marketing of the new tobacco
product would be appropriate for the protection of the public health;
and
    (11) A list identifying all enclosures, labels, and labeling being
submitted with the application.
    (d) Descriptive information. The application must contain
descriptive information in this section that outlines the major aspects
of the new tobacco product, including the following items:
    (1) A concise description of the new tobacco product;
    (2) A statement identifying all tobacco product standards issued
under section 907 of the Federal Food, Drug, and Cosmetic Act that are
applicable to the new tobacco product and a brief description of how
the new tobacco product fully meets any identified tobacco product
standard, or if the new tobacco product deviates from a product
standard, if applicable, the application must include adequate
information to identify and justify those deviations;
    (3) The name(s) of the product as designated on the product's
label;
    (4) A description of problems that were identified in prototypes
that are the subject of studies in the application and previous or
similar versions of the new tobacco product that were marketed, if any.
If there are previous or similar versions that are the subject of
studies in the application or were marketed, the application must
contain a bibliography of all reports regarding the previous or similar
version of the product, whether adverse or supportive; and
    (5) Any restrictions on the sale, distribution, advertising, or
promotion of the new tobacco product that the applicant proposes to be
included as part of a marketing order under section 910(c)(1)(B) of the
Federal Food, Drug, and Cosmetic Act to help support a showing that the
marketing of the product is appropriate for the protection of the
public health. If there are no proposed restrictions, the application
must contain a statement to that effect.
    (e) Samples of new tobacco products. After FDA accepts a PMTA for
review, it may require the submission of samples of the new tobacco
product, including its components and parts. If required, the applicant
must submit samples of the finished tobacco product or its components
or parts in accordance with instructions provided by FDA. FDA may also
require the submission of additional samples to further aid in its
review.
    (f) Labeling and marketing plans--(1) Labeling. The application
must contain specimens of all proposed labeling for the new tobacco
product, including labels, inserts, onserts, instructions, and other
accompanying information. The specimens of labeling must include all
panels, reflect the actual size and color proposed to be used for the
tobacco product, and include any warning label statements and other
information required by regulation or statute, as applicable.
    (2) Marketing plans. A PMTA must contain a description of the
applicant's plans for labeling, advertising, marketing, promotion, and
other consumer-directed activities regarding the new tobacco product
developed by the time of filing. Such marketing plans must contain
descriptions of actions that would be taken by the applicant, on behalf
of the applicant, or at the applicant's direction for at least the
first year the product would be marketed after receiving an order. If
an applicant does not intend to use any advertising, marketing,
promotion, or other communication activities directed at consumers, or
has not developed marketing plans by the time of submission, the PMTA
must contain a statement to that effect. As part of the description of
the marketing plan, the PMTA must specify items such as the intended
target audience(s), media and distribution channels, particular
tactics, total dollar amount(s) of media buys and marketing and
promotional activities (where applicable), and timing for the
activities, including, but not limited to, information describing:
    (i) The use of competent and reliable data sources, tools,
technologies, and methodologies to establish, maintain, and monitor
highly targeted marketing plans and media buys;
    (ii) The target adult audiences by age-range(s) (including young
adult audiences ages 18 to 24), and other demographic or psychographic
characteristics;
    (iii) The insights into the target audience the applicant is using
to inform its marketing plans, including its strategic approach, key
messages and themes, creative direction, and potential marketing
tactics or channels.
    (iv) Any means by which youth-access or youth-exposure to the
products' labeling, advertising, marketing, and promotion would be
limited;
    (v) The use of owned, earned, shared, or paid media to advertise or
promote the products;
    (vi) The use of partners, sponsors, influencers, bloggers, or brand
ambassadors to advertise or promote the products;
    (vii) The use of consumer engagements, including events at which
the products will be demonstrated or sampled; and
    (viii) The use of earned media, public-relations, or other
communications outreach to promote the products.
    (g) Statement of compliance with 21 CFR part 25. (1) The
application must contain an environmental assessment prepared in
accordance with Sec.  25.40 of this chapter, or a valid claim of
categorical exclusion, if applicable. If the applicant believes that
the action qualifies for an available categorical exclusion, the
applicant must state under Sec.  25.15(a) and (d) of this chapter that
the action requested qualifies for a categorical exclusion, citing the
particular exclusion that is claimed, and that to the applicant's
knowledge, no extraordinary circumstances exist under Sec.  25.21 of
this chapter.
    (2) Where the new tobacco product results from modifications to a
legally marketed predecessor product, the environmental assessment must
state whether the new tobacco product is intended to replace the
predecessor tobacco product once the new tobacco product receives
market authorization and is commercially marketed, be a line extension
of the predecessor tobacco product, be marketed along with the
predecessor product by the same manufacturer, or be marketed along with
the predecessor tobacco product by a different manufacturer.
    (h) Summary. The application must include a summary of all
information contained in the application, including the following
items, and identify areas in which there is a lack of information,
where applicable:

    (1) A summary of the product formulation section of the
application;
    (2) A summary of the manufacturing section of the application;
    (3) A summary of the health risk investigations section of the
application, including all information regarding:
    (i) The health risks of the tobacco product to both users and
nonusers of the product and whether the tobacco product may present
less health risk than other tobacco products;
    (ii) The impact the product and its marketing will have on the
likelihood of changes in tobacco use behavior, including cessation, of
tobacco product users;
    (iii) The impact the product and its marketing will have on the
likelihood of tobacco use initiation by tobacco products nonusers;
    (iv) How users and nonusers perceive the risk of the tobacco
product based upon its labeling, packaging, and marketing;
    (v) Whether users are able to understand the labeling and
instructions for use, and use the product in accordance with those
instructions; and
    (vi) The impact of human factors on the health risks to product
users and nonusers (as described in paragraph (k)(1)(v) of this
section);
    (4) A concluding discussion describing how the data and information
contained in the PMTA both constitute valid scientific evidence and
establish that permitting marketing of the new tobacco product is
appropriate for the protection of the public health, as determined with
respect to the risks and benefits to the population as a whole,
including users and nonusers of the tobacco product.
    (i) Product formulation. The application must contain a full
statement of the components or parts, materials, ingredients,
additives, constituents, properties, and the principle or principles of
operation, of the tobacco product, including the following information:
    (1) Components or parts, materials, ingredients, additives, and
constituents. The applicant must provide a full statement of:
    (i) Components or parts. The quantity, function, and purpose of,
and, where applicable, target specification(s) of, each component or
part in the product. Where the tobacco product contains software
components, the applicant must provide:
    (A) A description of the software or technology (e.g., Bluetooth);
    (B) The purpose of the software or technology, such as monitoring
where tobacco products are located, activated, or used;
    (C) A description of the data collected by the software and how it
will be used.
    (ii) Materials. For each material in the product, include:
    (A) The material name and common name(s), if applicable;
    (B) The component or part of the tobacco product where the material
is located;
    (C) The subcomponent or subpart where the material is located, if
applicable;
    (D) The function of the material;
    (E) The quantities (including ranges or means and acceptance
limits) of the material(s) in the new tobacco product;
    (F) The specification(s) (including quality/grades and suppliers)
used for the new tobacco product; and
    (G) Any other material properties to fully characterize the new
tobacco product.
    (iii) Ingredients other than tobacco. For ingredients other than
tobacco in each component or part of the product, include:
    (A) The International Union of Pure and Applied Chemistry (IUPAC)
chemical name and common name, if applicable;
    (B) The Chemical Abstracts Service (CAS) number or FDA Unique
Ingredient Identifier (UNII);
    (C) The function of the ingredient;
    (D) The quantity with the unit of measure (including ranges or
means and acceptance limits) of the material(s) of the ingredients in
the tobacco product reported as mass per gram of tobacco for
nonportioned tobacco products and as mass per portion for portioned
tobacco products;
    (E) The specification(s) (including purity or grade and supplier);
and
    (F) For complex purchased ingredients, each single chemical
substance reported separately.
    (iv) Tobacco ingredients. For tobacco ingredients in each component
or part, include the following information or, if applicable, a
statement that the product does not contain tobacco ingredients:
    (A) The type(s), including grade(s) and variety/varieties;
    (B) The quantity with the unit of measure (including ranges or
means, acceptance limits) of tobacco in the tobacco product reported as
mass per gram of tobacco for nonportioned tobacco products and as mass
per portion for portioned tobacco products (with any specification
variation, if applicable);
    (C) The specification of tobacco used for the new tobacco product
(with any specification variation, if applicable); and
    (D) A description of any genetic engineering of the tobacco that
impacts product characteristics.
    (v) Constituents. Constituents, including HPHCs and other
constituents, contained within, or emitted from (including its smoke or
aerosol), the product, including any reaction product from leaching or
aging, by providing:
    (A) The constituent names in alphabetical order;
    (B) The common name(s);
    (C) The Chemical Abstract Services number;
    (D) The mean quantity and variance with unit of measure;
    (E) The number of samples and measurement replicates for each
sample;
    (F) The analytical methods used and associated reference(s);
    (G) The name and location of the testing laboratory or laboratories
and documentation showing that the laboratory or laboratories is (or
are) accredited by a nationally or internationally recognized external
accreditation organization;
    (H) Length of time between dates of manufacture and date(s) of
testing;
    (I) Storage conditions of the tobacco product before it was tested;
and
    (J) Test data including test protocols, any deviation(s) from the
test protocols, quantitative acceptance (pass/fail) criteria, and line
data for all testing performed. Test data for combusted or inhaled
products must reflect testing conducted using both intense and
nonintense smoking regimens.
    (vi) Container closure system. A description of the container
closure system, including:
    (A) Information describing how the container closure system
protects and preserves the product from damage during transport,
environmental contaminants, and potential leaching and migration of
packaging constituents into the new tobacco product; and
    (B) Information describing design features developed to prevent the
risk of accidental exposure, if any.
    (vii) Statement of tobacco blending, reconstitution, or
manipulation. Information regarding tobacco blending, reconstitution,
or manipulation, where applicable.
    (2) Other properties. The applicant must provide a full description
of the additional properties of the tobacco product that includes:
    (i) Product dimensions and construction. The product dimensions and
the overall construction of the product using a diagram or schematic
drawing that clearly depicts the finished tobacco product and its
components with dimensions, operating parameters, and materials.
    (ii) Design parameters and test data. (A) All final design
parameters of the

product, specifying nominal values or the explicit range of values as
well as the design tolerance (where appropriate), including, but not
limited to, the parameters specified in tables 1 to 20 of this
paragraph as applicable; and
    (B) A quantitative description of the performance criteria,
including test protocols, line data, and a summary of the results, for
each applicable intermediate and final design parameter and
manufacturing step, that includes, but is not limited to the test data
specified in tables 1 to 20 of this paragraph for the product category
as applicable:

      Table 1 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                       Information for Cigarettes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigarette mass (mg).                Cigarette mass
                                             (mg).
 Cigarette length (mm).              Cigarette length
                                             (mm).
 Cigarette diameter (mm).            Cigarette
                                             diameter(mm).
 Cigarette draw resistance (mm       Cigarette draw
 H2O).                                       resistance (mm H2O).
 Tobacco rod length (mm).            Puff count.
 Tobacco filler mass (mg).           Tobacco rod length
                                             (mm).
 Tobacco rod density (g/cm\3\).      Tobacco filler mass
                                             (mg).
 Tobacco cut size (mm).              Tobacco rod density
                                             (g/cm\3\).
 Tobacco moisture (%).               Tobacco cut size
                                             (mm).
 Cigarette paper length (mm).        Tobacco moisture
                                             (%).
 Cigarette paper width (mm).         Cigarette paper
                                             length (mm).
 Cigarette paper base paper basis    Cigarette paper
 weight (g/m\2\).                            width (mm).
 Cigarette paper base paper          Cigarette paper
 porosity (CU).                              base paper basis weight (g/
                                             m\2\).
 Cigarette paper band porosity       Cigarette paper
 (CU).                                       base paper porosity (CU).
 Cigarette paper band diffusivity    Cigarette paper
 (cm\2\/s).                                  band porosity (CU).
 Cigarette paper band width (mm).    Cigarette paper
                                             band diffusivity (cm\2\/s).
 Cigarette paper band space (mm).    Cigarette paper
                                             band width (mm).
 Filter length (mm).                 Cigarette paper
                                             band space (mm).
 Filter diameter (mm).               Filter length (mm).
 Filter mass (mg)                    Filter diameter
                                             (mm).
 Filter density (g/cm\3\).           Filter mass (mg).
 Filter tow crimping index.          Filter density (g/
                                             cm\3\).
 Filter pressure drop (mm H2O).      Filter tow crimping
                                             index.
 Filter efficiency (%).              Filter pressure
                                             drop (mm H2O).
 Filter total denier (g/9000m).      Filter efficiency
                                             (%).
 Filter denier per filament (dpf)    Filter total denier
                                             (g/9000m).
 Plug wrap length (mm).              Filter denier per
                                             filament (dpf).
 Plug wrap width (mm).               Plug wrap length
                                             (mm).
 Plug wrap basis weight (g/m\2\).    Plug wrap width
                                             (mm).
 Plug wrap porosity (CU).            Plug wrap basis
                                             weight (g/m\2\).
 Tipping paper length (mm).          Plug wrap porosity
                                             (CU).
 Tipping paper width (mm).           Tipping paper
                                             length (mm).
 Tipping paper basis weight (g/      Tipping paper width
 m\2\).                                      (mm).
 Tipping paper perforation (CU).     Tipping paper basis
                                             weight (g/m\2\).
 Filter ventilation (%).             Tipping paper
                                             perforation (CU).
 Filter ventilation position of      Filter ventilation
 holes.                                      (%).
 Filter ventilation number of
 holes.
 Filter ventilation number of
 rows.
------------------------------------------------------------------------

      Table 2 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
  Information for Portioned and Nonportioned Smokeless Tobacco Products
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
                  Portioned Smokeless Tobacco Products
------------------------------------------------------------------------
 Tobacco cut size (mm).              Tobacco cut size
                                             (mm).
 Tobacco moisture (%).               Tobacco moisture
                                             (%).
 Portion length (mm).                Portion length
                                             (mm).
 Portion width (mm).                 Portion width (mm).
 Portion mass (mg).                  Portion mass (mg).
 Portion thickness (mm).             Portion thickness
                                             (mm).
 Pouch material basis weight (g/     Pouch material
 m\2\).                                      basis weight (g/m\2\).
 Pouch material air permeability     Pouch material air
 (L/m\2\/s).                                 permeability (L/m\2\/s).
 Pouch material nicotine             Pouch material
 dissolution rate (%/min).                   nicotine dissolution rate
                                             (%/min).
 Pouch material nicotine             Pouch material
 dissolution extent (mg).                    nicotine dissolution extent
                                             (mg).
 Pouch material thickness ([mu]m).   Pouch material
                                             thickness ([mu]m).
------------------------------------------------------------------------
                 Nonportioned Smokeless Tobacco Products
------------------------------------------------------------------------
 Tobacco cut size (mm).              Tobacco cut size
                                             (mm).

 Tobacco moisture (%).               Tobacco moisture
                                             (%).
------------------------------------------------------------------------

      Table 3 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
               Information for RYO Tobacco Rolling Papers
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Roll-your-own (RYO) paper length    RYO paper length
 (mm).                                       (mm).
 RYO paper width (mm).               RYO paper width
                                             (mm).
 RYO paper mass (mg).                RYO paper mass
                                             (mg).
 RYO paper base paper basis weight   RYO paper base
 (g/m\2\).                                   paper basis weight (g/
                                             m\2\).
 RYO paper base paper porosity       RYO paper base
 (CU).                                       paper porosity (CU).
 RYO paper band porosity (CU).       RYO paper band
                                             porosity (CU).
 RYO paper band diffusivity (cm\2\/  RYO paper band
 s).                                         diffusivity (cm\2\/s).
 RYO paper band width (mm).          RYO paper band
                                             width (mm).
 RYO paper band space (mm).          RYO paper band
                                             space (mm).
------------------------------------------------------------------------

      Table 4 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                    Information for RYO Tobacco Tubes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tube mass (mg).                     Tube mass (mg).
 Tube length (mm).                   Tube length (mm).
 Tube diameter (mm).                 Tube diameter (mm).
 Tube paper length (mm).             Tube paper length
                                             (mm).
 Tube paper width (mm).              Tube paper width
                                             (mm).
 Tube paper base paper basis         Tube paper base
 weight (g/m\2\).                            paper basis weight (g/
                                             m\2\).
 Tube paper base paper porosity      Tube paper base
 (CU).                                       paper porosity (CU).
 Tube paper band porosity (CU).      Tube paper band
                                             porosity (CU).
 Tube paper band diffusivity         Tube paper band
 (cm\2\/s).                                  diffusivity (cm\2\/s).
 Tube paper band width (mm).         Tube paper band
                                             width (mm).
 Tube paper band space (mm).         Tube paper band
                                             space (mm).
------------------------------------------------------------------------

      Table 5 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
               Information for RYO Tobacco Filtered Tubes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tube mass (mg).                     Tube mass (mg).
 Tube length (mm).                   Tube length (mm).
 Tube diameter (mm).                 Tube diameter (mm).
 Tube paper length (mm).             Tube paper length
                                             (mm).
 Nonfilter tube length (mm).         Nonfilter tube
                                             length (mm).
 Tube paper width (mm).              Tube paper width
                                             (mm).
 Tube paper base paper basis         Tube paper base
 weight (g/m\2\).                            paper basis weight (g/
                                             m\2\).
 Tube paper base paper porosity      Tube paper base
 (CU).                                       paper porosity (CU).
 Tube paper band porosity (CU).      Tube paper band
                                             porosity (CU).
 Tube paper band diffusivity         Tube paper band
 (cm\2\/s).                                  diffusivity (cm\2\/s).
 Tube paper band width (mm).         Tube paper band
                                             width (mm).
 Tube paper band space (mm).         Tube paper band
                                             space (mm).
 Filter length (mm).                 Filter length (mm).
 Filter diameter (mm).               Filter diameter
                                             (mm).
 Filter mass (mg).                   Filter mass (mg).
 Filter density (g/cm\3\).           Filter density (g/
                                             cm\3\).
 Filter tow crimping index.          Filter tow crimping
                                             index.
 Filter pressure drop (mm H2O).      Filter pressure
                                             drop (mm H2O).
 Filter efficiency (%).              Filter efficiency
                                             (%).
 Filter total denier (g/9000m).      Filter total denier
                                             (g/9000m).
 Filter denier per filament (dpf).   Filter denier per
                                             filament (dpf).
 Plug wrap length (mm).              Plug wrap length
                                             (mm).
 Plug wrap width (mm).               Plug wrap width
                                             (mm).
 Plug wrap basis weight (g/m\2\).    Plug wrap basis
                                             weight (g/m\2\).
 Plug wrap porosity (CU).            Plug wrap porosity
                                             (CU).
 Tipping paper length (mm).          Tipping paper
                                             length (mm).
 Tipping paper width (mm).           Tipping paper width
                                             (mm).
 Tipping paper basis weight (g/      Tipping paper basis
 m\2\).                                      weight (g/m\2\).

 Tipping paper perforation (CU).     Tipping paper
                                             perforation (CU).
 Filter ventilation (%).             Filter ventilation
                                             (%).
 Filter ventilation position of
 holes.
 Filter ventilation number of
 holes.
 Filter ventilation number of
 rows.
------------------------------------------------------------------------

      Table 6 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                       Information for RYO Tobacco
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tobacco filler mass (mg).           Tobacco filler mass
                                             (mg).
 Tobacco cut size (mm).              Tobacco cut size
                                             (mm).
 Tobacco moisture (%).               Tobacco moisture
                                             (%).
------------------------------------------------------------------------

      Table 7 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                 Information for RYO Tobacco Paper Tips
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 RYO paper tip length (mm).          RYO paper tip
                                             length (mm).
 RYO paper tip width (mm).           RYO paper tip width
                                             (mm).
 RYO paper tip mass (mg).            RYO paper tip mass
                                             (mg).
 RYO paper base paper basis weight   RYO paper base
 (g/m\2\).                                   paper basis weight (g/
                                             m\2\).
 RYO paper perforation (CU).         RYO paper
                                             perforation (CU).
 RYO paper tip ventilation (%).      RYO paper tip
                                             ventilation (%).
------------------------------------------------------------------------

      Table 8 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
              Information for Filtered Sheet-Wrapped Cigars
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigar length (mm).                  Cigar length (mm).
 Cigar diameter (mm).                Cigar diameter
                                             (mm).
 Tobacco filler mass (mg).           Tobacco filler mass
                                             (mg).
 Tobacco rod density (g/cm\3\).      Tobacco rod density
                                             (g/cm\3\).
 Tobacco cut size (mm).              Tobacco cut size
                                             (mm).
 Tobacco moisture (%).               Tobacco moisture
                                             (%).
 Cigar wrapper porosity (CU).        Cigar wrapper
                                             porosity (CU).
 Cigar binder porosity (CU).         Cigar binder
                                             porosity (CU).
 Filter length (mm).                 Filter length (mm).
 Filter diameter (mm).               Filter diameter
                                             (mm).
 Filter pressure drop (mm H2O).      Filter pressure
                                             drop (mm H2O).
 Filter efficiency (%).              Filter efficiency
                                             (%).
 Tipping paper length (mm).          Tipping paper
                                             length (mm).
 Filter ventilation (%).             Filter ventilation
                                             (%).
------------------------------------------------------------------------

      Table 9 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
             Information for Unfiltered Sheet-Wrapped Cigars
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigar mass (mg).                    Cigar mass (mg).
 Cigar length (mm).                  Cigar length (mm).
 Cigar minimum diameter (mm).        Cigar minimum
                                             diameter (mm).
 Cigar maximum diameter (mm).        Cigar maximum
                                             diameter (mm).
 Tobacco filler mass (mg).           Tobacco filler mass
                                             (mg).
 Cigar wrapper porosity (CU).        Cigar wrapper
                                             porosity (CU).
 Cigar tip length (mm) (if           Cigar tip length
 applicable).                                (mm) (if applicable).
 Cigar tip inner diameter (mm) (if   Cigar tip inner
 applicable).                                diameter (mm) (if
                                             applicable).
 Cigar tip width (mm) (if            Cigar tip width
 applicable).                                (mm) (if applicable).
------------------------------------------------------------------------

     Table 10 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                   Information for Leaf-Wrapped Cigars
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigar mass (mg).                    Cigar mass (mg).
 Cigar length (mm).                  Cigar length (mm).
 Cigar minimum diameter (mm).        Cigar minimum
                                             diameter (mm).
 Cigar maximum diameter (mm).        Cigar maximum
                                             diameter (mm).
 Tobacco moisture (%).               Tobacco moisture
                                             (%).
------------------------------------------------------------------------

     Table 11 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                      Information for Cigar Tobacco
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tobacco cut size (mm).              Tobacco cut size
                                             (mm).
 Tobacco moisture (%).               Tobacco moisture
                                             (%).
------------------------------------------------------------------------

     Table 12 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                     Information for Cigar Wrappers
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Cigar wrapper length (mm).          Cigar wrapper
                                             length (mm).
 Cigar wrapper minimum width (mm).   Cigar wrapper
                                             minimum width (mm).
 Cigar wrapper maximum width (mm).   Cigar wrapper
                                             maximum width (mm).
------------------------------------------------------------------------

     Table 13 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                       Information for Waterpipes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Number of hoses.                    Bowl volume (ml).
 Bowl volume (ml).
------------------------------------------------------------------------

     Table 14 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                    Information for Waterpipe Tobacco
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tobacco cut size (mm).              Tobacco cut size
                                             (mm).
 Tobacco moisture (%).               Tobacco moisture
                                             (%).
------------------------------------------------------------------------

     Table 15 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                Information for Waterpipe Heating Sources
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Heating source type.                Charcoal
                                             temperature ([deg]C) (if
                                             applicable).
 Charcoal temperature ([deg]C) (if   Coil temperature
 applicable).                                range ([deg]C) (if
                                             applicable).
 Coil temperature range ([deg]C)     PDU temperature cut-
 (if applicable).                            off ([deg]C) (if
                                             applicable).
 Power delivery unit (PDU)
 temperature cut-off ([deg]C) (if
 applicable).
------------------------------------------------------------------------

     Table 16 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                     Information for Waterpipe Foil
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Foil length (mm).                   Foil length (mm).
 Foil width (mm).                    Foil width (mm).
------------------------------------------------------------------------

     Table 17 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                          Information for Pipes
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Bore minimum diameter (mm).         Bore minimum
                                             diameter (mm).
 Bore maximum diameter (mm).         Bore maximum
                                             diameter (mm).
 Bit length (mm).                    Bit length (mm).

 Bit diameter (mm).                  Bit diameter (mm).
 Stem length (mm).                   Stem length (mm).
 Stem diameter (mm).                 Stem diameter (mm).
------------------------------------------------------------------------

     Table 18 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                      Information for Pipe Tobacco
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Tobacco cut size (mm).              Tobacco cut size
                                             (mm).
 Tobacco moisture (%).               Tobacco moisture
                                             (%).
------------------------------------------------------------------------

     Table 19 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                          Information for ENDS
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 Airflow rate (cc/min).              Airflow rate (cc/
                                             min).
 Coil resistance (ohms).             Coil resistance
                                             (ohms).
 Overall atomizer resistance         Overall atomizer
 (ohms).                                     resistance (ohms).
 Wick ignition temperature           Wick ignition
 ([deg]C).                                   temperature ([deg]C).
 Battery mAh rating (mAh).           Battery mAh rating
                                             (mAh).
 PDU wattage operating range (W).    PDU wattage
                                             operating range (W).
 Coil temperature cut-off            Coil temperature
 ([deg]C).                                   cut-off ([deg]C).
 Coil temperature range ([deg]C).    Coil temperature
                                             range ([deg]C).
------------------------------------------------------------------------

     Table 20 to Sec.   1114.7(i)(2)(ii)--Required Design Parameter
                        Information for E-liquids
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
 E-liquid volume (ml).               E-liquid volume
                                             (ml).
------------------------------------------------------------------------

    (iii) Function. How the product is intended to function.
    (iv) Product pH and nicotine formulation. The pH of the product and
the formulation of nicotine in the product, if applicable, including
the form (e.g., unprotonated nicotine, nicotine salts) and quantity.
    (v) Fermentation process. For those products that contain fermented
tobacco, information on the fermentation process, including the
following:
    (A) Composition of the inoculum (starter culture) with genus and
species name(s) and concentration(s) (if applicable);
    (B) Any step(s) taken to reduce endogenous microbes (e.g., cleaning
of product contact surfaces);
    (C) Specifications and test data for pH, temperature, moisture
content, and water activity;
    (D) Frequency of aeration or turning (if applicable);
    (E) Duration of fermentation;
    (F) Added ingredients; and
    (G) Method used to stabilize or stop (if applicable), fermentation,
including data to demonstrate that the process is effective at reducing
microbial content of the product and to suppress microbial activity of
residual microorganisms to preclude further in-package fermentation.
    (vi) Storage and stability information. The application must
contain product storage and stability information that establishes the
microbial and chemical stability of the product throughout the shelf
life, including:
    (A) A description of the shelf life and how it is indicated on the
tobacco product, if applicable; and
    (B) Testing on the tobacco product in the same container closure
system that will be used if granted a marketing order that was
performed at the beginning (zero time), middle, and end of the expected
storage time for the chemical and microbial endpoints for the following
items: Microbial content data, including total aerobic microbial count
and total yeast and mold count along with identification of detected
microbiological organisms by genus and species names, if applicable;
pH; moisture content; water activity; tobacco-specific nitrosamines
(TSNAs) (reported as separate amounts for the total TSNAs, NNN (N'-
nitrosonor-nicotine), NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-
butanone)); nitrate and nitrite levels; preservatives and microbial
metabolic inhibitors (if any); and method of heat treatment,
pasteurization, or other method used to reduce microbial loads.
    (vii) Product and packaging design risks and misuse hazards. A
review and assessment of reasonably foreseeable risks associated with
the design of the tobacco product and its package that may occur during
normal use of the tobacco product or during any foreseeable misuse of
the product, including user error, which may cause illness, injury, or
death not normally associated with the use of the tobacco product. The
review and assessment must identify the measures taken to reduce or
eliminate each risk associated with the design of the tobacco product
and package.
    (3) Principles of operation. The applicant must provide a full
statement of the principle or principles of operation of the tobacco
product, including full narrative descriptions of:
    (i) The way in which a typical consumer will use the new tobacco

product, including a description of how a consumer operates the product
and, where applicable, can change the product design and add or
subtract ingredients;
    (ii) The length of time it takes for a user to consume a single
unit of the product; and
    (iii) Whether the product incorporates a heating source, and if so,
a description of the heating source.
    (4) Product testing and analysis information. Each analysis
required in this paragraph must be performed on test samples that
reflect the finished tobacco product composition and design, and must
be conducted using a sufficient sample size and number of replicates to
substantiate the results of the type of testing conducted.
Additionally, the applicant must provide the following information:
    (i) The name and location of the testing laboratory or laboratories
and documentation showing that the laboratory or laboratories is (or
are) accredited by a nationally or internationally recognized external
accreditation organization;
    (ii) The length of time between dates of manufacture and date(s) of
testing;
    (iii) The storage conditions of the tobacco product before it was
tested;
    (iv) The number of samples and measurement replicates for each
sample;
    (v) A description of method procedure, method validation
information and rationale for selecting each test method, including
relevant voluntary testing standards, test protocols, quantitative
acceptance criteria, line data, and a summary of the results;
    (vi) Reports of product formulation testing that include test
protocols, quantitative acceptance criteria, line data, and a summary
of the results, for each applicable parameter; and
    (vii) Complete descriptions of any smoking or aerosol-generating
regimens used for analytical testing that are not standardized or
widely accepted by the scientific community, if applicable.
    (j) Manufacturing. The application must contain a full description
of the methods used in, and the facilities and controls used for, the
design (including design validation and design verification, to assess
whether the tobacco product, as manufactured, performs in accordance
with design specifications), manufacture, packing, and storage of the
tobacco product in sufficient detail to demonstrate whether the product
meets manufacturing specifications, can be manufactured in a manner
consistent with the information submitted in the application, and
conforms to the requirements of any regulations issued under section
906(e) of the Federal Food, Drug, and Cosmetic Act, including:
    (1) A list of all manufacturing, packaging, storage, and control
facilities for the product, including the facilities name, address, and
FEI number, if applicable, and a contact name and telephone number for
a representative from each facility;
    (2) A narrative description, accompanied by a list and summary, of
all standard operating procedures (SOPs) and examples of relevant forms
and records for the following categories of information for all
manufacturing, design controls, packing, and storage for the tobacco
product:
    (i) Manufacturing and production process activities at each
establishment, including a description of each establishment, all
production steps, and process controls, process specifications with
relevant acceptance criteria, and monitoring and acceptance activities;
    (ii) Managerial oversight and employee training related to the
manufacture, processing, packing, and installation of the tobacco
product, as applicable;
    (iii) Monitoring procedures and manufacturing controls for product
design, product characteristics, and changes in products,
specifications, methods, processes, or procedures, including a hazard
analysis that details the correlation of the product design attributes
with public health risk, as well as any mitigation strategies
implemented;
    (iv) Activities related to identifying and monitoring suppliers and
the products supplied (including, for example, purchase controls and
product acceptance activities);
    (v) Handling of complaints, nonconforming products and processes,
and corrective and preventative actions;
    (vi) Testing procedures carried out before the product is released
to market, including:
    (A) A list and summary of any standards used for all testing
methods;
    (B) Validation and verification activities for all test methods
used to ensure that the tobacco product meets specifications;
    (C) Documentation of accreditation information for all testing
laboratories;
    (D) Complete description of smoking or aerosol-generating regimes
used for analytical testing, if any; and
    (E) Tobacco product specifications (including any physical,
chemical, and biological specifications) and acceptance criteria for
those specifications;