Document ID: FDA-2016-N-3818-0001
Agency: fda
Document Type: Proposed Rule
Title: Content and Format of Substantial Equivalence Reports; Food and Drug
Administration Actions on Substantial Equivalence Reports
Posted Date: 2019-04-02T04:00Z

[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Proposed Rules]
[Pages 12740-12791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05787]

[[Page 12739]]

Vol. 84

Tuesday,

No. 63

April 2, 2019

Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 16 and 1107

Content and Format of Substantial Equivalence Reports; Food and Drug 
Administration Actions on Substantial Equivalence Reports; Proposed 
Rule

  Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / 
Proposed Rules  

[[Page 12740]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 1107

[Docket No. FDA-2016-N-3818]
RIN 0910-AH89

Content and Format of Substantial Equivalence Reports; Food and 
Drug Administration Actions on Substantial Equivalence Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed 
rule to establish requirements for the content and format of reports 
intended to establish the substantial equivalence of a tobacco product 
(SE Reports). The proposed rule would establish the information an SE 
Report must include so that FDA may make a substantial equivalence 
determination. In addition, the proposed rule would establish the 
general procedures FDA intends to follow when evaluating SE Reports, 
including procedures that would address communications with the 
applicant and the confidentiality of data in an SE Report. The proposed 
rule is intended to provide more clarity to applicants and support 
efficient and predictable reviews of SE Reports.

DATES: Submit either electronic or written comments on the proposed 
rule by June 17, 2019. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 by May 2, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 17, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of June 17, 2019. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-3818 for ``Content and Format of Substantial Equivalence 
Reports; Food and Drug Administration Actions on Substantial 
Equivalence Reports.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues to the Office of 
Management and Budget in the following ways: Fax to the Office of 
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 
202-395-7285, or email to [email protected]. All comments 
should be identified with the title, ``Substantial Equivalence Reports 
for Tobacco Products.''

FOR FURTHER INFORMATION CONTACT: Annette Marthaler or Daniel Gittleson, 
Office of Regulations, Center for Tobacco Products, Food and Drug 
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

Executive Summary

I. Background
II. Legal Authority
III. Description of Proposed Regulations
    A. General (Proposed Subpart B)
    B. Substantial Equivalence Reports (Proposed Subpart C)
    C. FDA Review (Proposed Subpart D)
    D. Miscellaneous (Proposed Subpart E)
IV. Other Issues for Consideration
V. Paperwork Reduction Act of 1995
VI. Executive Order 13132: Federalism
VII. Consultation and Coordination with Indian Tribal Governments
VIII. Analysis of Environmental Impact

[[Page 12741]]

IX. Economic Analysis of Impacts
X. References
XI. Effective Datep

Executive Summary

Purpose of the Regulatory Action

    This proposed rule would establish requirements related to the 
content and format of SE Reports, including the information that SE 
Reports must contain. FDA is basing this proposed rule on the 
experience the Agency has in reviewing thousands of SE Reports since 
2010. The SE Reports that FDA has seen to date range widely in the 
level of detail included. For example, some have very little 
information on the comparison of the new tobacco product with a 
predicate tobacco product while other SE Reports are much more detailed 
in describing how the new tobacco product compares to the identified 
predicate tobacco product and provide supporting information. This wide 
variation in the depth of content may be due, at least in part, to 
confusion about what information FDA needs from applicants to make a 
substantial equivalence finding. FDA's experience reviewing this wide 
range of SE Reports has been helpful in developing this proposed rule, 
which describes in detail the information that an applicant would be 
required to include in an SE Report.
    The proposed rule also addresses issues such as communications with 
the applicant, the retention of records that support the SE Report, 
confidentiality of SE Report information, and electronic submission of 
the SE Report and amendments. The proposed rule is intended to provide 
both applicants and FDA with more certainty about the content and 
format of SE Reports and FDA's review of the SE Reports. The proposed 
rule is also intended to provide more clarity to applicants and help 
ensure that the SE pathway for premarket review of a new tobacco 
product is used when appropriate, e.g., when there is a valid predicate 
tobacco product to which the new product can be scientifically compared 
and support efficient and predictable reviews.

Legal Authority

    This proposed rule is being issued based upon FDA's authority to 
require premarket review of new tobacco products under sections 905(j) 
and 910(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 387e(j) and 387j(a)), FDA's authority to require reports under 
section 909(a) of the FD&C Act (21 U.S.C. 387i(a)), FDA's authorities 
related to adulterated and misbranded tobacco products under sections 
902 and 903 (21 U.S.C. 387b and 387c), as well as FDA's rulemaking and 
inspection authorities under sections 701(a) and 704 of the FD&C Act 
(21 U.S.C. 371(a) and 374).

Summary of the Major Provisions

    This proposed rule would establish content and format requirements 
for SE Reports. Under the proposed rule, an SE Report must provide 
information comparing the new tobacco product to a predicate tobacco 
product, including information that would enable FDA to uniquely 
identify the new tobacco product and the predicate tobacco product. The 
proposed requirements would help ensure that an SE Report provides 
information necessary for FDA to determine whether the new tobacco 
product is substantially equivalent to a tobacco product commercially 
marketed in the United States as of February 15, 2007 (as required by 
section 910(a)(2)(A) of the FD&C Act).
    In addition, the proposed rule would explain how an applicant can 
amend or withdraw an SE Report, and explain how an applicant may 
transfer ownership of an SE Report to a new applicant. The proposed 
rule also would address FDA communications with applicants on SE 
Reports, including when FDA would issue deficiency notifications; 
explain FDA review cycles; and identify actions that FDA may take on SE 
Reports. The proposed rule would address when FDA may rescind an SE 
order and explain how long an applicant must maintain records related 
to the SE Report. The proposed rule also would explain FDA's disclosure 
provisions and provide for electronic submission of SE Reports, unless 
the applicant requests a waiver. FDA is basing the proposed rule on our 
experience reviewing SE Reports, and the proposed rule is intended to 
provide both applicants and FDA with more certainty related to the 
information needed to demonstrate substantial equivalence and FDA's 
review processes with the goal of an efficient and predictable review 
process for SE Reports.

Costs and Benefits

    This proposed rule would impose compliance costs on affected 
entities to read and understand the rule, establish or revise internal 
procedures, and fill out a form for SE Reports. We estimate that the 
present value of industry compliance costs ranges from $0.60 million to 
$2.64 million, with a primary estimate of $1.61 million at a 3 percent 
discount rate, and from $0.56 million to $2.32 million, with a primary 
estimate of $1.43 million at a 7 percent discount rate over 10 years. 
Annualized industry compliance costs over 10 years range from $0.07 
million to $0.31 million, with a primary estimate of $0.19 million at a 
3 percent discount rate and from $0.08 million to $0.33 million, with a 
primary estimate of $0.20 at a 7 percent discount rate.
    The benefits of this proposed rule are potential time-savings to 
industry and cost-savings to government. This proposed rule clarifies 
when applicants may certify that certain characteristics are identical 
in the new tobacco product and the predicate tobacco product. 
Certifying may save applicants time in preparing their SE Reports. In 
this proposed rule, we intend to shorten review times for SE Reports. 
In addition, based on our experience with prior SE Reports, we believe 
this proposed rule would lead to better SE Reports, saving us time in 
review and requiring fewer staff to review SE Reports, which would 
result in cost-savings. We estimate that the present value of 
government cost-savings ranges from $15 million to $198 million, with a 
primary estimate of $62 million at a 3 percent discount rate, and from 
$12 million to $163 million, with a primary estimate of $51 million at 
a 7 percent discount rate over 10 years. Annualized government cost-
savings over 10 years range from $1.7 million to $23.2 million, with a 
primary estimate of $7.2 million at both 3 and 7 percent discount 
rates.
    The qualitative benefits of this proposed rule include additional 
clarity to industry about the requirements for the content and format 
of SE Reports. The proposed rule would also establish the general 
procedures we intend to follow in reviewing and communicating with 
applicants. In addition, this proposed rule would make the SE pathway 
more predictable.

[[Page 12742]]

                                         Table 1--Summary of Annualized Costs and Benefits of the Proposed Rule
                                                                  [$2016 over 10 years]
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                                                             Low (3%)       Medium (3%)      High (3%)       Low (7%)       Medium (7%)      High (7%)
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Costs...................................................           $0.07           $0.19           $0.31           $0.08           $0.20           $0.33
Benefits................................................             1.7             7.2            23.2             1.7             7.2            23.2
Net Benefits (rounded)..................................             1.7             7.1            22.9             1.7             7.0            22.9
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I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) was enacted June 22, 2009, and provided 
FDA the authority to regulate tobacco products under the FD&C Act. The 
FD&C Act, as amended by the Tobacco Control Act, requires that before a 
new tobacco product may be introduced into interstate commerce for 
commercial distribution in the United States, the new tobacco product 
must undergo premarket review by FDA. Section 910(a)(1) of the FD&C Act 
defines a ``new tobacco product'' as: (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.
    The FD&C Act establishes three premarket review pathways for a new 
tobacco product:
     Submission of a premarket tobacco application under 
section 910(b);
     Submission of a report intended to demonstrate that the 
new tobacco product is substantially equivalent to a predicate tobacco 
product under section 905(j)(1)(A) (``SE Report''); and
     Submission of a request for an exemption under section 
905(j)(3) (implemented at Sec.  1107.1 (21 CFR 1107.1)).
    Under section 910(a)(2)(B) of the FD&C Act, a manufacturer of a 
tobacco product that was first introduced or delivered for introduction 
into interstate commerce for commercial distribution after February 15, 
2007, and prior to March 22, 2011, that submitted an SE Report \1\ 
prior to March 23, 2011, may continue to market the tobacco product 
unless FDA issues an order that the tobacco product is not 
substantially equivalent. For any new tobacco product introduced into 
commercial distribution on or after March 22, 2011, or for which a 
substantial equivalence report was not submitted by March 23, 2011, a 
manufacturer must first submit a premarket application under section 
910 for the new tobacco product to FDA, and FDA must issue an order 
authorizing the commercial distribution of the new tobacco product or 
find the product exempt from the requirements of substantial 
equivalence under section 910(a)(2)(A) of the FD&C Act, before the 
product may be introduced into commercial distribution. If a new 
tobacco product is marketed without an order or a finding of exemption 
from substantial equivalence, it is adulterated under section 902 of 
the FD&C Act and misbranded under section 903 of the FD&C Act and 
subject to enforcement action.
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    \1\ In this proposed rule, FDA refers to ``SE applications'' as 
``SE Reports,'' but the terms both refer to a premarket submission 
under section 905(j)(1)(A) of the FD&C Act.
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    Since 2010, FDA has received more than 5,000 premarket 
applications. Almost all of the premarket applications have been SE 
Reports. To assist manufacturers in preparing SE Reports, FDA has 
issued guidance documents; \2\ conducted Webinars; met with 
manufacturers; posted technical project lead reviews (which describe 
the administrative, compliance, and substantive scientific reviews 
completed on a specific SE Report), general information about not 
substantially equivalent (NSE) determinations, and orders (FDA posts 
the NSE orders for provisional tobacco products,\3\ and SE orders for 
all tobacco products); and issued letters outlining deficiencies in 
individual tobacco product SE Reports. Manufacturers are now more 
informed about what an SE Report should contain, and FDA is more 
informed about the range of tobacco products and changes made to these 
products and the data needed to demonstrate substantial equivalence. 
The proposed rule is based on this experience and would establish 
requirements related to the substantial equivalence premarket pathway 
and provide both manufacturers and FDA with more certainty related to 
the information needed to demonstrate substantial equivalence and FDA's 
review processes.
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    \2\ The guidance documents include: ``Section 905(j) Reports: 
Demonstrating Substantial Equivalence for Tobacco Products'' 
(January 2011); ``Establishing That a Tobacco Product Was 
Commercially Marketed in the United States as of February 15, 2007'' 
(September 2014); ``Demonstrating the Substantial Equivalence of a 
New Tobacco Product: Responses to Frequently Asked Questions'' 
(December 2016); and ``Meetings with Industry and Investigators on 
the Research and Development of Tobacco Products'' (July 2016). 
These guidance documents may be accessed at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.
    \3\ ``Provisional'' tobacco products refer to those tobacco 
products that were first introduced or delivered for introduction 
into interstate commerce for commercial distribution in the United 
States after February 15, 2007, and prior to March 22, 2011, and for 
which a 905(j) (Substantial Equivalence) Report was submitted no 
later than March 22, 2011.
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II. Legal Authority

    As described in the following paragraphs, FDA is proposing this 
rule to prescribe the content, form, and manner of reports intended to 
demonstrate the substantial equivalence of a new tobacco product to a 
predicate tobacco product, as well as to establish other requirements 
related to SE Reports including requirements for keeping records, 
making reports, and providing information essential to FDA's 
implementation of the FD&C Act. In accordance with section 5 of the 
Tobacco Control Act, FDA intends that the requirements that would be 
established by this proposed rule be severable and that the 
invalidation of any provision of this proposed rule would not affect 
the validity of any other part of this rule.
    Section 910(a)(2) of the FD&C Act requires a new tobacco product to 
be the subject of a premarket tobacco application (PMTA) order unless 
FDA has issued an SE order authorizing its commercial distribution or 
the tobacco product is exempt from substantial equivalence. To satisfy 
the requirement of premarket review, a manufacturer may submit a report 
intended to demonstrate the substantial equivalence of a new tobacco 
product to a predicate tobacco product under section 905(j) of the FD&C 
Act. Section 905(j) provides that FDA may prescribe the form and

[[Page 12743]]

manner of the substantial equivalence report, and section 910(a)(4) 
requires that as part of the 905(j) report, the manufacturer provide an 
adequate summary of any health information related to the new tobacco 
product or state that such information will be made available upon 
request.
    Based on the information provided by the applicant, section 
910(a)(3)(A) of the FD&C Act authorizes FDA to issue an order finding 
substantial equivalence when FDA finds that the new tobacco product is 
in compliance with the requirements of the FD&C Act and either: (1) Has 
the same characteristics as the predicate tobacco product or (2) has 
different characteristics and the information submitted contains 
information, including clinical data if deemed necessary by FDA, that 
demonstrates that it is not appropriate to regulate the product under 
(the premarket tobacco application or ``PMTA'' provisions) because the 
product does not raise different questions of public health.
    Section 909(a) of the FD&C Act authorizes FDA to issue regulations 
requiring tobacco product manufacturers or importers to maintain such 
records, make such reports, and provide such information as may be 
reasonably required to assure that their tobacco products are not 
adulterated or misbranded and to otherwise protect public health.
    Under section 902(6)(A) of the FD&C Act, a tobacco product is 
adulterated if it is required to have premarket review and does not 
have an order in effect under section 910(c)(1)(A)(i) of the FD&C Act. 
Under section 903(a)(6) of the FD&C Act, a tobacco product is 
misbranded if a notice or other information respecting it was not 
provided as required by section 905(j) of the FD&C Act. In addition, a 
tobacco product is misbranded if there is a failure or refusal to 
furnish any material or information required under section 909 (section 
903(a)(10)(B) of the FD&C Act).
    Section 701(a) of the FD&C Act gives FDA general rulemaking 
authority to issue regulations for the efficient enforcement of the 
FD&C Act, and section 704 of the FD&C Act provides FDA with general 
inspection authority.

III. Description of Proposed Regulations

    The proposed rule would add subparts B through E to current part 
1107 of Title 21. The requirements set out in this proposed rule would 
not apply to provisional SE Reports or to any SE Report submitted 
before the effective date of any final rule associated with this 
proposed rulemaking. FDA has published a final rule extending the 
Agency's ``tobacco product'' authorities in the FD&C Act to all 
categories of products that meet the statutory definition of ``tobacco 
product'' in the FD&C Act, except accessories of such newly deemed 
tobacco products (``Deeming Tobacco Products To Be Subject to the 
Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking 
Prevention and Tobacco Control Act; Restrictions on the Sale and 
Distribution of Tobacco Products and Required Warning Statements for 
Tobacco Products'' (81 FR 28974, May 10, 2016) (the Deeming final 
rule)). This proposed rule would apply to SE Reports for all tobacco 
products submitted after the final rule is effective, including the 
newly deemed tobacco products, that FDA regulates under Chapter IX of 
the FD&C Act. Proposed subparts D and E set out FDA's review processes 
and would be applicable to FDA's review of SE Reports after the 
effective date of any final rule. The proposed rule also would amend 
Sec.  16.1 (21 CFR 16.1) to add a reference to proposed Sec.  1107.50 
(this proposed section would address rescission of an SE order).

A. General (Proposed Subpart B)

1. Scope (Proposed Sec.  1107.10)
    According to proposed Sec.  1107.10, subparts B through E would 
establish the procedures and requirements for the submission of an SE 
Report under sections 905 and 910 of the FD&C Act, the basic criteria 
for establishing substantial equivalence, and the general procedures 
FDA intends to follow when evaluating SE Reports.
2. Definitions (Proposed Sec.  1107.12)
    Proposed Sec.  1107.12 sets forth the meaning of terms as they 
apply to proposed subparts B through E of part 1107. Proposed Sec.  
1107.12 includes the following definitions from the FD&C Act:
     Additive. As defined in section 900(1) of the FD&C Act (21 
U.S.C. 387), ``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.
    An additive can be a type of ingredient in a tobacco product; an 
example is methyl salicylate in smokeless tobacco, which can serve as 
an absorption enhancer and affect the characteristics of the tobacco 
product by changing the rate of absorption into the body. Tobacco is 
not an additive.
     Brand. As defined in section 900(2) of the FD&C Act, 
``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, 
identifiable pattern of colors, or any combination of such attributes.
     Characteristic. As defined in section 910(a)(3)(B) of the 
FD&C Act, ``characteristic'' means the materials, ingredients, design, 
composition, heating source, or other features of a tobacco product. 
All of the terms used in the definition of characteristic (materials, 
ingredients, design, etc.) are defined in proposed Sec.  1107.12.
     Distributor. As defined in section 900(7) of the FD&C Act, 
``distributor'' means any person who furthers the distribution of a 
tobacco product, whether domestic or imported, at any point from the 
original place of manufacture to the person who sells or distributes 
the product to individuals for personal consumption. Common carriers 
are not considered distributors for the purposes of this part.
     New tobacco product. As defined in section 910(a)(1) of 
the FD&C Act, ``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.
    Under the FD&C Act, and as reflected in the proposed definition, 
new tobacco products include those that are new because they have been 
rendered new through 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 (21 U.S.C. 387j(a)(1)(B)). For example, modifications to 
cigarette paper, container closure systems (e.g.,

[[Page 12744]]

change from glass to plastic e-liquid vials or from plastic to tin 
container closures), product quantity, specifications that change 
characteristics (e.g., a modification to a different tobacco cut size) 
would render a tobacco product new.
    Manufacturers sometimes co-package tobacco products. Co-packaging 
two or more legally marketed tobacco products, where there are no 
changes, including no change to the container closure system(s), does 
not result in a new tobacco product. Examples include a carton of 
cigarette packs and a variety pack of three smokeless tins shrink-
wrapped together where the cigarette packs and smokeless tins, 
respectively, could be legally marketed separately. However, if a 
manufacturer wishes to co-package two or more tobacco products 
(including their respective container closure systems), premarket 
review is required for any new tobacco product that the manufacturer 
intends to include in the co-package. An example includes shrink-
wrapping grandfathered tobacco filler (in its unmodified container 
closure system) with new rolling papers; here premarket authorization 
would be required for the rolling papers. In addition, co-packaging two 
or more tobacco products within the same container closure system 
results in a new tobacco product, unless such co-packaged product is 
grandfathered. Examples include an RYO kit where rolling papers are 
placed inside the tin of tobacco filler and shrink-wrapping together 
two soft-packs of cigarettes, neither of which had been individually 
shrink-wrapped prior to being co-packaged. FDA invites comment on 
approaches to its review of these types of SE Reports, including, where 
relevant, how co-packaging products impacts consumer use and behavior.
    In addition, for purposes of determining whether a tobacco product 
is new under section 910 of the FD&C Act, and therefore requires 
premarket authorization prior to marketing, a ``tobacco product'' can 
be considered to encompass the whole product (e.g., a pack of 
cigarettes or a tin of loose tobacco), and is not limited to a single 
unit or portion of the whole product (e.g., a single cigarette or a 
single snus pouch). See Philip Morris USA Inc. v. U.S. Food & Drug 
Admin., 202 F. Supp. 3d 31, 55-57 (D.D.C. 2016). Consequently, a change 
in product quantity (e.g., decreasing the weight of a smokeless package 
from 24 grams to 15 grams) results in a new tobacco product subject to 
premarket review since such a modification ``necessarily entails a 
change in the amount of the constituent ingredients and additives 
within the tobacco product, including nicotine'' (id. at 56).
    FDA also considers a tobacco product marketed exclusively in test 
markets on February 15, 2007, to be a new tobacco product that is 
subject to premarket review by FDA. In addition, such test marketed 
products cannot serve as valid predicate products in an SE Report. A 
tobacco product that the applicant intends to test market after 
February 15, 2007, is also a new tobacco product subject to premarket 
review under section 910(a) of the FD&C Act because it was not 
commercially marketed in the United States as of February 15, 2007.
    Because the terms ``test marketing'' and ``commercially marketed'' 
are not interchangeable, FDA is considering whether it would be useful 
to applicants for the rule to further expand on or define the terms 
``test marketing'' and ``commercially marketed.'' Specifically, FDA is 
considering whether to add the following definition of test marketing: 
``test marketing'' means distributing or offering for sale (which may 
be shown by advertisements, etc.) a tobacco product in the United 
States for the purpose of determining consumer response or other 
consumer reaction to the tobacco product, with or without the user 
knowing it is a test product, in which any of the following criteria 
apply:
     Offered in a limited number of regions;
     Offered for a limited time; or
     Offered to a chosen set of the population or specific 
demographic group.
    FDA is considering whether to define ``commercially marketed'' as 
offering a tobacco product for sale to consumers in all or in parts of 
the United States. Factors FDA may consider include advertising or 
other means used to communicate that the tobacco product was available 
for purchase, including dated advertisements, dated catalog pages, 
dated promotional material, dated trade publications, dated bills of 
lading, dated freight bills, dated waybills, dated invoices, dated 
purchase orders, dated manufacturing documents, inventory lists, or any 
other document that demonstrates that the product was commercially 
marketed (other than exclusively in test markets) in the United States 
as of February 15, 2007. FDA invites comment on what evidence would be 
sufficient to demonstrate that a product was commercially marketed 
(other than in test markets) as of February 15, 2007.
    FDA is inviting comments on: (1) Whether the rule should further 
expand on the interpretation or include definitions of these terms, (2) 
the substance of the definitions, if included, and (3) whether or not 
the approach described is adequate to protect the public health.
     Package or packaging. As defined in section 900(13) of the 
FD&C Act, ``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. A subset of package is the 
container closure system (also defined in this proposed rule). For 
example, the carton holding multiple soft packs of cigarettes is 
considered the package, and each soft pack with surrounding cellophane 
is considered the container closure system. Packaging that constitutes 
the container closure system is intended or reasonably expected to 
affect or alter the performance, composition, constituents, or 
characteristics of the tobacco product (e.g., leaching substances that 
are then incorporated into a tobacco product), but packaging that is 
not the container closure system is not intended or reasonably expected 
to affect or alter the performance, composition, constituents, or 
characteristics of the tobacco product.
     Substantial equivalence or substantially equivalent. As 
defined in section 910(a)(3)(A) of the FD&C Act, the term ``substantial 
equivalence'' or ``substantially equivalent'' means, with respect to 
the tobacco product being compared to the predicate tobacco product, 
that FDA, by order, has found that the tobacco product:
    [cir] Has the same characteristics as the predicate tobacco product 
or
    [cir] Has different characteristics and the information submitted 
contains information, including clinical data if deemed necessary by 
FDA that demonstrates that it is not appropriate to require premarket 
review under section 910(a), (b) and (c) of the FD&C Act because the 
product does not raise different questions of public health.
    FDA notes that this proposed rule does not include a proposed 
interpretation of ``same characteristics'' and ``different 
characteristics'' under section 910(a)(3)(A) of the FD&C Act.\4\ 
However, FDA recognizes that stakeholders have requested additional 
clarity on these terms. FDA continues to consider the appropriate 
implementation of these terms, as well as public feedback the Agency 
has received on the terms during workshops

[[Page 12745]]

and in response to other Federal Register notices (e.g., most recently, 
in response to a notice related to the Paperwork Reduction Act, 83 FR 
45251, September 6, 2018). For example, FDA is considering whether the 
``same characteristics'' prong might be appropriate for new tobacco 
products that are so similar to the predicate product that FDA would 
not need scientific information to determine whether the new product 
raises different questions of public health. Examples of changes 
between the new and predicate products that might be appropriate to 
proceed through ``same characteristics,'' either individually or in 
combination, include, non-exhaustively: (1) A change in product 
quantity between the new and predicate tobacco products; (2) a change 
in container closure system for non-moist tobacco products; (3) 
decreases in the total amount of tobacco in the new tobacco product 
without any corresponding changes in other ingredients or 
characteristics of the new tobacco product; and (4) changes in the non-
combusted portion of a cigarette, for example, a change in tipping 
paper color from plain to cork, or a change in adhesive, or the removal 
of a dye or ink.
---------------------------------------------------------------------------

    \4\ FDA notes that products with identical characteristics are 
not new products, and thus are not required to undergo premarket 
review.
---------------------------------------------------------------------------

    Under this approach, a new product would have ``different 
characteristics'' if a product were dissimilar enough from the 
predicate product that FDA could not determine without scientific 
information whether the new product raised different questions of 
public health. Examples of changes between the new and predicate 
products that might be appropriate to proceed through ``different 
characteristics,'' either individually or in the aggregate, include, 
non-exhaustively:
     A change in filter or ventilation of a combusted tobacco 
product, because such a change has the potential to affect the public 
health analysis required to assess substantial equivalence, such that 
FDA would need scientific information to determine whether the new 
product raises different questions of public health. For example, in 
some circumstances, a change in filter could result in an increase in 
ventilation and a change in harmful or potentially harmful constituent 
(HPHC) exposure levels to the user, with effects on the public health 
impact of the product. It is possible that in some other circumstances, 
a change in filter would not have results that would affect the public 
health impact of the product.
     A change in container closure system for a moist smokeless 
tobacco product, because FDA would need scientific information to 
determine, for example, whether or not such differences could result in 
a change in tobacco product stability that would increase HPHC levels 
and exposures to the user.
     A change in characterizing flavor in the new product 
because FDA would need scientific information to determine, for 
example, whether or not such differences could affect use behaviors.
    FDA notes that these examples are illustrative only and are not 
intended to convey that any differences specific to an individual case 
would or would not be appropriate to proceed through the ``different 
characteristics'' approach or result in a determination of SE.
    When a new product has different characteristics, FDA would 
evaluate whether the difference(s) in characteristics, individually and 
in the aggregate, do not cause the new product to raise different 
questions of public health. In determining if a new product raises 
different questions of public health, FDA may consider, among other 
things, whether one or more of the following is the case, as compared 
to the predicate product, (1) the new product has the potential to 
increase HPHC yields, and, if so, the degree of such an increase; (2) 
the new product has the potential to increase toxicity; (3) the new 
product has the potential to increase initiation; (4) the new product 
has the potential to increase abuse liability; (5) the new product has 
the potential to increase dependence; or (6) the new product has the 
potential to decrease cessation. Based on this analysis, FDA will 
determine whether the applicant has demonstrated that any differences 
do not cause the new product to raise different questions of public 
health.
    Please note that FDA is including these examples based on the 
Agency's experience to date in reviewing SE reports, and for purposes 
of soliciting comments on this approach, and FDA will continue to 
review each SE Report and make an SE determination on the basis of the 
information included in that SE Report. FDA invites comment on the 
terms ``same characteristics'' and ``different characteristics,'' the 
potential approach discussed above, and any alternative approaches to 
interpretation of these terms, including examples of new tobacco 
products that would have the ``same characteristics'' as the predicate, 
as well as new tobacco products that would have ``different 
characteristics'' from the predicate. While the rule proposes that 
certain information would be required for reports submitted under 
either the same characteristics or different characteristics prong, we 
welcome comments on what information would need to be included under 
either or both prongs if the approach described above, or an 
alternative approach, is implemented. FDA also invites comment on how 
we might evaluate different questions of public health. In your 
comment, please include your reasoning for how you would distinguish 
the scope of the same characteristics prong from the different 
characteristics prong, i.e., when an applicant might claim that a 
proposed new tobacco product is substantially equivalent to a predicate 
tobacco product because it has the ``same'' characteristics. FDA will 
consider all comments and will seek to provide additional clarity in 
the final rule, if possible.
     Tobacco product. As defined in section 201(rr) of the FD&C 
Act (21 U.S.C. 321(rr)), the term ``tobacco product'' means any product 
that is 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 is a drug 
under section 201(g)(1), a device under section 201(h), or a 
combination product described in section 503(g) of the FD&C Act (21 
U.S.C. 353(g)). As explained in the definition of ``new tobacco 
product,'' FDA 's interpretation is that the tobacco product 
encompasses the whole product and is not limited to a single unit or 
portion of the whole product.
     Tobacco product manufacturer. As defined in section 
900(20) of the FD&C Act, the term ``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. FDA interprets ``manufactures, 
fabricates, assembles, processes, or labels'' as including, but not 
being limited to: (a) Repackaging or otherwise changing the container, 
wrapper, or labeling of any tobacco product package; (b) reconstituting 
tobacco leaves; or (c) applying any chemical, additive, or substance to 
the tobacco leaf other than potable water in the form of steam or mist. 
Manufacturing activities typically do not include the activities of de-
stemming, drying, or packaging tobacco leaves; mechanically removing 
foreign material from tobacco leaves; and humidifying tobacco leaves 
with nothing other than potable water in the

[[Page 12746]]

form of steam or mist. A proposed definition for the term ``finished 
tobacco product'' is also included in the proposed rule.
    In addition, FDA proposes the following definitions:
     Accessory. FDA proposes to define ``accessory'' as 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:
    [cir] Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    [cir] Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product but solely controls moisture and/or temperature of a stored 
product; or solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product.
    Examples of accessories are ashtrays and spittoons because they do 
not contain tobacco, are not derived from tobacco, and do not affect or 
alter the performance, composition, constituents, or characteristics of 
a tobacco product. Examples of accessories also include humidors or 
refrigerators that solely control the moisture and/or temperature of a 
stored product and conventional matches and lighters that solely 
provide an external heat source to initiate but not maintain combustion 
of a tobacco product. This proposed definition is also in accord with 
the definition included in the Deeming final rule.
     Applicant. FDA proposes to define ``applicant'' as any 
manufacturer of tobacco products who is subject to chapter IX of the 
FD&C Act that submits a premarket application to receive marketing 
authorization for a new tobacco product. For the purposes of part 1107, 
a premarket application refers to an SE Report or an exemption request.
     Commercial distribution. FDA proposes to define 
``commercial distribution'' as any distribution of a tobacco product to 
consumers or to another person through sale or otherwise. This term 
does not include transfers of a tobacco product between registered 
establishments within the same parent, subsidiary, and/or affiliate 
company, nor does it include providing a tobacco product for product 
testing where such products are not made available for consumption or 
resale. This term would exclude the handing or transfer of a tobacco 
product from one consumer to another for personal consumption. For 
foreign establishments, the term ``commercial distribution'' has the 
same meaning except the term does not include distribution of any 
tobacco products that are neither imported nor offered for import into 
the United States. This term is intended to include a tobacco product 
that is test marketed after February 15, 2007, and this term would 
encompass distribution of free samples (e.g., smokeless products). FDA 
intends to limit our enforcement of the requirements of section 910 and 
905(j) to finished tobacco products (see the Guidance for Industry and 
FDA Staff entitled ``Section 905(j) Reports: Demonstrating Substantial 
Equivalence for Tobacco Products'' (76 FR 789, January 6, 2011); see 
also Deeming final rule, 81 FR at 29019).
     Component or part. FDA proposes to define ``component or 
part'' as any software or assembly of materials intended or reasonably 
expected: (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics or (2) to be used with or 
for the human consumption of a tobacco product. Component or part 
excludes anything that is an accessory of a tobacco product. A 
container closure system (which would also be defined in this proposed 
section) is considered a component or part. With respect to these 
definitions, FDA notes that ``component'' and ``part'' are separate and 
distinct terms within chapter IX of the FD&C Act. However, for purposes 
of this proposed rule, FDA is using the terms ``component'' and 
``part'' interchangeably and without emphasizing a distinction between 
the terms. FDA may clarify the distinctions between ``component'' and 
``part'' in the future. This proposed definition and approach are in 
accord with the Deeming final rule. FDA invites comments on this 
approach.
     Composition. FDA proposes to define ``composition'' as all 
of the materials in a tobacco product, including ingredients, 
additives, and biological organisms. The term also includes the manner 
in which these ingredients, additives, biological organisms, etc., are 
arranged and integrated to produce a tobacco product. Composition 
refers primarily to the chemical and biological properties of a tobacco 
product, whereas design refers to the physical properties of a tobacco 
product. A biological organism refers to any living biological entity, 
such as an animal, plant, fungus, or bacterium.
     Constituent. FDA proposes to define ``constituent'' as any 
chemical or chemical compound in a tobacco product that is or 
potentially is inhaled, ingested, or absorbed into the body, any 
chemical or chemical compound in an emission from a tobacco product, or 
any chemical or chemical compound in mainstream or sidestream tobacco 
smoke that either transfers from any component of the tobacco product 
to the smoke or that is formed by the combustion or heating of tobacco, 
additives, or other component of the tobacco product. Examples of 
constituents include harmful or potentially harmful constituents, total 
particulate matter, nicotine-free dry particulate matter, and water. A 
constituent also could include any other chemical or chemical compound 
contained in or produced by a tobacco product under conditions of use.
     Container closure system. FDA proposes to define 
``container closure system'' as any packaging materials that are a 
component or part of a tobacco product.
    Examples of a container closure system include the blister pack 
around a dissolvable tablet (in this example, if there is a box around 
a blister pack, the box is not considered a container closure system if 
it is not intended or reasonably expected to alter or affect the 
dissolvable tablet), the can that contains and protects a moist snuff 
product, and the plastic-wrapped hard pack or soft pack used to contain 
and protect cigarettes. In the context of determining whether a product 
is substantially equivalent as defined in section 910(a)(3)(A) of the 
FD&C Act, a container closure system is a component or part of a 
tobacco product because of its potential to alter or affect the 
performance, composition, constituents, or other physical 
characteristics of the product. For example, if a change in the 
container closure system could affect the chemistry of the product, FDA 
could require the applicant to demonstrate that the change in the 
container closure system does not cause the new tobacco product to 
raise different questions of public health. Although the FD&C Act does 
not itself define ``component'' or ``part,'' FDA recently promulgated 
definitions for these terms in the Deeming final rule. According to 21 
CFR 1100.3, ``component or part'' means any software or assembly of 
materials intended or reasonably expected: (1) To alter or affect the 
tobacco product's performance, composition, constituents, or 
characteristics or (2) to be used with or for the human consumption of 
a tobacco product. Component or part excludes anything that is an 
accessory

[[Page 12747]]

of a tobacco product.\5\ The same definitions are also reflected in 
this rule's proposed Sec.  1107.12.
---------------------------------------------------------------------------

    \5\ ``Accessory'' is defined as 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 solely controls moisture and/or temperature of a 
stored tobacco product or solely provides an external heat source to 
initiate but not maintain combustion of a tobacco product (Sec.  
1100.3).
---------------------------------------------------------------------------

    In addition, considering a distinct subset of packaging (i.e., 
container closure system) to be a component or part is consistent with 
the FD&C Act. For example, section 900(1) of the FD&C Act defines an 
``additive'' as 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 substance 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. This definition 
further evinces Congress's understanding that packaging is not entirely 
separable from the tobacco product. Finally, the definition of 
``package'' in section 900(13) of the FD&C Act does not dictate a 
contrary result, and can be reasonably interpreted to mean that a 
distinct subset of packaging is also a component or part of a tobacco 
product.
    According to the proposed definition above, packaging constitutes a 
container closure system if it is intended or reasonably expected to 
affect or alter the performance, composition, constituents, or 
characteristics of a tobacco product, even if it is also used to 
protect or contain the tobacco product. For example, packaging 
materials constitute a container closure system if substances within 
that packaging are intended or reasonably expected to affect product 
moisture, e.g., when the manufacturer changes the package of a moist 
snuff from plastic to fiberboard, which can affect microbial stability 
and TSNA formation during storage. Another example of this is when 
menthol or other ingredients are applied to the inner foil to become 
incorporated into the consumed product (Ref. 1). Packaging materials 
may also be intended or reasonably expected to affect the 
characteristics of a tobacco product by impacting the rate of leaching 
into, and ultimately, the amount of substances found in, the consumable 
tobacco product. In fact, it has been demonstrated that compounds in 
packaging materials may also diffuse into snuff and affect its 
characteristics (Ref. 2). Thus, for example, packaging material that 
affects the characteristics of a tobacco product by impacting the 
moisture level or shelf life of a tobacco product is a container 
closure system (e.g., a plastic versus a metal container of smokeless 
tobacco). A difference in tobacco moisture is reasonably expected to 
affect microbial growth in the product, extraction efficiency, and 
total exposure to nicotine or the carcinogens N-nitrosonornicotine 
(NNN) or 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) (Ref. 
26).
    Treating a distinct subset of packaging as a component or part thus 
furthers the fundamental purpose of the Tobacco Control Act to protect 
the public health. This interpretation is also consistent with the 
broad definition of ``tobacco product,'' as well the definition of 
``additive,'' which includes any substance that may be reasonably 
expected to result, directly or indirectly, in its becoming a component 
or otherwise affecting the characteristics of any tobacco product--and 
not just substances that do in fact have such effects. This shows that 
Congress did not intend for FDA to be required to show that a container 
closure system did in fact alter or affect the tobacco product's 
performance, composition, constituents, or other characteristics. 
Indeed, if FDA were to adopt a narrow construction of ``tobacco 
product'' to exclude these materials, the Agency's ability to evaluate 
whether the differences between the new and predicate tobacco product 
cause the new tobacco product to raise different questions of public 
health would be impeded, thereby leaving the Agency unable to fully 
execute its mission to protect the public health.
     Design. FDA proposes to define ``design'' to mean the form 
and structure concerning, and the manner in which, components or parts, 
ingredients, software, and materials are integrated to produce a 
tobacco product. This term refers to the physical properties of a 
tobacco product. Examples of design features include tip ventilation, 
paper porosity, tobacco cut width, and filter efficiency.
     Finished tobacco product. FDA proposes to define 
``finished tobacco product'' to mean a tobacco product, including all 
components and parts, sealed in final packaging (e.g., filters or 
filter tubes sold separately to consumers or as part of kits).
     Grandfathered tobacco product. FDA proposes to define a 
``grandfathered tobacco product'' to mean a tobacco product that was 
commercially marketed in the United States on February 15, 2007. This 
term does not include tobacco products exclusively marketed in a test 
market as of that date. FDA interprets the phrase ``as of February 15, 
2007,'' as meaning that the tobacco product was commercially marketed 
in the United States ``on February 15, 2007,'' and the proposed 
definition reflects this interpretation (see the final guidance 
entitled ``Establishing That a Tobacco Product Was Commercially 
Marketed in the United States as of February 15, 2007'' (79 FR 58358, 
September 29, 2014)). A grandfathered tobacco product is not subject to 
the premarket requirements of section 910 of the FD&C Act.
     Harmful or potentially harmful constituent (HPHC). FDA 
proposes to define ``harmful or potentially harmful constituent'' as 
any chemical or chemical compound in a tobacco product or tobacco smoke 
or emission that: (1) Is or that potentially could be inhaled, 
ingested, or absorbed into the body, including as an aerosol (vapor) or 
any other emission and (2) causes or has the potential to cause direct 
or indirect harm to users or nonusers of tobacco products.
    FDA has previously discussed HPHCs in FDA guidance documents (see 
the final guidance entitled ``Harmful and Potentially Harmful 
Constituents' in Tobacco Products as Used in Section 904(e) of the 
Federal Food, Drug, and Cosmetic Act'' (76 FR 5387, January 31, 2011; 
revised guidance issued August 2016)). The current established list of 
HPHCs can be found on FDA's website at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm297786.htm (77 FR 
20034, April 3, 2012). In addition, since the inception of the SE 
program for tobacco products, HPHCs have been considered ``other 
features,'' and the proposed definition of ``other features'' in this 
rule would include HPHCs (see the final guidance entitled ``Section 
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco 
Products,'' (January 5, 2011)).
     Health information summary. FDA proposes to define 
``health information summary'' to mean a summary, submitted by the 
applicant under section 910(a)(4) of the FD&C Act, of any health 
information related to the new tobacco product. This would

[[Page 12748]]

include detailed information concerning adverse health effects of the 
new tobacco product. For example, information concerning adverse health 
effects includes specific adverse events that have been reported to the 
applicant and also includes any research or data concerning adverse 
health effects of which the applicant is aware.
     Health information statement. FDA proposes to define 
``health information statement'' to mean a statement, made under 
section 910(a)(4) of the FD&C Act that health information related to 
the new tobacco product would be made available upon request by any 
person. Like the health information summary, the health information 
provided to a person requesting it would be required to include any 
health information related to the new tobacco product, including 
detailed information regarding data concerning adverse health effects 
of the new tobacco product.
     Heating source. FDA proposes to define ``heating source'' 
as the source of energy that is used to burn or heat a tobacco product. 
An example of a heating source is a flame.
     Ingredient. FDA proposes to define ``ingredient'' as 
tobacco, substances, compounds, or additives 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. For 
example, an ingredient may be a single chemical substance, leaf 
tobacco, or the product of a reaction, such as a chemical reaction, in 
manufacturing. Examples of substances and compounds (ingredients) 
reasonably expected to be formed through a chemical reaction during 
tobacco product manufacturing include the following:
    [cir] The reaction of sugars with amines to form families of 
compounds with new carbon-nitrogen bonds, including Maillard reaction 
products and Amadori compounds.
    [cir] The reaction of sodium hydroxide with citric acid to form 
sodium citrate.
    [cir] The production of ethyl alcohol, a residual solvent, from 
ethyl acetate during production of tipping paper adhesive.
    [cir] Products of thermolytic reactions, such as the production of 
carboxylic acids from sugar esters.
    [cir] Products of enzymatically or nonenzymatically catalyzed 
reactions, such as the hydrolytic production of flavor or aroma 
precursors from nonvolatile glucosides.
    [cir] Products of acid-base reactions, such as removal of a proton 
from protonated nicotine to generate the basic form of nicotine 
(``free'' nicotine).
     Material. FDA proposes to define ``material'' to mean an 
assembly of ingredients. Materials are assembled to form the tobacco 
product or components or parts of tobacco products. For example, 
material would include the glue or paper pulp for a cigarette where the 
paper pulp includes multiple ingredients (e.g., multiple types of 
tobacco, water, and flavors) assembled into the paper (or pulp 
depending on the water content).
     Other features. FDA proposes to define ``other features'' 
to mean any distinguishing qualities of a tobacco product similar to 
those specifically enumerated in section 910(a)(3)(B) of the FD&C Act. 
The definition would include: (1) HPHCs (note that the definition of 
new tobacco product includes any modification to any constituents, 
including smoke constituents, section 910(a)(1)(B) of the FD&C Act) and 
(2) any other product characteristics that relate to the chemical, 
biological, and physical properties of the tobacco product that are 
necessary for SE Report review. As described in the proposed definition 
of HPHC, HPHC information is necessary to provide a complete comparison 
between the new and predicate tobacco products: HPHCs are a subset of 
the chemical and chemical compounds in a tobacco product or tobacco 
smoke or emission. As such, HPHC information for the new and predicate 
tobacco products is necessary for FDA to determine whether the new 
tobacco product raises different questions of public health. Other 
features also would encompass other product characteristics that relate 
to the chemical, biological, and physical properties that would not be 
addressed as a material, ingredient, design, composition, or heating 
source.
     Predicate tobacco product. FDA proposes to define 
``predicate tobacco product'' to mean a tobacco product that is a 
grandfathered tobacco product or a tobacco product that FDA has 
previously found to be substantially equivalent under section 
910(a)(2)(A)(i) of the FD&C Act. This proposed definition is also based 
on language in section 905(j)(1)(A)(i) of the FD&C Act.
     Submission tracking number or STN means the number that 
FDA assigns to submissions that are received from a manufacturer of 
tobacco products, such as SE Reports and requests for grandfather 
determinations.
     Substantial equivalence report or SE Report. FDA proposes 
to define ``substantial equivalence report'' (also known as a 905(j) 
report) or SE Report to mean a submission under section 905(j)(1)(A)(i) 
of the FD&C Act that includes the basis for the applicant's 
determination that a new tobacco product is substantially equivalent to 
a predicate tobacco product. This term includes the initial SE Report 
and all subsequent amendments (e.g., amendments include information an 
applicant submits in response to a deficiency letter).

B. Substantial Equivalence Reports (Proposed Subpart C)

1. Submission of a Substantial Equivalence Report (Proposed Sec.  
1107.16)
    Proposed Sec.  1107.16 explains the basic timeframes that would be 
required for submitting an SE Report to FDA before commencing 
commercial distribution of a new tobacco product. An applicant may 
submit an SE Report to demonstrate that a new tobacco product is 
substantially equivalent to a predicate tobacco product (an applicant 
could also consider whether the exemption under Sec.  1107.1 or an 
application under section 910(b) of the FD&C Act is a more appropriate 
premarket pathway for the applicant's new tobacco product). If an 
applicant chooses to submit an SE Report for a new tobacco product, it 
must do so at least 90 calendar days before the date the applicant 
intends to begin commercial distribution of the product (see section 
905(j)(1) of the FD&C Act). The proposed rule also provides that an 
applicant may not begin commercial distribution of the new tobacco 
product that is the subject of the SE Report until FDA has issued an 
order stating that the Agency has determined that the new tobacco 
product is substantially equivalent to a predicate tobacco product 
(unless the new tobacco product has received authorization to be 
marketed through another premarket pathway, i.e., PMTA or exemption 
from substantial equivalence). Otherwise, the new tobacco product is 
both adulterated and misbranded (sections 902(6)(A) and 903(a)(6) of 
the FD&C Act) and subject to enforcement action.
2. Required Content and Format of an SE Report (Proposed Sec.  1107.18)
    Since March 22, 2011 (the date that SE Reports for provisional 
tobacco products were required to be submitted), FDA has gained 
considerable experience in reviewing more than 3,000 SE Reports 
submitted under sections 905(j) and 910(a) of the FD&C Act. As a 
result, FDA has identified information essential to the review of SE 
Reports, which is reflected

[[Page 12749]]

in the content and format requirements of proposed Sec.  1107.18.
    a. Overview. Proposed Sec.  1107.18(a) provides an overview of the 
requirements for the content and format of an SE Report. Proposed Sec.  
1107.18(a) would provide that the SE Report include information that 
would enable FDA to uniquely identify the new tobacco product and the 
predicate tobacco product and compare the new tobacco product to a 
predicate tobacco product. This information is necessary for FDA both 
in reviewing the SE Report so that we can understand the comparison and 
also to issue an order that appropriately identifies the tobacco 
product that is subject to the order. Providing sufficient information 
as described in proposed Sec.  1107.18 would help enable FDA to 
determine whether the new tobacco product is substantially equivalent 
to a tobacco product commercially marketed in the United States as of 
February 15, 2007 (as required by section 910(a)(2)(A) of the FD&C 
Act).
    The proposed provision would require that the SE Report contain the 
following elements:
     General information (described in proposed Sec.  
1107.18(c));
     Summary (described in proposed Sec.  1107.18(d));
     New tobacco product description (described in proposed 
Sec.  1107.18(e));
     Predicate tobacco product description (described in 
proposed Sec.  1107.18(f)). This would include a statement that the 
predicate tobacco product has not been removed from the market at the 
initiative of FDA and has not been determined by judicial order to be 
adulterated or misbranded, and the STN of the SE order finding the 
predicate tobacco product SE, or the STN of, or specific information 
sufficient to support, a grandfathered determination of the predicate 
tobacco product. If the SE Report includes information on the 
grandfathered status of the predicate tobacco product (but FDA has not 
yet made a grandfathered determination \6\), FDA would make the 
grandfathered determination before beginning substantive scientific 
review of the SE Report to ensure that the predicate tobacco product is 
valid;
---------------------------------------------------------------------------

    \6\ FDA discusses the information the Agency will consider, 
along with Agency's general thinking on grandfathered 
determinations, in the guidance document, ``Establishing That a 
Tobacco Product Was Commercially Marketed in the United States as of 
February 15, 2007'' (79 FR 58358, September 29, 2014).
---------------------------------------------------------------------------

     Comparison information (described in proposed Sec.  
1107.18(g));
     Comparative testing information (described in proposed 
Sec.  1107.18(h))
     Statement of compliance with applicable tobacco product 
standards under section 907 of the FD&C Act (21 U.S.C. 387g) (described 
in proposed Sec.  1107.18(i));
     Health summary or statement regarding the availability of 
such information as required by section 910(a)(4) of the FD&C Act 
(described in proposed Sec.  1107.18(j));
     Compliance with part 25 (21 CFR part 25) (environmental 
impact considerations) (described in proposed Sec.  1107.18(k)); and
     Certification statement (described in proposed Sec.  
1107.18(l)).
    If the SE Report were missing any of these items, the Agency would, 
under proposed Sec.  1107.44(a), refuse to accept the SE Report for 
review.
    b. General Format. Proposed Sec.  1107.18(b) provides the general 
requirements for the format of the SE Report and would require the 
applicant to submit the SE Report with the appropriate FDA form (Refs. 
3 and 4). Proposed Sec.  1107.18(b) would require the SE Report and any 
amendments to contain a comprehensive index and table of contents and 
be well organized, legible, and written in the English language. For 
any foreign language documents, the original foreign language document 
must be accompanied by the English translation and a certification by 
the applicant or responsible official authorized to represent the 
applicant that the translation into English is accurate. The 
comprehensive index would include the listing of files and data 
associated with those files (e.g., for an SE Report that is 
electronically submitted, the comprehensive index would include the 
listing of files and associated metadata).
    As described in proposed Sec.  1107.62, FDA is proposing that, for 
an SE Report and supporting documents to be accepted by FDA, the SE 
Report and documents must be submitted to FDA in an electronic format 
that the Agency can process, read, review, and archive, unless the 
Agency has previously granted a waiver from these requirements. FDA 
will not act on an SE Report until the Center for Tobacco Product's 
(CTP's) Document Control Center has received an SE Report that the 
Agency can process, read, review, and archive. Applicants that are 
unable to submit their reports in electronic format would be advised to 
consult proposed Sec.  1107.62, which explains how the applicant may 
obtain a waiver from the electronic filing requirement. FDA intends to 
provide information on our website about technical specifications 
related to submission, including the electronic formats, which would 
allow FDA to process, read, review, and archive the SE Report. 
Providing technical specifications information on our website enables 
FDA to periodically update the electronic formats that we are capable 
of accepting so that we can accommodate quickly evolving technology.
    The requirements in proposed Sec.  1107.18(b) and 1107.62 are 
intended to address some of the problems we have seen with SE Reports. 
For example, some SE Reports have been submitted to FDA in a 
proprietary format or password protected without providing FDA access 
or password information. Following up with an applicant to obtain 
access or password information takes time and contributes to delays. In 
addition, some electronic submissions have not been in a static format, 
and thus, the pages reformat, renumber, re-bullet, or re-date each time 
the document is accessed. Receiving SE Reports with these issues 
affects our ability to cross-reference, share, and efficiently evaluate 
information. Lastly, because FDA is required under regulations 
governing Federal records to maintain many files long term, and in a 
``sustainable'' format (for more information on sustainable formats, 
please refer to National Archives and Record Administration Bulletin 
2014-04, https://www.archives.gov/records-mgmt/bulletins/2014/2014-04.html), proposed Sec.  1107.18(b) would ensure that these files can 
be managed, opened, and read by the Agency for the duration of the 
retention period.
    c. General information. Proposed Sec.  1107.18(c) lists the 
information that the SE Report would be required to include. This 
information includes general administrative information that must 
specify the type of submission (e.g., SE Report); the new tobacco 
product with unique identification and the predicate tobacco product 
with unique identification (to enable us to identify the new tobacco 
product as well as identify the predicate product), as well as contact 
information. The SE Report must include the following information using 
the FDA-provided forms, as appropriate:
     The date the SE Report is submitted (using the applicant-
generated submittal date, i.e., the date the applicant assigns to it, 
which for a paper submission is the date typically located at the top 
of a cover letter, and for an electronic submission is the date when 
the document is uploaded to FDA's electronic submission system);
     Type of submission (e.g., SE Report or amendment to an SE 
Report);
     Previously assigned FDA STN, where applicable (e.g., in 
cases where

[[Page 12750]]

the applicant is submitting an amendment to an SE Report, the Agency 
has assigned a number in advance, or the applicant is referencing a 
previously denied SE Report);
     Any other relevant FDA STN, such as a request for a 
grandfathered determination, and cross-references to meetings regarding 
the new tobacco product (e.g., if FDA issues an order denying marketing 
authorization for a tobacco product and meets with the applicant about 
it before the applicant submits a new SE Report, the meeting should be 
referenced in the new SE Report);
     The name, address, and contact information for the 
applicant and the authorized representative or authorized U.S. agent 
(for a foreign applicant). FDA would require identification of an 
authorized representative or, for foreign applicants, authorized U.S. 
agent to help FDA ensure adequate notice is provided to applicants of 
official Agency communications. In particular, FDA may be unable to 
confirm that adequate notice of Agency action or correspondence 
concerning premarket submissions is provided to foreign applicants as 
FDA cannot necessarily confirm receipt of correspondence sent 
internationally. Accordingly, the designation of a U.S. agent provides 
an official contact to the Agency who can receive the information or 
documentation on behalf of the applicant. Providing notice regarding 
that SE Report to the U.S. agent would constitute notice to the foreign 
applicant. FDA requires identification of a U.S. agent to assist FDA in 
communicating with the foreign applicant and help permit the Agency to 
efficiently process SE Reports and avoid delays. In many instances 
during the SE Report review process, FDA has reached out numerous times 
to a foreign applicant and has either been unable to speak with the 
applicant or was unable to directly communicate questions and/or 
concerns. This impediment has resulted in delays or terminations in the 
review of specific SE Reports and a slowdown of the premarket 
application process as a whole. A U.S. agent would act as a 
communications link between FDA and the applicant and would facilitate 
timely correspondence between FDA and foreign applicants, including 
responding to questions concerning pending applications and, if needed, 
assisting FDA in scheduling meetings with the foreign applicants to 
resolve outstanding issues before agency action is taken. In addition, 
the authorized representative or U.S. agent would be authorized to act 
on behalf of the applicant for that specific SE Report.
     For both the new and predicate tobacco product, 
information needed to uniquely identify the products, including:
    [cir] The manufacturer;
    [cir] Product name, including the brand and sub brand;
    [cir] Product category; product subcategory; and product 
properties, as provided in table 2. The applicant would select and 
provide for both the new and predicate tobacco products the appropriate 
category, subcategory, and product properties (if the product does not 
have a listed product property, e.g., ventilation or characterizing 
flavor, the report must state ``none'' for that property):

 Table 2--Tobacco Product Category, Subcategory, and Product Properties
                               Information
------------------------------------------------------------------------
                                 Tobacco product
   Tobacco product category        subcategory       Product properties
------------------------------------------------------------------------
Cigarettes....................  Combusted,         --Package type (e.g.,
                                 Filtered.          hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89
                                                    millimeter (mm), 100
                                                    mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) \7\ (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Combusted, non-    --Package type (e.g.,
                                 filtered.          hard pack, soft
                                                    pack, 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).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Combusted, Other.  --Package type (e.g.,
                                                    hard pack, soft
                                                    pack, 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.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Non-Combusted      --Package type (e.g.,
                                 (e.g., a           hard pack, soft
                                 cigarette where    pack, clam shell).
                                 the tobacco is
                                 only heated not
                                 burned).
                                                   --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.,
                                                    none, 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).
                                Cigarette, Co-     --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple cigarette
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product, as
                                                    identified above.
Roll-Your-Own (RYO) Tobacco     RYO Tobacco        --Package type (e.g.,
 Products.                       Filler.            bag, pouch).

[[Page 12751]]

 
                                                   --Product quantity
                                                    (e.g., 20 g, 40 g).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Rolling Paper....  --Package type (e.g.,
                                                    bag, box, booklet).
                                                   --Product quantity
                                                    (e.g., 50 sheets,
                                                    200 papers).
                                                   --Length (e.g., 79
                                                    mm, 100 mm, 110 mm).
                                                   --Width (e.g., 28 mm,
                                                    33 mm, 45 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Filtered           --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --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.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Non-Filtered       --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --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).
                                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.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                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).
                                RYO Co-Package...  --For a new co-
                                                    packaged tobacco
                                                    product composed of
                                                    multiple RYO tobacco
                                                    products, include,
                                                    as applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product (e.g., RYO
                                                    tobacco, rolling
                                                    paper, filtered
                                                    cigarette tube, non-
                                                    filtered cigarette
                                                    tube, filter, paper
                                                    tip) as identified
                                                    above.
                                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.
Smokeless Tobacco Products....  Loose Moist Snuff  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 grams (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).
                                Portioned Moist    --Package type (e.g.,
                                 Snuff.             plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   ----Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 15 pouches,
                                                    20 pieces).
                                                   --Portion mass (e.g.,
                                                    1.5 g/pouch, 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).
                                Loose Snus.......  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).

[[Page 12752]]

 
                                                   --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).
                                Portioned Snus...  --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).
                                Loose Dry Snuff..  --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).
                                Dissolvable......  --Package type (e.g.,
                                                    plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 15 sticks, 20
                                                    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).
                                Loose Chewing      --Package type (e.g.,
                                 Tobacco.           bag, pouch,
                                                    wrapped).
                                                   --Product quantity
                                                    (e.g., 20 g, 3
                                                    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).
                                Portioned Chewing  --Package type (e.g.,
                                 Tobacco.           plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 g).
                                                   --Portion count
                                                    (e.g., 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).
                                Smokeless Co-      --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple smokeless
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified above.
                                Other............  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
ENDS (Electronic Nicotine       Open E-Liquid      --Package type (e.g.,
 Delivery System).               (e.g., an e-       bottle, box).
                                 liquid in a
                                 bottle with a
                                 removable cap).
                                                   --Product quantity
                                                    (e.g., 1 bottle, 5
                                                    bottles).
                                                   --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).

[[Page 12753]]

 
                                Closed E-Liquid    --Package type (e.g.,
                                 (e.g., a sealed    cartridge).
                                 cartridge for
                                 use in an e-
                                 cigarette).
                                                   --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).
                                Closed E-          --Package type (e.g.,
                                 Cigarette (e.g.,   box, none, plastic
                                 a cigalike).       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.
                                Open E-Cigarette   --Package type (e.g.,
                                 (e.g., a tank      box, none, plastic
                                 system).           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).
                                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).
                                ENDS Co-Package..  --For a new co-
                                                    packaged tobacco
                                                    product composed of
                                                    multiple ENDS
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified above.
                                ENDS Other.......  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
Cigars........................  Filtered, Sheet-   --Package type (e.g.,
                                 Wrapped Cigar.     hard pack, soft
                                                    pack, 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).
                                Unfiltered, Sheet- --Package type (e.g.,
                                 Wrapped Cigar.     box, film sleeve).
                                                   --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).
                                Leaf-Wrapped       --Package type (e.g.,
                                 Cigar.             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).

[[Page 12754]]

 
                                                   --Wrapper material
                                                    (e.g., burley
                                                    tobacco leaf,
                                                    Connecticut shade
                                                    grown tobacco leaf).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                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).
                                Cigar Tobacco      --Package type (e.g.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16
                                                    ounces).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    tobacco, menthol,
                                                    cherry).
                                                   --Tobacco cut size
                                                    (e.g., 5 mm, 10 mm).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Cigar Co-Package.  --For a new co-
                                                    packaged tobacco
                                                    product composed of
                                                    multiple cigar
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified above.
                                Other............  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
Pipe Tobacco Products.........  Pipe.............  --Package type (e.g.,
                                                    box, none).
                                                   --Product quantity
                                                    (e.g., 1 pipe).
                                                   --Length (e.g., 200
                                                    mm, 300 mm).
                                                   --Diameter (e.g., 25
                                                    mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Pipe Tobacco       --Package type (e.g.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16
                                                    ounces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    Cavendish, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Pipe Component...  --Package type (e.g.,
                                                    bowl, shank, stem,
                                                    screen, filter).
                                                   --Product quantity
                                                    (e.g., 1 bowl, 1
                                                    stem, 100 filters).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Pipe Co-Package..  --For a new co-
                                                    packaged tobacco
                                                    product composed of
                                                    multiple pipe
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified above.
                                Other............  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
Waterpipe Tobacco Products....  Waterpipe........  --Package type (e.g.,
                                                    box, none).
                                                   --Product quantity
                                                    (e.g., 1 waterpipe).
                                                   --Length (e.g., 200
                                                    mm, 500 mm).
                                                   --Width (e.g., 100
                                                    mm, 300 mm).
                                                   --Number of hoses
                                                    (e.g., 1, 2, 4).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Waterpipe Tobacco  --Package type (e.g.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16
                                                    ounces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, apple).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                Waterpipe Heat     --Package type (e.g.,
                                 Source.            box, film sleeve,
                                                    bag, none).
                                                   --Product quantity
                                                    (e.g., 150 g, 680
                                                    g).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    apple).
                                                   --Portion count
                                                    (e.g., 20 fingers,
                                                    10 discs, 1 base).
                                                   --Portion mass (e.g.,
                                                    15 g/finger).
                                                   --Portion length
                                                    (e.g., 40 mm, 100
                                                    mm).
                                                   --Portion width
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Source of energy
                                                    (e.g., charcoal,
                                                    battery,
                                                    electrical).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).

[[Page 12755]]

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

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

[[Page 12756]]

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

[[Page 12757]]

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

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

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

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

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

[[Page 12758]]

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

[[Page 12759]]

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

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

[[Page 12760]]

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

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

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

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

[[Page 12761]]

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

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

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

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

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

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

[[Page 12762]]

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

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

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

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

[[Page 12763]]

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

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

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

[[Page 12764]]

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

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

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

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

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

[[Page 12765]]

Report, including tobacco product testing at appropriate intervals, 
until the tentative expiration date could be verified or the 
appropriate expiration date could be determined.
    Proposed Sec.  1107.19(e)(v) and (vi) would require information on 
the stability testing laboratory and identification of the 
microbiological organisms by genus and species names, where applicable, 
along with the culture collection number either used during the 
manufacturing process and/or detected through stability testing.
    Proposed Sec.  1107.19(f) would require applicants to state that 
the new tobacco product has either: (1) The same characteristics as the 
predicate tobacco product and the basis for this determination or (2) 
different characteristics than the predicate tobacco product. Where an 
applicant states that its new tobacco product has different 
characteristics than the predicate tobacco product, the applicant must 
also include an explanation as to why a difference in any of the 
following characteristics do not cause the new product to raise 
different questions of public health: Product design (see Sec.  
1107.19(a)); heating source (see Sec.  1107.19(b)); materials and 
ingredients (see Sec.  1107.19(c)); and other features (see Sec.  
1107.19(d)). In addition, in order to demonstrate that a new tobacco 
product with different characteristics is substantially equivalent, an 
applicant must also explain why any differences in the manufacturing 
process that could affect the characteristics of the new product do not 
cause the new product to raise different questions of public health 
(see Sec.  1107.18(e)). Similarly, for smokeless tobacco products, an 
applicant must explain why any difference in stability between the new 
tobacco product and the predicate tobacco product does not raise 
different questions of public health (see Sec.  1107.19(e)).
    Proposed Sec.  1107.19(g) would explain that, if the applicant is 
comparing the new tobacco product to a predicate product that FDA has 
previously found to be substantially equivalent to another product, FDA 
may request that the applicant include information related to the 
original grandfathered tobacco product. Although an applicant can 
support a showing of SE by comparing the new tobacco product to a 
tobacco product that is grandfathered or that FDA has previously found 
SE, in order to issue an SE order, FDA must find that the new tobacco 
product is substantially equivalent to a tobacco product commercially 
marketed in the United States as of February 15, 2007 (see section 
910(a)(2)(A)(i)(I) of the FD&C Act). This statutory provision helps FDA 
ensure that new tobacco products using the substantial equivalence 
pathway and relying on predicate tobacco products previously found SE 
do not vary so much from the original grandfathered tobacco product 
that the new product would actually raise different questions of public 
health compared to the originally grandfathered tobacco product. New 
products with differences that may appear only incremental when a new 
tobacco product is compared to a predicate product previously found SE 
may actually have had significant changes when compared to the 
grandfathered tobacco product.
    Because the statute permits applicants to compare to either a 
grandfathered tobacco product or one that FDA has previously found SE 
(section 905(j)(1)(A)(i)) but also requires FDA to make an SE 
determination by comparing the new tobacco product to the grandfathered 
tobacco product (section 910(a)(2)(A)(i)(I)), FDA is proposing the 
approach in Sec.  1107.19(g). To meet its statutory obligation, FDA may 
need to look back to previously submitted SE Reports in the SE chain 
that rely on the original grandfathered product in order to issue an SE 
order. Manufacturers have been on notice since the passage of the 
Tobacco Control Act that FDA must make the comparison between the new 
tobacco product and the original grandfathered tobacco product, and in 
doing so, may need to rely on previously submitted SE Reports, even if 
submitted by a different manufacturer than the applicant at hand.
    Accordingly, for SE Reports that compare the new tobacco product to 
a predicate tobacco product that FDA previously found substantially 
equivalent, proposed Sec.  1107.19(g) states that, if requested by FDA, 
the applicant would be required to provide information related to the 
original grandfathered tobacco product, even if the grandfathered 
tobacco product is several tobacco products removed from the predicate 
identified by the applicant. FDA would request this information when 
necessary to ensure that any order issued by the Agency complies with 
section 910(a)(2)(A)(i)(I) of the FD&C Act. Before requesting this 
information from the applicant, FDA would review other relevant SE 
Reports in the chain, for example, the first SE Report that received an 
SE order using the grandfathered product as a predicate product to make 
this finding. If FDA is unable to look back to data provided to the 
Agency regarding the grandfathered product and the applicant does not 
provide the information, FDA would be unable to make the finding 
required by section 910(a)(2)(A)(i)(I) of the FD&C Act. FDA encourages 
applicants to provide this information with the initial SE Report to 
support an efficient review of the SE Report, although FDA acknowledges 
this may be more difficult if the applicant is not the manufacturer or 
owner of the predicate tobacco product. FDA requests specific public 
comment on this proposed provision and any challenges it may present.
4. Amendments (Proposed Sec.  1107.20)
    Proposed Sec.  1107.20(a) would permit an applicant to submit an 
amendment to an SE Report. Proposed Sec.  1107.20(a) would require any 
applicant who chose to submit a health information summary with its SE 
Report under proposed Sec.  1107.18(j)(1) to submit with the amendment 
a redacted copy of the amendment that excludes research subject 
identifiers and trade secret and confidential and commercial 
information as defined in Sec. Sec.  20.61 and 20.63 (21 CFR 20.61 and 
20.63).
    An applicant may not amend an SE Report to change the predicate 
tobacco product (proposed Sec.  1107.20(b)). Because the comparison 
between the new and predicate tobacco products is the crux of the 
substantial equivalence determination, changing the predicate product 
changes the fundamental basis of the analysis. An applicant that 
determines that a predicate change is necessary should withdraw the 
initial SE Report and resubmit the SE Report with the information 
related to the new predicate tobacco product as described in proposed 
Sec.  1107.18.
    In addition, under proposed Sec.  1107.20(c), an applicant may not 
amend a closed SE Report, e.g., one that FDA has refused to accept, 
closed, canceled, or issued an order for under proposed Sec.  1107.44, 
or one that has been withdrawn under proposed Sec.  1107.22. Proposed 
Sec.  1107.20(d) also explains that FDA would review the additional 
information in the next review cycle (proposed Sec.  1107.42 discusses 
review cycles). As explained in proposed Sec.  1107.62, SE Reports, 
including amendments, would be submitted to CTP's Document Control 
Center. Phone calls and emails to FDA staff would not be considered 
amendments to an SE Report.
5. Withdrawal by Applicant (Proposed Sec.  1107.22)
    Proposed Sec.  1107.22 would permit an applicant to make a request 
to withdraw an SE Report unless FDA has closed the SE Report through an 
action in proposed Sec.  1107.44 (all FDA actions in proposed Sec.  
1107.44 would close the SE

[[Page 12766]]

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

C. FDA Review (Proposed Subpart D)

1. Communications Between FDA and Applicants (Proposed Sec.  1107.40)
    Proposed Sec.  1107.40 would establish general principles and 
provide clarity regarding communications between FDA and applicants 
during review of an SE Report. Proposed Sec.  1107.40(a) explains that, 
during the course of FDA's review of an SE Report, FDA may seek to 
communicate with applicants about relevant matters, including 
scientific and procedural issues that arise during the review process. 
Communications regarding medical issues may arise if adverse events 
reports exist for the tobacco product. FDA may use a variety of methods 
to communicate with applicants, such as telephone conversations, 
letters, or emails, depending on the circumstances and issues. FDA 
would document any communications regarding an SE Report in accordance 
with 21 CFR 10.65.
    Proposed Sec.  1107.40(b) would provide that applicants and 
representatives of the Agency may have meetings to discuss scientific 
and other issues. Applicants interested in requesting meetings would 
direct their requests to the Office of Science through the Document 
Control Center. For further information, applicants may review the 
guidance entitled ``Meetings with Industry and Investigators on the 
Research and Development of Tobacco Products'' (May 25, 2012, 77 FR 
31368; revised guidance issued July 2016). As discussed in this 
guidance, FDA does not intend to grant meetings in most circumstances 
to discuss an applicant's questions related to a pending SE Report 
because the timing is frequently inappropriate (e.g., premature or 
late, depending on stage of review) and such meetings are generally an 
inefficient or duplicative use of resources. For example, the applicant 
may be seeking substantive information while FDA's review is underway 
but before FDA has issued a deficiency letter or other response. Please 
note that each SE Report has a specific CTP contact to whom an 
applicant may ask clarifying questions, which helps ensure faster and 
more direct responses. FDA specifically requests public comment on the 
proposed decision to not grant meetings to discuss an applicant's 
questions related to a pending SE Report. Specifically, FDA seeks to 
understand if there are reasons why such meetings may be necessary for 
an applicant to respond to a deficiency letter or if the absence of 
such meetings present obstacles to the applicant in responding to 
deficiency letters.
    Proposed Sec.  1107.40(c) would provide that, upon receipt of an SE 
Report under proposed Sec.  1107.18, FDA would either refuse to accept 
the SE Report or issue an acknowledgement letter. FDA requests comment 
on what a reasonable period of time would be within which such refusal 
to accept or acknowledgement of receipt letters should be issued.
    Proposed Sec.  1107.40(d) addresses FDA's notification of 
deficiencies in an SE Report submitted under proposed Sec.  1107.18. 
FDA reviewers would make reasonable efforts to communicate to 
applicants the procedural, administrative, or scientific deficiencies 
found in an SE Report and, if appropriate, the data needed to enable

[[Page 12767]]

the Agency's review. For example, a reviewer might inform the applicant 
that a signature is needed for a certification, that provided test 
results have last values cutoff or appear to have a typographical 
error, or that the SE Report is missing a reference for support. This 
communication is intended to give applicants an opportunity to correct 
deficiencies in the SE Report and to submit an amendment if needed.
    Proposed Sec.  1107.40(e) explains that an SE Report would be 
considered withdrawn when FDA issues a notice stating that it is 
withdrawn, which would ensure that FDA has received the withdrawal 
notification and that both FDA and the applicant now consider the SE 
Report as withdrawn.
    FDA invites public comments on the following topics related to 
reasonable time periods to respond to a deficiency letter:
     Appropriate timelines for responding to a deficiency 
letter identifying missing information that is described in the final 
rule;
     Appropriate timelines for responding to a deficiency 
letter identifying missing information that requests additional 
information not described in the final rule;
     When requests for extensions of time to respond to a 
deficiency letter should be granted, and
     Whether or not deadlines to respond to deficiency letters 
should be tailored to the relative burden of the request.
2. Review Cycles (Proposed Sec.  1107.42)
    Proposed Sec.  1107.42(a) would set forth the timeframe for FDA's 
initial review cycle. The ``initial review cycle'' would consist of the 
90 calendar days following: (1) FDA's receipt of the SE Report and 
determination that a predicate product is grandfathered (for SE Reports 
that claim the predicate product was commercially marketed in the 
United States as of February 15, 2007, and FDA has not already 
determined the tobacco product is grandfathered) or (2) FDA's receipt 
of an SE Report (for SE Reports that contain a predicate product that 
was previously found substantially equivalent or for which FDA has 
previously determined that the predicate product is grandfathered). As 
described in more detail in proposed Sec.  1107.44, FDA intends to 
review the SE Report and communicate with the applicant or take an 
action on an SE Report during this time period. At any time before FDA 
issues an order on the SE Report, the applicant would be allowed to 
withdraw it under proposed Sec.  1107.22.
    Proposed Sec.  1107.42(b) would provide for the use of additional 
review cycles to complete FDA's review of an SE Report. If FDA issues a 
deficiency letter for an SE Report under proposed Sec.  1107.40(d), FDA 
would stop reviewing the SE Report until it received a response to the 
notification of deficiencies (or deficiency letter) or the timeframe 
specified in the letter has elapsed. If the applicant fails to provide 
a response within the time period provided, FDA would issue an order 
denying marketing authorization for the new tobacco product under the 
criteria set forth in Sec.  1107.48. If the applicant provides a 
response within the allotted timeframe, but FDA identifies the need for 
additional information as a result of this response, FDA could issue an 
additional deficiency notification. Each response would begin a new 90 
calendar day review cycle for FDA to review the response.
    FDA's intent is to complete review of an SE Report submitted under 
proposed Sec.  1107.18 within a maximum of 270 review days (i.e., three 
90-day review cycles). Based on FDA's review experience, an SE Report 
should be resolved within three review cycles. If fewer review cycles 
are needed, FDA intends to decide in a shorter time period. Section 
1107.40 would not obligate FDA to notify applicants of deficiencies in 
all circumstances before taking an action on an SE Report per proposed 
Sec.  1107.44 or proposed Sec.  1107.48. In any case where the SE 
Report has significant deficiencies, FDA might issue an order denying 
marketing authorization without providing additional opportunities to 
provide the missing information. Examples of significant deficiencies 
include when an SE Report provides no scientific evidence to 
substantiate a statement from the applicant that the new tobacco 
product does not raise different questions of public health or when an 
SE Report has multiple deficiencies but the applicant does not provide 
responses to all of the deficiencies. FDA requests public comment on 
whether FDA should provide specific timeframes within which applicants 
would need to respond to deficiency letters, along with an explanation 
as to why the proposed timeframes may be suitable for addressing the 
concerns commonly cited in the letters and why.
    Proposed Sec.  1107.42(c) states that, in the event that an 
applicant's response to FDA's deficiency notification(s) does not 
provide adequate information or the applicant provides information but 
the SE Report remains deficient, FDA intends to issue an order denying 
market authorization under the criteria set forth in proposed Sec.  
1107.48. The applicant also could make a written request to withdraw 
the SE Report under proposed Sec.  1107.22 at any time before FDA 
issues an order regarding the SE Report.
3. FDA Action on an SE Report (Proposed Sec.  1107.44)
    Proposed Sec.  1107.44 lists six actions FDA may take after 
completing review of an SE Report:
     First, FDA could refuse to accept the SE Report and not 
begin substantive scientific review if the SE Report does not comply 
with the requirements of proposed Sec.  1107.18 (this action would stop 
the review clock and end the review cycle). For example, FDA could 
refuse to accept an SE Report that was not written in English as 
required under Sec.  1107.18(b), or did not provide the information on 
product composition as required under Sec.  1107.19(c)(1). Or, FDA 
could advise the applicant that the SE Report is not appropriate under 
chapter IX of the FD&C Act because the product does not meet the 
definition of a tobacco product under section 201(rr) of the FD&C Act.
     Second, FDA could request additional information as 
provided in proposed Sec.  1107.40(d).
     Third, FDA could issue a letter closing the SE Report if 
it not possible to make a determination on an SE Report (sometimes 
referred to as an administrative closure, for example, which we might 
do when there is no way to determine if a new product is SE or NSE and 
additional information is unavailable);
     Fourth, FDA could issue a letter canceling the SE Report 
if FDA finds it mistakenly acknowledged the SE Report, e.g., the SE 
Report does not pertain to a new tobacco product;
     Fifth, FDA could issue an order finding the new tobacco 
product to be substantially equivalent and in compliance with the 
requirements of the FD&C Act under proposed Sec.  1107.46.
     Sixth, FDA could issue an order denying marketing 
authorization under proposed Sec.  1107.48 (NSE order) because:
    [cir] The applicant has failed to provide the information needed 
for FDA to find that the new tobacco product is substantially 
equivalent to a tobacco product that was commercially marketed in the 
United States on February 15, 2007;
    [cir] The new tobacco product is not substantially equivalent to a 
tobacco product that was commercially marketed in the United States on 
February 15, 2007; or

[[Page 12768]]

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

D. Miscellaneous (Proposed Subpart E)

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

[[Page 12769]]

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

[[Page 12770]]

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

IV. Other Issues for Consideration

    In addition to comments and information on the proposed 
requirements described in section III, FDA is also seeking comments and 
information on whether some modifications to tobacco products that 
result in a new tobacco product, beyond those eligible for an exemption 
from substantial equivalence, might be handled through a 
``categorical'' approach to substantial equivalence. Under such an 
approach, FDA would establish categories of modifications, and if a 
modification is within a category, the applicant could then submit a 
streamlined SE Report that identifies the modification and demonstrates 
substantial equivalence. FDA is soliciting concerns or benefits of this 
type of approach, along with information on the types of modifications 
or categories that might be handled in this way, or should not be 
handled this way.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A 
description of these provisions is given in the Description section of 
this document with an estimate of the annual reporting and 
recordkeeping. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Substantial Equivalence Reports for Tobacco Products.
    Description: Tobacco Products, Substantial Equivalence Reports, 
Requirements for Submitting Information Needed to Determine Substantial 
Equivalence and Maintaining Records to Support a Substantial 
Equivalence Report.
    This proposed rule would establish requirements for the content and 
format of substantial equivalence (SE) Reports (proposed Sec. Sec.  
1107.18 and 1107.19). Most of the proposed requirements would mirror 
current practices and recommendations related to the submission of SE 
Reports, including information related to part 25 (environmental 
considerations), but the rule would provide both applicants and FDA 
more certainty regarding the content and format the SE Reports. A 
health information summary or statement would continue to be required 
(section 910(a)(4) of the FD&C Act) and the health summary or response 
to a request would be required to be in the format of a redacted SE 
Report, along with any additional health information about the new 
tobacco product, including any information, research, or data about 
adverse health effects, that the applicant has or knows about and that 
is not contained in the SE Report.
    As is currently the practice, the proposed rule would continue to 
permit amendments for SE Reports submitted under proposed Sec.  
1107.18, e.g., to address deficiencies (proposed Sec.  1107.20). Also 
in accordance with current practice, the proposed rule would continue 
to permit withdrawals (proposed Sec.  1107.22) of pending SE Reports. 
The proposed rule would also propose requirements for when the 
ownership of an SE Report changes to ensure that FDA has information 
related to the current applicant (proposed Sec.  1107.24).
    The proposed rule would establish a recordkeeping requirement, 
under which applicants would be required to maintain records supporting 
the SE Report for an authorized new tobacco product for 4 years from 
the date of an order finding substantial equivalence, even if such 
product is discontinued (proposed Sec.  1107.58).
    The proposed rule would require that respondents submit an SE 
Report in an electronic format, unless a waiver from this requirement 
is requested by the applicant and granted by FDA (proposed Sec.  
1107.62). FDA created two new forms for submission; Form FDA 3964, 
Tobacco Amendment and General Correspondence; and Form FDA 3965, 
Tobacco Substantial Equivalence Report Submission.
    Description of Respondents: Manufacturers of tobacco products who 
submit SE Reports.

Existing Burden OMB Control Number 0910-0673

                                 Table 9--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and                  410               1             410             300         123,000
 910(a).........................
Full SE 905(j)(1)(A)(i) and                  250               1             250              90          22,500
 910(a) Bundled.................
Product Quantity Change SE                   264               1             264              87          22,968
 Report.........................
Product Quantity Change Bundled               55               1              55              62           3,410
 SE Report......................
                                 -------------------------------------------------------------------------------
    Totals......................  ..............  ..............  ..............  ..............         171,878
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ This chart represents the currently OMB approved burden for the SE program.

Reporting Burden Updated Estimates

[[Page 12771]]

                                 Table 10--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and                  683               1             683             300         204,900
 910(a).........................
Full SE 905(j)(1)(A)(i) and                  456               1             456              90          41,040
 910(a) Bundled.................
Product Quantity Change SE                   239               1             239              87          20,793
 Report.........................
Product Quantity Change Bundled              192               1             192              62          11,904
 SE Report......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         278,637
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Draft burden not yet OMB approved.

    In the Federal Register of September 6, 2018 (83 FR 45251), FDA 
published a notice soliciting comments on the extension of the current 
SE program. The numbers above in table 10 represent the tentative 
revisions which have not yet been approved by OMB. These estimates 
revise the number of reports under OMB control number 0910-0673 and 
take into account updated registration and listing data. The previous 
estimate for reports was 979 and total burden hours were 171,878. This 
chart accounts for the tentative increase in burden due to the expected 
rise in submissions other than any increases in burden due to the 
proposed rule, if finalized.

New Reporting Per Rule

                                 Table 11--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                     Number of
           21 CFR part               Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
FDA 3965 Tobacco Substantial               1,570               1           1,570              .5             785
 Equivalence Report Submission..
FDA 3964 Tobacco Amendment and               628               1             628            .083              52
 General Correspondence.........
Waiver from Electronic                       240               1             240             .25              60
 submission 1107.62(b)..........
                                 -------------------------------------------------------------------------------
    Totals......................  ..............  ..............  ..............  ..............             897
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Draft burden not yet OMB approved.

Final Combined Reporting Burden (Tables 10 +11)

                                 Table 12--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
           21 CFR part               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
SE Report 1107.18...............             683               1             683             300         204,900
Bundled SE 1107.18..............             456               1             456              90          41,040
SE Report where applicant                    239               1             239              87          20,793
 provides certification for
 identical characteristics
 1107.18(g) and 1107.18(1)(2)...
SE Report where applicant                    192               1             192              62          11,904
 provides certification for some
 identical characteristics
 (bundled) 1107.18(g) and
 1107.18(1)(2)..................
FDA 3965 Tobacco Substantial               1,570               1           1,570              .5             785
 Equivalence Report Submission..
FDA 3964 Tobacco Amendment and               628               1             628            .083              52
 General Correspondence Report..
Waiver from Electronic                       240               1             240             .25              60
 submission 1107.62(b)..........
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Totals......................  ..............  ..............  ..............  ..............         279,534
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Draft burden not yet OMB approved.

New Final Recordkeeping Burden

[[Page 12772]]

                               Table 13--Estimated Annual Recordkeeping Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                 Number of
         21 CFR part             Number of      records per    Total annual     Average  burden     Total hours
                               recordkeepers   recordkeeper       records     per  recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping SE Report                  471               1             471                 2.5           1,178
 under 1107.18 1107.58......
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Draft burden not yet OMB approved.

    FDA's estimates are based on experience with SE Reports, 
registration and listing data, interactions with the industry, and 
information related to other regulated products. As explained above, 
taking into account the updated registration and listing data for 
deemed tobacco products, the estimated annual number of SE Reports is 
expected to be 1,570. That estimate is not expected to change as a 
result of the proposed rule, if finalized.
    When groups of full SE Reports or SE Reports that each contain a 
certification that some characteristics are identical have identical 
content, they may be bundled; when a group of similar reports are 
bundled, the subsequent bundled reports are expected to take less time 
to prepare than the initial report.
    FDA has based these estimates on information it now has available 
from interactions with the industry, information related to other 
regulated products, and FDA expectations regarding the tobacco 
industry's use of the substantial equivalence pathway to market their 
products. Table 9 describes the annual reporting burden for compliance 
with the requirements to demonstrate substantial equivalence under the 
FD&C Act. We do not expect a large burden increase for this program, 
as, without the proposed rule, manufacturers would routinely submit SE 
Reports for new tobacco products, and the Agency believes most 
respondents are currently practicing most of the proposed requirements. 
FDA will revise this collection with the new burden. FDA requests 
public comments on the estimated burden associated with the 
requirements associated with this rule and whether there is any 
evidence, information, or data to support alternate burden estimates.
    Table 11 describes the annual reporting burden as a result of the 
requirements proposed in Sec. Sec.  1107.18 and 1107.19, implementing 
the substantial equivalence requirements of section 905(j)(1)(A)(i) and 
910(a) of the FD&C Act. This proposed rule would require manufacturers 
to submit SE Reports electronically (proposed Sec.  1107.62). We 
estimate that it would initially take about 30 minutes per product to 
fill out the Form FDA 3965. However, for amendments we estimate that 
filling out the Form FDA 3964 will take 5 minutes as applicants can 
copy and paste from the first submission. Proposed 1107.62(b) also 
allows for waivers from the electronic format requirement. FDA 
estimates that 240 respondents or 15 percent of SE Reports (1,570) will 
submit a waiver.
    Based on updated information, FDA estimates that it will receive 
683 full initial SE Reports for a new tobacco product each year under 
proposed Sec.  1107.18 that take a manufacturer approximately 300 hours 
to prepare. Additionally, manufacturers may bundle groups of SE Reports 
for their new products in the same product category and subcategory 
where the proposed modifications are the same; when a group of similar 
SE Reports are bundled, the reporting burden for the initial SE Report 
is expected to take the same amount of time as a stand-alone SE Report. 
However, the reporting burden for subsequent bundled SE Reports is 
expected to be lower than the initial SE Report. We expect to receive 
456 bundled SE Reports under proposed Sec.  1107.18 (other than the 
initial SE Report in the bundle) at approximately 90 hours per response 
for a total of 41,040 hours.
    In the absence of more specific information concerning SE Reports 
where applicants provide a certification for some identical 
characteristics under proposed Sec.  1107.18(g) and 1107.18(l)(2), FDA 
estimates receiving 239 such SE Reports at 87 hours per response for a 
total of 20,973 hours. We also estimate receiving 192 bundled SE 
Reports where applicants provide a certification for some identical 
characteristics under proposed Sec. Sec.  1107.18(g) and 1107.18(l)(2) 
(other than the initial SE Report in the bundle) at 62 hours per 
response for a total of 11,904 hours. Although we believe that the 
number of SE Reports that include a certification will increase because 
the proposed rule clarifies when applicants may certify that certain 
characteristics are identical in the new tobacco product and the 
predicate tobacco product, in the absence of specific information on 
how many more applicants might choose to certify, we are maintaining 
our previous estimates at this time. We request comment on these 
estimates.
    FDA has based these estimates on the full analysis of economic 
impacts and experience with the recently-revised existing information 
collection that applies to tobacco products. In addition, anyone 
submitting an SE Report is required to submit an environmental 
assessment prepared in accordance with Sec.  25.40 under proposed Sec.  
1107.18(k). The burden for environmental reports has been included in 
the burden per response for each type of SE Report.
    Based on FDA's experience with EAs for currently regulated tobacco 
products, we expect industry to spend 80 hours preparing an 
environmental assessment for a full SE Report under proposed Sec.  
1107.18.
    Generally, an applicant may withdraw its SE Report after submission 
(proposed Sec.  1107.22), change the ownership of its SE Report 
(proposed Sec.  1107.24), and amend its SE Report (proposed Sec.  
1107.20). The information required to grant these requests is already 
being collected, so we do not expect a change in burden.
    FDA estimates that 30 percent of SE Reports or 471 respondents will 
maintain required records related to their SE Reports at 2.5 hours per 
record for a total of 1,178 recordkeeping hours.
    FDA estimates that the burden for new requirements will increase 
this collection by 108,834 (107,656 + 1,178 recordkeeping). The burden 
for the submission of substantial equivalence information is estimated 
to total 280,712 hours (279,534 reporting and 1,178 recordkeeping). 
This proposed rule also refers to previously approved collections of 
information found in FDA regulations. Proposed Sec.  1107.40 references 
meetings that may be held with applicants who want to meet with FDA to 
discuss scientific and other issues. Additional information about how 
to request meetings with FDA's CTP can be found in FDA's guidance 
entitled ``Meetings with Industry and Investigators on the Research and 
Development of Tobacco Products.'' The collections of information in 
the guidance referenced have been approved under OMB control number

[[Page 12773]]

0910-0731. In addition to the premarket application under section 
910(b) and a report under 905(j)(1)(A)(i), certain new tobacco products 
may use the exemption premarket pathway, see 21 CFR 1107.1. The 
collections of information found in 21 CFR 1107.1 have been approved 
under OMB control number 0910-0684.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be 
identified with the title of the information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), the Agency has submitted the information collection 
provisions of this proposed rule to OMB for review. These requirements 
will not be effective until FDA obtains OMB approval. FDA will publish 
a notice concerning OMB approval of these requirements in the Federal 
Register.

VI. Executive Order 13132: Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires Agencies to ``construe . . . a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.''
    Section 916(a)(2) of the FD&C Act (21 U.S.C. 387p) is an express 
preemption provision. Section 916(a)(2) provides that ``no State or 
political subdivision of a State may establish or continue in effect 
with respect to a tobacco product any requirement which is different 
from, or in addition to, any requirement under the provisions of this 
chapter relating to . . . premarket review.'' Thus, if this proposed 
rule is made final, the final rule would create requirements that fall 
within the scope of section 916(a)(2) of the FD&C Act.

VII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

VIII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. No extraordinary circumstances exist 
to indicate that the specific proposed action may significantly affect 
the quality of the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

IX. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). We believe that this 
proposed rule is not an economically significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because we have determined that the compliance costs are less 
than 0.1 percent of revenues, we propose to certify that the rule would 
not have a significant economic impact on a substantial number of small 
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $150 million, using the most current (2017) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    This proposed rule would impose compliance costs on affected 
entities to read and understand the rule, establish or revise internal 
procedures, and fill out a form for SE Reports. We estimate that the 
present value of industry compliance costs ranges from $0.60 million to 
$2.64 million, with a primary estimate of $1.61 million at a 3 percent 
discount rate, and from $0.56 million to $2.32 million, with a primary 
estimate of $1.43 million at a 7 percent discount rate over 10 years. 
Annualized industry compliance costs over 10 years range from $0.07 
million to $0.31 million, with a primary estimate of $0.19 million at a 
3 percent discount rate and from $0.08 million to $0.33 million, with a 
primary estimate of $0.20 million at a 7 percent discount rate.
    The benefits of this proposed rule are potential time-savings to 
industry and cost-savings to government. This proposed rule clarifies 
when applicants may certify that certain characteristics are identical 
in the new tobacco product and the predicate tobacco product. 
Certifying may save applicants time in preparing their SE Reports. In 
this proposed rule, we intend to shorten review times for SE Reports. 
In addition, based on our experience with prior SE Reports, we believe 
this proposed rule would lead to better SE Reports, saving us time in 
review and requiring fewer staff to review SE Reports, which would 
result in cost-savings. We estimate that the present value of 
government cost-savings ranges from $15 million to $198 million at a 3 
percent discount rate, and from $12 million to $163 million at a 7 
percent discount rate over 10 years. Annualized government cost-savings 
over 10 years range from $1.7 million to $23.2 million at both 3 and 7 
percent discount rates.
    The qualitative benefits of this proposed rule include additional 
clarity to industry about the requirements for the content and format 
of SE Reports. The proposed rule would also establish the general 
procedures we intend to follow in reviewing and communicating with 
applicants. In addition, this proposed rule would make the SE pathway 
more predictable.
    The proposed rule's costs and benefits are summarized in Table 14 
entitled ``Economic Data: Costs and Benefits Statement.''

[[Page 12774]]

                                                  Table 14--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                   Units
                                                                                   ------------------------------------
                   Category                         Low       Primary      High                               Period                  Notes
                                                 estimate    estimate    estimate      Year      Discount     covered
                                                                                      dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.......         1.7         7.2        23.2        2016           7          10  Cost-savings to government.
                                                       1.7         7.2        23.2        2016           3          10  Cost-savings to government.
    Annualized................................  ..........  ..........  ..........        2016           7          10  ................................
    Quantified................................  ..........  ..........  ..........        2016           3          10  ................................
    Qualitative...............................  ..........  ..........  ..........  ..........  ..........  ..........  Greater certainty for SE
                                                                                                                         applicants.
Costs:
    Annualized Monetized $millions/year.......        0.08        0.20        0.33        2016           7          10  ................................
                                                      0.07        0.19        0.31        2016           3          10
    Annualized................................  ..........  ..........  ..........        2016           7          10  ................................
    Quantified................................  ..........  ..........  ..........        2016           3          10  ................................
    Qualitative.                                ..........  ..........  ..........  ..........  ..........  ..........  ................................
Transfers:
    Federal Annualized Monetized $millions/     ..........  ..........  ..........        2016           7          10  ................................
     year.                                                                                2016           3          10
                                               ------------------------------------------------------------------------
                                                From:
                                                To:                                 ..........
                                               ------------------------------------------------------------------------
    Other Annualized Monetized $millions/year.  ..........  ..........  ..........        2016           7          10  ................................
                                                                                          2016           3          10
                                               ------------------------------------------------------------------------
                                                From:
                                                To:                                 ..........
                                               ---------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No effect
    Small Business: No effect
    Wages: No effect
    Growth: No effect
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in Table 15 we estimate present 
and annualized values of costs and cost-savings over an infinite time 
horizon. Our primary estimate of the present value over an infinite 
time horizon of net costs due to this proposed rule is -$101.4 million 
at a 7 percent discount rate, and -$237.7 million at a 3 percent 
discount rate. Our primary estimate of the annualized net costs is -
$7.1 million at a 7 percent discount rate and -$7.1 million at a 3 
percent discount rate. Table 15 summarizes the costs, cost-savings and 
net costs of this proposed rule. Based on these cost-savings this 
proposed rule, if finalized, would be considered a deregulatory action 
under E.O. 13771.

                                                           Table 15--E.O. 13771 Summary Table
                                                [In $ Millions 2016 dollars, over infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary  (7%)       (7%)            (7%)        Primary  (3%)       (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................           $2.05           $0.57           $3.56           $3.75           $0.69           $6.92
Present Value of Cost Savings...........................          103.49           24.84          331.18          241.48           57.96          772.75
Present Value of Net Costs..............................         (101.4)          (24.3)         (327.6)         (237.7)          (57.3)         (765.8)
Annualized Costs........................................            0.14            0.04            0.25            0.11            0.02            0.21
Annualized Cost Savings.................................            7.24            1.74           23.18            7.24            1.74           23.18
Annualized Net Costs....................................           (7.1)           (1.7)          (22.9)           (7.1)           (1.7)          (23.0)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Values in parentheses denote net negative costs (i.e., cost-savings).

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. The full analysis of 
economic impacts is available in the docket for this proposed rule 
(Ref. 54) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

X. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. Wayne, G. F. and G. N. Connolly, ``Application, Function, and 
Effects of Menthol in Cigarettes: A Survey of Tobacco Industry 
Documents,'' Nicotine & Tobacco Research, 6(Suppl. 1):S43-S54, 2004.
2. Brunnemann, K. D., J. C. Scott, and D. Hoffmann, ``N-
Nitrosomorpholine and

[[Page 12775]]

Other Volatile N-nitrosamines in Snuff Tobacco,'' Carcinogenesis, 
3(6):693-696, 1982.
3. Draft Form FDA 3965 (Substantial Equivalence Submission).
4. Draft Form FDA 3964 (Amendment).
5. Agaku, I. T., C. I. Vardavas, and G. N. Connolly, ``Cigarette Rod 
Length and Its Impact on Serum Cotinine and Urinary Total NNAL 
Levels, NHANES 2007-2010,'' Nicotine & Tobacco Research, 16(1):100-
107, 2014.
6. Eaker, D. W., ``Dynamic Behavior and Filtration of Mainstream 
Smoke in the Tobacco Column and Filter,'' Recent Advances in Tobacco 
Science, 16:103-187, 1990.
7. Connolly, G. N., H. R. Alpert, G. F. Wayne, et al., ``Trends in 
Nicotine Yield in Smoke and its Relationship with Design 
Characteristics Among Popular US Cigarette Brands, 1997-2005,'' 
Tobacco Control, 16(5):e5, 2007, doi: 10.1136/tc.2006.019695.
8. American Tobacco, ``Cigarette Pressure Drop,'' Bates Numbers 
991508327-991508331, 1990.
9. U.S. Department of Health and Human Services, ``The Health 
Consequences of Smoking: The Changing Cigarette,'' A Report of the 
Surgeon General; 1981.
10. Torikaiu, K., Y. Uwano, T. Nakamore, et al., ``Study on Tobacco 
Components Involved in Pyrolytic Generation of Selected Smoke 
Constituents,'' Food and Chemical Toxicology, 43: 559-568, 2005.
11. Spears, A. W., ``Effect of Manufacturing Variables on Cigarette 
Smoke Composition,'' CORESTA Information Bulletin, Special Issue: 
65-78, 1974.
12. Geiss, O. and D. Kotzias, ``Tobacco, Cigarettes and Cigarette 
Smoke: An Overview,'' Institute for Health and Consumer Protection, 
European Commission, Directorate-General, Joint Research Centre, 
2007, available at http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/8885/1/7472%20-%20EUR22783EN_Geiss_Kotzias.pdf.
13. DeBardeleben, M. Z., W. E. Claflin, and W. F. Gannon, ``Role of 
Cigarette Physical Characteristics on Smoke Composition,'' Recent 
Advances in Tobacco Science, 4:85-111, 1978.
14. Bourlas, M. C., D. F. Magin, R. A., Kornfeld, et al., ``The 
Generation of Water in the Tobacco Oven Volatile Test, Beitr[auml]ge 
zur Tabakfoschung International, 10(3), 149-154, 1980.
15. Coleman, W. M., ``Tobacco Volatiles: Gas Chromatography,'' R. J. 
Reynolds Tobacco Company, 4380-4388, Academic Press, 2000.
16. Owens, W. F., ``Effect of Cigarette Paper on Smoke Yield and 
Composition,'' Recent Advances in Tobacco Science, 4:3-24, 1978.
17. British American Tobacco, Research & Development, ``Lower 
Ignition Propensity.''
18. Adam, T., J. McAughey, C. Mocker, et al., ``Influence of Filter 
Ventilation on the Chemical Composition of Cigarette Mainstream 
Smoke,'' Analytica Chimica Acta, 657(1): 36-44, 2010.
19. Hammond, D., N. Collishaw, and C. Callard, ``Secret Science: 
Tobacco Industry Research on Smoking Behaviour and Cigarette 
Toxicity,'' The Lancet, 367 (9512) 781-787, 2006.
20. Browne, C. L., The Design of Cigarettes. Charlotte, NC: Hoechst 
Celanese, 1990.
21. World Health Organization, ``The Scientific Basis of Tobacco 
Product Regulation,'' Second Report of a WHO Study Group, WHO 
Technical Report Series 951, 2008.
22. Taylor, M. J., Scientific Services Manager, Filtrona Technology 
Centre, ``The Role of Filter Technology in Reduced Yield 
Cigarettes,'' Text of Presentation for World Tobacco Symposium 
Kunming, Nov. 17, 2004.
23. Podraza K., Director, Product Integrity, Philip Morris USA, 
``Basic Principles of Cigarette Design and Function,'' Presentation 
to LSRO, Oct. 29-30, 2001 (Slides 40 & 46).
24. O'Connor, R. J., D. Hammond, A. McNeill, et al., ``How Do 
Different Cigarette Design Features Influence the Standard Tar 
Yields of Popular Cigarette Brands Sold in Different Countries?,'' 
Tobacco Control, 17(Suppl. 1):i1-i5, 2008, doi:10.1136/
tc.2006.019166.
25. Dash, S., P. N. Murthy, L. Nath, et al., ``Kinetic Modeling on 
Drug Release from Controlled Drug Delivery Systems,'' Acta Poloniae 
Pharmaceutica--Drug Research, 67(3):217-223, 2010.
26. Gale, N., G. Errington, and K. McAdam, Group Research & 
Development, British American Tobacco, ``Effects of Product Format 
on Nicotine and TSNA Extraction from Snus Pouches,'' Presentation at 
the 67th Tobacco Science Research Conference, Williamsburg, VA, 
September 15-18, 2013.
27. Stepanov, I., J. Jensen, L. Biener, et al., ``Increased Pouch 
Sizes and Resulting Changes in the Amounts of Nicotine and Tobacco-
Specific N-Nitrosamines in Single Pouches of Camel Snus and Marlboro 
Snus,'' Nicotine & Tobacco Research, 14(10):1241-1245, 2012.
28. Zhang, H., J. Zhang, and J. B. Streisand, ``Oral Mucosal Drug 
Delivery: Clinical Pharmacokinetics and Therapeutic Applications,'' 
Drug Delivery Systems, 41(9):661-680, 2002.
29. Lewis, S., G. Subramanian, S. Pandey, et al., ``Design, 
Evaluation and Pharmacokinetic Study of Mucoadhesive Buccal Tablets 
of Nicotine for Smoking Cessation,'' Indian Journal of 
Pharmaceutical Sciences, 68:829-831, 2006.
30. Hoffmann, D. and I. Hoffmann, ``The Changing Cigarette: Chemical 
Studies and Bioassays,'' Chapter 5 in Risks Associated with Smoking 
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine, 
Smoking and Tobacco Control Monograph No. 13:159-191, Bethesda, MD: 
U.S. Department of Health and Human Services, National Institutes of 
Health, National Cancer Institute, 2001, available at https://cancercontrol.cancer.gov/brp/tcrb/Monographs/13/m13_5.pdf.
31. Hammond, D., G. T. Fong, K. M. Cummings, et al., ``Cigarette 
Yields and Human Exposure: A Comparison of Alternative Testing 
Regimens,'' Cancer Epidemiology, Biomarkers & Prevention, 
15(8):1495-1501, 2006.
32. Rees, V. W., G. F. Wayne, B. F. Thomas, et al., ``Physical 
Design Analysis and Mainstream Smoke Constituent Yields of the New 
Potential Reduced Exposure Product, Marlboro UltraSmooth,'' Nicotine 
& Tobacco Research, 9(11):1197-1206, 2007.
33. Ding, Y. S., J. S. Trommel, X. J. Yan, et al., ``Determination 
of 14 Polycyclic Aromatic Hydrocarbons in Mainstream Smoke from 
Domestic Cigarettes, Environmental Science & Technology, 39(2):471-
478, 2005.
34. Ding, Y. S., L. Zhang, R. B. Jain, et al., ``Levels of Tobacco-
Specific Nitrosamines and Polycyclic Aromatic Hydrocarbons in 
Mainstream Smoke from Different Tobacco Varieties,'' Cancer 
Epidemiology, Biomarkers & Prevention, 17(12):3366-3371, 2008.
35. Baker, R. R., ``The Generation of Formaldehyde in Cigarettes--
Overview and Recent Experiments,'' Food and Chemical Toxicology, 
44:1799-1822, 2006.
36. U.S. Department of Health and Human Services, ``Preventing 
Tobacco Use Among Young People,'' A Report of the Surgeon General; 
1994.
37. U.S. Department of Health and Human Services, ``How Tobacco 
Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-
Attributable Disease,'' A Report of the Surgeon General; 2010, 
available at https://www.ncbi.nlm.nih.gov/books/NBK53017.
38. National Cancer Institute, Centers for Disease Control and 
Prevention, U.S. Department of Health and Human Services, 
``Smokeless Tobacco and Public Health: A Global Perspective, 91-106, 
2014, available at https://cancercontrol.cancer.gov/brp/tcrb/global-perspective/SmokelessTobaccoAndPublicHealth.pdf.
39. German Cancer Research Center (DKFZ), ``Additives in Tobacco 
Products. Contribution of Carob Bean Extract, Cellulose Fibre, Guar 
Gum, Liquorice, Menthol, Prune Juice Concentrate and Vanillin to 
Attractiveness, Addictiveness and Toxicity of Tobacco Smoking,'' 
Report, 2012.
40. Naworal, J. D., ``Pyrolysis GC/MS analysis of Guar Gum and 
Hydroxypropyl Guar at 300 Degrees C and 600 Degrees C,'' Philip 
Morris, Inter-Office Correspondence, Mar. 26, 1990, available at 
https://industrydocuments.library.ucsf.edu/tobacco/docs/ptnn0108.
41. Baker, R. R. and L. J. Bishop, ``The Pyrolysis of Non-Volatile 
Tobacco Ingredients Using a System that Simulates Cigarette 
Combustion Conditions,'' Journal of Analytical and Applied 
Pyrolysis, 74:145-170, 2005.
42. Smith, T. E., ``A Literature Review of Aging and Fermentation of 
Tobacco,'' Brown and Williamson Tobacco Corporation, 1964.
43. Cornell, A., W. F. Cartwright, and T. A. Bertinuson, ``Influence 
of

[[Page 12776]]

Microorganisms (Fermentation) on the Chemistry of Tobacco,'' Recent 
Advances in Tobacco Science, 5:27-62, 1979.
44. Schulthess, D., Philip Morris International, ``Project Clover, 
Marlboro-Roll Your Own, Report on the Microbial Analysis,'' January 
26, 1984.
45. Geiss, V. L., Brown and Williamson Tobacco Corporation, 
``Control and Use of Microbes in Tobacco Product Manufacturing,'' 
1989.
46. Andersen, R. A., P. D. Fleming, T. R. Hamilton-Kemp, et al., 
``pH Changes in Smokeless Tobaccos Undergoing Nitrosation During 
Prolonged Storage: Effects of Moisture, Temperature, and Duration,'' 
Journal of Agricultural and Food Chemistry, 41:968-972, 1993.
47. Mutasa, E. S., K. J. Seal, and N. Magan, ``The Water Content/
Water Activity Relationship of Cured Tobacco and Water Relations of 
Associated Spoilage Fungi,'' International Biodeterioration, 26: 
381-896, 1990.
48. St. Charles, F. K., ``Reduction of the Water Activity of Wet 
Snuff/259,'' Brown and Williamson Tobacco Corporation, Research & 
Development, File Note, December 20, 1989.
49. Andersen, R. A., H. R. Burton, P. D. Fleming, et al., ``Effect 
of Storage Conditions on Nitrosated, Acylated, and Oxidized Pyridine 
Alkaloid Derivatives in Smokeless Tobacco Products,'' Cancer 
Research, 49:5895-5900, 1989.
50. Rutqvist, L.E., M. Curvall, T. Hassler, et al., ``Swedish Snus 
and the GothiaTek[supreg] Standard,'' Harm Reduction Journal, 8:11, 
2011.
51. Brunnemann, K. D., B. Prokopczyk, M. V. Djordjevic, et al., 
``Formation and Analysis of Tobacco-Specific N-Nitrosamines,'' 
Critical Reviews in Toxicology 26(2):121-137, 1996.
52. Fisher, M. T., C. B. Bennett, A. Hayes, et al., ``Sources of and 
Technical Approaches for the Abatement of Tobacco Specific 
Nitrosamine Formation in Moist Smokeless Tobacco Products,'' Food 
and Chemical Toxicology, 50:942-948, 2012.
53. Djordjevic, M. V., J. Fan, L. P. Bush, et al., ``Effects of 
Storage Conditions on Levels of Tobacco-Specific N-Nitrosamines and 
N-Nitrosamino Acids in U.S. Moist Snuff,'' Journal of Agricultural 
and Food Chemistry, 41:1790-1794, 1993.
54. Preliminary Regulatory Impact Analysis; Initial Regulatory 
Flexibility Analysis; Unfunded Mandates Reform Act Analysis, Content 
and Format of Substantial Equivalence Reports; Proposed Rule.

XI. Effective Date

    FDA proposes that any final rule that issues based on this proposal 
become effective 30 days after the final rule publishes in the Federal 
Register.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 1107

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

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

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

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

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

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

Sec.  16.1   Scope.

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

PART 1107--EXEMPTIONS AND SUBSTANTIAL EQUIVALENCE REPORTS

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

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

0
4. The heading of part 1107 is revised to read as set forth above.
0
5. Add subparts B through E to read as follows:
Subpart B--General
Sec.
1107.10 Scope.
1107.12 Definitions.
Subpart C--Substantial Equivalence Reports
1107.16 Submission of a substantial equivalence report.
1107.18 Required content and format of a report.
1107.19 Comparison information.
1107.20 Amendments.
1107.22 Withdrawal by applicant.
1107.24 Change in ownership of an SE report.
Subpart D--FDA Review
1107.40 Communications between FDA and applicants.
1107.42 Review cycles.
1107.44 FDA action on an SE report.
1107.46 Issuance of an order finding a new tobacco product 
substantially equivalent.
1107.48 Issuance of an order denying marketing authorization.
1107.50 Rescission of order.
Subpart E--Miscellaneous
1107.58 Record retention.
1107.60 Confidentiality.
1107.62 Electronic submission.

Subpart B--General

Sec.  1107.10  Scope.

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

Sec.  1107.12  Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected 
to be used with or for the human consumption of a tobacco product; does 
not contain tobacco and is not made or derived from tobacco; and meets 
either of the following:
    (1) Is not intended or reasonably expected to affect or alter the 
performance, composition, constituents, or characteristics of a tobacco 
product; or
    (2) Is intended or reasonably expected to affect or maintain the 
performance, composition, constituents, or characteristics of a tobacco 
product; but
    (i) Solely controls moisture and/or temperature of a stored 
product; or
    (ii) Solely provides an external heat source to initiate but not 
maintain combustion of a tobacco product.
    Additive means any substance the intended use of which results or 
may reasonably be expected to result, directly or indirectly, in its 
becoming a component or otherwise affecting the characteristic of any 
tobacco product (including any substances intended for use as a 
flavoring or coloring or in producing, manufacturing, packing, 
processing, preparing, treating,

[[Page 12777]]

packaging, transporting, or holding), except that the term does not 
include tobacco or a pesticide chemical residue in or on raw tobacco, 
or a pesticide chemical.
    Applicant means any manufacturer of tobacco products who is subject 
to chapter IX of the Federal Food, Drug, and Cosmetic Act that submits 
a premarket application to receive marketing authorization for a new 
tobacco product.
    Brand means a variety of tobacco product distinguished by the 
tobacco used, tar content, nicotine content, flavoring used, size, 
filtration, packaging, logo, registered trademark, brand name, 
identifiable pattern of colors, or any combination of such attributes.
    Characteristic means the materials, ingredients, design, 
composition, heating source, or other features of a tobacco product.
    Commercial distribution means any distribution of a tobacco product 
to consumers or to another person through sale or otherwise, but does 
not include interplant transfers of a tobacco product between 
registered establishments within the same parent, subsidiary, and/or 
affiliate company, nor does it include providing a tobacco product for 
product testing where such product is not made available for 
consumption or resale. ``Commercial distribution'' does not include the 
handing or transfer of a tobacco product from one consumer to another 
for personal consumption. For foreign establishments, the term 
``commercial distribution'' has the same meaning, except that it does 
not include distribution of a tobacco product that is neither imported 
nor offered for import into the United States.
    Component or part means any software or assembly of materials 
intended or reasonably expected:
    (1) To alter or affect the tobacco product's performance, 
composition, constituents, or characteristics; or
    (2) To be used with or for the human consumption of a tobacco 
product. Component or part excludes anything that is an accessory of a 
tobacco product.
    Composition means the materials in a tobacco product, including 
ingredients, additives, and biological organisms. The term includes the 
manner in which the materials, for example, ingredients, additives, and 
biological organisms, are arranged and integrated to produce a tobacco 
product.
    Constituent means any chemical or chemical compound in a tobacco 
product that is or potentially is inhaled, ingested, or absorbed into 
the body, any chemical or chemical compound in an emission from a 
tobacco product, or any chemical or chemical compound in mainstream or 
sidestream tobacco smoke that either transfers from any component of 
the tobacco product to the smoke or that is formed by the combustion or 
heating of tobacco, additives, or other component of the tobacco 
product.
    Container closure system means any packaging materials that are a 
component or part of a tobacco product.
    Design means the form and structure concerning, and the manner in 
which, components or parts, ingredients, software, and materials are 
integrated to produce a tobacco product.
    Distributor means any person who furthers the distribution of a 
tobacco product, whether domestic or imported, at any point from the 
original place of manufacture to the person who sells or distributes 
the product to individuals for personal consumption. Common carriers 
are not considered distributors for the purposes of this part.
    Finished tobacco product means a tobacco product, including all 
components and parts, sealed in final packaging (e.g., filters or 
filter tubes sold separately to consumers or as part of kits).
    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.
    Harmful or potentially harmful constituent (HPHC) means any 
chemical or chemical compound in a tobacco product or tobacco smoke or 
emission that:
    (1) Is or potentially is inhaled, ingested, or absorbed into the 
body; and
    (2) Causes or has the potential to cause direct or indirect harm to 
users or nonusers of tobacco products.
    Health information statement means a statement, made under section 
910(a)(4) of the Federal Food, Drug, and Cosmetic Act, that the health 
information related to a new tobacco product will be made available 
upon request by any person.
    Health information summary means a summary, submitted under section 
910(a)(4) of the Federal Food, Drug, and Cosmetic Act, of any health 
information related to a new tobacco product.
    Heating source means the source of energy used to burn or heat a 
tobacco product.
    Ingredient means tobacco, substances, compounds, or additives 
contained within or added to the tobacco, paper, filter, or any other 
component or part of a tobacco product, including substances and 
compounds reasonably expected to be formed through a chemical reaction 
during tobacco product manufacturing.
    Material means an assembly of ingredients. Materials are assembled 
to form a tobacco product or components or parts of tobacco products.
    New tobacco product means:
    (1) Any tobacco product (including those products in test markets) 
that was not commercially marketed in the United States as of February 
15, 2007; or
    (2) Any modification (including a change in design, any component, 
any part, or any constituent, including a smoke constituent, or in the 
content, delivery or form of nicotine, or any other additive or 
ingredient) of a tobacco product where the modified product was 
commercially marketed in the United States after February 15, 2007.
    Other features means any distinguishing qualities of a tobacco 
product similar to those specifically enumerated in section 
910(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. Such other 
features include harmful and potentially harmful constituents and any 
other product characteristics that relate to the chemical, biological, 
and physical properties of the tobacco product and are necessary for 
review.
    Package or packaging means a pack, box, carton, or container of any 
kind or, if no other container, any wrapping (including cellophane), in 
which a tobacco product is offered for sale, sold, or otherwise 
distributed to consumers.
    Predicate tobacco product means a tobacco product that is a 
grandfathered tobacco product or a tobacco product that FDA has 
previously found substantially equivalent under section 910(a)(2)(A)(i) 
of the Federal Food, Drug, and Cosmetic Act.
    Submission tracking number or STN means the number that FDA assigns 
to submissions that are received from a manufacturer of tobacco 
products, such as SE Reports and requests for grandfather 
determinations.
    Substantial equivalence or substantially equivalent means, with 
respect to a new tobacco product being compared to a predicate tobacco 
product, that FDA by order has found that the new tobacco product:
    (1) Has the same characteristics as the predicate tobacco product; 
or
    (2) Has different characteristics and the information submitted 
contains information, including clinical data if deemed necessary by 
FDA, that demonstrates that it is not appropriate

[[Page 12778]]

to require premarket review under section 910(b) and (c) of the Federal 
Food, Drug, and Cosmetic Act because the new tobacco product does not 
raise different questions of public health.
    Substantial equivalence report or SE Report means a submission 
under section 905(j)(1)(A)(i) of the Federal Food, Drug, and Cosmetic 
Act that includes the basis for the applicant's determination that a 
new tobacco product is substantially equivalent to a predicate tobacco 
product. This term includes the initial substantial equivalence report 
and all subsequent amendments.
    Tobacco product means any product made or derived from tobacco that 
is intended for human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials other than 
tobacco used in manufacturing a component, part, or accessory of a 
tobacco product). The term ``tobacco product'' does not mean an article 
that under the Federal Food, Drug, and Cosmetic Act is a drug (section 
201(g)(1)), a device (section 201(h)), or a combination product 
(section 503(g)).
    Tobacco product manufacturer means any person, including a repacker 
or relabeler, who:
    (1) Manufactures, fabricates, assembles, processes, or labels a 
tobacco product, or
    (2) Imports a finished tobacco product for sale or distribution in 
the United States.

Subpart C--Substantial Equivalence Reports

Sec.  1107.16  Submission of a substantial equivalence report.

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

Sec.  1107.18  Required content and format of a SE report.

    (a) Overview. The SE Report must provide information uniquely 
identifying the new tobacco product and the predicate tobacco product, 
and compare the new tobacco product to either a grandfathered tobacco 
product or a tobacco product that FDA previously found to be 
substantially equivalent. The SE Report must provide sufficient 
information as described in this section to enable FDA to determine 
whether the new tobacco product is substantially equivalent to a 
tobacco product that was commercially marketed in the United States as 
of February 15, 2007. If FDA cites deficiencies and requests 
information to support a statement in the SE Report, the applicant must 
provide that information for review to continue, or FDA may issue an 
order under Sec.  1107.48. FDA will refuse to accept an SE Report if it 
does not comply with this section. The SE Report must contain the 
following information:
    (1) General information (as described in paragraph (c) of this 
section);
    (2) Summary (as described in paragraph (d) of this section);
    (3) New tobacco product description (as described in paragraph (e) 
of this section);
    (4) Predicate tobacco product description (as described in 
paragraph (f) of this section), including a statement that the 
predicate tobacco product has not been removed from the market at the 
initiative of FDA and has not been determined by judicial order to be 
adulterated or misbranded, and the submission tracking number of the SE 
order finding the predicate product SE, or the submission tracking 
number of, or information to support, a grandfathered determination of 
the predicate tobacco product;
    (5) Comparison information (as described in paragraph (g) of this 
section);
    (6) Comparative testing information (as described in paragraph (h) 
of this section);
    (7) Statement of compliance with applicable tobacco product 
standards (as described in paragraph (i) of this section);
    (8) Health information summary or statement that such information 
will be made available upon request (as described in paragraph (j) of 
this section);
    (9) Compliance with 21 CFR part 25 (as described in paragraph (k) 
of this section); and
    (10) Certification statement (as described in paragraph (l) of this 
section).
    (b) Format. The applicant must submit the SE Report using the 
form(s) that FDA provides. The SE Report must contain a comprehensive 
index and table of contents, be well-organized and legible, and be 
written in English. As described in Sec.  1107.62, the applicant must 
submit the SE Report and all information supporting the SE Report in an 
electronic format that FDA can process, read, review, and archive, 
unless FDA has provided a waiver.
    (c) General information. The SE Report must include the following 
information, using the form FDA provides:
    (1) The date the SE Report is submitted;
    (2) Type of submission (e.g., the SE Report or amendment to a 
report);
    (3) FDA STN if previously assigned;
    (4) Any other relevant FDA STN, such as a request for grandfathered 
determination or SE Report previously found substantially equivalent 
(if applicable), and cross-references to meetings with FDA regarding 
the new tobacco product;
    (5) Applicant name, address, and contact information;
    (6) Authorized representative or U.S. agent (for a foreign 
applicant), including the name, address, and contact information;
    (7) For both the new and predicate tobacco products, the following 
information to uniquely identify the products:
    (i) Manufacturer;
    (ii) Product name, including the brand and sub brand (or other 
commercial name used in commercial distribution); and
    (iii) Product category, product subcategory, and product properties 
(if the product does not have a listed product property, e.g., 
ventilation or characterizing flavor, the report must state ``none'' 
for that property) as provided in the following table:

------------------------------------------------------------------------
                                 Tobacco product
   Tobacco product category:       subcategory:     Product properties:
------------------------------------------------------------------------
(A)Cigarettes.................  (1) Combusted,     --Package type (e.g.,
                                 Filtered.          hard pack, soft
                                                    pack, clam shell).
                                                   --Product quantity
                                                    (e.g., 20
                                                    cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89
                                                    millimeters (mm),
                                                    100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).

[[Page 12779]]

 
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (2) Combusted,     --Package type (e.g.,
                                 Non-filtered.      hard pack, soft
                                                    pack, 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).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Combusted,     --Package type (e.g.,
                                 Other.             hard pack, soft
                                                    pack, 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.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    Flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Non-Combusted  --Package type (e.g.,
                                 (e.g., a           hard pack, soft
                                 cigarette where    pack, clam shell).
                                 the tobacco is    --Product quantity
                                 heated not         (e.g., 20
                                 burned).           cigarettes, 25
                                                    cigarettes).
                                                   --Length (e.g., 89
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 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- For a new co-packaged
                                 Package.           tobacco product
                                                    composed of multiple
                                                    cigarette tobacco
                                                    products, include,
                                                    as applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product, as
                                                    identified in this
                                                    section.
(B) Roll-Your-Own Tobacco       (1) Roll-Your-Own  --Package type (e.g.,
 Products.                       Tobacco Filler.    bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 40 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., 50 sheets,
                                                    200 papers).
                                                   --Length (e.g., 79
                                                    mm, 100 mm, 110 mm).
                                                   --Width (e.g., 28 mm,
                                                    33 mm, 45 mm).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Filtered       --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --Product quantity
                                                    (e.g., 100 tubes,
                                                    200 tubes).
                                                   --Length (e.g., 89
                                                    mm, 100 mm).
                                                   --Diameter (e.g., 6
                                                    mm, 8.1 mm).
                                                   --Ventilation (e.g.,
                                                    none, 10%, 25%).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Non-Filtered   --Package type (e.g.,
                                 Cigarette Tube.    bag, box).
                                                   --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.,
                                                    none, 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).

[[Page 12780]]

 
                                (7) Roll-Your-Own  --For a new co-
                                 Co-Package.        packaged tobacco
                                                    product composed of
                                                    multiple RYO tobacco
                                                    products, include,
                                                    as applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product (e.g., roll-
                                                    your own tobacco,
                                                    rolling paper,
                                                    filtered cigarette
                                                    tube, non-filtered
                                                    cigarette tube,
                                                    filter, paper tip)
                                                    as identified in
                                                    this section.
                                (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) Loose Moist    --Package type (e.g.,
                                 Snuff.             plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 grams (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).
                                (2) Portioned      --Package type (e.g.,
                                 Moist.             plastic can with
                                (3) Snuff........   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).
                                (4) Loose Snuff..  --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).
                                (5) Portioned      --Package type (e.g.,
                                 Snuff.             plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 22.5 g, 20
                                                    g).
                                                   --Portion count
                                                    (e.g., 15 pouches,
                                                    20 pieces).
                                                   --Portion mass (e.g.,
                                                    1.5 g/pouch, 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).
                                (6) Loose Dry      --Package type (e.g.,
                                 Snuff.             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).
                                (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).
                                                   --Portion count
                                                    (e.g., 15 sticks, 20
                                                    tablets).
                                                   --Portion mass (e.g.,
                                                    1.5 g/strip, 1 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) Loose Chewing  --Package type (e.g.,
                                 Tobacco.           bag, pouch,
                                                    wrapped).
                                                   --Product quantity
                                                    (e.g., 20 g, 3
                                                    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).

[[Page 12781]]

 
                                (9) Portioned      --Package type (e.g.,
                                 Chewing Tobacco.   plastic can with
                                                    metal lid, plastic
                                                    can with plastic
                                                    lid).
                                                   --Product quantity
                                                    (e.g., 20 g).
                                                   --Portion count
                                                    (e.g., 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- --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple smokeless
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified in this
                                                    section.
                                (11) 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.
(D) ENDS (Electronic Nicotine   (1) Open E-Liquid  --Package type (e.g.,
 Delivery System).                                  bottle, box).
                                                   --Product quantity
                                                    (e.g., 1 bottle, 5
                                                    bottles).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry,
                                                    wintergreen).
                                                   --E-liquid volume
                                                    (e.g., 10
                                                    milliliters (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).
                                (2) Closed E-      --Package type (e.g.,
                                 Liquid.            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) Closed E-      --Package type (e.g.,
                                 Cigarette.         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) Open E-        --Package type (e.g.,
                                 Cigarette.         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
                                                    Watts (W), 200 W).
                                                   --Battery capacity
                                                    (e.g., 100 mAh, 200
                                                    mAh).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) ENDS           --Package type (e.g.,
                                 Component.         box, none, plastic
                                                    clamshell).
                                                   --Product quantity
                                                    (e.g., 1 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-       --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple ENDS
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified in this
                                                    section.
                                (7) ENDS Other...  --Package type (e.g.,
                                                    bag, box).
                                                   --Product quantity.
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, cherry).

[[Page 12782]]

 
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product.
(E) Cigars....................  (1) Filtered,      --Package type (e.g.,
                                 Sheet-Wrapped      hard pack, soft
                                 Cigar.             pack, 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) Unfiltered,    --Package type (e.g.,
                                 Sheet-Wrapped      box, film sleeve).
                                 Cigar.            --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) Leaf-Wrapped   --Package type (e.g.,
                                 Cigar.             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          --Package type (e.g.,
                                 Component.         box, booklet).
                                                   --Product quantity
                                                    (e.g., 10 wrappers,
                                                    20 leaves).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    menthol, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) Cigar Tobacco  --Package type (e.g.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16
                                                    ounces).
                                                   --Characterizing
                                                    flavor (e.g., none,
                                                    tobacco, menthol,
                                                    cherry).
                                                   --Tobacco cut size
                                                    (e.g., 5 mm, 10 mm).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (6) Cigar Co-      --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple cigar
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified
                                                    previously.
                                (7) 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.
(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   --Package type (e.g.,
                                 Filler.            bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16
                                                    ounces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    cavendish, cherry).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Pipe           --Package type (e.g.,
                                 Component.         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-       --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple pipe
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified
                                                    previously.
                                (5) 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.
(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).

[[Page 12783]]

 
                                                   --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      --Package type (e.g.,
                                 Tobacco Filler.    bag, pouch).
                                                   --Product quantity
                                                    (e.g., 20 g, 16
                                                    ounces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, tobacco,
                                                    menthol, apple).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (3) Waterpipe      --Package type (e.g.,
                                 Heat Source.       box, film sleeve,
                                                    bag, none).
                                                   --Product quantity
                                                    (e.g., 150 g, 680
                                                    g).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    apple).
                                                   --Portion count(e.g.,
                                                    20 fingers, 10
                                                    discs, 1 base).
                                                   --Portion mass (e.g.,
                                                    15 g/finger).
                                                   --Portion length
                                                    (e.g., 40 mm, 100
                                                    mm).
                                                   --Portion width
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Portion thickness
                                                    (e.g., 10 mm, 40
                                                    mm).
                                                   --Source of energy
                                                    (e.g., charcoal,
                                                    battery,
                                                    electrical).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (4) Waterpipe      --Package type (e.g.,
                                 Component.         bag, box, none).
                                                   --Product quantity
                                                    (e.g., 1 base, 1
                                                    bowl, 1 hose, 10
                                                    mouthpieces).
                                                   --Characterizing
                                                    flavor(s) (e.g.,
                                                    none, menthol,
                                                    apple).
                                                   --Additional
                                                    properties needed to
                                                    uniquely identify
                                                    the tobacco product
                                                    (if applicable).
                                (5) Waterpipe Co-  --For a new co-
                                 Package.           packaged tobacco
                                                    product composed of
                                                    multiple waterpipe
                                                    tobacco products,
                                                    include, as
                                                    applicable, all
                                                    properties for each
                                                    individual tobacco
                                                    product as
                                                    identified in this
                                                    section.
                                (6) Waterpipe      --Package type (e.g.,
                                 Other.             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).
------------------------------------------------------------------------

    (8) Address and the FDA Establishment Identifier (FEI) number(s) of 
the establishments involved in the manufacture and/or importation of 
the new and predicate tobacco products.
    (d) Summary. The SE Report must include a summary at the beginning 
of the SE Report that includes the following:
    (1) A concise description of the characteristics of the new tobacco 
product;
    (2) A statement as to whether the applicant believes the new 
tobacco product has the same characteristics as the predicate tobacco 
product or has different characteristics but does not raise different 
questions of public health; and
    (3) A concise description of the similarities and differences 
between the new tobacco product and the predicate tobacco product with 
respect to their characteristics (materials, ingredients, design, 
composition, heating source, or other features).
    (e) New tobacco product description. The applicant must identify 
one new tobacco product in the SE Report for comparison to one 
predicate tobacco product. The SE Report must describe the new tobacco 
product in sufficient detail to enable FDA to evaluate its 
characteristics. This part of the SE Report must include:
    (1) A narrative description of the new tobacco product and detailed 
drawings or schematics of the new tobacco product, including its 
container closure system, illustrating all components or parts of the 
product. For a portioned tobacco product, the SE Report must also 
include a diagram illustrating all components or parts of the 
individual unit of use;
    (2) A description and the function of each component or part of the 
new tobacco product, and an explanation of how each component or part 
is integrated into the design of the new tobacco product; and
    (3) A concise overview of the process used to manufacture the new 
tobacco product, including the fermentation process, where applicable, 
with information on the type and quantity of the microbial inoculum 
and/or fermentation solutions. If the manufacturing process for the new 
tobacco product does not affect the characteristics of the new tobacco 
product beyond what is described elsewhere in the SE Report, an 
applicant must state that to satisfy this provision.
    (f) Description of predicate tobacco product. (1) The applicant 
must identify a predicate tobacco product that is either a 
grandfathered tobacco product or a tobacco product that FDA previously 
found to be substantially equivalent.
    (2) A tobacco product to which a new tobacco product is compared 
must:
    (i) Be in the same category and subcategory of product as the new 
tobacco product;
    (ii) Have been either:
    (A) Commercially marketed (not exclusively in a test market) in the 
United States as of February 15, 2007, as shown by either specific 
information sufficient to support this in the SE Report, including a 
statement that ``I, (name of responsible official), confirm that the 
predicate tobacco product, (insert name of predicate tobacco product), 
was commercially marketed

[[Page 12784]]

other than for test marketing as of February 15, 2007'', or reference 
to an STN for a previous determination by FDA that the predicate 
product is grandfathered; or
    (B) Previously determined to be substantially equivalent by FDA;
    (iii) Be an individual product and not a composite of multiple 
products;
    (iv) Not be the subject of a rescission order by FDA, as described 
in Sec.  1107.50; and
    (v) Not have been removed from the market at the initiative of FDA 
and not have been determined by judicial order to be adulterated or 
misbranded.
    (g) Comparison information. The SE Report must include a comparison 
of the characteristics of the new tobacco product and the predicate 
tobacco product, as described in Sec.  1107.19. If the new tobacco 
product has limited changes to a characteristic(s) when compared to the 
predicate tobacco product, and all other characteristics are identical 
(e.g., a change to product quantity), the applicant must provide 
comparison information related to such characteristic(s), but may 
certify that the other characteristics identical under paragraph (1)(2) 
of this section. The applicant must maintain records supporting the 
certification consistent with Sec.  1107.58.
    (h) Comparative testing information. Other than for characteristics 
that are identical, and for which the applicant has certified that the 
characteristics are identical under paragraph (1)(2) of this section, 
the SE Report must provide comparative testing information on the 
characteristics of the new and predicate tobacco products, as described 
in Sec.  1107.19, except where the applicant adequately justifies that 
such comparative testing information is not necessary to demonstrate 
that the new product has the same characteristics as the predicate or 
does not raise different questions of public health. The testing 
information must:
    (1) Include the test protocols, quantitative acceptance criteria, 
and test results (including means and variances, data sets, and a 
summary of the results);
    (2) Be conducted on a sufficient sample size and on test samples 
that reflect the finished tobacco product composition and design;
    (3) State whether the same test methods were used for the new 
tobacco product and the predicate product, and if the methods differed, 
an explanation as to how the results of the different test methods can 
be compared; and
    (4) Identify national and international standards used to test the 
new and predicate tobacco products and explain any deviations from the 
standard, or state that no standards were used for the testing.
    (i) Statement of compliance with applicable tobacco product 
standards. The SE Report must either:
    (1) List and describe the action(s) taken by the applicant to 
comply with applicable requirements under section 907 of the Federal 
Food, Drug, and Cosmetic Act; or
    (2) State there are no applicable requirements under section 907 of 
the Federal Food, Drug, and Cosmetic Act.
    (j) Health information summary or statement regarding availability 
of such information. The SE Report must include either a health 
information summary or a statement that such information will be made 
available upon request, as provided in section 910(a)(4) of the Federal 
Food, Drug, and Cosmetic Act, in accord with the following:
    (1) Health information summary. If including a health information 
summary with the SE Report, the applicant must provide a copy of the 
full SE Report that excludes research subject identifiers and trade 
secret and confidential commercial information as defined in Sec. Sec.  
20.61 and 20.63 of this chapter (21 CFR 20.61 and 20.63); and either
    (i) Provide accurate, complete, and not false or misleading, 
additional health information, including information, research, or data 
about adverse health effects, that the applicant has or knows about 
concerning the new tobacco product that is not contained in the SE 
Report; or
    (ii) Provide the following statement, if true, about the new 
tobacco product: ``Applicant does not have or know of any additional 
health information, including information, research or data regarding 
adverse health effects, about the new tobacco product that is the 
subject of this SE Report.''
    (2) Statement regarding availability of health information. If the 
applicant chooses to make the health information available upon 
request, the SE Report must include the following statement, with the 
appropriate applicant information inserted as indicated by 
parenthetical text, signed by an authorized representative of the 
applicant, made on a separate page of the SE Report, and clearly 
identified as ``910(a)(4) health information statement''. ``I certify 
that, in my capacity as (the position held in company by person 
required to submit the SE Report, preferably the responsible official 
of the applicant) of (company name), I will make available, upon 
request, the information identified in 21 CFR 1107.18(j)(3) within 30 
calendar days of a request.''
    (3) Content of health information. The health information the 
applicant agrees to make available in paragraph (j)(2) of this section 
must be a copy of the full SE Report, excluding all research subject 
identifiers, trade secrets, and confidential commercial information, as 
defined in 21 CFR 20.61 and 21 CFR 20.63; and either.
    (i) Accurate, complete, and not false or misleading, additional 
health information, including information, research, or data about 
adverse health effects, that the applicant has or knows about 
concerning the new tobacco product and that is not contained in the SE 
Report; or
    (ii) The following statement, if true, about the new tobacco 
product. ``(Company name) does not have or know of any additional 
health information, including information, research or data regarding 
adverse health effects about the new tobacco product that is the 
subject of the provided SE Report.''
    (4) Requests for information. All requests for information under 
paragraph (j)(2) of this section must be made in writing to the 
authorized representative of the applicant, whose contact information 
will be posted on the FDA website listing substantial equivalence 
determinations. The applicant must provide FDA any updated information 
if the contact information changes.
    (5) No modified risk violations. To the extent information is 
included in the health information summary or health information 
provided upon request under paragraphs (j)(1) and (2) of this section 
that is not required by section 910(a)(4) of the Federal Food, Drug, 
and Cosmetic Act or paragraph (j) of this section, that information 
must not contain a statement that would cause the tobacco product to be 
in violation of section 911 of the Federal Food, Drug, and Cosmetic Act 
upon the introduction or delivery for introduction of the proposed new 
product into interstate commerce.
    (k) Compliance with 21 CFR part 25. (1) The SE Report must include 
an environmental assessment prepared in accordance with Sec.  25.40 of 
this chapter, or a valid claim of categorical exclusion. If the 
applicant believes that the action qualifies for an available 
categorical exclusion, the applicant must state under Sec.  25.15(a) 
and (d) of this chapter that the action requested qualifies for a 
categorical exclusion, citing the particular exclusion that is claimed, 
and that to the applicant's knowledge, no extraordinary circumstances 
exist under Sec.  25.21.

[[Page 12785]]

    (2) The environmental assessment must include a statement 
explaining whether the new tobacco product is intended to replace the 
predicate tobacco product once the new tobacco product receives market 
authorization, is intended to be a line extension of the predicate 
tobacco product, is intended to be introduced as an additional product 
by the same manufacturer, or if the new tobacco product will be 
introduced as an additional product but by a different manufacturer.
    (l) Certification Statement. (1) The SE Report must contain the 
following certification, with the appropriate information inserted (as 
indicated by parenthetical text), and be signed by an authorized 
representative of the applicant. ``I (name of responsible official) on 
behalf of (applicant), hereby certify that (applicant) will maintain 
all records to substantiate the accuracy of this SE Report for the 
period of time required in Sec.  1107.58 and ensure that such records 
remain readily available to the FDA upon request. I certify that this 
information and the accompanying submission are true and correct, that 
no material fact has been omitted, and that I am authorized to submit 
this on the applicant's behalf. I understand that under section 1001 of 
title 18 of the United States Code anyone who knowingly and willfully 
makes a materially false, fictitious, or fraudulent statement or 
representation in any matter within the jurisdiction of the executive, 
legislative, or judicial branch of the Government of the United States 
is subject to criminal penalties.''
    (2) The SE Report must include the following certification if an 
applicant chooses to certify that certain characteristics are identical 
in lieu of providing data for each characteristic of the new and 
predicate tobacco products. This certification must include the 
appropriate information inserted (as indicated by parenthetical text) 
and be signed by an authorized representative of the applicant. ``I, 
(name of responsible official), on behalf of (name of company), certify 
that (new tobacco product name) has the following modification(s) as 
compared to (name of predicate tobacco product): (describe 
modification(s), e.g., change in product quantity or change in 
container closure system). Aside from these modifications, the 
characteristics of (new tobacco product name) and (name of predicate 
tobacco product) are identical. I certify that (name of company) 
understands this means there is no other modification to the materials, 
ingredients, design features, heating source, or any other feature. I 
also certify that (name of company) will maintain records to support 
the comparison information in 21 CFR 1107.19 that substantiate the 
accuracy of this statement for the period of time required in 21 CFR 
1107.58, and ensure that such records remain readily available to FDA 
upon request.''

Sec.  1107.19  Comparison information.

    The SE Report must include a comparison of the characteristics of 
the new tobacco product to the predicate tobacco product. The 
comparison section of the SE Report must be organized in the following 
manner:
    (a) Comparison of product design. The SE Report must include 
descriptions of the product designs of the new and predicate tobacco 
products and identify any differences. The SE Report must include, in a 
tabular format, a side-by-side comparison of each design parameter of 
the new and predicate tobacco products. For each design parameter, the 
target value and range of acceptable values, actual measured value 
(where applicable), and range of measured values (where applicable) 
with units of measure must be provided. In addition, for each 
applicable design parameter, test data must be provided.
    (1) Cigarettes. For cigarettes, the required design parameter 
information to be provided for each predicate and new tobacco product 
is as follows:

                     Table 1 to Sec.   1107.19(a)(1)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Cigarette length (mm)                     --Puff count
--Cigarette circumference (mm)              --Cigarette draw resistance
                                             (mm H2O)
--Cigarette draw resistance (mm H2O)        --Tobacco filler mass (mg)
--Tobacco filler mass (mg)                  --Tobacco moisture (%)
--Tobacco rod density (g/cubic centimeter   --Filter ventilation (%)
 (cm3))
--Tobacco moisture (%)                      --Cigarette paper base paper
                                             basis weight (g/m2))
--Filter ventilation (%)                    --Cigarette paper base paper
                                             porosity (CU)
--Tipping paper length (mm)                 --Filter efficiency (%) (If
                                             no filter efficiency data
                                             is available for the
                                             products, include
                                             information sufficient to
                                             show that the cigarette
                                             filter is unchanged (e.g.,
                                             denier per filament, total
                                             denier, and filter
                                             density))
--Cigarette paper base paper basis weight   --Filter pressure drop (mm
 (g/m2)                                      H2O)
--Cigarette paper base paper porosity (CU)
--Cigarette paper band width (mm)
--Cigarette paper band space (mm)
--Filter efficiency (%) (If no filter
 efficiency data is available for the
 products, include information sufficient
 to show that the cigarette filter is
 unchanged (e.g., denier per filament,
 total denier, and filter density))
--Filter length (mm)
--Filter pressure drop (mm H2O)
------------------------------------------------------------------------

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

[[Page 12786]]

                     Table 2 to Sec.   1107.19(a)(2)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
                  Portioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm)                     --Tobacco cut size (mm).
--Tobacco moisture (%)                      --Tobacco moisture (%).
--Portion length (mm) (if applicable)       --Portion mass (mg) (if
                                             applicable).
--Portion width (mm) (if applicable)        --Pouch paper porosity (CU).
--Portion mass (mg) (if applicable)         --Pouch paper basis weight
                                             (g/m2).
 Portion thickness (mm) (if applicable)
 Pouch paper wicking
 Pouch paper porosity (CU)
 Pouch paper basis weight (g/m2)
------------------------------------------------------------------------
                 Nonportioned Smokeless Tobacco Products
------------------------------------------------------------------------
--Tobacco cut size (mm)                     --Tobacco cut size (mm).
--Tobacco moisture (%)                      --Tobacco moisture (%).
------------------------------------------------------------------------

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

                     Table 3 to Sec.   1107.19(a)(3)
------------------------------------------------------------------------
                                                   Provide test data
                                                (include test protocols,
 Provide target specification with upper and    quantitative acceptance
           lower range limits for:              criteria, data sets, and
                                               a summary of the results)
                                                          for:
------------------------------------------------------------------------
--Paper length(mm)                             --Mass per paper (mg).
--Paper width (mm)                             --Cigarette paper base
--Mass per paper (mg)                           paper basis weight (g/
--Cigarette paper base paper basis weight (g/   m2).
 m2)                                           --Cigarette paper base
                                                paper porosity (CU).
                                               --Cigarette paper band
                                                porosity (CU) (if
                                                applicable).
--Cigarette paper base paper porosity (CU)
--Cigarette paper band porosity (CU) (if
 applicable)
--Cigarette paper band width (mm) (if
 applicable)
--Cigarette paper band space (mm)
 (applicable)
------------------------------------------------------------------------

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

                     Table 4 to Sec.   1107.19(a)(4)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Tube length (mm)                          --Total mass (mg).
--Tube circumference (mm)                   --Cigarette paper base paper
--Total mass (mg)                            basis weight (g/m2).
--Cigarette paper base paper basis weight   --Cigarette paper base paper
 (g/m2)                                      porosity (CU).
                                            --Cigarette paper band
                                             porosity (CU).
--Cigarette paper base paper porosity (CU)
--Cigarette paper band porosity (CU)
--Cigarette paper band width (mm)
--Cigarette paper band space (mm)
------------------------------------------------------------------------

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

                     Table 5 to Sec.   1107.19(a)(5)
------------------------------------------------------------------------
                                             Provide test data (include
                                            test protocols, quantitative
  Provide target specification with upper     acceptance criteria, data
        and lower range limits for:          sets, and a summary of the
                                                    results) for:
------------------------------------------------------------------------
--Tube length (mm)                          --Total mass (mg).
--Tube circumference (mm)                   --Filter ventilation (%).
--Total mass (mg)                           --Cigarette paper base paper
--Tipping paper length (mm)                  basis weight (g/m2).
                                            --Cigarette paper base paper
                                             porosity (CU).

[[Page 12787]]

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

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

                     Table 6 to Sec.   1107.19(a)(6)
------------------------------------------------------------------------
                                             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 size (mm)                         --Tobacco size (mm).
--Tobacco moisture (%)                      --Tobacco moisture (%).
------------------------------------------------------------------------

    (b) Comparison of heating sources. The SE Report must include a 
description of the heating source for the new and predicate tobacco 
products and identify any differences, or state that there is no 
heating source.
    (c) Comparison of product composition. The SE Report must include 
descriptions of the product composition of the new and predicate 
tobacco products and identify any differences. The SE Report must 
include, in a tabular format, a side-by-side comparison of the 
materials and ingredients for each component or part of the new and 
predicate tobacco products. For each material and ingredient quantity, 
the target value and range of acceptable values, actual measured value 
(where applicable), and range of measured values (where applicable) 
reported as mass per component or part, must be provided.
    (1) Materials. For each material in the products include:
    (i) The material name and common name(s), if applicable;
    (ii) The component or part of the tobacco product where the 
material is located;
    (iii) The subcomponent or subpart where the material is located, if 
applicable;
    (iv) The function of the material;
    (v) The quantities (including ranges or means, acceptance limits) 
of the material(s) in each new tobacco product and predicate tobacco 
product (with any specification variation, if applicable);
    (vi) The specification(s) (including quality/grades, suppliers) 
used for the new tobacco product and predicate tobacco product (with 
any specification variations, if applicable); and
    (vii) Any other material properties necessary to characterize the 
new and predicate tobacco products.
    (2) Ingredients other than tobacco. For ingredients other than 
tobacco in each material and/or component or part of the product 
include:
    (i) The International Union of Pure and Applied Chemistry (IUPAC) 
chemical name and common name, if applicable;
    (ii) The Chemical Abstracts Service (CAS) number(s) or FDA Unique 
Ingredient Identifier (UNII);
    (iii) The function of the ingredient;
    (iv) The quantity with the unit of measure (including ranges or 
means, acceptance limits) of the material(s) in the new tobacco product 
and predicate tobacco product reported as mass per gram of tobacco for 
non-portioned tobacco products and as mass per portion for portioned 
tobacco products (with any specification variation, if applicable);
    (v) The specification(s) (including purity or grade and supplier);
    (vi) For complex purchased ingredients, each single chemical 
substance reported separately; and
    (vii) Any other ingredient information necessary to characterize 
the new and predicate tobacco products.
    (3) Tobacco ingredients. For tobacco include:
    (i) The type, including grade and variety;
    (ii) The quantity with the unit of measure (including ranges or 
means, acceptance limits) of tobacco in the new tobacco product and 
predicate tobacco product reported as mass per gram of tobacco for non-
portioned tobacco products and as mass per portion for portioned 
tobacco products (with any specification variation, if applicable);
    (iii) The specification of tobacco used for the new tobacco product 
and the predicate tobacco product (with any specification variation, if 
applicable);
    (iv) A description of any genetic engineering of the tobacco; and
    (v) Any other information necessary to characterize the new and 
predicate tobacco products.
    (vi) If the new tobacco product does not contain tobacco, then 
include a statement that the new tobacco product does not contain 
tobacco.
    (4) Container closure system. A description of the container 
closure system for the new and predicate tobacco products, including a 
side-by-side quantitative comparison of the components and materials 
and annotated illustrations.
    (d) Comparison of other features. The SE Report must include 
descriptions of any other features of the new and

[[Page 12788]]

predicate tobacco products, such as those described in this section, 
and identify any differences. If a specific feature specified in this 
section is not applicable to the product design, this must be stated 
clearly. If FDA requests a scientific justification explaining why a 
feature is not applicable, the applicant must provide the justification 
to FDA. The comparison of other features must include information on:
    (1) Constituents. HPHCs and other constituents, as appropriate, to 
demonstrate that:
    (i) The new tobacco product has the same characteristics as the 
predicate tobacco product, or
    (ii) Any differences in characteristics between the new and 
predicate product do not cause the new tobacco product to raise 
different questions of public health, including:
    (A) The constituent names in alphabetical order;
    (B) The common name(s);
    (C) The Chemical Abstract Services number(s);
    (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 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) Full test data (including test protocols, any deviation(s) from 
the test protocols, quantitative acceptance (pass/fail) criteria and 
complete data sets) for all testing performed.
    (2) Any other features. A description and comparison of any other 
features of the new tobacco product and the predicate tobacco product.
    (e) Stability information. For smokeless tobacco products and 
tobacco products that contain fermented tobacco, the SE Report must 
contain information on the stability of the new and predicate tobacco 
products, including the following information:
    (1) A description of how the stability is indicated on the tobacco 
product, and an explanation as to whether the stability testing is 
identical for the predicate and the new tobacco product;
    (2) Any known or expected impacts of the differences between the 
new and predicate products on the product stability. If no impact is 
known or expected, state that. For those products that contain 
fermented tobacco, the SE Report must provide information on the 
fermentation processing steps, including the composition of the 
inoculum, with species name(s) and concentration(s); pH; temperature; 
moisture content; water activity; duration; and added ingredients;
    (3) Detailed stability testing, including test protocols, 
quantitative acceptance criteria, data sets, and a summary of the 
results for all stability testing performed. Stability testing must be 
performed at the beginning (zero time), middle, and end of the expected 
storage time for the chemical and microbial endpoints as follows: 
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 
(total, N-nitrosonornicotine (NNN), 4-methylnitrosamino)-1-(3-
pydridyl)-1-butanone) (NNK)); nitrate and nitrite levels; preservatives 
and microbial metabolic inhibitors (if any); and method of heat 
treatment or pasteurization used to reduce microbial loads;
    (4) Testing information, including the storage conditions for 
samples retained for testing; identification of the test methods used; 
a statement that the testing was performed on a tobacco product in the 
same container closure system in which the tobacco product is intended 
to be marketed; and support for the expiration date (e.g., by showing 
that an adequate number of batches was tested);
    (5) Stability testing laboratory or laboratories used and 
documentation showing that the laboratory or laboratories is (or are) 
accredited by a nationally or internationally recognized external 
accreditation organization; and
    (6) Identification of microbiological organisms by genus and 
species names, where applicable, and culture collection number either 
used during the manufacturing process and/or detected through stability 
testing.
    (f) Applicant's basis for substantial equivalence determination. 
The applicant must state that the new tobacco product has either:
    (1) The same characteristics as the predicate tobacco product and 
the basis for this determination, or
    (2) Different characteristics than the predicate tobacco product. 
Where an applicant states that its new tobacco product has different 
characteristics than the predicate tobacco product, the applicant must 
also include an explanation as to why a difference in any of the 
following characteristics do not cause the new product to raise 
different questions of public health: Product design (Sec.  
1107.19(a)); heating source (Sec.  1107.19(b)); materials and 
ingredients (Sec.  1107.19(c)); and other features (Sec.  1107.19(d)). 
In addition, to demonstrate that a new tobacco product with different 
characteristics is substantially equivalent, an applicant must also 
explain why any differences in the manufacturing process between the 
new tobacco product and the predicate tobacco product does not raise 
different questions of public health (Sec.  1107.18(e)). Similarly, for 
smokeless tobacco products, an applicant must explain why any 
difference in stability between the new tobacco product and the 
predicate tobacco product does not raise different questions of public 
health (Sec.  1107.19(e)).
    (g) Comparison to grandfathered product. If the applicant is 
comparing the new tobacco product to a predicate tobacco product that 
FDA has previously found to be substantially equivalent, FDA may 
request that the applicant include information related to the original 
grandfathered tobacco product for that predicate, even if the 
grandfathered tobacco product is back several predicate tobacco 
products. FDA will request this information when necessary to ensure 
that any order the Agency may issue finding the new tobacco product 
substantially equivalent complies with section 910(a)(2)(A)(i)(I) of 
the Federal Food, Drug, and Cosmetic Act. FDA may need to review the 
first SE Report that received a finding of substantial equivalence 
using the grandfathered product as a predicate tobacco product in order 
to make this finding.

Sec.  1107.20  Amendments.

    (a) Except as provided in paragraphs (b) and (c) of this section, 
the applicant may submit an amendment to an SE Report in accordance 
with subpart C of this part. If an applicant chose to submit a health 
information summary with its SE Report under Sec.  1107.18(j)(1), the 
applicant must submit with the amendment a redacted copy of the 
amendment that excludes research subject identifiers and trade secret 
and confidential commercial information as defined in 21 CFR 20.61 and 
20.63.
    (b) An applicant may not amend an SE Report to change the predicate 
tobacco product.
    (c) An applicant may not amend an SE Report after FDA has closed 
the SE Report under Sec.  1107.44 or it has been withdrawn under Sec.  
1107.22.

[[Page 12789]]

    (d) In general, amendments will be reviewed in the next review 
cycle as described in Sec.  1107.42.

Sec.  1107.22  Withdrawal by applicant.

    (a) An applicant may at any time make a written request to withdraw 
an SE Report for which FDA has not issued an order. The withdrawal 
request must state:
    (1) Whether the withdrawal is due to a health or safety concern 
related to the tobacco product;
    (2) The submission tracking number; and
    (3) The name of the new tobacco product that is the subject of the 
SE Report.
    (b) An SE Report will be considered withdrawn when FDA issues a 
notice stating the SE Report has been withdrawn.
    (c) The SE Report is an agency record, even if withdrawn. FDA will 
retain the withdrawn SE Report under Federal Agency records schedules. 
The availability of the withdrawn SE Report will be subject to FDA's 
public information regulations in Sec.  20.45 of this chapter.

Sec.  1107.24  Change in ownership of an SE Report.

    An applicant may transfer ownership of its SE Report. On or before 
the time of transfer, the new and former applicants are required to 
submit information to FDA as follows:
    (a) The former applicant must sign and submit a notice to FDA that 
states that all of the former applicant's rights and responsibilities 
relating to the SE Report have been transferred to the new applicant. 
This notice must identify the name and address of the new applicant and 
the SE Report transferred.
    (b) The new applicant must sign and submit a notice to FDA 
containing the following:
    (1) The new applicant's commitment to agreements, promises, and 
conditions made by the former applicant and contained in the SE Report;
    (2) The date that the change in ownership is effective;
    (3) Either a statement that the new applicant has a complete copy 
of the SE Report and order (if applicable), including amendments and 
records that are required to be kept under Sec.  1107.58, or a request 
for a copy of the SE Report from FDA's files by submitting a request in 
accordance with 21 CFR part 20. In accordance with the Freedom of 
Information Act, FDA will provide a copy of the SE Report to the new 
applicant under the fee schedule in FDA's public information 
regulations in Sec.  20.45 of this chapter; and
    (4) A certification that no modifications have been made to the new 
tobacco product since the SE Report was submitted to FDA.

Subpart D--FDA Review

Sec.  1107.40  Communications between FDA and applicants.

    (a) General principles. During the course of reviewing an SE 
Report, FDA may communicate with applicants about relevant matters, 
including scientific, medical, and procedural issues that arise during 
the review process. These communications may take the form of telephone 
conversations, letters, or emails, and will be documented in the SE 
Report in accordance with Sec.  10.65 of this chapter.
    (b) Meeting. Meetings between FDA and applicants may be held to 
discuss scientific and other issues. Requests for meetings will be 
directed to the Office of Science, and FDA will make every attempt to 
grant requests for meetings that involve important issues.
    (c) Acknowledgement of an SE Report. After receiving an SE Report 
under Sec.  1107.18, FDA will either refuse to accept the SE Report or 
issue an acknowledgement letter.
    (d) Notification of deficiencies in a SE Report submitted under 
Sec.  1107.18. FDA will make reasonable efforts to communicate to 
applicants the procedural, administrative, or scientific deficiencies 
found in an SE Report and any additional information and data needed 
for the Agency's review. The applicant must also provide additional 
comparison information under Sec.  1107.19 if requested by FDA.
    (e) Withdrawal of SE Report. An SE Report will be considered 
withdrawn when FDA issues a notice stating that the SE Report has been 
withdrawn.

Sec.  1107.42  Review cycles.

    (a) Initial review cycle. FDA intends to review the SE Report and 
either communicate with the applicant as described in Sec.  1107.40 or 
take an action under Sec.  1107.44 within 90 calendar days of FDA's 
receipt of the SE Report, or within 90 days of determining that the 
predicate was found to be commercially marketed in the United States as 
of February 15, 2007 (if applicable), whichever is later. This 90-day 
period is called the ``initial review cycle.''
    (b) Additional review cycles. If FDA issues a deficiency 
notification under Sec.  1107.40(d) during the initial review cycle, 
FDA will stop reviewing the SE Report until it receives a response from 
the applicant or the timeframe specified in the notification of 
deficiencies for response has elapsed. If the applicant fails to 
respond within the time period provided in the notification of 
deficiency, FDA will issue an order denying marketing authorization 
under the criteria set forth in Sec.  1107.48. If the applicant's 
response to the notification of deficiencies provides the information 
FDA requested, but FDA identifies additional deficiencies, FDA may 
issue an additional deficiency notification. Each response will begin a 
new 90-day review cycle.
    (c) Inadequate response. If the applicant's response to FDA's 
deficiency notification(s) does not provide the information FDA 
requested, or the applicant provides information but the SE Report is 
still deficient, FDA will issue an order denying market authorization 
under the criteria set forth in Sec.  1107.48. At any time before FDA 
issues an order, an applicant may make a written request to withdraw a 
SE Report under Sec.  1107.22.

Sec.  1107.44  FDA action on an SE Report.

    After receipt of an SE Report, FDA will:
    (a) Refuse to accept the SE Report if it does not comply with Sec.  
1107.18;
    (b) Request additional information as provided in Sec.  1107.40(d);
    (c) Issue a letter administratively closing the SE Report if it is 
not possible to make a determination on an SE Report;
    (d) Issue a letter canceling the SE Report if FDA finds the SE 
Report was created in error;
    (e) Issue an order as described in Sec.  1107.46 finding the new 
tobacco product to be substantially equivalent and in compliance with 
the requirements of the Federal Food, Drug, and Cosmetic Act; or
    (f) Issue an order as described in Sec.  1107.48 denying marketing 
authorization because the new tobacco product is:
    (1) Not substantially equivalent to a tobacco product commercially 
marketed in the United States on February 15, 2007, or
    (2) Not in compliance with the requirements of the Federal Food, 
Drug, and Cosmetic Act.

Sec.  1107.46  Issuance of an order finding a new tobacco product 
substantially equivalent.

    If FDA finds that the information submitted in the SE Report 
establishes that the new tobacco product is substantially equivalent to 
a predicate tobacco product that was commercially marketed in the 
United States on February 15, 2007, and finds that the new tobacco 
product is in compliance with the requirements of the Federal

[[Page 12790]]

Food, Drug, and Cosmetic Act, FDA will send the applicant an order 
authorizing marketing of the product. A marketing authorization order 
becomes effective on the date the order is issued.

Sec.  1107.48  Issuance of an order denying marketing authorization.

    (a) General. FDA will issue an order that the new tobacco product 
cannot be marketed if FDA finds that:
    (1) The information submitted in the SE Report does not establish 
that the new tobacco product is substantially equivalent to a predicate 
tobacco product that was commercially marketed in the United States on 
February 15, 2007; or
    (2) The new tobacco product is not in compliance with the Federal 
Food, Drug, and Cosmetic Act.
    (b) Basis for order. The order will describe the basis for denying 
marketing authorization.

Sec.  1107.50  Rescission of order.

    (a) Grounds for rescinding a substantially equivalent order. FDA 
may rescind a substantial equivalence order allowing a new tobacco 
product to be marketed if FDA determines that:
    (1) The tobacco product for which the order has been issued:
    (i) Does not have the same characteristics as the predicate tobacco 
product; or
    (ii) Has different characteristics and there is insufficient 
information demonstrating that it is not appropriate to require a 
premarket tobacco product application under section 910(b) of the 
Federal Food, Drug, and Cosmetic Act because the product does not raise 
different questions of public health; or
    (2) The SE Report (including any submitted amendments) contains an 
untrue statement of material fact; or
    (3) Concerning a SE Report that compared the new tobacco product to 
a tobacco product that FDA previously found substantially equivalent:
    (i) The predicate tobacco product relied on in the SE Report has 
been found ineligible because its substantial equivalence SE Report 
(including any amendments) contains an untrue statement of material 
fact; or
    (ii) A predicate tobacco product on which any of the previous 
substantial equivalence determinations was based, going back to the 
original grandfathered product, has been found ineligible because its 
substantial equivalence SE Report (including any amendments) contains 
an untrue statement of material fact; or
    (4) FDA or the applicant has removed from the market, due to a 
health or safety concern related to the tobacco product:
    (i) The predicate tobacco product on which the substantial 
equivalence determination is based; or
    (ii) A predicate tobacco product on which any of the previous 
substantial equivalence determinations is based, going back to the 
original grandfathered product, if the substantial equivalence SE 
Report compared the new tobacco product to a tobacco product that FDA 
previously found substantially equivalent.
    (b) Opportunity for a hearing. In general, FDA will rescind an 
order only after notice and opportunity for a hearing under part 16 of 
this chapter. However, FDA may rescind a substantially equivalent order 
prior to notice and opportunity for a hearing under part 16 of this 
chapter if it finds that there is a reasonable probability that 
continued marketing of the tobacco product presents a serious risk to 
public health. In that case, FDA will provide the manufacturer an 
opportunity for a hearing as soon as possible after the rescission.

Subpart E--Miscellaneous

Sec.  1107.58  Record retention.

    Each applicant that receives an order under Sec.  1107.46 
authorizing the marketing of a new tobacco product must maintain all 
records required by this subpart and that support the SE Report for a 
substantial equivalence order. These records must be legible, in the 
English language, and available for inspection and copying by officers 
or employees duly designated by the Secretary. All records must be 
retained for a period of not less than 4 years from the date of the 
order even if such product is discontinued.

Sec.  1107.60  Confidentiality.

    (a) General. FDA will determine the public availability of any part 
of an SE Report and other content related to such an SE Report under 
this section and part 20 of this chapter.
    (b) Confidentiality of data and information prior to an order. 
Prior to issuing an order under this section:
    (1) FDA will not publicly disclose the existence of an SE Report 
unless:
    (i) The tobacco product has been introduced or delivered for 
introduction into interstate commerce for commercial distribution; or
    (ii) The applicant has publicly disclosed or acknowledged the 
existence of the SE Report (as such disclosure is defined in Sec.  
20.81 of this chapter), or has authorized FDA in writing to publicly 
disclose or acknowledge, that the applicant has submitted the SE Report 
to FDA;
    (2) FDA will not disclose the existence of or contents of an FDA 
communication with an applicant regarding its SE Report except to the 
extent that the applicant has publicly disclosed or acknowledged, or 
authorized FDA in writing to publicly disclose or acknowledge, the 
existence of or contents of that particular FDA communication.
    (3) FDA will not disclose information contained in an SE Report 
unless the applicant has publicly disclosed or acknowledged, or 
authorized FDA in writing to publicly disclose or acknowledge, that 
particular information. If the applicant has publicly disclosed or 
acknowledged, or authorized FDA in writing to publicly disclose or 
acknowledge, that particular information contained in an SE Report, FDA 
may disclose that particular information.
    (c) Disclosure of data and information after an order under Sec.  
1107.46. After FDA issues an order under Sec.  1107.46 finding a new 
tobacco product substantially equivalent, it will make the following 
information related to the SE Report and order available for public 
disclosure upon request or at FDA's own initiative, including 
information from amendments to the SE Report and FDA's reviews of the 
SE Report:
    (1) All data previously disclosed to the public, as such disclosure 
is defined in Sec.  20.81 of this chapter;
    (2) Any protocol for a test or study, except to the extent it is 
shown to fall within the exemption established for trade secrets and 
confidential commercial information in Sec.  20.61 of this chapter;
    (3) Information and data submitted to demonstrate that the new 
tobacco product does not raise different questions of public health, 
except to the extent it is shown to fall within the exemptions 
established in Sec.  20.61 of this chapter for trade secrets and 
confidential commercial information, or in Sec.  20.63 of this chapter 
for personal privacy;
    (4) Correspondence between FDA and the applicant, including any 
requests FDA made for additional information and responses to such 
requests, and all written summaries of oral discussions between FDA and 
the applicant, except to the extent it is shown to fall within the 
exemptions in Sec.  20.61 of this chapter for trade secrets and 
confidential commercial information, or in Sec.  20.63 of this chapter 
for personal privacy; and
    (5) In accordance with Sec.  25.51 of the chapter (21 CFR 25.51), 
the environmental assessment or, if applicable, the claim of 
categorical exclusion from the requirement to

[[Page 12791]]

submit an environmental assessment under part 25 of this chapter.
    (d) Disclosure of data and information after an order under Sec.  
1107.48. After FDA issues an order under Sec.  1107.48 (denying 
marketing authorization), FDA may make certain information related to 
the SE Report and the order available for public disclosure upon 
request or at FDA's own initiative except to the extent the information 
is otherwise exempt from disclosure under part 20 of this chapter. 
Information FDA may disclose includes the tobacco product category 
(e.g., cigarette), tobacco product subcategory (e.g., filtered), 
package size, and the basis for the order denying marketing 
authorization.
    (e) Health information summary or statement. Health information 
required by section 910(a)(4) of the Federal Food, Drug, and Cosmetic 
Act, if submitted as part of the SE Report (which includes any 
amendments), will be disclosed within 30 calendar days of issuing a 
substantially equivalent order. If the applicant has instead submitted 
a 910(a)(4) statement as provided in Sec.  1107.18(j)(2), FDA will make 
publicly available on FDA's website the responsible official to whom a 
request for health information may be made.

Sec.  1107.62  Electronic submission.

    (a) Electronic format requirement. Applicants submitting any 
documents to the Agency under this part must provide all required 
information to FDA using the Agency's electronic system, except as 
provided in paragraph (b) of this section. The SE Report and all 
supporting information must be in an electronic format that FDA can 
process, read, review, and archive.
    (b) Waivers from electronic format requirement. An applicant may 
submit a written request that is legible and written in English, to the 
Center for Tobacco Products asking that FDA waive the requirement for 
electronic format and content. Waivers will be granted if use of 
electronic means is not reasonable for the person requesting the 
waiver. To request a waiver, applicants can send the written request to 
the address included on our website (www.fda.gov/tobaccoproducts). The 
request must include the following information:
    (1) The name and address of the applicant, list of individuals 
authorized for the applicant to serve as the contact person, and 
contact information. If the applicant has submitted a SE Report 
previously, the regulatory correspondence must also include any 
identifying information for the previous submission; and
    (2) A statement that creation and/or submission of information in 
electronic format is not reasonable for the person requesting the 
waiver, and an explanation of why creation and/or submission in 
electronic format is not reasonable. This statement must be signed by 
the applicant or by an employee of the applicant who is authorized to 
make the declaration on behalf of the applicant.
    (c) Paper submission. An applicant who has obtained a waiver from 
filing electronically must send a written SE Report through the 
Document Control Center to the address provided in the FDA 
documentation granting the waiver.

    Dated: March 21, 2019.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2019-05787 Filed 3-28-19; 11:15 am]
 BILLING CODE 4164-01-P