Download:
pdf |
pdfDEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
TOBACCO SUBSTANTIAL EQUIVALENCE
REPORT SUBMISSION
Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/201x
(See Burden Statement on last page.)
FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Public Law 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
STATUTORY REQUIREMENTS
Section 910(a)(1) of the FD&C Act defines a new tobacco product as “(A)any tobacco product (including those
products in test markets) that was not commercially marketed in the United States as of February 15, 2007;
or (B) 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.”
Section 910(a)(2) of the FD&C Act states that premarket review is required for new tobacco products. There
are three pathways to receive marketing authorization. Substantial equivalence is one of the three pathways.
Section 910(a)(3) of the FD&C Act states that “substantial equivalence” means, with respect to the tobacco
product being compared to the predicate tobacco product, that the Secretary by order has found that the
tobacco product ‘‘(i) has the same characteristics as the predicate tobacco product; or (ii) has different
characteristics and the information submitted contains information, including clinical data if deemed necessary
by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because
the product does not raise different questions of public health.”
F
O
O
PR
Section 905(j)(1)(A)(i) of the FD&C Act includes the timeframe and basis for submission of a substantial
equivalence Report (SE Report).
FORM FDA 3965 (02/19)
General Information
PSC Publishing Services (301) 443-6740
EF
This page is deliberately blank.
Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/201x
(See Burden Statement on last page.)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
TOBACCO SUBSTANTIAL EQUIVALENCE
REPORT SUBMISSION
SECTION I – APPLICANT IDENTIFICATION
Type of Manufacturer (Check appropriate box)
Manufacture, fabricate, assemble, process, or label a
tobacco product (see section 900(20) of the FD&C Act)
Import a finished tobacco product for
sale or distribution in the U.S.
Manufacturer Name
FDA Establishment Identifier (FEI)
D&B DUNS Number of Headquarters
Designer note: This form will be
Building Number and Street made as a “508 compliant” Adobe
LiveCycle PDF with fillable entry
fields after FDA (along with OMB, if
City
applicable) gives final approval to this
“layout design” version.
Manufacturer Street Address
(Physical location)
Room, Suite, Office, etc. (If applicable)
State, Province, or Territory
Country
Postal Code
Authorized Representative
F
O
O
(Responsible official authorized to represent the applicant)
Prefix (e.g., Mr., Ms., Dr.):
First Name
PR
M.I.
Professional
Suffix(e.g., MD,
Position Title
Last Name
Suffix (e.g., Jr., III)
Email Address
Ph.D.)
Telephone (Include Country Code if applicable)
FAX
Building Number and Street
Authorized Representative
Mailing Street Address
Room, Suite, Office, etc. (If applicable)
State, Province, or Territory
City
Country
Postal Code
U.S. Agent
(For foreign firm where Authorized Representative does not reside in the U.S.)
Prefix (e.g., Mr., Ms., Dr.):
First Name
Professional
Suffix(e.g., MD,
M.I.
Last Name
Position Title
Suffix (e.g., Jr., III)
Email Address
Ph.D.)
FORM FDA 3965 (02/19)
Page 1 of 17
PSC Publishing Services (301) 443-6740
EF
Telephone (Include Country Code if applicable)
FAX
Building Number and Street
U.S. Agent
Mailing Street Address
Room, Suite, Office, etc. (If applicable)
City
State, Province, or Territory
Country
Postal Code
Alternate Point of Contact
(Secondary point of contact for applicant)
Prefix (e.g., Mr., Ms., Dr.):
First Name
Professional
Suffix(e.g., MD,
M.I.
Last Name
Position Title
Suffix (e.g., Jr., III)
Email Address
Ph.D.)
Telephone (Include Country Code if applicable)
FAX
SECTION II – SUBMISSION INFORMATION
Proposed modification(s) to the New Tobacco Product (as compared to the predicate tobacco product) (Check all
that apply)
Tobacco Blend
Container Closure System
Ingredients (Specify):
F
O
O
PR
Design
Heating Source
Material
Product Quantity
Other (Specify):
Submission Summary (As described in 21 C.F.R. 1107.18(d), please summarize the submission below)
Purpose of Application (Check only one)
This SE Report is for an individual new
tobacco product.
FORM FDA 3965 (02/19)
This SE Report is for a bundled submission containing
multiple new tobacco products with similar modifications in
comparison to one predicate tobacco product.
Page 2 of 17
References to Other Correspondence
Related Submission Tracking Numbers (STNs) (List below)
Cross Reference to Tobacco Product Master Files (As applicable, enter the STN, check the Attached Letter of
Authorization box (if letter will be attached to printout or otherwise provided), and provide Master File information.)
STN:
Attached Letter of Authorization
Information and Sections to be referenced from Master File (Enter below)
Formal Meetings Held with FDA pertaining to this tobacco product (For each meeting, as needed, enter the STN number
and meeting held date.)
STN
Meeting Held Date
1st Meeting
2nd Meeting
3rd Meeting
F
O
O
4th Meeting
5th Meeting
6th Meeting
7th Meeting
8th Meeting
PR
9th Meeting
10th Meeting
FORM FDA 3965 (02/19)
Page 3 of 17
SECTION III – NEW TOBACCO PRODUCT INFORMATION
Refer to Section VIII, Appendix B, and select the appropriate category and sub-category.
For a bundled or co-packaged submission, complete all parts of this Section III for each individual new tobacco
product.
For every comparison being made, the category and sub-category of both the new and predicate tobacco
product should be the same.
Select either or both, if applicable.
New tobacco product is a component
New tobacco product is co-packaged
Select all that apply below. Complete for each individual new tobacco product.
New Tobacco Product Name (Brand/Sub-Brand)
Product Category/Sub-Category
Cigarette
Roll-Your-Own Tobacco Products
Combusted, Filtered
Roll-Your-Own Tobacco Filler
Combusted, Non-Filtered
Rolling Paper
Non-combusted
Filtered Cigarette Tube
Combusted, Other (Specify below)
Non-Filtered Cigarette Tube
Filter
Paper Tip
Cigar
Roll-Your-Own, Other (Specify below)
F
O
O
Leaf-Wrapped
Filtered, Sheet-Wrapped
Non-Filtered, Sheet-Wrapped
Cigar Tobacco Filler
Cigar, Other (Specify below)
PR
Electronic Nicotine Delivery System (ENDS)
Open E-Liquid
Smokeless Tobacco Products
Loose Moist Snuff
Portioned Moist Snuff
Loose Snus
Portioned Snus
Loose Dry Snuff
Dissolvable
Closed E-Liquid
Loose Chewing
Open E-Cigarette
Portioned Chewing
Closed E-Cigarette
Smokeless, Other (Specify below)
ENDS, Other (Specify below)
Waterpipe Tobacco Products
Pipe Tobacco Products
Waterpipe
Pipe
Waterpipe Tobacco Filler
Pipe Tobacco Filler
Waterpipe Heat Source
Pipe, Other (Specify below)
Waterpipe, Other (Specify below)
FORM FDA 3965 (02/19)
Page 4 of 17
SECTION IV – PREDICATE TOBACCO PRODUCT INFORMATION
Refer to Section VIII, Appendix B, and select the appropriate category and sub-category.
The category and sub-category should be the same as each individual new tobacco product.
Select either or both, if applicable.
Predicate tobacco product is a component
Predicate tobacco product is co-packaged
Select all that apply below. Complete for each individual predicate tobacco product.
Predicate Tobacco Product Name (Brand/Sub-Brand)
Predicate Category/Sub-Category
Cigarette
Roll-Your-Own Tobacco Products
Combusted, Filtered
Roll-Your-Own Tobacco Filler
Combusted, Non-Filtered
Rolling Paper
Non-combusted
Filtered Cigarette Tube
Combusted, Other (Specify below)
Non-Filtered Cigarette Tube
Filter
Paper Tip
Cigar
Roll-Your-Own, Other (Specify below)
Leaf-Wrapped
Filtered, Sheet-Wrapped
Smokeless Tobacco Products
Non-Filtered, Sheet-Wrapped
F
O
O
Loose Moist Snuff
Cigar Tobacco Filler
Cigar, Other (Specify below)
PR
Electronic Nicotine Delivery System (ENDS)
Open E-Liquid
Closed E-Liquid
Portioned Moist Snuff
Loose Snus
Portioned Snus
Loose Dry Snuff
Dissolvable
Loose Chewing
Open E-Cigarette
Portioned Chewing
Closed E-Cigarette
Smokeless, Other (Specify below)
ENDS, Other (Specify below)
Waterpipe Tobacco Products
Pipe Tobacco Products
Waterpipe
Pipe
Waterpipe Tobacco Filler
Pipe Tobacco Filler
Waterpipe Heat Source
Pipe, Other (Specify below)
Waterpipe, Other (Specify below)
FORM FDA 3965 (02/19)
Page 5 of 17
Complete the subsection below for the predicate tobacco product if the Applicant is not the predicate tobacco product
manufacturer or the Applicant is an Importer of that individual predicate tobacco product.
Predicate Tobacco Product Manufacturer
(If other than Applicant or Applicant is an Importer)
Predicate Name
Manufacturer Name
FDA Establishment Identifier (FEI)
Street Address
D&B DUNS Number of Headquarters
Building Number and Street
Room, Suite, Office, etc. (If applicable)
State, Province, or Territory
City
Country
Postal Code
Predicate Tobacco Product Basis
Check the statement below that applies to the predicate tobacco product, and then complete all necessary information
for that statement.
The predicate tobacco product identified above was submitted for GF review independently of this SE Report
and was determined to be a grandfathered (GF) product.
Name of Product
GF/SE STN
F
O
O
PR
Date of FDA’s GF Determination
The predicate tobacco product was previously found to be substantially equivalent.
Name of Product
GF/SE STN
Date of FDA’s GF Determination
The predicate tobacco product was not previously submitted for GF review and was not previously found to be
substantially equivalent, but we believe it to be a grandfathered product.
FORM FDA 3965 (02/19)
Page 6 of 17
Complete A and B below and attach all documentation, which must demonstrate the predicate tobacco product
identified above was commercially marketed other than for test marketing in the United States as of February 15, 2007.
Subsection A should be completed for each attached document.
A. Evidence of Commercial Marketing as of February 15, 2007
Type of Evidence (e.g., Invoice)
Date of Evidence
Evidence Identifier (e.g., Invoice Number)
Commercial Information (e.g., UPC Code, SKU Number)
Building Number and Street
Commercially Marketed
Business Address
Room, Suite, Office, etc. (If applicable)
State, Province, or Territory
City
Country
Postal Code
B. Statement of Affirmation
I
, confirm that the predicate tobacco product
(Name of responsible official)
, was commercially marketed (other than
(Name of predicate tobacco product)
exclusively for test marketing) in the United States as of February 15, 2007.
Signature
F
O
O
PR
FORM FDA 3965 (02/19)
Page 7 of 17
Date
SECTION V – UNIQUE IDENTIFICATION OF NEW AND PREDICATE TOBACCO PRODUCTS
Each individual new tobacco product must be in comparison to one predicate tobacco product. Refer to the table below
and to section VIII, Appendix A, to determine the appropriate table needed to document all new tobacco products and
predicate tobacco products listed within this application. Fill in the table below and/or attach additional tables to this
section as needed.
Refer to Section VIII, Appendix B, to determine the specific properties that need to be reported based on the category
and sub-category of the tobacco product. Provide data for each required property by filling in the table below, and
provide the target value for both the new tobacco product(s) and predicate tobacco product(s).
Tobacco Product – Component or Co-Packaged? (If applicable, select the appropriate box(es))
Tobacco product is a component
Tobacco product is co-packaged
In the following table, please enter the name of both the new and predicate tobacco products, and list the properties of each
product below its name. Twenty-six rows for properties are provided, as needed, for each name.
Product Identification
New Tobacco Product
Predicate Tobacco Product
Name:
1
1
2
2
3
3
4
Designer note: Currently plan to have 26 separate entry
4
5
fields within each column (one user line of text per
5
6
field).
6
7
8
Properties
9
F
O
O
PR
7
8
9
10
10
11
11
12
12
13
13
14
14
15
15
16
16
17
17
18
18
19
19
20
20
21
21
22
22
23
23
24
24
25
25
26
26
FORM FDA 3965 (02/19)
Page 8 of 17
SECTION VI – CERTIFICATION STATEMENTS
For the following section, state the name of the responsible official, the name of the company being represented within
this application, the individual new tobacco product(s), and the individual predicate tobacco product(s). Complete the
information for all applications.
Name of authorized representative (In this section, referred to as “the authorized representative”)
Name company being represented (In this section, referred to as “the company”)
Name of new tobacco product(s) (In this section, referred to as “new tobacco product”)
Name of predicate tobacco product(s) (In this section, referred to as “predicate tobacco product”)
Complete the certification statement below.
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 § 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 to the Government of the United States is
subject to criminal penalties.
F
O
O
PR
Complete the statement below if choosing to certify that certain characteristics are identical in lieu of providing
data for each characteristic of the new and predicate tobacco products.
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)
due to
the following modification(s): (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 § 1107.19 that substantiate the accuracy of this statement for the period of
time required in § 1107.58, and ensure that such records remain readily available to FDA upon request.
FORM FDA 3965 (02/19)
Page 9 of 17
In accordance with proposed 1107.18, the following information is provided within the SE Report. Check all applicable
statements to which you attest, and then sign the statement below
General Information (1107.18(c)
Summary (1107.18(d)(1-3))
New tobacco product description (1107.18(e))
Predicate tobacco product description (1107.18(f))
Comparison information (1107.18(g))
Comparative testing information (1107.18(h))
Statement of compliance with applicable product standards (1107.18(i))
Health information summary or statement that health information is available upon request (1107.18(j))
Compliance with 21 CFR part 25 (1107.18(k))
Certification (As set out in Section IV of this form, and includes certifications on record maintenance and
availability, truthfulness, and as applicable, that certain characteristics are identical.) (1107.18(l)(1) and/or (2))
By signing below, I,
are true.
, certify that statements selected above
Signature
Date
F
O
O
PR
FORM FDA 3965 (02/19)
Page 10 of 17
SECTION VII – SUBMISSION INFORMATION AND CONTENTS
Ensure all appropriate documents are included in this SE Report. Check all that apply
Administrative
Cover Letter
Table of Contents
Submission Summary
Basis of SE Determination
Unique Identification of new tobacco product(s) and
predicate tobacco product(s)
Statements of Certification (Section VI)
Comparisons (Continued)
Composition
Materials
Ingredients, Tobacco
Ingredients, non-Tobacco
Other features
HPHCs
Product Information
List of Ingredients
Information on Manufacturing Process
Other (Specify below)
Stability
Applicant’s basis for SE
Comparison to grandfathered product (Check only if
predicate product was previously found SE.)
Health and Research (Select only one if this applies)
Health Information Summary
OR
Health Information Statement
Environmental Considerations (Select only one if this
applies)
Comparisons (New vs. Predicate Tobacco Product)
Product Design
Heating Sources
Environmental Assessment
OR
Claim for Categorical Exclusion
F
O
O
PR
FORM FDA 3965 (02/19)
Page 11 of 17
SECTION VIII – APPENDICES
Appendix A: New Tobacco Product and Predicate Tobacco Product Details
Use the tables below as examples of how to format and capture data necessary to uniquely identify products in
Section V.
Below is an example of a single new tobacco product in comparison to a single predicate tobacco product. Refer to
Appendix B for the list of properties necessary to uniquely identify a product depending upon the category and subcategory to which that product belongs.
Unique Product Identification
New Tobacco Product
Name: Product A
Predicate Tobacco Product
Name: Predicate A
Box
Box
20 Cigarettes per box
20 Cigarettes per box
100 mm
92 mm
Length
6 mm
6 mm
Ventilation
None
None
Characterizing Flavor
None
None
Additional Properties
Red color box
Blue color box
Properties
(Inserted on form)
Package Type
Product Quantity
Diameter
F
O
O
PR
Below is an example of multiple new tobacco products in comparison to a single predicate tobacco product.
Unique Product Identification
New Product 2
Name: Product B
New Product 3
Name: Product C
Predicate
Name: Predicate A
STN: N/A
STN: N/A
STN: N/A
STN: GF1234567
Box
Box
Box
Box
20 Cigarettes per box
20 Cigarettes per box
20 Cigarettes per box
20 Cigarettes per box
100 mm
96 mm
94 mm
92 mm
Diameter
6 mm
4 mm
6 mm
6 mm
Ventilation
None
None
None
None
Characterizing Flavor
None
None
None
None
Additional Properties
Red color box
Purple color box
Red color box
Blue color box
Properties
(Inserted on form)
Package Type
Product Quantity
Length
FORM FDA 3965 (02/19)
New Product 1
Name: Product A
Page 12 of 17
Below is an example of new tobacco products that are co-packaged together as part of one submission.
Name of Co-Package: Variety Pack A/B
Unique Product Identification
Co-Packaged Categories and
Unique Identification Properties
New Tobacco Product(s)
Category: Roll-Your-Own
Sub-Category: Roll-Your-Own
Tobacco Filler
Name: Product A
Package Type
Predicate Tobacco Product(s)
Name: Predicate A
Related STN: GF1234567
Bag
Bag
Product Quantity
100 g
100 g
Characterizing Flavor
None
None
Additional Properties
Re-sealable Bag
Blue Bag
Category: Roll-Your-Own
Sub-Category: Roll-Your-Own
Rolling Paper
Package Type
Name: Product B
Name: Predicate B
Related STN: GF7654321
Booklet
Booklet
100 sheets
85 sheets
Length
100 mm
98 mm
Width
56 mm
52 mm
None
None
Black Box
Black Box
Product Quantity
Characterizing Flavor
Additional Properties
FORM FDA 3965 (02/19)
F
O
O
PR
Page 13 of 17
Appendix B: Unique Identification of Category and Sub-Categories and Properties
The following are tables outlining all necessary properties to be captured for each category and sub-category of tobacco
products. An “X” denotes a required property for that given sub-category.
Reference the charts below for completing tables necessary for Section V.
Cigarette Tobacco Products
Sub-Categories
Properties
All Cigarettes
Package Type
X
Product Quantity
X
Diameter
X
Length
X
X
Ventilation
(except combusted, non-filtered)
Characterizing Flavor
X
Additional Properties
X
Note: For non-combusted cigarettes, include the source of energy.
F
O
O
Roll-Your-Own Tobacco Products
Properties
Tobacco
Filler
PR
Sub-Categories
Rolling
Paper
Filtered
Cigarette
Tube
NonFiltered
Cigarette
Tube
Filter
Paper Tip
Other
Package Type
X
X
X
X
X
X
X
Product Quantity
X
X
X
X
X
X
X
X
X
X
X
X
X
Diameter
Length
X
Ventilation
X
Width
X
X
X
X
Characterizing Flavor
X
X
X
X
X
X
X
Additional Properties
X
X
X
X
X
X
X
FORM FDA 3965 (02/19)
Page 14 of 17
Cigar
Sub-Categories
Component
Filtered
SheetWrapped
Unfiltered
SheetWrapped
LeafWrapped
Tobacco
Filler
Other
Package Type
X
X
X
X
X
X
Product Quantity
X
X
X
X
X
X
Length
X
X
X
Diameter
X
X
X
Ventilation
X
Properties
Tobacco Cut Size
X
Wrapper Material
X
Tip
X
Characterizing Flavor
X
X
X
X
X
X
Additional Properties
X
X
X
X
X
X
Smokeless Tobacco Products
F
O
O
Sub-Categories
Properties
PR
Loose Moist
Snuff
Portioned
Moist Snuff
Loose
Snus
Portioned
Snus
Loose Dry
Snuff
Dissolvable
Loose
Chewing
Portioned
Chewing
Other
Package Type
X
X
X
X
X
X
X
X
X
Product Quantity
X
X
X
X
X
X
X
X
X
Portion Count
Tobacco Cut Size
X
X
X
X
X
X
X
X
X
X
X
Portion Length
X
X
X
X
Portion Width
X
X
X
X
Portion Mass
X
X
X
X
Portion Thickness
X
X
X
X
Characterizing
Flavor
X
X
X
X
X
X
X
X
X
Additional
Properties
X
X
X
X
X
X
X
X
X
FORM FDA 3965 (02/19)
Page 15 of 17
Electronic Nicotine Delivery System (ENDS)
Sub-Categories
Properties
Component
Open ELiquid
Closed ELiquid
Open ECigarette
Closed ECigarette
Other
Package Type
X
X
X
X
X
X
Product Quantity
X
X
X
X
X
X
Length
X
X
Diameter
X
X
X
X
E-Liquid Volume
X
X
Nicotine Concentration
X
X
X
PG/VG Ratio
X
X
X
Battery Capacity
X
X
Wattage
X
X
Characterizing Flavor
X
X
X
X
X
X
Additional Properties
X
X
X
X
X
X
F
O
O
Pipe Tobacco Products
Properties
Package Type
Product Quantity
PR
Sub-Categories
Component
Pipe
Tobacco
Filler
Other
X
X
X
X
X
X
X
X
Length
X
Diameter
X
Characterizing Flavor
X
X
X
X
Additional Properties
X
X
X
X
FORM FDA 3965 (02/19)
Page 16 of 17
Waterpipe Tobacco Products
Sub-Categories
Properties
Component
Waterpipe
Heat Source
Tobacco
Filler
Other
Package Type
X
X
X
X
X
Product Quantity
X
X
X
X
X
Length
X
Width
X
Portion Count
X
Portion Length
X
Portion Width
X
Portion Mass
X
Portion Thickness
X
Number of Hoses
X
Source(s) of Energy
X
Characterizing Flavor
X
X
X
X
X
Additional Properties
X
X
X
X
X
F
O
O
PR
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 30 minutes per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”
FORM FDA 3965 (02/19)
Page 17 of 17
File Type | application/pdf |
File Modified | 2019-03-27 |
File Created | 2019-02-20 |