FDA Web Form 3965 Tobacco Substantial Equivalence Report

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SE I Tob,a,cco Substantial Equivalence Report
Nam1e andl D,e scriptiio1
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Submission Name D

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Submission Description f) *

Additional Comments 8

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

overview

Form Approved: 0MB No. 0910-0673

Food and Drug Administration
Section I -Applicant Identification

Expiration Date: XX/XX/20XX

A

Section II - New Product(s)
Information

Tobacco Substantial Equivalence (SE) Report Submission

Section 111 - Predicate Product(s)
Eligibility

Marketing a New Tobacco Product without a Substantially Equivalent Order is illegal and may be subject to enforcement. 1
Please carefully read the instructions located in the Appendix before completing this form.

Section IV - Submission Information "'

Section V-Application Contents
Checklist

Tobacco Substantial Equivalence (SE) Report Submission
On June 22, 2009, the President signed the Fam ily 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).

Section VI - Certification Statements "'

A Substantial Equ ivalence (SE) Report can be submitted by any ma nufacturer for any new tobacco product seeking an FDA substantially equivalent order, under
Submission Files

section 905(j) of the Federal Food, Drug, and Cosmetic (FD&C) Act. Asubstantially equivalent tobacco prod uct is one that has been found by FDA to have either
the same characteristics as a predicate product or has different characteristics than the predicate tobacco product but the Substantial Equ ivalence Report
demonstrates that the new product does not raised ifferent questions of public health. A predicate tobacco p roduct is one that was commercially marketed

Review and Submit

(other than for test marketing) in t he United States as of Feb. 15, 2007, o r is a product previously found to be su bsta ntia lly equivalent by FDA.
Complete the following question and answer form for the Tobacco Substantial Equivalence Report Submission and when all required data has bee n entered

0

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click Submit to deliver the submission to the FDA's Center for Tobacco Products.
For you r reference, see the Tobacco Substantia l E~uiva lence ReP-ort Submission gu idance for additional i nformation.

Provisional SE Tobacco Products
New tobacco products commercia lly ma rketed after February 15, 2007 but before March 22, 2011 with an SE ReP-ort submitted by March 22, 2011 are known as
provisio na l SE tobacco products-these may continue to be marketed unless FDA issues an orde r that the new prod uct is not substantia lly equivalent.

Instructions for Completion of the SE Form
Form FDA 3965 - Tobacco Substantial Equ ivalence Report Submission is a requ ired form for applicants to use when submitting an SE Report to FDA. This form
and the instructions for use are solely intended to provide the applicant an organized format to supply info rmation requ ired for submission of a Substantial
Equivalence (SE) Report. For mo re in formation on what to include in an SE submission, see 21 CFR § 1107.18.
This form is organized into the fo llowin g sections:
• Applicant Identification
• New Product(s) Info rm ation
• Predicate Product(s) El igibil ity
• Submission Information
• App lication Contents Checklist
• Certification Statements
• Submission Files
• Review and Submit
Each section contains one o r more pages that prov ide detai ls on the specific info rmation being requested along with fie lds and/or tools to assist you i n
providing the req uested informa tion. To he lp stream li ne the data entry process, information you provide is automatically saved when entered, and certain
pages and fields may be dynamically enabled or disabled depending on t he information you have provided ea rlier in the form. There are also several helpfu l
identifiers that may be associated with a fie ld to he lp provide further gu idance, including:
• Tooltips: Ind icated by a question ma rk icon, and provides additional instructions, definitions from the guidance document, and other helpful hints
• Required Indicators: Ind icated by a red asteri sk(' ) identifying tha t the specific field is requ ired before the form can be submitted
• Validation Errors: Indicated by descri ptive red text located be low the field identifying t hat the data entered in the fie ld has one or more issues

Both Standard and Advanced navigation options are provided to assist in navigating and completing the form , depending on your needs and com fort level:
• Standard: Previous and Next buttons are provided at the botto m of each page to guide you sequentially through the relevan t sections and pages of this

form. Requi red i nformation on each page must be completed before you can navigate to t he subsequent page, making this option well su ited for newer
users, t hose unfami liar with the fo rm, and/or those looki ng to be guided through the form completion process.
• Advanced: A clickab le hierarch ica l outl ine of the sections and pages in this form is provided on the left side of the scree n, allowing you to navigate to any

specific section or page in the form at any time, regardless of whether all of the req uired informatio n has been completed on the current page. This option
is well suited for more advanced users, those familiar w ith the form, and/ or those looking to quickly jump to a specific section to provide requested
information. Please note, when us ing the Advanced navigation option, there may be pages and fie lds that are d isabled as they rely on i nformation that
you have not yet provided in a previous portion of the form.
The Submission Fi les section allows you to upload and ma nage all of the files being subm itted with the form . As there are many questions th roughout the form
that req ui re or allow requested inform ation to be provided in a file, t he fo llowing tips for using t he Submission Files section are recommended (but not
required) to help exped ite the data entry process:
• Upload submission files first before filling out the rest of the form: You can quickly select from your previously uploaded submission files to provide

t he requested inform ation for each of these questions. If you haven 't uploaded submission files p reviously, you will need to up load a new file each time
you come across one of these questions.
The fo rm does not need to be completed in one session, and a d raft of your fo rm is saved so t hat you may return to it at any time to complete it.
The Review and Submit section w ill show how much req uired in formation is left to be prov ided, as wel l as identify any information that is recommended to be
included/ identified. When aII of the requ ired information has been provided, you can submit the submission package to the FDA.

Statutory Requirements
Section 910(a)(l) of the FD&C Act - Defines the term "new tobacco product" to mean "(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 mod ification (includ in g 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 ingred ient) of a tobacco product where
the mod ified prod uct was commercially marketed in the United States after February 15, 2007."
Section 910(a)(2) of the FD&C Act - Requ ires premarket review for new tobacco products. The re are th ree pat hways to seek premarket authorization, one of

which is submitting a Substantial Equivalence (SE) Report.

Paperwork Reduction Act
According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not req uired to respond to a col lection of
info rmat ion un less it displays a va lid 0MB Control Numbe r. The valid 0MB Control Number for this i nforma t io n collection is 0910-0673 and the expi ration date
is XX/XX/20XX.
The burden t ime for this collection of information is estimated to average 45 min utes per response, including the time to review instructions, search ex isting
data sources, gather and maintai n the data needed and complete and review the collection of information. Send comments regarding this burden estimate or
any other aspect of this infor mation collection, including suggestions for red ucing th is burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of operations
Paperwork Red uction Act (PRA) Staff
For PRA questions:
[email protected]

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Section 1- AppUcant ldentif1ication

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Section I - A!PPli,cant ldentifi,cation

Overview

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You a1re ir1 the AppUcant ldenrtification section..This section requests information regarding the identity of the applicant, anrd includes the·folll.owi ng p,a.rts:
Part A: Applicant Identification
Part B: Authorrized Reprresentative orr U.S.
Agent Information

Part A: Applicant Information
Part IB: Authorized Rep resentative or U.S. Agent Information

Part C: Alternate Point of Contact
Information

Part C: Alternate Point of Contact 1·nform a1tion (Optional)

Part D: Manufacturer Information

Part D: Manufa.c:turer lnform1ation

Part E: Manufacturer/Packaging/
Sterilization Sites Information

Part E.: Manufacturer/Packing/ Sterilization Sites Information (Optional)

Section II - New Product(s)
Information
Section Ill - Predicate Product(s)
Eligibility
Section IV - Submission Information .,,_

Section V-Appllication Contents
Checklist

A

Section VI - Certification Statements ,..

Submission Files

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Section I - Applicant Identification

Part A: Applicant Information
Part A shou ld in clude information regarding the applicant for the submission. An app licant may be any person that submits a PMTAwho seeks a ma rketi ng
autho rization,for a new tobacco product. Pa rt A should be completed for either an organization app lica,nt orr an individual applicant, NOT both .
ld€ntify whether the applicant is a manufactur€r OR importer? 2 • f)

(i}

Manufactu re r

Q

Importer

Is the applicant an Organization or an Ind ividual? *

(i)

organ izatio n

Q

Individual

Organization Information
Orga nization Na me tJ '"
Test Org
Other Organ ization Nam,es (if ap pl icalble) 6

Orga nization FDA-Assigned Facility Estab lishment lderitifier (FEil Number @

Orga nization D&B DU NS®Number 6
- :- -"' - -

Cou nt ry 6

"

I UNITED STATES

X

T

X

T

Street Address Line 1 0 ~
1234 7rest St
Street Address Line 2 (Apt., Suite, Bldg.,#) Q

City 6

•

Test
State ti

•

Virgi nia
Zip Code Q ·
00000-0000

Point of Contact for Organization
First Name ti '"
Overview

I

John
Section I - Applicant Identification

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Part A: Applicant Identification

Middle Initial ti

Part B: Authorized Representative or U.S.
Agent Information

Last Name @ •
Part C: Alternate Point of Contact
Information
Part D: Manufacturer Information

Doe
Genera,tion.a I Suffix Q

Part E: Manufacturer/Packaging/
Sterilization Sites Information

Section II - New Product(s)
Information
Section Ill - Predicate Product(s)
Eligibility

Professional Suffix 8

Position Title ti

Section IV - Submission Information ,,..._

Section V -Application Contents
Checklist

Email Address Q

Section VI - Certification Statements ,.._

Phone or Fax Number(s) ti
submission Files

+ Add Phone/Fax
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Section I - Applicant Identification,

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Part k Applicant Identification

w it hin t he United Sta,tes, p lease provide t he info rmation for an Aut horized Representatuve !below.

Con1tact llnfo.rmation fo•r the Authorized !Representative

Part C: Alternate Point of Contact
Information

II Select if authorized rep resentatuve us t he sa m,e as tlhe applican t ident ified i n Part A.

Part D: Manufacturer lnformatiorni

First INameti ..

Part E: Manufacturer/Packaging/
Sterilization Sites Information

John

Section II - New Product(s)
Information

Midd le Initial ti

Section Ill - Predicate Product(s)
Eligibility

LastNa mE! @ •
A

Doe
Generational Suffix Qi

Section V-Applicati,on Contents
Checldist
Section VI - Certification Statements

Part B: Authorized Representative or U.S. Agent Information
Pairt B shou ld include inform a,t ion f or eit her an Authorized Representative OR U.S. Agent (for a foreign App li cant). As the Ap plic ant provide d in Part A is located

Part IB: Authorized Representative or
U.S. Agent Information

Section IV - Submission Information

A

Profess.io1nal Suffix 0
Submission Files

Review and Submit

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Exipan d Alli Sections

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Sectio1rni I - Applli cant Identification,

Overview

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Posution Tit le @

Email Add ress @

Phone or Fax Mumber( s) f)

Organ i.zation Na,me ti ~
Test Org

II Select if autho1rized rep resentatuve add ress is t he sa,me as t he applicant adld ress iden t ified in Part A.
Country O "

I UNITED SiATES
St reet Address Lin e 10 *
1234 Test st

St reet Address Lin e 2 (Apt. , Su ite, Bldg.,#) Qi

City O

~

Test

Virginua
Ziip Code ti *
00000-0000

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Section 1- Applicant Identificat ion

overview

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Section I - Applicant Identification

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Part k. Applicant Identification

Part C: Alternate Point of Co1
n tact Information
Pa rt C is an optional space for information for ind ividuals not previous ly listed in Sect ion I Parts A and/or B. Use t he Add Alternate P:oint ofContact button below

Part B: Authorized Representative or U.S.
Agent Information

to add additional alternate points of contact, as 1r11eedled.

Alterna't e Point of Contact lnforr mation (Optional()

Part C: Alternate Point of Contact
lnfor;mation

Select .alternate:

Part D: Manufacturer Information
Part E: Manufacturer/Packaging/
Sterilization Sites Information

First Name & "

Section II - New Product(s)
Information
Section Ill - Predicate Product(s)
Eligibility

A

Mldd le Initial 6

Section IV - Submission Information ""
Last Name & *

Section V -Application Contents
Checklist
Section VI - Certification Statements

A

Generational[ Suffix 8

Submission Files

Review and Submit

0

IEX1Pandl AU Sections

Professional Suffix 0

Position Titlle f)

Ema il Address 8

Phone or Fax Mumber( s) 8

II

+ Add Phone/Fax

0rganizaition Na me ti

~

Country O •

Street Add ress Line 10 *

Street Add ress Line 2 (Apt., Suite, Bldg.,#) &

City 6 *

Province/Territory O *

Postal Code O *

+ Add Alternate POC

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Section I - Applicant Identification

Part D: Manufacturer Information
Part D shou ld i nc lud e i nformation for both the Manufacturer of the new tobacco product as we ll as the Manufacture r of the predicate tobacco prod uct. Us.e the

Add Manufactur~r button below to add add itiona l manufactu rersof the new and predicate tobacco products, as needed.

New and Predicate Product Manufacturer

Overview

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Section I - Applicant Identification

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New Product(s} Manufacturer

Pa rt A: App lican t Identification

The below fields apply to the Manufacturer of the NEW tobacco product Only co mplete th is sect io n if the Manufacturer of the new

Pa rt B: Autho rized Representat iv-e or U.S.
Agent Information

tobacco product is diffe rent fro m the App licant identified in Section I Part A. If the sa me, select the check box to ind icate t hey are the
same and continue to the Predicate Product(s.) Manufacturer section below.

a

Pa rt C: Alternate Point of Con tact
Information

Se lect here if Manufactu rer is the same as Appl icant identified in Part A

Organ ization Name O

Part D: Manufactul'er Information

~

Test org

Pa rt E: Ma nufacturer/Packaging/
Steril ization Sites Information

Organ ization FDA-Assigned Fac ility Establis hment Id en tifi er [FEI) Number O

Section II - New Product{s)
Information
Section Ill - Predicate Product(s)

Organ ization D&B DUNS 19 Number 0

Eligibility

- - - --

Section IV - Submission Information "'

I

Section 'V - Application Contents
Checklist

0

Select here if Manufacturer address is the same as the Applicant address identified in Part A.

Country & •

Section VI - Certification Statements

A

UNI TED STATES

Submission Files

Street Address Line 1 0

X

•

X

•

"

1234 Test St

Review and Submit

StreetAddre,ss Line, 2 (Apt., Su ite, Bldg., #) ti

0

Expand All Sections
City O •
Test
State t) "
Virgin fa
Zip Code O •

Point of Contact for New Product(s} Manufacturer
First Name t) •

Midd le Initial 0

Last Name &, ..
Doe
Generational Suffix O

•
Profess io nal Suffix 0

Position Tit le t)

Emai l Address f)

Phone or Fax Nu mber(s) t)

I

♦ Add

II

Ph-one/Fax

Predicate Product(s) Manufacturer

a

Select here if Predicate Manu factu rer is the same as Ap pl ic ant identified i n Part A and proceed to neict page

0

Select here if Predicate Manufacturer is the same as. New Product(s) Manufacturer identified above and proceed to next page

Organ ization Na me t)

I

0
0

Select here if Predicate Manufacturer address is the same as the Applicant address identified in Part A
Select here if Predicate Manufacturer address is the same as the New Product(s) Manufacturer's. address identified above

Country ()

•
Street Address Line 1 0

Street Address Line 2 (Apt., Suite, Bldg., #) 0

City O

Province/ Territory f)

Posta l Code f)

Point of Contact for Predicate Product(s} Manufacturer
First Name t)
John
Middle Initial t)

Last Name f)
Doe
Gen erational Suffix 0

•
Profess io nal Suffix f)

Position Title t)

Emai l Address 0

Phone or Fax Number(s)

l

e

+ Add Phone/Fax

♦ Add Manufacturer

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Part A:. Applicant Identification

Part E: Manufacturer/Packaging/Sterilization Sites Information
Part E is an opt ional space to provide add itio nal site information for the raw materials and/or components used i n t he man ufacture of the fin ished new and/or
predicate prod ucts (e.g., contract, processor of prim ary material, component fabricator, labeling service provider, repacking by t hi rd party). Use the Add

Part B: Authorized Representative or U.S.
Agent Information

Manufacturer/ Packaging/ Steriliza tion Site button below to add add itional sites, as needed.

Part C: Alternate Point of Contact
Information

Manufacturer/Packaging/Sterilization Sites Information

Part D: Manufacturer Information
Part E: Manufacturer/Packaging/

Sterilization Sites Information

Select type of site: 0
I

X .,.

Manufacturer

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Section 11- New Product(s)
Information

Alternate manu facturing site fo r: 0

...

Section Ill - Predicate Product{s)
Eligibility
Organi zation Name O •
Section IV - Submission Information -"
Testorg
Sect.ion V-Application Contents
Checklist

Orga nization FDA-Assign ed Facilit y Estab lishment Identifier (FEil Number O

Section VI - Certification Statements -"
Organi zation D&B DUNS®Number O
Submission Files
-----

Review and Submit

0

Divis ion Name (if applicable ) O

Expand Al l Sections
Is t he manufact uring/ p ackaging/ sterilization site ready for inspection?

Q

fi

Yes

(j) No

Co untry O "
I

X .,.

UNIT ED STATE S

I

Street Ad dress Lin e 10 •
1234 Test St

Street Add ress Line 2 (Ap t., Suite, Bldg.,#) 0

City O •
Test
State O •
X .,.

Virginia
Zip Code O •

Point of Contact Information for Manufacturer/Packaging/Sterilization Sites
First Name O "
John
Middle In itial 0

Last Name O •
Doe
Ge neratio nal Suffix 0

...
Professiona l Suffix 0

Position Title O

Email Ad dress 0

Pho ne or Fax Number( s) 0

+ Add Phone/Fax

+ Add Manufacturer/Packaging/Sterilization Site

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Section1II ., N,e w Pr,oduct(s) lnformatio1
n

Section 1- AppHcant Identification

.
I

Section II - New Product(s)
Information
Section Ill - Predicate Product(s)
Eligibi lity

You a1re in the New Product(s) lnformatio,n section. This section requests i111formatio•n for the new tobacco product(s), which must be provided using Form FDA
3965b ~ Jobacco Substantia1I !Equivalence Product Grouping Spreadsheet, which is a1va1ilable on the FDA website.
The Product Form Validator Tool,.which is availlable on the FDA website , can help validate the data in IForm1FDA 39'65b and confinm the form has been
comp leted consistent with !FDA requ irements before submitting to FDA. Applicants are not required to use tlhle•tool, but using the tool can h,elp reduce tlhl1e time
appllicants spend reviewing, correcting, and resubmitting the form. Whil.e the tool is designed to help applicants navigate the SE submission process,.successfiul

Section IV - Submission Information "'

Section V - Application Contents
Checklist

valida1tion using the tool does not guarantee that an application contains all elements required for acceptance.
Please 1U1pload Form FDA 3965b spn;mdsheets along with any com1pletion certific:ate·s fr.om the Pr,oduct Form Validator Tool in the Submission !files section..

Section VI - Certification Statements "'

S11Jbmission Files

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Secti·o1
n 111 - Predi·cate P1
roduct(s), Eligibility

overview
Section I -AppUcant Identification

Yoru arre in the Predicate IProdlutt(.s) E.ligribHity section. This section requests information reg.a rd ing, the predicate producti( s}, and includes the follow ing parts:
Section II - New Product(s)
Information

I

Section Ill - Predicate Product(s)
Eli gi bility

Part A: Predicate Product(s} Status
V

Part B: Predicate Product Evidence
P.art C: Statement of Affirmation

Part A: Predicate Product(s) Status
Part B: Evidence of Com me1cial Marketing
as of February 15, 2007
Part C: Statement of Affirmation

Section IV - Submission Inform ation .,...

Section V-Application Contents
Checklist
Section VI - CertifitatJon Statements

A

Submission Files

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Section 111 - P11redicate Product(s), Eligibility

overview

Part A: Pre,dicate Pro,d1
uct(s) Sta·tus

Section I -AppUcant Identification
Section II - New Product(s)
Information

Indicate how the predicate product(s) are er gilbl.e to serve as a predicate prod ct for the new product(s),.. Select all statements below that apply to the predicate
tollac:co product(s}. Compllete all necessary information lfor each state,ment

I

Section Ill - Predicate Product(s)
Eli gi bility

V

II Pre,viously Found SE G
• If sellected, skip Section HI Parts B andl C.

Part A: Predlcate Product(s) Status
Part B: Evidence of Com me1cial Marketing
as of February 15, 2007

D PTP Determined G

Part C: Statement of Affirmation

• If selected, complete Section 11111Part Conly.

Section IV - Submission Inform ation .,...

0

Section V-Application Contents
Checklist
Section VI - CertificatJon Statements

Claimed PTP G
• If selected, complete Section 111111Parts Band C..

A

Submission Files

Review and Submit

0

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Section 1111 - Predicate Product(s) Eligibility

overview

Part B: Evid,en,ce ,of Commercial Mariket.in1g as of Febr uary 15, 20 07
1

1

Section I -Applicant ldentHication
Section II - N,ew Product(s)
Information

Based on you r response i n Part A that the predicate prod ucts we re not previously subm1itted for PTIIP review aind were not previously found to be Sl!.lbstantiaHy
equivalent, pllease provide information regard i nig the·evidence of com1mercial ma riketing below.

I

Section Ill - P11redicate Product(s)
Eligibility

V

Part A: Predicate Product(s) Status

Evidence of Commercia,l lMlarketing

Pa11t B: Evidence of Commercial
Marketing as of February 15, 2007

Type of Evidence (e.g., Invoice)

0

Part C: Statemen t of Affirmation

Section IV - Submission lnforimation ,....

Section V-Application Contents
CheckUst

Date ,o1f Evider11ce 0

Evudence Ident ifier (e.g., lnvouce Mumber} 8

Section VI - Certification Statements .-..

Submission Files

Commercial lnformatioin (e..g.., UPC code, prodhu1c t description, item,nu m ber) 0

Review and Submit
Predicate Product IName(s} D

0

Expand AU Sections
Count ry O

•

Street Address Line 10

Street Address Line 2 (Apt.., Su ute, Bldg.,#) f)

City O

Provi nce/Ter ritory 0

Postal Code 0

+ Add Evidence of Commer,d al M,arketing

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Section IV - Submission Information

overview
Section I -Applcant Identification

You a1re ir1 the Submiss ion Info rmation section. This section requests informa1tion1regardin1g the submission,.an1d incl udes the fo llowi ng parts:
1

Section II - New Product(s)
Information

Part A: General Siubmissio•n Information

Section 111- Pr·edicate Product(s)
Eligibility

I

Part IB: cross-Referrenc.ed tnforma1tion i(Optiona.l)

Section IV - Submission Information v
Part A: Genera l Submission Information

Part C: Referenced Tobacco Product Master File(s) (TPMF) (Optional[)
Part D: Forma l Meetings Held with FDA Pertaining to the New Produc.t(s) (Optional)

Part B: Cross-Referenced Information
(Optional)
Part C: Referenced Tobacco Product
Master File(s) (TPMF) (Optional)
Part D: Formal Meetings Held with FDA
Perta in ing to the New Prod uct:(s)
(Optional)

Section V-Appliication Contents
Checklist
Section VI - Certification Statements

A

Submission Files

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0

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Overview
Section I -Applicant Identification
Section II - New Product(s)
Information

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Section IV - Submission Information

Part A: General s.ubmission lnformat·on
Applica1nts ma1y bundle groups ,of SE Reports for their new prodluct(s) in the same product category and subcategory where the proposed modific.ation1s are the
sam1e. For grouped submissi,onsJ the application type m1us.t be the sa1me and the proposed modificationi(s} to the new tobacco pr,oducts {.as co1
mpared to the

I

Section Ill - Predicate Product(s)
Eligibility

3965.

Section IV - Submission Information v

Ty pe of Application 2

predicate tobacco prod uct[s]) should be·sim ilar. If application type is not the sam•e and/or proposed 1modiflication are not s1m1ilar, submit a separate Form FDA

8

Part A: Genera l Submi.ssion Information

Q

Part B: Cross-Referenced Information
(Optional)

Submission Summ1aries 2 f)i

Same Characteristics !Reports

Q

Different Chara,cteris.tics Reports

Part C: Referenced Tobacco Product
Master File(s) (TPMFJ (Optional)
Part D: Formal Meetings Held with FDA
Pertaining to the New Product(s)
(Optional)

section v- Application contents
Checklist
Section VI - Certification Statements "'-

Submission Files

Review and Submit

0

l:xpandlAll. Sections.

!Proposed modification(s} to the tobacco product(s) {as compared to the predicate tobacco product[s]),2

0
0
0
0
0
0
0
0
0

8

Tobacco Blendl
Design
Materials
Container Closure System
Heating So urce!
Product ,Quantity
Composition
lngr,edien1ts (Specify bel,ow)
Other (Specify below),

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Section IV - Submission Information

Overview

Part 1
B: Cross-Referenced Information (Op,tionall)

Section I Applicant Identification
Section II - New Product(s)
Information

Compllete Part B if the applic.atior1 includes ,on,e or more cross-reference(s) to a stand.alone Pl P submission or a,uthorizedl SIE sub1mission other than the
predicate product listed in Form FDA 3965b. SE Reports should not cross-reference other pending SIE.applications.. To provide a cross-reference, use the Add

Section Ill - Predicate Product(s)
Eligibility

I

SAVE& EXIT

Cross-Referenced Information button bel.ow to add a row to the table to capt,ure the cross-reference information.. Within the table, utilize a single row for each
cross r-efe rence, and use the Add Cross~R,efe,renced Information button below to add additional rows to the table to provide additiona l cross references,..as
9

Section IV - Submission lnfor-mation v

9

needed.

Part A: General Submission Information

Part B: Cross-Referenced Information
(Optional)

0

I ha,ve·fi led an IM RlPA,. but I do n,ot yet ha,ve the STNI.

Cross Referenced STIN f)
9

"fr

Part C: Referenced Tobacco Product
Master File(s) (TPMFJ (Optional)
Part D: Formal Meetings Held with FDA
Pertaining to the New Prod uct(s)
(Optional)

Is the content rele·v ant to a Ill p•rroduots within this submission? 9

@ Yes

Section V Application Contents
Checklist
Section VI - Certification Statements

II

Q No
Information and sections to be referenced! (e.g. all.sections, sections 1-111) f)
A

Submission Files

Review and Submit

0

Expand!All Stictions

+ Add Cross Referenced Information

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Overview
Section 1- AppHcant Identification
Section II - New Produd(s)
Information

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Section IV - Submission llnf:ormation

Part ,c: Refe1
re1
nce,d To,bacco Product Master File(s,) (TPMF) (Optional)
Compllete Part C if t he application includes a Tobacco Product Master File·(TPMF) 21 CIFR § 1114.7 ,(b)(2),. To provide a r,eferenced TPMIF, 11.11se the Add Referenced
TPMFbutton below to add a row to the tab le to capture the referenced TIPMIF information. With in the table, utilize a1single ro-w fo r ea1clh TPMF, .and use t he Add

Section Ill - Predicate Product(s]
Eligibility

I

Section IV - Submission lnforimation v

Refere,nc,ed TPMFbutton lbellowto add add it iona1I rows to the table to provide additiona l refe rence TPMFs, as needed.

TPMF Owr1er &

Part A: Genera l Submission Information
Part B: Cross-Referenced In formatio n
(Optional}

TPMF STN (assigned by FDA), &

Part C: Referenced Tobacco Product
Master File(s) (1PM F) ,( Optional)

Part D: Formal Meetings Held with FDA
Pertai lining to the New Prod uct(s)
(Optional)

Section V Application Contents
Checklist

s the content appl.kable to aU products within the submissmon?

Q

Yes

Q

N,o

G

lr1formation and sections to,be referenced 0

II

Section VI - Certification Statements ,;,.

Submission Files

Review and Submit

0

Right of reference·included? &
!Expand All. Sections

Q

Yes

Q

No

+ Add Referenc,ed TPMIF

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Sectio,liil IV - SU1bimissioliil Information

overview

Part D: Formal Meetings Hleld with F'DA Pertaining to the New Product(s),
(Optional)

Section I -Applcant Identification
Section II - New Product(s)
Information

Complete Pa.rt D if FDA and tlhe .applicant held one or more m1eetings related to the new product(s). This ca1n include meetings for study design,.earllier versions

Section 111- Pr·edicate Product(s)
Eligibility

I

SAVE & EXIT

.of t he product, etc. To provide a Formall Meeting, use the Add Formal Meeting button below to add a ro:w to the ta bl.e to capture tlhe meeting information. Within
use tlheAdd Formal Meeting button below to adld additional rows to the ta bile to list additiona1I meetings, as
the table, utilize a single row for each meeting~ and 1

Section IV - Submission Information v

needed.

Part A: Genera l Submission Information
Part B: Cross-Referenced Information
(Optional)

Submission STN 8

Part C: Referenced Tobacco Product
Master File(s) (TPMF) (Optional)

Part D: Formal Meetings Held with FDA
Pertaining to the New Product(s)
(Optional)

Is the meeting relevant to an pirodL1cts within this submission?

Section V-Appliication Contents
Checklist
Section VI - Certification Statements

Meeting Held Date U

A

{i)

Yes.

Q

No

•

G

Submission Files

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0

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T'E Si ENVl~ONMENT

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Secti·on1V-App,licaitio,n Co,ntents Checkllist

overview
Section I - Applicant Identifiication

You are in the AppHcation Contents Checklist section, which is intended to help applicants organize th,eirsubm,ission per 21 CIFR § 1107.18, and includes the·
fol owing parts:

Section II - New Product(s)
Information

P.a rt A.: Administrative Content

Section 111 - Predicate Product( s)
Eli gi bility

P.art B: Product lnform,ation

Section IV - Submission Information ,..

I

Section V - Appl!ication Contents
Checklist

Part C: Hllealth and Researc.h
P.art D: Comparisons

V

P.art E.: Environ m,ental Considerations

Part A:. Adm inistrative Content

Each pa,rt of the Application Contents Checklist section conrains achecklist of releva,nt documents that are required or recommended for inclusion with your
Part B: Product Information
Part C: Hea lth and Research

submission. for ,each ite1m included! in your submission, select the corresponding checkbox in the list and provide the location of the document. for ,exa1mple,
ments should be uploaded in the Submission Fil,es section.
the file name, document na1me, andl page nu1mber. Select all that apply. Al docu1

Part D: Comparisons
Pa rt E: Environmental Considerations

Section VI - Certification Statements ,..

Submission Files

Review and Submit

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Sectio,lill V - App!icatiolil Contents Checklist

overview
Section I -Applicant ldentifiication

Part A: Administrative C,o ntent

Section II - New Product(s)
Information

Checlklist for Admi:n istrative Content
lhis application contains the following.Admin1istir.a tive Content items (se lect al l that a.pplly a1nd indicate fi le name and location of application content). AH

Section 111- Predicate Product(s)
Eligibility

documents should be 1u ploaded in the Submission Files section.

Section IV - Submission Information ,._

0

Cover Letter 0

Location,(Comments)

I

Section V - Application Contents
Checklist

v

Part A: Administrative Content
Part B: Piiod uct Information

D Com1prehe1n:s.ive lndex

2

.and Table of Contents2 0

Location,(Comments)
Part C: Hea lth and Research
Part D: Comparisons
Part E: Environmental Cons iderations

0

Section VI - Certification Statements ,._

Unique Identification of New Tobacc,o Product,(s) .and Predicate Tobacco P1
roduct(s) (Fo,rm FDA 3965b - Substantial
Equ1ivalen,ce Product Applicatio,n Group Produ,c t Submission Spr,eadshee,t ) 2 0

Location,(Comments)

Submission Files

Review and Submit

0
0

English 1·ra:n1slations for Noni- English l!nformation 2 8

Location,(Comments)
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Section V - Ap pllicatiollfl Contents Checklist

overview
Section I - Applicant Identifiication

Part B: Produ1ct lnfo1
rma'tion 2

Section II - New Product(s)
Information

Checklist for Prod1uct ln1formation
rh ·s a1pplication contains the folllowing Product llnforma1tion items (sellect all that applly and indicate file name a 1d location of appli-cation c,01r111tent),. All

Section 111 - Predicate Product( s)
Eli gi bility

docum1e·nts should be uploaded in the Submission Files section.

Section IV - Submission Information ,..

0

L.ist o,f llng:re,di,e,nts G

Loc.ati-on (Comments)

I

~::::: - Appli Draft Submissions > Edit Submission

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Section V - Ap pllicatiollfl Contents Checklist

overview
Section I - Applicant Identifiication

Part ,c : Health1and Res,earch 2

Section II - New Product(s)
Information

Checklist for He,alth and Rese,.arch (select 01n ly one)
Select only one checkbox i1r111Part C to indica1te whether the application contains a Health Information S1umma ry or Heallth Inform1ati-on Statem,ent, as r,equired lby

Section 111 - Predicate Product( s)
Eli gi bility

21 CFR 1107.180)- AH documents.should lbe uploaded in the Submission Files section.

Section IV - Submission Information ,..

0

Heall·th I nformatio,n Summary G
1

Loc.ati-on (Comments)

I

~::::: - Appli Draft Submissions > Edit Submission

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Sectioin V - Appll icatio1n Contents Checklist

Overview
Section I -Applicant Identification

Pa1
r t D: Comparisons 2

Section II - New Product(s)
Information

Checlklist for Com1parisons ,(New vs Predicate Tolbacco Product}
This application conta ins the folllowing Co1mparison ite1ms (select a1Hthat applly and indicate file name and location of application coin tent). All docu1ments

Section Ill - Predicate Product(s)
Eligibility

should be uploaded ini the Subm1!ssion1Files s,ection.

Section IV - Submission lnfor1mation ,,.._

0

Product Desig:n G

Location1(Comments)

I

Section V - Application Contents
Checklist

V

Part A: Admihiistrative Content

D

Part B: Product Information

Heating Source G

Location1(Comments)

Part C: Health and Research
Part D: Comparisons

Part E: Environmental Cons iderations

Section VI - Certification Statements

Submission Files

Review and submit

A

0
0
0
0

Com1position G
Materials
Ingredients, tobacco
Ingredients, non-tobacco

Location1(Comments)

0

Expand Al l Sections

0
0
0

0therFeatures O
HPHCs

Other (specify below)

Location1(Comments)

0

Stability &

Location1(Comments)

0

Comparison to Original Predicate Tobacco Product(s) (Select only if the predicate product was previously found SE)

G
Locat ion1(Comments)

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T'E Si ENVl~ONMENT

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Section V - Ap pllicatiollfl Contents Checklist

overview
Section I - Applicant Identifiication

Part E: Envir,onmental C,onsi,deraitio,ns 2

Section II - New Product(s)
Information

Checklist for Environmental C,on1sidle1
rations (sele,ct onlly one)
rh ·s a1pplication contains one ofth-e following Environmenta Considerations ite1
ms (select only one). AU docum1ents should be uploaded in the Submission Files

Section 111 - Predicate Product( s)
Eli gi bility

section.

Section IV - Submission Information ,..

0

Envir•o nmental Assessment 8

Loc.ati-on (Comments)

I

~::::: - Appli Draft Submissions >Edit Sub1mission

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Section VI -·Certificatio,n s·tatements

Overview
Section I -Applicant ldentifiication .,.._

You are ir1 the Cert1ification State:m,ents section. Jhis section will pre.sent you with the appropriate certification state1ment(s) to compl,ete based on the·spec:iflc
Section II - New Product(s)
Information
Section 111- Pr·edicate Product(s)
Eligibility

typ,e ofSE Report identified in Section IVPartAand the Health lnformatior1optiorn selected in SectionV PartC, as folllows:
i. Certification Statement for SE Report (for all SE !Reports)
A

ii. Cert[fication Statemernt for Sa.me Characterlstics SE Report (for Same Characteristics SIE Reports)
iil. Certification St.atem,e nt Reg.ardingAvaillabil.ity of Health 1n1orma1tlon ,(for SE Reports choosing to m1ake Health lnrormatlon available ru pon request)

Section IV - Submission
Information
Section V-AppUcation Contents
Checklist

For each applica1ble certification statement, provide all! of the requested information on the p.age, which willl them generate a compl,eted certification statement
that must he signed by the authorized representative.
V

Part A: Admi nistrative Conternt
Part B: Product Information
Part C: Hea lth and Research
Part D: Comparisons

I

Part E: Environmental Cons iderations

settian VI - certifi Dr.aft Submissions > Edit Subm ission

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Section VI - Certificatio n Statements

i. Cert.ification Statem,en't for SE R,eport
The Certification Statement for SE Report is requ ired for a ll SE Reports. To include th is certification statemient in your s.ubm1issiorn, p rovide the requested
intorrmation bellow, which will generate a certiflca1tion staterm ent that must then1be signed by the authorized rep resentative.
• The Na me of Application has al r·eady been popu laitedl below with the applicant identified in Section I Pa1rt A.
• For Name of Respornsible Official, select the autlhorized representative or U.S. agent below as identified in Section I Part B or Part C who is signing the
certification.
Use the Add Certlficalion Statement for SE Report button below to add additional c,e rtificationi statements, as needed.

Cert,ificatio,n Statement torr SE Report
overview
Section I -Applicant ldentificati,on , .,. _
Section II - New Product(s)
Information
Section Ill - Predicate Product(s)
Eligibility

Other "'
Test
A

section IV - submission
Information
Section V-Application contents
CheckHst

X .-

Other

TestOrg
I, Test, on behalf of the applicant, Te$t o,rg, hereby certify that Te.st Org will maintain all records to substantiate the aiccuracy of this SE Report for th1e

V

period of time req uired i n 21 CFR 1107.58 and ensure that such records remain read ily avai lable to FDA upon request. I certify that th is information
and the accompa1nying submission are true and correct. that no material fa1ct has been om itted, and that I am authorized to subm it this on the

Part A:. Adm iriistrative Content

a ppllicant's beha If. I understand that under section 1001 of tit le 18 of the U I ited States Code anyone who knowi nglly and willf I Uy makes a mate ria lly
Part B: Product Information

false, fictitious, or fraudu l•ent statement or rep resentation in any matter within the jurisdiction oft e executive, legislative, or j 1udlcial branch of the

Part C: Health and Research

Government of the ll.Jn ited States is subject to criminal p•ena lties.

Part D: Comparisons

Digital[ Sign atu re ..

...,
"'

Part E: Environmental Considerations

I

Section VI - Certification
Statements

V

i. Certification Statemelilt for SE
Report

Sign above
ii. Certification Statement for Same
Characteristics SE Report
iii. Certification Statement Regarding
Availability of Health Information

Logged in User Accou1
nt:

Digitally Signe,d For:

Digitally Signe,d On:

Simmons_1
[email protected]

Test

October 7th 2024,, 5:54::01 pm

V

0

!Expand All Sections

+ Add Certification Statement for SE Report

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TEST ENVl!.ONMENT

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Sectioin VI - Certification Statements

ii. Certification Stateme1n t for Sam,e Cha1racteristics SIE !Report
fhe Certification Statement for Same Characteristics SE Report is appropriate when subm,itting a Same Ch,aracte ristics SE Report and choos ing to certify
that certa in characteristics are identica I in li eu of providing data for each ch,aractefistic of the new a,nd pred icate products. To includle tlhis certification
state1m ent in your sub1mission, click the Add Certification Statement for Same Chorocteristics SE Report button and!Iprovide th,e requested i nformation below,
whiclh w i II generate a certification statem,ent that must then be signed by the a,uthorized rep resentative.
• fhe Name of Company has already been populated below with the app licant identified in Section I Pairt A.
• For Nam€! of Respornsib le Official, select the autlho rized rE!prE!sentative b@low as idE!ntified i n Section I Part B or Part C who is signing the certification.
• Provide the n.ame(s) of the individual new andl predicate product(s), as identified iin Section II.
• Provide a description of the modifications, as identified i1n Sectio1n IV Part A.
If subm,itting a grouped sub1miss ion, a certification statement is needed fo r each new product Use the Add Certification Statement for Same Characteristics SE

Report button lbelow to add additional certification statements, as needed.

Certiificatio•n Statement for Same Characteristics SE Report
Na,me of Respons ible Officia l! *
)(

John !Doe

....

Na,me of Company
Test Org
Na,me of Nlew Tobacco !Product *

I Test IProductA
136 characters remaining.
Name of P~edicate Tobacco Product ,.

I Test !Product B
136 characters remaining.
Overview
Section I - Applicant Identification

Describe Modification(s) •
A

I Product Test
487 characters remaining.

Section II - New Product(s)
Information

II

I, John Doe, on behall f of Test Org, ce1rtifythat Test Product A has the follow ing modification(s) as compa red to Test Produ,ct B due to
section 111 - Predicate Product(s)
Eligibility

A

a,re idlentica 1. 1certify that Test org understands th is mea,ns there is no other modification to the ma,terials, ingredients,.design fea,t u1res,
heating source, o r any other feature. I also certify that Test Org wi Hmaintain reco rds to support the comparison informatioin in 21 CFR

Section IV - Submission
Information
Section V -Applicati,on Contents
Checklist

the fo llowing modlification(sJ,: Prodluct Test. Aside from these mod ificat io ns, the cha racteristics of Te.st Product A and Test Product B

1107.19 that substantiate the accuracy of this statement for tlh@ period of time rE!qu i red in 21 CFR 1107..58, and ensure! that such records
rema,in readily availablle to FDA upon request.
V

Digital[ Signature *

,.,.
...,

Part A:. Administrative Content

*

Part B: Product Information
Part C: Health and Research
Part D: Comparisons.

Sign above

Part E: Environmental Considerations

I

section Viii- certification
Statements

V

i. Certification Statement for SE Report

ii. Certification Statement for Same

l ogged in User Accou1nt:
[email protected]
m

Digitally Sigrned

Fo1
r:
Jolhn Doe

Digitallly Signed On:
Octolber 7th 2024, 5:54:58
pm

Characteristics SE Repo:r t
iii. Certification Statement Regarding
Availability of Health Information

Submission Files

0

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Section VI• Certification State,ments

iii. Certification Sta1te1m1ent Regarding Availabi 1
lity of H,ealth lnfor1
m1ation
The Certification Statement Regarding Availability of Health Information is appropriate wlh.en clhloosing to m1ake health infoirmaition availablle upon request
as per 21 CFR li07.18(j)(2) rather than1including a health i nformation summa1ry w ith their SE Report. lo include tlhis. certification statem ent in you r siu1bmi ssion,
click the Add Certification Statement Regarding Availabifity of Health Information button aind provide the requested information below, which will generate a
certificat ion state ment that must t hen be sigined by U11e authorized rep resentative•.
• For Nam e •O f Responsib le Officia l, select the authioriz.ed representative below as identifiedll in Section I Part B or Part C who is signing the certification..
• The Position Held in Company by Person !Requ ired to Submit the SE !Report willl be populated with the posit ion title identified in Section I Part Bor Part C
for the se lected authorlzed rep1r•esentative
• The Name of Company wi ll be popullated w ith the org.aniza1tion name ident ified in Section I Part B or Part C for the selected authorized represen tative
Use the Add Certification Statement Regarding Availability ofHealth Information button below to adld addit iorn al certification statem1ents,.as n@eded.

Cet11ificatiion Statement Regarding Availability of Health ln1formation
Naim1e of Respons ible OfficuaI *
X

Jolhin [)oe

..,

Posution IHeldl i1n1Compa1ny by Person Req1uired to Submit the SE Report ..
Scientist

Information
Section Ill - Pl'edicate Product(s)
Eligibility

141 characters remaining.
A

Section IV - Submi.ssion
Information

TestOrg
142 characters remaining.

Section V -Appliication Contents
Checklist

V

I, John Doe, certify t hat, iin my ca pa city as Scientist of Test Org, I wi II maIke availablle, upon req uest,.the information identified in 21 CFR
1107.18(j)(3) w ith in 30 ca l endlar days of a requ@st

Part A: Administrative Content

Digita l[ Signature *

Part B: Product Information

,.,.
...,

*

Part C: Health and Research
Part D: Comparisons
Part E: Environmental Considerations

I

Section VI - Certifi(ation
Statements

V

Sign above

i. Certification Statement 1for SE Report

logged in User Account:

ii. Certification Statement for Same
Cmaracteristics SE Report

Sim [email protected],m1

iii. Certifi•cation Statement

Digitally Signe,d
For:
Jo,hn IDoe

Regarding Ava ilability of Health
Information

Digitally Signed On:
October 7th12024, 5:56:0•6

1
pm

Submission Files

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+ Add Same Tobacco Product Certification for Resubmission
V

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TEST ENVIRONMENT

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Section I - Applicant Identification

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Section II - New Product(s)
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Section Ill - Predicate Prc:,duct(s)
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Section IV - Submission Information """

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Section V - Application Contents
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Section VI - Certification Statements """

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Section 1- AppHcant Identification

You have reached the end of this subm1ission. You m1ay 1r111ow submit your submission to CTP in order to fulfi ll your require1ments. Submission via t h1e CTP Portal

Section II - New Product(s)
Information
Section Ill - Predicate Product(s)
Eli gibility
Section IV - Submission Information "'

Section V - Application Contents
Checklist
Section VI - Certification Statements "'

Next:Gen provides seoure transm1ission and enablles. the FDA to provide you with .an aiutomated acknowledgment of receipt
1€ you would like to submit this submission at this t ime,.please d ick the Submit button below. If any requi red data is missiniJ the submission will not be

submitted and you will be proimpted to provide the mis.sing data..Please ensure that all required questions are compl.eted and alll applicable docume·nts have
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You may a1lso save a1nd exit this submission to return to,it at a later t ime ifyou do not wish to siubmit it now. To do so, simply click Save·and Ex.it be-low. To re~
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