FDA Web Form 4057 Premarket Tobacco Product Application (PMTA) Submission

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PMTA I Premarket To!b acco Produ,c t A[p plli,c ation
Nam1e and o ,escription1
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Su bmission Description O *

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Overview

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Form Approved: 0MB No. 0910-0879

Food and Drug Administration
Section I -Applicant
ldentificatio n
Section II - New Tobacco
Product Information
Section Ill - Submission
Information

Expiration Date: 12/31/2025

Premarket Tobacco Product Application (PMTA)
Submission

Marketing without a Marketing Granted Order (MGO) is illegal and may be subject to enforcement.
Please carefully read the instructions below before completing this form.

Section IV -Application
Contents
Section V - Statements of
Compliance

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Premarket Tobacco Product Applications
On June 22, 2009, the President signed the Fam ily Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub lic

Section VI - Certification
Statements

Law 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
A premarket tobacco product application (PMTA) can be submitted by any person for any new tobacco product seeking an FDA

Submission Files
Review and Submit

marketing order, under section 910(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). A PMTA must provide sc ientific
data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to
authorize marketing, FDA considers (per section 910(c)(4)), among other things:

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• Risks and benefits to the population as a whole, inc lud ing peop le who would use the proposed new to bacco product as
well as nonusers
• Whether people who currently use any to bacco product would be more or less likely to stop using such products if the
proposed new tobacco product were available
• Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco
products if the new product were available
• The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product
Complete the following question and answer form for the Premarket Tobacco Product Application and when all requ ired data
has been entered click Submit to deliver the su bmission to the FDA's Center for Tobacco Products.
For your reference, see the Premarket Tobacco Product A1;1plications gu idance for add itional information.

Instructions for Completion of the PMTA Form
Form FDA 4057 - Premarket To bacco Product Application (PMTA) Submission is a req uired form for app licants to use when
submitting a PMTA to FDA. This form and the instructions are solely intended to provide the applicant an organized format to
supply information required for submission of a PMTA. For more information on what to include in a PMTA subm ission, see 21
CFR § 1114.7.
This form is organized into the following sections:
• Applicant Identification
• New Tobacco Product Information
• Submission Information
• Application Contents
• Statements of Compliance with the Federa l Food, Drug and Cosmetic (FD&C) Act
• Certification Statements
• Submission Files
• Review and Subm it
Each section contains one or more pages that provide details on the specific information being requested along with fields
and/or tools to assist you in providing the requested info rmation. To help streamline the data entry process, information you
provide is automatically saved when entered, and certain pages and fields may be dynamically enab led or disabled
depending on the information you have provided earlier in the form. There are also several helpfu I identifie rs that may be
associated with a field to help provide further guidance, including:
• Tooltips: Indicated by a question mark icon, and provides additional instructions, definitions fro m the guidance

document, and other he lpful hints
• Required Indicators: Indicated by a red asterisk(*) identifying that the specific fie ld is requi red before the form can be

submitted
• Validation Errors: Ind icated by descriptive red text located be low the fiel d identifying that the data entered in the field

has one or more issues
Both Standard and Advanced navigation options are provided to assist in navigating and completi ng the form, depending on
your needs and comfort level:
• Standard: Previous and Next buttons are provided at the bottom of each page to guide you sequentially through the

relevan t sections and pages of this fo rm. Required information on each page must be completed before you can navigate
to the subsequent page, ma king this option well suited for newer users, those unfamiliar with the form, and/or those
looki ng to be guided through the form completion process.
• Advanced: A clickable hierarchical outline of the sections and pages in this form is provided on the left side of the screen,

allowing you to navigate to any specific section or page in the form at any time, rega rdless of whether all of the requi red
information has been completed on the current page. This option is well suited for more advanced users, those fam iliar
with the form, and/or those looking to quickly jump to a specific section to provide requested information. Please note,
when using the Advanced navigation option, there may be pages and fields that are disabled as they rely on information
that you have not yet provided in a previous portion of the form .
The Submission Fi les section allows you to upload and manage all of the files being submitted with the form. As there are
many questions th roughout the form that require or allow requested informatio n to be provided in a file, the following ti ps for
using the Submission Files section are recommended (but not required) to hel p expedite 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 the requested information for each of these questions. If you haven't uploaded
submission files previous ly, you will need to upload a new fi le each time you come across one of these questions.
The form does not need to be completed in one session, and a draft of you r form is saved so that you may return to it at any
time to complete it.
The Review and Submit section will show how much required information is left to be provided, as well as identify any
information that is recommended to be inc luded/identified. When all of the required information has been provided, you can
submit the submission package to the FDA.

Statutory Requirements
Section 910(a){1) 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
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 othe r 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 - Requi res premarket review for new tobacco products. There are three pathways to seek

premarket authorization, one of which is submitting a Premarket Tobacco Product Application (PM TA).

Paperwork Reduction Act
According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a valid 0MB Control Number. The va lid OM B Control Number for this
information collection is 0910-0879 and the expiration date is 12/31/2025 .
The burden time for this collection of informatio n is estimated to average 35 minutes per response, inc luding the time to
review instructions, search existing data sources, gather and mainta in t he 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 th is burden, to:
Department of Health and Human Services
Food and Drug Ad ministration
Office of Ope rations
Paperwork Reduction Act (PRA) Staff
For PRA questions:
PRAStaff@fd a.hhs.gov

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Overview

Section I ,_Applicant ldentificat·i·o,n

Section I - Applicant
Identification

You are in the Ap,plicant lldenti·fication section. This section requests inform1ation regarding the identity of the applicant, and

Part A: Applicant
Identification
Part B: Authorized
Representative or U.S.
Agent Information
Part C: Alternate Point of

include·s the foUowing parts:
Part A: Applicant !Information
Part B: Autlho rized IRep resentative ,or U.S. A.g ent I nformation
Part C: Alternate Point of Contact llnformatio•n ,(Optiona l)
Part D: Manufacturer !Information

Contact Information

Part E: Manufacturer/Packi ng/Sterilization Sites Information (Optionan
Pa rt D: Manufacturer
Information
Part E: Manufacturer/
Packaging/Ste rilizatio n
Sites Information

Section II - New Tobacco
Product Information
Section 111 - Submission
Information
Section IV -Apptication

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Section I - Applica nt Identification

Overview

Part A: Applicant Information

Section I - Applicant
Identification

Part A shou Id include information regarding the applicant for the subm ission. An applicant may be any person that submits a
PMTA who seeks a marketing authorization for a new tobacco product. Part A should be completed for either an organization

Part A: Applicant
Identification

applicant or an individual applicant, NOT both.

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

Is the applicant an Organization or an Individual? *

Part C: Alternate Point of
Contact Information

{i)

Organization

Q

Individual

Organization Information

Part D: Manufacturer
Information

Organization Name G *

Part E: Manufacturer/
Packaging/Sterilization
Sites Information

Test Org.
Other Organization Names (if applicable) G

Section II - New Tobacco
Product Information
Section 111 - Submission
Information
Section IV - Application

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Organization FDA-Assigned Facility Esta blishment Identifier {FEI) Number G

---V

Organization D&B DUNS®Number O
Expand All Sections

---

Country G *

I UNITED STATES
Street Address Line 1 G *
1234 Test St

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

City G *

Test
State G *
X

Virginia
Zip Code G *

I 00000-0000

Point of Contact for Organization
First Name G •
John
Middle In itial G

Last Name G *
Doe
Generational Suffix G

Professional Suffix G

Position Title G

Em ail Address O

Phone or Fax Number(s) O

+Add Phone/Fax

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Section I - Applicant Id en t ification

Overview
Section I - Applicant
Identification

Part B: Authorized Representative or U.S. Agent Information
Part B should include information for either an Authorized Rep resentative OR U.S. Agent (for a foreign Applicant). As the
Applicant provided in Part A is located with in the United States, please provide the information for an Authorized

Part A: App licant
ldentification

Representative below.

Contact Information for the Authorized Representative

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

a

Part C: Alternate Point of

First Name O *

Select if authorized representative is the same as the applicant identi fi ed in Part A.

Contact Information

John
Part D: Manufacturer
Information

Middle Initial @

Part E: Manufacturer/
Packaging/Ste rilizatio n
Sites Information

Last Name O *
Section II - New Tobacco
Product Information
Section Ill - Submission
Information

Doe
Generational Suffix 0

Section IV -Application

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Professional Su ffix 0

Position Title 0

Ema il Address @

Phone or Fax Number(s) G

Organization Name O *
Test 0rg.

a

Select if authorized representative address is the same as the applicant address identifi ed in Part A.

Country €) *

I UNITED STATES
Street Add ress Line 1 G *

I 1234 Test St
Street Add ress Line 2 (Apt., Suite, Bldg.,#) G

City O *
Test
State O *
Virginia
Zip Code G *
1

00000-0000

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Overview
Section I - Applicant
Identification
Part A: Applicant

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Section I - Applicant Identifi cation

Part C: Alternate Point of Contact Information
Part Cis an optional space for information for individuals not previously listed in Section I Parts A and/or B. Use the Add
Alternate Point of Contact button below to add additional alternate points of contact, as needed.

ldentification
Part B: Authorized

Alternate Point of Contact Information (Optional)

Representative or U.S.
Agent Information

Part C: Alternate Point of
Contact Information
Part D: Manufacturer

Select alternate:
I

Authorized Representative

First Name G *

Information

Jane
Part E: Manufacturer/
Packaging/Ste ril izatio n
Sites Information

Middle Initial G

Section II - New Tobacco
Product Information
Section Ill - Submission
Information
Section IV -Application

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Last Name G *
Doe
Generational Suffix G

Expand All Sections
Professional Suffix Q

Position Title G

Email Address Q

Phone or Fax Number(s) 0

+Add Phone/Fax

Organization Name Q *
I

Testing Org.

Country O *
I

UNITED STATES

Street Address Line 1 G *
I

0000 Test St

Street Address Line 2 (Apt., Su ite, Bldg.,#) G

City G *

Test

State G *
I

Virginia

Zip Code O *
11111-1111

+ Add Alternate POC

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Section I - Applicant Identification

Overview

Part D: Manufacturer Information

Section I - Applicant
Identification

Part Dshould include information regarding the Manufacturer for the submission.

Part A: Appl icant
Identification

Manufacturer Information

a

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

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

Organization Name 9 *

Part C: Alternate Point of
Contact Information

Test Org.
Organization FDA-Assigned Facility Establishment Identifier (FEl) Number 9

Part D: Manufacturer
Information

---Part E: Manufacturer/
Packaging/Ste rilizatio n
Sites Information

Organization D&B DUNS®Number 9

---

Section II - New Tobacco
Product Information

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Section Ill - Submission
Information
Section IV-Application

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

Country G *
V

I UNITED STATES

Street Address Line

1G *

1234 Test St

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

City 9 *
Test
State 9 *
Virginia
Zip Code G *
I 00000-0000

Point of Contact for Manufacturer
First Name 9 *
John
Middle In itial 9

Last Name G *
Doe
Generational Suffix G

Professional Suffix 9

Position Title G

Email Address G

Phone or Fax Number(s) G

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Section I - Applicant Identification

Part E: Manufacturer/Packaging/Sterilization Sites Information
Part Eis an optional space for information for additional manufacturing sites. Use the Add Manufacturing/Packaging/

Sterilization Site button below to add additional sites, as needed.

Manufacturer/Packaging/Sterilization Sites Information
Overview

Section I - Applicant
Identification
Part A: Applicant
Identification

Select type of site:

I Manufacturer
Organization Name O •

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

Tester Org.

I

Organization FDA-Assigned Facility Establishment Identifier (FEI ) Number O
Part C: Alternate Point of
Contact Information
Part D: Manufacturer
Information
Part E: Manufacturer/
Packaging/Sterilization
Sites Information

Organization D&B DUNS® Number O

----Division Name (if applicab le) 0

I

Section II - New Tobacco
Product Information
Section Ill - Submission

Is the manufacturing/packaging/sterilization site ready for inspecti on?

Information

(i} Yes

Section IV - Application

0

D Expand All Sections

0

No

Country O •

I UNITED STATES
Street Address Line 10 •
1010 Test Ln
Street Address Line 2 (Apt., Suite, Bldg.,#) 0

City O •
Test

State O •
X •

Virginia

Zip Code O *

I 00000-0000

Point of Contact Information for Manufacturer/Packaging/
Sterilization Sites
FirstName O *
Jacob
Midd le Initial 0

Last Name O •
Doe

I

Generational Suffix 0

Professiona l Suffix 0

Position Title 0

Email Address 0

Phone or Fax Number(s) 0

+Add Phone/Fax

+Add Site
'--

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Overview

Se,ction II - New To·bacco,Product Information

Section I - Applicant
ldentificatio n

You are in the New Tolbac,co,Product Information section. This section requests information for the new tobacco product(s),

Section II - New Tobacco
Product Information

Spreadsheet, which il s availlable on tfne FDA website. Form FIDA 4057b aUows applicants to submit one PMTA for multiple

whicfn must be provided using Form FDA4057b Premarket Tobacco ProductAppllication Grouping Product Submission
products-such as e-liquids in varying sizes, nicotine strengths, or flavor combinations-as a grouped submission. Each
product in a grouped submission is cons·dered a separate, individual application and must include its own ilndividual

Section 111 - Submission
Information

environmental assessment. AppUcants should k,eep in mind that tfne content specific to each product in a grouped submission

Section IV - Appl·cation
Contents

The Prodluct Form Validator Tool, which is availabl,e on the FDA webs·te, can help validate the dat.a in Form FD.A 4057b and

needs to be clearly specified.

confirm,the form has been co1
mpleted consistent with FIDA requiremients before submitting to FDA. Apprcants are not required
Section V - Statements of
Compliance

to use the tool, but using the tool can help reduce the time applicants spend reviewing, correcting, and resubmitting the form.

Section VI - Certification
Statements

not guarantee tfnat an application contains alll element.s required for acceptance.

Submission Files

While the tool ·s designed to hellp appUcants navigate the PMTA submission process, successful val.idation us·ng the tool does

Ple·ase upload :Form 4057b spreadsheets along with any completion certificates from the Product Form Validator Tool in the
Submission Files section.

Review and Submit

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Overview

Section Ill - Submission lnformati,on

Section I - Applicant
Identification

You are in the Submissiion lnfo,r1
matio,n section. 'This section requests infonmation r,egardling the submission, and includes the

Section II - New Tobacco
Product Information

Section 111- Submission
Information
Part A: General Submission

Information

following parts:
Part A: General Subm1ission llnf;ormaition
Part B: Cross-Referenced Information (Optional)
Part C: Referenced Tobacco Product Master File{s) (TPIMF) (Optional)
Part D: Form1al Meetings Held with FDA Pertaining to the New Product(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 Pertaining to

the New Product(s)
(Optional)

Section IV -Application
Co11te11ts

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Overview

Section I - Applicant
Identification
Section II - New Tobacco

Product Information
Section 111- Submission
Information
Part A: Genera I

Submission Information
Part B: Cross-Referenced
Information (Optional)

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Section Ill - Submissrn on !Information

Part A: General Submission lnformiati,on
Sub,miss.ion Type
Identify submission type,{select one} *

(I')

Standard PMITA

Q

Resubmission

Q Supple1mental

Previously Commercially Marketed IProdu,ct

For products that were previously commercially marketed in the·United States, pr,ovide the·piroduct names and ,corresponding
marketing date(s):

N/A

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

2497 characters remaining.

Section IV -Application
Co11te11ts

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Section Ill - Submission llnform1ation

Part B: Cross,-Refe,r,enced lnforma'tion (Optional)
Complete Part B if the application includes one or more cross-referenoe(s) to another PMTA.or MRTl'A 21 CIFR § 1114.7(b), §
1114..lS(b), or§ 1114.17(b). Supplemental PMTAs and resubmissions may cross-reference content in standard IPMTAs. Standard
Overview
Section I - Applicant
ldentifcation

PMTAs shou ld not cross-reference another Standard PMTA or other pending applicati,ons with the exception of a pending
MIRTIPA for the same tobacco product. To provid,e a cross-reference; use the Add Cross-Referenced Information button below to
ad,d a r,o,w to the t-ablle to capture the cross-reference information. Within the table; utilize a single irow ifor each cross-reiference,
and use the Add Cross-Referenced Information button b,elow to add additional rows to the tabh~ to provide additional cross­

Section II - New Tobacco
Product Information

Section Ill - Submission
Information
Part A: General Submission
Information

Part B: Cross- Referenced
Information (Optional)

references, as ne,eded.

0

I have filed an MRTIPA, but I dlo not yet have the STN.

Cross-Reference STN O *

I PMOOOOOOO

Is the content releva nt to alll products within this sub1mission?
Part C: Referenced Tobacco
Product Master File(s)
(TPMF) (Optiona l)

(I)

G

Yes

QNo

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

Information an,d sections to be referen,ced (e.g..au sections) sections 1-1 11) 0
N/A

Section IV -Application
Contents

0

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+ Add Cross Referenced Information

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Overview

Section Ill - Submission Information

Sect ion I -Applicant
Identification

Part C: Referenced Tobacc,o P1
rodluc't Master File(s) (TPM IF')
(Optiona1l)

NEXT

Section II - New Tobacco
Product Information

Complete Part C if the appl.ication includes a l obacco Product Master Fi le (TPMIF) 21 ,CFR § l ll 14.7 (lb)(2). To provide a

a row to the table to capture the referenced TPMF

Section Ill - Submission

referenc.ed TIPIMF, use the Add Referenced TPMF button below to add

Information

information. Wit hin the tablle, utilize a singlle row for each l PMF, and use th e Add Referenced TPMF button below to add

Pa rt A: Genera I Subm ission
Information
Pa rt B: Cross-Referenced
Information !Optional}

additional.rows to the tabl.e to provide additional reference TPM Fs, as needed.

l PM IF Owneir

I John Doe
Part C: Referenced
Tobacco Product Master
File,(s) (TPMF) {Optional)

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

Section IV-Application
Contents

l PM IF STN (assigned by FDA)

I PMOOOOOOO
Is the conte,nt applicabl.e to all pr,oducts with in the sulbmission?

(i) Yes

0

No

lniormation and sections to be referenced

0

Expand AU Sections

N/A.

/4
Right of reference included?

(i) Yes

Q

No

+Add Referenced TPMF

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Overview

Section 1111- Submissm
on llniformat ion

Section I -Applicant
Identification

Part D: Form,al Me,etings,Held wi'th FDA Pertainin1g to the New
Product(s) (01
ptio,nal)
1

Section II - New Tobacco
Product Information

Section 111 - Submission
Information
Pa rt A: General Submission
Information
Pa rt B: Cross-Referenced
Information (Optiona l)
Part C: Referenced Tobacco
Product Master File(s)
(TPMF) (Optiona l)

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

Section IV -Appiication
Contents

0

Complet,e Part D if FDA and the applicant held one or mor,e meetings related to the new product(s). This can include m,eetings
for study design, earlier versions of the product, etc. To provide ai Fonmal Meeting, us,e tlhe Add Formal Meeting button below to
add a r,ow to the t-able to capture the meeti ng information. Within the table., utillize a si ngle r,o w f,o r ,each m1eeting, and use the
Add Formal Meeting button below to add addit ional rows to the table to list additional mieetm
ngs, as needled.

Submission STN 0

I PMOOOOOOO
Mle,eti ng Held IDate G
110-01-2024

m

Is the meeting rel.eva nt to alll products within this submission?

(I)

Yes

Q

No

8

Expand AU Sections

+ Add Formal Meeting

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I 'L. I I I 1i..'l.d '-I""' I I

Section II - New Tobacco
Product Information
Section 111 - Submission
Information

Section IV - Application
Contents
Part A: Administrative

Section IV - Application Contents
You are in the Ap,plication ,contents section, which is intend,edl to help applicants organize their submission per 21 CFR §
1114..7, and includes the following parts:
ministrativ,e Co,ntent
Part A: Ad 1
Part B: Labelling and Marketing Plans
Part C: Inspections

Content

Part D: Scientific Content
Part B: Labeling and
Marketing Plans

Each part of the Applicati,o,n Contents section contains a checklist of 1re~evant d,o,cuments that are·required or recomm1end,ed
for incl.usion with your subm1ission. For each item included in your subm1ission, se,lect the corresponding checkbox in the·list

Part C: Inspections
Pa rt D: Scientific Content

and provide the location of the docum1ent. For examp~e, the file name, document nam1,e, and page number..Select all that
apply. All documents should be uploaded in the Sub1mission Files section.

Section V - Statements of
Compliance
Section VI - Certification
Statements
Submission Files
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1 '"'-''\,;;,l l'LI 11,_Y._IWI I

Section IV - Applm
cation Contents

Section II - New Tobacco
Product In formation

Part A: Adminis,t r,ativ,e C,ontenit

Section 111 - Submission
Information

Document Checklist for Administra't ive Content

Section IV - Ap;pHcation
Contents
Part A: Administrative
Content
Part B: Labeling and
Marketing Plans

This app~ication contains the folllowing Adm inistrative Cont,ent items (select aH that apply and indicate fHe name and lo,cation
of application c.,o nt,ent). AH docu1ments should be uploaded in the Subm·ssion Files section.

■ Cover Lette1rG
Location (Com11ments)

//

Part C: Inspections

■ Comprehensive lnd,ex 1 and 'Table of Contents 1 0

Part D: Scientific Content

Location (Com11m,ents)

Section V - Statements of
Compliance

II

Section VI - Certification
Statements

■ English 1 Translatio1ns fo1r N,on1-English lnforrmation 0

Submission Files

Location (Com11ments)

Review and Submit

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//

□ Reque·st for IFDA to refer PMTA t,o TPSAC 1 G
Location (Com11m,ents)

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I 'L. I I I 1i..'l.d '-I""' I I

Section IV-Appllication Contents

Section II - New Tobacco
Product Information

Part B: L.abeling and Marketing Plans

Section 111 - Submission

Docume1
nt Checklist for ILalbelling and Marketi1
ng Plans

Information

Section IV - Application
Contents
Part A: Administrative
Content

'This application contains the folllowin,g Labeling and Marketing Plan ite1ms (select alll that apply and indicate file name·and
location of application content). AU documents should be uploaded in the Submission Files section..

D

Specimens of all Proposed Labeling 1 0

Location (Com ments),

Part B: Labeling and
Marketing Plans
Part C: Inspections

D

Pa rt D: Scientific Content

Location (Comments),

Des,cription of Marketing Plans 1 G

Section V - Statements of
Compliance
Section VI - Certification
Statements
Submission Files
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I 'L. I I I 1i..'l.d '-I""' I I

Section IV-Appllication Contents

Section II - New Tobacco
Product Information

Part C: lnsp,ections

Section 111 - Submission

Docume1
n't Checklist for Inspections

Information

Section IV - Application
Contents
Part A: Administrative
Content

'This application conta ins the folllowin,g Inspection ite·ms (select all that apply and indicate fH,e name and location of application
content). All documents should be uploaded in the Sub1m ission Files section..

D

Location and Contact Information tor Each L,ocation Subje,ct to Po,te,ntial lnspe,ction G

Location (Comments),

Part B: Labeling and
Marketing Plans

Part C: Inspections
Pa rt D: Scientific Content

Section V - Statements of
Compliance
Section VI - Certification
Statements
Submission Files
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111o..41,._,l l\.lll,.__U1..l.._,II

Section IV - Application Contents

Section II - New Tobacco
Product Information

Part D: Scientific Content

Section Ill - Submission

Document Checklist for Scientific Content

Information

This application contains the following Scientific Content items (select all that apply and indicate file name and location of

Section IV - Application

application content). All documents should be uploaded in the Submission Files section.

Contents

0

Part A: Administrative
Content

General lnformation 1 Q

Location (Comments)

Part B: Labeling and
Marketing Plans
Part C: Inspections

0

Part D: Scientific Content

Location (Comments)

Descriptive lnformation 1 Q

Section V - Statements of
Compliance
Section VI - Certification
Statements

0

Submission Files

Location (Comments}

Review and Submit

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Product Samples 2 Q

V

0

Statement of Compliance with 21 CFR part 25 1 @

Location (Comments)

0

Summary 1 Q

Location (Comments)

0

Product Formulation 1 @

Location (Comments)

0

Manufacturing 1 Q

Location (Comments)

0

Literature Search 1 Q

Location (Comments)

0

Organized References Q

Location (Comments)

0

Health Risk Investigations 1 Q

Location (Comments)

0

Study Reports 1 Q

Location (Comments)

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Section I -Applicant
Identification

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Se,ction V - Statements ,of Co1
mpliance with the Fe·deral Food,
Drug a 1n 1d Cos.metic (If D,&·C) Act
You are in the Statem1ents of CompUance section. This section requests descriptions of how the PMTA satisfies content

Section II - New Tobacco
Product Information
Section 111- Submission
Information

requirem,ents of section 910(b)(l) of the IFD&C .Act and how marketing the new tobacco product would be appropriate for the
protection of public. health. It includes the following pages:
i. §910(b)( l ) Requirements
ii.. Protection of Public Health

Section IV-Application
Contents
Section V - Statements of
Compliance
§910 Requi rements
Protection of Public Hea lth

Section VI - Certification
Statements

§·9 10(b)(l) Requi1
reme,nts
Provid,e infonmation for how the application m1,eets the requirements and addresses tthe question{s) in ,each of the statements
according to the requirements section 910(1b}(l) of the FD&C Act as re,quired by 21 CFIR § 1114.7(c)(10) and (11). Your
descriptions should add ress::
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Overview
Section I - Applicant
Identification
Section II - New Tobacco
Product Information

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Section V- Stateme~ts of Compliance with the Federal IFood, Drug and C,osmetmc i(FD&C) A,c t

i. §910 (b)(l) Re·quirements
1

Provide a bri,ef description of how tlhe PMTA satisfi,es content require1ments of section 910(b)(l} of th,e FD&C Act in the space
below: *
N/A

Section 111 - Submission
Information
Section IV- .Application
Contents

/4
1497 characters remaining.

Section V - Statements of
Compliance
§910 Requirements
Protection o·f Pulblic Health

Section VI - Certification
Statements
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Section I - Applicant
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Section V- Stateme~ts of Compliance with the Federal IFood, Drug and C,osmetm
c i(FD&C) A,ct

ii. Protection of Public Hlealth
Provide a brief description of how marketing the new tobacco product would be appropriate for the protection of public health

Section II - New Tobacco

as determined with respect to the population as a whole·including users and non-users of the tobacco product, and taking into

Product Information

account:*

Section 111 - Submission
Information
Section IV- .A pplication
Contents

• The increased or decreased lilkeli hood that existi ng users of tobacco products will stop using such products; and
• The increased or decreased lilkedi hood that those who do not use tobacco products wHl start using such products.

N/A

Section V - Statements of
Compliance
§910 Requirements

Protection of Public Health

1497 characters remaining.

Section VI - Certification
Statements
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Overview

Section VI - Certificati,on S,tate,me,nts

Section I - Applicant
Identification

You are in the Certification Statements section. Applications must contain the following c,ertifications, as appropriate·for the

Section II - New Tobacco
Product In formation

repr,esentativ,e of the applicant. You wiUbe pr,esented with the .appropriate certifi,cation statement(s) to complete based on

specific type of PMTA., witti ttie appropriate·infonmat.ion inserted; as descrilbedl in each parenthetical, signed by an authorized
the specific type ,o.f PMTA identified in Section 1111 Part A;.as follows::

i. Certification Statement for Standard PMTAs

Section 111 - Submission
Information

ii. Modified Tobac:co Product Certification for Supplemental PMTAs
iii. Same Pr,oduct C,ertirucation for Resubmissions

Section IV -Apptication
Contents

iv. Different Product Certiflication for IR,esubmissions
v. Financial Interest and Arrange1m,ents of Clinical Investigators Certification Statement (for all subm1ission types)

Section V - Statements of
Compliance

For each appllicable certification statem1ent, provide aU of the rrequest,edl information on the page, which will then gen,erate a
co1
mpleted certification statement that must be signed by the authorized representative.

Sect:ion VI - Certification
Statements
i. Certification Statement
for Standard PMTAs
ii. Modified Tobacco
Product Certificat ion for
Supplemental PMTAs
iii. Same Tobacco Product
Certification for

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Section VI - Certification Statements

i. Certification Statement for Standard PMTAs
Certification statement for standard IPMITAs is appropriate when submitting a standard PMTA.
Insert the name of the authorized representative as identified in Section I Part B or Part C, the name of the organization being
Overview
Section I -Applicant
ldentificatio n
Section II - New Tobacco
Product Information

represented as identified in Section I Part A.
Standard PIMTA Certifications

Standard Pmta Certification

Na1
me of Responsible Officia l *

Section 111 - Submission
Information

I Jane Doe

Section IV-Application
Contents

Applicant Name

Section V - Statements of
Compliance
Section VI - Certification
Statements

X ,..

I Test Org.
11

Jane Doe, on beha lf of the applicant, Test 01
rg., hereby certify that the applicant will maintairn all

records to substantiate the accuracy of this application for the period of time requ ired in 21 CFR 1114.45
and ensure that records remain readily availab le to IFDA upon request. I certify that this informiation and

i. Certification Statement
for Standard PMTAs

0

the accompanyingsub1mission are true and correct, that no material fact has been omitted, arndl that I
am authorized to subm it t his on the applicant's beha lf. I understand that under section 1001 of title 18 of

ii. Modified Tobacco

the United States Codie anyone who knowingly and willfully makes a materially false, fi ctitious, or

Prod1Jct Certification for

matter with in the ju risdiction of the executive, legislative,
fraudulent statement or representation in any 1

Supplemental PMTAs

or judicial branch of the Government of the United States is subject to crrim inal penalties.

iii. Same Tobacco ProdL11ct
Certification for

Digital Signatu re *

~

*

Expand All Sections

Sign above

Loggedlin User Account:
Simm1ons-;[email protected]

Digitally
Sig1
ned For:
Jane Doe

Dig:itally Signed
On:
October 4th

2024, 1:45:10
pm

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Section VI - Certification Statements

ii. Modified Tobacco Product Certification for Supplemental
PMTAs
The Modified Tobacco Product Certification for Supplemental PMTAs is appropriate when submitting a supplemental PMTA.
To include this certification statement in your subm ission, provide the requested information below, which will generate a
certification statement that must then be signed by the authorized representative.
The applicant identified in Section I Part A has already been populated below. For Name of Responsible Person, select the
authorized representative below as identified in Section I Part B or Part C who is signing the certification. Provide the individual
new product(s) names(s}, a description of each modification, and the name and STN of the previously submitted PMTA where
appropriate.
If submitting multiple products, it is recommended a separate certification is submitted for each product. Use the Add Modified
Tobacco Product Certification for Supplemental PMTAs button below to add additional certification statements, as needed.

Modified Tobacco Product Certification for Supplemental PMTAs

Overview
Section I - Applicant

Name of Responsible Official G *

Identification

X

I John Doe

Section II - New Tobacco
Product Information

..,.

Applicant Name G

Section 111 - Submission
Test Org.

Information
Section IV -Application

New Tobacco Product Name *

Contents
Product A
Section V - Statements of
Compliance

141 characters remaining.

Section VI - Certification
Statements

STN of Previously submitted PMTA(s) *

PMOOOOOO
i. Certification Statement
for Standard PMTAs

142 characters remaining.
Product Modifications *

ii. Modified Tobacco
Product Certification for
Supplemental PMTAs
iii. Same Tobacco Product
Certification for

0

Expand All Sections

N/A
497 characters remaining.
V

Original Tobacco Product *
Product B

141 characters remaining.
I, John Doe, on behalf of the applicant Test Org., certify that Product A has a different N/A than Product B
described in PMOOOOOO but is otherwise identical to Product BI certify that Test Org. understands this means there
is no other modification to the materials, ingredients, design, composition, heating source, or any other feature of
the original tobacco product. I also certify that Test Org. will maintain all records that substantiate the accuracy of
this application, and ensure that such records remain readily available to FDA upon request for the period of time
required in 21 CFR 1114.45. I certify that this information and the accompanying submission are true and correct,
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 j udicial branch of
the Government of the United States is subject to criminal penalties.
Digital Signature *

.....
...,

*

Sign above

Logged in User Account:
[email protected]

Digitally Signed
For:
John Doe

Digitally Signed On:
October 7th 2024,
4:29:34 pm

+ Add Modified Tobacco Product Certification for Supplemental PMTAs

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Section VI - Certification Statements

iii. Same Tobacco Product Certification for Resubmission
The Same Tobacco Product Certification for Resubmissions is appropriate when subm itting a resubmission PMTA where the
product is unchanged, and the applicant is addressing deficiencies outlined in the marketing denial order (MD0). To include
th is certification statement in you r subm ission, click the Add Same Tobacco Product Certification for Resubmissions button and
provide the requested information below, which will generate a certification statement that must then be signed by the

Overview

authorized representative.
Section I - Applicant
ldentificatio n

The applicant identified in Section I Part A has already been populated below. For Name of Responsible Person, select the
authorized representative below as identified in Section I Part B or Part Cwho is sign ing the certification. Provide the individual

Section II - New Tobacco
Product Information

new product(s) names(s), and the STN of the previously submitted PMTAwhereappropriate in the statement. Use the Add
Same Tobacco Product Certification for Resubmissions button be low to add add itional certification statements, as needed.

Section Ill - Submission
Information
Section IV -Application
Contents

Same Tobacco Product Certification for Resubmission

Name of Responsible Official G *

Section V - Statements of
Compliance

X •

I John Doe

Section VI - Certification
Statements

Applicant Name 0

L Certification Statement
for Standard PMTAs

I Test 0rg.

New Tobacco Product Name G *

ii. Modified Tobacco
Product Certification for
Supplemental PM TAs

ProductC
141 characters remaining.

iii. Same Tobacco Product
Certification for

0

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v

STN of Previously Submitted PMTA(s) €) *
PMOOOOOOO

141 characters remaining.
I, John Doe, on behalf of the applicant, Test Org., certify that this submission for Product C responds to
all deficiencies outlined in the marketing denial order issued in response to PMOOOOOOO and the new
tobacco product described herein is identical to the product descri bed in the previously submitted
PMTA. I certify that Test Org. understands th is means there is no modification to the materials,
ingred ients, design, composition, heating source, or any other feature. I also certify that Test Org. will
maintain all records that substantiate the accu racy of this statement, and ensure that such records
rema in readi ly available to FDA upon request for the period of time requ ired in 21 CFR 1114.45.1 certify
that this information and the accompanying subm ission are true and correct, and that I am authorized
to submit this on the company'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, fictit ious, or fraudulent
statement or representation in any matter within the jurisdiction of the executive, legislative, or judicia l
branch of the Government of the United States is subj ect to criminal penalties.
Digital Signature *

,..,.
....,

Sign above

Logged in User Account:
[email protected]

Digitally

Digitally Signed

Signed For:

On:

John Doe

October 7th
2024, 4:32:02 pm

+Add Same Tobacco Product Certification for Resubmissions

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Section VI - Certification Statements

iv. Different Tobacco Product Certification for Resubmission
The Different Tobacco Product Certification for Resubmissions is appropriate when submitting a resubmission PMTA where
the product is a modification of the previously submitted PMTA that results from changes necessary to add ress the deficiencies
outlined in the marketing denial order (MDO). To include th is certification statement in your submission, click the Add Different
Tobacco Product Certification for Resubmissions button and provide the requested information below, which will generate a

certification statement that must then be signed by the authorized representative.
The applicant identified in Section I Part A has already been populated below. For Name of Responsible Person, select the
authorized representative below as identified in Section I Part B or Part Cwho is signing the certification. Provide the individual
new product(s) names(s}, the name and the STN of the previously submitted PMTA, and a description of each modification
where appropriate.
If submitting multiple products, it is recommended a separate certification is submitted for each product. Use the Add Different
Tobacco Product Certification for Resubmissions button below to add additional certification statements, as needed.

Different Tobacco Product Certification for Resubmission

Name of Responsible Officia l G *
X

I John Doe

.,..

Applicant Name G
Test Org.
New Tobacco Product Name G *

I Product D
141 characters remaining.
STN of Previously Submitted PMTA(s) Q *

I PMOOOOOOO
141 characters remaining.
Product Modifications G *

I Product Update
486 characters remaining.
Original Tobacco Product O *
Product S
141 characters remaining.
I, John Doe on behalf of Test Org. certify that this submission for Product D responds to all deficiencies
outlined in the marketing denial order issued in response to PMOOOOOOO and the new tobacco product
described herein has a different Product Update than Product S described in PMOOOOOOO but is
otherwise identical to Product S described in PMOOOOOOO. I certify that Test Org. understands this
means there is no modification to the materials, ingredients, design, composition, heating source, or any
Overview

other feature of the original tobacco product, except for the Product Update. I also certify that Test Org.
will maintain all records that substantiate the accuracy of this statement and ensure that such records

Section I - Applicant
Identification

rema in readily available to FDA upon request for the pe riod of time required in 21 CFR 1114.45. I certify
that this information and the accompanying submission are true and correct, and that I am authorized

Section II - New Tobacco
Product Information

to submit this on the company's behalf. I understand that under section 1001 of title 18 of the United

Section Ill - Submission
Information

statement or representation in any matter within the jurisdiction of the executive, legislative, or judicial

Section IV -Application
Contents

Digital Signature *
.....
....,.

States Code, anyone who knowingly and willfully makes a materially false, fictitious, or fraudulent
branch of the Government of the United States is subject to criminal penalties.

*

Section V - Statements of
Compliance
Section VI • Certification
Statements

Sign above

i. Certification Statement
for Standard PMTAs
ii. Modified Tobacco
Product Certification for
Supplemental PMTAs
iii. Same Tobacco Product
Certification for

0

Logged in User Account:
Simmons_Kelvi [email protected]

Digitally

Digitally Signed

Signed For:

On:

John Doe

October 7th
2024, 4:34:02 pm

V

Expand All Sections

+ Add Different Tobacco Product Certification for Resubmission

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Overview

Section VI - Certification Statements

Section I - Applicant
ldentificatio n

v. F'inanciall Interest a1nd Ar1
rangements of Clinical Investigators
Certification

Section II - New Tobacco
Product Information

Financial Interest and Arrangements of Clinical Investigators Certification Statement is appropriate when submitting any type

Section 111 - Submission
Information

of PMTA and must be included if your application includes any type of study in support of this application. Th is certification
covers all actions taken to ensure the reliability of the study.
Insert the name of the authorized representative as identified in Section I Part B or Parrt C, and the name of the organizatiorn

Section IV -Application
Contents

being represented as identified in Section I Part A.
Financial Interest and Arrangements of Clinical Investigators Certification Statement is appropriate when submitting any type

Section V- Statements of
Compliance

Sect,ion VI - Certification
Statements
i. Certification Statement
for Standard PMTAs
ii. Modified Tobacco
Product Certification for
Supplemental PMTAs

of PMTA and must be included if your application includes any type of study in support of this application. This certification
covers all actions taken to ensure the reliability of the study. Insert the name of the authorized representative as identified in
Section I Part B or Part C, and the name of the organization being represented as identified in Section I Part A.

Financial Certification
Name of Responsible Official *
I

iii. Same Tobacco Product
Certification for

0

Expand All Sections

X ,.

Jane Doe

Name of Company
I

Test Org.

I, Jane Doe, on behalf of Test Org., certify that there are no financial conflicts of interest or have
included documentation fully disclosing any potential financial conflicts of interest required by 21 CFR §
1114.7(k){3) (ii).
ConfUcts of interest: *

(I}

Q

No, there are no financial conflicts of interest
Yes, there are financial conflicts of interest and documentation is provided (please specify in the
table of contents where the documentation is located)

Digital Signature *

..,.

*

Sign above

Logged in User Account:
[email protected]

Digitally

Digitally Signed

Signed For:

On:

Jane Doe

October 4th 2024,,
1:46:10 pm

+Add Financial Interest and Arrangements of Clinical Investigators Certification Statement

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Overv·ew
Section I - Applicant
ldentifcation
Section II - New Tobacco
Product Information

Selle·ct fil,e(s), to uplload
Allowed file·types:
.TXT,.. BM P~ . ,c ss,.c Ml,.csv,. DTD,.XLS, .XLSX,.XM L,.XS L,.G IF,. HTM,. HITM IL,.J PG, .J PEG,.. KMIL,. MOl,. MPG,. MIP EG,. MP3,. MP4,. P[)IF,. PN G,

. MOV,.XIPT,.XIPOIRT,.SVG ,.SDF,.WIMV,.WAV,.XSD

S,iz.e

File Name

Section Ill - Subm·ssion
lnformat·on

C

Section IV-Application

Drop files to attach, or browse

Contents
Section V - Statements of
Compliance
Section VI - Certification
Statements

I

Submission Files

Rows:

25

,.
I

V

Search table content

Review and Submit

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D

A.c tions

FUe Nlame

Descriptive 'Title

Statu:s

Fill e Size

Expand All Sections

Im

n

0
C

3

:::::i

Ul

>
I<

0 to O ofO

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Overview

Review and Submit

Section I - Applicant
ldentificatio n

You have reached the end of this subm1ission. You 1may now submit your sub1mission to CTP in order to fu lfill your requirem1ents.

Section II - New Tobacco
Product Information

acknowledgment -of receipt.

Section 111 - Submission
Information

the submission will not be subm1itted and you wHl be prompted to provide the missing data. Please ensure that all required

Submission via the CTP Portal Next,G,en provides secure transmission and enables the FDA to provide you with an automated

If you would l ike to submit this submission at this time, please click the Subm1it button below. If any required data is m1issing,
questions are completed and all applicable documents have been attached within the submission.

Section IV - Appl·cation
Contents

You may also save and exit this submission to return to it at a later time if you do not wish to submit it now. To do so, sil mply

Section V - Statements of
Compliance

landing page, click the actions button next to this submission package iri tlhe table and sele·ct Edit.

Section VI - Certification
Statements
Submission Files

I

SUBM~T

click Save .and Exit below. To re-open th·s submission aft.er exiting, navigate to the Subm·ssions > Draft Submission P.acikages

If you would like to prepare another sub1mission to flulfiU other FDA requirements, please select the Create Nlew Submission
mpiling a new submission and be sure to select the appropriate submission type..
button at the top of the page to begin co1

Submit Form

Review and Submit

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Submissions

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Conta,cts

Adlministration1v

Files

,create new submissio,n

Your submission package has been delivered to the Center for Tobacco Products (CTP) for additional processing. Pllease refer to the Sent Submission Packages page
at any time to view the status of your submission package.
A PDF report has been generated for your records detailing the contents of your submissi'on package. This report is available for downlload by clicking on the
Download Submission Package Report button below, and mIay also be accessed at any time from the Sent Sub1mission Packages page.
Once CTP completes processing of your submission package, CTP will assign a Submission Tracking Number (STN) for each submission created from the package
and wi'II notify your 01rgan1
ization that the submission(s) has been publlished and is available to view in the CTP Portal NextGen from the Published Submissi'ons page.
Please note this does not constitute review of the submission.
At th is time, if you woulld like to prepare another submission package to fulfill other FDA requirements, please select the Create New Submission button to begin
compiling a new submission package and be sure to select the appropriate submission type.
If you have any CTP Portal NextGen related technical questions or need assistance, please contact us at [email protected] or (877) 287-1373. To assist us in
helping you, please indlude your organization, upload date, and the submission package ID for your submission in all correspondence.