FDA Web Form 4057a Premarket Tobacco Product Application (PMTA) Amendment a

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PMTA Amendment I Premarket To·bacc,o Product Appl icatio1
n Amendment
Nam1e andl D,e scriptiio1
n
Submission Name D

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Submission Description f) *

Additional Comments 8

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DEPARTMENT OF HEALTH AND HU MAN SERVICES

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Form Approved: 0MB No. 0910-0879

Food and Drug Ad m inistration
Section I - Applicant Identification

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Expiration Date: XX/ XX/ 20XX

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Section II - Amendment Information "'

Premarket Tobacco Product Application (PMTA) Amendment
Submission

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

Premarket Tobacco Product Application (PMTA) Amendments
on June 22, 2009, the President signed the Family s moking Preventio n 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).
When submitting a PM TA, applicants are expected to submit al l required inform ation, as outlin ed in section 910(b )(l) of the FD&C Act and 21 CFR Part 1114, to
allow FDA to determin e whether it should authorize the ma rketing of a new tobacco product. However, add it ional in formation may be needed fo r FDA to
comp lete its review of a PMTA, so applicants are allowed to submit amendments to a pend ing application .
FDA may, at any ti me after it receives and before it acts on an application, request an app lica nt submit add itional in formation so t he agency can co mp lete its
review of a PMTA. Si milarly, an ap plicant may choose to submit an amendment with additional info rm ation on their own. Amendments may include
inform ation like a new study that is relevant to the PMTA, clarifications, or changes/u pdates to in formation sub mi tted in t he original PMTA.
Comp lete the follow ing question and answer form fo r t he Premarket Tobacco Prod uct App lication and when all required data has been entered click Sub mit to
deli ver the submission to the FDA's Center for Tobacco Products.
For your reference, see the How Do I PreP-a re an Amendment guidance fo r add itio nal info rm ation.

Instructions for Completion of the PMTA Amendment Form
Form FDA 4057a - Premarket Tobacco Product Application (PMTA) Amend ment Submission is a required form fo r applicants to use when subm itting a PMTA
Amendment to FDA. This fo rm and the inst ructions arl" soll"ly intended to provide the appl icant an organized fo rmat to supply informatio n required fo r
sub mission of a PMTA Amendment.
This fo rm is organ ized into the fo llow ing sections:
• App licant Identification
• Amendml" nt Inform ation
• Subm ission Fi les
• Rl"view and Submit
Each section contains one or more pages that provi di" dl"tai ls on thl" specific inform ation being requested alo ng with fie lds and/ or tools to assist you in
providing the requested information. To help stream li ne the data entry process, information you provide is automatically saved w hen entered, and certain
pages and fields may be dynamically enabled or disabll"d depending on t hl" info rmation you have provided ea rlier in thl" form. There arl" also several helpfu l
idl"ntifiers that may be associated with a fie ld to help provi de further gu idancl", includ ing:
• Tooltips: Indicated by a question ma rk icon , and provides additiona I instructions, dl"finitions from thl" gu ida nee docu ml"nt, and other helpfu I hints
• Required Indicators: Indicated by a rl"d asteri sk (*) identify ing that thl" specific fie ld is rl"qui rl"d before the form can be submitted
• Validation Errors: Ind icated by descri ptive red text located below t he fi eld identifyi ng t hat the data entered in the fie ld has one or more issues

Both Standard and Adva ncl"d navigation options are provided to assist in navigating and completing the form , dependi ng on your nel"ds and comfort ll"vel:
• Standard: Prl"vious and Next buttons are providl"d at the bottom of l"ach page to guide you sl"qul"ntially through t he relevant Sl"ctions and pages of this

form . Requ ired i nformatio n on l"ac h page must be comp leted befo re you can navigate to the subsequent pa gl", maki ng this option well su itl"d for newer
users, those unfa m i liar wit h the form, and/ or those looki ng to be guided through thl" form comp letion process.
• Advanced:A cl ickab le hierarchical outl ine of the Sl"ctio ns and pages in t his form is provided on the left side of thl" screl"n, allowing you to navigatl" to any

spl"cific section or pagl" in t he fo rm at any ti me, rl"gard less of w hether all of the requ irl"d inform ation has been com pleted on the current page. This option
is well suited for mo re advanced users, those fam il iar w it h the form, and/or those looki ng to quickly jump to a specific sectio n to providl" req uested
informat ion. Pll"a se note, when using the Advancl"d nav igation option, t herl" may bl" pagl"s and fie lds that arl" disab led as they rely on i nformat ion that
you have not yet prov ided in a previous portio n of the fo rm.
The Sub mi ssion Fil es section allows you to up load and managl" all of thl" files being subm itted with the form. As t here are many questions th roughout thl" form
t hat require or al low requested info rmation to be provided in a file, t he fo llowing tips for using t he Submission Files sectio n are recomme nded (b ut not
rl"qu ired) to help expeditl" thl" data entry process :
• Upload submission files first before filling out the rest of the form: You can quickly select from your previously up loadl"d submiss ion fi les to provide

t he rl"qul"sted info rmation for each of these questions. If you haven 't up loaded sub mission fi les prev io us ly, you wil l need to up load a new file each time
you come across one of these questions.
The form does not need to be completed in one sess ion, and a dra ft of your fo rm is saved so that you may return to it at any t ime to comp lete it.
The Rl"view and Submit section w iII show how much rl"q uirl"d information is ll"ft to be prov ided, as wel l as identify any information that is recom ml"ndl"d to be
incl uded/ identi fied. Whl"n all of the required information has been provided, you can submit t he submission packagl" to thl" 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 prod ucts in test markets) that

was not co mmercially marketed in the Un ited States asof Fl"b rua ry 15, 2007; or (B) any modificatio n (including a change in des ign, any component, any part, or
any constitul" nt, includ in g a smoke const ituent, or in thl" co ntent, de li very or form of nicotine, or any other add itive or ingred ient) of a tobacco product w here
the modified product was comme rcially markl"ted in the United States aftl"r Febru ary 15, 2007."
Section 910(a)(2) of the FD&C Act - Requ ires prema rket review for new tobacco products. There are three pathways to seek premarket authorizat ion, one of

which is submitting a Premarket Tobacco Product App lication (PMTA) .

Paperwork Reduction Act
Accardi ng 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
inform ation unless it disp lays a valid 0 MB Control Nu mber. The va lid 0MB Control Nu mber fo r this i nform ation collection is 0910 -0879 and t he expi ration date
is XX/ XX/ 20XX.
The burden time fo r th is collection of information is estimated to average 10 min utes pl"r respo nse, including t he ti me to review i nstructio ns, search existing
data sourcl"s,gather and ma intain the data needed and comp lete and review the collection of in fo rmation. Send com ments regardi ng this bu rden esti mate or
any other aspect of this i nformation colll"ction, including suggestions for rl"ducing this burden, to:
Department ofHl"alth and Human Servicl"s
Food and Drug Ad ministration
Officl" of operations
Paperwork Red uction Act [PRA) Staff
For PRA questions:
PRAStaff@fda .hhs.gov

Citations
The followi ng citations arl" referenced throughout the form:
1

Required content and form at as per §1114.7 (Standard PMTA), 1114.15 (Suppll"m enta l PMTA), and 1114.17 (Resubm ission).

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Section I - Applicant Identification

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Section I - Applicant ldentification 1

Overview

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You are in the Applicant l,d entification section. This section requests informatfo n rega rdfngthe fdentfityofthe appli,cant, and includes the following part:
Pa rt A: Applicant Identification

Section II-Amendment Information ""

P,art .A: Applicant Information

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Section 11- Applicant Identificati on

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Sed1ion I - Applicant Identification

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Part A! Applicant Identification

Section II - Amendment Information

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Part A: Applicant lnformation 1
Parrt A shou Id in clude inform ation rega rdl ng the applicant fo r the submission. An applicant may be a ma.nufactu rer or importer tl'lat submits a PMTA to receive

A

m arketing autho rization fo r a,new tobacco product. Part A sho uld be completed fo r either an organization app licant or an indiv idua l applicant, NOT both.

Is the applicant an Organization or an Ind ividual? *
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Organization

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!individ ual

Orga1nization Information

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organization Name @ •
Test Org.
Other Orga nization Names (if ap pl icable) 6

Organization FDA-Assign ed Facility Establishm ent Identifier (FEI) Number 0

Orga nization D&B DUNS®Number 6

Co unt ry 6

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X ,.

I UN ITED STATES
Street Address Lin e 10 ..
12345 Test st
Street Address Lin e 2 (Apt, Suite, Blldg., #) 6

City 6 *
Test
State @ "
X ,.

Virgi nia
Zi p Code & •
00000· 0000

Poin1t of Contact for Organization
First Name @ "

Middle Initial 0

Last Name O ..
Doe
Ge nerational Suffix 6

Profess i.ana l Suffix 0

Positio n Title @

Ema.il Address 6

Phone or Fax Number( s) 0

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Section II .,Amendm,ent lnformat.io,1n

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Section 1-AppHcant ldentif,ication

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You a1re ir1 the Ame:ndlmenrt lnforma1
tion1sectfon. This section requests information r,egarding th1e purpose of t he a1m endm1ent andl the details of the content

Section II Amendment Information v
Part A: Amendme nt Purpose
Part B: Update to Prod uct Properties (if
applicable)
Part C: Cross -Referelflced Infoirmation

being amended, and inchJdes the following parts:
Part A.: Am1endm1ent Purpose
Part B: Update to Product Properti,es (if applicable)
Part C: Cross~Referenced Information
Part D: Rellated Submissions
Part E: Referenced Tobacco Product Master File(s), (TIIPMIIF), (optional)

Part D: Related Submissions
Part E: Referenced Tobacco Product
Master File(s) (TPMF) (optional)

P.art F: Am1enclment Conte nts
Part G: Certification Statement

Part F: Amendment Contents
Part G: Certification Statement:

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Secti0111I 1- Am end ment lnformatiion

Part A: A 1m 1e 1n dment Purp,o,se
Use Part.A to provide tlhe IPUrpose for th,us amendment. Inform ation providled in PartAwilll diet.ermine wh,uch additional 1Parts need to be co mpleted. This fo rm
cannot be used to add new products as an a1mend1ment. A new PMTA is requ ired for add it ional.products.

PMTA(s) Bein1g A1mendled
L1stthe FDA Submission Tracking Number (STN) and Prodluct ldlentifiiier (PD) Number, or STN.PD# (e.g., PM5679840.PD1)·, assigned to the application being
a,m.endled
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Overview
Section I - Applie.ant Identification

I

A

Section II - Amendment Information v
Part A: Amendment Purpose
Part B: l!Jpdate to Product Properties (if
applicable)
Part C: Cross -Refere nced Information

S1u bject(s) of the Am,e ndment
Se!ect the subject,(s) of tlhe amendment (select all that apply):

II Res1poinse to Deficiency Letter G
II Respo1nse to Enviro:nmental lnfor1matio:n Reque.st Letter 0

Part D: Related Submissions
Part E: Referenced Tobacco Product
Master File(s) (TPMF) (optional)

II Res1poinseto Information Request Letter G
0

Request for Extension of Time to Respo,nd to Deficie,n cy Letter 0

Submission Files

D

Request to Withdraw the IPMTA Submission 0

Review and Submit

II Update to Unique Identification lnfor1m1at.io1n 0

Part F: Amendment Contents
Part G: Certification Statement

• If sellected, you must provide FDA Form 4057b for a1ny am,endled product properties with thi s sulbm,ussio1n,and add STIN.PD# in Addtionall Properties

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Exipand AU Sections

II Update to,Prod u1ct Properties 0
1

• If sellected, provide updates in Section II Part 1B

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Change i1n,Cross-Reference•d Information G
• If sellect@d, provide updates in Section II Part C

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Change i1
n Related Submissions 9
• If sellected, provide updates in Section II Part ID

0
0

Change i1
n Tobacco Prodluct Master File (TIPMF) Referen•ced G
Letter of Autho rization (LOA) 6
• If sellected, provide updates in Section II Part IE

0

Change i1n, Submission Co1
nte1
nts G

D Submit Adverse Experience Report G
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Other G
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Overview
Section 1-AppHcant Identification

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Section II - Amendment Information v
Part A: Amendment Purpose

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Section I1- Am end m,ent lnfo rmat·on

Part B: Updat.e to Product IPro,perties (if applicable}
1

Part B is requir,ed as yoIu selected " Update Product Prope rt ies" in Section II Part A as a subj ect of the .amendm1ent For t he add ition,.update·, or removal of any
pr,oduct 1s propE:!rtie·s,.use t he Add Updot,e to New Product Properti,es button bE:!low to add a row to the tab le to,capture th€! •Change to the product's properties.
Withi n the tab:t e, utilize a single row fo r each update, and use the Add Update to New Product Properties button to a1dd additional rows to the ta bl.e, as needecl .

Part B: Update to Product Properties (if
appUcable)
Part C: Cross -Refere nced Information

Note: This section is not fo r sub mitting changes to Unique Identification I1Info,r matio1r111. This form cannot be used to add new produc.ts ais an am,endment. A new
PMTA is required for additional procl ucts..If there are no planned updates to product properties for this amendment, please update Section II IPart A and
unselect 11 Update to IProduct Properties."

Part D: Related Submissions
Part E: Referenced Tobacco Product
Master File(s) (TPMF) (optional)

New Product Na1
me·O

Part F: Amendment Contents
Part G: Certification Statement

STN.PO.lf 0

Submission Files

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Action G

....

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•

Property IName G

Previously Su bmittedl f a1rget Valu€! t)i

New/ Updated Target Value 0

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Section I -Applicant Identification

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Section II - Amendment Information v
Part A:. Amendment Purpose

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Section Ill - Amendment Infoirmation

Part C: Cro,ss-,Reference,d lnformatio1
n
Part C is requiredll a1s you selected "Ch1ange in Cross-Referenced I n1fo rmatio n" in Section II Part A as a subject of the .am1endllment.For the adcl ition, update, or
rem.oval .of any crnss-reterer.ced info.rma1tion1, use the Add Change to Cross-Referenc,ed Information button below to add a row to th,e taible to capture the change
to the cross-referenced information. Within th1e talbl•e, utilize a sing.le row for each change, and use the Add Change,to Cross-Refer:enced information button to

Part B: Update to Prod uct: Properties (if
applicable)
Part C: Cross-Referenced lnforma1
t ion

add aclditional rows to t hetalbl.e, as neecled..
Note: If there an~ no planinedl changes to cross-referenced information for this am,endment, pLeas,e update Section Ill Part A.and unse!ect "Change in Cross­
Refere1r111ced Information.11

Part D: Related Submissions
Part E: Referenced Tobacco Product
Master File(s) (TPMF) (optional)
Part F: Amendment Contents
Part G: Certification Statement

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I have ffilled an MR1PA, but I do not yet have·the STNI.

Cross -lReferenced STN G •

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Is the content releva11t to aU products within this submiss~on? 0

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Information anid sections to be referenced (e.g.. aill sections, sections 1-111) G

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Section 1-AppHcant Identification

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Section II - Amendment Information v
Part A: Amendment Purpose

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Section Ill - Amendm,e nt lnformat·on

Part D: Relat,edlSulbmissions
Part Dis required as you selected! "Change in Rel ated Submissions" in Section UPart Aas a subject of the amendment. Forthe additior111, update, or removal of a
related submission, use th,e Add Change to Related Submissk)nS button below to add a row to t he table to capture the change to the re lated subm ission,. Within
the ta,ble, uti liz.e a single row for ea1ch1updaite, and use th,e·Add Change,to Related Submissions button to adld additional rows to th,e·table, a,s needed..

Part B: Update to Prod uct: Properties (if
applicable)

Note: If there are no plan ned cha,ng~s in re lated subimiss i,ons for this .amendm,ent, please·update Section 11Part A and unselect uchange in IRellated

Part C: Cross -Refere nced Information

Submissions."

Part D: Related Submissions
Part E: Referenced Tobacco Product
Master File(s) (TPMF) (optional)

Re-lated Submission(s) STN O "'

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Part F: Amendment Contents

Action G
Part G: Certification Statement:
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Is the content rel.e vant to aU p,roducts wrn thiin this submission?
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@ Yes

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Section II - Amendment Information v
Part A::. Amendment Purpose

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Sectiolill Ill - Amendment llillformaUon

Pa1
rt E:: Reference,d Toba1cco Product.Master Fil•e(s.) ,(TPMF) (opti,onal)
Part IE is required as you selected " Change in Tobacco Product Master Fil~ Referenced" in Section Ill Part A as a subject of the amendment. For tlhe addition,
1.J1se the Add Change to Refere·nced TPMFbutton !below to add a row to the·tabl•e to capture th1e change to t he TIPMf..
update, or removal of any referenced TPMFsJ 1
Witlhi n the tablle,.utilize a single row for each c.hang.eJ and use the Add Change to Re.ferenced TPMF button t o add additional! rows to the·ta bl•eJ as r11eedled.

Part B: Update to Prod uct Properties (if
applicable)

Note: If ther~ are no planned •Cha1nges to referenced TPMFs fo r th is amendm•entJ please update Section II Part A and unselect '''Change in Tobacco Product

Part C: Cross-Refere nced Information

Master Fi l e Referenced.."

Part D: Related Submissions
Pa1rt E: Referenced Toba~co Product

Master File(:s) (TPMF) (optional)

lPMIFOwner 8

I Jane Doe

Part F: Amendment Contents

JPMF STN (a.ssig.ned by FDA) 0
Part G: Certification Statement

I PMOOOOOOO
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Is the content applkable to all products within the submission?

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(j) Yes
Q

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Rm
ght of r:e·fere11ce induded?
@

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Q

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Section II Amendment Information v
Part A: Amendment Purpose

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Sectiolfl Ill - Amendm,e nt lnfo1
rrnat'ion

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Section 1-AppHcant ldentif,ication

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Part F: Amendmenit C,ontents
Compllete Part Fto describe·the ite1
ms inc.liuded in this a1mend m1ent For each itemJprovide a descr1ipt1ion of th•e content a1nd ind icate t he fi le name/ location of
the content. To add Amendment Content,.use the Add Amendment Content button bellow to add a row to the ta bl.e to ,captu re the information. Within tlh1etable,
utilize a single row fo r each item1, and use th,e Add Amendment Content button to add addit ional rows to the table, as needed.

Part B: Update to Product Properties (if
applicable)
Part C: Cross -Referelflced Infoirmation
Part D: Related Submissions
Part E: Referenced Tobacco Product
Master File(s) (TPMF) (optional)
Part IF: Amendment Contents

Description f) *
A1mendment Content Description
Location O

II

fest

Part G: Certification Statement:

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Sectiolil II • Amendment I 11forrmatm
on

Part ,G: Certification State1
ment
The foUowing certification state1
ment is requ ired for all.PIMTA Amendment Subm1ission1s. To include this c,ertification stateme·nt in your submission, provide the
requested informa1tion below, whi,ch will gener.ate a certification statement that must then be s.igned by an aJ1uthoriz,ed r,epre·sentative of the applicant.
• For Name,ofResponsible Official, select or provide the name ofthe authorized representative(s) or U.S. agent who is signing th1e certification.
• For Name,ofApplicant, th1e applicant identified in Section I Part A has been1a1utom1aticallly popullated..
Use the Add Certifico:tion Statement button below to add additional c,ertification sta1tements, as needed.

overview
Section I -Applicant Identification

I

A

certification Stat,ement for PMTA Ame1ndlment

Section II - Amendment Information v
X ...,

Part A: Amendme nt Purpose
Part B: Update to Prod uct Properties (if
applicable)
Part C: Cross-Refere nced In fo rmation
Part D: Related Submiss ions
Part E: Referenced Tobacco Product
Master File(s) (TPMF) (optionalJ
Part F: Amendment Contents

Nam1e of Applicant
Test Org.
I, Jane Doe, o I behailf olf the applicant Test Org., hereby certify that th1e applicant will maintain all records to substantiate the accuracy of th is

application for the period of t im•e required in 21 CFR 1114.45 a1nd ens1U1re that such records remain readny a1vailablle to FDA upon request. I certify th1at
this informaition and the accompanying S1U1bmlssion ar,e trlle and -correct,.that no material fact has been omitted, andl tha1t I am authorized to submit
this on th1e applie.ant's.behall I undle•rs.ta1nd that under secti1on 1001 of title 18 of the United States Code anyone who knowingly and wilUfuUy 1makes .a
materiallly false, fictitious, or fra1U1du lent statement or representation in any 1
mauer within the jurisdiction of the executive, legislative,.or j1udicial

Part G: Certification State1111ent

Submission Files

br.anch of th1e·Government of the United St.ates is subJect to crimi111,al penalties.
Digital Signature •

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Sign above

Log,gedl in User Account:

Digitally Signed For:

Digitally Signed On:

Jaine Doe

October 7th 20.2 4, 5:27:30 pm1

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Section II - Amendment Information ,,._

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.TXT~. BM P,.CSS,..CM lJ.csv,..DTD,,.XLS,..XlSX,.XMll,.XSLJ.Gllf ,.HITM ,.HTMIL,.JPG~.J PIEGJ.KM L,.MOLJ. MPG,.M PEGJ.M P3 ,.MP4,,.PDF,.PN G~. MOVJ.XPT,.XPORT,.SVG,.SDFJ.W'M

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Section I -Applicant Identification
You have reached the end of this subm1ission. You m1ay now·submit yo1U r submisslon to CTP in order to fulfill your requirements. Submission via the CTP Portal

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submission Files

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Your submission package has been deHvered to the Center for Tobacco Products (CTP) for additional processing. Please refer to the Sent Submission Packages page at any t ime to view the status of your
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P·MTA I Premarke,t Tolbacco,Pro,d ud Appllicati,on
f'DA Form 4057

0

Aprema1rket tobacco prodiuct applie,ati,on (PMITA),,c,an be submitted by any perso,n for a111y new tobacco product seeking an FDA 1marketing order, 1
under
sectio,n 9lO(b),,0€th1e IFederal Food, Drug,,a1nd Cosmietic Act (FID&C Act). A PMITA must provide scie1r111tilfic daita thatde,monstrates. a product is appropriate
for the protection ,o f public h1eaUh. 11 order to,reach ...

PIMTA Amenrdlm,ent I Premarket Toba1cco,Produd Appllicati,on Amendment
f'DA Form4057A

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FDA may request, oran applkant m1ay subrmit on its own initiative, an am,endment to a IPMTA containing intorrmation that is nece,ssary ·for FDA
complete the review of a pending IPMTA. An am,endment must include the aippr,opriate for1m and sp,ecify th1e,SlN assigned to the,or"ginal submission
and, if su bmittedl other than at FDA'1s re,que,st, the reason for subm1itting the amiendment. A1111,amendlment must ,al so include,the -certificatjon statement
set ·forth in§ l.114.7(m), with the appr,opriate,informati,on inserted, and signed by an authorized repr,esentative of the a1ppllicant

SE I Tolbaicco,Substa1
n'tial Equiv.ale,nce !Report
fDA Form 39'65 v.l

0

A Substantia1I Equivalence (SIIE) Report ca111 lbe,submitted by a1ny manu€a1cturer for ,any new·tobaic,co product seeking an FDA substantially equivailent
order~ under section 905( D,of tlh11e,IIFed eral Food, Diiug, ,an1d Cosmetic (FID&C) Act. A substainti,a Uy equ ivaLent to b.acc,o product is ,one,th at ha1s been fourrn1d
by fDA to haive either th1e,sam,e characteristics as ,a pr,e...

SE Amendment I To,bacc,o Substa1
ntial Equivale,nce Report Amenrdm,e,n t
fDA Form 39 65A

Any amend1ment 1must inc!ude,,among other things, the appropriate form andl specify the submission tracking number(s) of the aim1endled SE !Report in
the subject line.

1

(i) TC I Gene,ral ,c,orrespo1ndence
fDA Form 39 65A/4057A
1

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Information about what a TC G,enerall Correspondence is, including why an Industry user woiu.dd use it andl wh1at the requirements are to subm1it this
type of form. lnfor1mation about what a TC Generall Correspondence is, inc uding why an Industry user would use it and what the requirements are to
subm1it this type of form. ln~ormation about w·hat a...

eSubmitter Uploa,d I Subm·ssion P,a,ckage
Sellecti ng this option alllows yo11U1 to, upload the zip fUe(s) created for a submission pa,cka1g,e on eSubrmitter, the fDA1sso,ftwa1re a1vailabte ·fo1
r vol.unta1ry use,
by spo,nsors, manufaicturers,,,and im1p,01
rters to,cr,eaite a variety of subm1issio1111 typ,es within the drug,,blood, device, radliologica l healtlh11,tobacco, ,anima I
drug and anima1I foodl regulated industri,es.
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'TC I Ge1
nera1I C,o rrespondlence
Nam1e and D escriptio1
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Submissilon Description e *

A.ddiUonal Comments 0

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Overview

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Fo rms Approved: 0MB No. 0910-0673,
0910-0879

Food and Drug Administration
Section I - Applicant
Identifi cation

Expiration Date: XX/XX/20XX

Tobacco General Correspondence (TC) Submission

Section II - General
Correspondence Inform ation
submission Files

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

Review and Subm it

Tobacco General Correspondence (TC}

0

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31)
Expand All Sections

into law. The Tobacco Control Act amended the Federal Food , Drug, and Cosmetic Act (FD&C Act).
A tobacco-related genera I correspondence (TC) is any submission sent by any party th at is not an appl ication or intended to meet statutory
re qu irements with t he exception ofexcept for health summary and post market reports. A TC can include, but is not l im ited to:
• Formal Meeting Requests
• Changes in Authorized Representative, U.S. Agent, Manufactu rer, or Point of Contact
• Requests for Change in Ownershi p
• Requests to Withd raw Previously Submitted General Correspondence
Complete the fo llowing question and answer form for t he Tobacco General Correspondence (TC) Submiss ion and when al l required data
has been entered click Submit to deliver the submission to the FDA's Cente r for Tobacco Products.

Instructions for Completion of the TC Amendment Form
Form FDA 3965a and FDA Form 4057a both contain the Tobacco Genera l Correspondence (TC) Submiss ion form, which is a required form
for applicants submitting TC Submiss ions to FDA. This form and the inst ructions are solely inte nded to provide the applicant an organized
format to supply informa t ion req uired for submission ofa Tobacco General Correspondence (TC) Submission.
This form is organized into t he following sections:
• Applicant Identification
• General Correspondence Informatio n
• Submission Fi les
• Review and Submit
Each section co ntains one or more pages t hat provide details on the specific information be ing req uested along with fields and/or tools to
ass ist you in providi ng the requested info rm ation. To help streamline the da ta entry process, informa tion you provide is automatically
saved when entered, and certain pages and fie lds may be dynamically enabled or disabled depending on t he informat ion you have

provided earlier in the form . There are also several helpful identifiers that may be associated with a field to help provide further guidance,
includi ng:
• Tooltips: Ind icated by a question mark icon, and provides additional instructio ns, defin itions from the guidance document, and

other helpful hi nts
• Required Indicators: Indicated by a red asterisk( ' ) identifying that the specific field is requi red before the form can be submitted
• Validation Errors: Indicated by descriptive red text located below t he field identifying that 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 comp leting the form, dependi ng 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 re levant

sections and pages of this form. Requ ired info rmatio n on each page must be completed before you can navigate to the subsequent
page, ma king t his option well su ited for newer users, t hose unfamiliar with t he form, and/or those looking to be guided through the
form completion process.
• Advanced: A clicka ble hierarch ica l 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 i n the form at any time, rega rdless of whether all of the requ ire d information has been
completed on the cu rrent page. This option is well suited for more adva need users, those familiar with the form, and/o r those looking
to qu ickly jump to a specific section to p rovide requested info rmation. Please note, when using the Advanced navigation option,
there may be pages and fields that are disabled as they rely on informat io n that you have not yet provided in a previo us 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 the re are many questions
throughout the form that require or allow requested informa tion to be provided in a file, the following tips for using the Submission Files
section are recommended (but not required ) to help expedite the data entry process:
• Upload submission files first before filling out the rest of the form: You can qu ickly select from your previously up loaded

submission files to provide the req uested informatio n for each of these questions. If you haven't uploaded submission fi les
previously, you will need to upload a new file each time you come across one of these questions.
The form does not need to be completed in one sess ion, and a d raft of your form is saved so t hat 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 t hat is
recommended to be included/identified. When all of the required 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 prod uct" to mean "(A) any tobacco product (incl uding those products

in test markets) that was not commercially marketed in the United States as of February 15, 2007; or (B) any modification (including a
change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of
nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United
States after February 15, 2007 .''
Section 910(a)(2) of the FD&C Act - Requ ires premarket review for new to bacco products. There are th ree pathways to seek premarket

authorization, one of which is submitting a Pre ma rket Tobacco Product App lication (PMTA).

Paperwork Reduction Act
According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not req ui red to respo nd to a
collection of information u nless it dis plays a valid OM B Contro l Number. The valid 0MB Control Numbers for this informa tion collection are
0910-0673 and 0910-0879, and the exp iration dates are XX/XX/20XX and XX/XX/20XY-., respectively.
The b urden t ime for this collection of information is estimated to average 10 minutes per response, includ ing the time to review
instructions, search existing data sources, gather and ma in ta in the data needed and complete and review the collection of informat ion.
Send comments regarding this bu rden estimate or any other aspect of th is info rmation collection, including suggestions for reduci ng this
burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
For PRA questions:
[email protected]

Citations
The following citations are referenced th rough out the form:
1 A tobacco

product that was introd uced or delivered for introductio n i nto intersta te commerce after Fel:Jruary 15, 2007, and prior to

March 22, 2011, and for which a Substantial Equ ivalence (SE) Report was submitted by March 22, 2011, (Provisional SE Repo rts) may
continue to be marketed un less FDA issues an order that the new product is not substantially equivalent.
1

Required content and format as per §1107.18, §1114. 7, § 1114.15, and §1114.17.

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You ar~·i n the Appticant ldenti·fiicati:o n section. This secti,o n req ue·sts info rim ati on r,ega rd i ng the fdent ity of 'th€! app Iicant, aind inc l.udes tlhie·
folllow·ing part:

Part A:. Applicant Identification

Section 11- General
Correspondence Inform ation

NEXT

Section I - Applicant ldentification 2

Overview
Section I - Applicant
I. Identification

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Part A: Applicant I nformation
A

sI bmission Files
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Section I - Applicant Identification

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Sect.ion I - Applicant
Identification

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Part A: Applicant lnformation 2
V

Part A: Applicant Identification

Part A shou ld include inform ation rega rding the applicant fo r the submission. An applica nt may be a manufact urer or importer that
submits an SE Report to receive marketi ng authorization for a new tobacco product, or any person that submits a PMTA who seeks a

Section II - General
Correspondence Information
Submission Files

Review and Submit

0

Expand All Sections

ma rketi ng au tho rization for a new tobacco product. Part A sho uld be completed for either an organization applicant or an in dividual
applicant, NOT bot h.
Is the applicant an Organization or an Ind ivid ual? •

{I)

Organization

Q

Individual

Organization Information
Organization Name O ..

Other Organizat ion Na mes (if applicab le)

0

Organization FDA-Assigned Facil ity Estab lishment Ident ifie r (FEil Number @

Organization D&B DUNS®Number 8

Country 8 ""

I UNITED STATES

X ...-

Street Address Line I O •

Street Address Line 2 (Apt, Su it e, Bldg.,#) 0

City O •

State O •

Zip Code & •

Point of Contact for Organization
First Name f) ..

Midd le Initial f)

Last Name O *

Generational Suffix 0

Professional Suffix 0

Position Title O

EmailAddress O

Phone or Fax Number(s) 0

I
Locat ion

Phone o r Fax

•
Phone or fax nu mber

Type

•

•

II

Ext

+ Add Phone/Fax

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Sectio1
11 11- App~i1cant Identification

Overview

I

Section I - Applicant
Identification

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Part A: A1
pplicant lnformaition·2
V

Pa rt A: Applicant Identification

Part A shou ld incl1
1.Jde infonmation regarding the applica1nt for the submission. .An applica nt may be a1manufacti!Jrer or importer tlhat
submits an SE Report to receive marketing authorization for a new tobacco product, or .ar11y person that submits ai PMTAwho seeks a

Section II - General
Correspondence Information
S11Jbmission Files

Review and Submit

0

Expand All Sections

A

mairketing a1 thorization for a.new tobacco product. !Pa.rt A shoulc!I be completed for either an orga1r11ization applicant or an individual
1

applicant, NIOT both.
lls the applicant an Organization or an Ind ividuail? *

Q

Organization

(i)

Individua l

ln,d ividual Information
First IName O ..

Middle lnitial.O

Last Na1me 8 *

Generational! Suffix 8

Professior111al Suffix 8

Pos ition Title O

Email Address 8

Phone or Fax N.umber (s.) 0

+ Add Phone/Fax

Country O .,.

Street Address Line 18 *

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

City O *

Provinee/Territory 8 *

Postal Code O *

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Section II - General
Correspondence Information

A

Part A: Submission lnform1a1tion 'for General Correspondenc,e
Us-e Part A to provide th1e subj ect(s) and SU1mmary for t his correspoindence. Information provided in Part A will determ ine wlhich additional
parts need to be com1pleted.

V

ParrtA: Submission Inform ation

Subject(s),of the Correspondence

for General Co1Tespondence

Select the subject(s} of the correspondence (select all that apply):
Part B: Add, Update, or Remove
Applicant In formation or Point of
Contact (O ptiona l)

II Change in Authorize,d Repre,sentative, U.S. Agent, Ma1nufacturer, 0 1r Point of Contact 0
1

• If sellected,.provide updates in Section II Part 1B

Part C: Request for Cha11ge in
Ow nership
Part D: Meeti11g Request

S11bmission Files

Review and submit

a Request for Cha1n1ge in Ownership f)
• If sellected,.provide updates in Section II Part C

a Meeting:Request G
• If sellected,.provide updates in Section II Part ID

0

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Sectio11 Ill - General.Conrespondence lln1orm1atio 11

Overview
Section I -Applicant
Identification

SAVE & EXIT

!Expand All Sections

II Request to Withdra1w Previously·Submitted Ge1n1eram Corr,espondence G
Pr·ovide summary of the request to withdraw a previously su bmittedl General Correspondence "

II Submit Advers.e,Experience Report f)
Provide summary of the Adverse Experience Report

II Other @
Prnvide summary of the other su bject(s) for t his amend1
ment inot included a1bove

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Secti on II - General Correspondence Information

Overview
Section I - Applicant
Identification

A

section II - General
Correspondence
Information

V

Pa rt A: Submission
Information for General
Correspondence
Part B: Add, Update, or
Remove Applicant
I nformation or Point of
Contact (Optional)

Part B: Add, Update, or Remove Applicant Information or Point
of Contact (Optional)
Part B is requ ired as you se lected " Change in Authorized Representative, U.S. Agent, Manufact ure r, or Point of Contact" in
Section II Part A as a subject of the correspondence. For t he addition, update, or removal of any Authorize d Representative, U.S.
Agent, Man ufacturer, or Point of Con tact, use t he Add Change to Contact Information button be low to add a row to the table to
capture the change to the contact. Withi n the taole, uti lize a single row for each update, and use the Add Change to Contact
Information button to add additiona l rows to the table, as needed.

Note: If there are no planned changes to Authorized Representative, U.S. Agent, Manufacturer, or Point of Contact for th is
correspondence, please update Section 11Part A and unselect "Change in Authorized Representa t ive, U.S . Agent, Man ufacturer,
or Point of Contact."

Part C: Request for Change in
Ownership
Panel

Part D: Meeting Request
Submission Files

Review and Submit

Change to Contact Information

Choose an Action &
X

Update

0

Expand All Sections

NEXT

T

Select the type of contact &

Provide a brief description of t he update here

Is this ch ange applicab le fo r all current FDA submissions?

0

Yes

0

O No

Effective Date of Change &

Current Contact Information on
Record

Added/Updated Contact
Information

First Name &

First Name &

Middle Initial &

Middle In itial &

Last Name &

Last Name &

Generat iona l Su ffix &

Generational Suffix &

Professional Suffix &

Professional Suffix &

Position Tit le &

Position Title &

Email Address &

Email Address &

Phone or Fax Number(s) &

Phone or Fax Num ber(s) &

♦ Add Phone/Fax

♦ Add Phone/ Fax

Orga n ization Name &

Organization Name &

Orga n ization FDA-Assigned Fac ility Estab lishment
Identifier (FEI) Number &

Organization FDA-Assigned Facility Est ablishment
Identifi er {FEI) Number &

Organization D&B DUNS" Num ber &

Organization D&B DUNS" Number &

- - - --

-

-

Count ry &

Country &

Street Address Line 1 &

Street Address Line 1 &

Street Address Line 2 (Apt., Su ite, Bldg., II) &

St reet Address Line 2 (Apt., Suite, Bl dg., II) &

City &

City Qi

Province/Territory &

Province/ Territory &

Postal Co de &

Postal Code &

+Add Change to Contact Information

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Part C: Request for Change in Ownership

Section I - Applicant
Identification

Part C is required as yo!J selected "Request for Change in Owneirship" in Section II Part A as a subject of the correspondence.

Section II - General

Pa rt A: Submission
Information for Genera I
Correspondence
Part B: Add, Update, or
Remove Applicant
Information or Point of
Contact (Optional)

NEXT

Section II - General Correspondence Information

Overview

Correspondenc.e
Information

SAVE& EXIT

V

Use the Add Application, Submission, and Product to be Transferred button below to add a row to the table to capture the
required information. Within the table, utilize a single row for each update, and use the Add Application, Submission, and
Product to be Transferred button to add additional rows to the table, as needed.

A change in or transfer of ownership is for applicants (compan ies) who make a request to the IFDA to transfer the rights and
responsibilities for their applications and submissions to another company. The former applicant is the party that is listed in
FDA's records to date. The new applicant is the party taking responsibility for the submissions. The new and former applicant
must sign and submit certain informatiion and statements to complete the transfer. This information is submitted as a general
correspondence for all applications/submissions and not as an amendment to each application..The former applicant and new
applicant Imust subm it all information as outlined in Section 111, Part Bas applicable to their role in the transfer.

Part C: Request for Change
in Ownership

Note: The form.er applicant may select checkboxes for former and new if they are subm itting all requirements on behalf of both
parties. The new applicant cannot submit on behalf of the former. FDA will only process the request for change in ownership

Part D: Meeting Request
Submission Files

upon receipt of t lhe request from the former applicant.
For change in ownership requests that include Premarket Tobacco Prod uct Applications (PMTA) or Substantial Equivalence (SE)
Reports, Form FDA 4057a and/or Form FDA 3965a are required. A single form can be provided for transfer requests that include

Review and Submit

multiple submission types. Changes in ownership that do not include SE or PMTAsubmissions do not require Form FDA 4057a
or Form FDA 3965a, though we encourage the use of forms. The forms are available on the FDA website at: https://www.fda.gov/
about-fda/reports-manuals-forms/forms.

0

Expand All Sections
The following are submission types that FDA will transfer:
• Marketing Applications
o 910 Premarket Tobacco Application {PMTA)
o 90S(j)(1) Substantial Equivalence Reports (SE}
o 90S(j)(3) Exemption from Substantial Equivalence (EX)
o 911 Modified Risk Tobacco Product Application (MRTPA)
• Submissions
o 910(g) lnvestigational Tobacco Use (IU)
o General Correspondence and Meeting Requests (TC)
o Master Files (MF)
o Grandfather Determination Requests (GF)
o Pre-Existing Tobacco Products (PX)
o Warning Pla ns (WP)
o Other Media Notificatiorns (OM)
Note: If there are no planned change in ownership requests for this correspondence, please update Section II Part A and
unselect "R equest for Change in Ownership."

Applications, Submissions, and Product Names to be Transferred
PD Number (if applicable) f)

Product Name (if applicable) f)

II
+ Add Application, Submission, and Product to be Transferred

Effective Date of Change
Enter the Effective Date of Change (mm/dd/yyyy)

9

Transfer Req uest Contents
1

This transfer request contains the following items (select all that apply):

0
0
0

0
0
0

0
0
0
0

A signed transfer of ownership request letter from the former applicant must include: &
The specific applications, submissions, and product names by STN being transferred.
A statement that all rights of the applications have been transferred to the new applicant.
Contact information for the new applicant (name, mailing address, phone num ber, and email).

A signed letter from the new applicant accepting the change in ownership from the former
applicant must include: G
The specific applications, submissions, and product names by STN being accepted.
A statement committing to a,1I1agreements, promises, and conditions made by the current applicant of record contained in
the applications and submissions.
A statement that the new applicant has a complete copy of the applications and submissions, or state they will request a
copy per 21 CFR 20.40
A statement that no modifications have been made to the transferred tobacco applications and submissions.
Contact informaition for the new applicant (name, mailing address, phone num ber, and email).

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Section II - Genera1l Co rrespondence Information

Overview

Part o,: Meeting Request

Section I - Applicant
Identification
Section II - General
correspondence
Information

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Part D· is required as you selected "Meeting Request" in Section II Part A as a subject of the a1mendim1ent This is a request for a
V

Pa rt A: Submission
Information for Genera I
Correspondence
Pa rt B: Add, Update, or
Remove Applicant
Information or Point of
Contact (Optional)

formal 1meeti ng which may include topics such as study design, earlier versions of the product, etc. Provide the requested
informa1tion bell ow and use the Add Product to be Discussed at Meeting button below to add a row to the table to capture the
requested infonmation a1bout the product to be discussed at the 1m1eeting..Withi11 the table, utilize a single row for each change,
and use the Add Product to be Discusse,d at Meeting button to add additional rows to the table, as needed.
Note: If there aire no planned 1m eeting requests forth is correspondence, please update Section

11Part A and unselect "Meeting

Request."

Meeting IReq1u1es.t ln1formation
Meeting Topic 9

Part C: Request for Change in
Ownership

Part D: Meeting Request

Meeti ng Purpose f)

Submission Files

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0

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Meeting Format 9

Is the meeting inform1ation package included?

Q

Yes

Q

G

INo

P1
roducts to be Discussed at Meeting
Product Name 9

Product Use 9

I Choose an item

Product Category (if applicable) f)

x ..,

I Choose a product category

T

STN.PD# (if

applicable) 9

I I

------------~

I

~------~

II

+Add Product to be Discussed at Meeting

Meeting Req1u1est Contents
Th is meeting reque-st contains the folllowing items (select alll that apply):

0

A1
1>reliminary list of the specific objectives/o,utcomes expected from t lh1e meeting.

0

A 1>reliminary p1
ro1pose,d agenda, including an estim1ate of the ti1
me needed and a1designated
speake1r for each agenda item. G

0

A1
p reliminary list of specific critica1l questions, g1ro,upe,d by dliscipline (e.g:., chemistry,
clin1ical, non~clinical).

0

A Ust of all individlualls who will l attend th1e 1meeting on your beha1lf, including ti·t les andl
responsibiilities.

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overview
Section I - Appl" cant
ldent·fication

A

Select fi le(s) to upload
AUowed fi~-e types:
.TXT,.BM P,.CSS,.CML,.CSV~. D1D,.XLS,.XLSX,.XM L,.XSL,.GI F,.HTM,.HlM L,.JIPG,.JIPEG1,.KM L,.IMOL,.IM P,G,. MPEG,.MP3,.M P4,. PDF,. PN G,.
M0 V~.XPT,.XPORT~.SVG,.SDIF,.WMV,.WAV,.XSD
1

Section II - General
correspondence
Information

I Submiss on

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Size

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Rows:

D

25

A,c tions

Search tab le content

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StatuiS

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You have reached the end of tllhis submission. You may now submilt your submission to CTP in order to fulfi Uyour requiire1
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Section u- General
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1

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