FDA Web Form 3965a Tobacco Substantial Equivalence Report Amendment

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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 CTPeSub@fda.hhs.gov 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.

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P·MTA I Premarke,t Tolbacco,Pro,d ud Appllicati,on
f'DA Form 4057

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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

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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.

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(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
n
11

Submissilon Name O fr

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}

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On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31)
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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:
PRAStaff@fda.hhs.gov

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

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Section I - Applicant ldentification 2

Overview
Section I - Applicant
I. Identification

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Part A: Applicant I nformation
A

sI bmission Files
Review and Submit

0

Expand All l Sect~ons.

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Section I - Applicant Identification

Overview
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

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Sectio11 Ill - General.Conrespondence lln1orm1atio 11

Overview
Section I -Applicant
Identification

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!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

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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

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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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Expand AIII Sections

Meeting Format 9

Is the meeting inform1ation package included?

Q

Yes

Q

G

INo

P1
roducts to be Discussed at Meeting
Product Name 9

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