Form FDA 3965a Form FDA 3965a Tobacco Substantial Equivalence Report Amendment and Gen

Substantial Equivalence Reports for Tobacco Products

FDA_Form_3965a (2024)

Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a)

OMB: 0910-0673

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0673
Expiration Date: xx/xx/20xx
Paperwork Reduction Act Statement: The Paperwork Reduction Act of 1995
provides that an agency may not conduct or sponsor, and a person is not
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is 0910-0673. The time required to complete this information collection is
estimated to average 10 minutes per response.Send comments regarding this
burden estimate or any other aspects of this collection of information, including
suggestions for reducing burden to PRAStaff@fda.hhs.gov.

TOBACCO SUBSTANTIAL EQUIVALENCE
REPORT AMENDMENT AND GENERAL
CORRESPONDENCE SUBMISSION

Marketing a New Tobacco Product without a Substantially Equivalent Order is illegal and may be subject to enforcement.1
Please carefully read the instructions located in the Appendix before completing this form.
SECTION I – APPLICANT IDENTIFICATION¹

Part A: Applicant Information2
The applicant is the individual or organization (manufacturer/importer) seeking a marketing granted order for a new product. Complete
for either an organization or an individual, NOT both. Organization applicants should complete fields 1–20 only. Individual applicants
should complete fields 21–36 only

If applicant is an organization, complete Part A fields 1–20.
1. Organization Name

2. Other Organization Names (if applicable)

3. Organization FDA-Assigned Facility
Establishment Identifier (FEI) Number

4. Organization D&B DUNS® Number

5. Submit Date (mm/dd/yyyy)

8. City

6. Street Address Line 1

9. State, Province, or Territory

7. Street Address Line 2 (Apt.,
Suite, Bldg., #)
10. Country

11. ZIP or Postal Code

Point of Contact for Organization
12. First Name

15. Generational
Suffix

13. Middle Initial

16. Professional Suffix

18. Phone Number

19. Fax Number

14. Last Name

17. Position Title

20. Email Address

If applicant is an individual, complete fields 21–36 and proceed to Part B.
21. First Name

25. Generational Suffix

22. Middle Initial

26. Professional Suffix

23. Last Name

24. Submit Date (mm/dd/yyyy)

27. Position Title

28. Street Address Line 1

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

A tobacco product that was introduced or delivered for introduction into interstate commerce after February 15, 2007, and prior to March 22, 2011, and
for which a Substantial Equivalence (SE) Report was submitted by March 22, 2011, (Provisional SE Reports) may continue to be marketed unless FDA
issues an order that the new product is not substantially equivalent.

Required content and format as per 21 CFR 1107.18.

FORM FDA 3965a (4/24)

Page 1 of 30

30. City

31. State, Province, or Territory

34. Phone Number

32. Country

35. Fax Number

33. ZIP or Postal Code

36. Email Address

Part B: Submission Type
1. Identify the type of submission (select one):

□ Amendment (if selected, proceed to Section II)
□ General Correspondence (if selected, skip Section II and proceed to Section III)
SECTION II – AMENDMENT INFORMATION

Part A: Amendment Purpose
1. List the FDA Submission Tracking Number (STN) and Product Identifier (PD) Number, or STN.PD# (e.g.,
SE5679840.PD1), assigned to the application being amended
:

2. Select the subject(s) of the amendment (select all that apply):

□ Response to Deficiency Letter
□ Response to Environmental Information Request Letter
□ Response to Information Request Letter
□ Request for Extension of Time to Respond to Deficiency Letterr
□ Request to Withdraw the SE Report

–If selected, provide the name and STN.PD# of product(s) being withdrawn:

□ Select to indicate that the withdrawal is due to a health or safety concern related to the tobacco product.

□ Update to Unique Identification Information

–If selected, you must provide FDA Form 3965b for any amended product properties with this submission and an
STN.PD# in Additional Properties.

□ Update Product Properties

–If selected, provide updates in Section II.C below.

□ Submit Adverse Experience Report

–If selected, provide submission summary in Section II.A.3 below.

□ Change in Cross-Referenced Content .
□ Change in Related Submissions
FORM FDA 3965a (4/24)

Page 2 of 30

□ Change in Tobacco Product Master File Referenced
□ Letter of Authorization (LOA)
□ Change in Submission Contents

–If selected, provide submission summary in Section II.A.3 below.

□ Other

–If selected, provide submission summary in Section II.A.3 below.

3. Summarize the submission in the space provided, if you selected “Submit Adverse Experience Report,” “Change in
Submission Contents,” or “Other” in Section II.A.2:

Part B: Predicate Product Evidence

(Complete only if the predicate has not been previously reviewed by CTP)

Evidence of Commercial Marketing as of February 15, 2007
1. Type of Evidence (e.g., Invoice)

2. Date of Evidence (mm/dd/yyyy)

3. Evidence Identifier (e.g., Invoice Number)

4. Commercial Information (e.g., UPC code, product
description, item number)

5. Predicate Product Name(s)

Business Addresses Associated with Evidence of Commercial Marketing (optional)
6. (Ship from) Street Address Line 1
8. City

7. (Ship from) Street Address Line 2 (Apt., Suite,
Bldg., #)

9. State, Province, or Territory

10. Country

12. (Ship to) Street Address Line 1
14. City

FORM FDA 3965a (4/24)

11. ZIP or Postal Code

13. (Ship from) Street Address Line 2 (Apt., Suite,
Bldg., #)

15. State, Province, or Territory

16. Country

Page 3 of 30

17. ZIP or Postal Code

Part C: Update to Product Properties (if applicable)
Use this section if you selected “Update Product Properties” in Section II.A.2 and you are amending previously
submitted product property information
Update to New Product Properties
1. New Product
Name

2. STN.
PD#

3. Action

4. Property
Name

5. Previously
Submitted Target
Value

6. Updated Target Value

Choose an action

Continuation Page for Update to
New Product Properties
FORM FDA 3965a (4/24)

Page 4 of 30

Update to Predicate Product Properties
7. Predicate
Product Name

8. STN.
PD#

9. Action

10. Property
Name

11. Previously
Submitted Target
Value

12. Updated Target
Value

Choose an action

Continuation Page for Update to
Predicate Product Properties
FORM FDA 3965a (4/24)

Page 5 of 30

Part D: Cross-Referenced Information (Optional)

Use this section if you selected “Change in Cross-Referenced Content” in Section II.A.2 and you are adding, updating, or removing
any cross-referenced content.

1. CrossReferenced STN

2. Action

Choose an action

3. Is the content relevant to all
product(s) within this submission?

4. Information and sections to
be referenced

□ Yes
□ No (list applicable product name[s]):
□ Yes
□ No (list applicable product name[s]):
□ Yes
□ No (list applicable product name[s]):
□ Yes
□ No (list applicable product name[s]):
□ Yes
□ No (list applicable product name[s]):
□ Yes
□ No (list applicable product name[s]):
□ Yes
□ No (list applicable product name[s]):

Continuation Page for
Cross-Referenced Content
FORM FDA 3965a (4/24)

Page 6 of 30

Part E: Related Submissions

Use this section if you selected “Change in Related Submissions” in Section II.A.2 and you are adding, updating, or removing any
related submissions content.

1. Related
Submission(s)
STN

2. Action

Choose an action

3. Is the content relevant to all
product(s) within this submission?

4. Information and sections to
be referenced

Continuation Page for
Related Submissions
FORM FDA 3965a (4/24)

Page 7 of 30

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

Use this section if you selected “Change in Tobacco Product Master File Referenced” in Section II.A.2 and you are adding, updating,
or removing any referenced TPMFs. Complete fields 1–6 for each amended TPMF cross-reference. Use the Continuation Page
button below to list additional TPMFs.

1. TPMF Owner
4. Is the content applicable to all
products within this submission?

2. TPMF STN (assigned by FDA)

3. Action
Choose an action

□ Yes

□ No (list applicable product name[s]):

□ Yes

□ No

5. Information and sections to be
referenced (e.g., all sections,
sections I–III)
6. Right of reference included

1. TPMF Owner
4. Is the content applicable to all
products within this submission?

2. TPMF STN (assigned by FDA)

3. Action
Choose an action

□ Yes

□ No (list applicable product name[s]):

□ Yes

□ No

5. Information and sections to be
referenced (e.g., all sections,
sections I–III)
6. Right of reference included

1. TPMF Owner

2. TPMF STN (assigned by FDA)

3. Action
Choose an action

4. Is the content applicable to all
products within this submission?

□ Yes

□ No (list applicable product name[s]):

□ Yes

□ No

5. Information and sections to be
referenced (e.g., all sections,
sections I–III)
6. Right of reference included

Continuation Page for
Referenced TPMF
FORM FDA 3965a (4/24)

Page 8 of 30

Part G: Amendment Contents

This amendment contains the following items (provide description and indicate file name and location of amendment content):

1. ____________________________________________________________________________________
Location: ____________________________________________________________________________
2. ____________________________________________________________________________________
Location: ____________________________________________________________________________
3. ____________________________________________________________________________________
Location: ____________________________________________________________________________
4. ____________________________________________________________________________________
Location: ____________________________________________________________________________
5. ____________________________________________________________________________________
Location: ____________________________________________________________________________
6. ____________________________________________________________________________________
Location: ____________________________________________________________________________
7. ____________________________________________________________________________________
Location: ____________________________________________________________________________
8. ____________________________________________________________________________________
Location: ____________________________________________________________________________

Part H: Certification Statements

Insert the name of the authorized representative(s) or U.S. agent and the name of the organization being represented in the body of
the statement.

i. Certification Statement of Affimation
I, (name and position title of responsible official)

, confirm that the

predicate tobacco product(s) (listed below) was/were commercially marketed (other than for test marketing) in the
United States as of February 15, 2007.
1. Name(s) of predicate tobacco product(s)

2. Signature and Date (mm/dd/yyyy)

FORM FDA 3965a (4/24)

Page 9 of 30

ii. Certification Statement for SE Report:
I (name of responsible official)

, on behalf of (name of applicant)

, hereby certify that (name of applicant)

will

maintain all records to substantiate the accuracy of this SE Report for the period of time required in 21
CFR 1107.58 and ensure that such records remain readily available to FDA upon request. I certify that this
information and the accompanying submission are true and correct, that no material fact has been omitted, and
that I am authorized to submit this on the applicant’s behalf. I understand that under section 1001 of title 18 of
the United States Code anyone who knowingly and willfully makes a materially false, fictitious, or fraudulent
statement or representation in any matter within the jurisdiction of the executive, legislative, or judicial branch of
the Government of the United States is subject to criminal penalties.
1. Signature and Date (mm/dd/yyyy)

SECTION III – GENERAL CORRESPONDENCE INFORMATION

Submission Information for General Correspondence
1. Subject of Correspondence (select all that apply):

□ Change in Authorized Representative, U.S. Agent, Manufacturer, or Point of Contact
–If selected, complete Section III Part A below.

□ Request for Change in Ownership

–If selected, complete Section III Part B below.

□ Submit Adverse Experience Report

–If selected, provide submission summary in Section III field 2 below.

□ Request to Withdraw Previously Submitted General Correspondence

–If selected, provide submission summary in Section III field 2 below.

□ Meeting Request

–If selected, complete Section III Part C below.

□ Other

–If selected, provide submission summary in Section III field 2 below.

2. Summarize the correspondence in the space provided if you selected “Submit Adverse Experience Report,”
“Request to Withdraw Previously Submitted General Correspondence,” or “Other” in Section III field 1:

FORM FDA 3965a (4/24)

Page 10 of 30

Part A: Add, Update, or Remove Applicant Information or Point of Contact (Optional)

Complete this section if you selected “Change in Authorized Representative, U.S. Agent, Manufacturer, or Point of Contact
Information” in Section III field 1 and you are updating previously submitted contact information. Use the Continuation Page button
below to list additional changes in applicant information or points of contact.

1. Select only one:
Choose an action
–If “Update” is selected, provide a brief description of the update here:

2. Select the type of contact (select one):

□ Applicant □ Authorized Representative
(Address and contact information only)

□ Manufacturer

□ Contract Manufacturer

□U.S. Agent

□ Repacker/Relabeler

□ Other______________

3. Is this change applicable for all current FDA submissions?

□ Yes

□ No (list applicable STNs.PD#s):

4. Effective Date of Change (mm/dd/yyyy)

Current Contact Information on Record

Added/Updated Contact Information

5. First Name

6.
Middle
Initial

23. First Name

24.
Middle
Initial

8. Generational
Suffix

9. Professional Suffix

26. Generational Suffix

27. Professional Suffix

7. Last Name

10. Position Title

28. Position Title

11.Organization Name

29.Organization Name

12. Organization
FDA-Assigned Facility
Establishment Identifier
(FEI) Number

14. Street Address Line 1

FORM FDA 3965a (4/24)

13. Organization D&B DUNS®
Number

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

30. Organization
FDA-Assigned Facility
Establishment Identifier
(FEI) Number

32. Street Address Line 1

Page 11 of 30

25. Last Name

31. Organization D&B DUNS®
Number

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

Current Contact Information on Record (cont.)

Added/Updated Contact Information (cont.)

16. City

34. City

17. State, Province, or
Territory

18. Country

19. ZIP or Postal
Code

20. Phone Number

36. Country

21. Fax Number

38. Phone Number

22. Email Address

35. State, Province, or
Territory
37. ZIP or Postal
Code
39. Fax Number

40. Email Address

Continuation Page
for Part A
Part B: Request for Change in Ownership

Complete this section if you selected “Request for Change in Ownership” in Section III Submission for General Correspondence
field 1 and the correspondence includes a request for a change in ownership.

1. Applications, submissions, and product names to be transferred including the FDA Submission Tracking Number
and Product Identifier PD Number (STN.PD#):
(Optional: Applicants may provide a separate list of submissions subject to transfer)
STN

PD Number
(if applicable)

Product Name
(if applicable)

2. Effective Date of Change (mm/dd/yyyy)
3. This transfer request contains the following items (select all that apply):

□ 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 number, and email).
□ A signed letter from the new applicant accepting the change in ownership from the former applicant must include:
□ The specific applications, submissions, and product names by STN being accepted.
□ A statement committing to all agreements, promises, and conditions made by the former applicant of record
contained in the applications and submissions.

□ A statement that the new applicant has a complete copy of the applications and submissions including

amendments and records that are required to be kept, 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 information for the new applicant (name, mailing address, phone number, and email).
FORM FDA 3965a (4/24)

Page 12 of 30

Continuation Page
for Part B

Part C: Meeting Request

Complete this section if you selected “Meeting Request” in Section III Submission for General Correspondence field 1 and the
correspondence includes a meeting request.

1. Meeting Topic
2. Meeting Purpose
3. Meeting Format
4. Is the meeting information package included?

□ Yes

□ No (provide expected date of submission (mm/dd/yyyy)): __________________
Continuation Page
for Part C

Products to be Discussed at Meeting
5. Product Name

6. Product Use

7. Product Category (if applicable)

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product
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category
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product
category.

8. STN.PD# (if applicable)

9. This meeting request contains the following items (select all that apply):

□ A preliminary list of the specific objectives/outcomes expected from the meeting.
□ A preliminary proposed agenda, including an estimate of the time needed and a designated speaker for each
agenda item.

□ A preliminary list of specific critical questions, grouped by discipline (e.g., chemistry, clinical, non-clinical).
□ A list of all individuals who will attend the meeting on your behalf, including titles and responsibilities.

FORM FDA 3965a (4/24)

Page 13 of 30

SECTION VII – APPENDICES
CONTINUATION PAGES
Appendix A: Update to Product Properties (if applicable)
Submit a single Form FDA 3965a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION II, Part C: Update to Product Properties (if applicable)

Update to New Product Properties
1. New Product
Name

2. STN.
PD#

3. Action

4. Property
Name

Choose an action

FORM FDA 3965a (4/24)

Page 14 of 30

5. Previously
Submitted Target
Value

6. Updated Target Value

Update to Predicate Product Properties
7. Predicate
Product Name

8. STN.
PD#

9. Action

10. Property
Name

Choose an action

FORM FDA 3965a (4/24)

Page 15 of 30

11. Previously
Submitted Target
Value

12. Updated Target
Value

Appendix B: Cross-Referenced Content
Submit a single Form FDA 3965a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION II, Part D: Cross-Referenced Content
1. CrossReferenced
STN

2. Action

Choose an action

FORM FDA 3965a (4/24)

3. Is the content relevant to all
product(s) within this submission?

Page 16 of 30

4. Information and sections to
be referenced

Appendix C: Related Submissions
Submit a single Form FDA 3965a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION II, Part E: Related Submissions
1. Related
Submission(s)
STN

2. Action

Choose an action

FORM FDA 3965a (4/24)

3. Is the content relevant to all
product(s) within this submission?

Page 17 of 30

4. Information and sections to
be referenced

Appendix D: Referenced Tobacco Product Master File(s) (TPMF)
Submit a single Form FDA 3965a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION III, Part F: Referenced Tobacco Product Master File(s) (TPMF)
1. TPMF Owner
4. Is the content applicable to all
products within this submission?

2. TPMF STN (assigned by FDA)

3. Action
Choose an action

□ Yes

□ No (list applicable product name[s]):

□ Yes

□ No

5. Information and sections to be
referenced (e.g., all sections,
sections I–III)
6. Right of reference included

1. TPMF Owner
4. Is the content applicable to all
products within this submission?

2. TPMF STN (assigned by FDA)

3. Action
Choose an action

□ Yes

□ No (list applicable product name[s]):

□ Yes

□ No

5. Information and sections to be
referenced (e.g., all sections,
sections I–III)
6. Right of reference included

1. TPMF Owner

2. TPMF STN (assigned by FDA)

3. Action
Choose an action

4. Is the content applicable to all
products within this submission?

□ Yes

□ No (list applicable product name[s]):

□ Yes

□ No

5. Information and sections to be
referenced (e.g., all sections,
sections I–III)
6. Right of reference included

FORM FDA 3965a (4/24)

Page 18 of 30

Appendix E: Add, Update, or Remove Applicant Information or Point of Contact (Optional)
Submit a single Form FDA 3965a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION III, Part A: Add, Update, or Remove Applicant Information or Point of Contact (Optional)
1. Select only one:
Choose an action
–If “Update” is selected, provide a brief description of the update here:

2. Select the type of contact (select one):

□ Applicant □ Authorized Representative
(Address and contact information only)

□ Manufacturer

□ Contract Manufacturer

□U.S. Agent

□ Repacker/Relabeler

□ Other__________

3. Is this change applicable for all current FDA submissions?

□ Yes

□ No (list applicable STNs.PD#s):

4. Effective Date of Change (mm/dd/yyyy)

Current Contact Information on Record

Added/Updated Contact Information

5. First Name

6.
Middle
Initial

23. First Name

24.
Middle
Initial

8. Generational
Suffix

9. Professional Suffix

26. Generational Suffix

27. Professional Suffix

7. Last Name

10. Position Title

28. Position Title

11.Organization Name

29.Organization Name

12. Organization
FDA-Assigned Facility
Establishment Identifier
(FEI) Number

FORM FDA 3965a (4/24)

13. Organization D&B DUNS®
Number

30. Organization
FDA-Assigned Facility
Establishment Identifier
(FEI) Number

Page 19 of 30

25. Last Name

31. Organization D&B DUNS®
Number

Current Contact Information on Record (cont.)

Added/Updated Contact Information (cont.)

14. Street Address Line 1

32. Street Address Line 1

16. City

18. Country

20. Phone Number

22. Email Address

FORM FDA 3965a (4/24)

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

17. State, Province, or
Territory
19. ZIP or Postal
Code
21. Fax Number

34. City

36. Country

38. Phone Number

40. Email Address

Page 20 of 30

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

35. State, Province, or
Territory
37. ZIP or Postal
Code
39. Fax Number

Appendix F: Request for Change in Ownership (Optional)
Submit a single Form FDA 3965a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION III, Part B: Request for Change in Ownership
1. Applications, submissions, and product names to be transferred including the FDA Submission Tracking Number
and Product Identifier PD Number (STN.PD#):
(Optional: Applicants may provide a separate list of submissions subject to transfer)
STN

FORM FDA 3965a (4/24)

PD Number
(if applicable)

Page 21 of 30

Product Name
(if applicable)

Appendix G: Meeting Request
Submit a single Form FDA 3965a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION III, Part C: Meeting Request

Products to be Discussed at Meeting
5. Product Name

FORM FDA 3965a (4/24)

6. Product Use

7. Product Category (if applicable)

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Page 22 of 30

8. STN.PD# (if applicable)

Appendix H: Instructions for Completion of SE Amendment and General Correspondence Submission Form
This form and the instructions are used solely to provide the applicant an organized format with which to supply
information required for the submission of a Substantial Equivalence (SE) Report Amendment and General
Correspondence.
Form FDA 3965A – Tobacco Substantial Equivalence (SE) Report Amendment and General Correspondence
Submission is a required form for applicants submitting SE amendments or other general correspondence to FDA. The
numbered items in the below instructions correspond to those provided on the form. Prior to submitting to FDA, ensure
all information entered in each field is readable after saving.

SECTION I — APPLICANT IDENTIFICATION
Section I should include information regarding the identity of the applicant, including the following parts:
• Part A: Applicant Information
• Part B: Submission Type

Part A: Applicant Information

Part A should include information regarding the applicant for the submission. An applicant may be a manufacturer
or importer that submits an SE Report to receive marketing authorization for a new tobacco product. Part A should
be completed for either an organization applicant or an individual applicant, NOT both.
Note: Organization applicants should complete fields 1–20 only. Individual applicants should complete fields
21–36 only.

If applicant is an organization, complete Part A fields 1–20 and proceed to Part B.

For these fields, provide the following information for the organization:
I.A.1. The organization name is the party who takes responsibility for and initiates the submission of an SE
application to FDA. The legal name of the organization may be an individual or company name (private
or otherwise) and should match the applicant’s Dun & Bradstreet Data Universal Numbering System
D-U-N-S® (D&B DUNS®) number.
I.A.2. All other names the applicant operates under (e.g., any “Doing Business As” [D.B.A.]), if applicable.
I.A.3. The organization FDA-assigned Facility Establishment Identifier (FEI) number, if applicable.
Note: To obtain or retrieve an FEI number, applicants can use the FEI Search Portal at
https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login, and/or contact FEI Search
Portal support at feiportal@fda.hhs.gov for any FEI number-related questions.
I.A.4. The organization D&B DUNS number, if applicable.
Note: To obtain or retrieve a DUNS number, applicants can contact Dun and Bradstreet directly by
phone at 1.866.705.5711 or through their website at https://www.dnb.com/duns/get-a-duns.html.
I.A.5. The submit date, or date you are formally submitting the application to FDA (e.g., submitting via the CTP
Portal, the FDA Electronic Submissions Gateway [ESG], or handed to courier).
I.A.6. The street address for the organization (including street number, street name and type, suffix direction, etc.).
The street address cannot be a P.O. Box.
I.A.7. Additional street address information for the organization location (including apartment, suite, or building
number) that you were not able to include in I.A.6.
I.A.8. The city of the organization location.
I.A.9. The state, province, or territory of the organization location.
I.A.10. The country of the organization location.
I.A.11. The ZIP or postal code of the organization location.

Point of Contact for Organization (only complete if applicant is an organization)

I.A.12. The first name of the organization point of contact.

I.A.13.
I.A.14.
I.A.15.
I.A.16.

The middle initial of the organization point of contact, if applicable.
The last name of the organization point of contact.
The generational suffix (e.g., Jr., III) of the organization point of contact, if applicable.
The professional suffix (e.g., M.D., Ph.D.) of the organization point of contact, if applicable.

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I.A.17. The professional position title of the organization point of contact.
I.A.18. The phone number of the organization point of contact (include country code, if applicable, and area code).
I.A.19. The fax number of the organization point of contact, if applicable (include country code, if applicable, and
area code).
I.A.20. The email address of the organization point of contact.

If applicant is an individual, complete Part A fields 21–36 and proceed to Part B.

For these fields, provide the following information for the individual applicant:
I.A.21. The first name of the individual applicant.
I.A.22. The middle initial of the individual applicant, if applicable.
I.A.23. The last name of the individual applicant.
I.A.24. The submit date, or date you are formally submitting the application to FDA (e.g., submitting via the CTP
Portal, the FDA Electronic Submissions Gateway [ESG], or handed to courier).
I.A.25. The generational suffix (e.g., Jr., III) for the individual applicant, if applicable.
I.A.26. The professional suffix (e.g., M.D., Ph.D.) for the individual applicant, if applicable.
I.A.27. The professional position title of the individual applicant.
I.A.28. The street address for the individual applicant (including street number, street name and type, suffix
direction, etc.). The street address cannot be a P.O. Box.
I.A.29. Additional street address information for the individual applicant (including apartment, suite, or building
number) that you were not able to include in I.A.28.
I.A.30. The city of the individual applicant.
I.A.31. The state, province, or territory of the individual applicant.
I.A.32. The country of the individual applicant.
I.A.33. The ZIP or postal code of the individual applicant.
I.A.34. The phone number of the individual applicant (include country code, if applicable, and area code).
I.A.35. The fax number of the individual applicant, if applicable (include country code, if applicable, and area code).
I.A.36. The email address of the individual applicant.

Part B: Submission Type

I.B.1. Select only one checkbox to indicate the type of submission:
• Amendment – if selected, proceed to Section II
• General Correspondence – if selected, skip Section II and proceed to Section III
Note: If you need to submit both an amendment and general correspondence, include two separate forms.

SECTION II — AMENDMENT INFORMATION
Complete Section II if you selected “Amendment” as the submission type in Section I.B.1.

Part A: Amendment Purpose

II.A.1. List the SE Report(s) being amended in the space provided; include the FDA Submission Tracking
Number (STN) and Product (PD) Identifier, or STN.PD # (e.g., SE5679840.PD1).
II.A.2. Indicate the subject(s) of the amendment (select all that apply).

Note: If you select “Request to Withdraw the SE Report,” provide the product name and STN.PD#
of the products to be withdrawn and select the additional checkbox if the withdrawal is due to a
health or safety concern related to the tobacco product. If you select “Update to Unique Identification
Information,” submit Form FDA 3965b with the STN.PD# in additional properties. If you select
“Update Product Properties,” proceed to Section II.C.
II.A.3. Summarize the submission in the space provided if you selected one of the following options in
Section II.A.2:
• Submit Adverse Experience Report
• Change in Submission Contents
• Other

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Part B: Predicate Product Evidence

Use this section only if the predicate has not been previously reviewed by FDA .
Evidence of Commercial Marketing as of February 15, 2007:
For these fields, provide the following information regarding evidence of commercial marketing (as of February 15, 2007)
II.B.1. The type of evidence (e.g., invoice).
II.B.2. The date of evidence (in the format of mm/dd/yyyy).
II.B.3. The evidence identifier (e.g., invoice number).
II.B.4. The commercial information (e.g., UPC code, product description, item number).
II.B.5. The product quantity (as indicated by the evidence).
Business Addresses Associated with Evidence of Commercial Marketing (optional):
For these fields, provide the address(es) as reflected in the evidence demonstrating commercial marketing:
II.B.6. The street address of the physical location of the business (including street number, street name
and type, suffix direction, etc.). The street address cannot be a P.O. Box.
II.B.7. Additional street address information for the business (including apartment, suite, or building
number) that you were not able to include in II.B.6.
II.B.8. The city of the business.
II.B.9. The state, province, or territory of the business.
II.B.10. The country of the business.
II.B.11. The ZIP or postal code of the business.
II.B.12. The street address of the physical location of the business (including street number, street name
and type, suffix direction, etc.). The street address cannot be a P.O. Box.
II.B.13. Additional street address information for the business (including apartment, suite, or building
number) that you were not able to include in II.B.12.
II.B.14. The city of the business.
II.B.15. The state, province, or territory of the business.
II.B.16. The country of the business.
II.B.17. The ZIP or postal code of the business.

Part C: Update to Product Properties (if Applicable)

Complete Part C if you selected “Update Product Properties” in Section II.A.2 to amend previously submitted product
property information. This section is not for submitting changes to Unique Identification Information (see Section II.A).
Update(s) to New Product(s):
Within this table, utilize a single row for each update to a new product. Use the Continuation Page button within
the form to provide additional updates, as needed.
II.C.1. The name of the new product.
II.C.2. The STN.PD# for the new product, or FDA Submission Tracking Number (STN) and Product (PD )Identifier.
II.C.3. Choose an option from the dropdown to indicate an action: add, update, or remove (previously
submitted new product property information).
II.C.4. The name of the property.
II.C.5. The previously submitted target value.
II.C.6. The updated target value.

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Update(s) to Predicate Product(s):
Within this table, utilize a single row for each update to a predicate product. Use the Continuation Page button
within the form to provide additional updates, as needed.
II.C.7. The name of the predicate product.
II.C.8. The STN.PD# for the predicate product, or FDA Submission Tracking Number (STN) and Product
(PD) Identifier.
II.C.9. Choose an option from the dropdown to indicate an action: add, update, or remove (previously
submitted predicate product property information).
II.C.10. The name of the property.
II.C.11. The previously submitted target value.
II.C.12. The updated target value.

Part D: Cross-Referenced Content

Complete Part D if you selected “Change in Cross-Referenced Content” in Section II.A.2 for the addition, update,
or removal of any cross-referenced content. Within the table, utilize a single row for each cross-reference. Use
the Continuation Page button within the form to provide additional cross-references, as needed.
II.D.1. Provide the FDA submission tracking number (STN) for the cross-referenced submission.
II.D.2. Choose an option from the dropdown to indicate an action: add, update, or remove (the crossreferenced content).
II.D.3. Identify if the cross-reference provided in column 1 is for all products in the submission. If the crossreference is only for some of the new products in the submission, select “no” and list the name of
the product(s) that reference the cross-reference.
II.D.4. Identify what information in the cross-referenced submission you are seeking to reference for your
new submission. For example, if you have the specific file name, document name, and page number,
please list them.

Part E: Related Submissions

Complete Part E if you selected “Change in Related Submissions” in Section II.A.2 for the addition, update, or removal
of any related submissions. Within the table, utilize a single row for each related submission. Use the Continuation Page
button within the form to provide additional related submissions, as needed.
II.E.1. The FDA submission tracking number (STN) for the related submission.
II.E.2. Choose an option from the dropdown to indicate an action: add, update, or remove (the related submission).
II.E.3. Identify if the related submission provided in column 1 is for all products in the submission. If the related
submission only applies to some of the new products in the submission, select “no” and list the name of the
product(s) that reference the related submission.
II.E.4. The location within the related submission that you are seeking to reference for your new submission. For
example, list the specific file name, document name, and page number.

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

Complete Part F if you selected “Change in Tobacco Product Master File Referenced” in Section II.A.2 for the
addition, update, or removal of any referenced TPMFs. Complete one table (fields 1–6) for each TPMF. Use the
Continuation Page button within the form to provide additional TPMFs, as needed.
II.F.1. Identify the TPMF owner.
II.F.2. Provide the FDA submission tracking number (STN) of the TPMF. When a TPMF is established by FDA,
the TPMF STN is provided to the owner and can be referenced by the TPMF owner and/or an authorized
party. If the TPMF is not established at time of application submission, insert “N/A.”
II.F.3. Choose an option from the dropdown to indicate an action: add, update, or remove (the TPMF).
II.F.4. Identify if the TPMF is applicable to all products in the submission. If the TPMF is only for some of the new
products in the submission, select “no” and list the name of the product(s) that reference the TPMF.
II.F.5. Identify what information in the TPMF you are seeking to reference for the new submission(s) and which
sections in the TPMF are being referenced (e.g., all sections of the TPMF, sections I–III of the TPMF).
II.F.6. Indicate if the right of reference is included in the submission. The TPMF owner may authorize another
party to reference information contained within a TPMF through a right of reference such as a letter of
authorization (LOA).

Part G: Amendment Contents

Complete Part G to describe the items included in this amendment. For each item, provide a description of the
content and indicate the file name and location of the content.

Part H: Certification Statements

The application must contain the following certification, with the appropriate information inserted, as described in each
parenthetical, signed by an authorized representative of the applicant.
i. Statement of Affirmation
• Complete the Statement of Affirmation by providing the name and position title of the responsible official.
• The name(s) of the predicate tobacco product(s) to which the Statement of Affirmation would apply.
• Insert the signature of the responsible official and the date the statement is signed.
ii. Certification Statement for Standard SE Reports is required for all SE Reports.
• Provide the name of the responsible official, or the authorized representative who is signing the certification.
• Provide the name of the applicant being represented in the certification. Insert the name of the applicant as
identified in Section I, Part A.
• Provide the signature of the authorized representative of the applicant and the current date.

SECTION III – GENERAL CORRESPONDENCE INFORMATION
Complete Section III if you selected “General Correspondence” as the submission type in Section I.B.1.

Submission Information for General Correspondence
III.1.
III.2.

Select the checkbox(es) to indicate the subject(s) of the Correspondence.
Summarize the submission in the space provided, if you selected one of the following options in
Section III.1.
• Submit Adverse Experience Report
• Request to Withdraw Previously Submitted General Correspondence
• Other

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Part A: Add, Update, or Remove Applicant Information or Point of Contact (Optional)

Complete Part A if you selected “Change in Authorized Representative, U.S. Agent, Manufacturer, or Point of
Contact” in Section III.1. for the addition, update, or removal of contact/address information for the applicant or
another point of contact. Use the Continuation Page button within the form to list additional contact information
updates, as needed.
III.A.1. Select only one option from the dropdown to indicate an action: add, update, or remove (the contact/
address information).
• Add – Select to add a new party; if “Add” is selected, provide all contact information for the new
party in fields 23–40. FDA may contact this new party to discuss the submission.
• Update – Select to change the contact information for an existing party; if “Update” is selected,
provide the contact information as previously provided to FDA in fields 5–22 and the updated
contact information in fields 23–40. FDA will update the Applicant Identification address or contact
information that was previously submitted based on the updated information in field 23-40.
o Additionally, provide a brief description of the update in the space provided.
• Remove – Select to request that FDA remove an existing party on record. If “Remove” is selected,
provide only the name of the party (Person’s Name and/or Organization’s Name) to be removed in
fields 5–7 and/or 11. FDA will no longer contact the removed party to discuss to the submission.
III.A.2. Select only one checkbox to indicate the type of contact whose information should be added
updated/removed.
III.A.3. Indicate whether this change is applicable for all current FDA submissions. If the change is only for
some current submissions, select “no” and list the STN.PD#s that this change is applicable to.
III.A.4. Indicate the date of the effective change.
Complete fields 5–22 with contact information for the current, existing party.
III.A.5. The first name of the current party.
III.A.6. The middle initial of the current party, if applicable.
III.A.7. The last name of the current party.
III.A.8. The generational suffix (e.g., Jr., III) for the current party, if applicable.
III.A.9. The professional suffix (e.g., M.D., Ph.D.) for the current party, if applicable.
III.A.10. The professional position title of the current party.
III.A.11. The organization name representing the current party.
III.A.12. The organization FDA-assigned Facility Establishment Identifier (FEI) number, if applicable.
Note: To obtain or retrieve an FEI number, applicants can use the FEI Search Portal at
https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login, and/or contact FEI Search
Portal support at feiportal@fda.hhs.gov for any FEI number-related questions.
III.A.13. The organization D&B DUNS number, if applicable.
III.A.14. The street address for the current party (including street number, street name and type, suffix
direction, etc.). The street address cannot be a P.O. Box.
III.A.15. Additional street address information for the current party (including apartment, suite, or building
number) that you were not able to include in III.A.14.
III.A.16. The city of the current party.
III.A.17. The state, province, or territory of the current party.
III.A.18. The country of the current party
III.A.19. The ZIP or postal code of the current party.
III.A.20. The phone number of the current party (include country code, if applicable, and area code).
III.A.21. The fax number of the current party, if applicable (include country code, if applicable, and area code).
III.A.22. The email address of the current party.
Complete fields 23–40 with contact information for the new/updated party.
III.A.23. The first name of the new party.
III.A.24. The middle initial of the new party, if applicable.
III.A.25. The last name of the new party.
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III.A.26.
III.A.27.
III.A.28.
III.A.29.
III.A.30.

III.A.31.
III.A.32.
III.A.33.
III.A.34.
III.A.35.
III.A.36.
III.A.37.
III.A.38.
III.A.39.
III.A.40.

The generational suffix (e.g., Jr., III) for the new party, if applicable.
The professional suffix (e.g., M.D., Ph.D.) for the new party, if applicable.
The professional position title of the new party.
The organization name representing the new party.
The organization FDA-assigned Facility Establishment Identifier (FEI) number, if applicable.
Note: To obtain or retrieve an FEI number, applicants can use the FEI Search Portal at
https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login, and/or contact FEI Search
Portal support at feiportal@fda.hhs.gov for any FEI number-related questions.
The organization D&B DUNS number, if applicable.
The street address for the new party (including street number, street name and type, suffix direction, etc.).
The street address cannot be a P.O. Box.
Additional street address information for the new party (including apartment, suite, or building
number) that you were not able to include in III.A.32.
The city of the new party.
The state, province, or territory of the new party.
The country of the new party.
The ZIP or postal code of the new party.
The phone number of the new party (include country code, if applicable, and area code).
The fax number of the new party, if applicable (include country code, if applicable, and area code).
The email address of the new party.

Part B: Request for Change in Ownership

Complete Part B if you selected “Request for Change in Ownership” in Section III.1. Use the Continuation
Page button within the form to list additional applications, submissions, and/or product names to be
transferred, as needed.
A change in or transfer of ownership is for applicants (companies) that manufacture or sell tobacco products
and transfers 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 information
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 must submit all information as outlined in Section III, Part B as applicable to their role in the transfer.
Note: The former applicant may select checkboxes for former and new if they are submitting 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 upon receipt of the request from the
former applicant.
For change in ownership requests that include Premarket Tobacco Product Applications (PMTA) or Substantial
Equivalence (SE) Reports, FDA Form 4057a and/or FDA Form 3965a are required. A single form can be
provided for transfer requests that include multiple submission types. Changes in ownership that do not
include SE or PMTA submissions do not require FDA Form 4057a or FDA Form 3965a, though we encourage
the use of forms.

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The following are submission types that FDA will transfer:
• Marketing Applications
o 910 Premarket Tobacco Application (PMTA)
o 905(j)(1) Substantial Equivalence Reports (SE)
o 905(j)(3) Exemption from Substantial Equivalence (EX)
o 911 Modified Risk Tobacco Product Application (MRTPA)
• Submissions
o 910(g) Investigational 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 Plans (WP)
o Other Media Notifications (OM)
III.B.1. Indicate the applications, submissions, and product names to be transferred, including the STN, PD
numbers, and product names.
III.B.2. Indicate the effective date of the transfer.
III.B.3. Select the checkbox(es) to indicate the items included in the transfer request.

Part C: Meeting Request

Complete Part C if you selected “Meeting Request” in Section III.1. This is a request for a formal meeting which
may include topics such as study design, earlier versions of the product, etc. Use the Continuation Page button
within the form to list additional products, as needed.
III.C.1.
III.C.2.
III.C.3.
III.C.4.
III.C.5.
III.C.6.
III.C.7.
III.C.8.
III.C.9.

The topic of the meeting.
The purpose of the meeting.
The format of the meeting.
Indicate whether the meeting information package is included. If not, select “No” and provide the
expected date of the submission.
List the name of the product(s) to be discussed at the meeting.
The use of the product.
The product category (if applicable).
The STN.PD# of the product (if applicable).
Select the checkbox(es) to indicate the items included in the meeting request.

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File Type	application/pdf
File Modified	2024-10-28
File Created	2024-10-25