Form FDA 3965 Form FDA 3965 Tobacco Substantial Equivalence Report Submission

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

TOBACCO SUBSTANTIAL EQUIVALENCE
REPORT SUBMISSION

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 required to respond
to a collection of information unless it displays a valid OMB control number. The valid
OMB control number for this information collection 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 [email protected].

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 IDENTIFICATION
1. Identify whether the applicant is a manufacturer OR importer (select one)2:

□

□

Manufacturer

Importer

Part A: Applicant Information2
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 and proceed to Part B.
1. Organization Name

2. Other Organization Name (if applicable)

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

4. Organization D&B DUNS® Number

5. Submit Date (mm/dd/yyyy)

6. Street Address Line 1

8. City

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

9. State, Province, or Territory

10. Country

11. ZIP or Postal Code

Point of Contact for Organization
12. First Name

15. Generational Suffix

18. Phone Number

13. Middle Initial

16. Professional Suffix

14. Last Name

17. Position Title

19. Fax Number

20. Email Address

1

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.

2

Required content and format as per 21 CFR 1107.18.

FORM FDA 3965 (4/24)

Page 1 of 31

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

25. Generational
Suffix

22. Middle Initial 23. Last Name

26. Professional Suffix

27. Position Title

28. Street Address Line 1

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

30. City

34. Phone Number

24. Submit Date (mm/dd/yyyy)

31. State, Province, or Territory

35. Fax Number

32. Country

33. ZIP or Postal Code

36. Email Address

Part B: Authorized Representative2 or U.S. Agent Information2

□ 1. Select if authorized representative or U.S. agent is the same as the applicant identified in Part A. If the same, skip
Part B fields 2–18 and proceed to Part C.
2. Identify the authorized representative OR a U.S. agent (select one):

□ Authorized representative (responsible official authorized to represent the domestic applicant)
OR

□ U.S. agent (responsible official who either resides or maintains a place of business in the U.S. who is authorized to
represent the foreign applicant)

Contact Information for the Authorized Representative or U.S. Agent
3. First Name

6. Generational Suffix

9. Organization Name

4. Middle Initial

7. Professional Suffix

8. Position Title

10. Street Address Line 1

12. City

13. State, Province, or Territory

16. Phone Number

17. Fax Number

FORM FDA 3965 (4/24)

5. Last Name

11. Street Address Line 2 (Apt., Suite,
Bldg., #)
14. Country

18. Email Address

Page 2 of 31

15. ZIP or Postal Code

Part C: Alternate Point of Contact Information (Optional)

Use the Continuation Page button below to list additional alternate points of contact.

1. Select alternate:

□ Applicant □ Authorized representative □ U.S. agent □ Other
2. First Name

3. Middle Initial

5. Generational Suffix

6. Professional Suffix

8. Organization Name

4. Last Name

7. Position Title

9. Street Address Line 1

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

11. City

12. State, Province, or Territory

15. Phone Number

16. Fax Number

13. Country

14. ZIP or Postal Code

17. Email Address

Continuation Page
for Part C

Part D: Manufacturer Information2

Use the Continuation Page button below to list additional manufacturers.

New Product(s) Manufacturer

□ 1. Select here if New Product Manufacturer is the same as applicant provided in Part A; if the same, skip fields 2–19
and proceed to Predicate Product(s) Manufacturer field 20.

2. Organization Name

3. Organization FDA-Assigned FEI Number (if
applicable)

5. Street Address Line 1

7. City

4. Organization D&B DUNS® Number
(if applicable)

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

8. State, Province, or Territory

9. Country

10. ZIP or Postal Code

Point of Contact for New Product(s) Manufacturer
11. First Name

16. Position Title

12. Middle
Initial

13. Last Name

17. Phone Number

14. Generational Suffix

18. Fax Number

15. Professional Suffix

19. Email Address

Continuation Page
for Part D

FORM FDA 3965 (4/24)

Page 3 of 31

Predicate Product(s) Manufacturer

□ 20. Select here if Predicate Product Manufacturer is the same as Applicant identified in Part A; skip Part D fields
21–39 and proceed to Part E.

□ 21. Select here if Predicate Product Manufacturer is the same as New Product(s) Manufacturer identified in Part D
2–19; skip Part D fields 22–39 and proceed to Part E.

22. Organization Name

23. Organization FDA-Assigned FEI Number
(if applicable)

25. Street Address Line 1

24. Organization D&B DUNS® Number
(if applicable)

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

27. City

28. State, Province, or Territory

29. Country

30. ZIP or Postal Code

Point of Contact for Predicate Product(s) Manufacturer
31. First Name

32. Middle
Initial

36. Position Title

33. Last Name

37. Phone Number

34. Generational 35. Professional Suffix
Suffix

38. Fax Number

39. Email Address

Continuation Page
for Part D

Part E: Manufacturer/Packaging/Storage/Control Facility Information (Optional)
Use the Continuation Page button below for each additional site.

1. Select type of site:

□ Manufacturer

□ Contract manufacturer

□ Repacker/relabeler □ Other ______________________

2. Alternate manufacturing site for:

□ New product(s) manufacturer □ Predicate product(s) manufacturer □ Both new and predicate

product(s) manufacturer

3. Organization Name

4. Organization FDA-Assigned FEI Number (if
applicable)

5. Organization D&B DUNS® Number (if
applicable)

6. Division Name (if applicable)

7. Street Address Line 1

9. City

FORM FDA 3965 (4/24)

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

10. State, Province, or Territory

Page 4 of 31

11. Country

12. ZIP or Postal Code

Point of Contact for Manufacturer/Packaging/Storage/Control Facility Information
13. First Name

18. Position Title

14. Middle
Initial

15. Last Name

19. Phone Number

16. Generational
Suffix

20. Fax Number

17. Professional Suffix

21. Email Address

Continuation Page
for Part E
SECTION II – NEW PRODUCT(S) INFORMATION2
Use required Form FDA 3965b - Substantial Equivalence Product Application Group Product Submission
Spreadsheet to provide new and predicate product information. The form is available on the FDA website.
SECTION III – PREDICATE PRODUCT(S) ELIGIBILITY2

Part A: Predicate Product(s) Status
1. Select all statements below that apply to the predicate tobacco product(s). Complete all necessary information for
each statement.

□ Previously Found SE

–If selected, skip Part B.

□ PTP Determined

–If selected, complete the I. Certification Statement of Affirmation in Section VI.

□ Claimed PTP

–If selected, complete Part B and the I. Certification Statement of Affirmation in Section VI.

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

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

2. Date of Evidence
(mm/dd/yyyy)
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 3965 (4/24)

15. State, Province, or
Territory

11. ZIP or Postal Code

13. (Ship to) Street Address Line 2 (Apt., Suite,
Bldg., #)
16. Country

Page 5 of 31

17. ZIP or Postal Code

SECTION IV – SUBMISSION INFORMATION

Part A: General Submission Information
Applicants may bundle groups of SE Reports for their new product(s) in the same product category and subcategory where the
proposed modifications are the same.

1. Type of Application² Select only one.

□ Same Characteristics Reports

□ Different Characteristics Reports

2. Submission Summaries² As described in 21 C.F.R. 1107. 18(d), please summarize the submission below.

3. Proposed modification(s) to the tobacco product(s) (as compared to the predicate tobacco product[s])²
Select all that apply.

□ Tobacco Blend

□ Design

□ Materials

□ Container Closure System

□ Heating Source

□ Product Quantity

□ Composition

□ Other (Specify):___________

□ Ingredients (Specify below):

FORM FDA 3965 (4/24)

Page 6 of 31

Part B: Cross-Referenced Information (Optional)

Complete one row per Cross-Referenced submission. Use the Continuation Page button below to list additional Cross-References.

1. Cross-Referenced STN

2. Is the content relevant to all
products within this submission?

3. Information and sections to be
referenced (e.g., all sections,
sections I–IV)

□ 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 Part B

FORM FDA 3965 (4/24)

Page 7 of 31

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

Complete fields 1–5 for each TPMF Cross-Reference. Use the Continuation Page button below to list additional TPMFs.

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

Continuation Page
for Part C

FORM FDA 3965 (4/24)

Page 8 of 31

Part D: Formal Meetings Held with FDA Pertaining to the New Product(s)2 (If Applicable)
Indicate one meeting per row. As needed, enter the STN and meeting held date.
Use the Continuation Page button below to list additional meetings.

1. Submission STN

2. Meeting Held Date
(mm/dd/yyyy)

2. Is the meeting relevant to all products within this
submission?

□ 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 Part D

FORM FDA 3965 (4/24)

Page 9 of 31

SECTION V – APPLICATION CONTENTS
This application contains the following items (select all that apply and indicate file name and location of application content).

Part D: Comparisons2

Part A: Administrative Content
1.

□

(New vs. Predicate Tobacco Product)

Cover Letter

Location:
2.

□

1.

3.

4.

□

2.

Unique Identification of New Tobacco
Product(s) and Predicate Tobacco Product(s)
(Form FDA 3965b - Substantial Equivalence
Product Application Group Product Submission
Spreadsheet)2

□ Heating Source
Location:

Location:

□

□

Ingredients, tobacco

Ingredients, non-tobacco

3.

English Translations for Non-English
Information²

4.

□

Part B: Product Information2

2.

□ Information on Manufacturing Process
Location: ____________________

3.

□ Statement of Compliance with Applicable

5.

□ Health Information Summary

□

Stability

Location:
6.

□

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

Location:

Location: ______________________

1.

Other features

Location:

Tobacco Product Standards

Part C: Health and Research2 (Select only one)

Materials

HPHCs
Other (specify): _________________

□ List of Ingredients
Location:

Composition

Location:

Location:

1.

Product Design

Location:

Comprehensive Index2 and Table of Contents2

Location:

□

Part E: Environmental Considerations2 (Select only one)
1.

Location:

□

Environmental Assessment

Location:
OR

2.

□ Health Information Statement
Location:

FORM FDA 3965 (4/24)

OR
2.

□

Claim for Categorical Exclusion

Location:

Page 10 of 31

SECTION VI – CERTIFICATION STATEMENTS
The SE Report must contain the following certification, with the appropriate information inserted (as indicated by the
parenthetical text), and be signed by an authorized representative of the applicant:
i.
ii.
iii.
iv.

Certification Statement of Affirmation
Certification Statement for SE Report
Certification Statement for Same Characteristics SE Report
Certification Statement regarding availability of health information

For the following section, insert the name of an authorized representative(s) or U.S. agent as identified in Section I Part
B or Part C, the name of the organization being represented as identified in Section I Part A, the individual new tobacco
product(s), and the name of the predicate tobacco product(s). Complete the information for all applications. If you choose
to print and wet sign the certification statements, upload them as a separate document from Form FDA 3965 to maintain
the dynamic fields in Adobe and ensure all content is available for FDA to process, read, review, and archive.

i. Certification Statement of Affirmation:
I, (name 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 of predicate tobacco product(s)

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

ii. Certification Statement for SE Report2:
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)

FORM FDA 3965 (4/24)

Page 11 of 31

iii. Certification Statement for Same Characteristics SE Report2:
I, (name of responsible official)

, on behalf of (name of company)

, certify that (name of new tobacco product) _______________________________
has the following modification(s) as compared to (name of predicate tobacco product)
due to the following modification(s): (describe modification(s), e.g., change in product quantity or change in
container closure system) _________________________________________________________________.
Aside from these modifications, the characteristics of (name of new tobacco product) ____________________
and (name of predicate tobacco product) _________________________ are identical. I certify that (name
of company) _________________________understands this means there is no other modification to the
materials, ingredients, design features, heating source, or any other feature. I also certify that (name of
company) _________________________will maintain records to support the comparison information in 21 CFR
1107.19 that substantiate the accuracy of this statement for the period of time required in 21 CFR 1107.58, and
ensure that such records remain readily available to FDA upon request.
1. Signature and Date (mm/dd/yyyy)

iv. Certification Statement Regarding Availability of Health Information2:
910(a)(4) Health Information Statement
I, (name of responsible official)

, certify that, in my capacity as (the position held

in company by person required to submit the SE Report, preferably the responsible official of the applicant)
_____________________________ of (name of company)_________________________________, I will make
available, upon request, the information identified in 21 CFR 1107.18(j)(3) within 30 calendar days of a request.
1. Signature and Date (mm/dd/yyyy)

FORM FDA 3965 (4/24)

Page 12 of 31

SECTION VII – APPENDICES
CONTINUATION PAGES
Appendix A: Alternate Point of Contact Information
Submit a single Form FDA 3965 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 I, Part C: Alternate Point of Contact Information (Optional)
1. Select alternate:

□ Applicant □ Authorized representative □ U.S. agent □ Other
2. First Name

5. Generational Suffix

8. Organization Name

11. City

15. Phone Number

3. Middle Initial

4. Last Name

6. Professional Suffix

7. Position Title

9. Street Address Line 1

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

12. State, Province, or 13. Country
Territory
16. Fax Number

14. ZIP or Postal Code

17. Email Address

SECTION I, Part C: Alternate Point of Contact Information (Optional)
1. Select alternate:

□ Applicant □ Authorized representative □ U.S. agent □ Other
2. First Name

5. Generational Suffix

8. Organization Name

11. City

15. Phone Number

FORM FDA 3965 (4/24)

3. Middle Initial

4. Last Name

6. Professional Suffix

7. Position Title

9. Street Address Line 1

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

12. State, Province, or 13. Country
Territory
16. Fax Number

14. ZIP or Postal Code

17. Email Address

Page 13 of 31

Appendix B: Manufacturer Information
Submit a single Form FDA 3965 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 I, Part D: Manufacturer Information
New Product(s) Manufacturer

□ 1. Select here if Manufacturer is the same as Applicant address provided in Part A; if the same, skip fields 2–19 and
proceed to Predicate Product(s) Manufacturer field 20.

2. Organization Name

3. Organization FDA-Assigned FEI
Number (if applicable)

5. Street Address Line 1

7. City

4. Organization D&B DUNS® Number (if
applicable)

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

8. State, Province, or
Territory

9. Country

10. ZIP or Postal Code

Point of Contact for New Product(s) Manufacturer
11. First Name

12. Middle
Initial

16. Position Title

13. Last Name

17. Phone Number

14. Generational
Suffix

18. Fax Number

15. Professional Suffix

19. Email Address

Predicate Product(s) Manufacturer

□ 20. Select here if Predicate Manufacturer is the same as Applicant identified in Part A; skip Part D fields 21–39 and
proceed to Part E.

□ 21. Select here if Predicate Manufacturer is the same as New Product(s) Manufacturer identified in Part D 2–19; skip
Part D fields 20–39 and proceed to Part E.

22. Organization Name

23. Organization FDA-Assigned FEI
Number (if applicable)

25. Street Address Line 1

27. City

24. Organization D&B DUNS® Number (if
applicable)

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

28. State, Province, or
Territory

29. Country

30. ZIP or Postal Code

Point of Contact for Predicate Product(s) Manufacturer
31. First Name

36. Position Title

FORM FDA 3965 (4/24)

32. Middle
Initial

33. Last Name

37. Phone Number

38. Fax Number

Page 14 of 31

34. Generational
Suffix

35. Professional Suffix

39. Email Address

SECTION I, Part D: Manufacturer Information
New Product(s) Manufacturer

□ 1. Select here if Manufacturer is the same as Applicant address provided in Part A; if the same, skip fields 2–19 and
proceed to Predicate Product(s) Manufacturer field 20.

2. Organization Name

3. Organization FDA-Assigned FEI
Number (if applicable)

5. Street Address Line 1

7. City

4. Organization D&B DUNS® Number (if
applicable)

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

8. State, Province, or
Territory

9. Country

10. ZIP or Postal Code

Point of Contact for New Product(s) Manufacturer
11. First Name

12. Middle
Initial

16. Position Title

13. Last Name

17. Phone Number

14. Generational
Suffix

18. Fax Number

15. Professional Suffix

19. Email Address

Predicate Product(s) Manufacturer

□ 20. Select here if Predicate Manufacturer is the same as Applicant identified in Part A; skip Part D fields 21–39 and
proceed to Part E.

□ 21. Select here if Predicate Manufacturer is the same as New Product(s) Manufacturer identified in Part D 2–19; skip
Part D fields 20–39 and proceed to Part E.

22. Organization Name

23. Organization FDA-Assigned FEI
Number (if applicable)

25. Street Address Line 1

27. City

24. Organization D&B DUNS® Number (if
applicable)

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

28. State, Province, or
Territory

29. Country

30. ZIP or Postal Code

Point of Contact for Predicate Product(s) Manufacturer
31. First Name

36. Position Title

FORM FDA 3965 (4/24)

32. Middle
Initial

33. Last Name

37. Phone Number

38. Fax Number

Page 15 of 31

34. Generational
Suffix

35. Professional Suffix

39. Email Address

Appendix C: Manufacturer/Packaging/Storage/Control Facility Information
Submit a single Form FDA 3965 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 I, Part E: Manufacturer/Packaging/Storage/Control Facility Information
1. Select type of site:

□ Manufacturer

□ Contract manufacturer

□ Repacker/relabeler □ Other ______________________

2. Alternate manufacturing site for:

□ New product(s) manufacturer □ Predicate product(s) manufacturer □ Both new and predicate

product(s) manufacturer

3. Organization Name

4. Organization FDA-Assigned FEI Number (if
applicable)

5. Organization D&B DUNS® Number (if
applicable)

6. Division Name (if applicable)

7. Street Address Line 1

9. City

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

10. State, Province, or Territory

11. Country

12. ZIP or Postal Code

Point of Contact for Manufacturer/Packaging/Storage/Control Facility Information
13. First Name

18. Position Title

FORM FDA 3965 (4/24)

14. Middle
Initial

15. Last Name

19. Phone Number

20. Fax Number

Page 16 of 31

16. Generational
Suffix

17. Professional Suffix

21. Email Address

Appendix D: Cross-Referenced Information
Submit a single Form FDA 3965 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.
1. Cross-Referenced STN

2. Is the content relevant to all
products within this submission?

□ 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]):

FORM FDA 3965 (4/24)

Page 17 of 31

3. Information and sections to be
referenced (e.g., all sections,
sections I–IV)

Appendix E: Referenced Tobacco Product Master File(s) (TPMF)
Submit a single Form FDA 3965 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.
1. TPMF Owner
3. Is the content applicable to all
products within this submission?

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

FORM FDA 3965 (4/24)

Page 18 of 31

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

FORM FDA 3965 (4/24)

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

□ Yes

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

□ Yes

□ No

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

FORM FDA 3965 (4/24)

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Appendix F: Formal Meetings Held with FDA Pertaining to the New Product(s)2
Submit a single Form FDA 3965 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.
1. Submission STN

FORM FDA 3965 (4/24)

2. Meeting Held Date
(mm/dd/yyyy)

3. Is the content relevant to all products within this
submission?

□ 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]):

Page 21 of 31

Appendix G: Instructions for Completion of SE Form
This form and the instructions for use are solely intended to provide the applicant an organized format with which to
supply information required for submission of a Substantial Equivalence (SE) Report.
Form FDA 3965 – Tobacco Substantial Equivalence Report Submission is a required form for applicants to use when
submitting an SE Report 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. For more
information on what to include in an SE submission, see 21 CFR 1107.18.

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: Authorized Representative or U.S. Agent Information
• Part C: Alternate Point of Contact Information
• Part D: Manufacturer Information
• Part E: Manufacturer/Packaging/Storage/Control Facility Information

Complete Field 1 for all applicants and proceed to Part A.

I.1. Select only one checkbox to indicate whether the applicant is a manufacturer or importer:
• Manufacturer – manufactures, fabricates, assembles, processes, or labels a tobacco product
OR
• Importer – imports a finished tobacco product for sale or distribution in the United States

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 [email protected] 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,
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.
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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.
I.A.17.
I.A.18.
I.A.19.

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.
The professional position title of the organization point of contact.
The phone number of the organization point of contact (include country code, if applicable, and area code).
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, 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: Contact Information for the Authorized Representative or U.S. Agent

Part B should include information for either an authorized representative OR U.S. agent (for a foreign applicant).
For these fields, provide the following information for the authorized representative or U.S. agent:
I.B.1. Select the checkbox if the authorized representative/U.S. agent information is the same as the
applicant information identified in Part A. If the same, skip Part B fields 2–18 and proceed to Part C.
I.B.2. Select only one checkbox to indicate whether you are completing Part B for either an authorized
representative or an U.S. agent.
I.B.3. The first name of the authorized representative or the U.S. agent.
I.B.4. The middle initial of the authorized representative or the U.S. agent, if applicable.
I.B.5. The last name of the authorized representative or the U.S. agent.
I.B.6. The generational suffix (e.g., Jr., III) of the authorized representative or the U.S. agent, if applicable.
I.B.7. The professional suffix (e.g., M.D., Ph.D.) of the authorized representative or the U.S. agent, if applicable.
I.B.8. The professional position title of the authorized representative or the U.S. agent.
I.B.9. The legal name of the organization that the authorized representative or U.S. agent is associated with,
if applicable.
FORM FDA 3965 (4/24)

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I.B.10. The street address for the authorized representative or the U.S. agent (including street number,
street name and type, suffix direction, etc.). The street address cannot be a P.O. Box.
I.B.11. Additional street address information for the authorized representative or the U.S. agent (including
apartment, suite, building number, #) that you were not able to include in I.B.10.
I.B.12. The city of the authorized representative or the U.S. agent.
I.B.13. The state, province, or territory of the authorized representative or the U.S. agent.
I.B.14. The country of the authorized representative or the U.S. agent.
I.B.15. The ZIP or postal code of the authorized representative or the U.S. agent.
I.B.16. The phone number of the authorized representative or the U.S. agent (include country code, if applicable,
and area code).
I.B.17. The fax number of the authorized representative or the U.S. agent, if applicable (include country code, if
applicable, and area code).
I.B.18. The email address of the authorized representative or the U.S. agent.

Part C: Alternate Point of Contact Information (Optional)

Part C is an optional space for information for individuals not previously listed in Section I Parts A and/or B. Use
the Continuation Page button within the form for additional alternate points of contact, as needed.
For these fields, provide the following information for the alternate point of contact:
I.C.1. Indicate whether the alternate point of contact is one of the following:
• Applicant
• Authorized representative*
• U.S. agent*
• Other
*Note: Only contacts listed as the authorized representative and/or U.S. agent are authorized to act
on behalf of the applicant for the submission.
I.C.2.
I.C.3.
I.C.4.
I.C.5.
I.C.6.
I.C.7.
I.C.8.
I.C.9.
I.C.10.
I.C.11.
I.C.12.
I.C.13.
I.C.14.
I.C.15.
I.C.16.
I.C.17.

The first name of the individual.
The middle initial of the individual, if applicable.
The last name of the individual.
The generational suffix (e.g., Jr., III) for the individual, if applicable.
The professional suffix (e.g., M.D., Ph.D.) for the individual, if applicable.
The professional position title of the individual.
The legal name of the organization of the individual, if applicable.
The street address for the individual (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 individual (including apartment, suite, building number, #)
that you were not able to include in I.C.9.
The city of the individual.
The state, province, or territory of the individual.
The country of the individual.
The ZIP or postal code of the individual.
The phone number of the individual (include country code, if applicable, and area code).
The fax number of the individual (include country code, if applicable, and area code).
The email address of the individual

FORM FDA 3965 (4/24)

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Part D: Manufacturing Information
Manufacturer (of New Product)

Part D fields 1–19 apply to the manufacturer of the NEW tobacco product. In field 1, indicate if the new product
manufacturer is the same as the applicant (as identified in Section I Part A). If the same, skip Part D fields 2–19 and
proceed to Part D field 20.

New Product(s) Manufacturer
I.D.1.

Select the checkbox if the manufacturer (of the new product) and applicant information is the same. If the
same, skip Part D fields 2–19.
I.D.2. The legal name of the manufacturer as it appears in the manufacturer’s Dun & Bradstreet Data Universal
Numbering System D-U-N-S® (D&B DUNS®) number.
I.D.3. The manufacturer 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 or click here, and/or contact
FEI Search Portal support at [email protected] for any FEI number-related questions.
I.D.4. The manufacturer 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.D.5. The street address for the manufacturer (including street number, street name and type, suffix direction,
etc.). The street address cannot be a P.O. Box.
I.D.6. Additional street address information for the manufacturer location (including apartment, suite, building
number, #) that you were not able to include in I.D.5.
I.D.7. The city where the manufacturer is located.
I.D.8. The state, province, or territory where the manufacturer is located.
I.D.9. The country where the manufacturer is located.
I.D.10. The ZIP or postal code where the manufacturer is located.

Point of Contact for New Product(s) Manufacturer
I.D.11.
I.D.12.
I.D.13.
I.D.14.
I.D.15.
I.D.16.
I.D.17.
I.D.18.

The first name of the manufacturer point of contact.
The middle initial of the manufacturer point of contact, if applicable.
The last name of the manufacturer point of contact.
The generational suffix (e.g., Jr., III) of the manufacturer point of contact, if applicable.
The professional suffix (e.g., M.D., Ph.D.) of the manufacturer point of contact, if applicable.
The professional position title of the manufacturer point of contact.
The phone number of the manufacturer point of contact (include country code if applicable and area code).
The fax number of the manufacturer point of contact, if applicable (include country code if applicable
and area code).
I.D.19. The email address of the manufacturer point of contact.

Predicate Product(s) Manufacturer
Part D fields 20–39 apply to the manufacturer of the PREDICATE tobacco product. In fields 20 and 21, indicate if
the predicate product manufacturer is the same as the applicant (as identified in Section I Part A) or the new product
manufacturer (as identified in Section I Part D fields 2–19). Only complete the rest of this section (fields 22–39) if the
manufacturer of the predicate product is different from the applicant and different from the manufacturer of the new
product.
I.D.20. Select the checkbox if the manufacturer of the predicate product and applicant information is the same.
If the same, skip Part D fields 21–39.
I.D.21. Select the checkbox if the manufacturer of the predicate product and manufacturer of the new product
information is the same. If the same, skip Part D fields 22–39.
I.D.22. The legal name of the manufacturer as it appears in the manufacturer’s Dun & Bradstreet Data Universal
Numbering System D-U-N-S® (D&B DUNS®) number.
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I.D.23. The manufacturer 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 or click here, and/or
contact FEI Search Portal support at [email protected] for any FEI number-related questions.
I.D.24. The manufacturer 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.D.25. The street address for the manufacturer (including street number, street name and type, suffix direction,
etc.). The street address cannot be a P.O. Box.
I.D.26. Additional street address information for the manufacturer location (including apartment, suite, building
number, #) that you were not able to include in I.D.25.
I.D.27. The city where the manufacturer is located.
I.D.28. The state, province, or territory where the manufacturer is located.
I.D.29. The country where the manufacturer is located.
I.D.30. The ZIP or postal code where the manufacturer is located.

Point of Contact for Manufacturer (of Predicate Product)
I.D.31.
I.D.32.
I.D.33.
I.D.34.
I.D.35.
I.D.36.
I.D.37.
I.D.38.

The first name of the manufacturer point of contact.
The middle initial of the manufacturer point of contact, if applicable.
The last name of the manufacturer point of contact.
The generational suffix (e.g., Jr., III) for the of the manufacturer point of contact, if applicable.
The professional suffix (e.g., M.D., Ph.D.) of the manufacturer point of contact, if applicable.
The professional position title of the manufacturer point of contact.
The phone number of the manufacturer point of contact (include country code if applicable and area code).
The fax number of the manufacturer point of contact, if applicable (include country code if applicable
and area code).
I.D.39. The email address of the manufacturer point of contact.

Part E: Manufacturer/Packaging/Storage/Control Facility Information (Optional)

Use Part E to provide additional site information for the raw materials and/or components used in the manufacture
of the finished new and/or predicate products (e.g., contract, processor of primary material, component fabricator,
labeling service provider, repackaging by third party). Use the Continuation Page button within the form for
additional sites, as needed.
For these fields, provide the following information for the Manufacturer/Packaging/Storage/Control Facility:
I.E.1. Select the appropriate checkbox to indicate the type of site.
I.E.2. Indicate if the additional manufacturing site is for the new product manufacturer, predicate product
manufacturer, or both.
I.E.3. The organization name for the Manufacturer/Packaging/Storage/Control Facility (required by 21 CFR
1107.18(c)(8)).
I.E.4. The manufacturer FDA-assigned Facility Establishment Identifier (FEI) number, if applicable
(required by 21 CFR 1107.18(c)(8)).
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 or click here, and/or contact
FEI Search Portal support at [email protected] for any FEI number-related questions.
I.E.5. The manufacturer 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, at their website https://www.dnb.com/duns/get-a-duns.html, or click here.
I.E.6. The Manufacturer/Packaging/Storage/Control Facility division name, if applicable (required by 21 CFR
1107.18(c)(8)).
I.E.7. The street address for the Manufacturer/Packaging/Storage/Control Facility site (include street number,
street name, and street type, and suffix direction, etc.) (required by 21 CFR 1107.18(c)(8)).
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I.E.8.

Additional street address information (including apartment, suite, building number, #) that you were not
able to include in I.E.7. (required by 21 CFR 1107.18(c)(8)).
I.E.9. The city where the Manufacturer/Packaging/Storage/Control Facility is located (required by 21 CFR
1107.18(c)(8)). The street address cannot be a P.O. Box.
I.E.10. The state, province, or territory where the Manufacturer/Packaging/Storage/Control Facility is located
(required by 21 CFR 1107.18(c)(8)).
I.E.11. The country where the Manufacturer/Packaging/Storage/Control Facility is located (required by 21 CFR
1107.18(c)(8)).
I.E.12. The ZIP or postal code where the Manufacturer/Packaging/Storage/Control Facility is located (required
by 21 CFR 1107.18(c)(8)).

Point of Contact Information for Manufacturer/Packaging/Storage/Control Facility

For these fields, provide the following information for the Manufacturer/Packaging/Storage/Control Facility point of contact.
I.E.13. The first name of the Manufacturer/Packaging/Storage/Control Facility point of contact (required by
21 CFR 1107.18(c)(8)).
I.E.14. The middle initial of the Manufacturer/Packaging/Storage/Control Facility point of contact, if applicable
(required by 21 CFR 1107.18(c)(8)).
I.E.15. The last name of the Manufacturer/Packaging/Storage/Control Facility point of contact (required by 21
CFR 1107.18(c)(8)).
I.E.16. The generational suffix (e.g., Jr., III) of the Manufacturer/Packaging/Storage/Control Facility point of
contact, if applicable.
I.E.17. The professional suffix (e.g., M.D., Ph.D.) of the Manufacturer/Packaging/Storage/Control Facility
point of contact, if applicable.
I.E.18. The position title of the Manufacturer/Packaging/Storage/Control Facility point of contact, if
applicable (required by 21 CFR 1107.18(c)(8)).
I.E.19. The phone number of the Manufacturer/Packaging/Storage/Control Facility point of contact (include
country code if applicable and area code) (required by 21 CFR 1107.18(c)(8)).
I.E.20. The fax number of the Manufacturer/Packaging/Storage/Control Facility point of contact, if
applicable (include country code if applicable and area code) (required by 21 CFR 1107.18(c)(8)).
I.E.21. The email address of the Manufacturer/Packaging/Storage/Control Facility point of contact
(required by 21 CFR 1107.18 (c)(8)).

SECTION II — NEW TOBACCO PRODUCT INFORMATION
Use Form FDA 3965b - Substantial Equivalence Product Application Group Product Submission Spreadsheet
available on the FDA website to provide new and predicate product information.

SECTION III – PREDICATE PRODUCT ELIGIBILITY

Part A: Predicate Product(s) Status
III.A.1.

Indicate how the predicate product(s) are eligible to serve as a predicate product for the new
product(s). Select all that apply.
• Previously Found SE – Select the checkbox if the predicate products were previously found to be
substantially equivalent under section 910(a)(2)(A)(i) of the FD&C Act. If only Previously found SE
is selected, skip Section III, Part B.
• PTP Determined – Select the checkbox if the predicate products identified in Form FDA 3965b were
submitted for pre-existing tobacco product (PTP) review independently of these SE Reports, were
determined to be PTP and found eligible to serve as predicate products. FDA previously used the
term “grandfathered product” to describe a product that was commercially marketed in the United
States (other than in a test market) as of February 15, 2007. However, on November 4, 2021, FDA
updated the term “grandfathered tobacco product” (GF) to “pre-existing tobacco product” (PTP). If
only PTP Determined is selected, skip Section III, Part B; complete the I. Certification Statement of
Affirmation in Section VI.
• Claimed PTP – Select the checkbox if the predicate products were not previously submitted for PTP
review and were not previously found to be substantially equivalent as above, but you believe the
predicates products are pre-existing tobacco products. Complete Part B and the I. Certification
Statement of Affirmation in Section VI.

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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 the evidence of commercial marketing:
III.B.1. The type of evidence (e.g., Invoice, catalog pages, distributor or retailer inventory lists).
III.B.2. The date of evidence.
III.B.3. The identifier of the evidence (e.g., Invoice Number).
III.B.4. The commercial information (e.g., UPC code, product description, item number)
III.B.5. List the predicate product name(s) as indicated by the evidence provided for field III.B.1.
Business Addresses Associated with Evidence of Commercial Marketing (optional)
For these fields, provide the address(es) as reflected in the evidence demonstrating commercial marketing:
III.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.
III.B.7. Additional street address information for the business (including apartment, suite, or building
number) that you were not able to include in III.B.6.
III.B.8. The city of the business.
III.B.9. The state, province, or territory of the business.
III.B.10. The country of the business.
III.B.11. The ZIP or postal code of the business.
III.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.
III.B.13. Additional street address information for the business (including apartment, suite, or building number) that
you were not able to include in III.B.12.
III.B.14. The city of the business.
III.B.15. The state, province, or territory of the business.
III.B.16. The country of the business.
III.B.17. The ZIP or postal code of the business.

SECTION IV – SUBMISSION INFORMATION
Section IV should include submission information, including the following parts:
- Part A: General Submission Information
- Part B: Cross-Referenced Information
- Part C: Referenced Tobacco Product Master File(s) (TPMF)
- Part D: Formal Meetings Held with FDA Pertaining to this Tobacco Product

Part A: General Submission Information

For grouped submissions, the application type must be the same and the proposed modification(s) to the new
tobacco products (as compared to the predicate tobacco product[s]) should be similar. If application type is not
the same and/or proposed modification are not similar, submit a separate Form FDA 3965.
IV.A.1. Select only one checkbox to indicate whether the application type is Same Characteristics (such as
changes in product quantity or changes in container closure system) Reports or Different
Characteristics Reports.

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IV.A.2. Summarize the submission, as described in 21 CFR 1107.18(d), with a concise description of the
characteristics of the new tobacco product; A statement as to whether the applicant believes the
new tobacco product has the same characteristics as the predicate tobacco product or has different
characteristics but any differences in characteristics do not cause the new tobacco product to raise
different questions of public health; and A concise description of the similarities and differences between
the new tobacco product and the predicate tobacco product with respect to their characteristics (materials,
ingredients, design, composition, heating source, or other features).
IV.A.3. Select all checkboxes that apply to indicate proposed modification(s) to the new tobacco product(s)
compared to the predicate tobacco product(s).

Part B: Cross-Referenced Information (Optional)

Complete Part B if the application includes one or more cross-reference(s) to a standalone PTP submission or
authorized SE submission other than the predicate product listed in Form FDA 3965b. SE Reports should not
cross-reference other pending SE applications. 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.
IV.B.1. In column 1, provide the FDA submission tracking number (STN) for the cross-referenced submission.
IV.B.2. In column 2, identify if the cross-reference provided in column 1 is for all products in the submission.
If the cross-reference 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.
IV.B.3. In column 3, 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 C: Referenced Tobacco Product Master File(s) (TPMF) (Optional)

Complete Part C if the application includes a Tobacco Product Master File (TPMF).
Boxes 1–5 should be provided for each TPMF. Use the Continuation Page button within the form for additional
TPMFs, as needed.
IV.C.1. In field 1, identify the TPMF owner.
IV.C.2. In field 2, provide FDA the 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.”
IV.C.3. In field 3, 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.
IV.C.4. In field 4, identify what information in the TPMF you are seeking to reference for the new submission(s).
IV.C.5. In field 5, indicate if the right of reference is included in the submission. The TPMF owner may authorize
another party to reference information contained within the TPMF through a right of reference such as a
letter of authorization (LOA).

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

Complete Part D if FDA and the applicant held one or more meetings related to the new product(s). This can
include meetings for study design, earlier versions of the product, etc. Within the table, utilize a single row for each
meeting. Use the Continuation Page button within the form to list additional meetings, as needed.
IV.D.1. In column 1, provide the FDA submission tracking number (STN) for the industry meeting.
IV.D.2. In column 2, identify the date of the meeting between FDA and the applicant.
IV.D.3. In column 3, identify if the meeting topic was for all products in the submission. If the meeting
relates only to some of the new products in the submission, select “no” and list the name(s) of the
product(s) to which the meeting pertained.

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SECTION V – APPLICATION CONTENTS
Section V is intended to help applicants organize their submission per 21 CFR 1107.18. For each item included
in your submission, select the corresponding checkbox in the list and provide the location of the document. For
example, the file name, document name, and page number. Select all that apply.

Part A: Administrative Content

V.A.1. Cover Letter.
V.A.2. Comprehensive Index (i.e., a listing of files and data associated with those files) and Table of Contents
(21 CFR 1107.18(b)).
V.A.3. Unique Identification of new tobacco product(s) and predicate tobacco product(s) must be provided in
FDA form 3965b available on the FDA website.
V.A.4. Written in English or accompanied by an English translation for non-English information (21 CFR
1107.18(b)). For any document that contains content that is not in English, translation is required. If all
contents of the application are in English, leave the box blank. If you are providing translations for nonEnglish information, select the checkbox.

Part B: Product Information

V.B.1. List of Ingredients – The SE Report must include, in a tabular format, a side-by-side comparison
of the materials and ingredients for each component or part of the new and predicate tobacco
products. For each material and ingredient quantity, the target specifications and range of
acceptable values, actual measured value (where applicable), and range of measured values
(where applicable) reported as mass per component or part, must be provided (21 CFR 1107.19(c)).
V.B.2. Information on Manufacturing Process – A concise overview of the process used to manufacture the
new tobacco product. If the manufacturing process for the new tobacco product does not affect the
characteristics of the new tobacco product beyond what is described elsewhere in the SE Report, an
applicant must state that to satisfy this provision (21 CFR 1107.18(e)(3)).
V.B.3. Statement of compliance with applicable tobacco product standards – The SE Report must either
list and describe the action(s) taken by the applicant to comply with applicable requirements
under section 907 of the Federal Food, Drug, and Cosmetic Act or state there are no applicable
requirements under section 907 of the Federal Food, Drug, and Cosmetic Act (21 CFR 1107.18(i)).

Part C: Health and Research

Select only one checkbox in Part C to indicate whether the application contains a Health Information Summary or
Health Information Statement, as required by 21 CFR 1107.18(j).
V.C.1. Select this checkbox if the application includes a Health Information Summary.
V.C.2. Select this checkbox if the application includes a Health Information Statement. A copy of the
required statement can be found in Section VI for signature.

Part D: Comparisons (New vs. Predicate Tobacco Product)
V.D.1.
V.D.2.
V.D.3.
V.D.4.

Product Design as described in 21 CFR 1107.19(a).
Heating Source as described in 21 CFR 1107.19(b).
Composition (e.g., materials, tobacco ingredients, non-tobacco ingredients) per 21 CFR 1107.19(c).
Other features (e.g., HPHCs). If there are other features that are not HPHCs, please describe in the
“Other” field per 21 CFR 1107.19(d).
V.D.5. Stability as described in 21 CFR 1107.19(f).
V.D.6. Comparison to Original Predicate Tobacco Product – Select this checkbox only if you are using a
predicate tobacco product that FDA has previously found to be SE, and you have provided a
comparison of the new product and the original previously found SE predicate tobacco product per
21 CFR 1107.19(h).

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Part E: Environmental Considerations

V.E.1. Environmental Assessment as described in 21 CFR 25.40 and 21 CFR 1107.18(k)(2).
V.E.2. Claim for Categorical Exclusion as described in 21 CFR Part 25.35.

SECTION VI – CERTIFICATION STATEMENTS
The application must contain the following certifications, as appropriate for the specific type of SE Report, with the relevant
information inserted, as described in each parenthetical, signed by an authorized representative of the applicant.
The required Certification Statements (i.–iv.) are based on the specific type of SE you are submitting, as follows:
i.
Certification Statement of Affirmation is required for all SE Reports that use a pre-existing tobacco
product (PTP) determined or a PTP claimed predicate product.
• Provide the name of the applicant being represented in the certification, as identified in Section I Part A
• List the predicate product names subject to the Statement of Affirmation.
ii.
Certification Statement for SE Report is required for all SE Reports.
•
•

Provide the name of authorized representative signing the certification, as identified in Section I Part A
Provide the name of the applicant being represented in the certification, as identified in Section I
Part A (twice).

iii.
Certification Statement for Same Characteristics SE Report is appropriate when submitting a
Same Characteristics SE Report and choosing to certify that certain characteristics are identical in
lieu of providing data for each characteristic of the new and predicate products.
•
•
•

Provide the name of the authorized representative signing the certification, as identified in Section I Part A.
Provide the name of the applicant being represented in the certification, as identified in Section I
Part A (twice).
Provide the name(s) of the individual new and predicate product(s), as identified in Section II.

•

Provide a description of the modifications, as identified in Section IV Part A.
Note: If submitting a grouped submission, a certification statement is needed for each new
product. These can be provided as a separate document from 3965.
iv.
Certification Statement Regarding Availability of Health Information is appropriate when choosing
to make health information available upon request as per 21 CFR 1107.18(j)(2) rather than including a
health information summary with their SE Report.
•
•
•

Provide the name of the authorized representative signing the certification, as identified in Section I
Part A.
Provide the professional position title held by the authorized representative as identified in Section I
Part A
Provide the name of the company of the authorized representative.

For each certification statement applicable, insert the signature of the authorized representative and the date the
certification is signed.
If you choose to print and wet sign the certification statements, upload them as a separate document from Form FDA 3965
to maintain the dynamic fields in Adobe and ensure all content is available for FDA to process, read, review, and archive.

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