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

Premarket Tobacco Product Applications and Recordkeeping Requirements

FDA_Form_4057 (2024)

Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver

OMB: 0910-0879

Document [pdf]

Download: pdf | pdf

Form Approved: OMB No. 0910-0879
Expiration Date: xx/xx/20xx

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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 0910-0879. The time required to
complete this information collection is estimated to average 35 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].

PREMARKET TOBACCO PRODUCT
APPLICATION (PMTA) SUBMISSION

Marketing without a Marketing Granted Order (MGO) is illegal and may be subject to enforcement.
Please carefully read the instructions located in the Appendix before completing this form.
SECTION I – APPLICANT IDENTIFICATION

Part A: Applicant Information1
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

13. Middle Initial

15. Generational Suffix

16. Professional Suffix

18. Phone Number

14. Last Name

17. Position Title

19. Fax Number

20. Email Address

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

28. Street Address Line 1
30. City

34. Phone Number

FORM FDA 4057 (12/23)

24. Submit Date (mm/dd/yyyy)

27. Position Title

29. Street Address Line 2 (Apt., Suite, Bldg., #)
31. State, Province, or Territory

35. Fax Number

32. Country

36. Email Address

Page 1 of 26

33. ZIP or Postal Code

Part B: Authorized Representative1 or U.S. Agent Information1

□ 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

12. City

16. Phone Number

4. Middle Initial

7. Professional Suffix

5. Last Name

8. Position Title

10. Street Address Line 1

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

13. State, Province, or Territory

17. Fax Number

14. Country

15. ZIP or Postal Code

18. Email Address

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

5. Generational Suffix

8. Organization Name

11. City

15. Phone Number

3. Middle Initial

6. Professional Suffix

4. Last Name

7. Position Title

9. Street Address Line 1

12. State, Province, or Territory

16. Fax Number

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

13. Country

17. Email Address

¹ Required content and format as per §1114.7 (Standard PMTA), 1114.15 (Supplemental PMTA), and 1114.17 (Resubmission).
FORM FDA 4057 (12/23)

14. ZIP or Postal Code

Page 2 of 26

Continuation Page
for Part C

Part D: Manufacturer Information1

□ Select here if manufacturer is the same as applicant identified in Part A. If the same, skip Part D fields 2–20 and
proceed to Part E.

2. Organization Name

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

6. Street Address Line 1

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

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

□ 5. Select here if manufacturer address is the same as applicant address provided in Part A; if the same, skip fields
6–11 and proceed to field 12.

8. City

9. State, Province, or Territory

10. Country

11. ZIP or Postal Code

Point of Contact for Manufacturer
12. First Name

13. Middle Initial 14. Last Name

17. Position Title

18. Phone Number

15. Generational
Suffix

19. Fax Number

16. Professional Suffix

20. Email Address

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

1. Select type of site:

□ Manufacturer

□ Contract manufacturer

2. Organization Name

□ Repacker/relabeler □ Other ______________________

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

5. Division Name (if applicable)

6. Is the manufacturer/packaging/storage/control facility ready for inspection?

□ Yes

□ No

7. Street Address Line 1

9. City

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

78. 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
13. First Name

18. Position Title

FORM FDA 4057 (12/23)

14. Middle
Initial

15. Last Name

19. Phone Number

20. Fax Number

Page 3 of 26

16. Generational
Suffix

17. Professional Suffix

21. Email Address

Continuation Page
for Part E

SECTION II – NEW TOBACCO PRODUCT INFORMATION1
Use required Form FDA 4057b – Premarket Tobacco Product Application Grouping Product Submission Spreadsheet to
provide new product information. The form is available on the FDA website.
SECTION III – SUBMISSION INFORMATION

Part A: General Submission Information
1. Identify submission type (select one):¹

□ Standard PMTA □ Resubmission □ Supplemental PMTA

2. For products that were previously commercially marketed in the United States, provide the product names and
corresponding marketing date(s):¹

Part B: Cross-Reference Information (Optional)

Complete one row per cross-reference 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]):

Continuation Page
for Part A

FORM FDA 4057 (12/23)

Page 4 of 26

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 included¹

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 included¹

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 included¹

Continuation Page
for Part C

FORM FDA 4057 (12/23)

Page 5 of 26

Part D: Formal Meetings Held with FDA Pertaining to the New Product(s) (Optional)
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 Date¹
(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 4057 (12/23)

Page 6 of 26

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

Part A: Administrative Content
1.

□

Part D: Scientific Content
1.

Cover Letter

Location:
2.

□
□

Comprehensive Index¹ and Table of Contents¹

□

□ Specimens of all Proposed Labelling¹

□ Description of Marketing Plans¹

□ Statement of Compliance with Applicable

Tobacco Product Standards

Location: ______________________

□ Location and Contact Information for Each
Location Subject to Potential Inspection

□ Product Formulation¹
□ Manufacturing¹
Location:

Part C: Inspections
1.

□ Summary¹

Location:

Location: ____________________
3.

□ Statement of Compliance with 21 CFR part 25¹

Location:

Location:
2.

Location:

Part B: Labeling and Marketing Plans
1.

□ Product Samples
Location:

Request for FDA to refer PMTA to TPSAC¹

Location:

□ Descriptive Information¹
Location:

English¹ Translations for Non-English Information

Location:

General Information¹

Location:

Location:
3.

□

□ Literature Search¹
Location:

Location:

□ Organized References
Location:

10.

□ Health Risk Investigations¹
Location:

11.

□ Study Reports¹
Location:

² FDA generally expects that product samples will be a required part of a PMTA and that an applicant should be prepared to submit them in accordance with FDA instructions.
FORM FDA 4057 (12/23)

Page 7 of 26

SECTION V – STATEMENTS OF COMPLIANCE WITH THE FEDERAL FOOD, DRUG, AND COSMETIC (FD&C) ACT
1. Provide a brief description of how the PMTA satisfies content requirements of section 910(b)(1) of the FD&C Act
in the space below:

2. Provide a brief description of how marketing the new tobacco product would be appropriate for the protection of public
health as determined with respect to the population as a whole including users and non-users of the tobacco product,
and taking into account:
• The increased or decreased likelihood that existing users of tobacco products will stop
using such products; and
• The increased or decreased likelihood that those who do not use tobacco products will
start using such products.

FORM FDA 4057 (12/23)

Page 8 of 26

SECTION VI – CERTIFICATION STATEMENTS
Applications must contain the following certifications, as appropriate for the specific type of PMTA, with the appropriate
information inserted, as described in each parenthetical, signed by an authorized representative of the applicant:
i
ii
iii
iv
v

Certification Statement for Standard PMTAs
Modified Tobacco Product Certification for Supplemental PMTAs
Same Product Certification for Resubmissions
Different Product Certification for Resubmissions
Financial Interest and Arrangements of Clinical Investigators Certification Statement

For the following section, insert the name of the authorized representative 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 previously submitted PMTA 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 4057 to maintain the dynamic
fields in Adobe and ensure all content is available for FDA to process, read, review, and archive.

i. Certification Statement for Standard PMTAs:
I, (insert name of responsible official), _______________________ on behalf of the applicant, (applicant name),
________________________________hereby certify that the applicant will maintain all records to substantiate
the accuracy of this application for the period of time required in 21 CFR 1114.45 and ensure that 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 4057 (12/23)

Page 9 of 26

ii. Modified Tobacco Product Certification for Supplemental PMTAs
I, (name of responsible official), _______________________ on behalf of the applicant, (applicant name),
_______________________ certify that (new tobacco product name) _______________________ has a
different (describe each modification to the product) ___________________________________________
than (insert name of previously submitted tobacco product(s)) _______________________ described in (STN
of previously submitted PMTA) _______________________ but is otherwise identical to (name of previously
submitted PMTA(s)) _______________________ I certify that (name of applicant) _______________________
understands this means there is no other modification to the materials, ingredients, design, composition,
heating source, or any other feature of the original tobacco product. I also certify that (name of applicant)
_______________________ will maintain all records that substantiate the accuracy of this application, and
ensure that such records remain readily available to FDA upon request for the period of time required in 21 CFR
1114.45. I certify that this information and the accompanying submission are true and correct, and that I am
authorized to submit this on the applicant’s behalf. I understand that under section 1001 of title 18 of the United
States Code, anyone who knowingly and willfully makes a materially false, fictitious, or fraudulent statement
or representation in any matter within the jurisdiction of the executive, legislative, or judicial branch of the
Government of the United States is subject to criminal penalties.
1. Signature and Date (mm/dd/yyyy)

iii. Same Tobacco Product Certification for Resubmission
I, (insert name of responsible official), _______________________ on behalf of (name of applicant)
_______________________, certify that this submission for (new tobacco product name) _________________
responds to all deficiencies outlined in the marketing denial order issued in response to (STN of the
previously submitted PMTA) _______________________ and the new tobacco product described
herein is identical to the product described in the previously submitted PMTA. I certify that (name of
applicant) _______________________ understands this means there is no modification to the materials,
ingredients, design, composition, heating source, or any other feature. I also certify that (name of applicant)
_______________________ will maintain all records that substantiate the accuracy of this statement, and
ensure that such records remain readily available to FDA upon request for the period of time required in 21 CFR
1114.45. I certify that this information and the accompanying submission are true and correct, and that I am
authorized to submit this on the company’s behalf. I understand that under section 1001 of title 18 of the United
States Code, anyone who knowingly and willfully makes a materially false, 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 4057 (12/23)

Page 10 of 26

iv. Different Tobacco Product Certification for Resubmission
I, (name of responsible official) _______________________, on behalf of (name of applicant)
____________________ certify that this submission for (new tobacco product name) _______________________
responds to all deficiencies outlined in the marketing denial order issued in response to (STN of the
previously submitted PMTA) _______________________ and the new tobacco product described herein
has a different (describe each modification to the product) _______________________ than (name of
original tobacco product) _______________________________ described in (STN of the previously
submitted PMTA) _______________________ but is otherwise identical to (name of original tobacco product)
_______________________ described in (STN of the previously submitted PMTA) __________________________
I certify that (name of applicant) _______________________ understands this means there is no modification to
the materials, ingredients, design, composition, heating source, or any other feature of the original tobacco product,
except for the (describe each modification to the tobacco product) _______________________ I also certify
that (name of applicant) _______________________ will maintain all records that substantiate the accuracy of
this statement, and ensure that such records remain readily available to FDA upon request for the period of time
required in 21 CFR 1114.45. I certify that this information and the accompanying submission are true and correct,
and that I am authorized to submit this on the company’s behalf. I understand that under section 1001 of title 18
of the United States Code, anyone who knowingly and willfully makes a materially false, 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)

v. Financial Interest and Arrangements of Clinical Investigators Certification Statement:
I, (name of responsible official) _______________________, on behalf of (name of company)
_______________________, certify that there are no financial conflicts of interest or have included documentation
fully disclosing any potential financial conflicts of interest required by 21 CFR § 1114.7(k)(3)(ii).

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

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

FORM FDA 4057 (12/23)

Page 11 of 26

SECTION VII – APPENDICES
CONTINUATION PAGES
Appendix A: Alternate Point of Contact Information
Submit a single Form FDA 4057 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 4057 (12/23)

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 12 of 26

Appendix B: Manufacturer Information
Submit a single Form FDA 4057 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

2. Organization Name

□ Repacker/relabeler □ Other ______________________

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

5. Division Name (if applicable)

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

6. Is the manufacturer/packaging/storage/control facility ready for inspection?

□ Yes

□ No

7. Street Address Line 1

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

9. City

10. State, Province, or Territory

11. Country

12. ZIP or Postal Code

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

14. Middle
Initial

18. Position Title

15. Last Name

19. Phone Number

16. Generational
Suffix

20. Fax Number

17. Professional Suffix

21. Email Address

Section I Part E: Manufacturer/Packaging/Storage/Control Facility Information
1. Select type of site:

□ Manufacturer

□ Contract manufacturer

2. Organization Name

□ Repacker/relabeler □ Other ______________________

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

5. Division Name (if applicable)

6. Is the manufacturer/packaging/storage/control facility ready for inspection?

□ Yes

□ No

7. Street Address Line 1

9. City

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

78. 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
13. First Name

18. Position Title
FORM FDA 4057 (12/23)

14. Middle
Initial

15. Last Name

19. Phone Number

20. Fax Number
Page 13 of 26

16. Generational
Suffix

17. Professional Suffix

21. Email Address

Appendix C: Cross-Referenced Information
Submit a single Form FDA 4057 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 4057 (12/23)

Page 14 of 26

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

Appendix D: Referenced Tobacco Product Master File(s) (TPMF)
Submit a single Form FDA 4057 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 4057 (12/23)

Page 15 of 26

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 included1

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 4057 (12/23)

Page 16 of 26

Appendix E: Formal Meetings Held with FDA Pertaining to the New Product(s)2
Submit a single Form FDA 4057 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 4057 (12/23)

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 17 of 26

Appendix F: Instructions for Completion of PMTA Form
This form and the instructions for use are solely intended to provide the applicant an organized format to supply
information required for submission of a Premarket Tobacco Product Application (PMTA).
Form FDA 4057 - Premarket Tobacco Product Application (PMTA) Submission is a required form for applicants to
use when submitting a PMTA 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 a PMTA submission, see 21 CFR § 1114.7

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

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 individual applicant (including apartment, suite, building
number, #) that you were not able to include in I.A.6.
I.A.8. The city of the individual applicant.
I.A.9. The state, province, or territory of the individual applicant.
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. The middle initial of the organization point of contact, if applicable.
I.A.14. The last name of the organization point of contact.

FORM FDA 4057 (12/23)

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I.A.15.
I.A.16.
I.A.17.
I.A.18.
I.A.19.

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, ifapplicable.
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.
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.
FORM FDA 4057 (12/23)

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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

Part D: Manufacturing Information

Only complete this section if the manufacturer information is different from the applicant. If this information is the
same as the applicant, check the checkbox in I.D.1, skip Part D fields 2–20 and proceed to Part E.
I.D.1.
I.D.2.
I.D.3.

I.D.4.

Select the checkbox if the manufacturer and applicant information is the same. If the same, skip Part D
fields 2–20.
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.
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.
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.

FORM FDA 4057 (12/23)

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I.D.5.

Select the checkbox if the manufacturer address is the same as the applicant address, skip Part D fields
6–11 and proceed to Part D field 12.
I.D.6. 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.7. Additional street address information for the manufacturer location (including apartment, suite, building
number, #) that you were not able to include in I.D.6.
I.D.8. The city where the manufacturer is located.
I.D.9. The state, province, or territory where the manufacturer is located.
I.D.10. The country where the manufacturer is located.
I.D.11. The ZIP or postal code where the manufacturer is located.

Point of Contact for Manufacturer
I.D.12.
I.D.13.
I.D.14.
I.D.15.
I.D.16.
I.D.17.
I.D.18.
I.D.19.

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.20. The email address of the manufacturer point of contact.

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

Part E is an optional space for information for additional manufacturing sites. 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. The organization name for the Manufacturer/Packaging/Storage/Control Facility (required by 21 CFR
1114.7(j)).
I.E.3. The manufacturer FDA-assigned Facility Establishment Identifier (FEI) number, if applicable (required by
21 CFR 1114.7(j)).
I.E.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, at their website https://www.dnb.com/duns/get-a-duns.html, or click here.
I.E.5. The Manufacturer/Packaging/Storage/Control Facility , if applicable (required by 21 CFR 1114.7(j)).
I.E.6. The Manufacturer/Packaging/Storage/Control Facility is ready for inspection by checking “Yes” or “No.”
I.E.7. The street address for the Manufacturer/Packaging/Storage/Control Facility (include street number, street
name, and street type, and suffix direction, etc.) (required by 21 CFR 1114.7(j)). The street address cannot
be a P.O. Box.
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 1114.7(j)).
I.E.9. The city where the Manufacturer/Packaging/Storage/Control Facility is located (required by 21 CFR
1114.7(j)).
I.E.10. The state, province, or territory where the Manufacturer/Packaging/Storage/Control Facility is located
(required by 21 CFR 1114.7(j)).
I.E.11. The country where the Manufacturer/Packaging/Storage/Control Facility is located (required by 21
CFR 1114.7(j)).
I.E.12. The ZIP or postal code where the Manufacturer/Packaging/Storage/Control Facility is located (required by
21 CFR 1114.7(j)).

FORM FDA 4057 (12/23)

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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 1114.7(j)).
I.E.14. The middle initial of the Manufacturer/Packaging/Storage/Control Facility point of contact, if applicable
(required by 21 CFR 1114.7(j)).
I.E.15. The last name of the Manufacturer/Packaging/Storage/Control Facility point of contact (required by 21 CFR
1114.7(j)).
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 1114.7(j)).
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 1114.7(j)).
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 1114.7(j)).
I.E.21. The email address of the Manufacturer/Packaging/Storage/Control Facility point of contact
((required by 21 CFR 1114.7(j)).

SECTION II — NEW TOBACCO PRODUCT INFORMATION
Utilize form FDA-4057b Premarket Tobacco Product Application Grouping Product Submission Spreadsheet
available on the FDA website to provide new tobacco product(s) information..

SECTION III – SUBMISSION INFORMATION
Section IV should include submission information, including the following parts:
- Part A: Submission Type
- 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
III.A.1.

III.A.2.

Select the appropriate PMTA submission type: Standard, Resubmission, or Supplemental (as defined
below).
• A standard PMTA is a submission from an applicant seeking a marketing granted order to introduce a
new tobacco product into interstate commerce. 21 CFR 1114.7
• A resubmission PMTA is submitted to seek a marketing granted order for a new tobacco product by
providing new information to address the deficiencies outlined in a marketing denial order and crossreferencing applicable content from the denied PMTA. 21 CFR 1114.17
• A supplemental PMTA may be submitted by an applicant that is seeking authorization for
modifications made to a new tobacco product for which they have already received a previous
marketing granted order. 21 CFR 1114.15.15
If the new products were previously commercially marketed in the United States, list the product name and
provide the date(s) during which the product(s) were previously marketed.

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Part B: Cross-Referenced Information (Optional)

Complete Part B if the application includes one or more cross-reference(s) to another PMTA or MRTPA 21 CFR
1114.7(b), 1114.15(b), or 1114.17(b). Supplemental PMTAs and resubmissions may cross-reference content in standard
PMTAs. Standard PMTAs should not cross-reference another Standard PMTA or other pending applications with the
exception of a pending MRTPA for the same tobacco product. Within the table, utilize a single row for each crossreference. Use the Continuation Page button within the form to provide additional cross-references, as needed.
III.B.1. In column 1, provide the FDA submission tracking number (STN) for the cross-referenced submission.
III.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.
III.B.3. In column 3, identify what information in the cross-reference 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.
III.C.1. In field 1, identify the TPMF owner.
III.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.”
III.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.
III.C.4. In field 4, identify what information in the TPMF you are seeking to reference for the new submission(s).
III.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 a 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) (Optional)

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.
III.D.1. In column 1, provide the FDA submission tracking number (STN) for the industry meeting.
III.D.2. In column 2, identify the date of the meeting between FDA and the applicant.
III.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.

SECTION IV – APPLICATION CONTENTS
Section IV is intended to help applicants organize their submission per 21 CFR 1114.7. 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.

FORM FDA 4057 (12/23)

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Part A: Administrative Content

IV.A.1. Cover Letter.
IV.A.2. Comprehensive Index (i.e., a listing of files and data associated with those files) and Table of Contents
(21 CFR 1114.(b)(1)).
IV.A.3. Written in English or accompanied by an English translation for non-English information (21 CFR 1114.(b)(1)).
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 non-English information,
select the checkbox.
IV.A.4. Request for FDA to Refer PMTA to Tobacco Product Scientific Advisory Committee is optional. Select the
checkbox if you are requesting a referral to TPSAC (21 CFR 1114.7(c)(5)).

Part B: Labeling and Marketing Plans
IV.B.1. Specimens of all proposed labeling (21 CFR 1114.7(f)(1)).
IV.B.2. Marketing plans (21 CFR 1114.7(f)(2)).

Part C: Inspections
IV.C.1. Location and contact information for each location subject to potential inspection (21 CFR 1114.7(k)(3) (vii)).
Inspections may be conducted for manufacturing, clinical, or nonclinical sites.

Part D: Scientific Content
IV.D.1. General information (e.g., product name, product category, subcategory and product properties)
(21 CFR 1114.7(c)).
IV.D.2. Descriptive information (21 CFR 1114.7(d)).
IV.D.3. Product samples (21 CFR 1114.7(e)). FDA generally expects that product samples will be a required part
of a PMTA and that an applicant should be prepared to submit them in accordance with FDA instructions
within 30 days after submitting a PMTA. There may be situations in which sample submission may not
be necessary, including, in some circumstances, PMTAs that are resubmitted for the same product after
a marketing denial order (such as resubmissions as described in 21 CFR 1114.17) or PMTAs submitted
for modifications to an authorized product where the modifications do not require review of new samples
as part of the PMTA evaluation process. Pre-submission meetings with FDA may help provide additional
information about whether product samples will need to be included in a PMTA; however, in most
situations, FDA will only be able to determine the need for product samples after a PMTA is accepted for
review.
IV.D.4. Statement of compliance with 21 CFR part 25 (e.g., Environmental Assessment) (21 CFR 1114.7(g)).
IV.D.5. Summary (21 CFR 1114.7(h)).
IV.D.6. Product formulation (e.g., components, ingredients, additives, properties, and principles of operations)
(21 CFR 1114.7(i)).
IV.D.7. Manufacturing (e.g., methods, facilities, controls) (21 CFR 1114.7(j)).
IV.D.8. Literature search (21 CFR 1114.7(k)(2)). A literature search is a search of available documents that
includes: (1) clear search objectives, (2) a description of methodologies used in the search in detail, (3)
an identification of relevant documents, (4) a formal or informal evaluation of study quality, and (5) a
bibliography of referenced publications.
IV.D.9. Organized references used to compile information in the submission.
IV.D.10. Health risk investigations (21 CFR 1114.7(k)). Examples of health risk investigations include but are not
limited to: Toxicological Risk Evaluation, Health Impact (e.g., use behavior, health risk), and Tobacco
Product Perception and Intention Studies.

FORM FDA 4057 (12/23)

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IV.D.11. Study Report(s) – Examples of documents include:
• Study protocol
• Statistical analysis plan
□ Study report
□ Statistical software programming code
□ Study instruments (e.g., surveys/questionnaires)
□ Informed consent form
• Case Report Forms (CRFs):
□ In general, CRFs from clinical studies are not needed for filing a PMTA. However, FDA will require
them for filing the CRFs from clinical studies that have been made to show the health risks of the
PMTA product and whether such product presents less risk than other tobacco products where
the CRF: (1) relates to participant deaths, other serious and unexpected adverse experiences,
or participant discontinuation (including withdrawals) AND (2) where the study participant was
exposed to the tobacco product(s) which is/are the subject of the PMTA(s) or to a similar/
related product that the applicant is using to show that the PMTA product meets the standard for
marketing authorization under section 910.
□ Additional information may be requested on a case-by-case basis during FDA review. FDA expects
all CRFs would be available for review during agency inspections of clinical and/or nonclinical
study sites.
• Analyzable data sets:
□ In general, raw data such as raw chromatograms/spectra/mass spectra arising from analytical
chemistry testing and raw (meaning no integration of the data) output from high-throughput
(e.g., genomic) studies are not needed for filing a PMTA. Line data/ analyzable datasets that
are representative chromatograms/spectra/mass spectra that demonstrate the adequacy of
separations/specificity, standard solution, and sample solutions should be included. The line data/
analyzable data sets may be used to replicate findings or conduct alternative analyses of the
underlying data. Additional information may be requested on a case-by-case basis during FDA
review. FDA expects all raw data would be available for review during Agency inspection of clinical
and/or nonclinical study sites.

SECTION V – Statements of Compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act
V.1. Provide information for how the application meets the requirements and addresses the question(s) in each of
the statements according to the requirements section 910(b)(1) of the FD&C Act as required by 21 CFR
1114.7(c)(10) and (11). Your descriptions should address:
• Full reports of all information, published or known to, or which should reasonably be known to, the
applicant, concerning investigations which have been made to show the health risks of such tobacco
product and whether such tobacco product presents less risk than other tobacco products.
• Full statement of the components, ingredients, additives, and properties, and of the principle or principles
of operation, of such tobacco product.
• Full description of the methods used in, and the facilities and controls used for, the manufacture,
processing, and, when relevant, packaging and installation of, such tobacco product.
• An identifying reference to any tobacco product standard under section 907 which would be applicable
to any aspect of such tobacco product, and either adequate information to show that such aspect of such
tobacco product fully meets such tobacco product standard or adequate information to justify any deviation
from such standard.
• Specimens of the labeling proposed to be used for such tobacco product.
• Such other information relevant to the subject matter of the application as the Secretary may require.
V.2. Provide a brief description of how marketing the new tobacco product would be appropriate for the protection
of public health as determined with respect to the population as a whole, including users and non-users of the
tobacco product, and taking into account:
• The increased or decreased likelihood that existing users of tobacco products will stop using such
products.
• The increased or decreased likelihood that those who do not use tobacco products will start using such
products.
FORM FDA 4057 (12/23)

Page 25 of 26

SECTION VI – CERTIFICATION STATEMENTS
The application must contain the following certifications, as appropriate for the specific type of PMTA, with the appropriate
information inserted, as described in each parenthetical, signed by an authorized representative of the applicant.
Provide the name of authorized representative who is signing the certification. Insert name of authorized representative
as identified in Section I Part B or Part C. Provide the name of the applicant being represented in the certification. Insert
name of applicant as identified in Section I Part A.
The required Certification Statements (i.–iv.) are based on the specific type of PMTA you are submitting, as follows:
i.
Certification statement for standard PMTAs is appropriate when submitting a standard PMTA
•

Insert the name of the authorized representative as identified in Section I Part B or Part C, the name of
the organization being represented as identified in Section I Part A.
ii.
Modified tobacco product certification for supplemental PMTAs is appropriate when submitting a
supplemental PMTA.
•

Insert the name of the authorized representative 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 product(s)
names(s), a description of each modification, and the name and STN of the previously submitted PMTA
where appropriate in the statement. If submitting multiple products, it is recommended a separate
certification is submitted for each product.
iii.
Same product certification for resubmissions is appropriate when submitting a resubmission
PMTA where the product is unchanged, and the applicant is addressing deficiencies outlined in the
marketing denial order (MDO).
• Insert the name of the authorized representative 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 product(s)
names(s), and the STN of the previously submitted PMTA where appropriate in the statement.
iv.
Different product certification for resubmissions is appropriate when submitting a resubmission
PMTA where the product is a modification of the previously submitted PMTA that results from changes
necessary to address the deficiencies outlined in the marketing denial order (MDO).
•

Insert the name of the authorized representative as identified in Section I Part B or Part C, and the name
of the organization being represented as identified in Section I Part A.

For each certification statement applicable, insert the signature of the authorized representative and the date the
certification is signed.

OTHER INFORMATION
Identify and provide information for any additional information not captured in the PMTA submittal form that is
pertinent to your application.
We remind you that all regulatory correspondence can be submitted via the FDA Electronic Submission Gateway
(www.fda.gov/esg) using eSubmitter.
We are unable to accept regulatory submissions by electronic mail.
FORM FDA 4057 (12/23)

Page 26 of 26

File Type	application/pdf
File Modified	2024-11-12
File Created	2024-10-25