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

Premarket Tobacco Product Applications and Recordkeeping Requirements

FDA_Form_4057a (2024)

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

OMB: 0910-0879

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0879
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 0910-0879. 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].

PREMARKET TOBACCO PRODUCT
APPLICATION (PMTA) AMENDMENT AND
GENERAL CORRESPONDENCE SUBMISSION

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

Part A: Applicant Information1

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

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

2. Other Organization Names (if applicable)

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

4. Organization D&B DUNS® Number

5. Submit Date (mm/dd/yyyy)

8. City

6. Street Address Line 1

9. State, Province, or Territory

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

11. ZIP or Postal Code

Point of Contact for Organization
12. First Name

15. Generational
Suffix

13. Middle Initial

16. Professional Suffix

18. Phone Number

14. Last Name

17. Position Title

19. Fax Number

20. Email Address

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

25. Generational Suffix

22. Middle Initial

26. Professional Suffix

23. Last Name

27. Position Title

28. Street Address Line 1

30. City

34. Phone Number

FORM FDA 4057a (4/24)

24. Submit Date (mm/dd/yyyy)

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

31. State, Province, or Territory

32. Country

35. Fax Number

33. ZIP or Postal Code

36. Email Address
Page 1 of 25

Required content and format as per §1114.7 (Standard PMTA),
1114.15 (Supplemental PMTA), and 1114.17 (Resubmission).

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

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

Part A: Amendment Purpose
1. List the FDA Submission Tracking Number (STN) and Product Identifier (PD) Number, or STN.PD# (e.g.,
PM5679840.PD1), assigned to the application being amended
:

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

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

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

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

□ Update to Unique Identification Information

–If selected, you must provide FDA Form 4057b for any amended product properties with this submission and an
STN.PD# in Additional Properties.

□ Update Product Properties

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

□ Submit Adverse Experience Report

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

□ Change in Cross-Referenced Content .
□ Change in Related Submissions
□ Change in Tobacco Product Master File Referenced
□ Letter of Authorization (LOA)
□ Change in Submission Contents

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

□ Other

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

FORM FDA 4057a (4/24)

Page 2 of 25

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

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

2. STN.
PD#

3. Action

4. Property
Name

5. Previously
Submitted Target
Value

6. Updated Target Value

Choose an action

Continuation Page for Update to
New Product Properties
FORM FDA 4057a (4/24)

Page 3 of 25

Part C: Cross-Referenced Information (Optional)

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

1. CrossReferenced STN

2. Action

Choose an action

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

4. Information and sections to
be referenced

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

Continuation Page for
Cross-Referenced Content
FORM FDA 4057a (4/24)

Page 4 of 25

Part D: Related Submissions

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

1. Related
Submission(s)
STN

2. Action

Choose an action

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

4. Information and sections to
be referenced

Continuation Page for
Related Submissions
FORM FDA 4057a (4/24)

Page 5 of 25

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

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

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

2. TPMF STN (assigned by FDA)

3. Action

Choose an Choose
action an action.

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

3. Action
Choose an Choose
action an action.

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

3. Action

Choose an Choose
action an action.

□ Yes

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

□ Yes

□ No

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

Continuation Page for
Referenced TPMF
FORM FDA 4057a (4/24)

Page 6 of 25

Part F: Amendment Contents

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

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

Part G: Certification Statement

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

I (name of responsible official)
applicant)

, on behalf of the applicant (name of
, hereby certify 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 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 4057a (4/24)

Page 7 of 25

SECTION III – GENERAL CORRESPONDENCE INFORMATION

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

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

□ Request for Change in Ownership

–If selected, complete Section III Part B below.

□ Submit Adverse Experience Report

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

□ Request to Withdraw Previously Submitted General Correspondence

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

□ Meeting Request

–If selected, complete Section III Part C below.

□ Other

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

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

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

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

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

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

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

□ Manufacturer

FORM FDA 4057a (4/24)

□ Contract Manufacturer

□U.S. Agent

□ Repacker/Relabeler
Page 8 of 25

□ Other______________

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

□ Yes

□ No (list applicable STNs.PD#s):

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

Current Contact Information on Record

Added/Updated Contact Information

5. First Name

6.
Middle
Initial

23. First Name

24.
Middle
Initial

8. Generational
Suffix

9. Professional Suffix

26. Generational Suffix

27. Professional Suffix

7. Last Name

10. Position Title

28. Position Title

11.Organization Name

29.Organization Name

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

14. Street Address Line 1

16. City

18. Country

20. Phone Number

22. Email Address

13. Organization D&B DUNS®
Number

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

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

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

32. Street Address Line 1

34. City

36. Country

38. Phone Number

25. Last Name

31. Organization D&B DUNS®
Number

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

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

40. Email Address

Continuation Page
for Part A
FORM FDA 4057a (4/24)

Page 9 of 25

Part B: Request for Change in Ownership

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

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

PD Number
(if applicable)

Product Name
(if applicable)

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

□ A signed transfer of ownership request letter from the former applicant must include:
□ The specific applications, submissions, and product names by STN being transferred.
□ A statement that all rights of the applications have been transferred to the new applicant.
□ Contact information for the new applicant (name, mailing address, phone number, and email).
□ A signed letter from the new applicant accepting the change in ownership from the former applicant must include:
□ The specific applications, submissions, and product names by STN being accepted.
□ A statement committing to all agreements, promises, and conditions made by the former applicant of record
contained in the applications and submissions.

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

amendments and records that are required to be kept, or state they will request a copy per 21 CFR 20.40.

□ A statement that no modifications have been made to the transferred tobacco applications and submissions.
□ Contact information for the new applicant (name, mailing address, phone number, and email).
Continuation Page
for Part B

FORM FDA 4057a (4/24)

Page 10 of 25

Part C: Meeting Request

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

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

□ Yes

□ No (provide expected date of submission (mm/dd/yyyy)): __________________

Products to be Discussed at Meeting
5. Product Name

6. Product Use

7. Product Category (if applicable)

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

Choose an item

Choose a product category

8. STN.PD# (if applicable)

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

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

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

Continuation Page
for Part C
FORM FDA 4057a (4/24)

Page 11 of 25

SECTION VII – APPENDICES
CONTINUATION PAGES
Appendix A: Update to Product Properties (if applicable)
Submit a single Form FDA 4057a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION II, Part B: Update to Product Properties (if applicable)

Update to New Product Properties
1. New Product
Name

2. STN.
PD#

3. Action

4. Property
Name

Choose an
action.

Choose an action

Choose an
action.

Choose an action

Choose an
action.

Choose an action

Choose an
action.

Choose an action

Choose an
action.

Choose an action

Choose
an
Choose
an action
action.

Choose an
action.

Choose an action

Choose an
action.

Choose an action

FORM FDA 4057a (4/24)

Page 12 of 25

5. Previously
Submitted Target
Value

6. Updated Target Value

Appendix B: Cross-Referenced Content
Submit a single Form FDA 4057a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION II, Part C: Cross-Referenced Content
1. CrossReferenced
STN

2. Action

Choose an action

FORM FDA 4057a (4/24)

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

Page 13 of 25

4. Information and sections to
be referenced

Appendix C: Related Submissions
Submit a single Form FDA 4057a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION II, Part D: Related Submissions
1. Related
Submission(s)
STN

2. Action

Choose an action

FORM FDA 4057a (4/24)

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

Page 14 of 25

4. Information and sections to
be referenced

Appendix D: Referenced Tobacco Product Master File(s) (TPMF)
Submit a single Form FDA 4057a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION III, Part E: Referenced Tobacco Product Master File(s) (TPMF) (Optional)
1. TPMF Owner
4. Is the content applicable to all
products within this submission?

2. TPMF STN (assigned by FDA)

3. Action
Choose an Choose
action an action.

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

3. Action
Choose an Choose
action an action.

□ Yes

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

□ Yes

□ No

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

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

2. TPMF STN (assigned by FDA)

FORM FDA 4057a (4/24)

Choose an Choose
action an action.

□ Yes

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

□ Yes

□ No

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

3. Action

Page 15 of 25

Appendix E: Add, Update, or Remove Applicant Information or Point of Contact (Optional)
Submit a single Form FDA 4057a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION III, Part A: Add, Update, or Remove Applicant Information or Point of Contact (Optional)
1. Select only one:
Chooseananaction
action.
Choose
–If “Update” is selected, provide a brief description of the update here:

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

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

□ Manufacturer

□ Contract Manufacturer

□U.S. Agent

□ Repacker/Relabeler

□ Other__________

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

□ Yes

□ No (list applicable STNs.PD#s):

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

Current Contact Information on Record

Added/Updated Contact Information

5. First Name

6.
Middle
Initial

23. First Name

24.
Middle
Initial

8. Generational
Suffix

9. Professional Suffix

26. Generational Suffix

27. Professional Suffix

7. Last Name

10. Position Title

28. Position Title

11.Organization Name

29.Organization Name

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

14. Street Address Line 1

FORM FDA 4057a (4/24)

13. Organization D&B DUNS®
Number

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

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

32. Street Address Line 1

Page 16 of 25

25. Last Name

31. Organization D&B DUNS®
Number

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

Current Contact Information on Record (cont.)

Added/Updated Contact Information (cont.)

16. City

34. City

17. State, Province, or
Territory

18. Country

19. ZIP or Postal
Code

20. Phone Number

35. State, Province, or
Territory

36. Country

21. Fax Number

38. Phone Number

22. Email Address

37. ZIP or Postal
Code
39. Fax Number

40. Email Address

Appendix F: Request for Change in Ownership (Optional)
Submit a single Form FDA 4057a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION III, Part B: Request for Change in Ownership
1. Applications, submissions, and product names to be transferred including the FDA Submission Tracking Number
and Product Identifier PD Number (STN.PD#):
(Optional: Applicants may provide a separate list of submissions subject to transfer)
STN

FORM FDA 4057a (4/24)

PD Number
(if applicable)

Page 17 of 25

Product Name
(if applicable)

Appendix G: Meeting Request
Submit a single Form FDA4057a including all continuation additional page information. For Continuation Page entries
requiring extra space to provide additional information, use the sections provided below. Fill out as many additional
sections as needed, completing all fields within each section.
SECTION III, Part C: Meeting Request

Products to be Discussed at Meeting
5. Product Name

FORM FDA 4057a (4/24)

6. Product Use

7. Product Category (if applicable)

Choose
Choose
an an
itemitem.