FDA 4057a Premarket Tobacco Product Application Amendment and Gene

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB Control No. 0910-0879
Expiration Date: 12/31/2024
(See Burden Statement on last page.)

Premarket Tobacco Product Application Amendment
and General Correspondence Submission

The Applicant Identification section is comprised of three parts: Current Applicant Information; Request to Change
Ownership; and the Addition, Update, Replacement, or Removal of information. Please provide the Applicant information
most recently provided to the FDA under the heading: Subsection A: Current Applicant Information. Please provide the
proposed new Applicant information under the heading: Subsection B: Request for Change in Ownership. The addition of
other new information should be provided under the heading: Subsection C: Addition, Update, Replacement, or Removal of
Applicant Identification Information or Point of Contact.
SECTION I – APPLICANT IDENTIFICATION
Subsection A.
Current Applicant Information (The person or organization (manufacturer/importer) seeking a marketing granted order for
a new tobacco product)
Date of Submission
Name of Applicant (Provide only either a person's name or an organization's name)
Prefix (e.g., Mr., Mrs., Dr.) First Name
Generational Suffix (e.g., Jr., III)

M.I.

Professional Suffix (e.g., MD, Ph.D.)

Last Name
Position Title

Organization Name
Company Headquarters' FDA-Assigned Facility Establishment ID (FEI) Number
Company Headquarters' D&B DUNS® Number
Applicant Address and Contact Information
Primary Address (Street Address, P.O. Box)
City

Address 2 (Apt., Suite, Bldg., etc.)

ZIP or Postal Code

Country

State, Province, or Territory

Current Contact Name (Optional, for use only if Applicant is an organization)
Prefix (e.g., Mr., Mrs., Dr.) First Name
Generational Suffix (e.g., Jr., III)

Professional Suffix (e.g., MD, Ph.D.)

Telephone (Include Country Code if applicable)

FORM FDA 4057a (12/21)

M.I.

FAX

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Last Name
Position Title
Email Address

Organization Name and Address Information (Optional, for use only if Applicant is an individual)
Organization Name
Primary Address (Street Address, P.O. Box)

Select for same address as New Applicant
City

Address 2 (Apt., Suite, Bldg., etc.)

ZIP or Postal Code

Country

State, Province, or Territory
Subsection B.
Request for Change in Ownership

Proposed New Applicant Information (Complete this section to change the current Applicant Information, the owner of the
PMTA)
Effective Date of Ownership Change
Name of Applicant (Provide only either a person's name or an organization's name)
Prefix (e.g., Mr., Mrs., Dr.) First Name
Generational Suffix (e.g., Jr., III)

M.I.

Professional Suffix (e.g., MD, Ph.D.)

Last Name
Position Title

Organization Name
Company Headquarters' FDA-Assigned Facility Establishment ID (FEI) Number
Company Headquarters' D&B Duns® Number
Applicant Address and Contact Information
Primary Address (Street Address, P.O. Box)
City

Address 2 (Apt., Suite, Bldg., etc.)

ZIP or Postal Code

Country

State, Province, or Territory

Telephone (Include Country Code if applicable)

Email Address

FAX

New Contact Name (Optional, for use only if Applicant is an organization)
Prefix (e.g., Mr., Mrs., Dr.) First Name
Generational Suffix (e.g., Jr., III)

Professional Suffix (e.g., MD, Ph.D.)

Telephone (Include Country Code if applicable)

FORM FDA 4057a (12/21)

M.I.

FAX

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Last Name
Position Title
Email Address

Organization Name and Address Information (Optional, for use only if Applicant is an individual)
Organization Name
Primary Address (Street Address, P.O. Box)

Select for same address as New Applicant
City

Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory

ZIP or Postal Code

Country

A notice is included stating that all of the former applicant's rights and responsibilities relating to the PMTA have
been transferred to the new applicant.
A notice is included stating the new applicant's commitment to agreements, promises, and conditions made by
the former applicant and contained in the PMTA.
Transfer Requests
Request to transfer all related submissions for the named product(s) to the new owner
Tobacco Product Name (Brand/Sub-brand)
Related Submissions: List the FDA Submission Tracking Numbers (STNs) for all your previous submissions for the
tobacco product.
Related Submission Type

Related Submission STN

Submission Date

Subsection C.
Addition, Update, Replacement, or Removal of Applicant Identification Information or Point of Contact (Optional)
Addition, Update, Replacement, or Removal of Applicant Identification Information
If "Add" or "Replace" (not allowed for Current Applicant Information; use Subsection B.) is selected, provide all demographic
information for the new party.
If "Update" is selected, provide only Person's Name and/or Organization's Name and the information which will replace
previously submitted information.
If "Remove" is selected, provide only the Person's Name and/or Organization's Name of the party to be removed.
Select type of Applicant Identification Information (Select only one)
Applicant (Address and Contact information only)

Authorized Representative

U.S. Agent

Manufacturer
Effective Date of Change
Select one (If "Update" is selected, FDA will update the Applicant Identification address or contact information that was
previously submitted):
Add

Update

FORM FDA 4057a (12/21)

Replace

Remove

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Person's Name (Provide a person's name for Authorized Representative or U.S. Agent; optional for the Manufacturer)
Prefix (e.g., Mr., Mrs., Dr.) First Name
Generational Suffix (e.g., Jr., III)

M.I.

Professional Suffix (e.g., MD, Ph.D.)

Last Name
Position Title

Organization Name (Provide an organization name for the Manufacturer)
Address and Contact Information
Primary Address (Street Address, P.O. Box; Provide the postal address for the Authorized Representative; optional for the
Manufacturer or the U.S. Agent)
Street Address (Provide the physical location for the Manufacturer or the U.S. Agent; optional for the Authorized
Representative
City

Address 2 (Apt., Suite, Bldg., etc.)

ZIP or Postal Code

Country

State, Province, or Territory

Telephone (Include Country Code if applicable)

Email Address

FAX

New Contact Name (Optional, for use only if Applicant is an organization; do not use in conjunction with Subsection B)
Prefix (e.g., Mr., Mrs., Dr.) First Name
Generational Suffix (e.g., Jr., III)

M.I.

Professional Suffix (e.g., MD, Ph.D.)

Telephone (Include Country Code if applicable)

FAX

Last Name
Position Title
Email Address

Organization Name and Address Information (Optional, use for the Applicant only if a person (do not use in conjunction
with Subsection B); also may be used for Authorized Representative, or U.S. Agent)
Organization Name
Primary Address (Street Address, P.O. Box)

Select for same address as New Applicant
City

Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory

FORM FDA 4057a (12/21)

ZIP or Postal Code

Country

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Addition, Update, or Removal of Point of Contact
If "Add" is selected, provide all demographic information for the new party.
If "Update" is selected, provide only Company/Institution Name and the information which will replace previously submitted
information.
If "Remove" is selected, provide only the Company/Institution Name of the party to be removed.
Select type of Point of Contact Information (Select only one)
Applicant

Manufacturer (Other than Applicant)

Authorized Representative

U.S. Agent

Other, Regulatory

Other, Technical

Select one (If "Update" is selected, FDA will update the Point of Contact address or contact information that was previously
submitted):
Add

Update

Remove

Alternate Point of Contact Name
Company Name
Prefix (e.g., Mr., Mrs., Dr.) First Name
Generational Suffix (e.g., Jr., III)

M.I.

Professional Suffix (e.g., MD, Ph.D.)

Last Name
Position Title

Alternate Point of Contact Address and Contact Information
Primary Address (Street Address, P.O. Box)
City

Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory

ZIP or Postal Code

Country

Telephone (Include Country Code if applicable)

FAX

Email Address

SECTION II – TOBACCO PRODUCT INFORMATION
(Note: Use this section to correct previously submitted information. This section is not intended to be used in place of
submissions required for modifications for new tobacco products)

Unique Identification of Previously Submitted New Tobacco Product
(This Subsection is optional and to be used only to change previously submitted information
For individual tobacco products, fill in the Individual Tobacco Product sub-section below.
For a co-packaged tobacco product, complete Section II for each new tobacco product included within the co-package.
For grouped submissions complete a separate Section II for each tobacco product.)

FORM FDA 4057a (12/21)

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Individual Tobacco Product
(Only the Previously Submitted New Tobacco Product Name is required. Provide other information only for updates to
previously submitted information. Refer to Form 4057, Section VIII, Appendix B to select the appropriate Product Category
and Subcategory or Tobacco Product Properties.)
Update

Select to Update or Withdraw New Tobacco Product

Withdraw

Previously Submitted New Tobacco Product Name (Brand/Sub-Brand)
Updated New Tobacco Product Name (Brand/Sub-Brand) (if applicable)
Update New Tobacco Product Category or Subcategory or Update New Tobacco Product Subcategory
(Complete only if Category or Subcategory is different than previously submitted)
Previously Submitted New Tobacco Product:
Category:

Subcategory:

Updated New Tobacco Product:
Category:

Subcategory:

Tobacco Product Properties Needed to Uniquely Identify the Product
(Update previously submitted Tobacco Product Properties Needed to Uniquely Identify Product by selecting Add, Update, or
Remove and providing the Property Name. When updating properties provide both the previously submitted target value
and the updated target value for the previously submitted new tobacco product.)
New Tobacco Product Name (as provided above)
Action (Add, Update, Remove)

Property Name

Previously Submitted Target
Value

Updated Target Value

To submit information on additional tobacco product(s), use one or more copies of Section II as appropriate.

SECTION III – SUBMISSION INFORMATION
Type of Submission (Select only one)
Amendment (If selected, provide Date of FDA Letter, if applicable; select Amendment Response Type; and
indicate the Scientific Content in Section IV - Amendment Contents)
General Correspondence (if selected, provide Subject of Correspondence)
FDA Submission Tracking Number (STN) to be amended:
Date of FDA Letter (if applicable mm/dd/yy):
Amendment Response Type (Select one)
Deficiency Letter
Unsolicited (Describe in Submission Summary)
Other (Describe in Submission Summary)

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Subject of Correspondence (Select all that apply)
Request for Change in Ownership (Section I)
Change in Authorized Representative, U.S. Agent, or Manufacturer Address or Contact Information (Section I)
Addition or Removal of a Point of Contact (Section I)
Update to Unique Identification Information (Section II)
Change in Cross-referenced Content or Related Submissions (Section III)
Change in Submission Contents (Section IV)
Change in Manufacturing/Packaging/Sterilization Site Information (Section V)
Adverse Experience Report (Describe in Submission Summary)
Periodic Report (e.g., Annual Report) (Describe in Submissioin Summary)
Select to indicate if the withdrawal is due to a health
or safety concern related to the tobacco product

Request to Withdraw the PMTA
Other (Describe in Submission Summary)

Submission Summary (Required if instructed to "Describe" by a previous selection)

Purpose of Application (Check only one)
This PMTA Amendment is for a single new tobacco product
This PMTA Amendment is for a group of PMTA Amendments containing multiple new tobacco products with similar
modifications in comparison to one predicate tobacco product
Cross-referenced Content
(Optional, use this subsection to add new cross-referenced content, or update or remove previously submitted information)
Select to Add, Update, or Remove Cross-referenced Content
Add

Update

Remove

New Tobacco Product Name (either previously submitted or updated name)
Select if this update to Cross-referenced Content is relevant to all amended products in this submission
Identify Cross-referenced Submission Types as one of the following: PMTA, Tobacco Product Master File, or Modified
Risk Tobacco Product (MRTPA)
Cross-referenced Submission Type

FORM FDA 4057a (12/21)

Cross-referenced Submission STN

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Related Submissions
(List the FDA Submission Tracking Numbers (STNs) for all your previous requests for the new tobacco products (e.g., ITP,
SE, MRTPA) where applicable)
Select to Add, Update, or Remove Related Submissions
Add

Update

Remove

New Tobacco Product Name (either previously submitted or updated name)
Select if this update to Related Submission(s) is relevant to all amended products in this submission
Related Submission Type

Related Submission STN

Formal Meetings Held with FDA pertaining to this tobacco product
(For each meeting, as needed, enter the submission STN and meeting held date.)
Select to Add, Update, or Remove Formal Meetings Held with FDA
Add

Update

Remove

New Tobacco Product Name (either previously submitted or updated name)
Select if this update to Meeting(s) is relevant to all amended products in this submission
Submission STN

Meeting Held Date

To submit information on additional tobacco product(s), use one or more copies of Section III as appropriate.
SECTION IV – AMENDMENT AND GENERAL CORRESPONDENCE CONTENTS
List all documents included in the PMTA Amendment, according to their respective subject area.
(Refer to Form 4075, Section IV - Application Contents for a representative list of content categories by subject area.)
Administrative
(List the categories of Administrative content provided by this Amendment)
Labeling and Marketing Plans
(List the categories of Labeling and Marketing Plans content provided by this Amendment)
Inspections
(List the categories of Inspections content provided by this Amendment)

FORM FDA 4057a (12/21)

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Scientific Content
(Select the categories of Scientific Content provided by this Amendment)
Description of Scientific Content:
Check all that apply
General Information

Literature Search

Descriptive Information

Organized References

Product Samples

Health Risk Investigations

Statement of Compliance with 21 CFR part 25

Study Report(s)

Summary

Case Report Form(s)

Product Formulation

Analyzable Data Set(s)

Manufacturing
Other (Specify below)

Other Content (Describe the other content provided by this Amendment)
SECTION V – MANUFACTURING/PACKAGING/STERILIZATION SITE RELATING TO A SUBMISSION
(This section is optional.
If "Add" is selected, provide all demographic information for the new site.
If "Update" is selected, provide only Company/Institution Name and the information which will replace previously submitted
information.
If "Remove" is selected, provide only the Company/Institution Name of the site to be removed.)
Select to Add, Update, or Remove Manufacturing/Packaging/Sterilization Site
Add

Update

Remove

Company/Institution Name
Specify type of Manufacturing/Packaging/Sterilization site
Manufacturer

Contract Sterilizer

Contract Manufacturer

Re-packer/Relabeler

Company Headquarters' FDA-Assigned Facility Establishment ID (FEI) Number
Company Headquarters' D&B DUNS® Number
Division Name (if applicable)
Street Address (Physical location)
City

Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory

Telephone (Include Country Code if applicable)

FORM FDA 4057a (12/21)

ZIP or Postal Code

Country
FAX

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Email Address

Contact Name
Prefix (e.g., Mr., Mrs., Dr.) First Name
Generational Suffix (e.g., Jr., III)

M.I.

Professional Suffix (e.g., MD, Ph.D.)

The Manufacturing/Packaging/Sterilization Site is ready for inspection

Last Name
Position Title
Yes

No

SECTION VI – CERTIFICATION STATEMENT
Select one of the following, then enter Name of Appliant (or person signing on behalf of the Applicant if Applicant is an
organization), Authorized Representative, or U.S. Agent, and the name of the Applicant in the body of the statement.
I am signing as a/an:
First Name

Authorized Representative

Applicant
M.I.

Last Name

U.S. Agent
Generational Suffix (e.g., Jr., III)

I,
on behalf of the applicant,
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 the 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.

Signature

FORM FDA 4057a (12/21)

Date

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APPENDIX
INSTRUCTIONS FOR USE
This form and the instructions for use are solely intended to provide the applicant an organized format to supply information
required for a Premarket Tobacco Product Application (PMTA) Amendment and General Correspondence Submission.
Section I – Applicant Identification
Subsection A – Current Applicant Information

• Complete the Date of Submission
• Complete Name of Applicant name and optionally other identifying information. Provide only either a person’s name,
if the Applicant is an individual, or an Organization Name.

• Complete Applicant address information as previously submitted, and optionally provide contact name,telephone,
and email address. (Changes to the current Applicant information should be made only in Subsection C.)

• If the Applicant is an individual, the Organization Name and Address associated with the individual may be provided.
Subsection B – Request for Change in Ownership 21 CFR 1114.13

• Provide the effective date of the change in ownership.
• Complete the Name of the New Applicant and optionally other identifying information. Provide only either a person’s
name, if the Applicant is an individual, or an Organization Name.

• Provide the Applicant address information, and optionally provide contact name, telephone, and email address.
• If the Applicant is an individual, the Organization Name and Address associated with the individual may be provided.
• Indicate if any notices are included in the submission regarding the transfer of ownership. (List the notice(s) in
Section IV under Administrative contents.)
• Indicate if you are transferring all related submissions related to a brand or brands. If so, provide the tobacco
product names and corresponding STNs subject to the change in ownership
Subsection C – Addition, Update, or Removal of Applicant Identification Information or Point of Contact
21 CFR 1114.9

• Optionally select the type of Applicant information (e.g., Applicant, Authorized Representative, etc.) being provided.
• Optionally select to add, update, replace, or remove Applicant Information.
• To add a new party, complete all information. An Authorized Representative or U.S. Agent must be a person.
Provide the person’s name, address, and contact information.

• To update or remove party information, the Person’s Name or Organization Name must match previously submitted
•
•
•
•
•
•
•
•

information. For updates, the Address and Contact information provided will be used to update previously provided
information.
To replace a party, the Person’s Name or Organization Name must match previously submitted information. It is not
necessary to provide address information.
To provide additional Applicant Identification Information, select “Update Additional Applicant Identification
Information” on the form.
Optionally select the type of Point of Contact information (e.g., Applicant, Authorized Representative, etc.) being
provided.
Optionally select to add, update, or remove Point of Contact information.
Provide the Company Name associated with the Point of Contact
To add a new Point of Contact, complete all information. Provide the contact’s name, address, and contact
information.
To update or remove information for a Point of Contact, the Person's Name must match previously submitted
information.
To provide information for an addition Point of Contact, the Person's Name must match previously submitted
information

FORM FDA 4057a (12/21)

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Section II – Tobacco Product Identification 21 CFR 1114.7(c)

• For an individual tobacco product, provide the previously submitted new tobacco product’s names.

o Product category, sub-category, and product properties should be provided only if they are changing. When
updating product category, sub-category, or properties always give the both previously submitted and the
updated information.
For
a
co-packaged
tobacco product, provide the new tobacco products’ names for all products in the co-packaged
•
tobacco product.
o Product category, sub-category, and product properties should be provided only if they are changing. When
updating product category, sub-category, or properties always give the both previously submitted and the
updated information.
• For a grouped submission, add an individual or co-packaged tobacco product by selecting “Add Section II” on the
form.

Section III – Submission Information

• Indicate whether the submission is an Amendment or General Correspondence.

o For Amendments, provide the Date of FDA Letter, if applicable, and select the Amendment Response Type.
If the type of response, is “Unsolicited” or “Other”, describe the purpose of the submission in the Submission
Summary. Also indicate the subject of the amendment provided in Section IV – Amendment and General
Correspondence Contents.
o For General Correspondence, select Subject(s) of Correspondence and provide the appropriate information
in the Section indicated. If “Other”, describe the subject of the correspondence in the Submission Summary.
Also describe the subject of the correspondence in Section IV - Amendment and General Correspondence
Contents
• Provide the FDA STN being amended. The Premarket Tobacco Application Amendment and General
Correspondence Submission should be used to update only one STN.
• If instructed to do so, based on the selection of either Amendment Response Type or Subject of Correspondence,
or otherwise optionally, complete the Submission Summary.
• Indicate whether the Amendment submission is for a single individual tobacco product or for a group of tobacco
products previously submitted as a grouped PMTA submission.
• Optionally add, update, or remove cross-referenced content, including Tobacco Product Master Files
o Provide the New Tobacco Product Name for which the cross-referenced content is relevant. Optionally,
indicate if the content is relevant to all tobacco products which are the subject of this amendment
submission. By selecting this checkbox, multiple products can be updated with one Section III. However, a
Section II must be completed for each product updated by this amendment submission.
o Provide metadata for each document to identify the cross-referenced content.
o Select “Update Cross-Referenced Content Information” to add metadata for an additional document.
• Optionally add, update, or remove related submissions, (e.g., ITP, SE Report, MRTPA).
o Provide the New Tobacco Name for which the related submission is relevant. Optionally, indicate if the
submission is relevant to all tobacco products which are the subject of this amendment submission. By
selecting this checkbox, multiple products can be updated with one Section III. However, a Section II must
be completed for each product updated by this amendment submission.

FORM FDA 4057a (12/21)

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Section IV – Amendment and General Correspondence Contents

• Select the categories of document submitted from among Administrative, Labeling and Marketing Plans,

Inspections, Scientific Content, or Other. For each category (except Scientific Content), list the sub-categories that
describe the submission contents. For Scientific Content, select the all the content categories that apply to content
provided in this amendment submission. For Scientific Content that does not fit into one of the listed categories,
select “Other” and describe the content in the space provided.
• Submission Table of Contents: Optionally, select to add, replace, or suspend (i.e., remove from the active
documents for review) submission documents. Provide metadata for each submission document: Action (Add,
Replace, or Suspend), Date Document was Submitted if replacing or suspending, Document Filename, Document
or Study Title, Table of Contents Category, and all applicable Document Keywords.
• To provide metadata for additional documents select “Update Submission Document”. (A Sample of Table of
Contents can be found in CTP’s “Electronic Submission File Formats and Specifications”, Appendix A. The technical
specification is posted on CTP’s public website page at the very bottom of the “Manufacturing” page under
“Resources for Electronic Submissions”: https://www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatoryInformation/Manufacturing)
Section V – Manufacturing/Packaging Sites Relating to a Submission

• Optionally select to add, update, or remove Manufacturing/Packaging Site information. To update or remove

information for a Manufacturing/Packaging Site, the “Company/Institution Name” must match previously submitted
information.
• If "Add" is selected, provide all demographic information for the new site. If "Update" is selected, provide only
“Company/ Institution Name” and the information which will replace previously submitted information. If "Remove" is
selected, provide only the "Company/ Institution Name" of the site to be removed.
Section VI – Certification Statement 21 CFR 1114.7(m)

• Select if the signer is acting as an Authorized Representative or U.S. Agent.
• Insert the name of the signer, and sign and date the form where indicated.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 10 minutes per response, including the time to review
instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information.
Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this
burden, to:
Department of Health and Human Services Food and Drug
Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
[email protected]

FORM FDA 4057a (12/21)

“An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of
information unless it displays a currently valid OMB
number.”

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