Form FDA 4057a Premarket Tobacco Product Application Amendment and Gene

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

PREMARKET TOBACCO PRODUCT APPLICATION AMENDMENT
AND GENERAL CORRESPONDENCE SUBMISSION

Form Approved: OMB Control No. 0910-xxxx
Expiration Date: xx/xx/xxxx
See PRA Statement on page X.

SECTION I - APPLICANT IDENTIFICATION
1. Name of Applicant

2. Date of Submission

3. Name of Manufacturer (If different from applicant)
4. FDA Establishment Identifier (FEI) (If applicable)

5. D&B DUNS Number of Headquarters (If applicable)

6. Applicant Address and Contact Information
Primary Address (Street Address, P.O. Box)

City

State/Province/Region

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

Country

ZIP or Postal Code

Telephone

Email

FAX

SECTION II - Submission Information and Contents
Type of Submission (Select appropriate category, then you must fill in and/or select applicable follow-on items.)
General Correspondence

Amendment [Include submission tracking Number (PM#######)]

Change in Manufacturer, Authorized Representative, U.S.
Agent or Alternate Point of Contact Information
Change in Ownership
Request to Withdraw the PMTA [PM#######]

Scientific Content included in the amendment: (See instructions
for use for description)
General Information
Descriptive Information

Change in Manufacturing/Packaging/ Sterilization Site
Information

Product Samples
Statement of Compliance with 21 CFR part 25
Summary

Adverse Experience Report
Periodic Report (e.g. Annual Report)

Product Formulation
Manufacturing
Literature Search
Organized References

Other (Specify below)

Health Risk Investigations
Study Reports
Response to Advice/Information Request
Other (Specify below)

SECTION III - ADDITION OR REMOVAL OF AUTHORIZED REPRESENTATIVE, U.S. AGENT, OR ALTERNATE
POINT OF CONTACT
Addition or removal of Authorized Representative Select one:

Add

Remove

Effective date

7. Name of Authorized Representative
8. Authorized Representative Address and Contact Information
Primary Address (Street Address, P.O. Box)

City

State/Province/Region

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

Country

ZIP or Postal Code

Telephone

Email

FORM FDA 4057a (06/19)

FAX

Page 1 of 6

PSC Publishing Services (301) 443-6740

EF

Addition or Removal of U.S. Agent

Select one:

Add

Remove

Effective date

9. Name of U.S. Agent
10. U.S. Agent Address and Contact Information
Primary Address (Street Address, P.O. Box)

City

State/Province/Region

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

Country

ZIP or Postal Code

Telephone

Email

FAX

Addition or Removal of Alternate Point of Contact Select one:

Add

Remove

Effective date

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

City

State/Province/Region

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

Country

ZIP or Postal Code

Telephone

Email

FAX

SECTION IV - Change In Ownership
Effective Date of Ownership Change (mm/dd/yyyy)
Current Owner Information
Manufacturer Name
FDA Establishment Identifier (FEI)

D&B DUNS Number of Headquarters

Primary Address (Street Address, P.O. Box)

City

State/Province/Region

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

Country

ZIP or Postal Code

Telephone

Email

FAX

New Owner Information
Manufacturer Name
FDA Establishment Identifier (FEI)

D&B DUNS Number of Headquarters

Primary Address (Street Address, P.O. Box)

City

State/Province/Region

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

Country

ZIP or Postal Code

Telephone

Email

FAX

Transfer Request
Would you be transferring all submissions related to an entire brand to the new owner?

FORM FDA 4057a (06/19)

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Yes

No

If yes, identify the brand(s) for all submissions you would be transferring

List of submission tracking numbers that would be transferred

Have you submitted a signed notice to FDA stating that all rights to the PMTA have been transferred to the new owner?
Select one:

Yes

No

Have you submitted a signed noticed to FDA with the new applicant's commitment to agreements, promises and conditions made by the
former applicant and contained in the PMTA?
Select one:

Yes

No

SECTION V - ADDITION OR REMOVAL OF MANUFACTURING/PACKAGING/STERILIZATION SITES
Addition or removal of Manufacturing/Packaging/Sterilization sites:
Facility Establishment Identifier (FEI) Number

Select one:

Add

Remove

Manufacturer

Contract Sterilizer
Repacker/Relabeler

Contract Manufacturer
The Manufacturing/Packaging/Sterilization Site is ready for inspection

Select one:

Yes

Company/Institution Name

Establishment Registration Number

Division Name

Phone Number (Including area code)

Street Address

FAX Number (Including area code)

City
Contact Name

State/Province ZIP Code

No

Country

Contact Title

Email

SECTION VI - CERTIFICATION STATEMENT
Select one of the following, then sign after entering your name in the statement.
I am signing below as a/an:
Applicant
Authorized Representative
U.S. Agent
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 (06/19)

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

•
•
•
•
•
•

Provide applicant name (means any person that submits a premarket tobacco product application to receive a marketing order for a
new tobacco product
Provide date submission was submitted
Provide manufacturer name (if different from applicant)
Provide FDA Establishment identifier (FEI) (if applicable)
Provide D&B DUNS Number of Headquarters (if applicable)
Provide applicant address and contact information

Section II - Submission Information and Contents

•
•

•

Select type of submission: check box if the submission is a general correspondence or if the submission is an amendment
Check the appropriate box if:
• there is a change in manufacturer, authorized representative, U.S. Agent or alternate point of contact information

•
•
•
•
•
•
•
•

there is a change in ownership information 21 CFR § 1114.13
you would like to withdraw a PMTA, include PM# 21 CFR § 1114.11
you would like to inactivate a PMTA, include PM# 21 CFR § 1114.43
you would like to reactivate a PMTA, include PM# 21 CFR § 1114.43
the submission is to respond to an Advice/Information Request
there is a change in Manufacturing/Packaging/Sterilization Site Information 21 CFR § 1114.7(j)
the submission includes an Adverse Experience Report
the submission includes a Periodic Report 21 CFR § 1114.41(a)(1)

Select the type of scientific content included in the submission:
• General information 21 CFR § 1114.7(c)(e.g., product name, product category, subcategory and product properties)

•
•

•
•
•
•
•

•
•

Descriptive information 21 CFR § 1114.7(d)
Product samples 21 CFR § 1114.7(e)

•

FDA generally expects that product samples will be a required part of a PMTA. There may be situations in which sample
submission may not be necessary, including, for example, some PMTAs that are resubmitted for the same product after a no
marketing order and PMTAs submitted for modifications to an authorized product where the modifications do not require new
samples to be reviewed as part of the PMTA evaluation process. Presubmission meetings with the 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.

Statement of compliance with 21 CFR part 25 (e.g. Environmental Assessment) 21 CFR § 1114.7(g)
Summary 21 CFR §1114.7(h)
Product formulation 21 CFR § 111.7(i) (e.g., components, ingredients, additives, properties, and principles of operations)
Manufacturing 21 CFR 111.4.7(j) (e.g., methods, facilities, controls)
Literature Search

•

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 5) an analysis of study findings and 5) a bibliography of referenced publications.

Organized References used to compile information in the submission
Health Risk Investigations

•

Examples of health risk investigations include but not limited to; Toxicological Risk Evaluation, Health Impact (e.g., use behavior,
health risk), Tobacco Product Perception and Intention Studies

FORM FDA 4057a (06/19)

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•

Study Report(s) - examples of documents include:

•
•

Study protocol
Statistical analysis plan
i.
ii.
iii.
iv.

Study report
Statistical software programming code
Study instruments (e.g. surveys/questionnaires)
Informed consent form

•

Case Report Forms (as appropriate)
In general Case Report Forms (CRFs) from clinical studies are not needed for filing a PMTA. However, FDA will require for filing
the CFRs 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-bycase basis during FDA review. FDA expects all raw data would be available for review during Agency inspection of clinical and/or
nonclinical study sites.
Other

Section III - Additional or Removal of Authorized Representative, U.S. Agent or Alternate Point of Contact

•
•

Select add or remove if you are adding or removing the Authorized Representative, U.S. Agent or Alternate Point of Contact
Provide all demographic information for the Authorized Representative, U.S. Agent or Alternate Point of Contact

Section IV - Change in Ownership

•
•
•
•
•
•

Provide effective date of the change in ownership 21 CFR § 1114.13
Complete all manufacturer demographic information 21 CFR § 1114.7(j)
Identify if you are transferring all submissions related to a brand or brands
List all STNs subject to the change in ownership 21 CFR § 1114.13(a)
Select yes or no if you have submitted a signed notice to FDA stating that all rights to the PMTA have been transferred to the new
owner 21 CFR § 1114.13(a)
Select yes or no if you have submitted a signed notice to FDA with the new applicant's commitment to agreements, promises and
conditions made by the former applicant and contained in the PMTA 21 CFR § 1114.13(b)(1)

Section V - Manufacturing/Packaging/Sterilization Sites Relating to a Submission

•
•

Select add or remove if you are adding or removing a Manufacturing/Packaging/Sterilization Site
Complete all manufacturing demographic information 21 CFR § 1114.7(j)

Section VI - Certification Statement

•

Select the checkbox Applicant, Authorized Agent or U.S. Agent and sign the certification statement

FORM FDA 4057a (06/19)

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We remind you that all regulatory correspondence can be submitted via the FDA Electronic Submission Gateway ( www.fda.gov/esg )
using eSubmitter or mailed to:
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
We are unable to accept regulatory submissions by electronic mail.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 5 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 the following email address:
For PRA questions
[email protected]
OMB Statement: “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.”

FORM FDA 4057a (06/19)

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