Form FDA 3964 FDA 3964 Tobacco Amendment and General Correspondence Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

TOBACCO AMENDMENT AND GENERAL
CORRESPONDENCE REPORT

Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/201x
(See Burden Statement on last page.)

FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Public Law 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).
STATUTORY REQUIREMENTS
Section 910(a)(1) of the FD&C Act – Defines a new tobacco product as “(A) any tobacco product (including
those products in test markets) that was not commercially marketed in the United States as of February 15,
2007; or (B) any modification (including a change in design, any component, any part, or any constituent,
including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient)
of a tobacco product where the modified product was commercially marketed in the United States after
February 15, 2007.”
Section 910(a)(2) of the FD&C Act – Premarket review required for new tobacco products. There are three
pathways to achieve marketing authorization. Substantial Equivalence is one of the three pathways.
Section 910(a)(3) of the FD&C Act – “Substantial equivalence” means, with respect to the tobacco product
being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco
product ‘‘(i) has the same characteristics as the predicate tobacco product; or (ii) has different characteristics
and the information submitted contains information, including clinical data if deemed necessary by the
Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the
product does not raise different questions of public health.”

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Section 905(j)(1)(A)(i) of the FD&C Act – Includes the time frame and basis for submission of a
Substantial Equivalence Report (SE Report).

FORM FDA 3964 (05/18)

General Information

PSC Publishing Services (301) 443-6740

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

TOBACCO AMENDMENT AND GENERAL
CORRESPONDENCE REPORT

Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/201x
(See Burden Statement on last page.)

Please type. An item followed by an asterisk (*) denotes a required field. Please note that some subordinate items not marked
with an asterisk will be required under certain conditions, depending on the written prompt for preceding required item.

SECTION I – APPLICANT IDENTIFICATION
Applicant Name
FDA Establishment Identifier (FEI)

D&B DUNS Number of Headquarters
Building Number and Street*

Applicant Street Address
(Physical location)

Room, Suite, Office Mail Code, etc. (If applicable)
State, Province, or Territory*

City*

Country*

Postal Code*

SECTION II – SUBMISSION INFORMATION AND CONTENTS
Type of Submission* (Please select appropriate category, then you must fill in and/or select applicable follow-on items.)

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Amendment (If selected, fill in below, per prompts.)
For Amendments fill in information below.

General Correspondence (If selected, fill in below, per prompts.)

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For General Correspondence select one of the following.

Amending Submission Tracking Number
Date of FDA Letter (If applicable)(mm/dd/yyyy)
Response to Information Request (Select one):

Advice/Information Request
Preliminary Finding
Grandfathered Evidence (Complete Section IV)
Other (Describe in Submission Summary)

Change in Ownership Request (Complete Section III)
Request to Withdraw
Correction (Describe in Submission Summary)
Applicant Address or Information Change
Addition or Removal of a Point of Contact (Complete
section V)
Other (Describe in Submission Summary)

Submission Summary (Required if instructed to “Describe” by a previous prompt.)

SECTION III – REQUEST FOR CHANGE IN OWNERSHIP
Effective Date of Ownership Change (mm/dd/yyyy):

Current Ownership Information
Manufacturer Name
FDA Establishment Identifier (FEI)

FORM FDA 3964 (05/18)

D&B DUNS Number of Headquarters

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PSC Publishing Services (301) 443-6740

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Building Number and Street

Current Owner Street Address
(Physical location)

Room, Suite, Office Mail Code, etc. (If applicable)
State, Province, or Territory

City

Country

Postal Code

Proposed New Owner Information
Manufacturer Name
FDA Establishment Identifier (FEI)

D&B DUNS Number of Headquarters
Building Number and Street

Proposed New Owner Street Address
(Physical location)

Room, Suite, Office Mail Code, etc. (If applicable)
State, Province, or Territory

City

Country

Postal Code

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

Yes

No

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

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List of Submission Tracking Numbers that would be transferred:

SECTION IV – GRANDFATHERED PRODUCT EVIDENCE

(Complete only if the predicate has not been previously reviewed by CTP.)

Subsection A. Evidence of Commercial Marketing As of 2/15/2007
(For additional evidentiary items, attach sheet(s) following the format below.)

Type of Evidence (e.g., Invoice)

Date of Evidence

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

Commercial Information (e.g., UPC Code, Product
Description, Item Number)

Commercially Marketed Business Address

Building Number and Street

(Physical location)

Room, Suite, Office Mail Code, etc. (If applicable)
State, Province, or Territory
FORM FDA 3964 (05/18)

City

Country

Postal Code
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Subsection B. Test Market Statement
I,

confirm that the predicate tobacco product associated with this

Authorized Representative*

Substantial Equivalence Submission for

Name of Tobacco Product

was commercially marketed other than for test marketing in the United States as of February 15, 2007.
* Authorized representative should be an individual who has
knowledge of the test marketing status of the tobacco product
and who has authority to make such a statement.

Signature

SECTION V – ADDITION OR REMOVAL OF POINT OF CONTACT
Select one:

Add

Remove

Company Name
Prefix (e.g., Mr., Ms., Dr.):
First Name
Professional
Suffix(e.g., MD,

M.I.

Last Name

Position Title

Suffix (e.g., Jr., III)
Email Address

Ph.D.)

Telephone (Include Country Code if applicable)

FAX

Room, Suite, Office Mail Code, etc. (If applicable)
State, Province, or Territory

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Building Number and Street

Point of Contact Mailing Address

City

Country

Postal Code

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:
I,

Name

Authorized Representative

U.S. Agent

certify that the data in the submission have been reviewed and are

true and accurate, and that the applicant is not aware that any material fact has been omitted.
Signature

FORM FDA 3964 (05/18)

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INSTRUCTIONS
Section I – Applicant Identification
Complete all demographic information.
Section II – Submission Information and Contents
• Indicate Amendment or General Correspondence.
• If Amendment, provide reference or related STN and identify the submission contents.
• If General Correspondence, identify submission contents.
Section III – Request for Change in Ownership
• Provide the effective date of the change in ownership.
• Complete all manufacturer demographic information.
• Identify if you are transferring all submissions related to a brand or brands.
• List all STNs subject to the change in ownership.
Section IV – Grandfathered Product Evidence
Subsection A – Evidence Of Commercial Marketing As of 2/15/2007
Fill out Subsection A only if you are requesting grandfathered status with this application for your predicate
tobacco product. Repeat subsection A for additional evidentiary support.
• Type of Evidence: Provide brief description of what is submitted, e.g., invoice, bill of lading, etc.
• Date of Evidence: Provide the date on the evidence.
• Evidence Identifier: Provide an identifying number or code for the evidence type, e.g., invoice number.
• Commercial Information: Provide UPC Code, SKU number, or other identifier, if applicable.
• Tobacco Product Quantity: Provide the quantity of the product as identified in the type of evidence.
• Business Address where product was commercially marketed: Provide the address of the
establishment subject to the evidence provided, e.g., the location of the establishment that the product
was commercially sold on February 15, 2007.

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Subsection B – Test Market Statement
Complete all fields and Sign to affirm that the predicate product was commercially marketed other than for
test marketing in the United States as of February 15, 2007.

Section V – Addition or Removal of Point of Contact
• Select if you are adding or removing a Point of Contact.
• Provide all demographic information for the Point of Contact you are adding or removing.
Section VI – Certification Statement
• Select if you are acting as an authorized representative or U.S. Agent.
• Insert your name and sign where indicated.
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 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:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
FORM FDA 3964 (05/18)

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“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.”