Form FDA Tobacco Health Document Submission

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

TOBACCO HEALTH DOCUMENT
SUBMISSION

Form Approved: OMB No. 0910-0654
Expiration Date: 6/30/2019
(See page 5 for PRA Statement)

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
act) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.
STATUTORY REQUIREMENTS
Section 904(a)(4) of the act requires each tobacco product manufacturer or importer, or agent thereof, to submit all
documents developed after June 22, 2009 “that relate to health, toxicological, behavioral, or physiologic effects of
current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and
additives.” Information required under section 904(a) (4) must be submitted to FDA beginning December 22, 2009.
DEFINITIONS
FDA intends to use the following definitions in implementing the health document submission requirements of
section 904(a)(4) of the act.
1. Component or part: The term component or part means any software or assembly of materials intended or
reasonably expected:
(1) to alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or
(2) to be used with or for the human consumption of a tobacco product.
Component or part excludes anything that is an accessory of a tobacco product.
FDA notes that component and part are separate and distinct terms within chapter IX
of the FD&C Act. However, for purposes of this form, FDA is using the terms component and part
interchangeably and without emphasizing the distinction.
FDA may clarify the distinctions between component and part in the future.
2. Document: FDA views Federal Rule of Civil Procedure (FRCP) 34 as providing guidance in this area. Rule
34 defines “documents or electronically-stored information” as including “writings, drawings, graphs, charts,
photographs, sound recordings, images, and other data or data compilations – stored in any medium from
which information can be obtained either directly or, if necessary, after translation by the responding party into
a reasonably usable form” (Fed. R. Civ. P. 34(a)(1)(A)). FDA understands the term document in section 904(a)
(4) to include the types of documents or electronically stored information referenced in FRCP Rule 34. The term
document includes any original or any modified version or draft varying in any way, which is saved or stored
separately from other versions and/or distributed to others.
3. Finished tobacco product: The term finished tobacco product means a tobacco product, including all
components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold
separately to consumers or as part of kits).
4. Importer: The term importer means any person who imports any tobacco product that is intended for sale or
distribution to consumers in the United States.
5. Small-scale tobacco product manufacturer: The term small-scale tobacco product manufacturer means a
manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and
has annual total revenues of $5 million or less. FDA considers a manufacturer to include each entity that it
controls, is controlled by, or is under common control with.

FORM FDA 3743 (3/17)

General Information – Page i

PSC Publishing Services (301) 443-6740

EF

6. Tobacco product: The term tobacco product is defined in section 201(rr) of the FD&C Act, which states in
relevant part:

(1) The term “tobacco product” means any product made or derived from tobacco that is intended for
human consumption, including any component, part, or accessory of a tobacco product (except for
raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco
product).

(2) The term “tobacco product” does not mean an article that is a drug under [section 201(g)(1)], a
device under [section 201(h)], or a combination product described in section 503(g) [of the FD&C Act].
Note that this definition includes accessories and components and parts of tobacco products, whether
they are made or derived from tobacco and whether they are sold or distributed as finished tobacco
products.1
7. Tobacco product manufacturer: The term tobacco product manufacturer means “any person, including any
repacker or relabeler, who (A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or
(B) imports a finished tobacco product for sale or distribution in the United States” (section 900(20) of the FD&C
Act (21 U.S.C. 387(20)). Thus, the term is not limited to persons who manufacture products containing tobacco,
but includes anyone who manufactures any tobacco product as defined above.

  However, accessories of tobacco products subject to the deeming rule are explicitly excluded from the rule’s deeming
provision . Thus, although they meet the definition of tobacco product, such accessories are not currently subject to
regulation under the FD&C Act (including section 904(a)(4)). Reference the deeming rule for further information about
accessories (81 FR 28974).
1

FORM FDA 3743 (3/17)

General Information – Page ii

Form Approved: OMB No. 0910-0654
Expiration Date: 6/30/2019
(See page 5 for PRA Statement)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

TOBACCO HEALTH DOCUMENT
SUBMISSION
See page 6 for Instructions

Please type. An item followed by an asterisk (*) denotes a required field.

SECTION I - SUBMITTER IDENTIFICATION
Submitter Type (Check one)*

Manufacturer

Importer (Complete Section II)

Company Name*
Company Headquarters D&B D-U-N-S ® Number

Company Headquarters FDA-assigned Facility
Establishment Identifier (FEI) Number

Address*

City*

State, Province or Territory*

Country*

ZIP or Postal Code*

Authorized Representative (Responsible official authorized to represent the applicant)
Prefix (e.g., Mr., Ms., Dr.):
First/Given Name

Professional
Suffix (e.g., MD,

M.I.

Last Name

Position Title

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

Ph.D.)

Telephone (Include Country Code if applicable)
Company Name
Address

FAX

Check here if same as submitter company name above, and skip to Address.

Check here if same as above, and skip to Section II.

State, Province or Territory

Country

City

ZIP or Postal Code

SECTION II - MANUFACTURER OF IMPORTED PRODUCTS
Required only for importers
Company Name*
Company Headquarters D&B D-U-N-S ® Number

FORM FDA 3743 (3/17)

Company Headquarters FDA-assigned Facility
Establishment Identifier (FEI) Number

Page 1

Address*

City*

State, Province or Territory*

Country*

ZIP or Postal Code*

U.S. Agent (For foreign firm where Authorized Representative does not reside in the U.S.)
Prefix (e.g., Mr., Ms., Dr.):
First/Given Name

Professional
Suffix(e.g., MD,

M.I.

Last Name

Generational Suffix
(e.g., Sr., Jr., III)

Position Title

Email Address

Ph.D.)

Telephone (Include Country Code if applicable)
Company Name
Address

FAX

Check here if same as manufacturer company name above, and skip to Address.

Check here if same as above, and skip to Section III.

State, Province or Territory

City

Country

ZIP or Postal Code

SECTION III - SUBMISSION FORMAT AND CONTENTS
Indicate your submission format (Check all that apply).
Electronic Documents
1.

Number of documents

4.

Size of submission (e.g., MB)

2.

Media type (e.g., CD)

5.

File type (e.g., PDF)

3.

Media quantity (e.g., # of CDs)

6.

File software (e.g.,
Adobe Acrobat XI)

7. If you are submitting electronic documents, please detail any special instructions for loading or accessing your
submission, including contact information for IT professionals who may be able to provide additional technical
details about your submission.

Paper Documents
1.
None

Number of documents

2.

Number of volumes

3.

Number of boxes

I do not have any documents that relate to health, toxicological, behavioral or physiologic
effects of current or future tobacco products, their constituents (including smoke
constituents), ingredients, components, and additives to submit for this reporting period.
I do not anticipate having documents in the future. If at any time in the future I do have such
documents I will immediately notify FDA and begin submitting the documents as required by
section 904(a)(4) of the Federal Food, Drug, and Cosmetic Act.

FORM FDA 3743 (3/17)

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SECTION IV - CONFIRMATION STATEMENT

The data and information in this submission have been reviewed and, to the best of my
knowledge, are certified to be true and accurate. Electronic media has been scanned
and certified to be virus-free. I agree to report changes to this information as required
under section 904(c) of the act.

Agree

WARNING:
A willfully false statement is a criminal offense, U.S. Code, Title 18, Section 1001.
Signature of Authorized Representative or U.S. Agent

Date

Typed Name and Title:
Authorized Representative or U.S. Agent Contact Information
Check here if same as the submitter point of contact information in Section I. If so, you may skip to
Company Name.
Prefix (e.g., Mr., Ms., Dr.):
First/Given Name

Professional
Suffix(e.g., MD,

M.I.

Last Name

Position Title

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

Ph.D.)

Telephone (Include Country Code if applicable)
Company Name
Address

FAX

Check here if same as submitter, and skip to Address.

Check here if same as submitter company’s, and skip to Section V.

State, Province or Territory

FORM FDA 3743 (3/17)

Country

City

ZIP or Postal Code

Page 3

Submit a separate copy of this page for each document or each set of documents.

SECTION V - DOCUMENT CATEGORIZATION
1. This document or set of documents relates to
the following effects (Check all that apply)

Health
Toxicological

Behavioral
Physiological

2. This document or set of documents relates to the following: (Complete Parts A-D, as appropriate. You are to provide a
consistent, unique identifying name for each tobacco product, additive, ingredient, constituent or component. You may
use continuation sheets if necessary.)
Part A:  Uniquely identified current or future tobacco product(s)

Part B:  Category of current or future tobacco products (e.g., cigarettes)
Part C:  Specific ingredient(s), constituent(s), component(s), or additive(s)

Part D:  Class of ingredients, constituents, components, or additives (e.g., tobacco specific nitrosamines)

SECTION VI - DOCUMENT READABILITY AND ACCESSIBILITY
1. Glossary or explanation of any abbreviations, jargon or code names (You may describe below or attach a
separate glossary for your entire submission.)

SECTION VII - DOCUMENT METADATA
1. Document date:
2. Document author(s):
3. Document recipient(s):
4. Document custodian:
5. Document title or identification number

6. Beginning and ending Bates numbers

7. Bates number ranges for other documents physically or digitally attached to the document (e.g., an attachment to
an email)

8 Document type (See instructions)
9. Presence of document in the University of California San Francisco Truth Tobacco Documents database
(Check one)
FORM FDA 3743 (3/17)

Present

Not present
Page 4

Uknown

REFERENCES

Reference for the Tobacco Control Act:
http://www.accessdata.fda.gov/scripts/tobaccocontrol/index.cfm
Reference for Guidance on Health Document Submission:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm281147.htm
Reference for SRS UNII:
http://www.fda.gov/ForIndustry/DataStandards/ SubstanceRegistrationSystemUniqueIngredientIdentifierUNII
National Library of Medicine’s Medical Subject Headings: http://www.nlm.nih.gov/mesh/

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 50 hours 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
“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 3743 (3/17)

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INSTRUCTIONS
General
Provide pages 1 through 3 of this form (Sections I-IV) as a cover sheet for your complete submission. Provide page
4 of this form (Sections V-VII) as a cover sheet for each document.
In order for FDA to access, review, and archive your documents, they cannot be password protected.
If you are submitting paper documents, FDA recommends that all pages are Bates numbered. All regulatory
submissions should be hole-punched and bound with metal fasteners. Assure that text is not obscured by hole
punching. Ring binders (notebooks) are not recommended as they have been found to open during constant
moving. Shipping unbound documents may result in the loss of portions of the submission.

Section I – Submitter Identification
Identify whether the submitter is the manufacturer or the importer.
You are to provide the submitting party’s name and address. If you are submitting as an importer, you must
complete a separate submission for each manufacturer whose products you import.
If you are submitting on behalf of the manufacturer or importer as an agent, report information for the manufacturer
or importer, not your own information.

Section II – Manufacturer Identification
If you are submitting as an importer, you are to identify the manufacturer whose documents you are submitting by
completing this section for each submission.

Section III – Submission Format and Contents
Please indicate whether your submission contains electronic or paper documents.
Electronic Documents
Item 1: Indicate the total number of documents you are including in your submission.
Item 2: Specify the type of media you are submitting (e.g., CD, DVD, hard drive).
Item 3: Specify how many pieces of media you are submitting (e.g., 3 CDs).
Item 4: Indicate the total size of your submission.
Item 5: Specify the type of files contained in your submission (e.g., PDF, TIFF).
Item 6: Indicate the type of software used to create your documents (e.g., Adobe Acrobat XI or Summation).
Item 7: Provide any technical details needed for FDA to load or access your documents.
Paper Documents
Item 1: Indicate the total number of documents you are including in your submission.
Item 2: Specify how many volumes of documents you are including in your submission.
Item 3: Specify how many boxes of documents you are including in your submission.
None
If you do not have any health documents to report this period, you are to so inform FDA. If you do not anticipate
having any health documents to submit in the future, you may also state this.
FORM FDA 3743 (3/17)

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Section IV – Confirmation Statement
Please sign and date your submission. If you are submitting as an authorized agent, enter all required identifying
information in this section. Check your submission to ensure that you have included a copy of page 4 with each
submitted document.

Section V – Document Categorization
Item 1: Select all that apply. You are to select at least one category.
Item 2: Complete Parts A through D, as applicable to the information addressed by your document. You are to use
consistent terminology to identify tobacco products and constituents/ingredients/components across all documents
submitted under section 904 of the act.

Section VI – Document Readability and Accessibility
Item 1: FDA requests that you provide a glossary or explanation for any abbreviations, jargon or code names used
in your documents. You may provide any necessary explanations for this document in the box below, or attach a
separate glossary for your entire submission.

Section VII – Document Metadata
Item 1: Specify the document date.
Item 2: List all authors of the document
Item 3: List all recipients of the document
Item 4: Identify the custodian of the document. The custodian is the individual with physical control of the document.
Item 5: Identify the document title or identification number.
Item 6: FDA requests that you uniquely number each page of every document submitted, a practice referred to as
Bates numbering. Please provide the beginning and ending Bates numbers for each document.
Item 7: If you are submitting a document with physical or digital attachments (e.g., an email or other memo with
attached documents), provide the Bates number range(s) for the attached document(s). Each attached document is
to be submitted with a separate completed cover sheet (Sections V-VII of this form).
Item 8: Identify the type of document you are submitting as one of the following: Email, Briefing slides, Publication,
Memo, Report, Meeting minutes, Proposal, Study design, Teleconference, Lab Notes, Other.
Item 9: Identify the presence of the document in the University of California San Francisco Truth Tobacco
Documents Database as one of the following: present, not present, or unknown.

FORM FDA 3743 (3/17)

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