Form FDA 3964 FDA 3964 Tobacco Amendment and General Correspondence

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Tobacco Substantial Equivalence Report Amendment
and General Correspondence Submission

Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/202x
(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.” (Pre-Existing Tobacco Product) (PTP)
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 (11/20)

General Information

This section is deliberately blank.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Tobacco Substantial Equivalence Report Amendment
and General Correspondence Submission

Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/202x
(See Burden Statement on last page.)

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 (excluding Applicant name), or the update, replacement, or removal of previously provided 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 organization (manufacturer/importer) seeking a marketing authorization for a new tobacco product)

Date of Submission
Name of Applicant (Provide an organization's name)
Organization Name:
Company Headquarters' FDA-Assigned Facility Establishment ID (FEI) Number
Company Headquarters' D&B DUNS® Number

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Applicant Address and Contact Information
Primary Address (Street Address, P.O. Box)
Address 2 (Apt., Suite, Bldg., etc.)

City

State, Province, or Territory

Country

ZIP or Postal Code

M.I. Last Name
Current Contact Name First Name
(Optional)
Generational Suffix Professional Suffix Position Title
Prefix (e.g.,
Mr., Ms., Dr.):
(e.g., MD, Ph.D.)
(e.g., Jr., III)
Telephone (Include Country Code
if applicable)

FORM FDA 3964 (11/20)

FAX

Email Address

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Subsection B. Request for Change in Ownership

Proposed New Applicant Information

(Complete this section to update the Applicant Information to reflect information relating to the new owner of the SE Report)

Effective Date of Ownership Change
Name of Applicant (Provide an organization's name)
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)
Address 2 (Apt., Suite, Bldg., etc.)

City

State, Province, or Territory

Country

ZIP or Postal Code

First Name
M.I. Last Name
New Contact Name
(Optional)
Generational Suffix Professional Suffix Position Title
Prefix (e.g.,
Mr., Ms., Dr.):
(e.g., MD, Ph.D.)
(e.g., Jr., III)
Telephone (Include Country Code
if applicable)

FAX

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Email Address

Request to transfer all related submissions for the named product(s) to the new owner
A notice is included stating that all of the former applicant's rights and responsibilities relating to the SE Report have
been transferred to the new applicant.

Transfer Requests
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

FORM FDA 3964 (11/20)

Related Submission STN

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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 Applicant; use Subsection B.) 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 Applicant Identification Information (Select only one)
Applicant (Address and Contact information only)

Authorized Representative

U.S. Agent

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

Person's Name (Provide a person's name for Authorized Representative or U.S. Agent)
First Name
Prefix (e.g.,
Mr., Ms., Dr.):

M.I.
Generational Suffix Professional Suffix
(e.g., MD, Ph.D.)
(e.g., Jr., III)

Last Name
Position Title

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

City

State, Province, or Territory
Telephone (Include Country Code
if applicable)

Country

ZIP or Postal Code

FAX

Email Address

Organization Name and Address Information (Optional for the Authorized Representative or U.S. Agent)
Organization Name
Primary Address (Street Address, P.O. Box)

Select for same address as New Applicant

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

FORM FDA 3964 (11/20)

City
Country

ZIP or Postal Code

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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:

Add

Update

Remove

(If "Update" is selected, FDA will update the Applicant Identification address or contact information that was previously
submitted)

Contact Name
Prefix (e.g.,
Mr., Ms., Dr.):

First Name

M.I.

Generational Suffix Professional Suffix
(e.g., MD, Ph.D.)
(e.g., Jr., III)

Last Name

Position Title

Alternate Point of Contact Address and Contact Information
Primary Address (Street Address, P.O. Box)
Address 2 (Apt., Suite, Bldg., etc.)

City

State, Province, or Territory

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Country

Telephone (Include Country Code
if applicable)

FAX

ZIP or Postal Code
Email Address

SECTION II – TOBACCO PRODUCT INFORMATION
Subsection A. Unique Identification of New and Predicate Tobacco Products
(This Subsection is optional and to be used only to change previously submitted information.
For a co-packaged tobacco product, complete Section II for each new tobacco product included within the co-package.
For grouped submissions, complete Section II for each tobacco product included in the bundle.)

FORM FDA 3964 (11/20)

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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 3965, Section VIII,
Appendix B to select the appropriate Product Category and Subcategory.)

New Tobacco Product Identification
(Complete for each individual new tobacco product. Refer to Form 3965, Section VII, Appendix B to select the appropriate
Product Category and Subcategory.)
Select to Update or Remove New Tobacco Product
Update
Remove
Previously Submitted New Tobacco Product Name (Brand/Sub-Brand)
Updated New Tobacco Product Name (Brand/Sub-Brand) (if applicable)
Update New Tobacco Product Category and 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:

Predicate Tobacco Product Identification
(Complete for each individual predicate tobacco product. Refer to Form 3965, Section VII, Appendix B to select the
appropriate Product Category and Subcategory)
Select to Update or Remove Predicate Tobacco Product
Update
Remove

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

FORM FDA 3964 (11/20)

Subcategory:

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Tobacco Product Properties Needed to Uniquely Identify the Product
(Update previously submitted Tobacco Product Properties 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 either the new tobacco product or predicate tobacco product, or both.)
New Tobacco Product
Name:

Action
(Add, Update, Remove)

Property Name

Previously Submitted
Target Value

Updated Target Value

Predicate Tobacco Product
Name:
Previously Submitted
Target Value

Updated Target Value

Subsection B: Tobacco Product Manufacturer Identification
New Tobacco Product Manufacturer (Optional, provide if different from Applicant or Applicant is an Importer)
The New Tobacco Product Manufacturer subsection is provided if the Applicant is not the new tobacco product
manufacturer, or the Applicant is an importer of the new tobacco product. Provide information only to add new information,
or update or remove previously submitted information.
Select if Applicant is an Importer of the new tobacco product

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Select to Add, Update, Replace, or Remove New Tobacco Product Manufacturer Information:
Add

Update

Replace

Remove

Current New Tobacco Product Name (Brand/Sub-Brand)
(Provide the previous name if no update, or provide the updated name.)
Organization Name
Company Headquarters' FDA-Assigned Facility Establishment ID (FEI) Number
Company Headquarters' D&B DUNS® Number
Street Address (Physical location)
Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory

FORM FDA 3964 (11/20)

City
Country

ZIP or Postal Code

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Predicate Tobacco Product Manufacturer (if different from Applicant or Applicant is an Importer)
The Predicate Tobacco Product Manufacturer subsection is provided if the Applicant is not the new tobacco product
manufacturer, or the Applicant is an importer of the predicate tobacco product. Provide information only to add new
information, or update, replace, or remove previously submitted information.
Select if Applicant is an Importer of the Predicate Tobacco Product
Select to Add, Update, Replace, or Remove Predicate Tobacco Product Manufacturer Information:
Add

Update

Remove

Replace

Current Predicate Tobacco Product Name (Brand/Sub-Brand)
(Provide either the previously submitted name or the updated name provided on this amendment.)
Organization Name
Company Headquarters' FDA-Assigned Facility Establishment ID (FEI) Number
Street Address (Physical location)
Address 2 (Apt., Suite, Bldg., etc.)

City

State, Province, or Territory

Country

ZIP or Postal Code

Subsection C. Predicate Product Evidence
(Complete only if the predicate has not been previously reviewed by CTP.)

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Evidence of Commercial Marketing as of February 15, 2007
Type of Evidence (e.g., Invoice)

Date of Evidence

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

Evidence Identifier (e.g., Invoice Number)
Product Quantity (as indicated by the
evidence)

Commercially Marketed Business Address
Street Address (Physical location)
Address 2 (Apt., Suite, Bldg., etc.)

City

State, Province, or Territory

Country

ZIP or Postal Code

Test Market Statement
I am signing in as:
First Name

Applicant
M.I.

Authorized Representative
Last Name

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

I confirm that the predicate tobacco product associated with this Substantial Equivalence Submission for
was commercially marketed other than for test marketing in the United
States as of February 15, 2007.
FORM FDA 3964 (11/20)

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Signature

Date

SECTION III – SUBMISSION INFORMATION
Type of Submission (Select only one)
General Correspondence (If selected, provide Subject of

Amendment (If selected, provide Date of FDA Letter
and Response Type)

Correspondence.)

Subject of Correspondence (Select all that apply)
Change to Applicant Address or Contact Information
(Section I)
Request for Change in Ownership (Section I)
Change to Point of Contact (Section I)

FDA Submission Tracking Number (STN)
to be amended
Date of FDA Letter (If applicable mm/dd/yyyy)

Other (Describe in Submission Summary)

Amendment Response Type (Select one):
Deficiency Letter
Pre-Existing Tobacco Product Evidence (Section II)
Unsolicited (Describe in Submission Summary)
Correction to Product Identification Information (Section II)
Change in Cross-referenced Content or Related
Submissions (Section III)

Request to Withdraw SE Report
Select to indicate if the withdrawal is due to a health
or safety concern related to the tobacco product
Other (Describe in Submission Summary)
Submission Summary (Required if instructed to “Describe” by a previous selection.)

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Purpose of Application (Check only one)
This SE Report Amendment is for a single new tobacco product
This SE Report Amendment is for a group of SE Report Amendments containing multiple new tobacco products
with similar modifications in comparison to one predicate tobacco product
Cross Reference to Tobacco Master Files
(As applicable, enter the STN, check the Attached Letter of Authorization box (if letter will be attached to printout or
otherwise provided), and provide Master File information.)
Select to Add, Update, or Remove Tobacco Product Master File Information:
Add

Update

Remove

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

Attached Letter of Authorization

Information and Selections to be referenced from Master File

FORM FDA 3964 (11/20)

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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
Cross-referenced Submission Type

Cross-referenced Submission STN

Document Filename

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

Update

Remove

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New Tobacco Product Name (either previously submitted or updated name)
Select if this Related Submission is relevant to all grouped products
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

FORM FDA 3964 (11/20)

Meeting Held Date

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SECTION IV – AMENDMENT AND GENERAL CORRESPONDENCE CONTENTS
List all documents included in the SE Report Amendment, according to their respective subject area.
(Refer to Form 3965, 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)

Product Information
(List the categories of Product Information content provided by this Amendment)

Health and Research
(List the categories of Health and Research content provided by this Amendment)

Comparisons
(List the categories of Comparisons content provided by this Amendment)

Other Content (Describe the other content provided by this Amendment)

Environmental Considerations (Select only one)
Environmental Assessment

FORM FDA 3964 (11/20)

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Claim for Categorical Exclusion

SECTION V - MANUFACTURING/PACKAGING SITES 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 Site
Add

Update

Remove

Company/Institution Name
Specify Type of Manufacturing/Packaging Site
Manufacturer

Contract Manufacturer

Repacker/Relabeler

Company Headquarters' FDA-Assigned Facility Establishment ID (FEI) Number
Company Headquarters' D&B DUNS® Number
Division Name (if applicable)
Street Address (Physical location)
Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory
Telephone (Include Country Code
if applicable)

Contact Name
Prefix (e.g.,

Mr., Ms., Dr.):

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City

Country
FAX

First Name

M.I.

Generational Suffix Professional Suffix
(e.g., MD, Ph.D.)
(e.g., Jr., III)

FORM FDA 3964 (11/20)

ZIP or Postal Code
Email Address

Last Name

Position Title

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SECTION VI – CERTIFICATION STATEMENT
I am signing as a/an:
First Name

Applicant

Authorized Representative
M.I.

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

Last Name

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

Date

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FORM FDA 3964 (11/20)

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INSTRUCTIONS
Section I – Applicant Identification
Subsection A – Current Applicant Information
• Complete Applicant name and 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.)
Subsection B – Request for Change in Ownership
• Provide the effective date of the change in ownership.
• Complete proposed Applicant name and address information, and optionally provide contact name,
telephone, and email address.
• Indicate if a notice is included stating that all of the former applicant's rights and responsibilities relating to
the SE Report have been transferred to the new applicant. (List the notice 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
• Optionally select the type of Applicant information, e.g., Applicant, U.S. Agent, etc., being provided.
• Optionally select to add, update, or remove Applicant information. To update or remove information, the
Person’s Name or Organization name must match previously submitted information.
• Optionally select the type of Point of Contact information, e.g., Applicant, U.S. Agent, etc., being provided.
• Optionally select to add, update, or remove Point of Contact information. To update or remove information
for a Point of Contact, the Person's Name must match previously submitted information.

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Section II – Tobacco Product Identification
Subsection A – Unique Identification of Tobacco Products
• For an individual tobacco product, provide the new and predicate tobacco products’ names. Product
category, subcategory, and product properties should be provided only if they are changing.
• For a co-packaged tobacco product, provide the new and predicate tobacco products’ names for all
products in the co-packaged tobacco product by adding Section II for each products. Product category,
subcategory, and product properties should be provided only if they are changing.
• Add an individual tobacco product by selecting “Add Section II” on the form.
Subsection B – Tobacco Product Manufacturer Information
• Provide tobacco product manufacturer information only to add new information, or update or remove
previously submitted information. As explained in the SE Report submission form (3965), manufacturer
information need only be provided if the manufacturer is different from the Applicant.
• Optionally select to Add, Update, or Remove information for either the new tobacco product manufacturer
or the predicate tobacco product manufacturer.
Subsection C – Predicate Product Evidence
(Complete this section if relying on a pre-existing tobacco product as your predicate product. If necessary,
please update your application with additional evidence to support its pre-existing status.)
• 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 product identifier, if applicable.
• Tobacco Product Quantity: Provide the quantity of the product as identified in the 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.
FORM FDA 3964 (11/20)

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Section III – Submission Information
• Indicate whether the submission is an Amendment or General Correspondence.
• Provide the FDA STN being amended. The Tobacco Substantial Equivalence Report Amendment and
General Correspondence Submission should be used to update only one STN.
• If an amendment is responding to an FDA letter, provide the date of the letter and the type of FDA letter,
e.g., Advice/Information Request, or type of response, e.g., Unsolicited. If “Unsolicited” or “Other”,
describe the purpose of the submission in the Submission Summary.
• If the submission is General Correspondence, select the subject of the correspondence and provide the
appropriate information in the Section indicated. If “Other”, describe the subject of the correspondence in
the Submission Summary.
• Indicate whether the submission is for a single individual tobacco product or for a group of tobacco
products previously submitted as a grouped SE Report submission.
• Optionally add, update, or remove cross-referenced content, including Tobacco Product Master Files, by
referencing documents provided in related submissions.
• Optionally add, update, or remove related submissions, (e.g., SE, PTP, and TPMF).
• Optionally add, update, or remove formal meetings held with FDA pertaining to the new tobacco product.

Section IV – Amendment and General Correspondence Contents
• Select the categories of document submitted from among Administrative, Product Information, Health and
Research, Comparisons between the new and predicate products, or Environmental Considerations. For
each category, list the subcategories that describe the submission contents.
Section V – Manufacturing/Packaging Site 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.

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Section VI – Certification Statement
• 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.
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 3964 (11/20)

“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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