Form FDA 3979 FDA 3979 Alternative Test Method Notification

Form Approved: OMB No. 0910-XXXX
Expiration Date: xx/xx/20xx
(See page 6 for PRA Statement)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

ALTERNATIVE TEST METHOD NOTIFICATION

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

SECTION I - SUBMITTER IDENTIFICATION
Submission Date* (mm/dd/yyyy)

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 submitter)
Prefix (e.g., Mr., Ms., Dr.):
First/Given Name

Professional
Suffix(e.g., MD,

M.I.

Last Name

Position Title

Generational Suffix
(e.g., 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 3979 (12/16)

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

Page 1 of 6

Address*

City*

State, Province or Territory*

Country*

ZIP or Postal Code*

U.S. Agent (Responsible official authorized to represent the foreign manufacturer)
Prefix (e.g., Mr., Ms., Dr.):
First/Given Name

Professional
Suffix(e.g., MD,

M.I.

Last Name

Position Title

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

City*

Country*

State, Province or Territory*

ZIP or Postal Code*

SECTION III - SUBMISSION TYPE
1. Purpose of Submission*

To notify FDA of an alternative test method to be implemented in lieu of the FDA standard test method
2. Submission Type* (Select one)
Initial Submission of Notification (Complete Section IV, and skip Section V)
Amendment to Original Submission (Skip Section IV, and complete Section V)

SECTION IV - INITIAL SUBMISSION OF NOTIFICATION
If the submission is an initial submission of Notification, complete parts A-E.

Part A: Identification of Alternative Test Method* (Enter below; It should uniquely identify the procedure & reflect its
originating organization, procedure name & version date.)

FORM FDA 3979 (12/16)

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Part B: Identification of Product Category and Sub-Category* (Select all that apply)
Please select either or both (component and/or co-packaged), as applicable, then select all that apply futher below.
• If product is a component, check here
• If product is co-packaged, check here
Cigarette

Roll-Your-Own Tobacco Products

Combusted, Filtered

Roll-Your-Own Tobacco Filler

Combusted, Non-Filtered

Rolling Paper

Non-Combusted

Filtered Cigarette Tube

Combusted, Other (Specify below)

Non-Filtered Cigarette Tube
Filter
Paper Tip

Cigar

Roll-Your-Own Co-package

Leaf-Wrapped

Roll-Your-Own, Other (Specify below)

Filtered, Sheet-Wrapped
Unfiltered, Sheet-Wrapped

Smokeless Tobacco Products

Cigar Tobacco Filler

Loose Moist Snuff

Cigar, Other (Specify below)

Portioned Moist Snuff
Loose Snus

Electronic Nicotine Delivery System (ENDS)
Open E-Liquid

Portioned Snus
Loose Dry Snuff
Dissolvable

Closed E-Liquid

Loose Chewing Tobacco

Open E-Cigarette

Portioned Chewing Tobacco

Closed E-Cigarette

Smokeless, Other (Specify below)

ENDS, Other (Specify below)

Waterpipe Tobacco Products
Pipe Tobacco Products

Waterpipe

Pipe

Waterpipe Tobacco Filler

Pipe Tobacco Filler

Waterpipe Heat Source

Pipe, Other (Specify below)

Waterpipe, Other (Specify below)

Part C: Testing Facility ID
Establishment Name*
Establishment FDA-assigned Facility Establishment Identifier (FEI) Number
Address* (i.e., Physical location)

State, Province or Territory*

FORM FDA 3979 (12/16)

City*

Country*

ZIP or Postal Code*

Page 3 of 6

Accreditation Organization Name
Accredited Lab Number

Expiration Date (mm/dd/yyyy)

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

Professional
Suffix(e.g., MD,

M.I.

Last Name

Position Title

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

Ph.D.)

Telephone (Include Country Code if applicable)
Company Name
Address

FAX

Check here if same as establishment name above, and skip to Address.
Check here if same as establishment address, and skip
to Part D.

State, Province or Territory

Country

City

ZIP or Postal Code

Part D: Summary of Test Method Validation Report (Check the box if you are including this report.)
Summary of Test Method Validation Report is included.

Part E: Analytical Test Method* (Include attachments)
The proposed alternative analytical test method shall at a minimum include the following information:
• Full test data including the following for all testing performed during method validation:
–
–
–
–
–
–
–

Detailed description of method (protocol)
Complete data sets for each product tested
Accuracy
Precision
Robustness
Limit of detection (LOD)
Complete datasets for reference products (if
applicable)

– A summary of the results for all testing
performed
– Recovery
– Linearity
– Limit of quantitation (LOQ)
– Range
– Specificity

• Analytical procedures (including details regarding extraction, derivatization, and/or any other
procedures used during sample preparation), validation protocols, validation reports, system
suitability protocols, and any other pertinent information for that alternative analytical test method
• Representative chromatograms and calibration curves shall be provided in an image file format
(e.g., JPEG, GIF, TIFF).

FORM FDA 3979 (12/16)

Page 4 of 6

SECTION V - AMENDMENT TO ORIGINAL SUBMISSION
If the submission is an amendment to an original submission, complete parts A and B.

Part A: Original FDA Submission Tracking Number (STN)
FDA Submission Tracking Number (STN) of the original submission:

Part B: Identification of the Amendment Purpose (Check all that apply)
1. Response to an FDA Information Request dated:

(mm/dd/yyyy)

Provide submission description below.

2. Minor Updates (e.g., typographical corrections, change in contact)
Note: Changes in analyte,procedure, instrument/parameter, material/reagent, or lab) require submitting
as a new Notification.
Provide submission description below.

3. Request to Withdraw Initial Submission of Notification

FORM FDA 3979 (12/16)

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SECTION VI – CONFIRMATION STATEMENT

I certify that this information and the accompanying submission are true and correct,
and that I am authorized to submit this on the company’s behalf. I understand that under
section 1001 of title 18 of the United States Code, anyone who makes a materially false,
fictitious, or fraudulent statement to the Government of the United States is subject to
criminal penalties.

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
for Foreign Manufacturer

Typed Name and Title

Date

Contact Information of Authorized Representative or U.S. Agent for Foreign Manufacturer
If your point of contact information is the same as submitter in Section I, check here and 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., 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, and skip address items.

State, Province or Territory

City

Country

ZIP or Postal Code

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 20 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 3979 (12/16)

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