Net Changes from previous Form FDA 3741 version

Net Change
• New FDA Form 3741 will handle initial and
updates to establishment registration
information, initial and updates to product –
associated material files, and updates to
product list information.
• New FDA Form 3741b (tobacco product list
spreadsheet) will handle initial product list
information.
• The new 3741 form and 3741b spreadsheet
will replace the previous two forms (3741 and
3741a).

#1 – Merging Form FDA 3741 and FDA 3741a into consolidated FDA 3741
Summary of Change
Reason/Benefit of Change
•
New FDA Form 3741 will better align with TRLM-NG functionality.
•
Reduced redundancy and improved efficiency for
•
Industry will no longer have to differentiate between “traditional” vs. “deemed”
users relying on paper forms for submission (i.e.,
tobacco products.
paper submitters who manufactured pipe tobacco
•
Creation of 3741b spreadsheet will allow those who still utilize paper submissions to
products and cigarette products had to use two
include a USB or printout of the 3741b product spreadsheet that will help
different forms).
standardize product data collected from the paper form and electronically through
•
Better alignment of end user burden between paper
TRLM-NG.
and electronic submissions.

#2 – Restructuring and Redeveloping Sections for Ease of Navigation and Data Input
Summary of Change
Reason/Benefit of Change
Net Change
Streamlining Establishment •
Added Submission Checklist and Navigation Guide so industry knows which sections they •
Will allow industry to better convey what information they are updating,
need to complete depending on submission type and can focus on those applicable
Registration and Product
which will allow CTP to better track updates that would count toward
questions.
Listing Workflows
annual and biannual certification requirements.
•
Simplified “Registrant Identification” and removed numerous follow-up questions.
•
Updated Registration and Establishment Inactivation Reasons to better
•
Instead of having to reach out to CTP or the TRLM-NG helpdesk to initiate transfer of
reflect reasons industry would need to inactivate with less ambiguity.
TRLM-NG account management for their registration, industry will be able to provide
•
Streamlines the process for industry to identify establishment operations
the necessary information directly in TRLM-NG (for electronic submissions) or directly on
from increased selectable options.
the form (for paper submissions).
•
Reduces navigation burden to industry, as they no longer have different
•
Streamlined and standardized required data fields for businesses vs. individuals to clarify
directions depending on whether they are an owner registering alone,
where name refers to an individual Point of Contact (i.e., account manager/registrant,
owner registering on behalf of operator, operator registering alone, or
Owner Point of Contact, Operator Point of Contact, Additional User, Establishment Point
operator registering on behalf of owner. Each designation previously
of Contact) vs. the business entity they represent.
required completing different parts of the form and resulted in a lack of
•
Updated Establishment “Operations” to better align with industry operations
data consistency with owner and operator point of contact information.
communicated through “Other (Specify)” operations option.
•
Allowing better tracking of when the manufacturing site of a product
•
Added “Establishment Details Questions.”
changes or during data clean up when duplicate establishments or
•
Improvements to workflow when updating product manufacturing sites (productregistrations are inactivated.
establishment associations).
•
Ensures CTP has the establishment’s physical address for inspections and
•
Simplified Registration and Establishment Inactivation Reasons and improved workflow
mailing address (if different) for written correspondence.
when inactivating duplicate registrations or establishments.
•
Updated certification statement to be applicable to initial submission as well as updates
to establishment registration information and/or product listing information.
•
Ability to clearly distinguish between businesses’ physical vs. mailing address.

Figure 1 for #2: Comparison of current TRLM-NG workflow (top) vs. restructured workflow based on 3741 updates (bottom)
Current Workflow in TRLM-NG (after account creation)
Establishment Registration
Information

1. Owner(s)

2. Operator(s)

Product List
Information

3.Establishment(s)

4. Product(s)

Material File
Information

5. Material File
Associations

Certification
Statement

6. Material File 7. Review & Submit
Information

Proposed Updates (after account creation)
Establishment Registration
Information

1. Registrant and
TRLM-NG Secondary
Users

2. Establishment(s)

3.Owner(s)

4. Operator(s)

Product List
Information

Material File
Information

Certification
Statement

5. Product(s)

6. Material Files

7. Review & Submit

Figure 2 for #2: Setting Up Your Registration – Identifying Your Role

Figure 3 for #2: Owner Information (left) and Operator Information (right)

Figure 4 for #2: Establishment Details (left) and Establishment Operations and Point of Contact (right)

Table 1 for # 2: Comparison of Current (left) vs. Proposed (right) Establishment Operations
Current Establishment Operations Options
•
Blending
•
Manufacturing
•
Reconstituting
•
Packaging
•
Labeling
•
Saucing (or Casing)
•
Storing
•
Testing
•
Other (Specify)

Proposed Updated Establishment Operations Options
Distinguish whether registered establishment is manufacturing finished tobacco product or tobacco products
for further manufacturing, and then select all applicable operations in which the establishment engages.
General Operations
•
Assembling, Modifying, or Repairing Tobacco Products
•
Labeling/Re-Labeling Tobacco Products
•
Packaging/Re-Packaging Tobacco Products
•
Contract Manufacturing Tobacco Products
•
Co-Packing (3rd party packaging/labeling) Tobacco Products
Product Specific Operations
•
Blending, Casing, Processing, Mixing or Reconstituting Tobacco
•
E-Liquid Production (mixing/blending nicotine, flavorings, PG/VG or other ingredients)
•
E-Liquid Filling/Packaging (bottling or pod filling)
•
Artisanal Pipe Making
•
Slitting, Rolling, Printing, Perforating, Cutting (for RYO products)

Additional Operations
•
Distributing Tobacco Products
•
Importing Tobacco Products
•
Retailing Tobacco Products
•
Specify types of tobacco products distributed, imported, or sold
o
Cigarettes
o
Cigars
o
Electronic Nicotine Delivery Systems (ENDS/Vapes)
o
Heated Tobacco Products (HTP)
o
Pipe Tobacco Products
o
Roll-Your-Own Tobacco Products (RYO)
o
Smokeless Tobacco Products
o
Waterpipe Tobacco Products (Hookah)
o
Oral Nicotine Products
o
Other (Specify)
•
Storing Tobacco Products
•
Testing Tobacco Products
•
Other (specify)

Figure 5 for #2: Certification Statement

Figure 6 for #2: Updating Registration Status (left) and (right)

Table 2 for # 2: Proposed Establishment and Registration Inactivation Reasons
Current Inactivation Reasons

Proposed Inactivation Reasons

Registration Inactivation
•
Duplicate Registration
•
Out of Business
•
Owner Request for Cancellation
•
Not Engaged in Any Domestic Tobacco Manufacturing
•
Other

Registration/Establishment Inactivation
•
Data Clean-Up
•
Not Engaged in Tobacco Product Manufacturing Activities
•
Manufacturing only tobacco products that are not finished tobacco products
•
Out of Business
•
Other (Specify)
•
Operational, But Not Making Regulated Products
•
Other

Establishment Inactivation
•
Duplicate Registration
•
Out of Business
•
Operational, But Not Making Regulated Products
•
Other

Net Change
Updated existing definitions and
added new definitions to reflect
current terminology.

#3 – Proposed Terminology

Summary of Change
•
Updated definitions
o Commercial Distribution
•
Added new definitions
o “Registrant” (added to distinguish between person registering the establishment vs. the
actual establishment “registration” information itself
o Tobacco-Derived Nicotine (TDN)
o Non-Tobacco Nicotine (NTN)
o Retailer
o Submission Tracking Number (STN#) and Product Identifier Number (PD#)
o Material File
o Contract Manufacturer
o Electronic Nicotine Delivery System (ENDS)
o Component or part
o Authorized representative

Reason/Benefit of Change
•
Form has largely remained unchanged since 2017
and is missing relevant terminology for today’s
tobacco products

Figure 1 for #3: Definitions in Current 3741 Form (left) vs. Proposed Definitions (right)

Net Change
Updated Product Category and Product
Sub-Category Options

#4 – Aligning Tobacco Product Categories and Sub-Categories
Summary of Change
Reason/Benefit of Change
Will improve product searches on public registration and listing website, as drop-down lists
•
Consolidating current 24 product categories, which are dependent •
with available options for Product Category and Product Sub-category will be provided.
on Intent of Use (i.e., Consumer Use vs. For Further
Will make it easier for industry to accurately categorize their products and provide all
Manufacturing) to 10 product categories independent on Intent of •
necessary attributes.
Use.
•
Better standardization of product categories across CTP offices and OMB forms (i.e.,
•
Consolidating current 79 product sub-categories to 48 product
industry will no longer have to reference discordant product categories and attributes for
sub-categories.
marketing order applications vs. registration and product listing).
•
More accurate data that better reflects the nature of industry’s products and emerging
product trends.
•
Fewer items for industry to have to review to find an option that best represents their
products.
•
Reduce industry confusion and need to reach out to CTP for guidance on how to best
categorize their products and ensures more accurate and reliable data.
•
Enables CTP to better evaluate submitted information.
•
Will allow CTP to collect vital product attributes.

Table 1 for #4: Comparison of Current (left) vs. Proposed (right) Product Category Options
Current Product Categories in TRLM-NG
3741 (traditional tobacco products)
Consumer Use
•
Cigarettes
•
Chewing Tobacco
•
Dissolvables
•
Accessory Filters
•
Roll-Your-Own Tobacco
•
Roll-Your-Own Paper
•
Roll-Your-Own Filters
•
Dry Snuff
•
Moist Snuff
•
Snus
•
Other (Specify)
For Further Manufacturing Use
•
Tobacco
•
Paper
•
Filters
•
Pouch for Portioned Tobacco
•
Additive
•
Other (Specify)
3741a (deemed tobacco products)
•
Cigar
•
Cigar Component or Part
•
Pipe Tobacco
•
Waterpipe Tobacco
•
Waterpipe Tobacco Component or Part
•
Electronic Nicotine Delivery System
•
Electronic Nicotine Delivery System Component or Part
•
Other (Specify)

Proposed Product Category Options
•
Cigarettes
•
Cigars
•
Electronic Nicotine Delivery Systems (ENDS/Vapes)
•
Heated Tobacco Products (HTP)
•
Pipe Tobacco Products
•
Roll-Your-Own Tobacco Products (RYO)
•
Smokeless Tobacco Products
•
Waterpipe Tobacco Products
•
Oral Nicotine Products
•
Other (Specify)

Table 2 for #4: Comparison of Current (left) vs. Proposed (right) Product Sub-Category Options