Change Request Memo

“Potential Tobacco Product Violations Reporting Form”

(OMB Control Number 0910-0716)

Change Request (83-C)

May 2016

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to add new selections to the possible type of products reported via this form. The agency does not expect an increase in submissions due to these added selections. This change is necessary since the agency is issuing a final rule extending the Agency’s “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products.

Overview of the Change Request:

Current Form - Current Type of Product Drop down Menu

Cigarette,

Smokeless

Roll Your Own

Updated Form - Post-deeming dropdown options:

Cigarette

Cigars

Cigar Tobacco

Electronic Nicotine Delivery System

a. E-Cigarettes

b. E-Hookah

c. E-Cigars

d. Vape Pens

e. Electronic Pipes

f. Advanced Refillable Personal Vaporizers

E-Liquid

a. E-Juices

Hookah

Pipe Tobacco

Roll-Your-Own

Smokeless

Other

Current Form - Potential violation type

Vending machine/self-service display/direct access to cigarette or smokeless tobacco

Update form - Replaced with two new options:

1. Vending machine/direct access to cigarette or smokeless tobacco or covered tobacco products.

2. Self-service display/direct access to cigarette or smokeless tobacco.