Important Dates
Exemptions
Definitions
I Should Know This
Miscellaneous
100
June 22, 2009.
What is the date the Family Smoking Prevention and Tobacco Control Act was signed into law?
100
The tobacco product has the same characteristics as the predicate tobacco product; or 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 section 910 of the act because the product does not raise different questions of public health.
What is substantial equivalence?
100
A tobacco product.
What is any product made or derived from tobacco that is intended for human consumption including any component, part, or accessory of a tobacco product?
100
350 employees or less.
What is a small tobacco company?
100
This year, all 50 states plus Washington D.C. mandated the use of FSC (Fire Safe Cigarette) paper for all cigarettes.
What is 2012?
200
The date range a tobacco product must be on the market in order for it to be considered a provisional product.
What is February 16, 2007 - March 21, 2011?
200
A new tobacco product.
What is any tobacco product intended for human consumption, that is not classified as a drug or device, that was commercially marketed in the United States after February 15, 2007, or any modification to a commercially marketed tobacco product on the market as of February 15, 2007, that was introduced into interstate commerce after February 15, 2007?
200
Only in this case is it appropriate to delete something from the archive?
What is NEVER?
200
This is the number of office divisions in the Center for Tobacco Products.
What is 7?
300
April 10, 2013.
What is the date of the latest SE Webinar?
300
A section of the 905(j) report that should address any additional characteristics and their relation to the predicate product.
What are other features?
300
The materials, ingredients, design, composition, heating source, or other features of a tobacco product.
What are characteristics?
300
Administrative A/I Request Letters allow for a ____ day response time whil Scientific A/I letters allow for a ____ day response time.
What are 30 and 60?
300
This organization in HHS finalizes FDA guidance documents.
What is the Office of Management and Budget (OMB)?
400
The issue date of the finalized Guidance for Industry and FDA Staff: Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.
What is January 5, 2011?
400
CTP's preferred mthod of receiving an SE report.
What is electronic submission?
400
These two requirements must be met in order for a tobacco product to be considered provisional.
What are (1) Marketed between February 16, 2007 and March 21, 2011 and (2) 905(j) report must be submitted to FDA by March 22, 2011.
400
This states cigarettes cannot be legally sold in quantities less than 20 units per package.
What is the 1996 Rule?
500
This must happen on or before the 31st of December annually.
What is tobacco product listing and registration?
500
Only when this happens, will an applicant submission be considered for official review.
What is submission through the DCC?
500
A tobacco product that, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or devise, or any likeness thereof, a tobacco product listed in a registration under 905(i)(1).
What is a counterfeit tobacco product?
500
The location of establishment registration, product listing, and substantial equivalent reports in the code of federal regulations.
What is 21 CFR part 1107?
500
He signed the Food, Drug, & Cosmetic Act into law on June 25, 1938.
Who is Franklin D. Roosevelt?
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