Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Cigars 2 largest manufacturers Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007 New 50 500 0
Environmental Assessments Applications for Premarket Review of New Tobacco Products New 27 324 0
Environmental Assessments Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product New 2104 25248 0
Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007 New 1361 13610 0
Exemption from SE Report to demonstrate tobacco product modified under section 905(j)(3) New 701 2103 0
Exemptions From the Required Warning Statement Requirement New 1 20 0
Further Amendments to General Regulations of the FDA to Incorporate Tobacco Products New 237 5214 0
Health Document Submission New 20 1000 0
Importation of Tobacco Products New 50660 7092 0
Obtaining a Dun and Bradstreet D-U-N-S Number New 604 303 0
Obtaining an FDA order authorizing marketing of tobacco product (the application) New 27 135000 0
Preparation of Additional Information for Tobacco Product Exemption from Substantial Equivalence Request New 140 420 0
Preparation of Tobacco Product Exemption from Substantial Equivalence Request New 468 5616 0
Preparation of an Environmental Assessment New 468 5616 0
Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product New 2104 378720 0
Request for meeting with CTP's Office of Science to discuss Investigational Plan New 27 108 0
Tobacco Product Establishment Registration New 604 1812 0
Tobacco Product Ingredient Listing New 13745 41235 0
Tobacco Product Listing New 13745 10309 0
Total burden requested under this ICR: 87093 634250 0  
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