PRA IC List
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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Bundled Reports
Removed
0
0
0
Identical Characteristics (Bundled)
Removed
0
0
0
Other-Guidance
Recordkeeping; SE Report
Modified
471
2355
0
Reporting; Form FDA 3659b - SE Unique Identification for New Tobacco Products
New
1570
1570
0
Form and Instruction
Form FDA 3965b
Unique Identifying Information for New Tobacco Products
Reporting; SE Grouping Spreadsheet Validator
New
1570
126
0
Other-Validation Tool
Reporting; SE Report - certification for identical characteristics
Modified
431
4310
0
Reporting; Substantial Equivalence (SE) Report
Modified
1139
341700
0
Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a)
Modified
628
100
0
Form and Instruction
Form FDA 3965a
Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission
Form and Instruction
FDA Web Form 3965a
Tobacco Substantial Equivalence Report Amendment
Reporting; Tobacco Substantial Equivalence Report Submission (Form FDA 3965)
Modified
1570
1178
0
Form and Instruction
Form FDA 3965
Tobacco Substantial Equivalence Report Submission
Form and Instruction
FDA Web Form 3965
Tobacco Substantial Equivalence Report
Reporting; Waiver from electronic submission
Modified
5
1
0
Total burden requested under this ICR:
7384
351340
0
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