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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
CBER: IND Required Recordkeeping
Unchanged
2332
127220
0
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
Unchanged
722
17880
0
Form
Form FDA 1572
Statement of Investigator
Form and Instruction
FDA 1571
Investigator e-Form screenshots
Form
FDA 1571
Investigational New Drug Application
Instruction
CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
Unchanged
22510
5440784
0
CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA
Unchanged
713
119948
0
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
Unchanged
20980
1021944
0
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides
Unchanged
3254
93494
0
CDER: IND Required Recordkeeping
Unchanged
43451
2832742
0
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
Unchanged
553
14040
0
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
Unchanged
100566
20218932
0
Other-Agency Guidance Document
Other-Agency Guidance
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA
Unchanged
1102
150628
0
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
Unchanged
25081
2000704
0
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145)
Modified
24359
630299
0
Other-Agency Guidance
Total burden requested under this ICR:
245623
32668615
0
To view an IC, click on IC Title