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