Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
CBER: IND Required Recordkeeping Modified 2332 127220 0
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Modified 722 17880 0 Form Form FDA 1571 Investigational New Drug Application
Form Form FDA 1572 Statement of Investigator
Form and Instruction FDA 1571 Investigator e-Form screenshots
CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Modified 22510 5440784 0
CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA Modified 713 119948 0
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Modified 20980 1021944 0
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides Modified 3254 93494 0
CBER: Part 312 Subpart I - Expanded Access to INDs for Treatment Use; including emergency use of IND Removed 0 0 0
CDER: IND Required Recordkeeping Modified 43451 2832742 0
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Modified 553 14040 0
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Modified 100261 20215682 0 Other-Agency Guidance Document
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA Modified 1102 150628 0
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Modified 25081 2000704 0
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies Modified 15117 491555 0
CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND Removed 0 0 0
Total burden requested under this ICR: 236076 32526621 0  
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