Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
CBER: IND Required Recordkeeping Modified 2225 127006 0
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Modified 288 7632 0 Form Form FDA 1571 Investigational New Drug Application
Form Form FDA 1572 Statement of Investigator
CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Modified 7934 2518624 0
CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA Unchanged 356 50884 0
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Modified 15200 578568 0
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides Modified 3253 93486 0
CBER: Part 312 Subpart I - Expanded Access to INDs for Treatment Use; including emergency use of IND Modified 304 5412 0
CBER: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research) Removed 0 0 0
CBER: Records under 312.160(c) (disposition of unused drugs) Removed 0 0 0
CBER: Records under 312.57 (receipt, shipment, disposition of IND) Removed 0 0 0
CBER: Records under 312.62(a) (disposition of drugs) Removed 0 0 0
CBER: Records under 312.62(b) (individual case histories) Removed 0 0 0
CDER: IND Required Recordkeeping Modified 76576 4137622 0
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Modified 649 17760 0
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Modified 75152 19051616 0
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA Modified 896 112296 0
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Modified 42815 3418568 0
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies Modified 12563 413715 0
CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND Modified 4048 111572 0
CDER: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research) Removed 0 0 0
CDER: Records under 312.160(c) (disposition of unused drugs) Removed 0 0 0
CDER: Records under 312.57 (receipt, shipment, other disposition of IND) Removed 0 0 0
CDER: Records under 312.62(a) (disposition of drugs) Removed 0 0 0
CDER: Records under 312.62(b) (individual case histories) Removed 0 0 0
Total burden requested under this ICR: 242259 30644761 0  
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