Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Unchanged 287 7608 0 Form 1571 Investigational New Drug Application
Form and Instruction 1572 Statement of Investigator
CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Unchanged 7932 2518128 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 Unchanged 15193 578536 0
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides Unchanged 3254 93494 0
CBER: Part 312 Subpart I - Expanded Access to INDs for Treatment Use; including emergency use of IND Unchanged 304 5412 0
CBER: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research) Unchanged 155 78 0
CBER: Records under 312.160(c) (disposition of unused drugs) Unchanged 155 78 0
CBER: Records under 312.52(a) (transfer of obligations) Unchanged 105 210 0
CBER: Records under 312.57 (receipt, shipment, disposition of IND) Unchanged 904 90400 0
CBER: Records under 312.62(a) (disposition of drugs) Unchanged 453 18120 0
CBER: Records under 312.62(b) (individual case histories) Unchanged 453 18120 0
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Unchanged 958 24672 0
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Unchanged 67226 15392380 0
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA Unchanged 1087 130864 0
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Unchanged 41126 3071104 0
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies Unchanged 12572 414003 0
CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND Unchanged 1763 100512 0
CDER: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research) Unchanged 782 391 0
CDER: Records under 312.160(c) (disposition of unused drugs) Unchanged 782 391 0
CDER: Records under 312.52(a) (transfer of obligations) Unchanged 503 1006 0
CDER: Records under 312.57 (receipt, shipment, other disposition of IND) Unchanged 1689 168900 0
CDER: Records under 312.62(a) (disposition of drugs) Unchanged 1444 57760 0
CDER: Records under 312.62(b) (individual case histories) Unchanged 1444 57760 0
Total burden requested under this ICR: 160927 22800811 0  
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