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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
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
To view an IC, click on IC Title