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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
312.10 Applications for waiver of requirements under part 312
Modified
4
40
0
312.110(b) Request to export and investigational drug
Modified
420
31500
0
312.110(b) Request to export an investigational drug
Modified
21
1575
0
312.120 Submissions related to foreign clinical studies not conducted under an IND
Modified
575
18400
0
312.130(d) Biologics; Request for disclosable information for investigations involving an exception from informed consent
Modified
1
8
0
312.130(d) Request for disclosable information for investigations involving an exception from informed consent
Modified
3
24
0
312.160(a)(3) Biologics; Records maintenance: shipment of drugs for investigational use in laboratory research animals or in vitro tests
Modified
204
102
0
312.160(c) Biologics; Shipper records of alternative disposition of unused drugs
Modified
204
102
0
312.160(c) Shipper records of alternative disposition of unused drugs
Modified
782
391
0
312.2(e) Request for advice on applicability of part 312
Modified
469
11256
0
312.23 Investigational New Drug submission
Modified
3145
5032000
0
312.23 and 312.120(b)(c)(2)(c)(3). Biologics; Investigational New Drug Submission
Modified
563
1017904
0
312.30(a)-(e) Biologics; Protocol Amendments
Modified
4012
1139408
0
312.30(a)-(e) Protocol Amendments
Modified
18079
5134436
0
312.31(b) Biologics; Information amendments
Modified
7706
770600
0
312.31(b) Information Amendments
Modified
454
45400
0
312.310(b) and 312.305(b) Submissions related to expanded access and treatment of an individual
Modified
988
7904
0
312.310(d) Emergency use of an investigational new drug
New
646
10336
0
312.315(c) and 312.305 (b) Submissions related to expanded access and treatment of an individual patient.
New
68
8160
0
312.32(c)(d) and 312.56(c) Biologics; Safety Reports and Notifications
Modified
4028
128896
0
312.32(c)-(d) Safety Reports
Modified
22713
726816
0
312.320 Submissions related to treatment IND or treatment protocol
New
10
3000
0
312.33 Annual Reports
Modified
6000
2160000
0
312.33(a) -(f) and 312.56(c) Biologics; Annual reports and related notifications
Modified
1488
535680
0
312.38(b)(c) Biologics; Notification of withdrawal of an IND
Modified
152
4256
0
312.38(b)(c) Notification of withdrawal of an IND
Modified
874
24472
0
312.42(e) Biologics; Request to remove clinical hold
Modified
111
31524
0
312.42(e) Request to remove clinical hold
Modified
164
46576
0
312.44(c) and (d) Biologics; Response to termination of IND
Modified
18
304
0
312.44(c)(d) Response to termination of IND
Modified
44
704
0
312.45(a) and (b) Biologics; Request for or response to inactive status determination
Modified
108
1296
0
312.45(a)(b) Request for or response to inactive status determination
Modified
362
4344
0
312.47(b) Biologics; End-of-Phas 2 and Pre-NDA meetings
Modified
65
10400
0
312.47(b) End-of-Phase 2 and Pre-NDA meetings
Modified
506
80960
0
312.52(a) Biologics; Transfer of obligations to a contract research organization
Modified
195
390
0
312.52(a) Transfer of obligations to a contract research organization
Modified
503
1006
0
312.53(c) Biologics; Investigator Information
Modified
2297
183760
0
312.53(c) Investigator Information
Modified
21194
1695520
0
312.54(a) and (b) Biologics; Submissions concerning exception from informed consent under 50.24
Modified
1
48
0
312.54(a)(b) Submissions concerning exception from informed consent under 50.24
Modified
1
48
0
312.55(b) Biologics; Sponsor reports on new observations; e.g. adverse reactions and safe use
Modified
345
16560
0
312.55(b) Sponsor reports on new observations, e.g. adverse reactions and safe use
Modified
2271300
109022400
0
312.56(b) and (d) Biologics; Sponsor monitoring of clinical investigations; notification to FDA
Modified
22
1760
0
312.56(b)(c)(d) Sponsor monitoring of investigations;notifications to FDA
Modified
18
1440
0
312.57 Sponsor recordkeeping
Modified
36396
3639600
0
312.57(a)(b) Biologics; Sponsor recordkeeping
Modified
1126
112600
0
312.58(a) Biologics; Sponsor submission of records
Modified
8
64
0
312.58(a) Submission of records to FDA
Modified
373
2984
0
312.60(a)(3)Records of shipment of drugs for investigational use in laboratory research animals or in vitro tests
Modified
782
391
0
312.62(a) Biologics; Investigator recordkeeping of disposition of drugs
Modified
5570
222800
0
312.62(a) Investigator recordkeeping of disposition of drugs
Modified
14732
589280
0
312.62(b) Biologics; Investigator recordkeeping of case histories of individuals
Modified
55700
2228000
0
312.62(b) Investigator recordkeeping of case histories of individuals
Modified
147320
5892800
0
312.64 Investigator reports to the sponsor
Modified
31791
762984
0
312.64 Investigator Reports to the sponsor
Modified
21010
504240
0
312.70(a) Biologics; Investigator disqualification - opportunity to respond
Modified
6
240
0
312.70(a) Investigator disqualification; opportunity to respond
Modified
4
160
0
312.8 Biologics; Charging for investigational drugs under an IND
Modified
57
1368
0
312.8 Charging for investigational drugs under an IND
Modified
34
1632
0
Investigational New Drug Regulations
Removed
0
0
0
Investigational New Drug Regulations
Removed
0
0
0
Total burden requested under this ICR:
2685772
141870849
0
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