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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