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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
Removed
0
0
0
312.110(b) Request to export an investigational drug
Removed
0
0
0
312.130(d) Biologics; Request for disclosable information for investigations involving an exception from informed consent
Removed
0
0
0
312.160(a)(3) Biologics; Records maintenance: shipment of drugs for investigational use in laboratory research animals or in vitro tests
Removed
0
0
0
312.160(c) Biologics; Shipper records of alternative disposition of unused drugs
Removed
0
0
0
312.160(c) Shipper records of alternative disposition of unused drugs
Removed
0
0
0
312.23 Investigational New Drug submission
Removed
0
0
0
312.31(b) Information Amendments
Removed
0
0
0
312.310(b) and 312.305(b) Submissions related to expanded access and treatment of an individual
Removed
0
0
0
312.310(d) Emergency use of an investigational new drug
Removed
0
0
0
312.315(c) and 312.305 (b) Submissions related to expanded access and treatment of an individual patient.
Removed
0
0
0
312.32(c)-(d) Safety Reports
Removed
0
0
0
312.320 Submissions related to treatment IND or treatment protocol
Removed
0
0
0
312.33 Annual Reports
Removed
0
0
0
312.38(b)(c) Biologics; Notification of withdrawal of an IND
Removed
0
0
0
312.42(e) Biologics; Request to remove clinical hold
Removed
0
0
0
312.44(c) and (d) Biologics; Response to termination of IND
Removed
0
0
0
312.44(c)(d) Response to termination of IND
Removed
0
0
0
312.45(a) and (b) Biologics; Request for or response to inactive status determination
Removed
0
0
0
312.45(a)(b) Request for or response to inactive status determination
Removed
0
0
0
312.47(b) Biologics; End-of-Phas 2 and Pre-NDA meetings
Removed
0
0
0
312.52(a) Biologics; Transfer of obligations to a contract research organization
Removed
0
0
0
312.52(a) Transfer of obligations to a contract research organization
Removed
0
0
0
312.53(c) Biologics; Investigator Information
Removed
0
0
0
312.53(c) Investigator Information
Removed
0
0
0
312.54(a) and (b) Biologics; Submissions concerning exception from informed consent under 50.24
Removed
0
0
0
312.54(a)(b) Submissions concerning exception from informed consent under 50.24
Removed
0
0
0
312.55(b) Biologics; Sponsor reports on new observations; e.g. adverse reactions and safe use
Removed
0
0
0
312.56(b) and (d) Biologics; Sponsor monitoring of clinical investigations; notification to FDA
Removed
0
0
0
312.56(b)(c)(d) Sponsor monitoring of investigations;notifications to FDA
Removed
0
0
0
312.57 Sponsor recordkeeping
Removed
0
0
0
312.57(a)(b) Biologics; Sponsor recordkeeping
Removed
0
0
0
312.58(a) Biologics; Sponsor submission of records
Removed
0
0
0
312.60(a)(3)Records of shipment of drugs for investigational use in laboratory research animals or in vitro tests
Removed
0
0
0
312.62(a) Biologics; Investigator recordkeeping of disposition of drugs
Removed
0
0
0
312.62(a) Investigator recordkeeping of disposition of drugs
Removed
0
0
0
312.62(b) Biologics; Investigator recordkeeping of case histories of individuals
Removed
0
0
0
312.62(b) Investigator recordkeeping of case histories of individuals
Removed
0
0
0
312.64 Investigator Reports to the sponsor
Removed
0
0
0
312.70(a) Biologics; Investigator disqualification - opportunity to respond
Removed
0
0
0
312.8 Charging for investigational drugs under an IND
Removed
0
0
0
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
Modified
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
Modified
7932
2518128
0
CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA
Modified
356
50884
0
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
Modified
15193
578536
0
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides
Modified
3254
93494
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)
New
155
78
0
CBER: Records under 312.160(c) (disposition of unused drugs)
New
155
78
0
CBER: Records under 312.52(a) (transfer of obligations)
New
105
210
0
CBER: Records under 312.57 (receipt, shipment, disposition of IND)
New
904
90400
0
CBER: Records under 312.62(a) (disposition of drugs)
New
453
18120
0
CBER: Records under 312.62(b) (individual case histories)
New
453
18120
0
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
Modified
958
24672
0
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
Modified
67226
15392380
0
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA
Modified
1087
130864
0
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
Modified
41126
3071104
0
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies
Modified
12572
414003
0
CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND
Modified
1763
100512
0
CDER: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research)
Modified
782
391
0
CDER: Records under 312.160(c) (disposition of unused drugs)
Modified
782
391
0
CDER: Records under 312.52(a) (transfer of obligations)
Modified
503
1006
0
CDER: Records under 312.57 (receipt, shipment, other disposition of IND)
Modified
1689
168900
0
CDER: Records under 312.62(a) (disposition of drugs)
Modified
1444
57760
0
CDER: Records under 312.62(b) (individual case histories)
Modified
1444
57760
0
Total burden requested under this ICR:
160927
22800811
0
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