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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