OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

ICR 201709-0910-004 · OMB 0910-0014 · Public filing

Forms and Documents

Forms and supporting documents for this ICR
DocumentTypeStatusAvailability
Form 1572 Statement of Investigator Form and Instruction Unchanged Available
Form 1571 Investigational New Drug Application Form Unchanged Available
0014 Non sub change 2017.doc Justification for No Material/Nonsubstantive Change Uploaded 2017-09-21 Available
FDA Form 1571 PROPOSED.PDF Supplementary Document Uploaded 2017-09-21 Available
SUPPORTING STATEMENT 0014 FINAL VERSION 1-7-2016.doc Supporting Statement A Uploaded 2016-01-08 Available

IC Document Collections

Information collection document groups
IC IDCollectionTypeStatusForm
5669 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form and Instruction UnchangedStatement of Investigator
5669 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form UnchangedInvestigational New Drug Application
215569 CBER: Records under 312.160(c) (disposition of unused drugs) Unchanged
215568 CBER: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research) Unchanged
215567 CBER: Records under 312.62(b) (individual case histories) Unchanged
215566 CBER: Records under 312.62(a) (disposition of drugs) Unchanged
215565 CBER: Records under 312.57 (receipt, shipment, disposition of IND) Unchanged
215564 CBER: Records under 312.52(a) (transfer of obligations) Unchanged
189345 CDER: Records under 312.160(c) (disposition of unused drugs) Unchanged
189344 CDER: Records under 312.160(a)(3) (shipment of drugs for investigational use in laboratory research) Unchanged
189343 CDER: Records under 312.62(b) (individual case histories) Unchanged
189342 CDER: Records under 312.62(a) (disposition of drugs) Unchanged
189341 CDER: Records under 312.57 (receipt, shipment, other disposition of IND) Unchanged
189340 CDER: Records under 312.52(a) (transfer of obligations) Unchanged
189333 CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND Unchanged
189332 CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies Unchanged
189331 CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Unchanged
189330 CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA Unchanged
189329 CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Unchanged
189328 CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Unchanged
189326 CBER: Part 312 Subpart I - Expanded Access to INDs for Treatment Use; including emergency use of IND Unchanged
189323 CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides Unchanged
189320 CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Unchanged
189319 CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA Unchanged
189313 CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Unchanged

ICR Details

Record metadata
OMB Control No0910-0014