Investigational New Drug Regulations

ICR 202403-0910-001

OMB: 0910-0014

Federal Form Document

Forms and Documents

Document Name	Status
Form Form FDA 1572 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form	Unchanged
83-C for 0014 to add 0581 Guidance MARCH 2024.docx Justification for No Material/Nonsubstantive Change	2024-03-04
0014 INDs SSA AUG 2023 to add ICH Guidance REV.docx Supporting Statement A	2023-08-08
83-C for 0014 to add SPAs MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-13
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx Justification for No Material/Nonsubstantive Change	2022-09-01

IC Document Collections

IC ID	Document Title	Status
5669	CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form	Unchanged
215564	CBER: IND Required Recordkeeping	Unchanged
189340	CDER: IND Required Recordkeeping	Unchanged
189332	CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145) Other-Agency Guidance	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 Other-Agency Guidance Document	Modified
189328	CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	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