Information Collection Request

Investigational New Drug Regulations

ICR 202303-0910-008 · OMB 0910-0014 · Active

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0014 can be found here:

2025-12-02 - No material or nonsubstantive change to a currently approved collection
2024-03-05 - No material or nonsubstantive change to a currently approved collection

Forms and Documents

Forms and supporting documents for this ICR
Document	Type	Status	Availability
Form Form FDA 1572 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form	Unchanged	Available
Form Form FDA 1572 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form	Unchanged	Repair queued
83-C for 0014 to add SPAs MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-13	Available
83-C for 0014 to add SPAs MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-13	Repair queued
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-09-01	Available
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-09-01	Missing upstream
0014 IND Regs SSA 2022 Rev.docx	Supporting Statement A	Uploaded 2022-02-18	Available
0014 IND Regs SSA 2022 Rev.docx	Supporting Statement A	Uploaded 2022-02-18	Available

IC Document Collections

Information collection document groups
IC ID	Collection	Type	Status
5669	CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form	Unchanged
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		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

ICR Details

Record metadata
Status	Active
Agency/Subagency	HHS/FDA
OMB Control No	0910-0014
Type of Information Collection	No material or nonsubstantive change to a currently approved collection
Previous ICR Reference No	202209-0910-001
Agency Tracking No	CDER
Date Submitted to OIRA	2023-03-13
Requested Expiration Date	1969-12-31