Expanded Individual Patient Access Application Submissions

Individual Patient Expanded Access Applications

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0814 can be found here:

Documents and Forms

Document Name Document Type
0814 Exp Access GFI Updated Oct 2017.pdf Other-Agency Guidance
Form FDA 3926 Instructional Supplement.pdf Instruction
0814 submission app screenshots SEP 2020.pdf Other-eSubmitter screenshots
Form FDA 3926 Individual Patient Expanded Access Investigational New D Form FDA 3926 Expanded Access.pdf Form

Information Collection (IC) Details

IC Title:	Expanded Individual Patient Access Application Submissions	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.300-312.320

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0814 Exp Access GFI Updated Oct 2017.pdf	Yes	Yes	Fillable Fileable
Form	Form FDA 3926	Individual Patient Expanded Access Investigational New Drug Application	Form FDA 3926 Expanded Access.pdf	Yes	Yes	Fillable Fileable
Instruction			Form FDA 3926 Instructional Supplement.pdf	Yes	Yes	Fillable Fileable
Other-eSubmitter screenshots			0814 submission app screenshots SEP 2020.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 790	Number of Respondents for Small Entity: 790

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Previously Approved
Annual Number of Responses for this IC	2,394	2,394
Annual IC Time Burden (Hours)	1,796	1,796
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.