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⚠️ Notice: This information collection may be referencing outdated material.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
0814 Exp Access GFI Updated Oct 2017.pdf Other-Agency Guidance
0814_Form FDA 3926_Instructional Supplement_2021.pdf Instruction
0814_Form FDA 3926_Instructional Supplement_2021.pdf Instruction
0814 submission app screenshots SEP 2020.pdf Other-eSubmitter screenshots
0814 submission app screenshots SEP 2020.pdf Other-eSubmitter screenshots
Form FDA 3926 Individual Patient Expanded Access Investigational New D 0814_Form FDA 3926_2021.pdf Form
Form FDA 3926 Individual Patient Expanded Access Investigational New D 0814_Form FDA 3926_2021.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	0814_Form FDA 3926_2021.pdf	Yes	Yes	Fillable Fileable
Instruction			0814_Form FDA 3926_Instructional Supplement_2021.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.