Expanded Access Submission for Treatment of an Individual Patient, Including Submission of Form FDA 3926

Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926

⚠️ Notice: This information collection may be referencing outdated material.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
GUIDANCE IP EXPANDED ACCESS 3-23-2016.doc Other-Guidance
FORM FDA 3926 INSTRUCTIONS 3-23-2016.pdf Instruction
3926 Individual Patient Expanded Access Investigational New D FORM FDA 3926 FORM 3-23-2016.pdf Form

Information Collection (IC) Details

IC Title:	Expanded Access Submission for Treatment of an Individual Patient, Including Submission of Form FDA 3926	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.310

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			GUIDANCE IP EXPANDED ACCESS 3-23-2016.doc	Yes	Yes	Paper Only
Form	3926	Individual Patient Expanded Access Investigational New Drug Application	FORM FDA 3926 FORM 3-23-2016.pdf	Yes	Yes	Fillable Printable
Instruction			FORM FDA 3926 INSTRUCTIONS 3-23-2016.pdf	Yes	Yes	Paper Only

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	Program Change Due to Agency Discretion
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.