(CBER) Submissions related to expanded access and treatment of an individual patient

Expanded Access to Investigational Drugs for Treatment Use

⚠️ Notice: This information collection may be referencing outdated material.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
Form FDA 3926 (CBER) Submissions related to expanded access and treatment of an individual patient Form
FDA-3926_instructions.pdf Instruction
FDA-3926_instructions.pdf Instruction
eSubmitter Screenshots.pdf Other-eSubmitter Screenshots
eSubmitter Screenshots.pdf Other-eSubmitter Screenshots
0814_Guidance.pdf Other-Agency Guidance
0814_Guidance.pdf Other-Agency Guidance
FDA 3926 Individual Patient Expanded Access Investigational Form FDA 3926.pdf Form
FDA 3926 Individual Patient Expanded Access Investigational Form FDA 3926.pdf Form

Information Collection (IC) Details

IC Title:	(CBER) Submissions related to expanded access and treatment of an individual patient	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 312

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 3926	Individual Patient Expanded Access Investigational	Form FDA 3926.pdf	Yes	Yes	Fillable Fileable
Instruction			FDA-3926_instructions.pdf	Yes	No	Printable Only
Other-eSubmitter Screenshots			eSubmitter Screenshots.pdf	Yes	No	Fillable Fileable Signable
Other-Agency Guidance			0814_Guidance.pdf	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 118	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	154	154
Annual IC Time Burden (Hours)	1,232	1,232
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.