Information Collection

Expanded Access to Investigational Drugs for Treatment Use Submissions

IC 253117 under ICR 202610-0910-005 · OMB 0910-0814.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3926 Individual Expanded Patient Access Expanded Access to Investigational Drugs for Treatment Use Submissions	Form
eSubmitter Screenshots.pdf	Other-eSubmitter Screenshots
3926 Individual Expanded Patient Access FDA 3926 proposed rev 2026.pdf	Form

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 312.300 - 300.320 (Subpart I)

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-eSubmitter Screenshots					Yes	Yes	Fillable Fileable Signable
Form	3926				Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 1,573

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,143	-11,767	13,910
Annual IC Time Burden (Hours)	19,018	-236,308	255,326
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.

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