Expanded Access to Investigational Drugs for Treatment Use Submissions

Expanded Access to Investigational Drugs for Treatment Use

Documents and Forms

Document Name Document Type
eSubmitter Screenshots.pdf Other-eSubmitter Screenshots
eSubmitter Screenshots.pdf Other-eSubmitter Screenshots
Form FDA 3926 Instructions Rev 2023 highlighted.pdf Instruction
Form FDA 3926 Instructions Rev 2023 highlighted.pdf Instruction
FDA 3926 Individual Patient Expanded Access Investigational New D Form FDA 3926 Rev 2023 highlighted.pdf Form
FDA 3926 Individual Patient Expanded Access Investigational New D Form FDA 3926 Rev 2023 highlighted.pdf Form

Information Collection (IC) Details

IC Title:	Expanded Access to Investigational Drugs for Treatment Use Submissions	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:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-eSubmitter Screenshots			eSubmitter Screenshots.pdf	Yes	Yes	Fillable Fileable Signable
Instruction			Form FDA 3926 Instructions Rev 2023 highlighted.pdf	Yes	Yes	Fillable Fileable
Form	FDA 3926	Individual Patient Expanded Access Investigational New Drug Application (IND)	Form FDA 3926 Rev 2023 highlighted.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4,329	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	Previously Approved
Annual Number of Responses for this IC	13,910	10,900	3,010
Annual IC Time Burden (Hours)	255,326	253,068	2,258
Annual IC Cost Burden (Dollars)	0	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.