Information Collection

Expanded Individual Patient Access Application Submissions

IC 220651 under ICR 202106-0910-011 · OMB 0910-0814.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0814 can be found here:

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

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.