Information Collection

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

IC 220651 under ICR 201603-0910-009 · 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⚠️ Notice: This information collection may be referencing outdated material.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
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

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:

table that charts list of 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 %

table that charts list of burden
	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

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.