Information Collection

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

IC 253117 under ICR 202203-0910-005 · 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⚠️ Notice: This information collection may be referencing outdated material.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
Form Individual Patient (CDER) Submissions related to expanded access and treatment of an individual patient	Form
Form Individual Patient Form FDA 3926 (CDER) 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
Individual Patient Form FDA 3926 Form FDA 3926.pdf	Form
Individual Patient Form FDA 3926 Form FDA 3926.pdf	Form

IC Title:

(CDER) 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: Mandatory

CFR Citation: 21 CFR 312

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
Form	Individual Patient Expanded Access Investigational	Form FDA 3926	Form FDA 3926.pdf	Yes	Yes	Fillable Fileable
Instruction			FDA-3926_instructions.pdf	Yes	No	Printable Only
Other-eSubmitter Screenshots			eSubmitter Screenshots.pdf	Yes	Yes	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: 1,204

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
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	3,010	3,010
Annual IC Time Burden (Hours)	2,258	2,258
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.