Information Collection

CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND

IC 189333 under ICR 201802-0910-016 · OMB 0910-0014.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0014 can be found here:

Documents and Forms

Document Name Document Type

No indexed documents/forms are available for this IC yet. A refresh has been queued.

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	CDER: 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use; including emergency use of IND	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.300-312.320

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 694	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Previously Approved
Annual Number of Responses for this IC	1,763	1,763
Annual IC Time Burden (Hours)	100,512	100,512
Annual IC Cost Burden (Dollars)	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.