FDA Review of a Pre-EUA Package or an Amendment Thereto

Guidance: Emergency Use Authorization of Medical Products

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0595 can be found here:

Documents and Forms

Document Name Document Type
0595 EUA Final Guidance 12-18-12.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	FDA Review of a Pre-EUA Package or an Amendment Thereto	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			0595 EUA Final Guidance 12-18-12.pdf		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Illness Prevention

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 11	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 40 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	16	8	8
Annual IC Time Burden (Hours)	560	160	400
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.