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

Guidance on Emergency Use Authorization of Medical Products and Related Authorities

⚠️ Notice: This information collection may be referencing outdated material.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_Guidance_2019.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_Guidance_2019.pdf		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Illness Prevention

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 32	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	57	41	16
Annual IC Time Burden (Hours)	1,938	1,378	560
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.