Requests for substantive amendment to an existing EUA

Authorization of Medical Products for Use Emergencies

Documents and Forms

Document Name Document Type
0595_Guidance_2019.pdf Other-Guidance
0595_Guidance_2019.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Requests for substantive amendment to an existing EUA	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Required to Obtain or Retain Benefits

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: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,724	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Previously Approved
Annual Number of Responses for this IC	5,448	5,448
Annual IC Time Burden (Hours)	245,160	245,160
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.