Requests for an EUA and/or a substantive amendment to an existing EUA

Authorization of Medical Products for Use Emergencies

Documents and Forms

Document Name Document Type
0910-0595_Guidance; Emergency Use Authorization of Medical Products and Related Authorities.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-relate Other-Guidance; Emergency Use Author

Information Collection (IC) Details

IC Title:	Requests for an EUA and/or a substantive amendment to an existing EUA	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

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; Emergency Use Authorization of Medical Products and Related Authorities			0910-0595_Guidance; Emergency Use Authorization of Medical Products and Related Authorities.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 84	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Requested	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	143	-5,305	5,448
Annual IC Time Burden (Hours)	6,435	-238,725	245,160
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.