Information Collection

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

IC 43607 under ICR 202504-0910-001 · OMB 0910-0595.

Documents and Forms

Documents and forms in this information collection
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
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

IC Title:

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:

table that charts list of 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				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: 14

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	24	-5,424	5,448
Annual IC Time Burden (Hours)	1,080	-244,080	245,160
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.

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