Pre-EUA submissions or amendments

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 Other-Guidance; Emergency Use Author
Pre-EUA-Interactive-Review-Template.pdf Other-Submission Template
Surgical Masks EUA Template.pdf Other-Submission Template - Surgical
Ventilator EUA Interactive Review Template.pdf Other-Submission Template
EUA-Antigen-Monkeypox-Template 2022.docx Other-Agency Template
Summary-EUA-Antigen-Template-Monkeypox 2022.docx Other-Submission Template
EUA_Template_Monkeypox.docx Other-Submission Tmeplate
Summary_EUA_Template_Monkeypox (002).docx Other-Submission Template

Information Collection (IC) Details

IC Title:	Pre-EUA submissions or amendments	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	Instrument File	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	Yes	Yes	Printable Only
Other-Submission Template	Pre-EUA-Interactive-Review-Template.pdf	Yes	Yes	Fillable Fileable
Other-Submission Template - Surgical Masks EUA	Surgical Masks EUA Template.pdf	Yes	Yes	Fillable Fileable
Other-Submission Template	Ventilator EUA Interactive Review Template.pdf	Yes	Yes	Fillable Fileable
Other-Agency Template	EUA-Antigen-Monkeypox-Template 2022.docx	Yes	Yes	Fillable Fileable
Other-Submission Template	Summary-EUA-Antigen-Template-Monkeypox 2022.docx	Yes	Yes	Fillable Fileable
Other-Submission Tmeplate	EUA_Template_Monkeypox.docx	Yes	Yes	Fillable Fileable
Other-Submission Template	Summary_EUA_Template_Monkeypox (002).docx	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 27	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	38	-1,963	2,001
Annual IC Time Burden (Hours)	1,292	-66,742	68,034
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.