Information Collection

Pre-EUA submissions or amendments

IC 191140 under ICR 202209-0910-008 · OMB 0910-0595.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0595 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0595_Guidance_2019.pdf	Other-Guidance
0595_Guidance_2019.pdf	Other-Guidance
Pre-EUA-Interactive-Review-Template.pdf	Other-Submission Template
Pre-EUA-Interactive-Review-Template.pdf	Other-Submission Template
Surgical Masks EUA Template.pdf	Other-Submission Template
Surgical Masks EUA Template.pdf	Other-Submission Template
Ventilator EUA Interactive Review Template.pdf	Other-Submission Template
Ventilator EUA Interactive Review Template.pdf	Other-Submission Template

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:

table that charts list of instruments
Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance	0595_Guidance_2019.pdf	Yes	Yes	Printable Only
Other-Submission Template	Pre-EUA-Interactive-Review-Template.pdf	Yes	Yes	Fillable Fileable
Other-Submission Template	Surgical Masks EUA Template.pdf	Yes	Yes	Fillable Fileable
Other-Submission Template	Ventilator EUA Interactive Review Template.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 2,001

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	Previously Approved
Annual Number of Responses for this IC	2,001	2,001
Annual IC Time Burden (Hours)	68,034	68,034
Annual IC Cost Burden (Dollars)	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.