Information Collection

Manufacturers of an Unapproved EUA Product

IC 191143 under ICR 201212-0910-008 · 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⚠️ Notice: This information collection may be referencing outdated material.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
0910-0595 Guidance--Emergency Use Authorization of Medical Products.htm www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm	Other-guidance document

IC Title:

Manufacturers of an Unapproved EUA Product

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

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 document			0910-0595 Guidance--Emergency Use Authorization of Medical Products.htm	http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Illness Prevention

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 3

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 40 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	12	12
Annual IC Time Burden (Hours)	324	324
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.