Manufacturers of an Unapproved EUA Product

Draft Guidance: Emergency Use Authorization of Medical Products

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
0910-0595 Guidance--Emergency Use Authorization of Medical Products.htm www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm Other-guidance document

Information Collection (IC) Details

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:

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 %

	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

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.