Information Collection

Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

IC 255790 under ICR 202303-0910-005 · OMB 0910-0332.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0332 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0332_HDE guidance.pdf	Other-Agency Guidance
0332_HDE guidance.pdf	Other-Agency Guidance

IC Title:

Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

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-Agency Guidance			0332_HDE guidance.pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 5

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	5	5
Annual IC Time Burden (Hours)	360	360
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.