Information Collection

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

IC 255790 under ICR 202505-0910-007 · OMB 0910-0332.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff.pdf	Other-Guidance; Humanitarian Device
Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff.pdf	Other-Guidance; Humanitarian Device

IC Title:

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; Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff					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	Change Due to Potential Violation of the PRA
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.

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