Information Collection

Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H

IC 5922 under ICR 201411-0910-010 · OMB 0910-0332.

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Documents and Forms

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Document Name	Document Type

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IC Title:

Medical Devices; Humanitarian Use Devices; 21 CFR Part 814 - Subpart H

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 814.126(b)(1) 21 CFR 814.102 21 CFR 814.104 21 CFR 814.106 21 CFR 814.108 21 CFR 814.116(e)(3) 21 CFR 814.124(b)

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 192

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	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	192	38	154
Annual IC Time Burden (Hours)	19,710	7,125	12,585
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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