Information Collection

Reporting; User Facility Annual Reporting--803.33; FDA Form 3419

IC 202632 under ICR 202412-0910-004 · OMB 0910-0437.

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IC Title:

Reporting; User Facility Annual Reporting--803.33; FDA Form 3419

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 803 21 CFR 4

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: 82

Number of Respondents for Small Entity: 50

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	82	-104	186
Annual IC Time Burden (Hours)	82	-104	186
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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