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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Information Collection (IC) Details

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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:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 3419	User Facility Annual Report Form			Yes	No	Fillable Fileable Signable

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 %

	Requested	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

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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.