Information Collection

Recordkeeping for Electronic Products: General Requirements

IC 193017 under ICR 201706-0910-005 · OMB 0910-0025.

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Information Collection (IC) Details

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IC Title:	Recordkeeping for Electronic Products: General Requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1020.30 21 CFR 1040.10 21 CFR 1002.30 21 CFR 1002.31 21 CFR 1002.40 21 CFR 1002.41

Information Collection 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: 4,880	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	4,880	4,880
Annual IC Time Burden (Hours)	334,570	334,570
Annual IC Cost Burden (Dollars)	0	0

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