Information Collection

Recordkeeping under 21 USC 360b(l)(3)(C)

IC 206692 under ICR 202409-0910-001 · OMB 0910-0659.

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Information Collection (IC) Details

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IC Title:	Recordkeeping under 21 USC 360b(l)(3)(C)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 514

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: 23	Number of Respondents for Small Entity: 2

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

Percentage of Respondents Reporting Electronically: 90 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	23	2	21
Annual IC Time Burden (Hours)	46	4	42
Annual IC Cost Burden (Dollars)	0	-2,517	2,517

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