Information Collection

Recordkeeping requirements under 510.301 and 514.80

IC 197284 under ICR 202512-0910-008 · OMB 0910-0284.

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Information Collection (IC) Details

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IC Title:	Recordkeeping requirements under 510.301 and 514.80	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 510.301 21 CFR 514.80

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: 86	Number of Respondents for Small Entity: 0

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	Previously Approved
Annual Number of Responses for this IC	124,443	-1	124,444
Annual IC Time Burden (Hours)	1,742,132	-4	1,742,136
Annual IC Cost Burden (Dollars)	0	0	0

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