Information Collection

Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statement

IC 204939 under ICR 201903-0910-022 · OMB 0910-0734.

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IC Title:	Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statement	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 601.12 21 CFR 314.70

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: 36	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	36	-6	42
Annual IC Time Burden (Hours)	216	-36	252
Annual IC Cost Burden (Dollars)	16,200	16,200	0

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