Information Collection

Safety Labeling Changes; Posting Approved Labeling on Application Holder's website

IC 204940 under ICR 201903-0910-022 · OMB 0910-0734.

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Information Collection (IC) Details

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IC Title:	Safety Labeling Changes; Posting Approved Labeling on Application Holder's website	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: 351	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	351	-56	407
Annual IC Time Burden (Hours)	1,404	-224	1,628
Annual IC Cost Burden (Dollars)	105,300	105,300	0

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