Information Collection

Prescription Drug Product Labeling; Medication Guide Requirements

IC 6050 under ICR 200811-0910-007 · OMB 0910-0393.

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Information Collection (IC) Details

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IC Title:	Prescription Drug Product Labeling; Medication Guide Requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 208.20 21 CFR 314.70(b)(3)(ii) 21 CFR 601.12(f) 21 CFR 208.24 (c)

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 25	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	Previously Approved
Annual Number of Responses for this IC	25	-1,099,975	1,100,000
Annual IC Time Burden (Hours)	8,000	3,752	4,248
Annual IC Cost Burden (Dollars)	0	0	0

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