Information Collection

Format and Content Requirements for Over--the-Counter Drug Product Labeling - 201.66(c) and (d) - New OTC Drug Products

IC 5943 under ICR 201312-0910-009 · OMB 0910-0340.

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Information Collection (IC) Details

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IC Title:	Format and Content Requirements for Over--the-Counter Drug Product Labeling - 201.66(c) and (d) - New OTC Drug Products	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 201.66

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: 300	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	900	-4,750	5,650
Annual IC Time Burden (Hours)	10,800	-3,503	14,303
Annual IC Cost Burden (Dollars)	2,100,000	-1,563,000	3,663,000

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