Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products

Format and Content Requirements for Over-the-Counter Drug Product Labeling

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0340 can be found here:

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Format and Content Requirements for Over--the-Counter Drug Product Labeling; 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 21 CFR 201.66(c) and (d)

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	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	900	0	900
Annual IC Time Burden (Hours)	10,800	0	10,800
Annual IC Cost Burden (Dollars)	0	-2,100,000	2,100,000

Documents for IC

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