OTC User Fee Program

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⚠️ Notice: This information collection may be referencing outdated material.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
Form FDA 5009 OTC User Fee Program Form
FDA 5009 OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET Draft OTC Coversheet Form FDA 5009 Dec 2020.docx Form

Information Collection (IC) Details

IC Title:	OTC User Fee Program	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA 5009	OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET	Draft OTC Coversheet Form FDA 5009 Dec 2020.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	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 New Statute
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	575	575
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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