OTC User Fee Program

General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

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
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: Unchanged

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 %

	Requested	Previously Approved
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.