Information Collection

OTC User Fee Program

IC 244708 under ICR 202112-0910-002 · OMB 0910-0340.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	Approved	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

table that charts IC Documents
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.