Information Collection

Device Facility User Fee Cover Sheet (Form FDA 3601(a))

IC 248796 under ICR 202107-0910-002 · OMB 0910-0511.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0511 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3601(a) Device Facility User Fee Cover Sheet (Form FDA 3601(a))	Form
FDA 3601(a) Device Facility User Fee 0511_Form 3601(a).pdf	Form
FDA 3601(a) Device Facility User Fee 0511_Form 3601(a).pdf	Form

IC Title:

Device Facility User Fee Cover Sheet (Form FDA 3601(a))

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Mandatory

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 3601(a)	Device Facility User Fee	0511_Form 3601(a).pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 24,086

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	24,086	24,086
Annual IC Time Burden (Hours)	4,095	4,095
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.