Requests for Information under 513(g) of the FFDCA

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

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
CDRH Requests for Info 513(g) December 2019.pdf Other-Agency Guidance
CDRH Requests for Info 513(g) December 2019.pdf Other-Agency Guidance
513(g) Flat (eSTAR).pdf Other-Digital Screenshot
513(g) Flat (eSTAR).pdf Other-Digital Screenshot

Information Collection (IC) Details

IC Title:	Requests for Information under 513(g) of the FFDCA	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
Other-Agency Guidance			CDRH Requests for Info 513(g) December 2019.pdf		Yes	Yes	Fillable Fileable
Other-Digital Screenshot			513(g) Flat (eSTAR).pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 118	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	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	118	118
Annual IC Time Burden (Hours)	1,416	1,416
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.