Information Collection

CBER 513(g) Requests

IC 215616 under ICR 201501-0910-006 · OMB 0910-0705.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0705 can be found here:

Documents and Forms

Document Name Document Type
guidance 513(g) Requests.pdf www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209852.htm Other-513(g) guidance

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	CBER 513(g) Requests	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-513(g) guidance			guidance 513(g) Requests.pdf	http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209852.htm	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	4	4
Annual IC Time Burden (Hours)	48	48
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.