Information Collection

Notification under 506J & Additional voluntary collections related to 506J

IC 244590 under ICR 202310-0910-002 · OMB 0910-0491.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Device-Shortages-Guidance.pdf	Other-Guidance
Select Updates for the 506J Guidance_ 506J Device List and Additional Notifications.pdf	Other-Guidance
0491_Webform.pdf	Other-Notify the FDA About an Interr

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance	Device-Shortages-Guidance.pdf	Yes	Yes	Fillable Fileable
Other-Guidance	Select Updates for the 506J Guidance_ 506J Device List and Additional Notifications.pdf	Yes	No	Fillable Fileable
Other-Notify the FDA About an Interruption of Permanent Discontinuance in Device Manufacturing (506J Notification)	0491_Webform.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: 8,400

Number of Respondents for Small Entity: 800

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	16,800	16,800
Annual IC Time Burden (Hours)	4,200	4,200
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.