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

Shortages Data Collection

Documents and Forms

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

Information Collection (IC) Details

IC Title:	Notification under 506J & Additional voluntary collections related to 506J	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection 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 %

	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

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.