OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

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

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

Documents and Forms
Document Name
Document Type
Other-Guidance
Other-Guidance
Other-Notify the FDA About an Interr
Information Collection (IC) Details

View Information Collection (IC)

Notification under 506J & Additional voluntary collections related to 506J
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL 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

Health Consumer Health and Safety

 

8,400 800
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 16,800 0 0 0 0 16,800
Annual IC Time Burden (Hours) 4,200 0 0 0 0 4,200
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.