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Information Collection

Recordkeeping by device-led, drugs and biologics-led combination products; and shared records

IC 191024 under ICR 202008-0910-012 · OMB 0910-0834.

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Recordkeeping by device-led, drugs and biologics-led combination products; and shared records
 
No Removed
 
Mandatory
 
21 CFR 4.105 21 CFR 4.103

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

498 0
   
Private Sector Businesses or other for-profits
 
   10 %

  Approved 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 0 0 -4,059 0 0 4,059
Annual IC Time Burden (Hours) 0 0 -680 0 0 680
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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