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Manufacturer/Distributor provides user manual with device; provides copy of manual upon request (one-time burden)

IC 223482 under ICR 201609-0910-001 · OMB 0910-0825.

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Manufacturer/Distributor provides user manual with device; provides copy of manual upon request (one-time burden)
 
No New
 
Mandatory
 
21 CFR 878.4635(c)(3)

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

Health Consumer Health and Safety

 

20 0
   
Private Sector Businesses or other for-profits
 
   90 %

  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 20 0 20 0 0 0
Annual IC Time Burden (Hours) 300 0 300 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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