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Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4)

IC 202639 under ICR 202101-0910-014 · OMB 0910-0719.

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Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4) CDER
 
No Unchanged
 
Mandatory
 
21 CFR 601.2(a) and 601.60-601.65

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

Health Consumer Health and Safety

 

2 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 2 0 0 0 0 2
Annual IC Time Burden (Hours) 1,720 0 0 0 0 1,720
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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