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Proposed Verification Requirements for NDA and BLA Holders Under 314.70(c)(8) and 601.12(f)(2)(iii)

IC 209606 under ICR 201312-0910-001 · OMB 0910-0757.

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Proposed Verification Requirements for NDA and BLA Holders Under 314.70(c)(8) and 601.12(f)(2)(iii)
 
No New
 
Required to Obtain or Retain Benefits
 
21 CFR 314.70(c)(8)&601.12(f)(2)(iii)

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

Health Consumer Health and Safety

 

173 0
   
Private Sector Businesses or other for-profits
 
   75 %

  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 230 0 230 0 0 0
Annual IC Time Burden (Hours) 115 0 115 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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