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Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements

IC 190522 under ICR 200908-0910-006 · OMB 0910-0838.

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Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
 
  New
 
Required to Obtain or Retain Benefits
 
21 CFR 600.81(b)(2)

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

Health Public Health Monitoring

 

1 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 1 1 0 0 0 0
Annual IC Time Burden (Hours) 1 1 0 0 0 0
Annual IC Cost Burden (Dollars) 68 68 0 0 0 0

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