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Proposed Rule - Adverse Drug Experience Reporting Requirements For Marketed Prescription Drugs Without Approved New Drug Or Abbreviated New Drug Applications

IC 165481 under ICR 198606-0910-002 · OMB 0910-0210.

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PROPOSED RULE - ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS FOR MARKETED PRESCRIPTION DRUGS WITHOUT APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPLICATIONS
 
No Migrated
 
Mandatory
 

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


    

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

  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 1,200 0 1,199 0 0 1
Annual IC Time Burden (Hours) 1,600 0 1,599 0 0 1
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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