503B Annual Reporting

Guidance for Industry (GFI): Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0827

IC ID: 224062

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Information Collection (IC) Details

View Information Collection (IC)

503B Annual Reporting
 
No New
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance praCompoundingProductReportingFGuidance.May2016.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

55 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 24,201 0 24,201 0 0 0
Annual IC Time Burden (Hours) 12,101 0 12,101 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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