503B Recordkeeping; AERs

Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0800

IC ID: 217572

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503B Recordkeeping; AERs CDER
 
No Modified
 
Mandatory
 
21 CFR 310.305

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

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 55 0 0 0 0 55
Annual IC Time Burden (Hours) 880 0 0 0 0 880
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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