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

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

View Information Collection (IC)

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

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance 503B Adverse Event Reporting Guidance.docx Yes No Paper Only

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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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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