Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance

Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0800

IC ID: 217571

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Document Name
Document Type
Other-Guidance
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Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance CDER
 
No New
 
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 Public Health Monitoring

 

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 55 0 0 0
Annual IC Time Burden (Hours) 61 0 61 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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