AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1))

Postmarketing Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 234420

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

View Information Collection (IC)

AER records under FFDCA 760(e)(1) (21 U.S.C. 379aa(e)(1))
 
No Unchanged
 
Mandatory
 
21 CFR 329.100

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0636 GFI on AER for NonRx Human Drug Products.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

300 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 265,700 0 0 0 0 265,700
Annual IC Time Burden (Hours) 2,125,600 0 0 0 0 2,125,600
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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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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