AER under FFDCA sec. 760 - nonprescription drug products

Postmarketing Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 234419

Information Collection (IC) Details

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AER under FFDCA sec. 760 - nonprescription drug products
 
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
Other-Agency Guidance 0701 AER Pandemic GFI 2020.pdf https://www.fda.gov/media/72498/download Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

285 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 196,650 0 0 0 0 196,650
Annual IC Time Burden (Hours) 1,179,900 0 0 0 0 1,179,900
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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