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Serious adverse event reports for dietary supplements

IC 186732 under ICR 201602-0910-006 · OMB 0910-0635.

Documents and Forms
Document Name
Document Type
Other-Statute
Other-guidance document
Information Collection (IC) Details

View Information Collection (IC)

Serious adverse event reports for dietary supplements
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Statute 21 USC 379aa.doc Yes No Paper Only
Other-guidance document Guidance-DS AER 30-day 8-21-08 oc2008209.doc Yes No Paper Only

Health Consumer Health and Safety

 

170 0
   
Private Sector Businesses or other for-profits
 
   75 %

  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 2,890 0 0 -5,270 0 8,160
Annual IC Time Burden (Hours) 5,780 0 0 -10,540 0 16,320
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.