Submitting various reports

Postmarketing Safety Reporting for Combination Products

OMB: 0910-0834

IC ID: 191023

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

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Submitting various reports
 
No Removed
 
Mandatory
 
21 CFR 4.102

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

267 0
   
Private Sector Businesses or other for-profits
 
   50 %

  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 0 0 -12,015 0 0 12,015
Annual IC Time Burden (Hours) 0 0 -11,997 0 0 11,997
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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