Voluntary Adverse Event Reporting via the SRP (other than RFR reports)

FDA Adverse Event and Products Experience Reports; Electronic Submissions

OMB: 0910-0645

IC ID: 192360

Information Collection (IC) Details

View Information Collection (IC)

Voluntary Adverse Event Reporting via the SRP (other than RFR reports)
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-eForm Submission 0645 IC 1 CTP Wireframe TPRv2.pdf Yes Yes Fillable Fileable
Other-eForm Submission 0645 IC 1 CTP Wireframe TIR.pdf Yes Yes Fillable Fileable
Other-eForm Submission 0645 IC 1 Voluntary DSR Wireframes.pdf Yes Yes Fillable Fileable
Other-eForm Submission 0645 RQ for Foods.xlsx Yes Yes Fillable Fileable
Other-eForm Submission 0645 RQ for Infant Formula.xlsx Yes Yes Fillable Fileable
Other-E-form Screenshots 0645 83C April 2019 CFSAN RQ Screenshots for SRP.pdf https://www.safetyreporting.hhs.gov/SRP2/en/Home.aspx?sid=a461d596-9ac1-4df0-b780-48feb90d4f09 Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

1,800 0
   
Individuals or Households
 
   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 1,800 0 0 14 0 1,786
Annual IC Time Burden (Hours) 1,080 0 0 8 0 1,072
Annual IC Cost Burden (Dollars) 84,454 0 0 84,454 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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