Clinical Trial Data in Professional Prescription Drug Promotion

Data to Support Drug Product Communications as Used by the FDA

OMB: 0910-0695

IC ID: 220363

Information Collection (IC) Details

View Information Collection (IC)

Clinical Trial Data in Professional Prescription Drug Promotion CDER
 
Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Survey Participant Screener 1-25-2016.doc Yes Yes Fillable Fileable

Health Health Care Services

 

372 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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 372 0 0 0 0 372
Annual IC Time Burden (Hours) 96 0 0 0 0 96
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Justification Memo for Generic Clearance of Communication Testing for Drug Products 0695 OMB Justification Memo for generic clearance for Clinical Trial Data 1-25-2016.doc 03/01/2016
Interview Guide FDA Physician Interviews Discussion Guide 1-25-2016.docx 03/01/2016
Consent Form Consent Form 1-25-2016.doc 03/01/2016
Recruitment Email Recruitment Emails 1-25-2016.doc 03/01/2016
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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