Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Patient Experiences with REMS Programs (CDER)

Data To Support Social and Behavioral Research as Used by the Food and Drug Administration

OMB: 0910-0847

IC ID: 249972

Documents and Forms
Document Name
Document Type
Other-Interview Guide
Other-Interview Guide
Other-Consent Form
Other-Consent Form
Other-Recruitment Message-Email-All
Other-Recruitment Message-Email-All
Other-Recruitment Message-Email-Pati
Other-Recruitment Message-Email-Pati
Other-Recruitment Message-Email Forw
Other-Recruitment Message-Email Forw
Other-Recruitment Message-Email Forw
Other-Recruitment Message-Email Forw
Other-Recruitment Message-Rally-All
Other-Recruitment Message-Rally-All
Other-Recruitment Message-Rally-C an
Other-Recruitment Message-Rally-C an
Other-Recruitment Research Match-All
Other-Recruitment Research Match-All
Other-Recruitment Research Match-Pat
Other-Recruitment Research Match-Pat
Other-Drug Specific Content
Other-Drug Specific Content
Other-IRB Letter
Other-IRB Letter
IC Document
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Patient Experiences with REMS Programs (CDER) CDER
 
Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Interview Guide Patient Interview Guide.docx Yes No Printable Only
Other-Consent Form Consent Form.docx Yes No Printable Only
Other-Recruitment Message-Email-All Drugs-Patient Only Recruitment Messages - Email - All Drugs - Patient Only.docx Yes No Printable Only
Other-Recruitment Message-Email-Patient or Caretaker Recruitment Messages - Email - Patient Or Caretaker.docx Yes No Printable Only
Other-Recruitment Message-Email Forward- Patient Only Recruitment Messages - Email Forward - Patient Only.docx Yes No Printable Only
Other-Recruitment Message-Email Forward-Patient or Caretaker Recruitment Messages - Email Forward - Patient or Caretaker.docx Yes No Printable Only
Other-Recruitment Message-Rally-All Drugs-Patient Only Recruitment Messages - Rally - All Drugs - Patient Only.docx Yes No Printable Only
Other-Recruitment Message-Rally-C and P - Patient Only Recruitment Messages - Rally - C and P - Patient Only.docx Yes No Printable Only
Other-Recruitment Research Match-All Drugs - Patient Only Recruitment Research Match - All Drugs - Patient Only.docx Yes No Printable Only
Other-Recruitment Research Match-Patient or Caretaker Recruitment Research Match - Patient or Caretaker.docx Yes No Printable Only
Other-Drug Specific Content Drug Specific Content for Patient Interview Guide.docx Yes No Printable Only
Other-IRB Letter IRB Approval Letter.pdf Yes No Printable Only

Health Consumer Health and Safety

 

160 0
   
Individuals or Households
 
   0 %

  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 160 0 0 0 0 160
Annual IC Time Burden (Hours) 160 0 0 0 0 160
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB approval memo 0847 OMB Approval Memo REMS Patient Interview 2021.docx 10/29/2021
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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