View Information Collection (IC)
View Information Collection (IC)

View Information Collection (IC)

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

  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 160 0 160 0 0 0
Annual IC Time Burden (Hours) 160 0 160 0 0 0
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.