Risk Evaluation and Mitigation Strategy Programs to Promote Appropriate Medication Use and Knowledge: Physician Interviews on 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: 250770

Documents and Forms
Document Name
Document Type
Other-Recruitment Message - Physicia
Other-Recruitment Message - Physicia
Other-Recruitment Message - Professi
Other-Recruitment Message - Professi
Other-Consent
Other-Consent
Other-Interview Guide - Alemtuzumab
Other-Interview Guide - Alemtuzumab
Other-Alvimopan
Other-Alvimopan
Other-Interview Guide - Pegvaliase
Other-Interview Guide - Pegvaliase
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: Physician Interviews on 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-Recruitment Message - Physicians Recruitment Messages - Physician.docx Yes No Printable Only
Other-Recruitment Message - Professional Society Recruitment Message - Professional Society.docx Yes No Printable Only
Other-Consent Consent Form.docx Yes No Printable Only
Other-Interview Guide - Alemtuzumab Interview Guide - Alemtuzumab.docx Yes No Printable Only
Other-Alvimopan Interview Guide - Alvimopan.docx Yes No Printable Only
Other-Interview Guide - Pegvaliase Interview Guide - Pegvaliase.docx Yes No Printable Only
Other-IRB Letter IRB Letter 2021P002615.pdf Yes No Printable Only

Health Health Care Services

 

60 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 60 0 0 0 0 60
Annual IC Time Burden (Hours) 60 0 0 0 0 60
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Approval Memo 0847 OMB Approval Memo - REMS Physician Experience Interviews (3 Covered Drugs) 2021.docx 12/15/2021
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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