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Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups and INterviews with Healthcare Professionals

IC 231073 under ICR 201712-0910-001 · OMB 0910-0695.

Documents and Forms
Document Name
Document Type
Other-Survey Instrument
Other-Consent form - focus groups
Other-Consent form - individual grou
Other-Invitation Email
Other-Appointment confirmation email
Other-Interview guide
Other-Moderator guide
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups and INterviews with Healthcare Professionals CDER
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Survey Instrument Focus Group and IDI Screener.docx Yes No Paper Only
Other-Consent form - focus groups Consent Form focus groups.docx Yes No Paper Only
Other-Consent form - individual groups Consent Form individual interviews.docx Yes No Paper Only
Other-Invitation Email Screening Invitation Email.docx Yes No Paper Only
Other-Appointment confirmation email Appointment Confirmation Email.docx Yes No Paper Only
Other-Interview guide FDA Biosimilar Interview Guide.docx No   Paper Only
Other-Moderator guide FDA Biosimilar Moderator Focus Group Guide.docx No   Paper Only

Health Consumer Health and Safety

 

316 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 316 0 316 0 0 0
Annual IC Time Burden (Hours) 263 0 263 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB approval memo 0695 OMB approval memo for Biosimilar Drug Products.doc 04/16/2018
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.