Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups with Patients

Data to Support Drug Product Communications

OMB: 0910-0695

IC ID: 236377

Documents and Forms
Document Name
Document Type
Other-Split Web and Phone Screener
Other-Consent Form
Other-Invitation Email
Other-Confirmation Email
Other-Moderator Guide
Other-InterVu Respondent Invitation
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Focus Groups with Patients CDER
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Split Web and Phone Screener Split Web and Phone Screener.docx Yes Yes Fillable Fileable
Other-Consent Form Consent Form.docx Yes Yes Fillable Fileable
Other-Invitation Email Screener Invitation Email.docx Yes No Printable Only
Other-Confirmation Email Confirmation Email.docx Yes No Printable Only
Other-Moderator Guide Moderator Guide.docx Yes No Printable Only
Other-InterVu Respondent Invitation Template InterVu Respondent Invitation Template.docx Yes No Printable Only

Health Consumer Health and Safety

 

1,000 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 1,000 0 1,000 0 0 0
Annual IC Time Burden (Hours) 192 0 192 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 Addressing Biosimilar Drug Product 2019.docx 06/17/2019
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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