Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)

Data to Support Drug Product Communications

OMB: 0910-0695

IC ID: 247939

Documents and Forms
Document Name
Document Type
Other-Advance Email
Other-Advance Email
Other-Consent Form
Other-Consent Form
Other-Invitation
Other-Invitation
Other-Confirmation Script
Other-Confirmation Script
Other-Interview Guide
Other-Interview Guide
Other-Recruitment Screener - Web
Other-Recruitment Screener - Web
Other-Recruitment Screener - Telepho
Other-Recruitment Screener - Telepho
Other-Patience Infographic
Other-Patience Infographic
Other-Diabetes Fact Sheet
Other-Diabetes Fact Sheet
Other-Patient Fact Sheet
Other-Patient Fact Sheet
IC Document
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER) CDER
 
Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Advance Email Advance Email.docx Yes No Printable Only
Other-Consent Form Consent Form.docx Yes No Printable Only
Other-Invitation Interview Invitation.docx Yes No Printable Only
Other-Confirmation Script Confirmation Script.docx Yes No Printable Only
Other-Interview Guide Interview Guide.docx Yes No Printable Only
Other-Recruitment Screener - Web Recruitment Screener - Web.docx Yes No Printable Only
Other-Recruitment Screener - Telephone Recruitment Screener - Phone.docx Yes No Printable Only
Other-Patience Infographic Patient Infographic.pdf Yes No Printable Only
Other-Diabetes Fact Sheet FDA Bio Diabetes Fact Sheet.pdf Yes No Printable Only
Other-Patient Fact Sheet FDA Bio Patient General Factsheet.pdf Yes No Printable Only

Health Consumer Health and Safety

 

30 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 30 0 0 0 0 30
Annual IC Time Burden (Hours) 65 0 0 0 0 65
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Approval Memo 0695 OMB Approval Memo - Biosimilar Drug Products 2021.docx 06/16/2021
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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