Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations

Data to Support Drug Product Communications

OMB: 0910-0695

IC ID: 252505

Documents and Forms
Document Name
Document Type
Other-Sample Recruitment Media Adver
Other-Sample Recruitment Media Adver
Other-Youth Screener
Other-Youth Screener
Other-Adult Screener
Other-Adult Screener
Other-Programmed pre-screener
Other-Programmed pre-screener
Other-Adult Consent Form
Other-Adult Consent Form
Other-Youth Assent Form
Other-Youth Assent Form
Other-Parental Permission Form
Other-Parental Permission Form
Other-Moderator Guide
Other-Moderator Guide
Other-Recruitment Confirmation and R
Other-Recruitment Confirmation and R
Other-Advance Letter
Other-Advance Letter
Other-Mailed Instructions
Other-Mailed Instructions
Other-Workbook
Other-Workbook
IC Document
IC Document
IC Document
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Formative Research Study to Understand the Impact of Generic Substitutes for Various Patient and Caregiver Populations CDER
 
Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Sample Recruitment Media Advertisement Language Appendix M Sample Recruitment Media Advertisement Language_virtual revisions.docx Yes Yes Fillable Fileable
Other-Youth Screener Appendix N Adolescent Screener EpiPens_virtual revisions.docx Yes Yes Fillable Fileable
Other-Adult Screener Appendix O Adult AutoInjector Screener_virtual revisions.docx Yes Yes Fillable Fileable
Other-Programmed pre-screener Appendix P Programmed pre-screener_virtual revisions.docx Yes Yes Fillable Fileable
Other-Adult Consent Form Appendix Q Adult Consent Form_virtual revisions.docx Yes Yes Fillable Fileable
Other-Youth Assent Form Appendix R Youth Assent Form_virtual revisions.docx Yes Yes Fillable Fileable
Other-Parental Permission Form Appendix S Parental Permission Form_virtual revisions.docx Yes Yes Fillable Fileable
Other-Moderator Guide Appendix T Moderator Guide_virtual revisions.docx Yes Yes Fillable Fileable
Other-Recruitment Confirmation and Reminder E-mails Appendix U Recruitment Confirmation and Reminder Emails_virtual revisions.docx Yes Yes Fillable Fileable
Other-Advance Letter Appendix V Advance Letter_virtual groups.docx Yes Yes Fillable Fileable
Other-Mailed Instructions Appendix W Mailed Instructions_virtual groups.docx Yes Yes Fillable Fileable
Other-Workbook Appendix X Focus Group Workbook__virtual revisions.docx Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

32 0
   
Individuals or Households
 
   100 %

  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 32 0 0 0 0 32
Annual IC Time Burden (Hours) 48 0 0 0 0 48
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Memo - Formative Research Study on Impact of Generic Substitutions OMB Memo - Formative Research Study on Impact of Generic Substitutions.docx 03/31/2022
List of Appendices (original submission and resubmission to complete study) FDA Generic List of Appendices for OMB 2.18.22.docx 03/31/2022
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