End-User Testing Associated with the "Pregnancy and Lactation Labeling Rule" to Improve Health Communications and Prescribing Decisions in Pregnant Women - WAVE i

Focus Groups as Used by the Food and Drug Administration

OMB: 0910-0497

IC ID: 241273

Documents and Forms
Document Name
Document Type
Other-Screener
Other-Recruitman Email
Other-Consent Forms
Other-Moderator Guide
Other-Labeling Examples with Infogra
IC Document
Information Collection (IC) Details

View Information Collection (IC)

End-User Testing Associated with the "Pregnancy and Lactation Labeling Rule" to Improve Health Communications and Prescribing Decisions in Pregnant Women - WAVE i CDER
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Screener Appendix 1 - Participant Screeners - Wave 1.docx Yes Yes Fillable Fileable
Other-Recruitman Email Appendix 2 - Recruitment Email Wave 1.docx Yes No Printable Only
Other-Consent Forms Appendix 3 - Informed Consent Wave 1.docx Yes Yes Fillable Fileable Signable
Other-Moderator Guide Appendix 4 PLLR Moderators guide Wave 1.docx Yes No Printable Only
Other-Labeling Examples with Infographics Appendix 5 Labeling examples with infographic mockup.docx Yes No Printable Only

Health Consumer Health and Safety

 

360 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 360 0 360 0 0 0
Annual IC Time Burden (Hours) 143 0 143 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Approval Memo 0497 OMB Approval Memo PLLR - Wave 1 2020.docx 04/08/2020
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