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End-User Testing Associated with the "Pregnancy and Lactation Labeling Rule" to Improve Health Communications and Prescribing Decisions in Pregnant Women – WAVE II (CDER) 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 II.docx Yes Yes Fillable Fileable
Other-Recruitment Email Appendix 2 - Recruitment Email - Wave II.docx Yes No Printable Only
Other-Consent Forms Appendix 3 - Informed Consent - Wave II.docx Yes Yes Fillable Fileable
Other-Moderator Guide Appendix 4 - Moderators Guide for Pharmacists.docx Yes No Printable Only
Other-Labeling Examples with Infographic Mockup Appendix 5 - Labeling Examples with Infographic Mockup - Wave II.docx Yes No Printable Only

Health Health Care Services

 

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) 120 0 120 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 II 2021.docx 06/23/2021
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.