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Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adult All Comers) CDER
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Online Screener Attachment A Online Screener (Group 1 and 2).docx No   Paper Only
Other-Telephone Screener (Group 1 and 2) Attachment B1 Telephone Screener (Group 1 and 2).docx No   Paper Only
Other-Telephone Screener (Group 4) Attachment B2 Telephone Screener (Group 4).docx No   Paper Only
Other-Interview Guide (Group 1 and 2) Attachment C1 - Structured Interview Guide (Group 1 and 2).doc No   Paper Only
Other-Interview Guide (Group 4) Attachment C2 - Structured Interview Guide (Group 4).doc No   Paper Only
Other-Information Sheet (Group 1 and 2) Attachment D - Provider Information Sheet (Group 1 and 2).docx No   Paper Only
Other-Study Flyer (Group 1 and 2) Attachment E Study Flyer (Group 1 and 2).pdf No   Paper Only
Other-Palm Cards (Group 1 and 2) Attachment F - Palm Cards (Group 1 and 2).docx No   Paper Only
Other-Description Table (Group 1 and 2) Attachment G -Description Table (Group 1 and 2).docx No   Paper Only
Other-Online Advertisement (Group 1 and 2) Attachment H - Online Ad (Group 1 and 2).docx No   Paper Only
Other-Telephone and Email Scripts (Group 1 and 2) Attachment I - Telephone and Email Scripts (Group 1 and 2).docx No   Paper Only
Other-Closing Script (Group 1 and 2) Attachment J1 Closing Script (Group 1 and 2).docx No   Paper Only
Other-Closing Script (Group 4) Attachment J2 - Closing Script (Group 4).docx No   Paper Only
Other-Consent Form (Group 1,2,&4) Attachment K1 Consent Form for Group 1, 2, and 4.docx No   Paper Only
Other-Label - Injector Attachment L1 - Injector Supine Label.pdf No   Paper Only
Other-Label - Nasal Attachment L2 - Nasal Supine Label.pdf No   Paper Only
Other-Screenshot - Exhibit 3 Screenshot of Exhibit 3 (Group 1-2).docx No   Paper Only
Other-Screenshot of Exhibit 4 Screenshot of Exhibit 4.docx No   Paper Only
Other-Certificate of Confidentiality Certificate of Confidentiality CDER.pdf No   Paper Only

Health Consumer Health and Safety

 

570 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 570 0 570 0 0 0
Annual IC Time Burden (Hours) 498 0 498 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB approval memo OMB Approval Memo CONFER Study Adults (Task 3).doc 04/04/2018
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.