Naloxone Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 3 - Adolescents)

Data to Support Drug Product Communications

OMB: 0910-0695

IC ID: 230838

Documents and Forms
Document Name
Document Type
Other-Telephone Screener
Other-Interview Guide
Other-Script and Contact Information
Other-Permission Form
Other-Assent Form
Other-Injector Label
Other-Nasal Label
IC Document
Information Collection (IC) Details

View Information Collection (IC)

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

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Telephone Screener Attachment B3 - Telephone Screener.docx No   Paper Only
Other-Interview Guide Attachment C3 Structured Interview Guide.doc No   Paper Only
Other-Script and Contact Information Sheets Attachment J3 Closing Script and Contact Information Sheet.docx No   Paper Only
Other-Permission Form Attachment K2 Parental Permission Form.docx No   Paper Only
Other-Assent Form Attachment K3 Assent Form.docx No   Paper Only
Other-Injector Label Attachment L1 Injector Spine Label.pdf No   Paper Only
Other-Nasal Label Attachment L2 Nasal Supine Label.pdf No   Paper Only

Health Consumer Health and Safety

 

1,120 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 1,120 0 1,120 0 0 0
Annual IC Time Burden (Hours) 163 0 163 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB approval memo 0695 OMB Approval Memo CONFER Study - Adolescents (Task 3).doc 03/28/2018
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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