CONFER: Comprehension of Over-the-Counter Naloxone for Emergency Response (Task 2 - Adolescents)

Data to Support Drug Product Communications as Used by the FDA

OMB: 0910-0695

IC ID: 227844

Information Collection (IC) Details

View Information Collection (IC)

CONFER: Comprehension of Over-the-Counter Naloxone for Emergency Response (Task 2 - Adolescents) CDER
 
Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Study Screener Attachment C Group 3 Screener Adolescent.docx Yes Yes Fillable Fileable
Other-Closing Script and Contact Information Attachment C2 Group 3 Closing Script and Contact Info.docx Yes Yes Fillable Fileable
Other-Interview Guide Attachment E Adolescent Questionnaire.doc Yes Yes Fillable Fileable
Other-Parental Permission Form Attachment N Group 3 Parental Permission Form.docx Yes Yes Fillable Fileable
Other-Assent Form Attachment O Group 3 Assent Form for Adolescents.docx Yes Yes Fillable Fileable
Other-Drug Facts Label Attachment P Label Version N Injector Supine.pdf Yes Yes Fillable Fileable
Other-Drugs Facts Label Attachment P Label Version N Nasal Supine.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

99 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 99 0 0 0 0 99
Annual IC Time Burden (Hours) 15 0 0 0 0 15
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
CONFER OMB approval request memorandum 0695 OMB Approval Memo CONFER Study - Adolescents 8-7-2017.doc 08/07/2017
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