Naloxone Pilot Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 2)

Data to Support Drug Product Communications as Used by the FDA

OMB: 0910-0695

IC ID: 227062

Documents and Forms
Document Name
Document Type
Other-Study Screener
Other-Closing Script and Contact Inf
Other-Study Screener
Other-Closing Script and Contact Inf
Other-Interview Guide
Other-Provider Info
Other-Recruitment Flyer
Other-Recruitment Cards
Other-Online Screener
Other-Online Ad
Other-Consent Form 1-2
Other-Consent Form 4
Other-Label: Injector Supine
Other-Label: Nasal Supine
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Naloxone Pilot Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 2) CDER
 
Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Study Screener Attachment A Group 1-2 Screener.docx Yes Yes Fillable Fileable
Other-Closing Script and Contact Info 1-2 Attachment A-2 Group 1-2 Closing Script and Contact Information.docx Yes Yes Fillable Fileable
Other-Study Screener Attachment D Group 4 Screener Adults.docx Yes Yes Fillable Fileable
Other-Online Ad Attachment J Group 1-2 Online Advertisement.docx Yes Yes Fillable Fileable
Other-Consent Form 1-2 Attachment M Consent Form Group 1-2.docx Yes Yes Fillable Fileable
Other-Consent Form 4 Attachment M-2 Consent Form Group 4 adults.docx Yes Yes Fillable Fileable
Other-Label: Injector Supine Attachment P Label Version M Injector Supine.pdf Yes Yes Fillable Fileable
Other-Label: Nasal Supine Attachment P Label Version M Nasal Supine.pdf Yes Yes Fillable Fileable
Other-Closing Script and Contact Info 4 Attachment D-2 Closing Script and Contact Information.docx Yes Yes Fillable Fileable
Other-Interview Guide Attachment E Structured Interview Guide with Adult REALM.doc Yes Yes Fillable Fileable
Other-Provider Info Attachment F Provider Information Sheet Adults.docx Yes Yes Fillable Fileable
Other-Recruitment Flyer Attachment G Group 1-2 Flyer Adults 50 Incentive.pdf Yes Yes Fillable Fileable
Other-Recruitment Cards Attachment H Group 1-2 Palm Cards.docx Yes Yes Fillable Fileable
Other-Online Screener Attachment I Group 1-2 Online Screener.docx Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

177 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 177 0 0 0 0 177
Annual IC Time Burden (Hours) 40 0 0 0 0 40
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
CONFER OIMB Approval Request Memo 0695 OMB Approval Memo CONFER Study Naloxone 6-5-2017.doc 06/05/2017
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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