OMB.report

Federal forms, ICRs, and supporting documents

Information Collection

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

IC 230946 under ICR 201712-0910-001 · OMB 0910-0695.

Documents and Forms

Documents and forms in this information collection
Document NameDocument Type
Attachment A Online Screener (Group 1 and 2).docx Other-Online Screener
Attachment B1 Telephone Screener (Group 1 and 2).docx Other-Telephone Screener (Group 1 an
Attachment B2 Telephone Screener (Group 4).docx Other-Telephone Screener (Group 4)
Attachment C1 - Structured Interview Guide (Group 1 and 2).doc Other-Interview Guide (Group 1 and 2
Attachment C2 - Structured Interview Guide (Group 4).doc Other-Interview Guide (Group 4)
Attachment D - Provider Information Sheet (Group 1 and 2).docx Other-Information Sheet (Group 1 and
Attachment E Study Flyer (Group 1 and 2).pdf Other-Study Flyer (Group 1 and 2)
Attachment F - Palm Cards (Group 1 and 2).docx Other-Palm Cards (Group 1 and 2)
Attachment G -Description Table (Group 1 and 2).docx Other-Description Table (Group 1 and
Attachment H - Online Ad (Group 1 and 2).docx Other-Online Advertisement (Group 1
Attachment I - Telephone and Email Scripts (Group 1 and 2).docx Other-Telephone and Email Scripts (G
Attachment J1 Closing Script (Group 1 and 2).docx Other-Closing Script (Group 1 and 2)
Attachment J2 - Closing Script (Group 4).docx Other-Closing Script (Group 4)
Attachment K1 Consent Form for Group 1, 2, and 4.docx Other-Consent Form (Group 1,2,&4)
Attachment L1 - Injector Supine Label.pdf Other-Label - Injector
Attachment L2 - Nasal Supine Label.pdf Other-Label - Nasal
Screenshot of Exhibit 3 (Group 1-2).docx Other-Screenshot - Exhibit 3
Screenshot of Exhibit 4.docx Other-Screenshot of Exhibit 4
Certificate of Confidentiality CDER.pdf Other-Certificate of Confidentiality
OMB Approval Memo CONFER Study Adults (Task 3).doc
OMB approval memo		IC Document

Information Collection (IC) Details

View Information Collection (IC)

layout table

Information Collection Instruments:
table that charts list of instruments
Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Online Screener No   Paper Only
Other-Telephone Screener (Group 1 and 2) No   Paper Only
Other-Telephone Screener (Group 4) No   Paper Only
Other-Interview Guide (Group 1 and 2) No   Paper Only
Other-Interview Guide (Group 4) No   Paper Only
Other-Information Sheet (Group 1 and 2) No   Paper Only
Other-Study Flyer (Group 1 and 2) No   Paper Only
Other-Palm Cards (Group 1 and 2) No   Paper Only
Other-Description Table (Group 1 and 2) No   Paper Only
Other-Online Advertisement (Group 1 and 2) No   Paper Only
Other-Telephone and Email Scripts (Group 1 and 2) No   Paper Only
Other-Closing Script (Group 1 and 2) No   Paper Only
Other-Closing Script (Group 4) No   Paper Only
Other-Consent Form (Group 1,2,&4) No   Paper Only
Other-Label - Injector No   Paper Only
Other-Label - Nasal No   Paper Only
Other-Screenshot - Exhibit 3 No   Paper Only
Other-Screenshot of Exhibit 4 No   Paper Only
Other-Certificate of Confidentiality No   Paper Only

Federal Enterprise Architecture Business Reference Module


table that charts list of burden
  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

Documents for IC
table that charts IC Documents
Title Document Date Uploaded
OMB approval memo 04/04/2018
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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