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.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0695 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document 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)

IC Title:

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

Agency IC Tracking Number:

CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Instrument File	Available 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

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 570

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	570	570
Annual IC Time Burden (Hours)	498	498
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.