Information Collection

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

IC 227062 under ICR 201701-0910-014 · 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⚠️ Notice: This information collection may be referencing outdated material.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 Group 1-2 Screener.docx	Other-Study Screener
Attachment A-2 Group 1-2 Closing Script and Contact Information.docx	Other-Closing Script and Contact Inf
Attachment D Group 4 Screener Adults.docx	Other-Study Screener
Attachment D-2 Closing Script and Contact Information.docx	Other-Closing Script and Contact Inf
Attachment E Structured Interview Guide with Adult REALM.doc	Other-Interview Guide
Attachment F Provider Information Sheet Adults.docx	Other-Provider Info
Attachment G Group 1-2 Flyer Adults 50 Incentive.pdf	Other-Recruitment Flyer
Attachment H Group 1-2 Palm Cards.docx	Other-Recruitment Cards
Attachment I Group 1-2 Online Screener.docx	Other-Online Screener
Attachment J Group 1-2 Online Advertisement.docx	Other-Online Ad
Attachment M Consent Form Group 1-2.docx	Other-Consent Form 1-2
Attachment M-2 Consent Form Group 4 adults.docx	Other-Consent Form 4
Attachment P Label Version M Injector Supine.pdf	Other-Label: Injector Supine
Attachment P Label Version M Nasal Supine.pdf	Other-Label: Nasal Supine
0695 OMB Approval Memo CONFER Study Naloxone 6-5-2017.doc CONFER OIMB Approval Request Memo	IC Document

IC Title:

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

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?	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-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
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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 177

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	177	177
Annual IC Time Burden (Hours)	40	40
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.