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

IMPROVE Study Phase 2

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

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

Information Collection (IC) Details

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:

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 %

	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

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.