CONFER Study; Comprehension of Over-the-Counter Naloxone for Emergency Response

Data to Support Drug Product Communications as Used by the FDA

⚠️ Notice: This information collection may be referencing outdated material.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_Groups 1-3 screener_v8_clean.pdf Other-Study Screener
Attachment B_Group 4 Screener_v8_clean.pdf Other-Study Screener 2
Attachment C_Provider Information Sheet_clean.pdf Other-Study Document: Provider Info.
Attachment D_Recruitment Flyer_clean.pdf Other-Study Document: Recruitment Fl
Attachment E_Recruitment Palm Card_clean.pdf Other-Study Document: Recruitment Ca
Attachment F_Agreement to Participate bc edits_clean.pdf Other-Study Document: Partipation Ag
Attachment G_Naloxone DFL_clean.pdf Other-Study Document: Sample Drug Fa
Attachment H_Moderator Guide_8 11 16_clean.pdf Other-Study Document: Moderator Guid
0695 CONFER Study Re Nalozone for Emergency Response OMB Approval Request Memo.pdf CONFER OMB Approval Request Memorandum IC Document

Information Collection (IC) Details

IC Title:	CONFER Study; Comprehension of Over-the-Counter Naloxone for Emergency Response	Agency IC Tracking Number:	CDER

IC Status: Unchanged

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_Groups 1-3 screener_v8_clean.pdf	Yes	Yes	Fillable Fileable
Other-Study Screener 2	Attachment B_Group 4 Screener_v8_clean.pdf	Yes	Yes	Fillable Fileable
Other-Study Document: Provider Info. Sheet	Attachment C_Provider Information Sheet_clean.pdf	Yes	Yes	Fillable Fileable
Other-Study Document: Recruitment Flyer	Attachment D_Recruitment Flyer_clean.pdf	Yes	Yes	Fillable Fileable
Other-Study Document: Recruitment Card	Attachment E_Recruitment Palm Card_clean.pdf	Yes	Yes	Fillable Fileable
Other-Study Document: Partipation Agreement	Attachment F_Agreement to Participate bc edits_clean.pdf	Yes	Yes	Fillable Fileable
Other-Study Document: Sample Drug Facts Label	Attachment G_Naloxone DFL_clean.pdf	Yes	Yes	Fillable Fileable
Other-Study Document: Moderator Guide	Attachment H_Moderator Guide_8 11 16_clean.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: 2,778	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Previously Approved
Annual Number of Responses for this IC	2,778	2,778
Annual IC Time Burden (Hours)	599	599
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
CONFER OMB Approval Request Memorandum	0695 CONFER Study Re Nalozone for Emergency Response OMB Approval Request Memo.pdf	08/24/2016

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.