Information Collection

Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge About How FDA Communicates Risks and Benefits of Prescription Medicines

IC 218426 under ICR 201607-0910-010 · 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⚠️ Notice: This information collection may be referencing outdated material.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
DSC QUESTIONNAIRE.docx	Other-Survey
DSC SCREENER ONLY.docx	Other-Screener Questions
OMB JUSTIFICATION MEMO FOR GENERIC CLEARANCE OF DSC WITH CONSUMERS 0695.doc Justification Memo for Generic Clearance of DSC	IC Document
INTRODUCTION AND CONSENT ONLY.doc Intro and Consent Form	IC Document
M1_DSC SGLT2 inhibitors_1 - original - no headings - no bullets - no bold_final.docx Manipulation 1: Diabetes - Inhibitors 1	IC Document
M1_DSC SGLT2 inhibitors_2 - no headings - no bullets - bold_final.docx Manipulation 1: Diabetes - Inhibitors 2	IC Document
M1_DSC SGLT2 inhibitors_3 - no headings - bullets - bold__final.docx Manipulation 1: Diabetes - Inhibitors 3	IC Document
M1_DSC SGLT2 inhibitors_4 - headings - bullets - bold_final.docx Manipulation 1: Diabetes - Inhibitors 4	IC Document
M1_DSC SGLT2 inhibitors_5 - headings - bullets - no bold_final.docx Manipulation 1: Diabetes - Inhibitors 5	IC Document
M1_DSC SGLT2 inhibitors_6 - no headings - bullets - no bold_final.docx Manipulation 1: Diabetes - Inhibitors 6	IC Document
M1_DSC SGLT2 inhibitors_7 - headings - no bullets - bold_final.docx Manipulation 1: Diabetes - Inhibitors 7	IC Document
M1_DSC SGLT2 inhibitors_8 - headings - no bullets - no bold_final.docx Manipulation 1: Diabetes - Inhibitors 8	IC Document
M1_DSC Sodium Phosphate_1 - original - no headings - no bullets - no bold_final.docx Manipulation 1: Sodium Phosphate 1	IC Document
M1_DSC Sodium Phosphate_2 - no headings - no bullets - bold_final.docx Manipulation 1: Sodium Phosphate 2	IC Document
M1_DSC Sodium Phosphate_3 - no headings - bullets - bold_final.docx Manipulation 1: Sodium Phosphate 3	IC Document
M1_DSC Sodium Phosphate_4 - headings - bullets - bold_final.docx Manipulation 1: Sodium Phosphate 4	IC Document
M1_DSC Sodium Phosphate_5 - headings - bullets - no bold_final.docx Manipulation 1: Sodium Phosphate 5	IC Document
M1_DSC Sodium Phosphate_6 - no headings - bulllets - no bold_final.docx Manipulation 1: Sodium Phosphate 6	IC Document
M1_DSC Sodium Phosphate_7 - headings - no bullets - bold_final.docx Manipulation 1: Sodium Phosphate 7	IC Document
M1_DSC Sodium Phosphate_8 - headings - no bullets - no bold_final.docx Manipulation 1: Sodium Phosphate 8	IC Document
M2_DSC Constipation_All conditions_final.docx Manipulation 2: Constipation - All Conditions	IC Document
M2_DSC Diabetes_All conditions_final.docx Manipulation 2: Diabetes - All Conditions	IC Document
M3_DSC Constipation_All conditions_final.docx Manipulation 3: Constipation - All Conditions	IC Document
M3_DSC Diabetes_All conditions_final.docx Manipulation 3: Diabetes - All Conditions	IC Document
M4_DSC Constipation_Terminology_All conditions_final.docx Manipulation 4: Constipation - Terminology (All Conditions)	IC Document
M4_DSC Diabetes_Terminology_All conditions_final.docx Manipulation 4: Diabetes - Terminology (All Conditions)	IC Document
M5_DSC Constipation_All conditions_final.docx Manipulation 5: Constipation (All Conditions)	IC Document
M5_DSC Diabetes_All conditions_final.docx Manipulation 5: Diabetes (All Conditions)	IC Document
Ipsos Survey Invitation.png Invitation	IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge About How FDA Communicates Risks and Benefits of Prescription Medicines

Agency IC Tracking Number:

CDER

IC Status: Unchanged

Obligation to Respond: Voluntary

CFR Citation:

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-Survey			DSC QUESTIONNAIRE.docx		Yes	Yes	Fillable Fileable
Other-Screener Questions			DSC SCREENER ONLY.docx		Yes	Yes	Fillable Fileable

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: 2,600

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	2,600	2,600
Annual IC Time Burden (Hours)	1,083	1,083
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Justification Memo for Generic Clearance of DSC	OMB JUSTIFICATION MEMO FOR GENERIC CLEARANCE OF DSC WITH CONSUMERS 0695.doc	10/01/2015
Intro and Consent Form	INTRODUCTION AND CONSENT ONLY.doc	10/01/2015
Manipulation 1: Diabetes - Inhibitors 1	M1_DSC SGLT2 inhibitors_1 - original - no headings - no bullets - no bold_final.docx	10/01/2015
Manipulation 1: Diabetes - Inhibitors 2	M1_DSC SGLT2 inhibitors_2 - no headings - no bullets - bold_final.docx	10/01/2015
Manipulation 1: Diabetes - Inhibitors 3	M1_DSC SGLT2 inhibitors_3 - no headings - bullets - bold__final.docx	10/01/2015
Manipulation 1: Diabetes - Inhibitors 4	M1_DSC SGLT2 inhibitors_4 - headings - bullets - bold_final.docx	10/01/2015
Manipulation 1: Diabetes - Inhibitors 5	M1_DSC SGLT2 inhibitors_5 - headings - bullets - no bold_final.docx	10/01/2015
Manipulation 1: Diabetes - Inhibitors 6	M1_DSC SGLT2 inhibitors_6 - no headings - bullets - no bold_final.docx	10/01/2015
Manipulation 1: Diabetes - Inhibitors 7	M1_DSC SGLT2 inhibitors_7 - headings - no bullets - bold_final.docx	10/01/2015
Manipulation 1: Diabetes - Inhibitors 8	M1_DSC SGLT2 inhibitors_8 - headings - no bullets - no bold_final.docx	10/01/2015
Manipulation 1: Sodium Phosphate 1	M1_DSC Sodium Phosphate_1 - original - no headings - no bullets - no bold_final.docx	10/01/2015
Manipulation 1: Sodium Phosphate 2	M1_DSC Sodium Phosphate_2 - no headings - no bullets - bold_final.docx	10/01/2015
Manipulation 1: Sodium Phosphate 3	M1_DSC Sodium Phosphate_3 - no headings - bullets - bold_final.docx	10/01/2015
Manipulation 1: Sodium Phosphate 4	M1_DSC Sodium Phosphate_4 - headings - bullets - bold_final.docx	10/01/2015
Manipulation 1: Sodium Phosphate 5	M1_DSC Sodium Phosphate_5 - headings - bullets - no bold_final.docx	10/01/2015
Manipulation 1: Sodium Phosphate 6	M1_DSC Sodium Phosphate_6 - no headings - bulllets - no bold_final.docx	10/01/2015
Manipulation 1: Sodium Phosphate 7	M1_DSC Sodium Phosphate_7 - headings - no bullets - bold_final.docx	10/01/2015
Manipulation 1: Sodium Phosphate 8	M1_DSC Sodium Phosphate_8 - headings - no bullets - no bold_final.docx	10/01/2015
Manipulation 2: Constipation - All Conditions	M2_DSC Constipation_All conditions_final.docx	10/01/2015
Manipulation 2: Diabetes - All Conditions	M2_DSC Diabetes_All conditions_final.docx	10/01/2015
Manipulation 3: Constipation - All Conditions	M3_DSC Constipation_All conditions_final.docx	10/01/2015
Manipulation 3: Diabetes - All Conditions	M3_DSC Diabetes_All conditions_final.docx	10/01/2015
Manipulation 4: Constipation - Terminology (All Conditions)	M4_DSC Constipation_Terminology_All conditions_final.docx	10/01/2015
Manipulation 4: Diabetes - Terminology (All Conditions)	M4_DSC Diabetes_Terminology_All conditions_final.docx	10/01/2015
Manipulation 5: Constipation (All Conditions)	M5_DSC Constipation_All conditions_final.docx	10/01/2015
Manipulation 5: Diabetes (All Conditions)	M5_DSC Diabetes_All conditions_final.docx	10/01/2015
Invitation	Ipsos Survey Invitation.png	10/01/2015

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