Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products

Data To Support Social and Behavioral Research as Used by the Food and Drug Administration

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0847 can be found here:

Documents and Forms

Document Name Document Type
Questionnaire.docx Other-Questionnaire
Moderator Guide.docx Other-Moderator guide
Patient Recruitment Screening Guide.docx Other-Screener
Medication Risk and Benefit Brochure.pdf Other-Brochure
Guide on Medicine for Older Adults.pdf Other-Guide on medicine
Drug Safety health communication tool.pdf Other-Drug safety health communicati
Screen Shots of Vaccine Communications.docx Other-Screenshots of vaccine communi
Screenshots of CDER Communications to Patients.doc Other-Screenshots of CDER communicat
Reminder Email.docx Other-Reminder email
Consent form.docx Other-Consent form
0847 OMB approval memo for Improving FDA Health Communications with Older Women 2018.doc OMB approval memo IC Document

Information Collection (IC) Details

IC Title:	Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products	Agency IC Tracking Number:	CDER

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Electronic Capability
Other-Moderator guide	Moderator Guide.docx	No	Paper Only
Other-Screener	Patient Recruitment Screening Guide.docx	No	Paper Only
Other-Brochure	Medication Risk and Benefit Brochure.pdf	No	Paper Only
Other-Guide on medicine	Guide on Medicine for Older Adults.pdf	No	Paper Only
Other-Drug safety health communication tool	Drug Safety health communication tool.pdf	No	Paper Only
Other-Screenshots of vaccine communication	Screen Shots of Vaccine Communications.docx	No	Paper Only
Other-Screenshots of CDER communications	Screenshots of CDER Communications to Patients.doc	No	Paper Only
Other-Reminder email	Reminder Email.docx	No	Paper Only
Other-Consent form	Consent form.docx	No	Paper Only
Other-Questionnaire	Questionnaire.docx	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 120	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	120	120
Annual IC Time Burden (Hours)	240	240
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
OMB approval memo	0847 OMB approval memo for Improving FDA Health Communications with Older Women 2018.doc	06/25/2018

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