Information Collection

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

IC 231932 under ICR 201709-0910-002 · OMB 0910-0847.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.