Information Collection

Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products (CDER)

IC 238930 under ICR 202205-0910-005 · 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⚠️ Notice: This information collection may be referencing outdated material.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
Consent Form.docx	Other-Consent Form
Consent Form.docx	Other-Consent Form
Screener and Scheduling Script.docx	Other-Script
Screener and Scheduling Script.docx	Other-Script
Reminder Email.docx	Other-Reminder Email
Reminder Email.docx	Other-Reminder Email
Drug Safety Health Communication Tool.pdf	Other-Drug Safety Health Communicati
Drug Safety Health Communication Tool.pdf	Other-Drug Safety Health Communicati
Phase 1b Moderator Guide.docx	Other-Moderator Guide
Phase 1b Moderator Guide.docx	Other-Moderator Guide
Guide on Medicine for Older Adults.pdf	Other-Guide on Medicine
Guide on Medicine for Older Adults.pdf	Other-Guide on Medicine
Screenshots of CDER Communications to Patients.doc	Other-Screenshot of CDER Communicati
Screenshots of CDER Communications to Patients.doc	Other-Screenshot of CDER Communicati
Screenshots of Vaccine Communications.docx	Other-Screenshot of Vaccine Communic
Screenshots of Vaccine Communications.docx	Other-Screenshot of Vaccine Communic
Medication Risk and Benefit Brochure.pdf	Other-Medication Risk and Benefit Br
Medication Risk and Benefit Brochure.pdf	Other-Medication Risk and Benefit Br
Questionnaire.docx	Other-Survey Instrument
Questionnaire.docx	Other-Survey Instrument
0847 OMB Approval Memo for Improving FDA Health Comm with Older Women 2020.doc OMB Approval Memo	IC Document
0847 OMB Approval Memo for Improving FDA Health Comm with Older Women 2020.doc OMB Approval Memo	IC Document

IC Title:

Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products (CDER)

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	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Consent Form	Consent Form.docx	Yes	No	Paper Only
Other-Script	Screener and Scheduling Script.docx	Yes	No	Paper Only
Other-Reminder Email	Reminder Email.docx	Yes	No	Printable Only
Other-Drug Safety Health Communication Tool	Drug Safety Health Communication Tool.pdf	Yes	No	Paper Only
Other-Moderator Guide	Phase 1b Moderator Guide.docx	Yes	No	Paper Only
Other-Guide on Medicine	Guide on Medicine for Older Adults.pdf	Yes	No	Paper Only
Other-Screenshot of CDER Communications	Screenshots of CDER Communications to Patients.doc	Yes	No	Paper Only
Other-Screenshot of Vaccine Communication	Screenshots of Vaccine Communications.docx	Yes	No	Paper Only
Other-Medication Risk and Benefit Brochure	Medication Risk and Benefit Brochure.pdf	Yes	No	Paper Only
Other-Survey Instrument	Questionnaire.docx	Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 192

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	192	192
Annual IC Time Burden (Hours)	384	384
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 Comm with Older Women 2020.doc	01/06/2020

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