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Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
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
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Questionnaire
Questionnaire.docx
No
Paper Only
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
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:
120
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
0 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
120
0
120
0
0
0
Annual IC Time Burden (Hours)
240
0
240
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
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.