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Collection of Data to Support Training Decay Selection for Medical Product Usability Validation Testing (CDER)
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
OMB: 0910-0847
IC ID: 238929
OMB.report
HHS/FDA
OMB 0910-0847
ICR 201910-0910-010
IC 238929
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0847 can be found here:
2023-11-03 - No material or nonsubstantive change to a currently approved collection
2022-12-28 - Extension without change of a currently approved collection
Documents and Forms
Document Name
Document Type
Moderators Script.docx
Other-Moderator Script
Initial Training Script.docx
Other-Initial Training Script
Informed Consent Form for All Participants.docx
Other-Consent Forms
Protocol.docx
Other-Protocol
UserWiseFDA05_rev02_End of Study Questionnaire_09Dec19.pdf
Other-post-survey questionnaire
0847 OMB Approval Memo Training Decay 2019.docx
0847 OMB Approval Memo
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Collection of Data to Support Training Decay Selection for Medical Product Usability Validation Testing (CDER)
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-Moderator Script
Moderators Script.docx
Yes
No
Paper Only
Other-Initial Training Script
Initial Training Script.docx
Yes
No
Paper Only
Other-Consent Forms
Informed Consent Form for All Participants.docx
Yes
No
Paper Only
Other-Protocol
Protocol.docx
Yes
No
Paper Only
Other-post-survey questionnaire
UserWiseFDA05_rev02_End of Study Questionnaire_09Dec19.pdf
No
Paper Only
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Health Care Services
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
139
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
139
0
139
0
0
0
Annual IC Time Burden (Hours)
348
0
348
0
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
0847 OMB Approval Memo
0847 OMB Approval Memo Training Decay 2019.docx
12/12/2019
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.