Information Collection

Collection of Data to Support Training Decay Selection for Medical Product Usability Validation Testing (CDER)

IC 238929 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⚠️ Notice: This information collection may be referencing outdated material.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
Moderators Script.docx	Other-Moderator Script
Moderators Script.docx	Other-Moderator Script
Initial Training Script.docx	Other-Initial Training Script
Initial Training Script.docx	Other-Initial Training Script
Informed Consent Form for All Participants.docx	Other-Consent Forms
Informed Consent Form for All Participants.docx	Other-Consent Forms
Protocol.docx	Other-Protocol
Protocol.docx	Other-Protocol
UserWiseFDA05_rev02_End of Study Questionnaire_09Dec19.pdf	Other-post-survey questionnaire
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
0847 OMB Approval Memo Training Decay 2019.docx 0847 OMB Approval Memo	IC Document

IC Title:

Collection of Data to Support Training Decay Selection for Medical Product Usability Validation Testing (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-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

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 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	139	139
Annual IC Time Burden (Hours)	348	348
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.