Information Collection

Training Decay for Medical Products: Insulin Pump Usability Study (CDER)

IC 250366 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⚠️ Notice: This information collection may be referencing outdated material.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
Attachment A - Initial Training Script.docx	Other-Initial Training Script
Attachment A - Initial Training Script.docx	Other-Initial Training Script
Attachment B - Moderators Script.docx	Other-Moderators Script
Attachment B - Moderators Script.docx	Other-Moderators Script
Attachment C-End of Study Questionnaire.pdf	Other-End of Study Questionnaire
Attachment C-End of Study Questionnaire.pdf	Other-End of Study Questionnaire
Attachment D - Informed Consent.docx	Other-Informed Consent
Attachment D - Informed Consent.docx	Other-Informed Consent
IRB Approval Notification #F19089.pdf	Other-IRB Letter
IRB Approval Notification #F19089.pdf	Other-IRB Letter
0847 OMB Approval Memo - Training Decay for Medical Products 2021.docx OMB Approval Memo	IC Document
0847 OMB Approval Memo - Training Decay for Medical Products 2021.docx OMB Approval Memo	IC Document

IC Title:

Training Decay for Medical Products: Insulin Pump Usability Study (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	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Initial Training Script	Yes	No	Printable Only
Other-Moderators Script	Yes	No	Printable Only
Other-End of Study Questionnaire	Yes	Yes	Fillable Fileable
Other-Informed Consent	Yes	Yes	Fillable Fileable
Other-IRB Letter	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 150

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	150	150
Annual IC Time Burden (Hours)	285	285
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Approval Memo		11/16/2021

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

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