Information Collection

CDRH Rapid Message Testing with Consumers and Caregivers-May 2023 Renuvion/J-Plasma Device Safety Communication

IC 261580 under ICR 202303-0910-022 · OMB 0910-0678.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0678 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Attachment A UPDATE Use of Renuvion J-Plasma Device.pdf	Other-FDA Safety Communication
Attachment B Renuvion J-Plasma Device Screener.docx	Other-Screener
Attachment C Confirmation Email.docx	Other-Confirmation of participation
Attachment D Renuvion J-Plasma Device Interview Guide.docx	Other-Interview guide
0678 OMB memo Renuvion J-Plasma Device JC passback.docx OMB Memo / Abbreviated Supporting Statement	IC Document

IC Title:

CDRH Rapid Message Testing with Consumers and Caregivers-May 2023 Renuvion/J-Plasma Device Safety Communication

Agency IC Tracking Number:

CDRH

IC Status: New

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-FDA Safety Communication	Yes	No	Printable Only
Other-Screener	Yes	Yes	Fillable Fileable
Other-Confirmation of participation email	Yes	No	Printable Only
Other-Interview guide	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 400

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	400	400
Annual IC Time Burden (Hours)	36	36
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Memo / Abbreviated Supporting Statement		08/15/2023

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

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