Information Collection

CDRH Rapid Message Testing with Consumers and Caregivers -- March 2023 Breast Implant Safety Communication

IC 261063 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⚠️ Notice: This information collection may be referencing outdated material.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_ Reports of Squamous Cell Carcin--07-13-23.pdf	Other-Attachment A - FDA Safety Comm
Attachment B_MSG4 Breast Implant_Screener--07-13-23.docx	Other-Attachment B - Screener
Attachment C_Confirmation Email--07-13-23.docx	Other-Appendix C - Confirmation Emai
Attachment D_MSG4 Breast Implant_Interview Guide--07-13-23.docx	Other-Attachment D - Interview Guide
0678-memo-#4 Breast Implant Safety Communication--07-13-23.docx OMB Memorandum	IC Document

IC Title:

CDRH Rapid Message Testing with Consumers and Caregivers -- March 2023 Breast Implant 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	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Attachment A - FDA Safety Communication, "Update: Reports of Squamous Cell Carcinoma in the Capsule Around Breast Implants"	Attachment A_UPDATE_ Reports of Squamous Cell Carcin--07-13-23.pdf	Yes	No	Printable Only
Other-Attachment B - Screener	Attachment B_MSG4 Breast Implant_Screener--07-13-23.docx	Yes	Yes	Fillable Fileable
Other-Appendix C - Confirmation Email	Attachment C_Confirmation Email--07-13-23.docx	Yes	No	Printable Only
Other-Attachment D - Interview Guide	Attachment D_MSG4 Breast Implant_Interview Guide--07-13-23.docx	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 450

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	504	504
Annual IC Time Burden (Hours)	41	41
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
OMB Memorandum	0678-memo-#4 Breast Implant Safety Communication--07-13-23.docx	07/13/2023

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