CDRH Rapid Message Testing with Consumers and Caregivers- Information About At-Home COVID-19 Diagnostic Tests

Testing Communications On Medical Devices and Radiation-Emitting Products

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
Attachment A_At-Home OTC COVID-19 Diagnostic Tests _ FDA.pdf Other-FDA Webpages-list of authorize
Attachment B_At-Home COVID-19 Diagnostic Tests_ Frequently Asked Questions _ FDA.pdf Other-FDA Webpages-FAQs
Attachment C_CDRH Rapid Message Testing_Screener_COVID Tests 2-9-2023.docx Other-Screener
Attachment D_CDRH Rapid Message Testing_Interview Guide_COVID Tests 2-9-2023.docx Other-Interview guide
0678 OMB Memo At-Home COVID-19 Tests 2-9-2023.docx OMB Memo / Abbreviated Supporting Statement IC Document

Information Collection (IC) Details

IC Title:	CDRH Rapid Message Testing with Consumers and Caregivers- Information About At-Home COVID-19 Diagnostic Tests	Agency IC Tracking Number:	CDRH

IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-FDA Webpages-list of authorized tests	Attachment A_At-Home OTC COVID-19 Diagnostic Tests _ FDA.pdf	Yes	No	Printable Only
Other-FDA Webpages-FAQs	Attachment B_At-Home COVID-19 Diagnostic Tests_ Frequently Asked Questions _ FDA.pdf	Yes	No	Printable Only
Other-Screener	Attachment C_CDRH Rapid Message Testing_Screener_COVID Tests 2-9-2023.docx	Yes	Yes	Fillable Fileable
Other-Interview guide	Attachment D_CDRH Rapid Message Testing_Interview Guide_COVID Tests 2-9-2023.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 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	450	450
Annual IC Time Burden (Hours)	36	36
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
OMB Memo / Abbreviated Supporting Statement	0678 OMB Memo At-Home COVID-19 Tests 2-9-2023.docx	02/09/2023

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