Information Collection

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

IC 258448 under ICR 202206-0910-013 · 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⚠️ Notice: This information collection may be referencing outdated material.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_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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.