Attachment C_CDRH Rapid Message Testing_Screener_COVID Tests 2-9-2023

OMB Control No. 0910-0678

Expiration date: 4/30/2023

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0678 and the expiration date is 4/30/2023. The time required to complete this information collection is estimated to average 3 minutes per response. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to [email protected].

FDA Rapid Message Testing:

At-Home COVID-19 Test Information

Introduction

The U.S. Food and Drug Administration, or FDA, hired Westat to help them get opinions about health information. PRC is helping Westat and FDA find people who may be interested in being interviewed about health information. To make sure you are a good fit for the interview, please take about 3 minutes to answer the questions below.

1. What is your age?

 Under 18  INELIGIBLE

 18 to 29

 30 to 49

 50 or older

2. Do you, or does any member of your household or immediate family work…?

• For a market research company  INELIGIBLE

• For an advertising agency, communications, or
  public relations firm  INELIGIBLE

• In the media (TV, radio, newspapers, magazines)  INELIGIBLE

• As a healthcare professional (doctor, nurse,
  pharmacist, medical assistant, dietician, etc.)  INELIGIBLE

• In a healthcare position or for a health organization
  (health consultant, health advocacy, state or local
  health department, U.S. Department of Health and
  Human Services or any of its agencies)  INELIGIBLE

• In the medical device industry  INELIGIBLE

• None of the above  GO TO Q3

3. Are you a parent or guardian of any children living in your household?

• Yes

• No

4. [Ask if Q3=Yes] What age are the children living in your household? Select all that apply.

• Under 2 years old

• 2 to 13 years old

• 14 to 17 years old

• 18 years old or older

5. In the past 6 months, have you used an at-home COVID-19 test?

• Yes

• No

• Don’t Know  INELIGIBLE

6. What is the highest grade or level of education you have completed?

• Less than High School

• High School Diploma or GED

• Some College, but no degree

• Associate’s Degree  INELIGIBLE

• Bachelor’s Degree  INELIGIBLE

• Graduate or Professional Degree  INELIGIBLE

7. What sex were you assigned at birth on your original birth certificate?

 Female

 Male

 Prefer not to answer  INELIGIBLE

8. Are you of Hispanic, Latino, or Spanish origin?

 Yes

 No

9. What is your race? Please select one or more.

□ White

□ Black or African-American

□ American Indian or Alaska Native

□ Asian

□ Native Hawaiian or other Pacific Islander

10. What state do you live in? [DROP DOWN LIST OF US STATES, INCLUDING “OUTSIDE OF THE US”] [“OUTSIDE OF THE US”  INELIGIBLE]

11. Do you have access to high-speed (in other words, not dial-up) internet?

 Yes

 No  INELIGIBLE

12. For this discussion, the interviewer would like to share her computer screen during the interview so that you can view the health information together. Do you have a computer (laptop, tablet, or desktop) with a webcam and audio that you can use to participate? 

 Yes

 No  INELIGIBLE

13. Have you participated in an interview or focus group for a research study within the past 6 months?

 Yes  INELIGIBLE

 No

Request for Contact Information

C1. Thank you for answering the questions. Based on your answers, you may be selected for a 45-minute online interview. If selected, you will receive $50 as a token of appreciation for your participation. At the start of the interview, the interviewer will ask if it’s okay to record it. This helps Westat make sure they correctly hear everything you say. Are you okay with being audio and video recorded during the interview?

 Yes

 No  INELIGIBLE

Contact Information

C2. In the space below, please provide us with your contact information, including phone number and email address. PRC will not share your contact information with anyone else, including the FDA. Your personal information will be deleted upon completion of the research project.

Name ______________________________________________________________________

Phone Number _______________________________________________________________

Email Address ________________________________________________________________

Closing

Thank you for your answers to these questions. If you are chosen for an interview, someone will contact you within the next 1-2 days.

[INELIGIBLE] Thank and Terminate

Thank you for taking our survey. Unfortunately, based on your responses, you are not eligible for this study. However, we appreciate you taking the time to answer our questions today.