Attachment B_MSG4 Breast Implant_Screener--07-13-23

OMB Control No. 0910-0678

Expiration Date: 5/31/2026

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 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 PRAStaff@fda.hhs.gov.

FDA Rapid Message Testing:

March 2023 Breast Implant Safety Communication

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 34

 35 to 54

 55 or older

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

 Yes  INELIGIBLE

 No

3. Are you a healthcare professional?

 Yes, physician (MD, DO)  GO TO Q4

 Yes, physician assistant  GO TO Q4

 Yes, nurse practitioner  GO TO Q4

 Yes, nurse  GO TO Q4

 Yes, pharmacist  INELIGIBLE

 Yes, medical assistant  INELIGIBLE

 Yes, dietician  INELIGIBLE

 No  GO TO Q7

4. [Ask if Q3 = Yes, physician] Which of the following best describes your primary area of specialization?

 Primary care, family practice, general medicine, or internal medicine

 Oncology

 Plastic surgery

 Other  INELIGIBLE

5. [Ask if Q4 NOT Other] In an average year, what percentage of your work time is spent on patient care? Patient care activities include examining patients, performing diagnostic tests, prescribing or dispensing medications, reviewing patient records, and other activities directly connected to treatment. Non-patient care activities include teaching, research, and administration.

 50% or more  GO TO Q6

 Less than 50%  INELIGIBLE

6. [Ask if Q5 = 50% or more] Are you an…?

1. Employee of the U.S. Department of Health and Human Services, or any of its agencies including the Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health INELIGIBLE

2. Employee of a state or local health department INELIGIBLE

3. None of the above  GO TO Q8

7. [Ask if Q3 = No] Are you an…?

1. Employee in a healthcare position or working for a health organization (for example: health consultant, health advocacy)  INELIGIBLE

2. Employee of the U.S. Department of Health and Human Services, or any of its agencies including the Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health INELIGIBLE

3. Employee of a state or local health department INELIGIBLE

4. None of the above  GO TO Q8

8. 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

• In the medical device industry  INELIGIBLE

• None of the above  IF Q6C = None of the above GO TO Q12  IF Q7D = None of the above GO TO Q9

9. Have you ever had breast implants?

• Yes, I currently have breast implants  GO TO Q11

• Yes, I had breast implants but had them removed  GO TO Q11

• No

10. [Ask if Q9=No] Have you ever considered getting breast implants?

• Yes

• No  INELIGIBLE

• Don’t Know  INELIGIBLE

11. [Ask if Q3=No] 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

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

Male

 Female

 Don’t know

13. Do you currently describe yourself as male, female, or transgender?

 Male

 Female

 Transgender

 None of these

14. [Ask if Q12=Female and Q13=Male] Just to confirm, you were assigned female at birth and now you describe yourself as male. Is that correct?

• Yes

• No

• Don’t Know

15. [Ask if Q12=Male and Q13=Female] Just to confirm, you were assigned male at birth and now you describe yourself as female. Is that correct?

• Yes

• No

• Don’t Know

16. Are you Hispanic or Latino?

 Yes

 No

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

□ American Indian or Alaska Native

□ Asian

□ Black or African American

□ Native Hawaiian or Other Pacific Islander

□ White

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

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

 Yes

 No  INELIGIBLE

20. 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 desktop computer, laptop, tablet, or mobile phone with a webcam and audio that you can use to participate? 

 Yes

 No  INELIGIBLE

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 (consumers) OR $100 (Primary Care) OR $150 (Oncology or Plastic surgery)] 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 to schedule your interview.

[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.