OMB Memo-COVID Messaging

FDA DOCUMENTATION FOR THE GENERIC CLEARANCE,
“Testing Communications on Drugs”
(0910-0695)
TITLE OF INFORMATION COLLECTION: Rapid Message Testing with Consumers —
Terminology Routinely Used in CDER Communications
DESCRIPTION OF THIS SPECIFIC COLLECTION
1. Statement of need:
COVID-19 is a respiratory disease caused by SARS-CoV-2, a coronavirus discovered in
2019. The virus spreads mainly from person to person through respiratory droplets
produced when an infected person coughs, sneezes, or talks 1. The purpose of this project
is to test consumer website content and videos produced by the FDA’s Office of External
Affairs (OEA) about US-Authorized or FDA approved COVID-19 vaccines. The website
content and videos are for parents of children age 5-15 or for adults in the United States.
The US Food and Drug Administration has approved vaccines for COVID-19 in the
United States for people age 5 and older. Current rates of full vaccination in the US are
around 65.7% with only 45% of eligible people having received a booster dose 2.
The FDA’s OEA maintains these Q&A websites on COVID-19 for the FDA and creates
videos to help answer questions related to the pandemic and vaccines. The website and
videos seek to educate consumers about the benefits and risks of the COVID-19 vaccines
and offer information about eligibility and boosters. The parents or caregivers of kids age
5-9 will view a Q&A material about COVID-19 vaccines for their age children and a
video about long-term health consequences about COVID-19 vaccines. The parents or
caregivers of kids age 12-15 will view a Q&A material about COVID-19 vaccines for
their age children and a video about long-term health consequences about COVID-19
vaccines. The adults will view Q&A material related to adult vaccinations and a video
about booster doses.
Communications science tells us that we must test messages with our intended audiences.
Thus, FDA plans to test these communications using cognitive interviews with a small
sample of 24 U.S. adults drawn from diverse consumer and healthcare professional
(HCP) panels. The sample will include 12 parents/caregivers of children age 5-9 years
old; 8 parents/caregivers of children age 12-15 years old and 10 adults.
Each month millions of people view the FDA website and consumer communication
materials about COVID-19 vaccines. Attitudes and knowledge about COVID-19 vaccines
change quickly, alongside new FDA authorizations and approvals of COVID-19 vaccines
and boosters for different populations. FDA’s OEA would like to know as soon as
possible if the communication materials are responsive to consumer concerns and
questions, and if they are helping people make decisions about getting themselves and
their families fully vaccinated against COVID-19.
1
2

https://www.cdc.gov/dotw/covid-19/index.html
https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-onedose-pop-5yr
1

This data collection is the 29th in a series of FDA rapid message tests submitted to OMB
under generic clearance. These projects are part of FDA’s effort to make target audience
testing part of its routine communication development processes. This project is in
keeping with the spirit of the 2015 Executive Order 3 to improve how information is
presented to consumers by applying behavioral science insights, and it meets repeated
calls from FDA’s Risk Communication and Advisory Committee to conduct message
testing with targeted samples of the general public.
2. Intended use of information:
FDA’s contractor Westat will test the Q&A content and videos with a small sample of
target audience members to ensure the message meets its objectives without causing
unintended negative effects. FDA’s Risk Communication and Advisory Committee
includes renowned experts and researchers in social sciences, marketing, health literacy,
and related fields. From its very first meeting in 2008, the Committee has consistently
advised and reaffirmed that testing communications with the target audience is necessary
for FDA, and that using small samples is an effective approach for testing and
communicating in a timely manner. In fact, research has shown that “saturation,” or the
point at which no new information or themes are observed, can occur with as few as 12
interviews, as described in Guest et al (2006).
FDA will use the collected interview data to refine its messaging by improving the
comprehensibility for a higher public health impact. Specifically, FDA is asking Westat
to gain insight to the following questions:
1. What main message(s) do participants get from the material?
2. Overall, how do participants feel about the information they read/saw and
why/what specifically caused that reaction?
3. What are the materials recommending and are they described clearly?
4. Do participants understand from the material that the vaccine is safe and approved
for children/adults?
5. What is unclear or hard to understand?
6. How much, if any, of the material’s information is new to them and if so, what?
7. Do participants see themselves/their children as at risk for COVID-19?
8. How does the information in the QA change participants minds about getting
themselves/their children vaccinated?
9. Does the information in the QA provide useful information for deciding whether
participants want to get themselves/their children vaccinated?
10. How likely are adult/parent/caregiver participants to get/have their child/children
vaccinated for COVID-19?
11. What would motivate/motivated participants to get themselves/their children
vaccinated?
12. What in the information would cause participants to hesitate to get
themselves/their children vaccinated?
https://obamawhitehouse.archives.gov/the-press-office/2015/09/15/executive-order-using-behavioral-scienceinsights-better-serve-american
3

2

13. What additional information would participants like to see included?
14. Do the images and language in the video resonate with participants? (For the
videos)
15. How well do participants think the visuals match the messages? (For the videos)
The data collected will not be statistically representative of the target audience
population. Therefore, the data will not be used for making policy or regulatory
decisions.
3. Description of respondents:
We will conduct 30 45-minute interviews with U.S. adults. Westat has partnered with
Plaza Research, a recruitment specialist to recruit respondents from its general population
panel. Plaza Research tracks and stores all database member activity and assigns a unique
ID number which stays with the member throughout their entire membership. These
tracking records consist of profile information provided during enrollment, profile
updates, and past focus group or in-depth interview involvement. Plaza Research
monitors the quality of their data through various quality checks to save time and provide
confidence in data accuracy. These quality checks include individual vetting of contact
information, and review of enrollment data, as well as review of screener questions,
rescreening of participants before participation, and client feedback on past focus group
and interview response.
We will use a participant screener to recruit a mix of 12 parents/caregivers of kids age 59 years old and 8 parents/caregivers of kids age 12-15 years old and 10 adults. To the
extent possible, the participant pool will be diverse in terms of gender, age,
race/ethnicity, and geography.
4. Date(s) to be Conducted:
We plan to conduct interviews in April 2022.
5. How the Information is being collected:
We will conduct all interviews remotely using telephone and screen sharing technology
with participants on web-enabled devices such as desktop computers, laptops, or tablets.
We will ensure that any materials provided to the participants for the test are compatible
with these devices.
For each 45-minute interview, a trained interviewer will lead the discussion using a semistructured interview guide that ensures consistency in major topics but allows flexibility
in probing each participant on particular questions.
Note takers will chart their findings into a standardized reporting template so that all
notes are organized in a consistent manner. Interviewers will review the notes to ensure
accuracy. With the consent of participants, we will audio record each interview.

3

FDA staff will have the ability to listen to the interview sessions, and this will be made
known to participants as part of the informed consent.
6. Confidentiality of Respondents:
We will provide all respondents with informed consent language that ensures they
understand the project purpose, that their participation is voluntary, and that their
responses will be kept secure to the extent permitted by law. As part of the consent
procedure, respondents will be asked whether they allow audio recording of the
interview. Recording will not begin before participants have had the opportunity to ask
for any clarification and provide consent. Participants will be asked to again confirm their
consent when recording begins. Participants who do not allow audio recording will not be
invited to participate in the interview.
No participant’s identifiable information such as name will be included in the interview
notes. All interview materials will be stored on a secure network drive, which will only
be accessible to individuals granted access to work on the project. Interview notes will
be zipped electronically and password-protected for email or secure file transfer delivery.
Prior to forwarding any data to FDA, Westat will destroy all names and contact
information of participants to protect their personal identity. Additionally, the interview
notes and interpretive report delivered to FDA after message testing will omit all
information that could be used to identify respondents.
All electronic data storage media that contain confidential, private, or proprietary
information will be maintained within secure areas. Data collected in hard copy will be
kept in locked cabinets when not in use.
FDA’s Institutional Review Board (IRB) reviewed this study and determined it is exempt
from the requirements of 45 CFR §46.101b(2).
7. Amount and justification for any proposed incentive
For this project, Plaza Research will provide $50 incentives to participants at the end of
each 45-minute interview in the form of a check. Plaza Research uses a “by-invitationonly” recruitment methodology and incentivizes panelists for any participation to
maintain a quality filled panel. Panel members do not volunteer their time. Plaza’s
incentive scale is based on set time increments and is applied equally across all study
topics, sponsors, and data collection modes. The table below details the previous
incentives approved by OMB for this series of rapid message tests with consumers and
healthcare professionals (HCPs).
Project
#

Communication Tested

Population

Interview
Length/Incentive

1
2
3

Clinical Trials Brochure
Caregiver Tipsheet
Public Service
Announcement Video about
Generic Drugs

Consumers
Consumers
Consumers

45 min/$50
30 min/$35
30 min/$35

4

OMB
approval
date
8/4/2017
9/26/2017
10/25/2017

Project
#

Communication Tested

Population

Interview
Length/Incentive

4

Opioid Analgesics Patient
Counseling Guide
Vaccines and Seniors
Brochure
Public Service
Announcements about Safe
Disposal of Opioids
Nicotine Dialogue
Campaign Branding
Testosterone Medication
Guide
Asthma Fact Sheet
Transmucosal Immediate
Release Fentanyl Risk
Evaluation Mitigation
Strategy Program PatientPrescriber Agreement Form
BeSafeRx Campaign
Messages
Safe Drug Disposal
Notecard
Medical Countermeasures
Warnings on Opioid
Packaging
Messages About
Cannabidiol (CBD)
FDA’s Purple Book Website
Storyboards about Safe
Disposal of Opioids and
Other Medicines
Medication Guide Template
for Buprenorphine Products
Retest Warnings on Opioid
Packaging
Search and Rescue Website

Consumers

45 min/$50

OMB
approval
date
11/27/2017

Consumers

30 min/$35

5/10/2018

Consumers

30 min/$35

7/26/2018

Consumers

30 min/$35

8/23/2018

Consumers

45 min/$50

10/12/2018

Consumers
Consumers

30 min/$35
45 min/$50

2/12/2019
4/4/2019

Consumers

45 min/$50

5/17/2019

Consumers

30 min/$35

6/28/2019

Consumers
Consumers

45 min/$50
30 min/$35

9/10/2019
10/22/2019

Consumers

30 min/$35

1/2/2020

Consumers
Consumers

45 min/$50
45 min/$50

1/16/2020
4/14/2020

Consumers

30 min/$35

5/13/2020

Consumers

30 min/$35

6/19/2020

HCPs

9/23/2020

Drug Safety
Communications About
Misuse and Abuse of Overthe-Counter Medications

Consumers

45 min/$100
(primary care) or
$150 (specialists)
45 min/$50

5
6
7
8
9
10

11
12
13
14
15
16
17
18
19
20
21

5

12/9/2020

Project
#

Communication Tested

Population

Interview
Length/Incentive

22

Additional Testing of Drug
Safety Communications
About Misuse and Abuse of
Over-the-Counter
Medications
Drug Safety Communication
(DSC) Landing Page and
Format
Children’s Cough and Cold
Consumer Update

Consumers

45 min/$50

OMB
approval
date
3/12/2021

Consumers

45 min/$50

4/14/2021

Consumers
and
HCPs

45 min/$50

6/3/2021

23
24

45 min/$100
(primary care) or
$150 (specialists)

8. Questions of a Sensitive Nature
We do not anticipate asking any sensitive questions in the interviews. Instead, the
questions will focus on individuals’ reactions to the messages and materials.
Nevertheless, respondents will be told that they may skip any question that they do not
want to answer or may stop participating at any time.
9. Description of Statistical Methods
We do not plan to use formal statistical methods in this study but rather qualitative
analysis methods. Our analysis approach is based on the Framework method, as described
in Spencer et al (2003). Framework is a matrix-based approach to data management,
which facilitates both case and theme-based analysis. The Framework method allows for
data reduction through summarization and synthesis yet retains links to original data, in
this case the interview notes. We will use the qualitative analysis software NVivo, which
has included a Framework functionality since 2011. The software will allow us to import
interview notes, create links between the notes and the Framework matrices, and develop
new queries or matrices as needed.
The Framework method will allow us to recognize patterns within the data. Findings will
be supported with verbatim participant quotes and grounded in accepted principles of
health communications.
Bibliography
Guest, G., Bunce, A., & Johnson, L. (2006). How many interviews are enough? An experiment
with data saturation and variability. Field methods, 18(1), 59-82.
Spencer, L., Ritchie, J., & O'Connor, W. (2003). Analysis practices, principles and processes. In
Qualitative research practice. London: Sage Publications.
BURDEN HOUR COMPUTATION (Number of responses (X) estimated response or
participation time in minutes (/60) = annual burden hours):
6

Type/Category
of Respondent

No. of Respondents

Screener
Interviews

1500
30

Participation
Time
(minutes)
3
45
Total

REQUESTED APPROVAL DATE: April 19, 2022
NAME OF PRA ANALYST & PROGRAM CONTACT:
Paperwork Reduction Act Staff
PRAStaff@fda.hhs.gov
Alexandria Smith
CDER/Office of Communications
Alexandria.Smith@fda.hhs.gov
(240) 402-2192
FDA CENTER: Center for Drug Evaluation and Research (FDA/CDER)

7

Burden
(hours)
75
23
98