Consumer Knowledge and Behavior Re: Agricultural Biotechnology and Biotechnology-Derived Food Products and Animal Feed - Wave III: Focus Groups Exploring Consumer Reactions to Educational Materials

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OMB No: 0910-0497 Expiration Date: 10/31/2020

Paperwork Reduction Act Statement: 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 0910-0497 and the expiration date is 10/31/2020. The time required to complete this information collection is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

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.

Appendix I

Foods Focus Groups (Wave III)

Participant Screener

Recruiting Goals:

• People who have done a focus group or other interview-based research in the last 6 months are not eligible.

• People who have ever done five or more focus groups are not eligible.

• When calling potential participants, recruiters should use general interactions throughout all calls to make judgments about each person’s ability and willingness to participate in a focus group discussion.

• We are looking to recruit participants who are talkative and articulate. Everyone will be expected to participate in the discussion and contribute her/his opinions. All participants will need to be comfortable conversing in English.

• All participants must be able to read, understand, and speak English.

• All groups will be conducted with individuals ages 18 and over who do at least half of the grocery shopping for their households and who are at least somewhat knowledgeable and interested in issues of food and nutrition.

• Each group will include a mix of ages, genders and race/ethnicities.

• The groups will be segmented by education level; half of the group discussions in each location will be conducted with lower education participants who hold an Associate’s degree from a community college or lower, and the other half with higher educated participants who hold a Bachelor’s degree or higher;

• Each group will include a mix of ages, genders and race/ethnicities. (See the Table below).

Study Protocol:

• Sufficient recruits will be invited to achieve a target of 8-10 participants per group.

• Each group will last approximately 2 hours (a 90-minute discussion plus time needed for signing in before the group starts and signing out after the group ends).

• Each participant will receive a cash token of appreciation for participating in the focus group.

• Groups will be audio- and video-recorded and live-streamed for off-site observers.

• Signed Informed Consents will be processed at sign-in, and a verbal consent will be obtained before the start of the discussion.

• The identity of the participants will be kept secure to the extent provided by law.

• Groups will be observed by staff from the U.S. Food and Drug Administration, USDA, and EPA.

• Participants do not have to answer any questions that they do not want to but are encouraged to participate.

Table: Group Composition and Location:

Group Number	Location	Education	Test Materials
1	New York, NY	Lower education	101 Web and infographic
2		Lower education	Social media visuals and video
3		Higher education	201 Web content and infographic
4		Higher education	Social media visuals and video
5	Des Moines, IA	Lower education	201 Web and infographic
6		Lower education	Social media visuals and video
7		Higher education	101 Web content and infographic
8		Higher education	Social media visuals and video
9	Chicago, IL	Lower education	101 Web and infographic
10		Lower education	Social media visuals and video
11		Higher education	201 Web content and infographic
12		Higher education	Social media visuals and video
13	L.A., CA	Lower education	201 Web and infographic
14		Lower education	Social media visuals and video
15		Higher education	101 Web content and infographic
16		Higher education	Social media visuals and video
17	Dallas, TX	Lower education	101 Web and infographic
18		Lower education	Social media visuals and video
19		Higher education	201 Web content and infographic
20		Higher education	Social media visuals and video

SCRIPT:

Hello Mr./Ms. __________________________________, my name is __________________ and I'm calling about a research study sponsored by the U.S. Food and Drug Administration in your area. We are recruiting for an upcoming focus group in which participants will be asked to share their thoughts and understanding of different foods. Participants in this study will receive a token of appreciation for participating in the focus group. Let me assure you that this is a legitimate research study. I am not trying to sell anything.

1. First, are you at least 18 years of age? IF NO: We are only recruiting people who are 18 years of age or older for these groups. May I please speak with someone in your household who is at least 18 years of age? IF NO ONE, THANK RESPONDENT POLITELY AND END CALL.

IF NEW RESPONDENT, REPEAT STARTING WITH THE INTRODUCTION ABOVE.

2. Are you interested in participating?

• Yes  continue

• No  eliminate [thank respondent politely]

3. Would you mind answering a few questions? This will only take a few minutes of your time.

• Yes  continue

• No  eliminate [thank respondent politely]

4. The focus group will be conducted in English. Are you comfortable reading and speaking English?

• Yes  continue

• No  eliminate [thank respondent politely]

5. Do you or someone from your immediate family work for any of the following:

• A Market Research Firm  eliminate [thank respondent politely]

• State or local food agency, EPA,

U.S. Department of Agriculture, or

U.S. Food and Drug Administration  eliminate [thank respondent politely]

6. Do you do at least half of the grocery shopping for your household?

• Yes  continue

• No  eliminate [thank respondent politely]

7. Thinking about your eating habits in general, how much attention do you pay to the nutritional content of the foods you eat? Would you say:

• A lot  continue

• A little  continue

• Almost none or none at all

8. How often, if at all, do you check information on the label when you buy a food product for the first time? Would you say

• Often  continue

• Sometimes  continue

• Almost never or never

9. How often, if at all, do you buy organic produce?

• Often  continue

• Sometimes  continue

• Almost never or never

10. How many of your meals you prepare by yourself?

• A lot  continue

• A little  continue

• Almost None or none at all

11. How much would you say you know about GMO foods?

• A lot  continue

• A little  continue

• Almost nothing or Nothing

NOTE TO RECRUITER: If ALL respondent’s answers to Q7-11 are “Almost none or none at all” and “Almost never or never”. ELIMINATE [THANK POLITELY].

12. DETERMINE GENDER. IF UNSURE, ASK RESPONDENT IF S/HE IS MALE OR FEMALE.

• Male  continue

• Female  cotinue

[recruit a mix of genders in each focus group]

13. What is the highest level of education that you have completed? [READ ALL ANSWER OPTIONS. RECRUIT A MIX WITHIN EACH GROUP AND ACROSS STUDY]

• Less than high school  recruit to lower ed group

• High school graduate or GED  recruit to lower ed group

• Technical/vocational school  recruit to lower ed group

• Some community college  recruit to lower ed group

(towards an Associate’s degree or other

community college degree)

• Community college degree (e.g., Associate’s degree)  recruit to lower ed group

-------------------------------------------------------------------------------------------------------

• Some college  recruit to higher ed group

(toward Bachelor’s degree)

• College degree (Bachelor’s degree)  recruit to higher ed group

• Advanced degree (postgraduate degree)  recruit to higher ed group recruit no more than ABOUT 5 per group TO SEAT NO MORE THAN ABOUT 3 PER GROUP]

14. Are you of Hispanic or Latino origin? [ENSURE ABOUT 2 PER GROUP AS REFLECTIVE OF THE AREA]

• Yes  continue

• No  continue

15. What is your race? I am going to read several categories of race. You may choose one or more categories. Are you…? [Recruit a diverse group reflective of the area.]

• White

• Black or African American

• Asian

• Native Hawaiian or Other Pacific Islander

• American Indian or Alaska Native

• Prefer not to answer

16. I am going to read some age categories, could you please tell me in which category your age falls? [RECRUIT A MIX FOR EACH AGE CATEGORY WITHIN EACH GROUP AND ACROSS STUDY]

• 18-34  continue, RECRUIT TO YOUNGER GROUPS

• 35-65  continue, RECRUIT TO OLDER GROUPs

• 66 and above  eliminate [thank respondent politely]

17. I am going to read some income categories; could you classify your annual household income to one of these categories? [RECRUIT A MIX PER GROUP]

• Less than $25,000 per year

• $25,000 to less than $50,000 per year

• $50,000 to less than $75,000 per year

• $75,000 and over per year

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FINALIZING SCREENER QUESTIONS FOR ALL GROUPS

Thank you for answering these questions. We would like to invite you to participate in a focus group with about eight other participants to discuss your thoughts and understanding of different foods. The discussion will last approximately an hour and a half. The discussion will be video- and audio-recorded, and also observed by researchers. Your participation and everything you say during the discussion will remain secure to the extent allowed by law and your personal identifying information will not be included in any reports. At the conclusion of the focus group, you will receive $75.00 as a token of our appreciation for your participation. The focus group will last approximately 2 hours (a 90-minute discussion plus time needed for signing in before the group starts and signing out after the group ends). Are you interested in participating in this focus group?

• Yes [CONTINUE]

• No [Thank the person for his/her time]

I’m glad that you will be able to join us! The focus group will take place on (DAY), (DATE), at [6:00 or 8:00 p.m.] at [SITE LOCATION].

Will you be available to participate at this time?

• Yes [CONTINUE]

• No [Thank the person for his/her time]

I would like to send you a confirmation letter and directions to the facility. In order to do so, could you please tell me the best way of contacting you:

______________________________________________________________________________

[INSERT CONTACT INFORMATION]

Date of focus group:__________________ Time:________________

We are only inviting a few people, so it is very important that you notify us as soon as possible if for some reason you are unable to attend. Please call [RECRUITER] at [TELEPHONE NUMBER] if this should happen. We look forward to seeing you on [DATE] at [TIME]. If you use reading glasses, please bring them with you to the focus group.