FDA Response

Mental Models Study of Food Terrorism Risk Awareness

Responses to OMB Comments of January 2, 2008

January 25, 2008

This memorandum is being sent with a revised supporting statement in red-line.

OMB Question:

1. In the response to questions about procuring interviewees/building rapport, FDA states,

 

"The purpose of this first level of contact is to identify and speak with individuals who are likely to know a large number of community leaders. A second level of contact is with these community leaders, who are canvassed by phone to locate those who are able and interested enough in helping researchers identify interview candidates."

 

Is the burden associated with these intermediate responders included in item #12 of the supporting statement? If not, please add. It's not currently clear as written.

FDA Response:

 

We have revised the burden estimates in the supporting statement. After reviewing the sampling plan for the Food Terrorism Mental Models study, we have decided to use a professional recruiting firm to obtain interview candidates for the study. Such firms have access to lists of people who have agreed to participate in research studies. These lists are used to recruit participants for qualitative projects such as focus groups and usability studies. Please see Section #A2 in the Supporting Statement for the revised sampling discussion.

Detailed information about the recruitment is provided below, in our response to question #2.

OMB Question:

2. What sort of response rate does FDA expect to receive? How many folks does FDA expect to have to contact to reach the desired number of respondents?

 

FDA Response:

Based on our previous experience using the same type of sampling methodology for qualitative research, such as focus groups, the incidence of a successful, completed telephone screening is between 30-40%. FDA expects to have to contact approximately 114 people to achieve completed interviews with 40 respondents, using proprietary lists of people who have agreed to participate in research studies.

The recruiter will require approximately five minutes to complete the screening interview for a selected participant, and will require less time to disqualify a potential respondent.

To maximize participation, recruiters will attempt to contact each respondent at least five times to screen for eligibility and recruit for participation.

The essential recruiting criteria are:

• at least one child in the home, at least half time, between the ages of four & fourteen years, and

• at least some prior food purchase experience.

Other recruiting targets include:

• one third of participants with education attainment at the level of high school graduate or below,

• half of participants are male, and

• at least one third of participants are non-white.

OMB Question:

3. Please provide information on how the sites would be selected, how many different sites will be used and how many folks expected to be contacted per site. This was also a question remaining from the call.

 

FDA Response:

Our revised sampling plan does not involve the selection of sites. Instead, recruiters will utilize their own local list of research volunteers and access a national list maintained by an associated survey research company. Recruiters will select volunteers from geographically diverse locations to participate in the interviews.

OMB Question:

4.  "The product of the consumer interviews will be a mapping of factors, both internal (social psychological) and external (environmental) that impact decision-making with respect to a response to food terrorism. The factors are variables that can take on different values across the population. "

 

What are the specific factors to be mapped in this collection (do they correspond to the bolded headings on the questionnaire, to the parentheticals)? What is the "population" relevent to this collection? Please briefly explain the mapping process and how values will be assigned.

 

FDA Response:

The specific factors to be mapped do not correspond exactly to the bolded headings on the questionnaire. The consumer questionnaire was designed to follow from, but not replicate, the nodes and relationships “mapped” on the “Expert Model.” Using the “Expert Model” as a guide, consumer interview results will be used to create a “Consumer Model.” What is referred to above as a “mapping process” entails noting themes or phrasing that are repeated among respondents and creating a model of the relationship between the relevant factors. Thus, we allow for the potential for the following factors to be mapped for the Consumer Model: [the effects of media communication, government communication, and communications from other sources; the consumers’ own information gathering and processing; the impact of social and cultural factors; health and safety related family values and objectives; consumer vulnerability; consumer adaptive capacity; how all the above impact the consumers assessment of the threat of food terrorism, and the resulting impact on their decision to act (or not) on the basis of the increased threat of food terrorism ], but we anticipate that additional factors may be identified through the interviewing process.

Qualitative (categorical) “values” are assigned in a variety of ways, such as by noting the tone taken by the interviewee, the degree of emphasis placed on words or phrases, repeated reference, word choice.

The general population of the U.S. is relevant to this collection. We chose to interview parents of young children because we think we may garner more thoughtful responses from people who have to be concerned about the food intake of a dependent who likely eats the same food as the rest of the family.

OMB Question:

5. Given the qualitative nature of this research, and our discussion during the last call, I was under the impression that FDA intended this research to be very exploratory/formative... for problem identification or as a way to determine if more research would be helpful or necessary (e.g., might test messages with focus groups). However, the statement below from FDA's response makes it appear that FDA views the results more definitively.

 

"The results provide a researched understanding of what consumers want and need to know about food terrorism. It is not a foregone conclusion that it is appropriate for the FDA to design food terror awareness messages for the “average consumer.” Targeted messages might be more appropriate. The research will answer this question. But in either case, because of the study, we will have a much better idea about how to motivate consumers to promote preferred outcomes."

 

Given the methodological limitations of this approach, OMB is more comfortable with this being used more as formative research. If that is FDA's intent, response #2 should be revised to make that more clear.

 

FDA Response:

We intend to use the Food Terrorism Mental Models Study as formative research. We have revised the supporting statement by adding the following paragraph to Section #A2:

FDA intends this collection to be used as formative research. As with our focus group research, the results of this formative research will provide direction toward potential areas of focus. Further research would be necessary to test messages crafted from these results. If we see what appears to be a clear trend in responses and if we need to understand whether that trend is representative (i.e., what proportion of the general population would provide that response), the research will be very useful in designing survey questions.

4