Cognitive Interview (phone and mail)

Food and Drug Administration

College Park, MD 20740

For Address-based, mail push to web survey, we will prepare:

1. A letter on FDA letterhead explaining the study and inviting them to respond to the survey via the Web at a URL provided in the letter and including two $1 bills;

2. A reminder/thank you post card sent 5 days later to all households;

3. A second letter sent 10 days after the post card to all non-respondents;

4. A hard-copy questionnaire mailed to non-respondents 10 days later;

5. A reminder postcard for the mail survey sent 10 days after the mail survey to non-respondents.

Table of Contents

1. Initial Contact Letter 2

2. Reminder/Thank you post card to all 3

3. Second letter to non-respondents 4

4. Letter with hard-copy questionnaire to non-respondents 5

5. Reminder postcard to non-respondents 6

1. Initial Contact Letter

OMB Control No. 0910-0345 Expiration Date: xx/xx/xxxx

Dear Resident:

I am writing you to ask you to take part in an important study about food and nutrition.

The U.S. Food and Drug Administration (FDA) is conducting a survey to hear your views and opinions about food and nutrition in the United States. FDA will use the results to develop food and nutrition educational materials and to provide critical up-to-date information for our food and nutrition programs.

Your address was randomly selected for a list of residential addresses so that everyone in the country has the same chance of being chosen. Your participation is voluntary. However, it is important to the success of the study that everyone chosen takes part. We expect it to take 20 minutes to complete the survey. As a way of saying thank you we enclose $2 with this letter.

Please respond by [enter date]

To take the survey, go to: [insert URL]

To begin, enter this access code: [insert login ID]

This survey should be completed by the adult (age 18 and older) in your household who has had the most recent birthday.

We can assure you that your individual privacy will be maintained in all published and written data resulting from this study. The information will be combined for all participants and reported only as statistical summaries. You will not be individually identified and our personal information will ne be shared unless required by law.

If you have any questions or comments about this study, we are happy to talk with you. Please call Westat, a research company conducting this survey on behalf of the FDA, at 1-888-XXX-XXXX or email us XXXX@XXXX.westat.com. You can find more information about this study online at [provide website link].

Thank you very much for your contribution to this important study.

Sincerely,

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 0910-0345. The time required to complete this information collection is estimated to average 20 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.

2. Reminder/Thank you post card to all

Dear Resident:

OMB Control No. 0910-0345 Expiration Date: xx/xx/xxxx

A few days ago, a letter was sent to your household inviting you to complete an important national survey about your opinion on food and nutrition issues for the U.S. Food and Drug Administration (FDA).

If you have completed the survey already – thank you! Your help is very much appreciated.

If you have not yet completed the survey – please log on to take the survey. If you have any questions, please call 1-8XX-XXX-XXXX or email XXXX@XXXX.wetat.com.

Please respond by [enter date]

To take the survey, go to: [insert URL]

To begin, enter this access code: [insert login ID]

Thank you,

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 0910-0345. The time required to complete this information collection is estimated to average 20 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.

3. Second letter to non-respondents

OMB Control No. 0910-0345 Expiration Date: xx/xx/xxxx

Dear Resident:

A couple of weeks ago we asked for your help with an important survey about your opinions about food and nutrition. We asked you to complete an online survey, but we have not heard back from you.

Those who have already responded have given a wide variety of useful opinions about food and nutrition. I am writing to you again because it is important that we hear back from as many people as possible, so we can be confident that the results are representative of all people who live in the United States. This is a research study. We are not selling anything, and your name will not be sold to any third-party organizations.

Please respond by [enter date]

To take the survey, go to: [insert URL]

To begin, enter this access code: [insert login ID]

at [insert URL]

Password: [insert password]

To make sure we hear from all different types of people who live in the United States, we hope the adult (age 18 and older) in your household who has had the most recent birthday can take the time to fill out this brief survey.

This survey is voluntary and we respect your privacy. Your name is not being collected and no personal information will be used in any published or written data.

We hope that you can take part. If you have any questions about this study please call Westat, a research company conducting this survey on behalf of the FDA, at 1-800-XXX-XXXX or email XXXX@westat.fda.gov.

Thank you for your help.

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 0910-0345. The time required to complete this information collection is estimated to average 20 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.

4. Letter with hard-copy questionnaire to non-respondents

OMB Control No. 0910-0345 Expiration Date: xx/xx/xxxx

Dear Resident:

Over the past few weeks I have sent you several mailings asking for your help with a national survey about food and nutrition. FDA will use the results to develop food and nutrition educational materials and to provide critical up-to-date information for our food and nutrition programs.

This study is drawing to a close, but I would like to include your views as you may have different

experiences from those who have already taken part. Hearing from everyone chosen assures that

the survey results are as accurate as possible.

You can take part by completing the enclosed survey questionnaire. Please mail back the survey

in the pre-addressed return envelope. Postage has already been paid.

We can assure you that your individual privacy will be maintained in all published and written data

resulting from the study. The information will be combined for all participants and reported only as

statistical summaries. You will not be individually identified and your personal information will not

be shared unless required by law.

Your participation is voluntary, but we hope that you will fill out and return the questionnaire soon.

If you have any questions or comments about this study please call Westat, a research company

conducting this survey on behalf of the FDA, at 1-855-XXX-XXXX or email XXXX@westat.com.

Sincerely,

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 0910-0345. The time required to complete this information collection is estimated to average 20 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.

5. Reminder postcard to non-respondents

OMB Control No. 0910-0345 Expiration Date: xx/xx/xxxx

Dear Resident:

We recently mail you the Food Safety, Health, and Diet Survey. If you returned the survey, thank you for your time, it is much appreciated. If you haven’t yet, please take a few minutes to complete it. The study is almost over and this is the last reminder you will receive.

We hope you will take this final chance to complete the questionnaire that was sent to you last week. Your views are important to us, and your participation is critical so that the information we collect represents the experience of people across the United States.

If you prefer, there is still time to complete the survey online.

Go to: [insert URL]

Enter this access code: [insert login ID]

If you have any questions, please 1-800-XXX-XXXX or email XXXX@westat.com.

Thank you,

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 0910-0345. The time required to complete this information collection is estimated to average 20 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.