Frozen Berries Recall - Link to Hepatitis A

FDA DOCUMENTATION FOR THE GENERIC CLEARANCE

OF SURVEYS FOR

REAL TIME SURVEYS OF CONSUMERS’ KNOWLEDGE, PERCEPTION AND REPORTED BEHAVIOR CONCERNING FOODBORNE ILLNESS OUTBREAKS OR FOOD RECALLS (0910-0711)

DESCRIPTION OF THIS SPECIFIC COLLECTION

1. Statement of need:

FDA is seeking clearance under the terms of a generic clearance associated with OMB Control Number 0910-0711, “Real Time Surveys of Consumers` Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls” to survey consumers on their awareness, knowledge, and reported behaviors associated with an outbreak of Hepatitis A potentially linked to frozen berry products (see the following link for more information: http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm354698.htm.) A major product retailer (COSTCO) has pulled the products from their shelves and has contacted customers who have purchased the product, advising them to throw away any unused portion. The CDC and FDA are monitoring the outbreak. This request is for up to five waves of the survey for this incident. The initial survey will provide baseline data. Depending on the severity, duration, or information environment associated with the outbreak, the subsequent survey waves may be needed.

2. Intended use of information:

The survey results will be used to assess the degree to which consumers are aware of the current Hepatitis A outbreak potentially linked to frozen berry products and are taking appropriate corrective action – or would take appropriate corrective action. The information will help FDA protect the public by helping to inform decisions about whether we should adjust our communication strategies and/or messaging for this outbreak to help consumers respond (or have the ability to respond) appropriately.

3. Description of respondents:

The respondent universe for the survey is Synovate’s online Consumer Opinion Panel (“ePanel”).  U.S. consumers who are 18 or older are invited to join the ePanel primarily through an affiliate marketing program. 

The target sample size for each wave of the survey is 2000 adult consumers. Contractors will e-mail an introduction to the survey which will include a link to the screener and the survey instrument.

4. Date(s) to be conducted:

June 20, 2013 to June 26, 2013

5. How the information is being collected:

The survey sample will be drawn from a proprietary, web-based consumer panel and the survey will be completed online. Screening will be used to identify eligible household members; one respondent per household will be allowed to complete the survey.

6. Amount and justification for any proposed incentive:

Respondents will be recruited from members of Synovate’s Consumer Opinion Panel. Members voluntarily agree to join the panel and participate in regular online surveys conducted by Synovate. Synovate offers panelists two main incentive programs: a sweepstakes draw and a points rewards program. The sweepstakes draw is conducted quarterly or monthly, depending upon the market. Panel members are automatically entered into a sweepstakes draw upon registering for the panel and for each survey completed during this time period. Sweepstakes prizes include one cash prize of $1,000, 10 prizes of $100, 15 prizes of $50, 30 prizes of $25, and 150 prizes of $10.”  In the Points Rewards Program, panelists earn points for every survey completed and can redeem these points for cash in their native currency. Panelists receive 50 points for every survey minute anticipated. One thousand points = $1. 

7. Are there any deviations to the described methods, procedures, and uses of data contained in the Real Time Food Recall Surveys 2010 Justification Statement?

YES ______

NO ___X__ (if NO, skip to #8)

7a. If YES, please describe:

8. Burden Chart and Description:

To conduct five survey waves, we will screen a total of 10000 individuals, each taking approximately 20 seconds to complete for a total of 55 hours of respondent burden. Two thousand respondents will complete the baseline survey. We estimate that the baseline survey will take 10 minutes to complete for a total of 334 burden hours. Subsequent survey waves (up to 4 subsequent waves) may be administered to 2000 individuals each. Each survey will take 10 minutes to complete for a total of 1336 hours for the subsequent waves and a total of 1670 hours for all survey waves. The total estimated burden hours, including the screener, baseline survey and four subsequent waves of this administration of the Real Time Food Recall Surveys are 1725.

Activity	No. of Respondents	Number of responses per respondent	Average burden per response	Total hours
Screener	10000	1	.0055 (20 seconds)	55
Survey - Baseline	2000	1	.167(10 minutes)	334
Survey – Wave 2	2000	1	.167(10 minutes)	334
Survey – Wave 3	2000	1	.167(10 minutes)	334
Survey – Wave 4	2000	1	.167(10 minutes)	334
Survey – Wave 5	2000	1	.167(10 minutes)	334
Total				1725

9. Attach Questions

Please see attached files:

1. Hepatitis A and Frozen Berries Questionnaire 6-6-13

2. Hepatitis A and Frozen Berries Screener 6-6-13

REQUESTED APPROVAL DATE: 06/20/13

NAME OF PROGRAM CONTACT: Linda Verrill, Ph.D.

Linda.verrill@fda.hhs.gov

240-402-1765

FDA CENTER: CFSAN

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