Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on “Real Time” surveys of consumers' knowledge, perceptions, and beliefs concerning foodborne illness outbreaks or food recalls.
Submit written or electronic comments on the collection of information by January 19, 2010.
Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Denver Presley Jr., Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3793.End Further Info End Preamble Start Supplemental Information
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
“Real Time” Surveys of Consumers' Knowledge, Perceptions, and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls—Federal Food, Drug, and Cosmetic Act/Section 903(d)(2)(C)—(OMB Control Number 0910-NEW)
FDA communicates with consumers about food recalls directly, on its own Web site, and through various mass media channels, such as television and newspapers, during a foodborne illness outbreak or food recall. In these communications, FDA typically identifies the implicated food, the symptoms of the foodborne illness at issue, any subpopulations at elevated risk of infection or illness, and protective measures individuals can or should take. The purpose of these communications is to provide consumers with information so they can protect themselves from potential health risks associated with an outbreak or food recall. Consumers also get information about an outbreak or recall from other sources, including other federal and state agencies, industry, consumer groups, and the mass media, Start Printed Page 59559which may or may not relay FDA's public announcements.
Existing data show that many consumers do not take appropriate protective actions during a foodborne illness outbreak or food recall (Refs. 1 and 2). For example, 41 percent of U.S. consumers say they have never looked for any recalled product in their home (Ref. 2). Conversely, some consumers overreact to the announcement of a foodborne illness outbreak or food recall. In response to the 2006 fresh, bagged spinach recall which followed a multistate outbreak of E coli 0157: H7 infections (Ref. 3), 18 percent of consumers said they stopped buying other bagged, fresh produce because of the spinach recall (Ref. 1). Existing research also suggests that many consumers may not have correct knowledge about products subject to a given recall. For example, in a survey conducted 2 months after the onset of the 2006 spinach recall, one third of respondents did not know that, in addition to bagged spinach, fresh loose spinach was part of the recall, while 22 percent believed that frozen spinach was subject to the recall (it was not) (Refs. 1 and 3). In order for FDA to protect the public health during foodborne illness outbreaks or food recalls, the agency needs timely information collected from consumers as the events unfold to ensure that consumers understand the extent of the incident and that they are taking appropriate actions. Results from the information collection will indicate to FDA whether the agency should adjust its communications to help consumers react appropriately.
FDA conducts research and educational and public information programs relating to food safety under to its broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393 (b)(2), to protect the public health by ensuring that foods are “safe, wholesome, sanitary, and properly labeled,” and in section 903(d)(2)(C), to conduct research relating to foods, drugs, cosmetics and devices in carrying out the act.
FDA plans to survey U.S. consumers using a web-based panel of U.S. households to collect information on consumers' “real time” knowledge, perceptions, beliefs, and self-reported behaviors for up to five foodborne illness outbreaks or food recalls a year. Moreover, because the information environment during certain foodborne illness outbreaks or food recalls evolves as new information emerges, the agency plans to field up to three waves of independent surveys per event (i.e., outbreak or recall). The surveys will query consumers on topics such as: (1) The products that are subject to the outbreak or recall; (2) the implicated pathogens; (3) the food vehicle of the outbreak or recall; and (4) how consumers can protect themselves. FDA plans to conduct the surveys soon after the onset of an outbreak or recall and whenever the agency suspects that: (1) Messages are not reaching consumers; and/or (2) consumers do not understand the messages; and/or (3) consumers are not taking appropriate actions in response to the messaging. Collecting information quickly during a foodborne illness outbreak or food recall is important because erroneous perceptions or misinterpreted information about an outbreak or recall can impede consumer adoption of recommended protective behaviors. Criteria for selecting a particular foodborne illness outbreak or food recall for a survey will include a qualitative assessment of the salience of some or all of the following: the geographical dispersion of the event, the number of illnesses or deaths associated with it, the relative familiarity of the food product, the complexity of consumer precaution instructions, and the presence of national media focus.
The agency will use the survey results to help adjust its communication strategies and messages for foodborne illness outbreaks or food recalls, when needed. The results will not be used to develop population estimates.
FDA estimates the burden of this collection of information as follows:
|Portion of Study||No. of Respondents||Annual Frequency per Response||Total Annual Responses||Hours per Response||Total Hours|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
Approximately 30,000 respondents of a web-based consumer panel will be screened, (3 waves (independent surveys) for each of 5 incidents; 2,000 respondents per wave). We estimate that it will take a respondent 20 seconds (0.0055 hours) to complete the screening questions, for a total of 165 hours. We will conduct a pretest of the first survey with 40 respondents; we estimate that it will take a respondent 10 minutes (0.167 hours) to complete the pretest, for a total of 7 hours. Fifteen thousand (15,000) respondents will complete the surveys (3 waves (independent surveys) for each of 5 incidents; 1,000 respondents per wave). We estimate that it will take a respondent 10 minutes (0.167 hours) to complete the survey, for a total of 2,505 hours. Thus, the total estimated annual reporting burden is 2,677 hours. FDA's burden estimate is based on prior experience with consumer surveys that are similar to these.
The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Cuite, C., S. Condry, M. Nucci, and W. Hallman, “Public Response to the Contaminated Spinach Recall of 2006,”Publication number RR-0107-013, New Brunswick, New Jersey: Rutgers, the State University of New Jersey, Food Policy Institute, 2007.
2. Hallman, W., C. Cuite, and N. Hooker, “Consumer Responses to Food Recalls: 2009 National Survey Report,” Publication number RR-0109-018, New Brunswick, New Jersey: Rutgers, the State University of New Jersey, Food Policy Institute, 2009.
3. Acheson, D., “Outbreak of Escherichia coli 0157 Infections Associated With Fresh Spinach—United States, August-September 2006,” 2007, (http://first.fda.gov/cafdas/documents/Acheson_Spinach_Outbreak_2006_FDA_pres.ppt).Start Signature
Dated: November 12, 2009.
Assistant Commissioner for Policy.
[FR Doc. E9-27659 Filed 11-17-09; 8:45 am]
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