[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65406-65408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26144]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1161]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Safety Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 4, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#d2bdbba0b38da1a7b0bfbba1a1bbbdbc92bdbfb0fcb7bda2fcb5bda4"><span class="__cf_email__" data-cfemail="620d0b10033d1117000f0b11110b0d0c220d0f004c070d124c050d14">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0345. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Road, COLE-14526, Silver 
Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#b0e0e2f1e3c4d1d6d6f0d6d4d19ed8d8c39ed7dfc6"><span class="__cf_email__" data-cfemail="154547544661747373557371743b7d7d663b727a63">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food Safety Survey--(OMB Control Number 0910-0345)--Reinstatement

I. Background

    Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 393(b)(2)), we are authorized to conduct research relating 
to foods and to conduct educational and public information programs 
relating to the safety of the nation's food supply. The Food Safety 
Survey measures consumers' knowledge, attitudes, and beliefs about food 
safety. Previous versions of the survey were collected in 1988, 1993, 
1998, 2001, 2006, and 2010. Data from the previous Food Safety Surveys 
and from this proposed survey will be used to evaluate two Healthy 
People 2020 objectives: (1) Increase the proportion of consumers who 
follow key food safety practices (Objective FS-5) and (2) reduce severe 
allergic reactions to food among adults with a food allergy diagnosis 
(Objective FS-4) (Ref. 1). Data from this survey will also be used to 
measure progress toward the United States Department of Agriculture's 
Food Safety Inspection Service's Fiscal Year 2011-Fiscal Year 2016 
Strategic Plan goal of ensuring that, ``Consumers, including vulnerable 
and underserved populations, adopt food safety best practices'' (Ref. 
2). Additionally, Food Safety Survey data are used to measure trends in 
consumer food safety habits including hand and cutting board washing, 
cooking practices, and use of food thermometers. Finally, data are used 
to evaluate educational messages and to inform policymakers about 
consumer attitudes about technologies such as food irradiation and 
biotechnology.
    The proposed Food Safety Survey will contain many of the same 
questions and topics as previous Food Safety Surveys to facilitate 
measuring trends in food safety knowledge, attitudes, and behaviors 
over time. The proposed survey will also be updated to explore emerging 
consumer food safety topics and expand understanding of previously 
asked topics. For example, recent papers in both the United States 
(Ref. 3) and Europe (Refs. 4 and 5) have pointed to changing 
epidemiology of listeriosis where adults over 60 years old have the 
highest rates of the illness. One reason for the increase in 
listeriosis rates among those over 60 years old could be increasing 
host susceptibility due to widened use of immunocompromising 
medications. We plan to include questions on the proposed survey to 
document the proportion of those over 60 years old who self-report 
taking a defined list of major immunocompromising medications. In 
conjunction with our established questions about safe food handling and 
eating potentially risky foods, the additional questions will expand 
our understanding of listeriosis among those over 60. Other new topics 
planned to be covered on the survey include: Consumer understanding of 
mechanically tenderized beef, awareness of foodborne pathogens such as 
Toxoplasma gondii, and awareness of the risks associated with eating 
raw sprouts.
    The methods for the proposed Food Safety Survey will be largely the 
same as those used with the previous Food Safety Surveys. One major 
difference is that, unlike the data collection mode for previous Food 
Safety Surveys that used only land telephone lines, the proposed survey 
will include cell phones in addition to landlines. A nationally 
representative sample of 4,000 adults

[[Page 65407]]

(2,400 landline and 1,600 cell phone) will be selected at random for 
the telephone interviews. The survey will also include an oversample of 
Hispanics and Blacks to ensure a minimum of 400 each. Additionally, 50 
non-respondents will be asked to participate in a short version of the 
survey from which we will conduct a non-response analysis. 
Participation in the survey will be voluntary. Cognitive interviews and 
a pre-test will be conducted prior to fielding the survey.
    In the Federal Register of November 1, 2013 (78 FR 65661), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received two letters in response to the 
notice, each containing one comment. The comments, and our responses, 
are discussed in the following paragraphs. For ease of reading, we 
preface each comment with a numbered ``Comment''; and each response by 
a corresponding numbered ``Response.'' We have numbered each comment to 
help distinguish between different topics. The number assigned to each 
comment is for organizational purposes only and does not signify the 
comment's value, or importance, or the order in which it was received.
    (Comment 1) One comment asked if a sample size of 4,000 was 
sufficient for this study, and suggested that FDA work with the Centers 
for Disease Control (CDC) on questions related to Toxoplasma gondii.
    (Response 1) We believe that a sample size of 4,000 adults is 
sufficient for this study since this study evaluates consumer 
knowledge, attitudes, and perceptions related to food safety. It is not 
a clinical study looking at the effects of Toxoplasma gondii in the 
U.S. population. We consult with our Federal partners, including the 
CDC and the U.S. Department of Agriculture to make sure this survey 
meets their needs.
    (Comment 2) One comment suggested that we add questions to the 
survey about preparing offals at home, washing raw poultry and meat, 
and cooking turkeys in the oven overnight.
    (Response 2) We agree that these are interesting additional topics 
and have added questions about washing raw poultry and cooking turkeys 
to the survey. Due to space constraints, we are unable to add questions 
about preparing offals at home to the survey questionnaire. This topic 
will be considered for future research.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual          Average  burden per  response          Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive interview screener................              75               1              75  0.083 (5 minutes).........................               6
Cognitive interview.........................               9               1               9  1.........................................               9
Pretest screener............................              45               1              45  0.0167 (1 minute).........................               1
Pretest.....................................              18               1              18  0.33 (20 minutes).........................               6
Survey screener.............................          10,000               1          10,000  0.0167 (1 minute).........................             167
Survey......................................           4,000               1           4,000  0.33 (20 minutes).........................           1,320
Non-response survey screener................             125               1             125  0.0167 (1 minute).........................               2
Non-response survey.........................              50               1              50  0.167 (10 minutes)........................               8
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           1,519
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimate of the number of respondents and the average 
burden per response on our experience with previous Food Safety 
Surveys. We will use a cognitive interview screener with 75 individuals 
to recruit prospective interview participants. We estimate that it will 
take a screener respondent approximately 5 minutes (0.083 hours) to 
complete the cognitive interview screener, for a total of 6 hours, 
rounded down from 6.225 hours. We will conduct cognitive interviews 
with nine participants. We estimate that it will take a participant 
approximately 1 hour to complete the interview, for a total of 9 hours. 
Prior to the administration of the Food Safety Survey, we plan to 
conduct a pretest to identify and resolve potential survey 
administration problems. We will use a pretest screener with 45 
individuals; we estimate that it will take a respondent approximately 1 
minute (0.0167 hours) to complete the pretest screener, for a total of 
1 hour, rounded up from 0.7515 hours. The pretest will be conducted 
with 18 participants; we estimate that it will take a participant 20 
minutes (0.33 hours) to complete the pretest, for a total of 6 hours, 
rounded up from 5.94 hours. We will use a survey screener to select an 
eligible adult respondent in each household reached by landline and 
cell phone telephone numbers to participate in the survey. A total of 
10,000 individuals in the 50 states and the District of Columbia will 
be screened by telephone. We estimate that it will take a respondent 1 
minute (0.0167 hours) to complete the screening, for a total of 167 
hours. We estimate that 4,000 eligible adults will participate in the 
survey, each taking 20 minutes (0.33 hours), for a total of 1,320 
hours. Additionally, we will administer a non-response survey using a 
short version of the survey from which we will conduct a non-response 
analysis. We will use a non-response survey screener with 125 
individuals; we estimate that it will take a respondent approximately 1 
minute (0.0167 hours) to complete the non-response survey screener, for 
a total of 2 hours, rounded down from 2.0875 hours. The non-response 
survey will be conducted with 50 participants; we estimate that it will 
take a participant 10 minutes (0.167 hours) to complete the non-
response survey, for a total of 8 hours, rounded down from 8.35 hours. 
This is a correction to our previous estimate of 5 hours to complete 
the non-response survey. Thus, the total estimated burden is 1,519 
hours, which incorporates the correction of the estimate to complete 
the non-response survey.

II. References

1. U.S. Department of Health and Human Services, ``Healthy People 
2020--Improving the Lives of Americans,'' July 30, 2013. Available 
at http://www.healthypeople.gov/2020/default.aspx.
2. U.S. Department of Agriculture, Food Safety Inspection Service, 
``Strategic Plan FY 2011-2016,'' April 6, 2012. Available at http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/strategic-planning/fy-2011-2016-strategic-plan/ct_index.
3. Pouillot, R., K. Hoelzer, K. A. Jackson, et al. ``Relative Risk 
of Listeriosis in Foodborne Diseases Active Surveillance

[[Page 65408]]

Network (FoodNet) Sites According to Age, Pregnancy, and 
Ethnicity,'' Clinical Infectious Diseases, 54(S5): S401-410, 2012.
4. Goulet, V., C. Hedberg, A. Le Monnier, et al. ``Increasing 
Incidence of Listeriosis in France and other European Countries,'' 
Emerging Infectious Diseases, 14(5): 734-740, 2008.
5. Mu[ntilde]oz, P., L. Rojas, E. Bunsow, et al. ``Listeriosis: An 
Emerging Public Health Problem Especially Among the Elderly,'' 
Journal of Infection, 64: 19-33, 2012.

    Dated: October 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26144 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>