[Federal Register Volume 83, Number 157 (Tuesday, August 14, 2018)]
[Notices]
[Pages 40293-40294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17363]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2701]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration Food Safety, Health, and Diet Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, 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 
September 13, 2018.

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#c9a6a0bba896babcaba4a0babaa0a6a789a6a4abe7aca6b9e7aea6bf"><span class="__cf_email__" data-cfemail="e986809b88b69a9c8b84809a9a808687a986848bc78c8699c78e869f">[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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
<a href="/cdn-cgi/l/email-protection#79292b382a0d181f1f391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="217173607255404747614745400f4949520f464e57">[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, Health, and Diet Survey

OMB Control Number 0910-0345--Reinstatement

    This information collection supports the above captioned FDA 
survey. Under section 1003(b)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 393(b)(2)), FDA is 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. Accordingly, we are proposing a survey to measure consumers' 
knowledge, attitudes, beliefs, and reported behavior about food safety 
and various topics related to health, nutrition, and physical activity. 
Survey questions covering hand washing, using food thermometers, 
cleaning cutting boards, and properly storing food support ``Healthy 
People 2030'' objectives relating to consumer food safety and help 
evaluate and develop strategies and programs to encourage consumers to 
adopt healthy lifestyles.
    Since late 1990, we have deployed two separate surveys to address 
these topics: The ``Food Safety Survey,'' approved under OMB control 
no. 0910-0345; and the ``Health and Diet Survey,'' approved under OMB 
control no. 0910-0545. The surveys have provided data used in support 
of Nutritional Facts labeling and have helped inform the focus and 
scope of food safety educational campaigns. Because there are many 
related topic areas included in the two surveys, we have decided to 
combine them. The newly proposed ``FDA Food Safety, Health, and Diet 
Survey'' will contain many of the same questions and topics as the 
previous surveys, measuring trends in food safety, diet knowledge, 
attitudes, and behaviors over time. The survey will focus on three 
major themes: Eat, Shop, and Prepare. These themes and survey questions 
were selected to gather information from consumers that will help FDA 
monitor and evaluate its programs and policies relating to menu 
labeling, use of the Nutrition Facts label, and food safety education 
activities.
    The theme ``Eat'' will include questions related to eating at 
restaurants, including the frequency of eating at restaurants, 
awareness of menu labeling, and use of restaurant health inspection 
scores. It will also include questions about consumers' overall dietary 
patterns, consumption of potentially risky foods, and perceptions of 
food safety risks. The theme ``Shop'' will include questions about use 
of the Nutrition Facts label, claims made on the front of food 
packages, and perceptions related to organic and genetically engineered 
foods. Finally, the theme ``Prepare'' will include questions about food 
handling practices related to cleaning hands and surfaces, separating 
raw meat from ready-to-eat foods, using food thermometers, preparing 
ready- and non-ready-to-eat foods, and properly chilling foods.
    The survey will be administered using two sampling and 
administrative methodologies: A random-digit-dial telephone survey of 
both landline and cell phones, and an addressed-based, mail push-to-web 
survey. Previously, for both the ``Health and Diet Survey'' and

[[Page 40294]]

the ``Food Safety Survey,'' only random digit dialing sampling 
techniques and telephone interviewing were used. By using both phone 
and address-based survey methods we will be able to explore the effects 
of survey mode and sampling frames on question responses with the goal 
of potentially transitioning the survey entirely to an address-based, 
mail push-to-web survey. A nationally representative sample of 2,000 
adults will be selected at random to complete the telephone survey. The 
addressed-based survey will seek 4,000 respondents. Additionally, 
methods will be employed to see if response bias is a problem in the 
survey. As noted above, participation in the survey will be voluntary. 
Cognitive interviews and a pretest will be conducted prior to fielding 
the survey.
    In the Federal Register of July 3, 2017 (82 FR 30871), we published 
a 60-day notice requesting public comment on the proposed collection of 
information for OMB control no. 0910-0345, ``Food Safety Survey.'' Two 
comments were received. One discussed the importance of food safety, 
and the other comment was unrelated to the information collection.
    In the Federal Register of July 18, 2017 (82 FR 32832), we 
published a 60-day notice requesting public comment on the proposed 
collection of information for OMB control no. 0910-0545, ``Health and 
Diet Survey.'' No comments were received. Because we are proposing to 
combine the surveys, we are consolidating the burden under OMB control 
no. 0910-0345 and discontinuing OMB control no. 0910-0545.
    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     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener                75               1              75  0.083 (5                       6
 (phone survey).                                                                 minutes).
Cognitive interview screener                75               1              75  0.083 (5                       6
 (mail survey).                                                                  minutes).
Cognitive interview (phone                   9               1               9  1...............               9
 survey).
Cognitive interview (mail                    9               1               9  1...............               9
 survey).
Pre-test screener (phone                   100               1             100  0.0167 (1                      2
 survey).                                                                        minute).
Pre-test screener (mail                    100               1             100  0.0167 (1                      2
 survey).                                                                        minute).
Pretest (phone survey)........              40               1              40  0.25 (15                      10
                                                                                 minutes).
Pretest (mail survey).........              25               1              25  0.33 (20                       9
                                                                                 minutes).
Survey screener (phone survey)          20,000               1          20,000  0.0167 (1                    334
                                                                                 minute).
Survey screener (mail survey).          40,000               1          40,000  0.0167 (1                    668
                                                                                 minute).
Phone survey..................           2,000               1           2,000  0.25 (15                     500
                                                                                 minutes).
Mail survey...................           4,000               1           4,000  0.33 (20                   1,320
                                                                                 minutes).
Non-Response phone survey                  200               1             200  0.0167 (1                      3
 screener.                                                                       minute).
Non-Response mail survey                   200               1             200  0.0167 (1                      3
 screener.                                                                       minute).
Non-Response phone survey.....             100               1             100  0.167 (10                     16
                                                                                 minutes).
Non-Response mail survey......             100               1             100  0.167 (10                     16
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           2,913
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We will use a cognitive interview screener with 75 individuals for 
each of the phone and mail surveys to recruit prospective interview 
participants for a total of 150 individuals. We estimate that it will 
take a screener respondent approximately 5 minutes (0.08 hour) to 
complete the cognitive interview screener, for a total of 12 hours for 
both surveys. We will conduct cognitive interviews with 18 
participants, 9 for each survey. We estimate that it will take a 
participant approximately 1 hour to complete the interview, for a total 
of 18 hours. Prior to the administration of the surveys, the Agency 
plans to conduct a pretest to identify and resolve potential survey 
administration problems.
    We will use a pre-test screener with 175 individuals total; we 
estimate that it will take a respondent approximately 1 minute (0.0167 
hour) to complete the pre-test screener, for a total of 4 hours. The 
pretest will be conducted with 65 total participants (40 phone and 25 
mail); we estimate that it will take a participant 15 minutes (0.25 
hour) to complete the phone pretest and 20 minutes (0.33 hour) for the 
mail pretest for a total of 19 hours.
    We will use a survey screener to select an eligible adult 
respondent in each household to participate in the survey. A total of 
60,000 individuals in the 50 states and the District of Columbia will 
be screened by telephone or mail. We estimate that it will take a 
respondent 1 minute (0.0167 hour) to complete the screening, for a 
total of 1,002 hours for both phone and mail surveys. We estimate that 
2,000 eligible adults will participant in the phone survey and 4,000 
eligible adults will participate in the mail survey, the phone survey 
taking 15 minutes (0.25 hour) and the mail survey taking 20 minutes 
(0.33 hour), for a total of 1,820 hours.
    We will use a non-response survey screener to select an eligible 
adult respondent in each household to participate in a non-response 
survey. A total of 400 participants in the 50 states and the District 
of Columbia will be screened by telephone or mail. We estimate that it 
will take a respondent 1 minute (0.0167 hour) to complete the 
screening, for a total of 6 hours for both the phone and mail surveys. 
We estimate that 200 respondents total, 100 for the phone survey and 
100 for the mail survey, will complete the non-response survey taking 
10 minutes (0.167 hour) for a total of 32 hours. Thus, the total 
estimated burden is 2,913 hours.

    Dated: August 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17363 Filed 8-13-18; 8:45 am]
 BILLING CODE 4164-01-P


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