[Federal Register Volume 79, Number 175 (Wednesday, September 10, 2014)]
[Notices]
[Pages 53711-53712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-21532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0920]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 October 
10, 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 [email protected]. 
All comments should be identified with the OMB control number 0910-
0545. 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, [email protected].

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.

Health and Diet Survey as Used by the Food and Drug Administration--
(OMB Control Number 0910-0545)--(Revision)

    We are seeking OMB approval to revise the Health and Diet Survey, 
which is a voluntary consumer survey intended to gauge and to track 
consumer attitudes, awareness, knowledge, and behavior regarding 
various topics related to health, nutrition, physical activity, and 
product labeling. Currently this collection is approved as a 
traditional collection; however, the Agency wishes to employ future 
collections under the generic collection process. The authority for FDA 
to collect the information derives from FDA's Commissioner of Food and 
Drugs authority provided in section 903(d)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).
    We will use the Health and Diet Survey findings to test and refine 
our ideas, but will generally conduct further research before making 
important decisions such as adopting new policies and allocating or 
redirecting significant resources to support these policies.
    This survey has been repeated approximately every 3 to 5 years over 
the course of the past 3 decades for the purpose of tracking changes 
and trends in public opinions and consumer behavior, with some new 
questions added or omitted or partially modified in each iteration in 
response to emerging and current events or issues. In the next 3 years, 
we plan to field the survey two to three times. We will use the 
information from the Health and Diet Survey to evaluate and develop 
strategies and programs to encourage and help consumers adopt healthy 
diets and lifestyles. The information will also help FDA evaluate and 
track consumer awareness and behavior as outcome measures of their 
achievement in improving public health.
    Description of Respondents: The respondents are adults, age 18 and 
older, drawn from the 50 States and the District of Columbia. 
Participation will be voluntary.
    In the Federal Register of July 14, 2014 (79 FR 40760), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                Number of
                  Activity                      Number of     responses per   Total annual           Average burden per response            Total hours
                                               respondents     respondent       responses
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Cognitive interview screener...............             100               1             100  0.083 (5 minutes)..........................               8
Cognitive interview........................              18               1              18  1..........................................              18
Pretest screener...........................           2,000               1           2,000  0.033 (2 minutes)..........................              66
Pretest....................................             200               1             200  0.25 (15 minutes)..........................              50
Survey screener............................          30,000               1          30,000  0.033 (2 minutes)..........................             990
Survey.....................................           3,000               1           3,000  0.25 (15 minutes)..........................             750
                                            =================
    Total..................................  ..............  ..............  ..............  ...........................................           1,882
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\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 Health and Diet 
Surveys. We will use a cognitive interview screener with 100 
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 8 
hours, rounded down from 8.3 hours. We will conduct cognitive 
interviews with 18 participants. We estimate that it will take a 
participant approximately 1 hour

[[Page 53712]]

to complete the interview, for a total of 18 hours. Prior to the 
administration of the Health and Diet Survey, the Agency plans to 
conduct a pretest to identify and resolve potential survey 
administration problems. We will use a pretest screener with 2,000 
individuals; we estimate that it will take a respondent approximately 2 
minutes (0.033 hours) to complete the pretest screener, for a total of 
66 hours. The pretest will be conducted with 200 participants; we 
estimate that it will take a participant 15 minutes (0.25 hours) to 
complete the pretest, for a total of 50 hours. We will use a survey 
screener to select an eligible adult respondent in each household 
reached by landline telephone numbers to participate in the survey. A 
total of 30,000 individuals in the 50 states and the District of 
Columbia will be screened by telephone. We estimate that it will take a 
respondent 2 minutes (0.033 hours) to complete the screening, for a 
total of 990 hours. We estimate that 3,000 eligible adults will 
participate in the survey, each taking 15 minutes (0.25 hours), for a 
total of 750 hours. Thus, the total estimated burden is 1,882 hours.
    We are requesting this burden for unplanned surveys so as not to 
restrict our ability to gather information on consumer attitudes, 
awareness, knowledge, and behavior regarding various topics related to 
health, nutrition, physical activity, and product labeling. This 
ability will help the Agency identify and respond to emerging issues in 
a more timely manner.

    Dated: September 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21532 Filed 9-9-14; 8:45 am]
BILLING CODE 4164-01-P