
[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Notices]
[Pages 40760-40761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16384]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Health and Diet Survey, as Used by the Food and Drug 
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice invites comments on the Health and Diet Survey as 
used by FDA to gauge and to track consumer attitudes, awareness, 
knowledge, and behavior regarding various topics related to health, 
nutrition, physical activity, and product labeling.

DATES: Submit either electronic or written comments on the collection 
of information by September 12, 2014.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY 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, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
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.

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

[[Page 40761]]

in each iteration in response to emerging and current events or issues. 
In the next 3 years, we plan to field the survey 2 to 3 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.
    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     Total hours
                                  respondents     respondent       responses      per response
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Cognitive interview screener..             100               1             100  0.083 (5                       8
                                                                                 minutes).
Cognitive interview...........              18               1              18  1...............              18
Pretest screener..............           2,000               1           2,000  0.033 (2                      66
                                                                                 minutes).
Pretest.......................             200               1             200  0.25 (15                      50
                                                                                 minutes).
Survey screener...............          30,000               1          30,000  0.033 (2                     990
                                                                                 minutes).
Survey........................           3,000               1           3,000  0.25 (15                     750
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    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 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: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16384 Filed 7-11-14; 8:45 am]
BILLING CODE 4164-01-P


