[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52053-52055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24409]


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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, 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 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.

[[Page 52054]]


DATES: Fax written comments on the collection of information by 
December 11, 2017.

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#b1ded8c3d0eec2c4d3dcd8c2c2d8dedff1dedcd39fd4dec19fd6dec7"><span class="__cf_email__" data-cfemail="c3acaab1a29cb0b6a1aeaab0b0aaacad83acaea1eda6acb3eda4acb5">[email protected]</span></a>. 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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
<a href="/cdn-cgi/l/email-protection#603032213314010606200604014e0808134e070f16"><span class="__cf_email__" data-cfemail="8ddddfccdef9ecebebcdebe9eca3e5e5fea3eae2fb">[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.

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

    We are seeking to renew OMB approval of 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. OMB approved this collection as a generic collection 
on December 5, 2014. The authority for FDA to collect the information 
derives from FDA's Commissioner of Food and Drugs authority provided in 
section 1003(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 this 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 18, 2017 (82 FR 32832), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received no comments.
    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...................             100               1             100  .08....................................               8
                                                                                                 (5 minutes)............................
Cognitive interview............................              18               1              18  1......................................              18
Pretest screener...............................           2,000               1           2,000  .033 (2 minutes).......................              66
Pretest........................................             200               1             200  .25 (15 minutes).......................              50
Survey screener................................          40,000               1          40,000  .033 (2 minutes).......................           1,320
Survey.........................................           4,000               1           4,000  .25 (15 minutes).......................           1,000
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................           2,462
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 and we estimate that the burden for this information collection 
has increased by 580 hours (from 1,882 to 2,462 hours) since the last 
OMB approval. The increase is due to an expected increase in the number 
of participants completing the survey screener (from 30,000 to 40,000 
participants) and number of participants taking the survey (from 3,000 
to 4,000). 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 (0.08 
hours) to complete the cognitive interview screener, for a total of 8 
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 40,000 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 1,320 hours. We estimate that 4,000 eligible adults will 
participate in the survey, each taking 15 minutes (0.25 hours), for a 
total of 1,000 hours. Thus, the total estimated burden is 2,462 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

[[Page 52055]]

Agency identify and respond to emerging issues in a more timely manner.

    Dated: November 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24409 Filed 11-8-17; 8:45 am]
 BILLING CODE 4164-01-P


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