[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32832-32834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15001]


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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 solicits comments on the Health and Diet Survey as used by FDA 
to gauge and to track consumer attitudes, awareness, knowledge, and 
behavior

[[Page 32833]]

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 18, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of September 18, 2017. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-0920 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Health and Diet Survey, as Used 
by the Food and Drug Administration.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites 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--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

[[Page 32834]]

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.
    FDA estimates 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  0.08 (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.............................          40,000               1          40,000  0.033 (2 minutes).........................           1,320
Survey......................................           4,000               1           4,000  0.25 (15 minutes).........................           1,000
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................           2,462
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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 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 Agency identify and respond to emerging issues in 
a more timely manner.

    Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15001 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P