[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29757-29758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0001]


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 June 
22, 2011.

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 e-mailed 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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--(OMB Control Number 0910-0545)--Extension

    FDA is seeking extension of OMB approval for the Health and Diet 
Survey, which is a voluntary consumer survey intended to gauge and 
track consumer attitudes, awareness, knowledge, and behavior regarding 
various topics related to health, nutrition, and physical activity. 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)).
    The survey consists of two independent data collection activities. 
One collection, entitled ``Health and Diet Survey--General Topics,'' 
tracks a broad range of consumer attitudes, awareness, knowledge, and 
self-reported behaviors related to key diet and health issues. The 
other collection, entitled ``Health and Diet Survey--Dietary Guidelines 
Supplement,'' will provide FDA with updated information about consumer 
attitudes, awareness, knowledge, and behavior regarding various 
elements of nutrition and physical activity based on the key 
recommendations of the Dietary Guidelines for Americans, which are 
jointly issued by the Department of Health and Human Services and the 
U.S. Department of Agriculture every 5 years.
    The information to be collected with the Health and Diet Survey--
General Topics will include: (1) Awareness of diet-disease 
relationships, (2) food and dietary supplement label use, (3) dietary 
practices including strategies to lose or maintain weight, and (4) 
awareness and knowledge of dietary fats. This survey has been repeated 
approximately every 3 years over the course of the past several years 
for the purpose of tracking changes and trends in public opinions and 
consumer behavior, with some new questions added or omitted or 
partially modified each iteration in response to current events. In the 
next 3 years, FDA plans to field the Health and Diet Survey--General 
Topics in 2012 and anticipates that it might have the need for 
additional iterations in 2014. The information to be collected with the 
Health and Diet Survey--Dietary Guidelines Supplement will include: (1) 
Awareness and sources of information, (2) attitudes toward diet and 
physical activity, and (3) practice and knowledge related to 
recommended behaviors. The survey will also ask about perceptions and 
use of Federal nutrition information, special diet, weight status, 
health status, and demographics. In the next 3 years, FDA anticipates 
to field the Health and Diet Survey--Dietary Guidelines Supplement in 
2011-2012.
    FDA and other Federal Agencies will use the information from the 
Health and Diet Survey to evaluate and develop strategies and programs 
to encourage

[[Page 29758]]

and help consumers adopt healthy lifestyles. The information will also 
help FDA and other Federal Agencies 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 bases its estimate of the number of respondents and the hours 
per response on its experience with previous Health and Diet Surveys. 
Prior to the administration of the Health and Diet Survey--General 
Topics, the Agency plans to conduct a pretest to identify and resolve 
potential problems. The pretest will be conducted with 27 participants; 
we estimate that it will take a respondent 15 minutes (0.25 hours) to 
complete the pretest, for a total of 6.75 hours, rounded to 7. The 
Agency will use a screener to select an eligible adult respondent in 
each household to participate in the survey. For the Health and Diet 
Survey--General Topics data collection activity, a total of 10,000 
individuals in the 50 States and the District of Columbia will be 
screened by telephone. We estimate that it will take a respondent 1 
minute (0.02 hours) to complete the screening, for a total of 200 
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. 
For the Health and Diet Survey--Dietary Guidelines Supplement data 
collection activity, 4,000 individuals in the 50 States and the 
District of Columbia will be screened by telephone. We estimate that it 
will take a respondent 1 minute (0.02 hours) to complete the screening 
questions, for a total of 80 hours. Of these respondents, 1,200 will 
complete the survey. We estimate that it will take a respondent 13 
minutes (0.22 hours) to complete the entire survey, for a total of 264 
hours. Thus, the total estimated burden is 1,301 hours.
    In the Federal Register of January 7, 2011 (76 FR 1168), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments in response to the 
30-day notice. The letters contained comments outside the scope of the 
four collection of information topics on which the notice solicits 
comments and, thus, will not be addressed here.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of                       Average burden
                              Activity                                  Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses      (in hours) \2\
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General Topics: Pretest............................................               27                1               27            15/60                7
General Topics: Screener...........................................           10,000                1           10,000             1/60              200
General Topics: Survey.............................................            3,000                1            3,000            15/60              750
Dietary Guidelines Supplement: Screener............................            4,000                1            4,000             1/60               80
Dietary Guidelines Supplement: Survey..............................            1,200                1            1,200            13/60              264
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    Total..........................................................  ...............  ...............  ...............  ...............            1,301
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the form ``[number of minutes per response]/60''.


    Dated: May 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12554 Filed 5-20-11; 8:45 am]
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