Document ID: FDA-2010-N-0640-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data to Support Food and Nutrition Product Communications
Posted Date: 2011-05-23T04:00Z

[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29760-29762]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12557]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0640]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Data To Support Food 
and Nutrition Product Communications, 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 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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Data to Support Food and Nutrition Product Communications, as 
Used by the Food and Drug Administration.'' 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.

[[Page 29761]]

Data To Support Food and Nutrition Product Communications, as Used by 
the Food and Drug Administration--(OMB Control Number 0910-NEW)

    FDA plans to use the data collected under this generic clearance to 
inform its nutrition and foods communications campaigns. FDA expects 
the data to guide the formulation of its food and nutrition 
communication objectives. FDA also plans to use the data to help tailor 
print, broadcast, and use electronic media communications in order for 
them to have powerful and desired impacts on target audiences. The data 
will not be used for the purposes of making policy or regulatory 
decisions.
    The information collected will serve two major purposes. First, as 
formative research, it will provide the critical knowledge needed about 
target audiences. FDA must explore audiences' beliefs, perceptions, and 
decisionmaking processes about nutrition and food consumption in order 
to formulate the basic objectives of its risk communication campaigns. 
Such knowledge will provide the needed target audience understanding to 
design effective communication strategies, messages, and product 
labels. These communications will aim to improve public understanding 
of the risks and benefits of consuming certain foods or nutritional 
products by providing users with a better context in which to place 
risk information more completely.
    Second, as initial testing, it will give FDA some information about 
the potential effectiveness of messages and materials in reaching and 
successfully communicating with their intended audiences. Testing 
messages with a sample of the target audience will allow FDA to refine 
messages while still in the developmental stage. Respondents may be 
asked to give their reaction to the messages in individual or group 
settings.
    FDA's Center of Food Safety and Applied Nutrition, Office of the 
Commissioner, and other Centers or Offices will use this mechanism to 
test messages about regulated food and nutrition products on a variety 
of subjects related to consumer, patient, or health care professional 
perceptions and use of foods and related materials, including but not 
limited to, food advertising, food and nutrition labeling, emerging 
risk communications, online sales of food products, and consumer and 
professional education. The data will not be used for the purposes of 
making policy or regulatory decisions.
    In the Federal Register of December 29, 2010 (75 FR 82030), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment. It complimented 
the data collection tools that FDA proposed to use within this 
clearance and suggested use of newer technologies to improve data 
collection. It also noted that automated survey data collection (audio 
computer-assisted self interview, for example) does not reduce 
respondent burden, which FDA acknowledges. The other parts of the 
comment were beyond the scope of the questions asked in the 60-day 
Federal Register notice.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
                                    respondents    responses per     responses     response  (in    Total hours
                                                    respondent                      hours) \2\
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Individual indepth interviews...             360               1             360           45/60             270
General public focus group                   144               1             144         1 30/60             216
 interviews.....................
Intercept interviews:
    Central location............             600               1             600           15/60             150
Intercept interviews:
    Telephone...................      10,000 \3\               1          10,000            5/60             800
Self-Administered surveys.......           2,400               1           2,400           15/60             600
Gatekeeper reviews..............             400               1             400           30/60             200
Omnibus surveys.................           2,400               1           2,400           10/60             408
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    Total (General public)......          16,304  ..............          16,304  ..............           2,644
                                 ===============================================================================
Total Physician focus group                  144               1             144         1 30/60             216
 interviews.....................
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    Total (Overall).............  ..............  ..............  ..............  ..............           2,860
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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 format ``[number of
  minutes per response]/60''.
\3\ Brief interviews with callers to test messages, concepts, and strategies following their call-in request to
  an FDA Center 1-800 number.

[[Page 29762]]

    Annually, FDA projects about 30 communication studies using the 
variety of test methods listed in table 1. FDA is requesting this 
burden so as not to restrict the Agency's ability to gather information 
on public sentiment for its proposals in its regulatory and 
communications programs.

    Dated: May 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12557 Filed 5-20-11; 8:45 am]
BILLING CODE 4160-01-P