[Federal Register Volume 75, Number 249 (Wednesday, December 29, 2010)]
[Notices]
[Pages 82030-82031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a generic clearance to collect information 
to support communications about nutrition and food products regulated 
by FDA. This data collection will gauge, informally, public opinion on 
a variety of subjects related to consumer, patient, or health care 
professional perceptions and use of nutrition and food products 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.

DATES: Submit either electronic or written comments on the collection 
of information by February 28, 2011.

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

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 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.

[[Page 82031]]

Data to Support Food and Nutrition Product Communications, as Used by 
the Food and Drug Administration--21 U.S.C. 393(d)(2)(D) (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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                             Annual
                                            Number of     frequency per   Total annual      Hours per     Total
                                           respondents      response        responses       response      hours
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Individual indepth interviews..........             360               1             360            0.75      270
General public focus group interviews..             144               1             144             1.5      216
Intercept interviews: central location.             600               1             600            0.25      150
Intercept interviews: telephone........      10,000 \2\               1          10,000            0.08      800
Self-administered surveys..............           2,400               1           2,400            0.25      600
Gatekeeper reviews.....................             400               1             400            0.50      200
Omnibus surveys........................           2,400               1           2,400            0.17      408
                                        ------------------------------------------------------------------------
    Total (general public).............          16,304  ..............          16,304  ..............    2,644
                                        ------------------------------------------------------------------------
    Total physician focus group                     144               1             144             1.5      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\ Brief interviews with callers to test messages, concepts and strategies following their call-in request to
  an FDA Center 1-800 number.

    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: December 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32739 Filed 12-28-10; 8:45 am]
BILLING CODE 4160-01-P