[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
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Total (general public)............. 16,304 .............. 16,304 .............. 2,644
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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]
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