[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29760-29762]
From the Federal Register Online via the Government Publishing 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 [email protected]. 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
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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