Agency Information Collection Activities; Proposals, Submissions, and Approvals:
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
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.
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\
Average
Number of
Number of
Total annual
burden per respondents responses per
responses
response (in
Total hours respondent
hours) \2\
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
Total (General public)......
16,304 ..............
16,304 ..............
2,644
Total Physician focus group
144
1
144
1 30/60
216 interviews.....................
Total (Overall)............. .............. .............. .............. ..............
2,860
\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
