2011-12557. 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: [phone], or e-mailed to [e-mail]. 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.

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

	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response (in hours) 2	Total hours
Individual indepth interviews	360	1	360	45/60	270
General public focus group interviews	144	1	144	1 30/60	216
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 interviews	144	1	144	1 30/60	216
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.

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.