Daily Rules, Proposed Rules, and Notices of the Federal Government


Food and Drug Administration

[Docket No. FDA-2008-N-0286]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT

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 April 29, 2009.
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: 202-395-6974, or e-mailed All comments should be identified with the OMB control number 0910-NEW and title "Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT." Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT

In July 2006, FDA announced its Food Defense Awareness Initiative, called ALERT (the letters stand for the five key components of the initiative: assure, look, employees, report, and threat). The ALERT initiative is intended to raise the awareness of State and local government agencies and the food industry regarding food defense issues. ALERT identifies five key points that industry and businesses can use to decrease the risk of intentional food contamination at their facility. The ALERT Web-based training module and more information on ALERT are available˜dms/defterr.html.

Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(b)(2)), FDA is authorized to conduct research relating to foods and to conduct educational and public information programs relating to the safety of the nation's food supply. Under this authority, FDA is planning to conduct a survey of first line supervisors working in a range of capacities in the food industry about their awareness and perceptions of the agency's ALERT initiative and the ALERT initiative informational materials. The purpose of the survey is to help FDA evaluate ALERT informational materials and to gauge whether the materials succeed in informing food industry supervisory employees about the risk of intentional food contamination and in motivating them to engage in protective behaviors. The survey results will be used to assess how knowledge and awareness, threat perceptions, attitudes, norms, benefits and barriers affect the implementation of the ALERT initiative.

The data will be collected using a Web-based questionnaire. The survey will employ a stratified sampling design. Using industry networks and listings, we will randomly sample from databases of seven industry groups (growers, packers, processors, warehouses, transporters, retailers, and food service operators). We will stratify within groups by organization size (small, medium, and large) based on number of employees on the payroll, for a total random sample of 2,500 organizations. Participation in the survey is voluntary. Cognitive interviews and a pre-test will be conducted prior to fielding the survey.

In theFederal Registerof May 22, 2008 (73 FR 29759), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden 1 Activity No. of
  • Respondents
  • Annual Frequency
  • per Response
  • Total Annual
  • Responses
  • Hours per
  • Response
  • Total Hours
    Cognitive Interviews 7 1 7 1 7 Telephone Interview - Pre-test Invitation 28 1 28 0.10 3 Completed Pre-test 14 1 14 0.25 4 Telephone Interview - Survey Invitation 5,000 1 5,000 0.10 500 Completed Survey 2,500 1 2,500 0.25 625 Total 1,139 1There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the 60-day notice published on May 22, 2008, FDA estimated the total burden hours to be 94 hours. FDA has made several changes to its burden estimate, reflected in table 1 of this document. The agency reduced the number of cognitive interviews from 10 to 7, added hours for 28 telephone pre-test invitations, increased the number of pre-tests from 10 to 14, added 5,000 survey invitations, and increased the number of completed surveys from 200 to 2,500. The total burden hours are estimated to be 1,138.3 (rounded to 1,139).

    Cognitive interviews will be conducted with seven participants. We estimate that the cognitive interviews will take 60 minutes (1 hour) to complete for a total of 7 hours. An invitation to take a pre-test will be extended to 28 food-defense decision-makers; we estimate that it will take respondents 6 minutes (0.10 hours) to respond to the invitation and make arrangements to complete the pretest, for a total of 2.8 hours (rounded to 3). Fourteen respondents will complete the pre-test; we estimate that it will take respondents 15 minutes (0.25 hour) to complete the pretest for a total of 3.5 hours (rounded to 4). An invitation to take the survey will be extended to 5,000 food defense decision-makers; we estimate that it will take 6 minutes (0.10 hours) to respond to the invitation and make arrangements to complete the survey, for a total of 500 hours. Twenty-five hundred respondents will complete the survey. We estimate that it will take a respondent 15 minutes (0.25 hours) to complete the entire survey, for a total of 625 hours. Thus, the total estimated burden is 1,138.3 hours (rounded to 1,139).

    FDA's burden estimate is based on prior experience with surveys that are similar to this proposed survey.

    Dated: March 23, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning.