Document ID: FDA-2008-N-0286-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-03-30T04:00Z

[Federal Register: March 30, 2009 (Volume 74, Number 59)]
[Notices]               
[Page 14135-14137]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr09-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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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.

[[Page 14136]]

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 to oira_submission@omb.eop.gov. 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.

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.

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 at www.cfsan.fda.gov/~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 the Federal Register of 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\
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                        No. of         Annual Frequency       Total Annual       Hours per
    Activity         Respondents         per Response          Responses          Response        Total Hours
----------------------------------------------------------------------------------------------------------------
Cognitive                         7                     1                  7                1                  7
 Interviews
----------------------------------------------------------------------------------------------------------------
Telephone                        28                     1                 28             0.10                  3
 Interview - Pre-
 test Invitation
----------------------------------------------------------------------------------------------------------------
Completed Pre-                   14                     1                 14             0.25                  4
 test
----------------------------------------------------------------------------------------------------------------
Telephone                     5,000                     1              5,000             0.10                500
 Interview -
 Survey
 Invitation
----------------------------------------------------------------------------------------------------------------
Completed Survey              2,500                     1              2,500             0.25                625
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     1,139
----------------------------------------------------------------------------------------------------------------
\1\There 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).

[[Page 14137]]

    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.
[FR Doc. E9-7002 Filed 3-27-09; 8:45 am]

BILLING CODE 4160-01-S