[Federal Register Volume 73, Number 100 (Thursday, May 22, 2008)]
[Notices]
[Pages 29759-29760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11514]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a survey of food industry supervisory 
employees about their awareness and perceptions of FDA's Food Defense 
Awareness Initiative ALERT.

DATES:  Submit written or electronic comments on the collection of 
information by July 21, 2008.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food

[[Page 29760]]

and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-4659.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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, cluster sampling design. Using 
industry networks and listings, we will randomly sample from databases 
of eight industry groups (regulators, growers, packers, processors, 
warehousers, 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 200 organizations. Participation in the survey is voluntary. 
Cognitive interviews and a pre-test will be conducted prior to fielding 
the survey.
    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
                     Questionnaire                         Respondents         per Response          Responses           Response         Total Hours
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Cognitive Interviews                                                   10                    10                 10                  1                 10
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Pre-tests                                                              10                     1                 10                 .4                  4
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Survey                                                                200                     1                200                 .4                 80
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Total                                                                                                                                                 94
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's burden estimate is based on prior experience with consumer 
surveys similar to this proposed survey.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: May 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11514 Filed 5-21-08; 8:45 am]
BILLING CODE 4160-01-S