[Federal Register: May 22, 2008 (Volume 73, Number 100)]
[Notices]
[Page 29759-29760]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my08-49]
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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