[Federal Register: March 30, 2007 (Volume 72, Number 61)]
[Notices]
[Page 15140-15141]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr07-81]
[[Page 15140]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0105]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Mental Models Study of Food Bioterrorism Risk
Awareness
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 the information collection provisions of
the mental models study of food bioterrorism risk awareness.
DATES: Submit written or electronic comments on the collection of
information by May 29, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. 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 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.
Mental Models Study of Food Bioterrorism Risk Awareness
The proposed information collection will help FDA protect the
public from food bioterrorism by preparing the agency to take
appropriate action in the event of a crisis. Under the Federal Food,
Drug, and Cosmetic Act of 1938, as amended, FDA has authority to act to
protect the safety of the nation's food supply. Under title 42 of the
Public Health Service Act (1944), FDA has authority to act to protect
the public health. In addition, title III of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-
188), FDA has authority to act to improve the ability of the United
States to prevent, prepare for, and respond to bioterrorism and other
public health emergencies.
FDA has crafted and disseminated messages intended to raise the
awareness of state and local government agency and industry
representatives regarding food defense issues and preparedness, but FDA
does not currently have similar initiatives for consumers. Extensive
research exists in disaster preparedness and in effective communication
to the public of risk or crisis information by government or non-
government entities. However, additional research is needed to help FDA
design communications that will increase consumer awareness of the
potential for food bioterrorism and help consumers to make good
decisions in the event of a food bioterrorism emergency.
The project will use ``mental modeling,'' a qualitative research
method wherein the decision-making processes of a group of consumer
respondents (described in the next paragraph) concerning food
bioterrorism are modeled and compared to a model based on expert
knowledge and experience in food bioterrorism. The information will be
collected via a telephone interview concerning the factors that
influence the perceptions and motivations related to the threat of food
bioterrorism. A comparison between expert and consumer models based on
the collected information may identify ``consequential knowledge gaps''
that can be redressed through messages or information campaigns
designed by FDA.
Description of Respondents: Respondents will be adult parents over
the age of 18 who have at least one child age 4 to 13 residing in the
home at least half-time. The sample will be divided by gender.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per
No. of Respondents Response Total Annual Responses Hours per Response Total Hours
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45 1 1 .75 33.75
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 15141]]
The study will involve 45 respondents and take approximately 45
minutes each to complete. These estimates are based on FDA's experience
with consumer research.
Dated: March 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1577 Filed 3-29-07; 8:45 am]
BILLING CODE 4160-01-S