[Federal Register: March 29, 2002 (Volume 67, Number 61)]
[Notices]
[Page 15209-15210]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr02-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0104]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Consumer Handling of Ready-to-Eat Foods
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 that will occur
during research to determine how consumers handle ready-to-eat (RTE)
food products and how consumer practices impact the microbiological
safety of RTE foods.
DATES: Submit written or electronic comments on the collection of
information by May 28, 2002.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (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: Peggy Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
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: (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.
Consumer Handling of Ready-to-Eat Foods
Section 402 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 342) authorizes FDA to regulate foods so that they are not
adulterated. FDA's research in food safety seeks to reduce the
incidence of foodborne illness by improving the ability to find new
ways to detect, enumerate, and control pathogens in the food supply.
FDA's Center for Food Safety and Applied Nutrition (CFSAN) awarded two
grants of research funds in September 2001 to support research into
consumer refrigeration practices and shelf-life for RTE foods entitled
``Consumer Storage Length Practices for Ready-to-Eat Foods'' and
``Consumer Handling of Ready-to-Eat Foods After Purchase.''
The information that will be collected concerns consumer handling
of RTE food products. The research will provide data on the storage of
RTE foods in unopened and opened packages in home refrigerators;
consumer understanding of expiration dates; and consumer use of this
information in making decisions regarding purchases, consumption, and
home storage conditions. The data from these surveys will be used to
refine the Department of Health and Human Services and United States
Department of Agriculture Listeria monocytogenes (LM) risk assessment,
issued in draft for public comment on January 19, 2001 (66 FR 5515).
The values used for home storage of foods in the draft LM risk
assessment were largely based on expert opinion, not statistically
supportable data. Thus, the consumer storage data from these two grants
will improve FDA's confidence in the predicted risks by reducing the
uncertainty in consumer practices.
For the ``Consumer Storage Length Practices for Ready-to-Eat
Foods,'' approximately 2,400 respondents will be selected from an
already existing nationally representative web-enabled panel. For
``Consumer Handling of Ready-to-Eat Foods After Purchase,'' a more
traditional survey approach will be used and will be conducted in three
parts. In part 1, approximately 400 in-person interviews will be
conducted in Tennessee, Illinois, Kansas, Missouri, Florida, and New
York. Participants will
[[Page 15210]]
be selected to represent both sexes, different income groups and
education levels, and a wide range of adults from different ethnic
groups. In part 2, 100 respondents from part 1 will complete food
diaries of specific foods from the day the food dairy is initiated
until those foods are consumed or discarded. In part 3, two mass
mailings of questionnaires will be conducted one in fall-winter and the
second in spring-summer for a total of 2,000 respondents.
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 per Total Annual
Respondents Response Responses Hours per Response Total Hours
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Web-enabled panel 2,400 1 2,400 0.25 600
survey
Interview survey 400 1 400 0.5 200
Food diary 100 1 100 0.5 50
Mail survey 2,000 1 2,000 0.3 600
Total 1,450
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The number of respondents given in table 1 is based on the study
design in the two grant applications. The hours per response was
estimated based on experience of the grantees for similar surveys and
also on the number of questions to be included in each survey
instrument.
Dated: March 22, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7580 Filed 3-28-02; 8:45 am]
BILLING CODE 4160-01-S