[Federal Register Volume 67, Number 61 (Friday, March 29, 2002)]
[Notices]
[Pages 15209-15210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7580]


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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