[Federal Register: May 23, 2000 (Volume 65, Number 100)]
[Notices]
[Page 33329-33330]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my00-64]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0356]


Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Survey of Incidence of Gastroenterological
Parasitic Infections in the United States as a Result of Consumption of
Raw Fish

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by June
22, 2000.

ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Wendy Taylor, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Survey of Incidence of Gastroenterological Parasitic Infections in
the United States as a Result of Consumption of Raw Fish

    Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(b)(2)), FDA has the responsibility to conduct research
relating to foods and to conduct educational and public information
programs relating to the safety of the nation's food supply. The
``Survey of Incidence of Gastroenterological Parasitic Infections in
the United States as a Result of Consumption of Raw Fish'' will provide
information on the actual frequency of occurrence of fish-borne
helminth illnesses. Detailed information will be obtained from the
target population of clinical gastroenterologists who are likely to
have encountered and treated food-borne parasitic infections.
Respondents will also be asked to provide demographic information about
the most recent cases. The information will be used to better evaluate
the need for control of helminth parasites in fish intended for raw
consumption and to evaluate effective means for control where such
controls are found necessary. A national representative sample of 1,000
clinical gastroenterologists will be selected by a random procedure and
interviewed by questionnaire.
    In theFederal Register of February 22, 2000 (65 FR 8713), the
agency requested comments on the proposed collections of information.
One comment was received. The comment commended the concept of
conducting the survey, but requested that the survey gather information
sufficient to determine whether implicated fish were from commercial or
recreational sources.
    The comment's point is that because the purpose of the survey is to
help determine whether infection from fish-borne helminth parasites is
a hazard that is responsibly likely to occur in the United States in
commercial species of fish, data on parasite infections from
noncommercial species could skew the outcome. While the comment's point
is valid in theory, it is highly unlikely that recreational species are
a significant source of parasite infections. It is more likely that
commercial species intended for raw consumption, as in sushi and
sashimi, provide an appreciable risk of parasite infection.
Consequently, the agency does not regard differentiation between
commercial and recreational sources to be critical to the success of
the survey. As a practical matter, moreover, information on whether an
infection was from a commercially or recreationally obtained fish is
probably not available through the kind of survey that is being
conducted. Consequently, FDA does not contemplate any change in the
survey.
    Any findings of significant levels of infection will guide FDA in
evaluating its current policy that fish intended for raw consumption
should have been previously frozen to eliminate the hazard from live
parasites. This recommendation is adhered to by many members of the
seafood industry. To the extent that parasite infection from raw fish
is demonstrated through this survey to be a hazard reasonably likely to
occur, the agency would focus its attention to such actions as
increased consumer education, which would apply to raw fish from any
source, and to ensuring the implementation of hazard analysis critical
control points controls for fish sold for raw consumption.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1.--Estimated Annual Reporting Burden <SUP>1</SUP>
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                                                      Annual
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours
                                                     Response        Responses       Response
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500                                                     1             500                .50         250
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 33330]]

    This is a one-time survey. The burden estimate is based on FDA's
experience with conducting similar surveys.

    Dated: May 15, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-12854 Filed 5-22-00; 8:45 am]
BILLING CODE 4160-01-F