[Federal Register Volume 65, Number 100 (Tuesday, May 23, 2000)]
[Notices]
[Pages 33329-33330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12854]


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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 1
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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