[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Notices]
[Pages 8713-8714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0356]


Agency Information Collection Activities; Proposed Collection; 
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 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 a voluntary survey about the incidence of 
gastroenterological parasitic infections in the United States as a 
result of the consumption of raw fish.

DATES: Submit written comments on the collection of information by 
April 24, 2000.

ADDRESSES: 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, Room 16B-26; 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.

Title: 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(d)(2)), the 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 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

[[Page 8714]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table1.--Estimated Annual Reporting Burden \1\
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                                                      Annual
              Number 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.

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

    Dated: February 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-4020 Filed 2-18-00; 8:45 am]
BILLING CODE 4160-01-F