[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Notices]
[Pages 17283-17284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7934]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1061]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Resource Assessment of Programs and Services in Food 
Safety

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 project supported by FDA to collect 
information on food safety programs and services and the resources 
devoted thereto by State and local agencies nationwide.

DATES: Submit written comments on the collection of information by May 
30, 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: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Assessment of Local and State Resources in Food Safety Programs and 
Services

    In 1998, FDA began an effort, in cooperation with local, State, and 
other Federal agencies, to develop an integrated national food safety 
system. The system would coordinate the activities and resources of all 
levels of government devoted to regulatory food safety programs to 
maximize the impact of available resources, reduce overlapping 
functions, coordinate responses to foodborne disease outbreaks, share 
information, improve communications and training, establish minimum 
national uniform standards and identify gaps in food safety controls 
for correction at any level of government. The effort is consistent 
with the ``farm to table'' approach and sound scientific and risk-based 
priorities called for by the National Academy of Science's Report of 
August 20, 1998, and the President's Council on Food Safety, 
established by Executive Order 13100 on August 25, 1998. A number of 
workgroups of local, State,

[[Page 17284]]

and Federal officials have been formed to address the integration 
effort including one on roles and responsibilities of Federal, State, 
and Local agencies.
    The Roles and Responsibilities Work Group, consisting of local, 
State, and Federal officials as part of the National Food Safety System 
(NFSS), has recommended the preparation of a resource assessment survey 
to determine the capacity and needs of State and local government 
agencies involved in food safety. The information will be collected by 
a contractor, to be determined, using a resource assessment 
questionnaire developed by the Roles and Responsibilities Work Group. 
The information gathered by the survey will help to determine what 
capabilities can be coordinated in each State and nationally and where 
there are gaps or insufficiencies that need to be addressed. The 
questionnaire will be provided electronically to State and local 
agencies for automated responses to minimize the reporting burden. Mail 
or facsimile hard copies will only be used for those jurisdictions that 
do not have electronic response capability. The resulting information 
will be computerized for analysis and reporting.
    The survey will include questions on laws and regulations in 
effect; staffing; information systems; funding sources, mechanisms and 
amounts; staff training, certification, and qualifications; consumer 
and industry education; emergency response systems; laboratory 
resources and capabilities; epidemiology resources; official 
establishment inventories; routine inspection frequencies; surveillance 
sampling; minimum performance standards; program scope; and types of 
assistance needed from State and/or Federal agencies.
    The questionnaire is intended to be a one-time effort but may 
involve additional contacts with respondents to clarify information 
supplied or to encourage participation. Responses to this questionnaire 
are voluntary. It should be noted that the State and local members of 
the Roles and Responsibilities Work Group have strongly endorsed the 
need for this survey so that informed and balanced recommendations can 
be made to policymaking and funding officials.
    Authority for providing such assistance is derived from section 
311(a) of the Public Health Service Act (42 U.S.C. 243) and delegation 
of authority from the Public Health Service to the Commissioner of Food 
and Drugs relative to food protection is contained in 21 CFR 5.10(a)(2) 
and (a)(4). Assistance to local, State, and Federal agencies is also 
based on FDA's authorities and responsibilities under the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301). Under 31 U.S.C. 1535, FDA 
provides assistance to other Federal agencies.
    There are approximately 4,200 local jurisdictions conducting food 
safety activities, about 150 State agencies, and an estimated 150 
tribal agencies. More accurate counts will be available after the 
survey because one of the purposes will be to identify the local, 
State, and tribal agencies involved in food safety.
    This will be a one-time survey with followup contacts to clarify 
responses or to elicit information from initial nonrespondents. Contact 
will be by electronic means whenever possible to minimize the burden on 
the respondent. Computerized data will be encouraged. FDA will likely 
contract with a third party to conduct the information gathering and 
compilation/analysis.
    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     Frequency per   Total Annual    Hours per     Total Hours
 Respondents      Response      Responses       Response
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       4,500              1          4,500              4       18,000
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.


    Dated: March 24, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-7934 Filed 3-30-00; 8:45 am]
BILLING CODE 4160-01-F