[Federal Register Volume 66, Number 90 (Wednesday, May 9, 2001)]
[Notices]
[Pages 23715-23717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11618]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0208]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Voluntary National Retail Food Regulatory Program 
Standards

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 FDA's collection of information from local, 
State, and tribal agencies concerning their use of or planned use of 
all or part of the Voluntary National Retail Food Regulatory Program 
Standards.

DATES: Submit written or electronic comments on the collection of 
information by July 9, 2001.

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: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-26, 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

[[Page 23716]]

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.

Voluntary National Retail Food Regulatory Program Standards

    FDA has developed the Voluntary National Retail Food Regulatory 
Program Standards (the National Standards) to assist and promote the 
uniform application of provisions of the model FDA Food Code by several 
thousand local, State, and tribal jurisdictions that have primary 
responsibility for the regulation or oversight of retail level food 
operations. The National Standards are intended to serve as a guide to 
regulatory retail food program managers in the design and management of 
a retail food program that is focused on the reduction of risk factors 
know to cause foodborne illness. The National Standards also promote 
active management control by industry of all risk factors that may 
cause foodborne illness. Authority for providing such assistance is 
derived from section 311 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 related to food protection is contained 
in 21 CFR 5.10(a)(2) and (a)(4). Under 31 U.S.C. 1535, FDA provides 
financial assistance to other Federal agencies such as the Indian 
Health Service. FDA has established a section on the Internet at http:/
/vm.cfsan.fda.gov/dms/ret-toc.html under ``Federal/State Food 
Programs--Retail Food Safety References'' to list jurisdictions that 
have voluntarily elected to use the National Standards.
    Utilization of the National Standards by local, State, and tribal 
regulatory agencies is an important step to further the goals of the 
President's Council on Food Safety and FDA program goals. All 
regulatory agencies are encouraged to voluntarily utilize the National 
Standards as a guide for the design and management of a retail food 
safety program. There is no reporting or recordkeeping requirement for 
those jurisdictions that wish to utilize part or all of the National 
Standards to enhance or measure program performance. Reporting is only 
a requirement for those jurisdictions that request to be listed in the 
FDA National Registry.
    Jurisdictions that request listing in the FDA National Registry of 
participating regulatory agencies will be expected to perform certain 
management tasks and periodically report the results to FDA. Voluntary 
listing in the FDA National Registry requires that the following tasks 
be performed by State, local, and tribal program managers: (1) Conduct 
a program self assessment, (2) conduct a baseline survey of the 
regulated industry, and (3) obtain an independent outside audit. All 
three tasks must be completed within a 3-year time span. The tasks must 
be performed in accordance with the guidance provided in the National 
Standards and the results reported to FDA.
    FDA based its estimate on the number of State agencies (100) 
involved in Food Code related regulatory programs, 300 local agencies 
with local ordinance authority that may consider Food Code adoption in 
any one year and 100 tribal agencies. The presumption being that those 
agencies most likely to utilize the National Standards are also those 
agencies with authority to adopt and enforce the model FDA Food Code. 
There is only one required report, the FDA National Registry Report 
(Appendix I), which is used to report program self assessment, baseline 
surveys of industry, and outside audits. The time required to complete 
the actual reporting document is minimal, however, additional time is 
required to analyze and review existing records, conduct baseline 
inspections, and secure an outside audit. The hour burden estimate 
includes the time required to review the instructions in the National 
Standards, search existing data sources, gather and maintain the data 
needed, complete worksheets, and review the collected information. The 
estimate of 92 hours to complete a program self assessment is based on 
the average time reported by the four State and three local 
jurisdictions that participated in the National Standards Pilot. The 
amount of time expended by individual jurisdictions ranged from 40 to 
215 hours. This range is reflective of the difference in size between 
jurisdictions. The baseline survey of industry and the outside audit 
are expected to require a similar amount of time to complete. Because 
only one of the three tasks is required per year, the average annual 
reporting burden is estimated to be 92 hours per year for each 
participating jurisdiction.
    Because the records of establishment inspections, investigations, 
and enforcement activities are routinely maintained and accepted 
management practices already necessitate the collection of some 
required information and maintenance of records, the recordkeeping 
burden is minimal.
    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    Total Annual        Hours per
                 Standard No.                      Respondents      per Response        Responses         Response         Total Hours
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9\2\..........................................       500                 1               500                92            46,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Includes the use of Forms FDA 3519 and 3520.


[[Page 23717]]


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                                                  Annual Frequency
                         Standard No.                                No. of              per          Total Annual        Hours per        Total Hours
                                                                  Recordkeepers     Recordkeeping        Records        Recordkeeper
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3, 4, and 6\2\................................................       500                 1               500                 5             2,500
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\The standards incorporate the best program management practices currently in use in the regulatory community. The recommended policies, procedures,
  and standard operating procedures contained in the various national standards are considered usual and customary management practices for State,
  local, and tribal agencies that regulate the retail segment of the food industry.


    Dated: May 4, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-11618 Filed 5-8-01; 8:45 am]
BILLING CODE 4160-01-S