[Federal Register Volume 65, Number 67 (Thursday, April 6, 2000)]
[Notices]
[Pages 18110-18111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8416]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1060]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Adoption of the FDA Food Code by Local, State, and 
Tribal Governments

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 adoption of, or plans to 
adopt, all or portions of the FDA Food Code or its equivalent by 
regulation, law, or ordinance. The Association of Food and Drug 
Officials (AFDO) has been contracted by FDA to telephonically and/or 
electronically contact local, State, and tribal food program 
administrators to determine Food Code adoption in their respective 
jurisdictions.

DATES: Submit written comments on the collection of information by June 
5, 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.

Adoption of the FDA Food Code by Local, State, and Tribal 
Governments

    FDA has developed the model Food Code to assist and promote 
consistent implementation of national food safety regulatory policy 
among the several thousand local, State, and tribal jurisdictions that 
have primary responsibility for the regulation or oversight of retail 
level food operations. The FDA Food Code provides a scientifically 
sound technical and legal basis for regulating the retail segment of 
the food industry. 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). Under 31 U.S.C. 1535, FDA provides 
assistance to other Federal agencies such as the Indian Health Service.
    Nationwide adoption of the model FDA Food Code is an important step 
to further the goals of the President's Council on Food Safety for 
consistent, scientifically sound, and risk-based food safety standards 
and practices and to work more effectively with partners in State, 
local, and tribal governments. FDA has established a site on the 
Internet at http://www.cfsan. fda.gov under ``Federal/State Food 
Programs''

[[Page 18111]]

and ``Retail Food Safety References'' to list jurisdictions that have 
reported adoptions of the FDA Food Code. Because it is self-reported, 
the list is incomplete and has not been evaluated to determine whether 
all the adopted codes are equivalent to the model Food Code. It is 
important to FDA to have a comprehensive, accurate, and current 
inventory of Food Code adoptions to help achieve the aims of the 
President's Council on Food Safety and the agency's Food Safety 
Initiative goals.
    FDA has obtained the services of AFDO to develop and implement an 
active surveillance system to track and report on the adoption of the 
FDA Food Code by State and local agencies and tribal nations of native 
Americans. The contractor will develop and maintain an active data base 
to track adoptions of the Food Code; identify and periodically contact 
State, local, and tribal food safety program administrators to 
determine the current status of adoptions of the Food Code or its 
equivalent; evaluate the equivalency of the adopted codes with the FDA 
Food Code; and provide quarterly progress reports to FDA from the data 
base in tabular and graphic form. Reports may be placed on the Internet 
at http://www.fda.gov.
    Initial contacts by AFDO to local, State, and tribal program 
administrators will be by telephone and/or e-mail to determine the Food 
Code status in their jurisdiction(s). Verbal responses to questions 
will be acceptable as will electronic or facsimile information. 
Followup contacts to clarify responses will be by telephone or e-mail 
to minimize the burden on respondents.
    The types of questions to be asked will be whether or not the FDA 
Food Code has been adopted in the respondent's jurisdiction, which 
version of the Food Code is in effect, and if not, which local 
jurisdictions need to be contacted for Food Code adoption status. AFDO 
will also determine with the local/State/tribal governments that it has 
the latest version of the code for analysis.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden\1\
------------------------------------------------------------------------
                          Annual
 No. of Respondents   Frequency per  Total Annual   Hours per     Total
                         Response      Responses     Response     Hours
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500                   2              1,000         1            1,000
Total Hours                                                     1,000
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    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. Estimating the number of local 
agencies is difficult before the start of this project because in some 
States, adoption by a State agency automatically applies to all local 
jurisdictions in that state. In other States, some metropolitan 
jurisdictions may adopt the FDA Food Code individually. Similar 
circumstances may apply to tribal nations' agencies that may be 
adopting the FDA Food Code. When the initial information gathering is 
completed, FDA will be able to identify more accurately the number of 
local and tribal agencies for which tracking adoption of the FDA Food 
Code will be necessary.
    Frequency of reporting will range from once per year to quarterly 
for any one jurisdiction. This is because agencies that have already 
adopted the Food Code will require less frequent contact, perhaps only 
annually, than those that are in the process of adopting the Food Code. 
An average of two contacts in 1 year, therefore, was selected. Because 
most reporting will be done telephonically or electronically, reporting 
times often will be much less than 1 hour.
    These estimates will fluctuate from year to year as agencies adopt, 
revise, and consider adoption of the FDA Food Code. Over the next 3 
years, the frequency of contacts should decrease as jurisdictions adopt 
the FDA Food Code. This project will take several years to complete 
because the adoption process in some States can extend to 2 years or 
more. For example, some States have biennial legislative sessions. 
Others have extensive notice-and-comment administrative rulemaking 
procedures that can extend well beyond 1 year.

    Dated: March 30, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-8416 Filed 4-5-00; 8:45 am]
BILLING CODE 4160-01-F