[Federal Register Volume 65, Number 150 (Thursday, August 3, 2000)]
[Notices]
[Pages 47736-47738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1060]


Agency Information Collection Activities; Submission for OMB 
Review; 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

[[Page 47737]]

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 
September 5, 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: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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.

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 for 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://cfsan.fda.gov under ``Federal/State Food Programs'' 
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 the Association of Food and Drug 
Officials (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. AFDO 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 questions will concern 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 whether 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\
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                                   Annual Frequency      Total Annual
       No. of Respondents            per Response          Responses      Hours per Response      Total Hours
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500                                       2               1,000                   1               1,000
Total                                                                                            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 estimates 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 nation's 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 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 
longer. For example, some States have biennial legislative sessions. 
Others have extensive notice-and-comment administrative rulemaking 
procedures that can extend well beyond 1 year.

[[Page 47738]]

    In accordance with 5 CFR 1320.8(d) on April 6, 2000 (65 FR 18110), 
a 60-day notice for public comment was published in the Federal 
Register. One comment was received which questioned the necessity for 
the information and criticized the funding mechanism for obtaining the 
information. FDA disagrees with the commentator on both points.
    Regarding the necessity for a 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 and with other 
Federal agencies. To help achieve these aims and FDA's Food Safety 
Initiative goals, FDA needs a comprehensive, accurate, and current 
inventory of Food Code adoptions to monitor the effectiveness of FDA's 
assistance to these agencies and to identify gaps where additional 
assistance may be needed.
    FDA has established a site on the Internet at http://www.cfsan.fda.gov ``Federal/State Food Programs'' and ``Retail Food 
Safety References'' to list agencies that have reported adoptions of 
the FDA Food Code. Because it is self-reported, the current list is 
incomplete and those codes adopted have not been evaluated for 
consistency with the model FDA Food Code. FDA has obtained the services 
of AFDO to develop and implement an active surveillance system to track 
and report on the adoptions of the FDA Food Code by State and local 
agencies and tribal nations of native Americans.
    AFDO will develop an active computer data base that will capture 
adoptions of the FDA Food Code; identify and periodically contact 
State, local, and tribal food safety program administrators to 
determine the current status of Food Code adoptions; collect 
information to identify consistency of adopted codes with the FDA Food 
Code focused only on the Centers for Disease Control identified risk 
factors and the FDA Food Code interventions; 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.cfsan.fda.gov.
    On the comment's second point regarding propriety of funding the 
project, the purchase requisition for services was well within the 
limits and fully compliant with regulations for purchasing the services 
of AFDO to conduct the information gathering.

    Dated: July 28, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-19626 Filed 8-2-00; 8:45 am]
BILLING CODE 4160-01-F