[Federal Register Volume 68, Number 74 (Thursday, April 17, 2003)]
[Notices]
[Pages 18989-18990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9533]



[[Page 18989]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0136]


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 
including each proposed extension of an existing 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.

DATES: Submit written or electronic comments on the collection of 
information by June 16, 2003.

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: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 including 
each proposed extension of an existing 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 
(OMB Control Number 0910-0448)--Extension

    FDA has developed its model Food Code to assist and promote 
consistent implementation of national food safety regulatory policy 
among the 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(a)) 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 (IHS).
    Nationwide adoption of the model FDA Food Code is an important step 
towards the agency's goal for consistent, scientifically sound, and 
risk-based food safety standards and practices. A current, 
comprehensive, and accurate inventory of food code adoptions by States 
and U.S. territories, local, and tribal governments is necessary to 
determine the status of up-to-date protection of the U.S. population 
and to identify areas where assistance to these governments may promote 
the adoption of regulations based on the FDA Food Code.
    This collection effort, which began in 2001, has had remarkable 
success with 97 percent participation from State and territorial 
agencies. FDA contracted with the Association of Food and Drug 
Officials (AFDO) to conduct the initial survey using the OMB approved 
survey form. Contacts were made by telephone and e-mail to determine 
the Food Code status in their jurisdiction(s). Follow up contacts by 
telephone and e-mail to minimize the burden on respondents were made to 
clarify responses.
    The rulemaking process that local, State, territorial, and tribal 
governments must follow to adopt the Food Code is often a long and 
complicated process that can extend 2 or more years. For this reason, 
many agencies reported in the initial survey that they were still in 
the rulemaking process to adopt or update their food codes for the 
years 2004 and 2005 or beyond. Thus, FDA believes that further 
implementation of the initial survey is needed to cover this additional 
rulemaking in order to keep the current database accurate and up-to-
date. Based on experience gained in the past 3 years from the initial 
survey, FDA has developed a more condensed follow up survey to further 
minimize the burden requirements on respondent agencies. For example, 
FDA now knows if responding agencies have adopted a new code since 
1993, the types of establishments regulated by those codes, the 
populations of the jurisdiction covered, and the status of local health 
agencies in the States. This information will not be collected again. 
We have reduced the number of questions from 16 to 5. Collection(s) of 
information will be electronically and/or telephonically obtained thus, 
providing respondents with data already in the database to further the 
ease of response and lower the burden.
    FDA estimates the burden of this collection of information as 
follows:

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                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                 Annual Frequency per       Total Annual
                                            No. of Respondents         Response              Responses         Hours per Response        Total Hours
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Food Code Survey                                  150                     4                    600                     1                   600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Experience in the initial survey has more clearly identified the 
respondents for updating the information in the database. For example, 
FDA will obtain information from IHS, relative to the tribal nations' 
adoption of the Food Code that IHS maintains, using the information 
categories in the revised follow up survey form for which this 
extension is requested. Seventy-three State and territorial agencies 
were identified as respondents for Food Code adoption and it appears 
that initially, only 30 local agencies in cities of 500,000 or more 
will need to be contacted because most local jurisdictions are under 
State requirements. This further reduces the total burden on 
respondents. Quarterly updates from respondents under active rulemaking 
will be requested by AFDO to keep the database current and accurate. 
Respondents that have concluded rulemaking will likely need only annual 
contact. Estimated response time is about 1 hour or less because most 
reporting will be done telephonically or electronically.

    Dated: April 10, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9533 Filed 4-16-03; 8:45 am]
BILLING CODE 4160-01-S