[Federal Register Volume 75, Number 71 (Wednesday, April 14, 2010)]
[Notices]
[Pages 19405-19406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0180]


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 governmental 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 14, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (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, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 these topics: (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--
42 U.S.C. 243 (a); (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 governmental agencies 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)). 
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 
toward 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 
governmental agencies. FDA contracted with the Association of Food and 
Drug Officials (AFDO) to conduct the initial survey using the OMB 
approved survey form. The rulemaking process that local, State, 
territorial, and tribal governmental agencies must follow to adopt the 
model FDA Food Code is often a long and complicated process that can 
extend for several years. For this reason, many agencies have reported 
that they are still in the rulemaking process to adopt or update their 
food codes. Thus, FDA believes that extension of OMB approval of the 
survey is needed in order to keep the current database accurate and up-
to-date. The contractor will collect the information electronically 
and/or telephonically and will be able to provide respondents with 
previous survey responses already in the database.
    Description of Respondents: Respondents to this information 
collection are States and U.S. territories, local, and tribal 
governmental agencies.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 19406]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of       Annual Frequency per     Total Annual        Hours per
                   Food Code Survey                        Respondents           Response            Responses           Response         Total Hours
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Respondents                                                            75                     4                300                  1                300
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This estimate is based on FDA's experience and the number of 
updates received in the past 3 years. FDA estimates that 75 respondents 
will provide four quarterly updates each, resulting in an estimated 300 
total annual responses. The agency estimates that each quarterly update 
will take about 1 hour. Of the 75 respondents, those who amend their 
regulations with changes unrelated to the risk factors and 
interventions, and those who are not adopting model FDA Food Code 
provisions, but are incorporating certain Conference for Food 
Protection recommendations only, will likely need only annual contact.

    Dated: April 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8510 Filed 4-13-10; 8:45 am]
BILLING CODE 4160-01-S