[Federal Register Volume 71, Number 139 (Thursday, July 20, 2006)]
[Notices]
[Pages 41221-41223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11539]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0246]


Draft Manufactured Food Regulatory Program Standards; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Manufactured Food 
Regulatory Program Standards'' (draft program standards). The draft 
program standards, which establish a uniform foundation for the design 
and management of State programs responsible for regulation of plants 
that manufacture, process, pack, or hold foods in the United States, 
are being distributed for comment purposes only. This document is 
neither final nor is it intended for implementation at this time.

DATES: Written comments on the draft program standards may be submitted 
by September 18, 2006. General comments on the draft program standards 
are welcome at any time. Submit written comments on the information 
collection provisions by September 18, 2006.

ADDRESSES: Submit written comments on the information collection 
provisions to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. 
Identify comments with the docket number found in brackets in the 
heading of this document.
    Submit written requests for single copies of the draft program 
standards to the Division of Federal-State Relations (HFC-150), Office 
of Regional Operations, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist the office in processing your request, or fax your request to 
716-551-3845. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft program standards.

FOR FURTHER INFORMATION CONTACT: Beverly Kent, Division of Federal-
State Relations, Food and Drug Administration, 300 Pearl St., suite 
100, Buffalo, NY 14202, 716-541-0331.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Manufactured Food Regulatory Program Standards.'' The standards were 
developed after the Department of Health and Human Services, Office of 
Inspector General (OIG) audited FDA's oversight of food firm 
inspections conducted by States through contracts. In June 2000, the 
OIG released its findings. The OIG recommended that FDA take steps to 
promote ``equivalence among Federal and State food safety standards, 
inspection programs, and enforcement practices.'' The report is on the 
Internet at http://www.oig.hhs.gov/oei/reports/oei-01-98-00400.pdf. 
(FDA has verified the Web site address, but FDA is not responsible for 
any subsequent changes to the Web site after this document publishes in 
the Federal Register.)
    In response to the OIG's findings, FDA established a committee to 
draft a set of quality standards for manufactured food regulatory 
programs. The committee was comprised of officials from FDA and from 
State agencies responsible for the regulation and inspection of food 
plants.
    These draft program standards establish a uniform foundation for 
the design and management of a State program that is an operational 
unit(s) responsible for the regulatory oversight of food plants that 
manufacture, process, pack, or hold foods in the United States. The 
elements of the draft program standards describe best practices of a 
high-quality regulatory program. Achieving conformance with these 
program standards will require comprehensive self-assessment on the 
part of a State program and will encourage continuous improvement and 
innovation. All self-assessment

[[Page 41222]]

worksheets and supporting documents will be retained by the State 
agency.

II. Significance of Program Standards

    These draft program standards represents the agency's current 
thinking on how to build a uniform foundation for managing a State 
program that is an operational unit(s) responsible for the regulatory 
oversight of food plants that manufacture, process, pack, or hold foods 
in the United States. The elements of the draft program standards 
describe best practices of a high-quality regulatory program.

III. Electronic Access

    Persons with access to the Internet may obtain the draft program 
standards at either http://www.fda.gov/ora/fed_state/default.htm or 
http://www.fda.gov.ohrms/dockets/default.htm.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 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 of 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 the following 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.
    Title: Manufactured Food Regulatory Program Standards
    Description: The elements of the draft program standards are 
intended to ensure that the States have the best practices of a high-
quality regulatory program to use for self-assessment and continuous 
improvement and innovation. The ten standards describe the critical 
elements of a regulatory program designed to protect the public from 
foodborne illness and injury. These elements include the State 
program's regulatory foundation, staff training, inspection, quality 
assurance, food defense preparedness and response, foodborne illness 
and incident investigation, enforcement, education and outreach, 
resource management, laboratory resources, and program assessment. Each 
standard has corresponding self-assessment worksheets, and certain 
standards have supplemental worksheets and forms that will assist State 
programs in determining their level of conformance with the standard. 
The State program is not required to use the forms and worksheets 
contained herein; however, alternate forms should be equivalent to the 
forms and worksheets in the draft program standards. These draft 
program standards do not address the performance appraisal processes 
that a State agency may use to evaluate individual employee 
performance. When finalized, FDA will use the program standards as a 
tool to improve contracts with State agencies. The program standards 
will assist both FDA and the States in fulfilling their regulatory 
obligations.
    The implementation of the program standards will be negotiated as 
an option for payment under the State contract. States that are awarded 
this option will receive up to $5,000 to perform the self assessment 
and to maintain an operational plan for self improvement. FDA 
recognizes that full use and implementation of the program standards by 
those States will take several years. Such States will, however, be 
expected to implement improvement plans to demonstrate that their 
programs are moving toward full implementation. Those self assessments 
and improvement plans will be audited as a part of the program 
oversight of the FDA state contracts.
    The goal is to enhance food safety by establishing a uniform basis 
for measuring and improving the performance of manufactured food 
regulatory programs in the United States. The development and 
implementation of these program standards will help Federal and State 
programs better direct their regulatory activities at reducing 
foodborne illness hazards in plants that manufacture, process, pack, or 
hold foods. Consequently, the safety and security of the food supply in 
the United States will improve.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                       Annual Frequency     Total Annual        Hours per
         No. of Respondents              per Response        Responses           Response         Total Hours
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40                                                  0.5                 20                 40                800
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\1\ Because State agencies already keep records of the usual and customary activities required by their
  inspection programs, the burden from compiling these records is not included in the burden chart.


                                Table 2.--Estimated 5-Year Self Assessment Burden
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                          5-Year Frequency per      Total 5-Year            Hours per
   No. of  Respondents          Response              Responses            Response\1\         Total Hours\1\
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40                                           1                    40                100/40           4,000/1,600
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\1\ The initial self assessment is estimated at 100 hours per respondent. Subsequent updates of the self
  assessments will be conducted every 5 years and should be completed in 40 hours or less.


[[Page 41223]]


                             Table 3.--Estimated Annual ``Improvement Plan'' Burden
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                                       Annual Frequency     Total Annual        Hours per
         No. of Respondents              per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
40                                                    1                 40                  5                200
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V. Comments

    The draft program standards are being distributed for comment 
purposes only and are not intended for implementation at this time. 
Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. A copy of the draft program standards 
and received comments are available for public examination in the 
Division of Dockets Management between 9 a.m. and 4 p.m. Monday through 
Friday.

    Dated: July 14, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11539 Filed 7-19-06; 8:45 am]
BILLING CODE 4160-01-S