[Federal Register: July 20, 2006 (Volume 71, Number 139)]
[Notices]
[Page 41221-41223]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy06-48]
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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are being distributed for comment purposes only.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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/fed_state/default.htm or
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
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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