[Federal Register: December 18, 2006 (Volume 71, Number 242)]
[Notices]
[Page 75760-75762]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de06-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0246]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Manufactured Food
Regulatory Program Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
17, 2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (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.
Manufactured Food Regulatory Program Standards
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 purposed only. This document is
neither final nor is it intended for implementation.
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
[[Page 75761]]
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.
In the Federal Register of July 20, 2006 (FR 71 41221), FDA
published a 60-day notice requesting public comment on the information
collection provisions in the draft program standards. FDA received a
number of comments on the draft program standards; however, only two
letters of comment included comments regarding the information
collection provisions. An additional letter supported the comments
provided in one of the two letters of comment.
Two comments stated that the record collection required to meet the
standards is cumbersome and voluminous. FDA does not agree with the
comments about the record collection. The record collection requested
by the program standards is not outside the information collected and
reported by an efficient and effective regulatory program. The program
standards capture the State program's accomplishments in standardized
forms.
FDA reminds you that in the draft program standards FDA anticipates
full implementation of the program standards will take several years so
that State programs can integrate the program standards into its own
quality assurance programs. FDA estimates that the majority of the
State agencies have quality assurance programs and only a minimum
amount of time would be necessary to revise or update them to comply
with the program standards. Ultimately, the program standards will
assist both FDA and the States in fulfilling their regulatory
obligations and developing strategies that will continuously improve
the State programs.
Furthermore, the total estimated burden under the draft program
standards did not consider the use of forms in Portable Document Format
(PDF) that will be filled and submitted electronically. The PDF fill-in
forms will reduce the estimated burden for both the reporting and
recordkeeping burdens and should be accessible when the program
standards are negotiated as an option for payment under the State
contracts.
One comment requested that alternative mechanisms to document
compliance with the standards be permitted. FDA further reminds you
that in the draft program standards we provide for using alternate
forms.
In revising the draft program standards, FDA will consider the
general comments on draft program standards.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency per
Respondents Response Total Annual Responses Hours per Response Total Hours
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40 0.5 20 40 800
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Five-Year Self Assessment Burden\1\
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Number of Five-Year Frequency per Total Five-year
Respondents Response Responses Hours per Response\2\ Total Hours\2\
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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 five years and should be completed in 40 hours or less.
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Table 3.--Estimated Annual Improvement Plan Burden
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No. of Annual Frequency Per
Respondents Response Total Annual Responses Hours per Response Total Hours
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40 1 40 5 200
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Dated: December 11, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21472 Filed 12-15-06; 8:45 am]
BILLING CODE 4160-01-S