[Federal Register Volume 71, Number 242 (Monday, December 18, 2006)]
[Notices]
[Pages 75760-75762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21472]


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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.


[[Page 75762]]


                               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