In June 2000, the Department of Health
and Human Services, Office of Inspector General (OIG) recommended
that FDA improve its oversight of food firm inspections conducted
by States through contracts. Consequently, FDA developed the
Manufactured Food Regulatory Program Standards (program standards),
which establish a uniform foundation for the design and management
of a State program that is responsible for the regulatory oversight
of food plants that manufacture, process, pack, or hold foods in
the United States. Achieving conformance with these program
standards requires comprehensive self-assessment of the State
program. Each standard has corresponding self-assessment
worksheets, and certain standards have supplemental worksheets and
forms that will assist the State programs in determining their
level of conformance with the standard. The State program is not
required to use the forms and worksheets for the standard; however,
alternative forms should be equivalent to the forms and worksheets
in the program standards. FDA needs the data from the forms and
worksheets to assess the State program's conformance with the
program standards and to improve contracts with State agencies.
Ultimately, the program standards will assist both FDA and the
States in fulfilling their regulatory obligations.
The hours per response
increased because the Baseline Self-Assessment includes developing
a strategic plan to fully implement the standards. FDA reduced the
estimated first-year baseline self-assessment burden when it
replaced the verification audit performed by the State with a
program assessment validation audit that would be done by FDA.
However, the burden was increased because States needed additional
time to obtain the documents needed to conduct their
self-assessment. Additionally, in the past FDA had always beleived
that the recordkeeping was usual and customary. We learned from the
program assessment validation audits of 15 states that the States
were not keeping records on a usual and customary basis.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Supporting Statement-MFRPS-2010-Reapproval-Aug2010.doc
Manufactured Food Regulatory Program Standards