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