E6-21472. 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.

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: [phone].

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 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 Burden¹

No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
40	0.5	20	40	800
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.—Estimated Five-Year Self Assessment Burden¹

Number of Respondents	Five-Year Frequency per Response	Total Five-year Responses	Hours per Response2	Total Hours2
40	1	40	100/40	4,000/1,600
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.

Table 3.—Estimated Annual Improvement Plan Burden

No. of Respondents	Annual Frequency Per Response	Total Annual Responses	Hours per Response	Total Hours
40	1	40	5	200

Dated: December 11, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.