Approved with change under the following conditions:
1) FDA will consider results of the pretest along with OMB comments on the survey instrument and provide a revised draft for review and approval prior to initiating the study.
2) FDA will report back the response rate and other summary information at the conclusion of the study. (A briefing would be very much appreciated).
Inventory as of this Action
Requested
Previously Approved
08/31/2011
36 Months From Approved
3,076
0
0
1,257
0
0
0
0
0
FDA's regulations in part 110 of Title 21 of the Code of Federal regulations (21 CFR part 110) describe the methods, equipment, facilities and controls for producing processed food, hereafter referred to as food CGMPs. As the minimum sanitary and processing requirements for producing safe and wholesome food, CGMPs are an important part of regulatory control of the nation's food supply. FDA believes that it is necessary to revisit and modernize the food CGMPs. Since the food CGMPs were last revised in 1986, there have been significant changes in food production technology and important advances in the understanding of foodborne illnesses. Accordingly, the agency will rigorously assess the impacts of any modernization policies on food facilities. To assess the impacts of the modernization policy, information is needed to help understand baseline or current industry practice. At present, however, FDA lacks baseline information on the nature of current manufacturing practices that would serve as part of a regulatory impact analysis.
FDA plans to conduct an Internet survey of all domestic FDA-registered facilities that primarily manufacture or process food and all foreign FDA-registered facilities that primarily manufacture or process food, which are located in those countries that are the largest food exporters to the United States: Japan, Canada, China, France, Italy and Mexico. The Internet survey may be supplemented by extended case study interviews with selected respondents from the survey. The survey and extended case studies will solicit detailed information about six key topics relevant to the food CGMPs modernization effort: employee training, sanitation and personal hygiene, allergen controls, process controls, post-production processing, and recordkeeping. Additionally, FDA will collect information on establishment characteristics, such as facility size and industry, which are expected to correlate with the presence or absence of various manufacturing practices, such as electronic recordkeeping, ongoing employee training in food safety, and product-to-label conformance procedures. The case study interviews, if conducted, will provide qualitative, in-depth information about various factors that influence decisions to implement these types of manufacturing practices, as well as about the circumstances that underlie the cost and effectiveness of such programs.
The authority for FDA to collect the information derives from the FDA Commissioner's authority to conduct research, as specified in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).
This is a new information collection. The increase in burden hours reflects the total number of hours necessary for the respondents to complete this new internet survey. FDA believes that it is necessary to revisit and modernize the food CGMPs. Since the food CGMPs were last revised in 1986, there have been significant changes in food production technology and important advances in the understanding of foodborne illnesses. Accordingly, the agency will rigorously assess the impacts of any modernization policies on food facilities. To assess the impacts of the modernization policy, information is needed to help understand baseline or current industry practice. At present, however, FDA lacks baseline information on the nature of current manufacturing practices that would serve as part of a regulatory impact analysis.
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.
Food GMP ssB 08-28-2008 (2).doc
Survey of Current Manufacturing Practices in the Food Industry