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