[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Notices]
[Pages 39623-39626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13951]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0349]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; FDA Survey of Current 
Manufacturing Practices in the Food Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
September 17, 2007, the comment period for a notice that published in 
the Federal Register of May 8, 2007 (72 FR 26132). In the notice, FDA 
announced that a proposed collection of information had been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA). FDA is reopening 
the comment period in light of continued public interest in this 
collection of information and in response to a request for an extension 
of the comment period for this notice.

DATES: Fax written comments on the collection of information by 
September 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: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number ``0910-NEW'' and title 
``FDA Survey of Current Manufacturing Practices in the Food Industry.'' 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 8, 2007 (72 
FR

[[Page 39624]]

26132), FDA solicited comments on a proposed collection of information 
that the agency had submitted to OMB for review and clearance under the 
PRA. Interested persons were given until June 7, 2007, to submit 
written comments by fax directly to OMB. As a result of continued 
public interest, and in response to a request to extend the comment 
period by 60 days, FDA is reopening the comment period until September 
17, 2007, to allow interested persons additional time to submit 
comments to OMB.
    In compliance with 44 U.S.C. 3507, FDA has submitted the following 
proposed collection of information to OMB for review and clearance.

FDA Survey of Current Manufacturing Practices in the Food Industry--
(OMB Control Number 0910-NEW)

    The authority for FDA to collect the information derives from the 
FDA Commissioner's authority, as specified in section 903(d)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).
    FDA's regulations in part 110 (21 CFR part 110) describe the 
methods, equipment, facilities and controls for producing processed 
food, hereafter referred to as food current good manufacturing 
practices (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, indepth 
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 survey will be sent to every FDA-registered facility in 
the United States, Japan, Canada, China, France, Italy, and Mexico that 
primarily manufactures or processes food products and that included an 
e-mail address with their registration. Participation will be voluntary 
and the respondent identifiers that would permit an association of 
specific responses to specific respondents will not be accessible to 
FDA.
    The proposed Internet survey will collect the information from 
respondents electronically. With a custom-designed online survey 
system, responses will be entered directly into a computer database, 
eliminating the need for additional coding and data entry operations. 
Also, the system will ensure that conditional questions are asked in 
proper order, freeing the respondent from the need to keep track of the 
question order and skip patterns. The data quality will also be higher 
because the instrument will contain built-in edits, prompts, and data 
validation features.
    The Internet survey method was selected due to the following 
considerations: (1) E-mail addresses of the respondents are available 
from the FDA Food Facility Registration database and are continuously 
validated by FDA; (2) the Internet survey method is the least costly to 
the agency when compared with other modes of collection and generates 
the timeliest responses; (3) the Internet survey will impose a 
relatively modest reporting burden on small entities; and (4) the 
Internet survey method is the only feasible method by which FDA may 
survey foreign facilities that export food products to the United 
States.
    The Internet survey includes a pledge of confidentiality regarding 
the contractor's use of the data provided by the respondents. All data 
will be collected and compiled by Eastern Research Group, Inc. (ERG), 
an independent consulting firm contracted by FDA. ERG will provide FDA 
personnel only with a summary of data (aggregated statistical data) 
compiled in the course of the study. No reports will have information 
about individual facility's participation or lack of participation, or 
information that enables FDA to determine individual responses. In 
keeping with longstanding FDA practice, ERG will not provide FDA with 
identifiers that would permit the association of specific responses 
with a given respondent. Responses will not be the property of the 
Federal Government. The raw data generated by the Food CGMP Survey will 
not be owned by FDA, will not be an FDA record, and will not be 
provided, or otherwise made available, to FDA.
    The key information to be collected includes responses to questions 
about the following: (1) Training procedures and practices for food 
production managers, production supervisors, quality control personnel, 
sanitation and cleaning supervisors and production line employees on 
the topics of food safety, basic cleaning, sanitizing, sanitation, 
personal hygiene, specific product and equipment training and allergen 
control; (2) pest control and sanitation procedures and practices for 
food contact surfaces, non-food contact surfaces, production areas and 
warehouses; (3) allergen control procedures and practices for soybean 
or soybean-based ingredients, peanuts or peanut-based ingredients, 
finfish and crustacea, tree nuts, milk and other diary products, eggs, 
and wheat or wheat-based products; (4) process controls, including 
written procedures for handling incoming raw materials, approving 
vendors, the calibration of operating equipment, pathogen control, and 
a Hazard Analysis and Critical Control Point system; (5) recordkeeping 
practices; (6) the primary operation characteristics conducted at the 
facility, such as the type of food manufactured or processed for human 
consumption; and (7) fresh produce and ready to eat packing practice 
and post-harvest operations.
    In the Federal Register of September 14, 2005 (70 FR 54390), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. We received comments from three respondents on 
the 60-day notice

[[Page 39625]]

regarding FDA's survey of current manufacturing practices in the food 
industry. One of the respondents' comments was received after the 60-
day comment period closed and is not addressed.
    Respondents were asked to submit comments pertaining to: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of FDA's functions, including whether the 
information will have practical utility; (2) the accuracy of FDA's 
estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology. Comments outside the scope of these four questions are not 
addressed in this notice.
    (Comment 1) One industry respondent wanted assurances from FDA that 
individual company information was not subject to release under the 
Freedom of Information Act (FOIA).
    (Response) The Internet survey includes a pledge of confidentiality 
regarding the data provided by the respondent. All data will be 
collected, compiled, and owned by ERG, an independent consulting firm 
contracted by FDA. ERG is contractually obligated to retain the raw 
data and to not provide FDA with access to it. ERG will provide FDA 
personnel only with anonymous summary and aggregate statistical data 
compiled during the course of the study; ERG is contractually 
restricted from providing FDA with raw or other data that has 
identifiers that would permit the association of specific responses to 
a given respondent. Data that FDA does not own cannot be requested 
through FOIA.
    (Comment 2) The respondent requests that only one contact be made 
for each individual firm through the parent company contact listed on 
the firm's facility registration form and not to each location where 
the firm has a production facility.
    (Response) We recognize the additional burden this places on a firm 
but because we need current information from each manufacturing plant 
we do not believe that we have an alternative approach. Not every 
facility processes the same types of foods with the same preventive 
controls even when the parent company is the same. We need to get an 
idea of CGMPs at each facility location. Having a parent company 
respond could give us inaccurate information.
    (Comment 3) The respondent requests that each firm (facility) 
receive only one solicitation for information.
    (Response) Response to this survey is voluntary. For the sake of 
statistical reliability, we must contact non-responders more than just 
initially or our survey data result could be subject to a non-response 
bias. Non-response bias is affected by both the proportion of non-
responders and the extent to which non-respondents and respondents 
differ on key questions being measured in the survey. To reduce the 
bias, it is necessary to reduce the number of non-responders by 
contacting them multiple times. It also helps to obtain information 
about non-responders to assess whether their sociodemographic 
characteristics differ systematically from survey responders. Survey 
researchers should always try to followup with individuals who do not 
consent to participate in a survey and ascertain their reasons for non-
response. We do recognize that there should be an upper limit for the 
number of times a non-responder should be contacted before being 
dropped. From our experience, data quality will not be improved 
significantly by more than six contacts, so we will set our upper limit 
at six contacts.
    (Comment 4) One respondent opposes investigating foreign 
manufacturers.
    (Response) We are not investigating foreign manufacturers; we are 
surveying them to get an idea about their manufacturing practices. 
Nearly 20% of all imports into the United States are food and food 
products; imported fresh produce and seafood make up a large percentage 
of these imports. All food, including imported and domestic food, must 
follow the same manufacturing regulations, thus information on foreign 
manufacturing processes is necessary and relevant to help inform us 
about how to modernize our regulation on CGMPs for food facilities.
    At that time of the 60-day notice, approximately 45,000 domestic 
and 55,000 foreign facilities were registered with FDA. Now 
approximately 126,000 domestic and 81,000 facilities from Japan, 
Canada, China, France, Italy, and Mexico are registered with FDA.Recent 
experience with online surveys has shown that fewer respondents respond 
than estimated at the time of the 60-day notice. Estimates of public 
burden have been adjusted to account for the increase in respondents 
and our estimate of the decrease in response rate.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
     Activity         Respondents        per Response        Responses           Response         Total Hours
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Domestic           .................  .................  .................  .................  .................
 Facilities
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Screening                     17,000                  1             17,000               .067              1,139
 questions only
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Completed Survey              44,500                  1             44,500                .75             33,375
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Total Domestic                61,500  .................             61,500  .................             34,514
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Foreign            .................  .................  .................  .................  .................
 Facilities
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Screening                     14,000                  1             14,000               .067                938
 questions only
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Completed Survey              26,000                  1             26,000                .75             19,500
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Total Foreign                 40,000                  1             40,000  .................             20,438
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Grand Total                  101,500  .................  .................  .................             54,952
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 39626]]

    These estimates of the number of respondents and the burden hours 
per response are based on FDA's registration database and FDA and the 
contractor's experience with previous surveys. The respondents are 
divided into two groups: Domestic and foreign. We estimate the number 
of domestic facilities at 126,000 based on information in the 
registration database. However, we do not expect that all of these 
firms will participate in the survey. We anticipate that approximately 
61,500 facilities will participate, which takes into account typical 
response rates to these types of surveys and inaccurate contact 
information that facilities have entered into the registration database 
(see http://www.cfsan.fda.gov/furls/ffregacc.html). Similarly, among 
the 81,000 foreign facilities in the registration database, we expect 
that 40,000 foreign facilities will respond.
    We estimate that it will take a respondent 4 minutes (.067 hours) 
to complete the screening questions and 45 minutes (0.75 hours) to 
complete the entire survey.
    Prior to the administration of the survey, the agency plans to 
conduct a pretest of the final survey to identify and resolve potential 
problems. The pretest will be conducted with nine participants.

    Dated: July 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13951 Filed 7-18-07; 8:45 am]
BILLING CODE 4160-01-S