[Federal Register Volume 72, Number 88 (Tuesday, May 8, 2007)]
[Notices]
[Pages 26132-26134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8783]



[[Page 26132]]

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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; Food and Drug 
Administration Survey of Current Manufacturing Practices in the Food 
Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 June 7, 
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. 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 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 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 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 its 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 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 Internet 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

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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 regarding the collection entitled ``FDA 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 these 
topics: (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 1) 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 the 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 2) 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 3) 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 socio-demographic 
characteristics differ systematically from survey responders. Survey 
researchers should always try to follow up 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 4) We are not investigating foreign manufacturers; we are 
surveying them to get an idea about their manufacturing practices. 
Nearly 20 percent 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 the 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 questions only                                          17,000                     1             17,000                .067              1,139
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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 questions only                                          14,000                     1             14,000                .067                938
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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.

    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: May 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8783 Filed 5-7-07; 8:45 am]
BILLING CODE 4160-01-S