Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Current Manufacturing Practices in the Food Industry, 39623-39626 [E7-13951]
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39623
Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Notices
prior to 1900, but gradually more states
submitted monthly and annual
summaries. In 1912, state and territorial
health authorities—in conjunction with
PHS—recommended immediate
telegraphic reports of five diseases and
monthly reporting by letter of 10
additional diseases, but it was not until
after 1925 that all states reported
regularly. In 1942, the collection,
compilation, and publication of
morbidity statistics, under the direction
of the Division of Sanitary Reports and
Statistics, PHS, was transferred to the
Division of Public Health Methods,
PHS.
A PHS study in 1948 led to a revision
of the morbidity reporting procedures,
and in 1949 morbidity reporting
activities were transferred to the
National Office of Vital Statistics.
Another committee in PHS presented a
revised plan to the Association of State
and Territorial Health Officers (ASTHO)
at its meeting in Washington, DC,
October 1950. ASTHO authorized a
Conference of State and Territorial
Epidemiologists (CSTE) for the purpose
of determining the diseases that should
be reported by the states to PHS.
Beginning in 1951, national meetings of
CSTE were held every two years until
1974, then annually thereafter.
In 1961, responsibility for the
collection of data on nationally
notifiable diseases and deaths in 122
U.S. cities was transferred from the
National Office of Vital Statistics to
CDC. For over 40 years the Morbidity
and Mortality Weekly Report (MMWR)
has consistently served as the CDC
premier communication channel for
disease outbreaks and trends in health
and health behavior. The data collected
for publication in the MMWR provides
information which CDC and State
epidemiologists use to detail and more
effectively interrupt outbreaks.
Reporting also provides the timely
information needed to measure and
demonstrate the impact of changed
immunization laws or a new therapeutic
measure. Users of data include, but are
not limited to, congressional offices,
state and local health agencies, health
care providers, and other health related
groups.
The dissemination of public health
information is accomplished through
the MMWR series of publications. The
publications consist of the MMWR, the
CDC Surveillance Summaries, the
Recommendations and Reports, and the
Annual Summary of Notifiable Diseases.
There are no costs to respondents
except their time to participate in the
survey. The total estimated burden
hours are 4,927.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
States ...........................................................................................................................................
Territories .....................................................................................................................................
Average
burden per
respondent
(in hours)
Number of
responses per
respondent
Cities ............................................................................................................................................
50
4
1
2
52
52
52
52
1
1
30/60
1
Subtotals ...............................................................................................................................
City health officers or Vital statistics registrars ...........................................................................
States ...........................................................................................................................................
57
122
50
........................
52
1
........................
12/60
14
Territories .....................................................................................................................................
Cities ............................................................................................................................................
Subtotals ...............................................................................................................................
5
2
........................
1
1
........................
14
14
........................
Totals .............................................................................................................................
179
........................
........................
Dated: July 13, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–13985 Filed 7–18–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[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
ACTION:
Notice; reopening of comment
period.
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.
Fax written comments on the
collection of information by September
17, 2007.
DATES:
AGENCY:
Food and Drug Administration,
HHS.
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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
baguilar@omb.eop.gov. 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.
ADDRESSES:
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.
In the
Federal Register of May 8, 2007 (72 FR
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Notices
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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 FDAregistered 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
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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-tolabel 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
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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
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Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Notices
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 nonresponders 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 nonresponders 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 BURDEN1
No. of
Respondents
Activity
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Domestic Facilities
Screening questions only
17,000
1
17,000
.067
1,139
Completed Survey
44,500
1
44,500
.75
33,375
TOTAL DOMESTIC
61,500
61,500
34,514
Foreign Facilities
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Screening questions only
14,000
1
14,000
.067
938
Completed Survey
26,000
1
26,000
.75
19,500
TOTAL FOREIGN
40,000
1
40,000
GRAND TOTAL
101,500
1 There
20,438
54,952
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 72, No. 138 / Thursday, July 19, 2007 / Notices
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 https://
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of December 15, 2006
(71 FR 75554), the agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0533. The
approval expires on June 30, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: July 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–14010 Filed 7–18–07; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration
[Docket No. 2006N–0036]
Food and Drug Administration,
HHS.
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Experimental Study of Trans Fat
Claims on Foods
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Experimental Study of Possible
Footnotes and Cueing Schemes to Help
Consumers Interpret Quantitative Trans
Fat Disclosures on the Nutrition Facts
Panel’’ has been approved by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995.
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.
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC66 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Experimental Study of Trans Fat
Claims on Foods’’ has been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
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BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary
Registration of Cosmetic Product
Establishments
AGENCY:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Experimental Study of Possible
Footnotes and Cueing Schemes to
Help Consumers Interpret Quantitative
Trans Fat Disclosures on the Nutrition
Facts Panel
[Docket No. 2006N–0037]
AGENCY:
Dated: July 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–14011 Filed 7–18–07; 8:45 am]
[Docket No. 2007N–0278]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration
FR 10220), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0532. The
approval expires on June 30, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Notice.
In the
Federal Register of March 7, 2007 (72
SUPPLEMENTARY INFORMATION:
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Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in theFederal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the voluntary registration of cosmetic
product establishments with FDA.
DATES: Submit written or electronic
comments on the collection of
information by September 17, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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]]>Agencies
[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Notices]
[Pages 39623-39626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13951]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 baguilar@omb.eop.gov. 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\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Domestic ................. ................. ................. ................. .................
Facilities
----------------------------------------------------------------------------------------------------------------
Screening 17,000 1 17,000 .067 1,139
questions only
----------------------------------------------------------------------------------------------------------------
Completed Survey 44,500 1 44,500 .75 33,375
----------------------------------------------------------------------------------------------------------------
Total Domestic 61,500 ................. 61,500 ................. 34,514
----------------------------------------------------------------------------------------------------------------
Foreign ................. ................. ................. ................. .................
Facilities
----------------------------------------------------------------------------------------------------------------
Screening 14,000 1 14,000 .067 938
questions only
----------------------------------------------------------------------------------------------------------------
Completed Survey 26,000 1 26,000 .75 19,500
----------------------------------------------------------------------------------------------------------------
Total Foreign 40,000 1 40,000 ................. 20,438
----------------------------------------------------------------------------------------------------------------
Grand Total 101,500 ................. ................. ................. 54,952
----------------------------------------------------------------------------------------------------------------
\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 https://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
