Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers, 11783-11786 [2011-4474]
Download as PDF
Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
srobinson on DSKHWCL6B1PROD with NOTICES
Recovery and Reinvestment Act of 2009
(ARRA). For ease of reference, the APOE
will be exclusively referred to by its
new name in the remainder of this
notice, even if it is referring to past
activities.
The charter will terminate on January
21, 2013, unless renewed by appropriate
action. The APOE was chartered under
42 U.S.C. 222 of the PHSA, as amended.
The APOE is governed by provisions of
Public Law 92–463, as amended (5
U.S.C. Appendix 2), which sets forth
standards for the formation and use of
advisory committees.
Pursuant to the amended charter, the
APOE will advise the Secretary of
Health and Human Services and the
CMS Administrator concerning optimal
strategies for the following:
• Developing and implementing
education and outreach programs for
individuals enrolled in or eligible for
Medicare, Medicaid, and CHIP.
• Enhancing the Federal
government’s effectiveness in informing
the Medicare, Medicaid and CHIP
consumers, providers and stakeholders
pursuant to education and outreach
programs of issues regarding these and
other health coverage programs,
including the appropriate use of publicprivate partnerships to leverage the
resources of the private sector in
educating beneficiaries, providers and
stakeholders.
• Expanding outreach to vulnerable
and underserved communities,
including racial and ethnic minorities,
in the context of Medicare, Medicaid,
and CHIP education programs.
• Assembling and sharing an
information base of ‘‘best practices’’ for
helping consumers evaluate health plan
options.
• Building and leveraging existing
community infrastructures for
information, counseling and assistance.
• Drawing the program link between
outreach and education, promoting
consumer understanding of health care
coverage choices and facilitating
consumer selection/enrollment, which
in turn support the overarching goal of
improved access to quality care,
including prevention services,
envisioned under health care reform.
B. Requests for Nominations
The APOE shall consist of no more
than 20 members. The Chair shall either
be appointed from among the 20
members, or a Federal official will be
designated to serve as the Chair. The
charter requires that meetings shall be
held approximately four times per year.
Members will be expected to attend all
meetings. The members and the Chair
shall be selected from authorities
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knowledgeable in one or more of the
following fields:
• Senior citizen advocacy.
• Outreach to minority communities.
• Health communications.
• Disease-related advocacy.
• Disability policy and access.
• Health economics research.
• Health insurers and plans.
• Health IT.
• Direct patient care.
• Matters of labor and retirement.
Representatives of the general public
may also serve on the APOE.
This notice also announces that as of
January 2011, there are 12 expired terms
of membership. This notice is an
invitation to interested organizations or
individuals to submit their nominations
for membership on the APOE. The CMS
Administrator will appoint new
members to the APOE from among those
candidates determined to have the
expertise required to meet specific
agency needs, and in a manner to ensure
an appropriate balance of membership.
We have an interest in ensuring that the
interests of both women and men,
members of all racial and ethnic groups,
and physically challenged individuals
are adequately represented on the
APOE. Therefore, we encourage
nominations of qualified candidates
who can represent these interests. Any
interested person may nominate one or
more qualified persons.
Current members whose terms
expired in 2010 or 2011 may be
considered for reappointment, subject to
committee service guidelines.
Each nomination must state that the
nominee has expressed a willingness to
serve as a Panel member and must be
accompanied by a curricula vitae and a
brief biographical summary of the
nominee’s experience.
While we are looking for experts in a
number of fields, our most critical needs
are for experts in health disparities,
State Health Insurance Assistance
Programs (SHIPs), health insurance
plans, aging, Web health education, eprescribing, retirement/financial
planning, health research, public health
and prevention, caregiving, CHIP, health
insurance exchanges, and minority
health education.
We are requesting that all curricula
vitae include the following:
• Date of birth.
• Place of birth.
• Title and current position.
• Professional affiliation.
• Home and business address.
• Telephone and fax numbers.
• E-mail address.
• List of areas of expertise.
Phone interviews of nominees may
also be requested after review of the
nominations.
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11783
In order to permit an evaluation of
possible sources of conflict of interest,
potential candidates will be asked to
provide detailed information concerning
such matters as financial holdings,
consultancies, and research grants or
contracts.
Members are invited to serve for 2year terms, contingent upon the renewal
of the APOE by appropriate action prior
to its termination. A member may serve
after the expiration of that member’s
term until a successor takes office. Any
member appointed to fill a vacancy for
an unexpired term shall be appointed
for the remainder of that term.
III. Copies of the Charter
The Secretary’s Charter for the APOE
is available on the CMS Web site at:
https://www.cms.gov/FACA/
04_APOE.asp, or you may obtain a copy
of the charter by submitting a request to
the contact listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice.
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: February 25, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2011–4754 Filed 2–28–11; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0265] (formerly
Docket 2007N–0026)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Canning
Establishment Registration, Process
Filing, and Recordkeeping for Acidified
Foods and Thermally Processed LowAcid Foods in Hermetically Sealed
Containers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(the PRA).
SUMMARY:
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Fax written comments on the
collection of information by April 4,
2011.
DATES:
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0037. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
srobinson on DSKHWCL6B1PROD with NOTICES
Food Canning Establishment
Registration, Process Filing, and
Recordkeeping for Acidified Foods and
Thermally Processed Low-Acid Foods
in Hermetically Sealed Containers—
(OMB Control Number 0910–0037)—
Revision
Under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), FDA is
authorized to prevent the interstate
distribution of food products that may
be injurious to health or that are
otherwise adulterated, as defined in
section 402 of the FD&C Act (21 U.S.C.
342). Under the authority granted to
FDA by section 404 of the FD&C Act (21
U.S.C. 344), FDA regulations require
registration of food processing
establishments, filing of process or other
data, and maintenance of processing
and production records for acidified
foods and thermally processed low-acid
foods in hermetically sealed containers.
These requirements are intended to
ensure safe manufacturing, processing,
and packing procedures and to permit
FDA to verify that these procedures are
being followed. Improperly processed
low-acid foods present life-threatening
hazards if contaminated with foodborne
microorganisms, especially Clostridium
botulinum. The spores of C. botulinum
must be destroyed or inhibited to avoid
production of the deadly toxin that
causes botulism. This is accomplished
with good manufacturing procedures,
which must include the use of adequate
heat processes or other means of
preservation.
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To protect the public health, FDA
regulations require that each firm that
manufactures, processes, or packs
acidified foods or thermally processed
low-acid foods in hermetically sealed
containers for introduction into
interstate commerce register the
establishment with FDA using Form
FDA 2541 (§§ 108.25(c)(1) and
108.35(c)(1) (21 CFR 108.25(c)(1) and
108.35(c)(1))). In addition to registering
the plant, each firm is required to
provide data on the processes used to
produce these foods, using Form FDA
2541a for all methods except aseptic
processing, or Form FDA 2541c for
aseptic processing of low-acid foods in
hermetically sealed containers
(§§ 108.25(c)(2) and 108.35(c)(2)). Plant
registration and process filing may be
accomplished simultaneously. Process
data must be filed prior to packing any
new product (§§ 108.25(c)(2) and
108.35(c)(2)). For processors of
thermally processed low-acid foods in
hermetically sealed containers,
operating processes and procedures
must be posted near the processing
equipment or made available to the
operator (§ 113.87(a) (21 CFR
113.87(a))).
Regulations in parts 108, 113, and 114
(21 CFR parts 108, 113, and 114) require
firms to maintain records showing
adherence to the substantive
requirements of the regulations. These
records must be made available to FDA
on request. Firms are also required to
document corrective actions when
process controls and procedures do not
fall within specified limits (§§ 113.89,
114.89, and 114.100(c)); to report any
instance of potential health-endangering
spoilage, process deviation, or
contamination with microorganisms
where any lot of the food has entered
distribution in commerce (§ 108.25(d)
and § 108.35(d) and (e)); and to develop
and keep on file plans for recalling
products that may endanger the public
health (§§ 108.25(e) and 108.35(f)). To
permit lots to be traced after
distribution, acidified foods and
thermally processed low-acid foods in
hermetically sealed containers must be
marked with an identifying code
(§§ 113.60(c) (thermally processed
foods) and 114.80(b) (acidified foods)).
These collection of information
provisions are currently approved under
OMB control number 0910–0037
(expires August 31, 2011). In the
Federal Register of March 14, 2007 (72
FR 11990), FDA published a proposed
rule entitled ‘‘Temperature-Indicating
Devices; Thermally Processed Low-Acid
Foods Packaged in Hermetically Sealed
Containers’’ (the proposed rule). This
document proposed to revise FDA’s
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regulations for thermally processed lowacid foods in part 113 to, among other
things, provide for the use of
temperature-indicating devices other
than mercury-in-glass thermometers
during processing, require that
temperature-indicating devices be tested
for accuracy against a calibrated
reference device, and to establish
recordkeeping requirements for
temperature-indicating devices and
reference devices maintained by the
processor. In compliance with the PRA
(44 U.S.C. 3506(c)(2)(B)), the Agency
requested public comment on the
information collection provisions of the
proposed rule (72 FR 11990 at 12004).
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
entitled ‘‘Temperature-Indicating
Devices; Thermally Processed Low-Acid
Foods Packaged in Hermetically Sealed
Containers’’ (the final rule). The final
rule revises the information collection
currently approved under OMB control
number 0910–0037 by adding
recordkeeping requirements in new
§ 113.100(c) and (d). The information to
be recorded under these regulations is
related to accuracy tests of temperatureindicating devices and reference devices
maintained by processors of low-acid
canned foods. These tests must be
performed to ensure the accuracy of the
devices during the processing of these
foods. If these devices are not accurate,
the processor cannot ensure that the
low-acid canned foods it produces are
safe to eat, and consumers may be
harmed. The recordkeeping
requirements of the final rule are
necessary to document that appropriate
accuracy tests have been performed
with the appropriate frequencies for
each temperature-indicating device and
each reference device maintained by the
processor. Records of accuracy tests for
these devices also help processors
determine how frequently the devices
should be tested for accuracy. Much of
the information is currently generated
for accuracy tests performed under
current regulations. However, the
information may not be recorded as
required under the final rule.
Current low-acid canned food
regulations recommend, but do not
require, that processors keep records of
accuracy tests for mercury-in-glass
thermometers, including test date,
standard used, method used, and person
performing the test. The final rule
requires processors to keep records
documenting the accuracy of
temperature-indicating devices
(including but not limited to mercuryin-glass thermometers) and of reference
devices that are maintained by the
processor. These records include the
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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
identifier of the device being tested,
such as its tag or seal; the name of the
manufacturer of the device; the identity
of the reference device, equipment, and
procedures used for the accuracy test
and to adjust the device or, if an outside
facility conducts the accuracy test,
documentation regarding the
traceability of the accuracy to a National
Institute of Standards and Technology
or other national metrology institute
standard; the identity of the person or
facility that performed the accuracy test
and adjusted or calibrated the device;
the date and results of each accuracy
test, including the amount of
adjustment; and the date on or before
which the next accuracy test must be
performed.
In addition to requesting public
comment on the new recordkeeping
provisions, the proposed rule also stated
that FDA had submitted the
recordkeeping provisions to OMB for
review (72 FR 11990 at 12005).
However, due to an administrative error,
the Agency did not actually do so, and,
therefore, FDA is submitting them to
OMB now. Because OMB approval for
the collections of information in the
regulations the final rule amends is set
to expire on August 31, 2011, FDA is
also submitting those collections (as
revised by the final rule) for OMB
review, along with the others currently
approved under OMB control number
0910–0037.
Description of Respondents: The
respondents to this information
collection are commercial processors
and packers of acidified foods and
thermally processed low-acid foods in
hermetically sealed containers.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency
per response
Number of
respondents
Total annual
responses
Form No.
21 CFR section
Form FDA 2541 (Registration)
Form FDA 2541a (Process Filing).
Form FDA 2541c (Process Filing).
108.25 and 108.35 ....
108.25 and 108.35 ....
515
1,489
1
8.62
515
12,835
108.35 .......................
84
7.77
653
Total ..................................
....................................
........................
..........................
........................
Hours per
response
1 There
.17
.333
.75
..........................
Total hours
88
4,274
490
4,852
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimates of the number
of respondents and the hours per
response on its experience with
registration and process filing and on
information from industry. FDA
estimates the total burden of registration
under §§ 108.25 and 108.35 to be 88
hours (515 respondents × 1 annual
response × 0.17 hours = 87.55 hours,
rounded to 88 hours). FDA estimates the
total burden of process filing on Form
FDA 2541a under §§ 108.25 and 108.35
to be 4,274 hours (1,489 respondents ×
8.62 annual responses × 0.333 hours =
4,274.12 hours, rounded to 4,274 hours).
FDA estimates the total burden of
process filing on Form FDA 2541c
under § 108.35 to be 490 hours (84
respondents × 7.77 annual responses ×
0.75 hours = 489.51 hours, rounded to
490 hours). The reporting burden for
§ 108.25(d) and § 108.35(d) and (e) is
minimal because notification of
spoilage, process deviation, or
contamination of product in distribution
occurs less than once per year. Most
firms discover these problems before the
product is distributed and, therefore, are
not required to report the occurrence.
To avoid double-counting, estimates for
§§ 108.25(g) and 108.35(h) have not
been included because they merely
cross-reference recordkeeping
requirements contained in parts 113 and
114.
FDA permits electronic registration
and filing on the Internet. The electronic
submission capability of the Low Acid
Canned Food (LACF) Program entitled
eLACF was the second major
registration application to be supported
by and integrated under the FDA
Unified Registration and Listing System
(FURLs). Food canning establishments
can request an electronic account by
sending an e-mail to lacf@fda.hhs.gov.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
Annual
frequency of
recordkeeping
21 CFR Parts 113 and 114 .................................................
Burden added by new § 113.100(c) and (d) ........................
9,500
4,225
1
15
9,500
63,375
250
0.0097
2,375,000
615
Total ..............................................................................
........................
........................
........................
........................
2,375,615
21 CFR part/section
srobinson on DSKHWCL6B1PROD with NOTICES
1 There
Total annual
records
Hours per
record
Total hours
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA received six letters, each
containing one or more comments on
the proposed rule. Although the Agency
did not identify any comments referring
specifically to the PRA, several
comments discussed the proposed
recordkeeping provisions. FDA has
summarized and responded to these
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comments in section II of the final rule
(Comments 1, 4, 11 through 13, and 18).
None of the comments on the proposed
rule suggested that we modify our
burden estimates for the new
information collection provisions. Thus,
we have not changed our estimates of
the annual frequency per recordkeeping
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Sfmt 4703
or the hours per record. We have,
however, increased the estimated
number of recordkeepers to reflect
growth in the low-acid canned food
processing industry since the 2007
proposed rule.
Currently, there are 9,491 active firms
in the LACF database, which
encompasses processors of low-acid
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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices
canned food, processors of acidified
food, and processors of both types of
food. Thus, we estimate the number of
processors keeping records under parts
113 and 114 to be 9,500, as shown in
table 2, row 1 of this document. In the
final rule, we estimated that there are
approximately 8,450 foreign and
domestic low-acid canned food
processing establishments. This
estimate, which does not encompass
establishments that process only
acidified foods (because such processors
are not affected by the final rule), was
based on data in the LACF database as
of September 2009. As discussed in the
explanation of the recordkeeping
estimate for the final rule in the
following paragraphs, our estimate
assumes that half of the LACF industry
currently does not record all of the
device accuracy testing information that
the final rule requires. Thus, as shown
in table 2, row 2 of this document, we
estimate that 4,225 low-acid canned
food manufacturers that are not
currently keeping the records that are
required under the final rule will begin
to keep such records to comply with the
final rule when it becomes effective.
FDA bases its estimates of the number
of recordkeepers and the hours per
record on its experience and on
information from industry. FDA
estimates that it takes 250 hours per
respondent to comply with the
recordkeeping requirements in parts 113
and 114. In table 2, row 1 of this
document, FDA estimates the total
burden of recordkeeping under parts
113 and 114 before the effective date of
the final rule to be 2,375,000 hours
(9,500 respondents × 250 hours =
2,375,000 hours). Table 2, row 2 reports
the average annual recordkeeping
burden of the final rule. The burden of
the recordkeeping requirement of the
final rule consists of the set-up time
required to design and establish a form
for recording the required information,
and the additional hours of labor
needed to record the information. The
set-up time required for designing a new
recordkeeping form is assumed to be
minimal because we estimate that only
a few data elements required in the final
rule are currently unreported by some
processors and that only small
modifications to a processor’s
recordkeeping form would be required
to accommodate the additional data
elements.
We estimate that the amount of time
needed to comply with the
recordkeeping requirements of the final
rule will be small because current
industry practice is to keep track of
most, if not all, of this information.
Because current incentives to track
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accuracy of mercury-in-glass
thermometers may vary across the
industry, however, some information
that is currently generated during
accuracy tests may not be recorded as
required under the final rule. Thus, we
assume there will be a burden incurred
from the final rule to record information
that is currently generated, but not
recorded.
We assume that half of the industry
currently does not record all of the
device accuracy testing information that
the final rule requires. We further
assume that current practice by these
firms is to leave unrecorded 1 to 4
separate pieces of information required
under the final rule, and that each piece
of information takes between 10 and 15
seconds to record. Consequently, we
estimate that half of all low-acid canned
food manufacturers will spend between
10 seconds and 1 minute (i.e., 1 × 10
seconds and 4 × 15 seconds) per device
to record information required in the
final rule.
Based on a survey conducted by FDA
between 1992 and 1993 of mercury-inglass thermometer calibration in the
low-acid canned food industry, we
estimate that low-acid food firms use an
average of 10 temperature-indicating
devices, including reference devices.
We estimate that 4,225 low-acid canned
food manufacturers (half of the
industry) currently do not fully record
the accuracy test results required by the
final rule. Because the regulations
specify that each device must be tested
upon installation and at least once per
year thereafter, or more frequently if
necessary to ensure accuracy, we
estimate that each device requires 1 to
2 tests per year (midpoint of 1.5 tests
per year). We therefore estimate the
annual frequency per recordkeeping to
be 15 (i.e., 10 devices × 1.5 tests per
year). We estimate the burden for
recording the additional information to
be between 10 and 60 seconds per
device (midpoint of 35 seconds or
0.0097 hours per device). Therefore, the
estimated total annual burden in hours
for the recordkeeping requirements of
the final rule is approximately 615
hours (63,375 × 0.0097 = 614.7 hours,
rounded to 615 hours). Thus, the final
rule increases the total burden of this
information collection by approximately
0.3 percent, from 2,375,000 hours to
2,375,615 hours.
Dated: February 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–4474 Filed 3–2–11; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0583]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Radioactive Drug
Research Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 April 4,
2011.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0053. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
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.
SUMMARY:
Radioactive Drug Research
Committees—(OMB Control Number
0910–0053)—Extension
Under sections 201, 505, and 701 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321, 355, and 371), FDA
has the authority to issue regulations
governing the use of radioactive drugs
for basic scientific research. Section
361.1 (21 CFR 361.1) sets forth specific
regulations regarding the establishment
and composition of Radioactive Drug
Research Committees and their role in
approving and monitoring basic
research studies utilizing
radiopharmaceuticals. No basic research
E:\FR\FM\03MRN1.SGM
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Agencies
[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11783-11786]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4474]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0265] (formerly Docket 2007N-0026)
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Canning
Establishment Registration, Process Filing, and Recordkeeping for
Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically
Sealed Containers
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 (the PRA).
[[Page 11784]]
DATES: Fax written comments on the collection of information by April
4, 2011.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0037.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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.
Food Canning Establishment Registration, Process Filing, and
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid
Foods in Hermetically Sealed Containers--(OMB Control Number 0910-
0037)--Revision
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA
is authorized to prevent the interstate distribution of food products
that may be injurious to health or that are otherwise adulterated, as
defined in section 402 of the FD&C Act (21 U.S.C. 342). Under the
authority granted to FDA by section 404 of the FD&C Act (21 U.S.C.
344), FDA regulations require registration of food processing
establishments, filing of process or other data, and maintenance of
processing and production records for acidified foods and thermally
processed low-acid foods in hermetically sealed containers. These
requirements are intended to ensure safe manufacturing, processing, and
packing procedures and to permit FDA to verify that these procedures
are being followed. Improperly processed low-acid foods present life-
threatening hazards if contaminated with foodborne microorganisms,
especially Clostridium botulinum. The spores of C. botulinum must be
destroyed or inhibited to avoid production of the deadly toxin that
causes botulism. This is accomplished with good manufacturing
procedures, which must include the use of adequate heat processes or
other means of preservation.
To protect the public health, FDA regulations require that each
firm that manufactures, processes, or packs acidified foods or
thermally processed low-acid foods in hermetically sealed containers
for introduction into interstate commerce register the establishment
with FDA using Form FDA 2541 (Sec. Sec. 108.25(c)(1) and 108.35(c)(1)
(21 CFR 108.25(c)(1) and 108.35(c)(1))). In addition to registering the
plant, each firm is required to provide data on the processes used to
produce these foods, using Form FDA 2541a for all methods except
aseptic processing, or Form FDA 2541c for aseptic processing of low-
acid foods in hermetically sealed containers (Sec. Sec. 108.25(c)(2)
and 108.35(c)(2)). Plant registration and process filing may be
accomplished simultaneously. Process data must be filed prior to
packing any new product (Sec. Sec. 108.25(c)(2) and 108.35(c)(2)). For
processors of thermally processed low-acid foods in hermetically sealed
containers, operating processes and procedures must be posted near the
processing equipment or made available to the operator (Sec. 113.87(a)
(21 CFR 113.87(a))).
Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and
114) require firms to maintain records showing adherence to the
substantive requirements of the regulations. These records must be made
available to FDA on request. Firms are also required to document
corrective actions when process controls and procedures do not fall
within specified limits (Sec. Sec. 113.89, 114.89, and 114.100(c)); to
report any instance of potential health-endangering spoilage, process
deviation, or contamination with microorganisms where any lot of the
food has entered distribution in commerce (Sec. 108.25(d) and Sec.
108.35(d) and (e)); and to develop and keep on file plans for recalling
products that may endanger the public health (Sec. Sec. 108.25(e) and
108.35(f)). To permit lots to be traced after distribution, acidified
foods and thermally processed low-acid foods in hermetically sealed
containers must be marked with an identifying code (Sec. Sec.
113.60(c) (thermally processed foods) and 114.80(b) (acidified foods)).
These collection of information provisions are currently approved
under OMB control number 0910-0037 (expires August 31, 2011). In the
Federal Register of March 14, 2007 (72 FR 11990), FDA published a
proposed rule entitled ``Temperature-Indicating Devices; Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers''
(the proposed rule). This document proposed to revise FDA's regulations
for thermally processed low-acid foods in part 113 to, among other
things, provide for the use of temperature-indicating devices other
than mercury-in-glass thermometers during processing, require that
temperature-indicating devices be tested for accuracy against a
calibrated reference device, and to establish recordkeeping
requirements for temperature-indicating devices and reference devices
maintained by the processor. In compliance with the PRA (44 U.S.C.
3506(c)(2)(B)), the Agency requested public comment on the information
collection provisions of the proposed rule (72 FR 11990 at 12004).
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule entitled ``Temperature-Indicating Devices; Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers''
(the final rule). The final rule revises the information collection
currently approved under OMB control number 0910-0037 by adding
recordkeeping requirements in new Sec. 113.100(c) and (d). The
information to be recorded under these regulations is related to
accuracy tests of temperature-indicating devices and reference devices
maintained by processors of low-acid canned foods. These tests must be
performed to ensure the accuracy of the devices during the processing
of these foods. If these devices are not accurate, the processor cannot
ensure that the low-acid canned foods it produces are safe to eat, and
consumers may be harmed. The recordkeeping requirements of the final
rule are necessary to document that appropriate accuracy tests have
been performed with the appropriate frequencies for each temperature-
indicating device and each reference device maintained by the
processor. Records of accuracy tests for these devices also help
processors determine how frequently the devices should be tested for
accuracy. Much of the information is currently generated for accuracy
tests performed under current regulations. However, the information may
not be recorded as required under the final rule.
Current low-acid canned food regulations recommend, but do not
require, that processors keep records of accuracy tests for mercury-in-
glass thermometers, including test date, standard used, method used,
and person performing the test. The final rule requires processors to
keep records documenting the accuracy of temperature-indicating devices
(including but not limited to mercury-in-glass thermometers) and of
reference devices that are maintained by the processor. These records
include the
[[Page 11785]]
identifier of the device being tested, such as its tag or seal; the
name of the manufacturer of the device; the identity of the reference
device, equipment, and procedures used for the accuracy test and to
adjust the device or, if an outside facility conducts the accuracy
test, documentation regarding the traceability of the accuracy to a
National Institute of Standards and Technology or other national
metrology institute standard; the identity of the person or facility
that performed the accuracy test and adjusted or calibrated the device;
the date and results of each accuracy test, including the amount of
adjustment; and the date on or before which the next accuracy test must
be performed.
In addition to requesting public comment on the new recordkeeping
provisions, the proposed rule also stated that FDA had submitted the
recordkeeping provisions to OMB for review (72 FR 11990 at 12005).
However, due to an administrative error, the Agency did not actually do
so, and, therefore, FDA is submitting them to OMB now. Because OMB
approval for the collections of information in the regulations the
final rule amends is set to expire on August 31, 2011, FDA is also
submitting those collections (as revised by the final rule) for OMB
review, along with the others currently approved under OMB control
number 0910-0037.
Description of Respondents: The respondents to this information
collection are commercial processors and packers of acidified foods and
thermally processed low-acid foods in hermetically sealed containers.
FDA estimates the burden of this information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Form No. 21 CFR section Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 2541 (Registration)........ 108.25 and 108.35................. 515 1 515 .17 88
Form FDA 2541a (Process Filing)..... 108.25 and 108.35................. 1,489 8.62 12,835 .333 4,274
Form FDA 2541c (Process Filing)..... 108.35............................ 84 7.77 653 .75 490
-------------------------------------------------------------------------------------------------------------------
Total........................... .................................. .............. .............. .............. .............. 4,852
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimates of the number of respondents and the hours
per response on its experience with registration and process filing and
on information from industry. FDA estimates the total burden of
registration under Sec. Sec. 108.25 and 108.35 to be 88 hours (515
respondents x 1 annual response x 0.17 hours = 87.55 hours, rounded to
88 hours). FDA estimates the total burden of process filing on Form FDA
2541a under Sec. Sec. 108.25 and 108.35 to be 4,274 hours (1,489
respondents x 8.62 annual responses x 0.333 hours = 4,274.12 hours,
rounded to 4,274 hours). FDA estimates the total burden of process
filing on Form FDA 2541c under Sec. 108.35 to be 490 hours (84
respondents x 7.77 annual responses x 0.75 hours = 489.51 hours,
rounded to 490 hours). The reporting burden for Sec. 108.25(d) and
Sec. 108.35(d) and (e) is minimal because notification of spoilage,
process deviation, or contamination of product in distribution occurs
less than once per year. Most firms discover these problems before the
product is distributed and, therefore, are not required to report the
occurrence. To avoid double-counting, estimates for Sec. Sec.
108.25(g) and 108.35(h) have not been included because they merely
cross-reference recordkeeping requirements contained in parts 113 and
114.
FDA permits electronic registration and filing on the Internet. The
electronic submission capability of the Low Acid Canned Food (LACF)
Program entitled eLACF was the second major registration application to
be supported by and integrated under the FDA Unified Registration and
Listing System (FURLs). Food canning establishments can request an
electronic account by sending an e-mail to lacf@fda.hhs.gov.
Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR part/section Number of frequency of Total annual Hours per Total hours
recordkeepers recordkeeping records record
----------------------------------------------------------------------------------------------------------------
21 CFR Parts 113 and 114........ 9,500 1 9,500 250 2,375,000
Burden added by new Sec. 4,225 15 63,375 0.0097 615
113.100(c) and (d).............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,375,615
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA received six letters, each containing one or more comments on
the proposed rule. Although the Agency did not identify any comments
referring specifically to the PRA, several comments discussed the
proposed recordkeeping provisions. FDA has summarized and responded to
these comments in section II of the final rule (Comments 1, 4, 11
through 13, and 18). None of the comments on the proposed rule
suggested that we modify our burden estimates for the new information
collection provisions. Thus, we have not changed our estimates of the
annual frequency per recordkeeping or the hours per record. We have,
however, increased the estimated number of recordkeepers to reflect
growth in the low-acid canned food processing industry since the 2007
proposed rule.
Currently, there are 9,491 active firms in the LACF database, which
encompasses processors of low-acid
[[Page 11786]]
canned food, processors of acidified food, and processors of both types
of food. Thus, we estimate the number of processors keeping records
under parts 113 and 114 to be 9,500, as shown in table 2, row 1 of this
document. In the final rule, we estimated that there are approximately
8,450 foreign and domestic low-acid canned food processing
establishments. This estimate, which does not encompass establishments
that process only acidified foods (because such processors are not
affected by the final rule), was based on data in the LACF database as
of September 2009. As discussed in the explanation of the recordkeeping
estimate for the final rule in the following paragraphs, our estimate
assumes that half of the LACF industry currently does not record all of
the device accuracy testing information that the final rule requires.
Thus, as shown in table 2, row 2 of this document, we estimate that
4,225 low-acid canned food manufacturers that are not currently keeping
the records that are required under the final rule will begin to keep
such records to comply with the final rule when it becomes effective.
FDA bases its estimates of the number of recordkeepers and the
hours per record on its experience and on information from industry.
FDA estimates that it takes 250 hours per respondent to comply with the
recordkeeping requirements in parts 113 and 114. In table 2, row 1 of
this document, FDA estimates the total burden of recordkeeping under
parts 113 and 114 before the effective date of the final rule to be
2,375,000 hours (9,500 respondents x 250 hours = 2,375,000 hours).
Table 2, row 2 reports the average annual recordkeeping burden of the
final rule. The burden of the recordkeeping requirement of the final
rule consists of the set-up time required to design and establish a
form for recording the required information, and the additional hours
of labor needed to record the information. The set-up time required for
designing a new recordkeeping form is assumed to be minimal because we
estimate that only a few data elements required in the final rule are
currently unreported by some processors and that only small
modifications to a processor's recordkeeping form would be required to
accommodate the additional data elements.
We estimate that the amount of time needed to comply with the
recordkeeping requirements of the final rule will be small because
current industry practice is to keep track of most, if not all, of this
information. Because current incentives to track accuracy of mercury-
in-glass thermometers may vary across the industry, however, some
information that is currently generated during accuracy tests may not
be recorded as required under the final rule. Thus, we assume there
will be a burden incurred from the final rule to record information
that is currently generated, but not recorded.
We assume that half of the industry currently does not record all
of the device accuracy testing information that the final rule
requires. We further assume that current practice by these firms is to
leave unrecorded 1 to 4 separate pieces of information required under
the final rule, and that each piece of information takes between 10 and
15 seconds to record. Consequently, we estimate that half of all low-
acid canned food manufacturers will spend between 10 seconds and 1
minute (i.e., 1 x 10 seconds and 4 x 15 seconds) per device to record
information required in the final rule.
Based on a survey conducted by FDA between 1992 and 1993 of
mercury-in-glass thermometer calibration in the low-acid canned food
industry, we estimate that low-acid food firms use an average of 10
temperature-indicating devices, including reference devices. We
estimate that 4,225 low-acid canned food manufacturers (half of the
industry) currently do not fully record the accuracy test results
required by the final rule. Because the regulations specify that each
device must be tested upon installation and at least once per year
thereafter, or more frequently if necessary to ensure accuracy, we
estimate that each device requires 1 to 2 tests per year (midpoint of
1.5 tests per year). We therefore estimate the annual frequency per
recordkeeping to be 15 (i.e., 10 devices x 1.5 tests per year). We
estimate the burden for recording the additional information to be
between 10 and 60 seconds per device (midpoint of 35 seconds or 0.0097
hours per device). Therefore, the estimated total annual burden in
hours for the recordkeeping requirements of the final rule is
approximately 615 hours (63,375 x 0.0097 = 614.7 hours, rounded to 615
hours). Thus, the final rule increases the total burden of this
information collection by approximately 0.3 percent, from 2,375,000
hours to 2,375,615 hours.
Dated: February 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-4474 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P