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, 45293-45295 [2017-20791]
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FDA’s normal procedures for timely
payment of the PDUFA fee for the
human drug application.
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currency by electronic check, check,
bank draft, wire transfer, credit card, or
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8455 Colesville Rd., 14th Floor, Silver
Spring, MD 20993–0002.
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V. Reference
The following reference is on display
in the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday.
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe,
‘‘Developing Drugs for Developing
Countries,’’ Health Affairs, vol. 25, no. 2,
pp. 313–324, 2006.
Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20798 Filed 9–27–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1119]
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
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 October 30,
2017.
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 emailed 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.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00038
Fmt 4703
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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:
I. Background
Food Canning Establishment
Registration, Process Filing, and
Recordkeeping for Acidified Foods and
Thermally Processed Low-Acid Foods
in Hermetically Sealed Containers 21
CFR 108.25 and 108.35, and Parts 113
and 114
OMB Control Number 0910–0037—
Extension
BILLING CODE 4164–01–P
AGENCY:
45293
Sfmt 4703
Section 402 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 342) deems a food to be
adulterated, in part, if the food bears or
contains any poisonous or deleterious
substance that may render it injurious to
health. Section 301(a) of the FD&C Act
(21 U.S.C. 331(a)) prohibits the
introduction or delivery for introduction
into interstate commerce of adulterated
food. Under section 404 of the FD&C
Act (21 U.S.C. 344), our 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
us 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
need to 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, our
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 us using Form FDA
2541 (§§ 108.25(c)(1) and 108.35(c)(2)
(21 CFR 108.25(c)(1) and 108.35(c)(2)).
In addition to registering the plant, each
firm is required to provide data on the
processes used to produce these foods,
using Forms FDA 2541d, FDA 2541e,
E:\FR\FM\28SEN1.SGM
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45294
Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices
and FDA 2541f for all methods except
aseptic processing, or Form FDA 2541g
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, and operating processes
and procedures must be posted near the
processing equipment or made available
to the operator (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 also must 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)).
The records of processing information
are periodically reviewed during factory
inspections by FDA to verify fulfillment
of the requirements in parts 113 or 114.
Scheduled thermal processes are
examined and reviewed to determine
their adequacy to protect public health.
In the event of a public health
emergency, records are used to pinpoint
potentially hazardous foods rapidly and
thus limit recall activity to affected lots.
As described in our regulations,
processors may obtain the paper
versions of Forms FDA 2541, FDA
2541d, FDA 2541e, FDA 2541f, and FDA
2541g by contacting us at a particular
address or by visiting https://
www.fda.gov/Food/Guidance
Regulation/FoodFacilityRegistration/
AcidifiedLACFRegistration/
ucm2007436.htm. Processors mail
completed paper forms to us. However,
processors who are subject to § 108.25,
§ 108.35, or both, have an option to
submit Forms FDA 2541, FDA 2541d,
FDA 2541e, FDA 2541f, and FDA 2541g
electronically (Ref. 1).
Although we encourage commercial
processors to use the electronic
submission system for plant registration
and process filing, we will continue to
make paper-based forms available. To
standardize the burden associated with
process filing, regardless of whether the
process filing is submitted electronically
or using a paper form, we are offering
the public the opportunity to use four
forms, each of which pertains to a
specific type of commercial processing
and is available both on the electronic
submission system and as a paper-based
form. The electronic submission system
and paper-based form ‘‘mirror’’ each
other to the extent practicable. The four
process filing forms are as follows:
• Form FDA 2541d (Food Process
Filing for Low-Acid Retorted Method)
(Ref. 2);
• Form FDA 2541e (Food Process
Filing for Acidified Method) (Ref. 3);
• Form FDA 2541f (Food Process
Filing for Water Activity/Formulation
Control Method) (Ref. 4); and
• Form FDA 2541g (Food Process
Filing for Low-Acid Aseptic Systems)
(Ref. 5).
At this time, the paper-based versions
of the four forms and their instructions
are all available for review as references
to this document (Refs. 2 through 5) or
at https://www.fda.gov/Food/Guidance
Regulation/FoodFacilityRegistration/
AcidifiedLACFRegistration/
ucm2007436.htm.
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.
In the Federal Register of June 20,
2017 (82 FR 28069), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. While no comments were
submitted to the docket, it was noted
that the notice included an inadvertent
reference to outdated forms. We regret
this oversight and have made
appropriate corrections in this notice.
The forms developed in support of the
information collection are intended to
minimize burden on respondents while
maximizing utility for FDA, and thus we
are continuously open to suggestions on
how they might be improved.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA
form number
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
(minutes)
Total hours
§§ 108.25(c)(1) and 108.35(c)(2); Food
canning establishment registration .......
2541
645
1
645
0.17
(10)
110
§ 108.25(c)(2); Food process filing for
acidified method ...................................
2541e
726
11
7,986
0.333
(20)
2,659
§ 108.35(c)(2); Food process filing for
low-acid retorted method ......................
2541d
336
12
4,032
0.333
(20)
1,343
§ 108.35(c)(2); Food process filing for
water activity/formulation control method ..........................................................
2541f
37
6
222
0.333
(20)
74
§ 108.35(c)(2); Food process filing for
low-acid aseptic systems .....................
2541g
42
22
924
0.75
(45)
693
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Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section
FDA
form number
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
§§ 108.25(d) and 108.35(d) and (e); Report of any instance of potential health
endangering spoilage, process deviation, or contamination with microorganisms where any lot of the food has
entered distribution in commerce .........
Total ..................................................
N/A
........................
1
........................
1
........................
Average
burden per
response
(minutes)
1
........................
1 There
Total hours
4
4,883
4
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of the number
of respondents in table 1 on
registrations, process filings, and reports
received over the past 3 years. The
hours per response reporting estimates
are based on our experience with
similar programs and information
received from industry. 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 a year. Most firms
discover these problems before the
product is distributed, and are therefore
not required to report the occurrence.
We estimate that we will receive one
report annually under §§ 108.25(d) and
108.35(d) and (e). The report is expected
to take 4 hours per response, for a total
of 4 hours.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
108, 113, and 114 ..........................................................
10,392
1
10,392
250
2,598,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of 10,392
recordkeepers in table 2 on its records
of the number of registered firms,
excluding firms that were inactive or
out of business, yet still registered. To
avoid double-counting, we have not
included estimates for §§ 108.25(g),
108.35(c)(2)(ii), and 108.35(h) because
they merely cross-reference
recordkeeping requirements contained
in parts 113 and 114 and have been
accounted for in the recordkeeping
burden estimate. We estimate that
10,392 firms will expend approximately
250 hours per year to fully satisfy the
recordkeeping requirements in parts
108, 113 and 114, for a total of 2,598,000
hours.
Finally, our regulations require that
processors mark thermally processed
low-acid foods in hermetically sealed
containers (§ 113.60(c)) and acidified
foods (§ 114.80(b)) with an identifying
code to permit lots to be traced after
distribution. We seek OMB approval of
the third-party disclosure requirements
in §§ 113.60(c) and 114.80(b). However,
we have not included a separate table to
report the estimated burden of these
regulations. No burden has been
estimated for the third-party disclosure
requirements in §§ 113.60(c) and
114.80(b) because the coding process is
done as a usual and customary part of
normal business activities. Coding is a
VerDate Sep<11>2014
18:44 Sep 27, 2017
Jkt 241001
business practice in foods for liability
purposes, inventory control, and
process control in the event of a
problem. Under 5 CFR 1320.3(b)(2), the
time, effort, and financial resources
necessary to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of activities. The
burden for this information collection
has not changed since the last OMB
approval.
II. References
The following references are on
display in the Dockets Management
Staff (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov/. FDA has verified
the Web site addresses as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. FDA 2016. ‘‘Guidance for Industry:
Submitting Form FDA 2541 (Food
Canning Establishment Registration) and
Forms FDA 2541d, FDA 2541e, FDA
PO 00000
Frm 00040
Fmt 4703
Sfmt 9990
2541f, and FDA 2541g (Food Process
Filing Forms) to FDA in Electronic or
Paper Format.’’ Available at https://
www.fda.gov/Food/GuidanceRegulation/
GuidanceDocumentsRegulatory
Information/AcidifiedLACF/
ucm309376.htm.
2. Form FDA 2541d. Food Process Filing for
Low-Acid Retorted Method. Available at
https://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/
Forms/UCM465591.pdf.
3. Form FDA 2541e. Food Process Filing for
Acidified Method. Available at https://
www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM465593.pdf.
4. Form FDA 2541f. Food Process Filing for
Water Activity/Formulation Control
Method. Available at https://
www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM465595.pdf.
5. Form FDA 2541g. Food Process Filing for
Low-Acid Aseptic Systems. Available at
https://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/
Forms/UCM465598.pdf.
Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20791 Filed 9–27–17; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Notices]
[Pages 45293-45295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1119]
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 or we) 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 October
30, 2017.
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 emailed 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@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.
I. Background
Food Canning Establishment Registration, Process Filing, and
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid
Foods in Hermetically Sealed Containers 21 CFR 108.25 and 108.35, and
Parts 113 and 114
OMB Control Number 0910-0037--Extension
Section 402 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 342) deems a food to be adulterated, in part, if the
food bears or contains any poisonous or deleterious substance that may
render it injurious to health. Section 301(a) of the FD&C Act (21
U.S.C. 331(a)) prohibits the introduction or delivery for introduction
into interstate commerce of adulterated food. Under section 404 of the
FD&C Act (21 U.S.C. 344), our 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 us 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 need to 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, our 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 us using Form FDA 2541 (Sec. Sec. 108.25(c)(1) and 108.35(c)(2)
(21 CFR 108.25(c)(1) and 108.35(c)(2)). In addition to registering the
plant, each firm is required to provide data on the processes used to
produce these foods, using Forms FDA 2541d, FDA 2541e,
[[Page 45294]]
and FDA 2541f for all methods except aseptic processing, or Form FDA
2541g 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, and
operating processes and procedures must be posted near the processing
equipment or made available to the operator (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 also must 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. Sec. 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 (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. 113.60(c))
(thermally processed foods) and Sec. 114.80(b) (acidified foods)).
The records of processing information are periodically reviewed
during factory inspections by FDA to verify fulfillment of the
requirements in parts 113 or 114. Scheduled thermal processes are
examined and reviewed to determine their adequacy to protect public
health. In the event of a public health emergency, records are used to
pinpoint potentially hazardous foods rapidly and thus limit recall
activity to affected lots.
As described in our regulations, processors may obtain the paper
versions of Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA
2541g by contacting us at a particular address or by visiting https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. Processors mail completed
paper forms to us. However, processors who are subject to Sec. 108.25,
Sec. 108.35, or both, have an option to submit Forms FDA 2541, FDA
2541d, FDA 2541e, FDA 2541f, and FDA 2541g electronically (Ref. 1).
Although we encourage commercial processors to use the electronic
submission system for plant registration and process filing, we will
continue to make paper-based forms available. To standardize the burden
associated with process filing, regardless of whether the process
filing is submitted electronically or using a paper form, we are
offering the public the opportunity to use four forms, each of which
pertains to a specific type of commercial processing and is available
both on the electronic submission system and as a paper-based form. The
electronic submission system and paper-based form ``mirror'' each other
to the extent practicable. The four process filing forms are as
follows:
Form FDA 2541d (Food Process Filing for Low-Acid Retorted
Method) (Ref. 2);
Form FDA 2541e (Food Process Filing for Acidified Method)
(Ref. 3);
Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method) (Ref. 4); and
Form FDA 2541g (Food Process Filing for Low-Acid Aseptic
Systems) (Ref. 5).
At this time, the paper-based versions of the four forms and their
instructions are all available for review as references to this
document (Refs. 2 through 5) or at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm.
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.
In the Federal Register of June 20, 2017 (82 FR 28069), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. While no comments were submitted to the
docket, it was noted that the notice included an inadvertent reference
to outdated forms. We regret this oversight and have made appropriate
corrections in this notice. The forms developed in support of the
information collection are intended to minimize burden on respondents
while maximizing utility for FDA, and thus we are continuously open to
suggestions on how they might be improved.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
FDA form Number of Number of Total annual burden per
21 CFR section number respondents responses per responses response Total hours
respondent (minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. Sec. 108.25(c)(1) and 108.35(c)(2); Food canning 2541 645 1 645 0.17 110
establishment registration............................. (10)
Sec. 108.25(c)(2); Food process filing for acidified 2541e 726 11 7,986 0.333 2,659
method................................................. (20)
Sec. 108.35(c)(2); Food process filing for low-acid 2541d 336 12 4,032 0.333 1,343
retorted method........................................ (20)
Sec. 108.35(c)(2); Food process filing for water 2541f 37 6 222 0.333 74
activity/formulation control method.................... (20)
Sec. 108.35(c)(2); Food process filing for low-acid 2541g 42 22 924 0.75 693
aseptic systems........................................ (45)
[[Page 45295]]
Sec. Sec. 108.25(d) and 108.35(d) and (e); Report of N/A 1 1 1 4 4
any instance of potential health endangering spoilage,
process deviation, or contamination with microorganisms
where any lot of the food has entered distribution in
commerce...............................................
Total............................................... .............. .............. .............. .............. 4,883
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of the number of respondents in table 1 on
registrations, process filings, and reports received over the past 3
years. The hours per response reporting estimates are based on our
experience with similar programs and information received from
industry. The reporting burden for Sec. Sec. 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 a
year. Most firms discover these problems before the product is
distributed, and are therefore not required to report the occurrence.
We estimate that we will receive one report annually under Sec. Sec.
108.25(d) and 108.35(d) and (e). The report is expected to take 4 hours
per response, for a total of 4 hours.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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108, 113, and 114............................................... 10,392 1 10,392 250 2,598,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of 10,392 recordkeepers in table 2 on its
records of the number of registered firms, excluding firms that were
inactive or out of business, yet still registered. To avoid double-
counting, we have not included estimates for Sec. Sec. 108.25(g),
108.35(c)(2)(ii), and 108.35(h) because they merely cross-reference
recordkeeping requirements contained in parts 113 and 114 and have been
accounted for in the recordkeeping burden estimate. We estimate that
10,392 firms will expend approximately 250 hours per year to fully
satisfy the recordkeeping requirements in parts 108, 113 and 114, for a
total of 2,598,000 hours.
Finally, our regulations require that processors mark thermally
processed low-acid foods in hermetically sealed containers (Sec.
113.60(c)) and acidified foods (Sec. 114.80(b)) with an identifying
code to permit lots to be traced after distribution. We seek OMB
approval of the third-party disclosure requirements in Sec. Sec.
113.60(c) and 114.80(b). However, we have not included a separate table
to report the estimated burden of these regulations. No burden has been
estimated for the third-party disclosure requirements in Sec. Sec.
113.60(c) and 114.80(b) because the coding process is done as a usual
and customary part of normal business activities. Coding is a business
practice in foods for liability purposes, inventory control, and
process control in the event of a problem. Under 5 CFR 1320.3(b)(2),
the time, effort, and financial resources necessary to comply with a
collection of information are excluded from the burden estimate if the
reporting, recordkeeping, or disclosure activities needed to comply are
usual and customary because they would occur in the normal course of
activities. The burden for this information collection has not changed
since the last OMB approval.
II. References
The following references are on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov/. FDA has
verified the Web site addresses as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. FDA 2016. ``Guidance for Industry: Submitting Form FDA 2541 (Food
Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e,
FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in
Electronic or Paper Format.'' Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/ucm309376.htm.
2. Form FDA 2541d. Food Process Filing for Low-Acid Retorted Method.
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465591.pdf.
3. Form FDA 2541e. Food Process Filing for Acidified Method.
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465593.pdf.
4. Form FDA 2541f. Food Process Filing for Water Activity/
Formulation Control Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465595.pdf.
5. Form FDA 2541g. Food Process Filing for Low-Acid Aseptic Systems.
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465598.pdf.
Dated: September 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20791 Filed 9-27-17; 8:45 am]
BILLING CODE 4164-01-P
