Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers, 16990-16992 [2023-05742]
Download as PDF
<![CDATA[
16990
Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1119]
Agency Information Collection
Activities; Proposed Collection;
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 or the Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal 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 information
collection provisions of reporting and
recordkeeping requirements for firms
that process acidified foods and
thermally processed low-acid foods in
hermetically sealed containers.
DATES: Either electronic or written
comments on the collection of
information must be submitted by May
22, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 22, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
VerDate Sep<11>2014
19:23 Mar 20, 2023
Jkt 259001
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–1119 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Canning Establishment Registration,
Process Filing, and Recordkeeping for
Acidified Foods and Thermally
Processed Low-Acid Foods in
Hermetically Sealed Containers.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
E:\FR\FM\21MRN1.SGM
21MRN1
Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Notices
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.
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 21 CFR
Parts 113 and 114
OMB Control Number 0910–0037—
Extension
Section 402 of the Federal Food, Drug,
and Cosmetic Act (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)(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 Forms FDA 2541d, FDA 2541e,
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 lowacid foods) and § 114.80(b) (acidified
foods)).
The records of processing information
are periodically reviewed during factory
inspections by FDA to verify fulfillment
16991
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 version
of Forms FDA 2541, FDA 2541d, FDA
2541e, FDA 2541f, and FDA 2541g at
https://www.fda.gov/Food/
GuidanceRegulation/FoodFacility
Registration/AcidifiedLACFRegistration/
ucm2007436.htm. Processors mail
completed paper forms to us. However,
processors who are subject to § 108.25
and/or § 108.35 have an option to
submit Forms FDA 2541, FDA 2541d,
FDA 2541e, FDA 2541f, and FDA 2541g
electronically.
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);
• Form FDA 2541e (Food Process
Filing for Acidified Method);
• Form FDA 2541f (Food Process
Filing for Water Activity/Formulation
Control Method); and
• Form FDA 2541g (Food Process
Filing for Low-Acid Aseptic Systems).
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.
We estimate the burden of this
collection of information as follows:
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
FDA form No.
108.25(c)(1) and
108.35(c)(1); Food canning establishment registration.
2541
VerDate Sep<11>2014
19:23 Mar 20, 2023
Jkt 259001
Number of
respondents
PO 00000
Number of
responses per
respondent
645
Frm 00054
1
Fmt 4703
Sfmt 4703
Total
annual
responses
645
Average
burden per
response 2
0.17 (10 minutes) ...............
E:\FR\FM\21MRN1.SGM
21MRN1
Total hours
110
16992
Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section; activity
FDA form No.
Number of
responses per
respondent
Number of
respondents
Total
annual
responses
Average
burden per
response 2
Total hours
108.25(c)(2); Food process
filing for acidified method.
108.35(c)(2); Food process
filing for low-acid retorted
method.
108.35(c)(2); Food process
filing for water activity/formulation control method.
108.35(c)(2); Food process
filing for low-acid aseptic
systems.
108.25(d); 108.35(d) and
(e); Report of any instance of potential healthendangering spoilage,
process deviation, or contamination with microorganisms where any lot
of the food has entered
distribution in commerce.
2541e
726
11
7,986
0.333 (20 minutes) .............
2,659
2541d
336
12
4,032
0.333 (20 minutes) .............
1,343
2541f
37
6
222
0.333 (20 minutes) .............
74
2541g
42
22
924
0.75 (45 minutes) ...............
693
N/A
1
1
1
4 .........................................
4
Total .............................
........................
........................
........................
........................
.............................................
4,883
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number
of respondents in table 1 on
registrations, process filings, and reports
received. The hours per response
reporting estimates are based on our
experience with similar programs and
information received from industry.
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
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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. 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
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.
Based on a review of the information
collection since our last request for
VerDate Sep<11>2014
19:23 Mar 20, 2023
Jkt 259001
OMB approval, we have made no
adjustments to our burden estimate.
Dated: March 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05742 Filed 3–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–E–5280]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ESPEROCT
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
for ESPEROCT and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by May 22, 2023.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 21, 2023. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
E:\FR\FM\21MRN1.SGM
21MRN1
]]>Agencies
[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 16990-16992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05742]
[[Page 16990]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1119]
Agency Information Collection Activities; Proposed Collection;
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 the Agency) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal 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 information collection
provisions of reporting and recordkeeping requirements for firms that
process acidified foods and thermally processed low-acid foods in
hermetically sealed containers.
DATES: Either electronic or written comments on the collection of
information must be submitted by May 22, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 22, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-1119 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Canning Establishment
Registration, Process Filing, and Recordkeeping for Acidified Foods and
Thermally Processed Low-Acid Foods in Hermetically Sealed Containers.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether
[[Page 16991]]
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.
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
21 CFR Parts 113 and 114
OMB Control Number 0910-0037--Extension
Section 402 of the Federal Food, Drug, and Cosmetic Act (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)(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 Forms FDA 2541d, FDA 2541e, 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 low-acid 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
version of Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA
2541g at 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 and/or Sec. 108.35 have an option to
submit Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g
electronically.
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);
Form FDA 2541e (Food Process Filing for Acidified Method);
Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method); and
Form FDA 2541g (Food Process Filing for Low-Acid Aseptic
Systems).
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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
108.25(c)(1) and 108.35(c)(1); Food 2541 645 1 645 0.17 (10 minutes)........... 110
canning establishment registration.
[[Page 16992]]
108.25(c)(2); Food process filing for 2541e 726 11 7,986 0.333 (20 minutes).......... 2,659
acidified method.
108.35(c)(2); Food process filing for low- 2541d 336 12 4,032 0.333 (20 minutes).......... 1,343
acid retorted method.
108.35(c)(2); Food process filing for 2541f 37 6 222 0.333 (20 minutes).......... 74
water activity/formulation control method.
108.35(c)(2); Food process filing for low- 2541g 42 22 924 0.75 (45 minutes)........... 693
acid aseptic systems.
108.25(d); 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number of respondents in table 1 on
registrations, process filings, and reports received. The hours per
response reporting estimates are based on our experience with similar
programs and information received from industry.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden per
21 CFR part recordkeepers per recordkeeper records 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.
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. 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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: March 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05742 Filed 3-20-23; 8:45 am]
BILLING CODE 4164-01-P
