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, 28069-28072 [2017-12783]
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Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
Dated: June 13, 2017.
Daniel P. Berger,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2017–12755 Filed 6–19–17; 8:45 am]
BILLING CODE 4154–01–P
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 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: Submit either electronic or
written comments on the collection of
information by August 21, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 21,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 21, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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• 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.
• 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
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28069
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the PRA (44 U.S.C. 3501–
3520), 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,
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Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
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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
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 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 which 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
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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 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, 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.
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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
2541a, and FDA 2541c by contacting us
at a particular address. 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 2541a,
and FDA 2541c electronically (Ref. 1)
(see also 76 FR 11783 at 11785; March
3, 2011).
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 pertain to a
specific type of commercial processing
and are available both on the electronic
submission system and as a paper-based
form. The electronic submission system
and the 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. 3);
• Form FDA 2541e (Food Process
Filing for Acidified Method) (Ref. 4);
• Form FDA 2541f (Food Process
Filing for Water Activity/Formulation
Control Method) (Ref. 5); and
• Form FDA 2541g (Food Process
Filing for Low-Acid Aseptic Systems)
(Ref. 6).
At this time, the paper-based versions
of the four proposed replacement forms
and their instructions are all available
for review as references to this
document (Refs. 4 through 6) 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.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
FDA
Form No.
§§ 108.25(c)(1) and 108.35(c)(2);
Food canning establishment registration.
§ 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) 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.
2541 .........
645
1
645
0.17 (10 minutes) ......
110
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
Number of
respondents
Average
burden per
response
21 CFR section
Total annual
responses
Total hours
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, therefore, are
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
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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 §§ 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
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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
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
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customary because they would occur in
the normal course of activities.
II. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) 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 2541a and FDA 2541c (Food
Process Filing Forms) to FDA in
Electronic or Paper Format.’’ Available at
https://www.fda.gov/Food/
GuidanceRegulation/Guidance
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DocumentsRegulatoryInformation/
AcidifiedLACF/ucm309376.htm.
2. Form FDA 2541. Food Process Filing for
All Methods Except Low-Acid Aseptic.
Available at https://www.fda.gov/
downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM076778.pdf.
3. Form 2541d. Food Process Filing for LowAcid Retorted Method. Available at
https://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/
Forms/UCM465591.pdf.
4. Form 2541e. Food Process Filing for
Acidified Method. Available at https://
www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM465593.pdf.
5. Form 2541f. Food Process Filing for Water
Activity/Formulation Control Method.
Available at https://www.fda.gov/
downloads/AboutFDA/
ReportsManualsForms/Forms/
UCM465595.pdf.
6. Form 2541g. Food Process Filing for LowAcid Aseptic Systems. Available at
https://www.fda.gov/downloads/
AboutFDA/ReportsManualsForms/
Forms/UCM465598.pdf.
Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12783 Filed 6–19–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–3101]
Abbreviated New Drug Applications:
Pre-Submission Facility
Correspondence Associated with
Priority Submissions; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘ANDAs:
Pre-Submission Facility
Correspondence Associated with
Priority Submissions.’’ The PreSubmission Facility Correspondence
(PFC) process was identified as part of
the performance goals and program
enhancements for the Generic Drug User
Fee Amendments reauthorization for
Fiscal Years 2018–2022 (GDUFA II). A
complete and accurate PFC allows the
Agency to begin the facility assessment
process in advance of the planned
abbreviated new drug application
(ANDA) submission. This draft
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SUMMARY:
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guidance describes PFC content and
format, as well as the Agency’s
approach to assessing this information.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 18,
2017. Submit either electronic or
written comments concerning the
collection of information proposed in
the draft guidance by September 18,
2017.
ADDRESSES:
You may submit comments
as follows:
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–
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2017–D–3101 for ‘‘ANDAs: PreSubmission Facility Correspondence
Associated with Priority Submissions.’’
Received comments 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
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]]>Agencies
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28069-28072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12783]
-----------------------------------------------------------------------
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 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: Submit either electronic or written comments on the collection
of information by August 21, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 21, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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.
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.fda.gov/regulatoryinformation/dockets/default.htm.
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.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the PRA (44 U.S.C. 3501-3520), 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,
[[Page 28070]]
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 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
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 which 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 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, 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. Sec.
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 2541a, and FDA 2541c by contacting us
at a particular address. 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 2541a, and FDA 2541c
electronically (Ref. 1) (see also 76 FR 11783 at 11785; March 3, 2011).
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
pertain to a specific type of commercial processing and are available
both on the electronic submission system and as a paper-based form. The
electronic submission system and the 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. 3);
Form FDA 2541e (Food Process Filing for Acidified Method)
(Ref. 4);
Form FDA 2541f (Food Process Filing for Water Activity/
Formulation Control Method) (Ref. 5); and
Form FDA 2541g (Food Process Filing for Low-Acid Aseptic
Systems) (Ref. 6).
At this time, the paper-based versions of the four proposed
replacement forms and their instructions are all available for review
as references to this document (Refs. 4 through 6) 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.
FDA estimates the burden of this collection of information as
follows:
[[Page 28071]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. Sec. 108.25(c)(1) and 2541............... 645 1 645 0.17 (10 minutes).............. 110
108.35(c)(2); Food canning
establishment registration.
Sec. 108.25(c)(2); Food process 2541e.............. 726 11 7,986 0.333 (20 minutes)............. 2,659
filing for acidified method.
Sec. 108.35(c)(2); Food process 2541d.............. 336 12 4,032 0.333 (20 minutes)............. 1,343
filing for low-acid retorted
method.
Sec. 108.35(c)(2); Food process 2541f.............. 37 6 222 0.333 (20 minutes)............. 74
filing for water activity/
formulation control method.
Sec. 108.35(c)(2); Food process 2541g.............. 42 22 924 0.75 (45 minutes).............. 693
filing for low-acid aseptic
systems.
Sec. Sec. 108.25(d) and N/A................ 1 1 1 4.............................. 4
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......................... ................... .............. .............. .............. ............................... 4,883
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, therefore, are 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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.
II. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) 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 2541a and FDA
2541c (Food Process Filing Forms) to FDA in Electronic or Paper
Format.'' Available at https://www.fda.gov/Food/GuidanceRegulation/
Guidance
[[Page 28072]]
DocumentsRegulatoryInformation/AcidifiedLACF/ucm309376.htm.
2. Form FDA 2541. Food Process Filing for All Methods Except Low-
Acid Aseptic. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076778.pdf.
3. Form 2541d. Food Process Filing for Low-Acid Retorted Method.
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465591.pdf.
4. Form 2541e. Food Process Filing for Acidified Method. Available
at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465593.pdf.
5. Form 2541f. Food Process Filing for Water Activity/Formulation
Control Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465595.pdf.
6. Form 2541g. Food Process Filing for Low-Acid Aseptic Systems.
Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465598.pdf.
Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12783 Filed 6-19-17; 8:45 am]
BILLING CODE 4164-01-P
