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, 18995-18998 [2020-07007]
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
elements: A declaration of ingredients
in decreasing order of predominance, a
statement of the identity of the product,
a specification of the name and place of
business of the establishment, and a
declaration of the net quantity of
contents. These requirements increase
the time establishments needed to
design labels because they increase the
number of label elements that
establishments must consider when
designing labels. These requirements do
not generate any recurring burden per
label because establishments must
18995
already print and affix labels to
cosmetic products as part of normal
business practices. We estimate that the
total third-party disclosure burden is
141,174 hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section or part
Form FDA No.
Number of
respondents
2 2511
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Part 710 (registrations) ......................
720.1 through 720.4 (new submissions).
720.6 (amendments) ..........................
720.6 (notices of discontinuance) ......
720.8 (requests for confidentiality) ....
3 2512
1,702
6,843
1
1
1,702
6,843
0.20 (12 minutes)
0.33 (20 minutes)
340
2,258
2512
2512
........................
2,477
232
1
1
1
1
2,477
232
1
0.17 (10 minutes)
0.10 (6 minutes) ..
2 ...........................
421
23
2
Total ............................................
........................
........................
........................
........................
..............................
3,044
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
The term ‘‘Form FDA 2511’’ refers to both the paper Form FDA 2511 and online Form FDA 2511 in the online system known as the VCRP,
which is available at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
3 The term ‘‘Form FDA 2512’’ refers to the paper Forms FDA 2512 and 2512a and online Form FDA 2512 in the online system known as the
VCRP, which is available at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
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2
We base our estimate on information
from cosmetic industry personnel and
FDA experience entering data submitted
on paper Forms FDA 2511, 2512, and
2512a into the online system. We
estimate that, annually, 1,702
establishments that manufacture or
package cosmetic products will each
submit 1 registration on Form FDA
2511, for a total of 1,702 annual
responses. Each submission is estimated
to take about 0.20 hour per response for
a total of 340.4 hours, rounded to 340.
We estimate that, annually, firms that
manufacture, pack, or distribute
cosmetics will file 6,843 ingredient
statements for new submissions on
Forms FDA 2512 and FDA 2512a. Each
submission is estimated to take about
0.33 hour per response for a total of
2,258.19 hours, rounded to 2,258. We
estimate that, annually, firms that
manufacture, pack, or distribute
cosmetics will file 2,477, amendments
to product formulations on Forms FDA
2512 and FDA 2512a. Each submission
is estimated to take about 0.17 hour per
response for a total of 421.09 hours,
rounded to 421. We estimate that,
annually, firms that manufacture, pack,
or distribute cosmetics will file 232
notices of discontinuance on Form FDA
2512. Each submission is estimated to
take about 0.10 hour per response for a
total of 23.2 hours, rounded to 23. We
estimate that, annually, one firm will
file one request for confidentiality. Each
such request is estimated to take 2 hours
to prepare for a total of 2 hours. Thus,
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the estimated total reporting burden is
3,044 hours.
Our estimated burden for the
information collection reflects an
overall increase of 3,044 hours and a
corresponding increase of 11,255
responses. We attribute this adjustment
to an increase in the number of hours
and responses due to the consolidation
of OMB control numbers 0910–0027 and
0910–0599. Total burden for the
combined collection of information is
therefore, 144,218 hours (141,174 hours
from OMB control number 0910–0599
and 3,044 hours from OMB control
number 0910–0027).
Dated: March 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06982 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–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.
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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 June 2, 2020.
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 June 2, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 2, 2020. 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.
SUMMARY:
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
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’’).
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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
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17:45 Apr 02, 2020
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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-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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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
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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
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 (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
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
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,
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 version
of Forms FDA 2541, FDA 2541d, FDA
2541e, FDA 2541f, and FDA 2541g by
contacting us at a particular address by
visiting 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,
§ 108.35, or both, 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
18997
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).
At this time, the paper-based versions
of the four forms and their instructions
are all available for review 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.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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21 CFR section; activity
FDA Form No.
108.25(c)(1) and 108.35(c)(1); 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); 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 ..........................................
Number of
responses per
respondent
Number of
respondents
Average
burden per
response 2
Total annual
responses
2541
645
1
645
0.17 (10 mins.) ......
110
2541e
726
11
7,986
0.33 (20 mins.) ......
2,659
2541d
336
12
4,032
0.33 (20 mins.) ......
1,343
2541f
37
6
222
0.33 (20 mins.) ......
74
2541g
42
22
924
0.75 (45 mins.) ......
693
N/A
1
1
1
4 ............................
4
........................
........................
........................
........................
...............................
4,883
1 There
2 The
are no capital costs or operating and maintenance costs associated with this collection of information.
calculation for 20 minutes uses 0.333 hour.
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Total hours
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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. 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. 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
Number of
recordkeepers
21 CFR part
108, 113, and 114 ................................................................
1 There
10,392
Total annual
records
1
10,392
Average
burden per
recordkeeping
250
Total hours
2,598,000
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of 10,392
recordkeepers in table 2 on the number
of registered firms, excluding firms that
were inactive or out of business, yet still
registered. We estimate that 10,392
firms will each 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. 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.
Dated: March 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–07007 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
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Number of
records per
recordkeeper
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1619]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by May 4,
2020.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0606. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
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20852, 301–796–5733, 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.
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements—21 CFR Part 111; OMB
Control Number 0910–0606—Revision
The Dietary Supplement Health and
Education Act (Pub. L. 103–417) added
section 402(g) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
342(g)), which provides, in part, that the
Secretary of Health and Human Services
may, by regulation, prescribe good
manufacturing practice for dietary
supplements. Section 402(g) of the
FD&C Act also stipulates that such
regulations will be modeled after
current good manufacturing practice
(CGMP) regulations for food and may
not impose standards for which there
are no current, and generally available,
analytical methodology. Section
402(g)(1) of the FD&C Act states that a
dietary supplement is adulterated if it
has been prepared, packed, or held
under conditions that do not meet
current good manufacturing practice
regulations.
Accordingly, we have promulgated
regulations in part 111 (21 CFR part
111) establishing minimum CGMP
requirements pertaining to the
manufacturing, packaging, labeling, or
holding of dietary supplements to
ensure their quality. Included among
the requirements is recordkeeping,
documenting, planning, control, and
improvement processes of a quality
control system. Implementation of these
processes in a manufacturing operation
serves as the backbone to CGMP. The
records must show what is being
manufactured and whether the controls
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Agencies
[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18995-18998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07007]
-----------------------------------------------------------------------
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 June 2, 2020.
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 June 2, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 2, 2020. 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.
[[Page 18996]]
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.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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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 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 (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
[[Page 18997]]
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, 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
version of Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA
2541g by contacting us at a particular address 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.
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).
At this time, the paper-based versions of the four forms and their
instructions are all available for review 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.
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 mins.)............. 110
canning establishment registration.
108.25(c)(2); Food process filing for 2541e 726 11 7,986 0.33 (20 mins.)............. 2,659
acidified method.
108.35(c)(2); Food process filing for low- 2541d 336 12 4,032 0.33 (20 mins.)............. 1,343
acid retorted method.
108.35(c)(2); Food process filing for 2541f 37 6 222 0.33 (20 mins.)............. 74
water activity/formulation control method.
108.35(c)(2); Food process filing for low- 2541g 42 22 924 0.75 (45 mins.)............. 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.
\2\ The calculation for 20 minutes uses 0.333 hour.
[[Page 18998]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. 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. 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.
We base our estimate of 10,392 recordkeepers in table 2 on the
number of registered firms, excluding firms that were inactive or out
of business, yet still registered. We estimate that 10,392 firms will
each 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. 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.
Dated: March 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07007 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P