Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice, 12939-12941 [2023-04174]
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Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, VERZENIO
(abemaciclib). VERZENIO is indicated:
• in combination with fulvestrant for
the treatment of women with hormone
receptor (HR)-positive, human
epidermal growth factor receptor 2
(HER2)-negative advanced or metastatic
breast cancer with disease progression
following endocrine therapy and
• as monotherapy for the treatment of
adult patients with HR-positive, HER2negative advanced or metastatic breast
cancer with disease progression
following endocrine therapy and prior
chemotherapy in the metastatic setting.
Subsequent to this approval, the
USPTO received a patent term
restoration application for VERZENIO
(U.S. Patent No. 7,855,211) from Eli
Lilly and Company, and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
May 13, 2019, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of VERZENIO
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
ddrumheller on DSK120RN23PROD with NOTICES
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
VERZENIO is 2,907 days. Of this time,
2,760 days occurred during the testing
phase of the regulatory review period,
while 147 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: October 15,
2009. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on October 15, 2009.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: May 5, 2017. FDA has
verified the applicant’s claim that the
new drug application (NDA) for
VERZENIO (NDA 208716) was initially
submitted on May 5, 2017.
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18:10 Feb 28, 2023
Jkt 259001
3. The date the application was
approved: September 28, 2017. FDA has
verified the applicant’s claim that NDA
208716 was approved on September 28,
2017.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 652 days of patent
term extension.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1427]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Hazard Analysis
and Critical Control Point Procedures
for the Safe and Sanitary Processing
and Importing of Juice
AGENCY:
Food and Drug Administration,
HHS.
III. Petitions
ACTION:
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04177 Filed 2–28–23; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
12939
Notice.
The Food and Drug
Administration (FDA or the Agency) 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 March 31,
2023.
ADDRESSES: 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 0910–0466. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Hazard Analysis and Critical Control
Point (HACCP) Procedures for the Safe
and Sanitary Processing and Importing
of Juice—21 CFR Part 120
OMB Control Number 0910–0466—
Extension
This information collection supports
regulations in part 120 (21 CFR part
120) which mandate the application of
HACCP procedures to the processing of
fruit and vegetable juices. HACCP is a
Frm 00031
Fmt 4703
Sfmt 4703
E:\FR\FM\01MRN1.SGM
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12940
Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
preventative system of hazard control
designed to help ensure the safety of
foods. The regulations were issued
under FDA’s statutory authority to
regulate food safety under section
402(a)(4) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
342(a)(4)). Under section 402(a)(4) of the
FD&C Act, a food is adulterated if it is
prepared, packed, or held under
insanitary conditions whereby it may
have been contaminated with filth or
rendered injurious to health. The
Agency also has authority under section
361 of the Public Health Service Act (42
U.S.C. 264) to issue and enforce
regulations to prevent the introduction,
transmission, or spread of
communicable diseases from one State,
territory, or possession to another, or
from outside the United States into this
country. Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA is
authorized to issue regulations for the
efficient enforcement of the FD&C Act.
Under HACCP, processors of fruit and
vegetable juices establish and follow a
preplanned sequence of operations and
observations (the HACCP plan) designed
to avoid or eliminate one or more
specific food hazards, and thereby
ensure that their products are safe,
wholesome, and not adulterated, in
compliance with section 402 of the
FD&C Act. Information development
and recordkeeping are essential parts of
any HACCP system. The information
collection requirements are narrowly
tailored to focus on the development of
appropriate controls and document
those aspects of processing that are
critical to food safety.
In an effort to reduce burden and
assist respondents, our website (https://
www.fda.gov/food/hazard-analysiscritical-control-point-haccp/juicehaccp) offers guidance for industry,
training and education, and background
information to assist the food industry
in developing and implementing a juice
HACCP. Included in this information
are guidance documents entitled ‘‘Juice
HACCP and the FDA Food Safety and
Modernization Act’’ (December 2021)
(available at: https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/guidanceindustry-juice-haccp-and-fda-foodsafety-modernization-act) and ‘‘Juice
HACCP Hazards and Controls
Guidance—First Edition’’ (March 2004)
(available at: https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/guidanceindustry-juice-hazard-analysis-criticalcontrol-point-hazards-and-controlsguidance-first). All Agency guidance
documents are issued in accordance
with our good guidance practice
regulations in 21 CFR 10.115, which
provide for public comment at any time
In the Federal Register of October 7,
2022 (87 FR 61087), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
ddrumheller on DSK120RN23PROD with NOTICES
21 CFR section; activity
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total
hours
120.6(c) and 120.12(a)(1) and (b); require written monitoring
and correction records for Sanitation Standard Operating
Procedures.
120.7, 120.10(a), and 120.12(a)(2), (b)–(c); require written
hazard analysis of food hazards.
120.8(b)(7) and 120.12(a)(4)(i) and (b); require a recordkeeping system that documents monitoring of the critical
control points and other measurements as prescribed in the
HACCP plan.
120.10(c) and 120.12(a)(4)(ii) and (b); require that all corrective actions taken in response to a deviation from a critical
limit be documented.
120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) and (b); require
records showing that process monitoring instruments are
properly calibrated and that end-product or in-process testing is performed in accordance with written procedures.
120.11(b)–(c) and 120.12(a)(5) and (b); require that every
processor record the validation that the HACCP plan is adequate to control food hazards that are likely to occur.
120.11(c) and 120.12(a)(5) and (b); require documentation of
revalidation of the hazard analysis upon any changes that
might affect the original hazard analysis (applies when a
firm does not have a HACCP plan because the original hazard analysis did not reveal hazards likely to occur).
120.14(a)(2), (c)–(d), and 120.12(b); require that importers of
fruit or vegetable juices, or their products used as ingredients in beverages, have written procedures to ensure that
the food is processed in accordance with our regulations in
part 120.
120.8(a)–(b) and 120.12(a)(3), (b)–(c); require written HACCP
plan.
1,875
365
684,375
0.1 (6 minutes) ....
68,438
2,300
1.1
2,530
20 ........................
50,600
1,450
14,600
21,170,000
0.01 (1 minute) ....
211,700
1,840
12
22,080
0.1 (6 minutes) ....
2,208
1,840
52
95,680
0.1 (6 minutes) ....
9,568
1,840
1
1,840
4 ..........................
7,360
1,840
1
1,840
4 ..........................
7,360
308
1
308
4 ..........................
1,232
1,560
1.1
1,716
60 ........................
102,960
Total ....................................................................................
....................
........................
........................
..............................
461,426
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate for the
next 3 years for the total annual
VerDate Sep<11>2014
18:10 Feb 28, 2023
Jkt 259001
recordkeeping burden of our regulations
in part 120. Based on our experience
PO 00000
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with the information collection over the
past 3 years, our burden estimate
E:\FR\FM\01MRN1.SGM
01MRN1
Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
remains unchanged since our last
review of the information collection.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04174 Filed 2–28–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1047]
Q13 Continuous Manufacturing of
Drug Substances and Drug Products;
International Council for
Harmonisation; 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 final
guidance for industry entitled ‘‘Q13
Continuous Manufacturing of Drug
Substances and Drug Products.’’ The
guidance was prepared under the
auspices of the International Council for
Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use (ICH). The guidance
provides clarification on continuous
manufacturing (CM) concepts and
describes scientific approaches and
regulatory considerations specific to CM
of drug substances and drug products.
The guidance is intended to provide
scientific and regulatory considerations
for the development, implementation,
operation, and life-cycle management of
CM. The guidance replaces the draft
guidance entitled ‘‘Q13 Continuous
Manufacturing of Drug Substances and
Drug Products’’ issued on October 14,
2021. This guidance also replaces the
draft guidance entitled ‘‘Quality
Considerations for Continuous
Manufacturing’’ issued on February 27,
2019.
DATES: The announcement of the
guidance is published in the Federal
Register on March 1, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ddrumheller on DSK120RN23PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
18:10 Feb 28, 2023
Jkt 259001
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–
2021–D–1047 for ‘‘Q13 Continuous
Manufacturing of Drug Substances and
Drug Products.’’ 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, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
PO 00000
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12941
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this 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, or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Sau Lee,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 4182, Silver Spring,
MD 20993–0002, 301–796–2905; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12939-12941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04174]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1427]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Hazard Analysis and
Critical Control Point Procedures for the Safe and Sanitary Processing
and Importing of Juice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) 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 March 31, 2023.
ADDRESSES: 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 0910-0466. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
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.
Hazard Analysis and Critical Control Point (HACCP) Procedures for the
Safe and Sanitary Processing and Importing of Juice--21 CFR Part 120
OMB Control Number 0910-0466--Extension
This information collection supports regulations in part 120 (21
CFR part 120) which mandate the application of HACCP procedures to the
processing of fruit and vegetable juices. HACCP is a
[[Page 12940]]
preventative system of hazard control designed to help ensure the
safety of foods. The regulations were issued under FDA's statutory
authority to regulate food safety under section 402(a)(4) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
342(a)(4)). Under section 402(a)(4) of the FD&C Act, a food is
adulterated if it is prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth or rendered
injurious to health. The Agency also has authority under section 361 of
the Public Health Service Act (42 U.S.C. 264) to issue and enforce
regulations to prevent the introduction, transmission, or spread of
communicable diseases from one State, territory, or possession to
another, or from outside the United States into this country. Under
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to
issue regulations for the efficient enforcement of the FD&C Act.
Under HACCP, processors of fruit and vegetable juices establish and
follow a preplanned sequence of operations and observations (the HACCP
plan) designed to avoid or eliminate one or more specific food hazards,
and thereby ensure that their products are safe, wholesome, and not
adulterated, in compliance with section 402 of the FD&C Act.
Information development and recordkeeping are essential parts of any
HACCP system. The information collection requirements are narrowly
tailored to focus on the development of appropriate controls and
document those aspects of processing that are critical to food safety.
In an effort to reduce burden and assist respondents, our website
(https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp) offers guidance for industry, training and education, and
background information to assist the food industry in developing and
implementing a juice HACCP. Included in this information are guidance
documents entitled ``Juice HACCP and the FDA Food Safety and
Modernization Act'' (December 2021) (available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-haccp-and-fda-food-safety-modernization-act) and ``Juice HACCP
Hazards and Controls Guidance--First Edition'' (March 2004) (available
at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first). All Agency guidance
documents are issued in accordance with our good guidance practice
regulations in 21 CFR 10.115, which provide for public comment at any
time
In the Federal Register of October 7, 2022 (87 FR 61087), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of records per Total annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and 1,875 365 684,375 0.1 (6 minutes).... 68,438
(b); require written monitoring
and correction records for
Sanitation Standard Operating
Procedures.
120.7, 120.10(a), and 2,300 1.1 2,530 20................. 50,600
120.12(a)(2), (b)-(c); require
written hazard analysis of food
hazards.
120.8(b)(7) and 120.12(a)(4)(i) 1,450 14,600 21,170,000 0.01 (1 minute).... 211,700
and (b); require a recordkeeping
system that documents monitoring
of the critical control points
and other measurements as
prescribed in the HACCP plan.
120.10(c) and 120.12(a)(4)(ii) 1,840 12 22,080 0.1 (6 minutes).... 2,208
and (b); require that all
corrective actions taken in
response to a deviation from a
critical limit be documented.
120.11(a)(1)(iv) and (a)(2) and 1,840 52 95,680 0.1 (6 minutes).... 9,568
120.12 (a)(5) and (b); require
records showing that process
monitoring instruments are
properly calibrated and that end-
product or in-process testing is
performed in accordance with
written procedures.
120.11(b)-(c) and 120.12(a)(5) 1,840 1 1,840 4.................. 7,360
and (b); require that every
processor record the validation
that the HACCP plan is adequate
to control food hazards that are
likely to occur.
120.11(c) and 120.12(a)(5) and 1,840 1 1,840 4.................. 7,360
(b); require documentation of
revalidation of the hazard
analysis upon any changes that
might affect the original hazard
analysis (applies when a firm
does not have a HACCP plan
because the original hazard
analysis did not reveal hazards
likely to occur).
120.14(a)(2), (c)-(d), and 308 1 308 4.................. 1,232
120.12(b); require that
importers of fruit or vegetable
juices, or their products used
as ingredients in beverages,
have written procedures to
ensure that the food is
processed in accordance with our
regulations in part 120.
120.8(a)-(b) and 120.12(a)(3), 1,560 1.1 1,716 60................. 102,960
(b)-(c); require written HACCP
plan.
------------------------------------------------------------------------------
Total........................ ............. .............. .............. ................... 461,426
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 1 provides our estimate for the next 3 years for the total
annual recordkeeping burden of our regulations in part 120. Based on
our experience with the information collection over the past 3 years,
our burden estimate
[[Page 12941]]
remains unchanged since our last review of the information collection.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04174 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P
