Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice, 50852-50854 [2019-20937]
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Federal Register / Vol. 84, No. 187 / Thursday, September 26, 2019 / Notices
Topic
‘‘FDA and Industry Procedures for Section 513(g) Requests for
Information under the Federal Food, Drug, and Cosmetic
Act‘‘.
‘‘Requests for Feedback on Medical Device Submissions: The
Q-Submission Program and Meetings with Food and Drug
Administration Staff‘‘.
800, 801, and 809 .......................................................................
‘‘Humanitarian Device Exemption Regulation: Q&As‘‘ ...............
513(G) Request For Information ................................................
0910–0705
Q-Submissions ...........................................................................
0910–0756
Medical Device Labeling Regulations ........................................
Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements.
Emergency Use Authorization ...................................................
Biologics License Applications ...................................................
Investigational New Drug Regulations .......................................
CLIA Waiver Applications ..........................................................
0910–0485
0910–0661
0910–0595
0910–0338
0910–0014
0910–0598
CLIA Categorizations .................................................................
0910–0607
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.
0910–0073
‘‘Emergency Use Authorization of Medical Products‘‘ ................
601 ..............................................................................................
312 ..............................................................................................
‘‘Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices‘‘.
‘‘Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization‘‘.
820 ..............................................................................................
Dated: September 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–20949 Filed 9–25–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1427]
Agency Information Collection
Activities; Proposed Collection;
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.
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 collection
provisions of our regulations mandating
the application of hazard analysis and
critical control point (HACCP)
principles to the processing of fruit and
vegetable juices.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
OMB control
No.
21 CFR part or guidance
VerDate Sep<11>2014
16:48 Sep 25, 2019
Jkt 247001
Submit either electronic or
written comments on the collection of
information by November 25, 2019.
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 November 25,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 25, 2019.
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.
DATES:
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
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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–1427 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Hazard
Analysis and Critical Control Point
Procedures for the Safe and Sanitary
Processing and Importing of Juice.’’
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
E:\FR\FM\26SEN1.SGM
26SEN1
Federal Register / Vol. 84, No. 187 / Thursday, September 26, 2019 / Notices
‘‘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.
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. 3501–3520), 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,
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.
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
FDA’s regulations in part 120 (21 CFR
part 120) mandate the application of
50853
HACCP procedures to the processing of
fruit and vegetable juices. HACCP is a
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 that 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.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
khammond on DSKJM1Z7X2PROD with NOTICES
21 CFR Section; activity
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) and (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.
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PO 00000
Frm 00037
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
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
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E:\FR\FM\26SEN1.SGM
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50854
Federal Register / Vol. 84, No. 187 / Thursday, September 26, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR Section; activity
Total
annual
records
Average
burden per
recordkeeping
Total
hours
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) and (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), and (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), 120.8(b), and 120.12(a)(3), (b), and (c); require written HACCP plan.
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 ......................................................................
........................
........................
21,980,369
...............................
461,426
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate of the
total annual recordkeeping burden of
our regulations in part 120. Our estimate
remains unchanged since last review of
the information collection. We base our
estimate of the average burden per
recordkeeping on our experience with
the application of HACCP principles in
food processing. We base our estimate of
the number of recordkeepers on our
estimate of the total number of juice
manufacturing plants affected by the
regulations (plants identified in our
official establishment inventory plus
very small apple juice and very small
orange juice manufacturers). These
estimates assume that every processor
will prepare sanitary standard operating
procedures and an HACCP plan and
maintain the associated monitoring
records, and that every importer will
require product safety specifications. In
fact, there are likely to be some small
number of juice processors that, based
upon their hazard analysis, determine
that they are not required to have an
HACCP plan under these regulations.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
records per
recordkeeper
Dated: September 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–20937 Filed 9–25–19; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:48 Sep 25, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
Section 2112(b)(2) of the Public Health
Service (PHS) Act, as amended. While
the Secretary of HHS is named as the
respondent in all proceedings brought
by the filing of petitions for
compensation under the Program, the
United States Court of Federal Claims is
charged by statute with responsibility
for considering and acting upon the
petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
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Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the United States Court of Federal
Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
E:\FR\FM\26SEN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50852-50854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20937]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1427]
Agency Information Collection Activities; Proposed Collection;
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 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 collection provisions of our
regulations mandating the application of hazard analysis and critical
control point (HACCP) principles to the processing of fruit and
vegetable juices.
DATES: Submit either electronic or written comments on the collection
of information by November 25, 2019.
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 November 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 25, 2019. 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-1427 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Hazard Analysis and Critical
Control Point Procedures for the Safe and Sanitary Processing and
Importing of Juice.'' 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
[[Page 50853]]
``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/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. 3501-3520), 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, 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.
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
FDA's regulations in part 120 (21 CFR part 120) mandate the
application of HACCP procedures to the processing of fruit and
vegetable juices. HACCP is a 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 that 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.
We estimate 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 recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and (b); Require 1,875 365 684,375 0.1 (6 minutes)......................... 68,438
written monitoring and correction records for
Sanitation Standard Operating Procedures.
120.7; 120.10(a); and 120.12(a)(2), (b) and 2,300 1.1 2,530 20...................................... 50,600
(c); require written hazard analysis of food
hazards.
120.8(b)(7) and 120.12(a)(4)(i) and (b); 1,450 14,600 21,170,000 0.01 (1 minute)......................... 211,700
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); 1,840 12 22,080 0.1 (6 minutes)......................... 2,208
require that all corrective actions taken in
response to a deviation from a critical limit
be documented.
[[Page 50854]]
120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) 1,840 52 95,680 0.1 (6 minutes)......................... 9,568
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) and (c); and 120.12(a)(5) and (b); 1,840 1 1,840 4....................................... 7,360
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 1,840 1 1,840 4....................................... 7,360
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), and (d) and 120.12(b); 308 1 308 4....................................... 1,232
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), 120.8(b), and 120.12(a)(3), (b), and 1,560 1.1 1,716 60...................................... 102,960
(c); require written HACCP plan.
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Total..................................... .............. .............. 21,980,369 ........................................ 461,426
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate of the total annual recordkeeping
burden of our regulations in part 120. Our estimate remains unchanged
since last review of the information collection. We base our estimate
of the average burden per recordkeeping on our experience with the
application of HACCP principles in food processing. We base our
estimate of the number of recordkeepers on our estimate of the total
number of juice manufacturing plants affected by the regulations
(plants identified in our official establishment inventory plus very
small apple juice and very small orange juice manufacturers). These
estimates assume that every processor will prepare sanitary standard
operating procedures and an HACCP plan and maintain the associated
monitoring records, and that every importer will require product safety
specifications. In fact, there are likely to be some small number of
juice processors that, based upon their hazard analysis, determine that
they are not required to have an HACCP plan under these regulations.
Dated: September 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20937 Filed 9-25-19; 8:45 am]
BILLING CODE 4164-01-P
