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, 69689-69690 [2013-27811]
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Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices
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) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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
our regulations mandating the
application of hazard analysis and
critical control point (HAACP)
principles to the processing of fruit and
vegetable juices.
DATES: Submit either electronic or
written comments on the collection of
information by January 21, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
SUMMARY:
Dr., PI50–400B, Rockville, MD 20850,
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 regulations in part 120 (21 CFR
part 120) mandate the application of
HACCP principles to the processing of
fruit and vegetable juices. HACCP is a
preventive 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.
The rationale in establishing an
HACCP system of preventive controls is
to design and check the process so that
the final product is not contaminated—
not test for contamination after it may
have taken place. 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeeper
tkelley on DSK3SPTVN1PROD with NOTICES
21 CFR Section
120.6(c) and 120.12(a)(1) and (b)—Require written monitoring and correction records for Sanitation Standard
Operating Procedures. .....................................................
120.7 and 120.12(a)(2), (b) and (c)—Require written hazard analysis of food hazards. ...........................................
VerDate Mar<15>2010
16:04 Nov 19, 2013
Jkt 232001
PO 00000
Frm 00050
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
1,875
365
684,375
0.1
68,438
2,300
1.1
2,530
20
50,600
Fmt 4703
Sfmt 4703
E:\FR\FM\20NON1.SGM
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69690
Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeeper
21 CFR Section
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)—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 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. ............................................................
120.14(a)(2), (c), and (d)—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. ............................................................
120.11(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 an HACCP plan because the original hazard analysis did not reveal hazards likely to occur.) .........................................................
Total ..............................................................................
1 There
Average
burden per
recordkeeping
Total annual
records
Total hours
1,450
14,600
21,170,000
0.01
211,700
1,840
12
22,080
0.1
2,208
1,840
52
95,680
0.1
9,568
1,840
1
1,840
4
7,360
308
1
308
4
1,232
1,840
1
1,840
4
7,360
........................
........................
........................
........................
358,466
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. 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.
tkelley on DSK3SPTVN1PROD with NOTICES
Number of
records per
recordkeeper
Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27811 Filed 11–19–13; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
16:04 Nov 19, 2013
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0576]
Draft Guidance for Industry:
Considerations for the Design of EarlyPhase Clinical Trials of Cellular and
Gene Therapy Products; Extension of
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA) is extending the
comment period for the draft guidance
for industry entitled ‘‘Guidance for
Industry: Considerations for the Design
of Early-Phase Clinical Trials of Cellular
and Gene Therapy Products’’ that
appeared in the Federal Register of July
2, 2013 (78 FR 39736). The draft
guidance document provides sponsors
of Investigational New Drug
Applications for cellular therapy (CT)
and gene therapy (GT) products
(referred to collectively as CGT
products) with recommendations to
assist in designing early-phase clinical
trials of CGT products. In the notice, we
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
requested comments on the draft
guidance. We are taking this action to
allow interested persons additional time
to submit comments and to allow for
public discussion at the February 25–26,
2014, Cellular, Tissue, and Gene
Therapies Advisory Committee meeting,
where FDA will present the draft
guidance document for review.
DATES: FDA is extending the comment
period on the draft guidance. Submit
either electronic or written comments
by May 9, 2014.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Submit
written requests for single copies of the
draft guidance to the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your request.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
E:\FR\FM\20NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69689-69690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27811]
[[Page 69689]]
-----------------------------------------------------------------------
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 our regulations mandating the application of hazard
analysis and critical control point (HAACP) principles to the
processing of fruit and vegetable juices.
DATES: Submit either electronic or written comments on the collection
of information by January 21, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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 regulations in part 120 (21 CFR part 120) mandate the
application of HACCP principles to the processing of fruit and
vegetable juices. HACCP is a preventive 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.
The rationale in establishing an HACCP system of preventive
controls is to design and check the process so that the final product
is not contaminated--not test for contamination after it may have taken
place. 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of records per Total annual burden per Total hours
recordkeeper recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and 1,875 365 684,375 0.1 68,438
(b)--Require written monitoring
and correction records for
Sanitation Standard Operating
Procedures.....................
120.7 and 120.12(a)(2), (b) and 2,300 1.1 2,530 20 50,600
(c)--Require written hazard
analysis of food hazards.......
[[Page 69690]]
120.8(b)(7) and 120.12(a)(4)(i) 1,450 14,600 21,170,000 0.01 211,700
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 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 9,568
120.12 (a)(5)--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 120.12(a)(5) and 1,840 1 1,840 4 7,360
(b) -..........................
Require that every processor
record the validation that the
HACCP plan is adequate to
control food hazards that are
likely to occur................
120.14(a)(2), (c), and (d)-- 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............................
120.11(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 an HACCP
plan because the original
hazard analysis did not reveal
hazards likely to occur.)......
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 358,466
----------------------------------------------------------------------------------------------------------------
\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. 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: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27811 Filed 11-19-13; 8:45 am]
BILLING CODE 4160-01-P
