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, 40839-40840 [2010-17150]
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Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Notices
functions, to the extent permitted by
law. A copy of the Commission charter
can be obtained from the designated
contacts or by accessing the FACA
database that is maintained by the GSA
Committee Management Secretariat. The
website for the FACA database is
https://fido.gov/facadatabase/.
Dated: July 9, 2010.
Kathy Greenlee,
Assistant Secretary for Aging.
[FR Doc. 2010–17197 Filed 7–13–10; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0357]
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
recordkeeping requirements for
applying hazard analysis and critical
control point (HAACP) procedures for
safe and sanitary processing for
processors of fruit and vegetable juice.
DATES: Submit either electronic or
written comments on the collection of
information by September 13, 2010.
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
40839
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 fruit and
vegetable juice processing. HACCP is a
preventative system of hazard control
that can be used by all food processors
to ensure the safety of their products to
consumers. A HACCP system of
preventive controls is the most effective
and efficient way to ensure that these
food products are safe. FDA’s mandate
to ensure the safety of the Nation’s food
supply is derived principally from the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 321 et seq.). Under
the act, FDA has authority to ensure that
all foods in interstate commerce, or that
have been shipped in interstate
commerce, are not contaminated or
otherwise adulterated, are produced and
held under sanitary conditions, and are
not misbranded or deceptively
packaged; under section 701 (21 U.S.C.
371), the act authorizes the agency to
issue regulations for its efficient
enforcement. 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 to another other State.
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. Through these
regulations, FDA is implementing its
authority under section 402(a)(4) of the
act (21 U.S.C. 342(a)(4)).
FDA estimates the burden of this
collection of information as follows:
emcdonald on DSK2BSOYB1PROD with NOTICES
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No of
Recordkeepers
120.6(c) and 120.12(a)(1)
and (b)
1,875
120.7; 120.10(a); and
120.12(a)(2), (b), and (c)
Annual Frequency per
Recordkeeping
2,300
VerDate Mar<15>2010
16:07 Jul 13, 2010
Jkt 220001
PO 00000
Total Annual
Records
365
1.1
Frm 00070
Fmt 4703
Sfmt 4703
Hours Per
Record
684,375
0.1
2,530
E:\FR\FM\14JYN1.SGM
Total Hours
20
14JYN1
68,437.5
50,600
40840
Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section
No of
Recordkeepers
Annual Frequency per
Recordkeeping
Total Annual
Records
Hours Per
Record
Total Hours
120.8(b)(7) and
120.12(a)(4)(i) and (b)
1,450
14,600
21,170,000
120.10(c) and
120.12(a)(4)(ii) and (b)
1,840
12
22,080
0.1
2,208
120.11(a)(1)(iv) and (a)(2)
and 120.12(a)(5)
1,840
52
95,680
0.1
9,568
120.11(b) and 120.12(a)(5)
and (b)
1,840
1
1,840
4
7,360
120.11(c) and 120.12(a)(5)
and (b)
1,840
1
1,840
4
7,360
308
1
308
4
1,232
120.14(a)(2), (c), and (d)
0.01
Total
emcdonald on DSK2BSOYB1PROD with NOTICES
1 There
211,700
358,466
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 of this document provides a
breakdown of the total estimated annual
recordkeeping burden. FDA bases this
hour burden estimate on its experience
with the application of HACCP
principles in food processing.
The burden estimates in table 1 of this
document are based on an estimate of
the total number of juice manufacturing
plants (i.e., 2,300) affected by the
regulations. Included in this total are
850 plants currently identified in FDA’s
official establishment inventory plus
1,220 very small apple juice
manufacturers and 230 very small
orange juice manufacturers. The total
burden hours are derived by estimating
the number of plants affected by each
portion of this final rule and
multiplying the corresponding number
by the number of records required
annually and the hours needed to
complete the record. These numbers
were obtained from the agency’s final
regulatory impact analysis prepared for
these regulations.
Moreover, these estimates assume that
every processor will prepare sanitary
standard operating procedures and a
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 a HACCP plan under
these regulations.
Dated: July 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–17150 Filed 7–13–10; 8:45 am]
BILLING CODE 4160–01–S
VerDate Mar<15>2010
16:07 Jul 13, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0355]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
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
FDA’s regulations regarding current
good manufacturing practice (CGMP) for
dietary supplements.
DATES: Submit either electronic or
written comments on the collection of
information by September 13, 2010.
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
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Notices]
[Pages 40839-40840]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17150]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0357]
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 recordkeeping requirements for
applying hazard analysis and critical control point (HAACP) procedures
for safe and sanitary processing for processors of fruit and vegetable
juice.
DATES: Submit either electronic or written comments on the collection
of information by September 13, 2010.
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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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 fruit and vegetable juice
processing. HACCP is a preventative system of hazard control that can
be used by all food processors to ensure the safety of their products
to consumers. A HACCP system of preventive controls is the most
effective and efficient way to ensure that these food products are
safe. FDA's mandate to ensure the safety of the Nation's food supply is
derived principally from the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 321 et seq.). Under the act, FDA has authority to
ensure that all foods in interstate commerce, or that have been shipped
in interstate commerce, are not contaminated or otherwise adulterated,
are produced and held under sanitary conditions, and are not misbranded
or deceptively packaged; under section 701 (21 U.S.C. 371), the act
authorizes the agency to issue regulations for its efficient
enforcement. 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 to another other State.
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.
Through these regulations, FDA is implementing its authority under
section 402(a)(4) of the act (21 U.S.C. 342(a)(4)).
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No of Annual Frequency per Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours Per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and (b) 1,875 365 684,375 0.1 68,437.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.7; 120.10(a); and 120.12(a)(2), (b), and 2,300 1.1 2,530 20 50,600
(c)
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 40840]]
120.8(b)(7) and 120.12(a)(4)(i) and (b) 1,450 14,600 21,170,000 0.01 211,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.10(c) and 120.12(a)(4)(ii) and (b) 1,840 12 22,080 0.1 2,208
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.11(a)(1)(iv) and (a)(2) and 120.12(a)(5) 1,840 52 95,680 0.1 9,568
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.11(b) and 120.12(a)(5) and (b) 1,840 1 1,840 4 7,360
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.11(c) and 120.12(a)(5) and (b) 1,840 1 1,840 4 7,360
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.14(a)(2), (c), and (d) 308 1 308 4 1,232
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 358,466
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 of this document provides a breakdown of the total
estimated annual recordkeeping burden. FDA bases this hour burden
estimate on its experience with the application of HACCP principles in
food processing.
The burden estimates in table 1 of this document are based on an
estimate of the total number of juice manufacturing plants (i.e.,
2,300) affected by the regulations. Included in this total are 850
plants currently identified in FDA's official establishment inventory
plus 1,220 very small apple juice manufacturers and 230 very small
orange juice manufacturers. The total burden hours are derived by
estimating the number of plants affected by each portion of this final
rule and multiplying the corresponding number by the number of records
required annually and the hours needed to complete the record. These
numbers were obtained from the agency's final regulatory impact
analysis prepared for these regulations.
Moreover, these estimates assume that every processor will prepare
sanitary standard operating procedures and a 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 a HACCP plan
under these regulations.
Dated: July 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17150 Filed 7-13-10; 8:45 am]
BILLING CODE 4160-01-S
