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, 27138-27140 [E7-9220]
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27138
Federal Register / Vol. 72, No. 92 / Monday, May 14, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Annual
Frequency per
Response
No. of
Respondents
21 CFR Section/Part
101.36
Total Annual
Responses
Hours per
Response
Total Operating &
Maintenance
Costs
Total
Hours
300
40
12,000
4
48,000
0
1,000
1
1,000
0.5
500
0
101.45(c)
5
4
20
4
80
0
101.69
3
1
3
25
75
0
101.70
5
1
5
80
400
$889,332
1,000
1
1,000
0.25
250
0
100
1
100
0.25
25
0
1,000
1
1,000
1
1,000
0
25,000
1.03
25,750
0.5
12,875
0
0
0
40
0
0
101.42 and 101.45
101.79(c)(2)(ii)(D)
101.79(c)(2)(iv)
101.100(d)
101.105 and 101.100(h)
101.108
Total
1There
1,109,833
$1,422,932
are no capital costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
101.12(e)
Annual
Frequency per Recordkeeping
Total Annual
Records
Hours per
Record
Total
Hours
25
1
25
1
25
101.13(q)(5)
300,000
1.5
450,000
0.75
337,500
101.14(d)(2)
300,000
1.5
450,000
0.75
337,500
101.22(i)(4)
25
1
25
1
25
1,000
1
1,000
1
1,000
100
1
100
1
100
101.100(d)(2)
101.105(t)
Total
pwalker on PROD1PC71 with NOTICES
1There
676,150
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual reporting and
recordkeeping burdens are based on
agency communications with industry
and FDA’s knowledge of and experience
with food labeling and the submission
of petitions and requests to the agency.
Where an agency regulation implements
an information collection requirement
in the act or the FPLA, only any
additional burden attributable to the
regulation has been included in FDA’s
burden estimate.
No burden has been estimated for
those requirements where the
information to be disclosed is
information that has been supplied by
FDA. Also, no burden has been
estimated for information that is
disclosed to third parties as a usual and
customary part of a food producer’s
normal business activities. Under 5 CFR
1320.3(c)(2), the public disclosure of
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Jkt 211001
information originally supplied by the
Federal Government to the recipient for
the purpose of disclosure to the public
is not a collection of information. Under
5 CFR 1320.3(b)(2), the time, effort, and
financial resources necessary to comply
with a collection of information are
excluded from the burden estimate if
the reporting, recordkeeping, or
disclosure activities needed to comply
are usual and customary because they
would occur in the normal course of
activities.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9219 Filed 5–11–07; 8:45 am]
HHS.
BILLING CODE 4160–01–S
PO 00000
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Food and Drug Administration
[Docket No. 2007N–0165]
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:
ACTION:
Food and Drug Administration,
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
E:\FR\FM\14MYN1.SGM
14MYN1
27139
Federal Register / Vol. 72, No. 92 / Monday, May 14, 2007 / Notices
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 written or electronic
comments on the collection of
information by July 13, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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 RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Sections
Annual Frequency
of Recordkeeping
Hours
per Record
120.7; 120.10(a) and 120.12(a)(2), (b),
and (c)
2,300
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)
pwalker on PROD1PC71 with NOTICES
1,875
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
1.1
684,375
0.1
Total Hours
120.6(c) and 120.12(a)(1) and (b)
120.14(a)(2), (c), and (d)
365
Total Annual
Records
2,530
20
0.01
Total
1 There
68,437.5
50,600
211,700
358,466
are no capital costs or operating and maintenance costs associated with this collection of information.
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27140
Federal Register / Vol. 72, No. 92 / Monday, May 14, 2007 / Notices
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: April 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9220 Filed 5–11–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0182]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Information
Program on Clinical Trials for Serious
or Life-Threatening Diseases:
Maintaining a Data Bank
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
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
VerDate Aug<31>2005
18:21 May 11, 2007
Jkt 211001
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 of information contained
in the guidance entitled ‘‘Information
Program on Clinical Trials for Serious or
Life-Threatening Diseases and
Conditions’’ dated March 18, 2002.
DATES: Submit written or electronic
comments on the collection of
information by July 13, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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.
Information Program on Clinical Trials
for Serious or Life-Threatening
Diseases: Maintaining a Data Bank
(OMB Control Number 0910–0459)—
Extension
In the Federal Register of March 18,
2002 (65 FR 12022), FDA issued a
guidance to industry on
recommendations for investigational
new drug application (IND) sponsors on
submitting information about clinical
trials for serious or life- threatening
diseases to a Clinical Trials Data Bank
developed by the National Library of
Medicine (NLM), National Institutes of
Health (NIH). This information is
especially important for patients and
their families seeking opportunities to
participate in clinical trials of new drug
treatments for serious or life-threatening
diseases. The guidance describes three
collections of information: Mandatory
submissions, voluntary submissions,
and certifications.
Mandatory Submissions
Section 113 of the Food and Drug
Administration Modernization Act
(FDAMA) of 1997 (the Modernization
Act) (Public Law 105–115) requires that
sponsors shall submit information to the
Clinical Trials Data Bank when the
clinical trial: (1) Involves a treatment for
a serious or life-threatening disease and
(2) is intended to assess the
effectiveness of the treatment. The
guidance discusses how sponsors can
fulfill the requirements of section 113 of
the Modernization Act. Specifically,
sponsors should provide: (1)
Information about clinical trials, both
federally and privately funded, of
experimental treatments (drugs,
including biological products) for
patients with serious or life-threatening
diseases; (2) a description of the
purpose of the experimental drug; (3)
patient eligibility criteria; (4) the
location of clinical trial sites; and (5) a
point of contact for patients wanting to
enroll in the trial.
Senate 1789, ‘‘Best Pharmaceuticals
for Children Act’’ (Public Law 107–109)
(BPCA), established a new requirement
for the Clinical Trials Data Bank
mandated by section 113 of FDAMA.
Information submitted to the data bank
must now include ‘‘a description of
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 72, Number 92 (Monday, May 14, 2007)]
[Notices]
[Pages 27138-27140]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9220]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0165]
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
[[Page 27139]]
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 written or electronic comments on the collection of
information by July 13, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Sections Recordkeepers of Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
120.6(c) and 1,875 365 684,375 0.1 68,437.5
120.12(a)(1) and
(b)
----------------------------------------------------------------------------------------------------------------
120.7; 120.10(a) 2,300 1.1 2,530 20 50,600
and
120.12(a)(2),
(b), and (c)
----------------------------------------------------------------------------------------------------------------
120.8(b)(7) and 1,450 14,600 21,170,000 0.01 211,700
120.12(a)(4)(i)
and (b)
----------------------------------------------------------------------------------------------------------------
120.10(c) and 1,840 12 22,080 0.1 2,208
120.12(a)(4)(ii)
and (b)
----------------------------------------------------------------------------------------------------------------
120.11(a)(1)(iv) 1,840 52 95,680 0.1 9,568
and (a)(2) and
120.12 (a)(5)
----------------------------------------------------------------------------------------------------------------
120.11(b) and 1,840 1 1,840 4 7,360
120.12(a)(5) and
(b)
----------------------------------------------------------------------------------------------------------------
120.11(c) and 1,840 1 1,840 4 7,360
120.12(a)(5) and
(b)
----------------------------------------------------------------------------------------------------------------
120.14(a)(2), 308 1 308 4 1,232
(c), and (d)
----------------------------------------------------------------------------------------------------------------
Total 358,466
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 27140]]
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: April 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9220 Filed 5-11-07; 8:45 am]
BILLING CODE 4160-01-S
