Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice, 40885-40886 [E7-14403]
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40885
Federal Register / Vol. 72, No. 142 / Wednesday, July 25, 2007 / Notices
ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Respondents
Average
burden
per response
(in hours)
Total burden
(in hours)
Retail food service workers .............................................................................
Food safety program regulators ......................................................................
Water system operators ..................................................................................
Water safety program regulators .....................................................................
3,713
1,237
1,781
594
1
1
1
1
90/60
90/60
90/60
90/60
5,570
1,855
2,671
891
Total ..........................................................................................................
........................
........................
........................
10,987
Dated: July 18, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–14389 Filed 7–24–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. 2007N–0165]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Hazard Analysis
and Critical Control Point Procedures
for the Safe and Sanitary Processing
and Importing of Juice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0466. Also
include the FDA docket number found
in brackets in the heading of this
document.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 24,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Hazard Analysis and Critical Control
Point Procedures for the Safe and
Sanitary Processing and Importing of
Juice—(OMB Control Number 0910–
0466)—Extension
FDA’s regulations in part 120 (21 CFR
part 120) mandate the application of
hazard analysis and critical control
point (HAACP) 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 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)).
In the Federal Register of May 14,
2007 (72 FR 27138), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Sections
No. of
Recordkeepers
1,875
120.7; 120.10(a); and
120.12(a)(2), (b), and (c)
rwilkins on PROD1PC63 with NOTICES
120.6(c) and 120.12(a)(1) and
(b)
2,300
120.8(b)(7) and
120.12(a)(4)(i) and (b)
Annual Frequency
of Recordkeeping
1,450
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19:31 Jul 24, 2007
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PO 00000
365
1.1
14,600
Frm 00061
Fmt 4703
Sfmt 4703
Total Annual
Records
Hours per
Record
684,375
0.1
2,530
20
21,170,000
E:\FR\FM\25JYN1.SGM
Total Hours
0.01
25JYN1
68,437.5
50,600
211,700
40886
Federal Register / Vol. 72, No. 142 / Wednesday, July 25, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
21 CFR Sections
No. of
Recordkeepers
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
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)
Total
1There
358,466
are no capital costs or operating and maintenance costs associated with this collection of information.
rwilkins on PROD1PC63 with 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: July 19, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–14403 Filed 7–24–07; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
19:31 Jul 24, 2007
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Clinical Center; Submission for OMB
Review; Comment Request Customer
and Other Partners Satisfaction
Surveys
SUMMARY: In compliance with the
requirement of Section 3507(A)(1)(D) of
the Paperwork Reduction Act of 1995
for the opportunity for pubic comment
on the proposed data collection projects,
the Clinical Center (CC) of the National
Institutes of Health, (NIH) has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on May 9, 2007 (Volume 72,
page 26400–26401) and allowed 60days for public comments. One
comment regarding resources required
to conduct surveys was received during
the 60-day comment period. The
purpose of this notice is to provide an
additional 30 days for public comment.
5 CFR 1320.5 Respondents to this
request for information collection
should not respond unless the request
displays a currently valid OMB control
number.
Proposed Collection: Title: Generic
Clearance for Satisfaction Surveys of
Customer and Other Partners. Type of
Information Collection Request:
Reinstatement (OMB Control Number:
0925–0458). Need and Use of
Information Collection: The information
collected in these surveys will be used
by Clinical Center personnel: (1) To
evaluate the satisfaction of various
Clinical Center customers and other
partners with Clinical Center services;
(2) to assist with the design of
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
modifications of these services, based
on customer input; (3) to develop new
services, based on customer need; and
4) to evaluate the satisfaction of various
Clinical Center customers and other
partners with implemented service
modifications. These surveys will
almost certainly lead to quality
improvement activities that will
enhance and/or streamline the Clinical
Center’s operations. The major
mechanisms by which the Clinical
Center will request customer input is
through surveys and focus groups. The
surveys will be tailored specifically to
each class of customer and to that class
of customer’s needs. Surveys will either
be collected as written documents, as
faxed documents, mailed electronically
or collected by telephone from
customers. Information gathered from
these surveys of Clinical Center
customers and other partners will be
presented to, and used directly by,
Clinical Center management to enhance
the services and operations of our
organization. Frequency of Response:
The participants will respond yearly.
Affected public: Individuals and
households, businesses and other for
profit, small businesses and
organizations. Types of respondents:
These surveys are designed to assess the
satisfaction of the Clinical Center’s
major internal and external customers
with the services provided. These
customers include, but are not limited
to, the following groups of individuals:
Clinical Center patients, family
members of Clinical Center patients,
visitors to the Clinical Center, National
Institutes of Health investigators, NIH
intramural collaborators, private
physicians or organizations who refer
patients to the Clinical Center,
volunteers, vendors and collaborating
commercial enterprises, small
E:\FR\FM\25JYN1.SGM
25JYN1
]]>Agencies
[Federal Register Volume 72, Number 142 (Wednesday, July 25, 2007)]
[Notices]
[Pages 40885-40886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14403]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0165]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Hazard Analysis and
Critical Control Point Procedures for the Safe and Sanitary Processing
and Importing of Juice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
24, 2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0466. Also
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Hazard Analysis and Critical Control Point Procedures for the Safe and
Sanitary Processing and Importing of Juice--(OMB Control Number 0910-
0466)--Extension
FDA's regulations in part 120 (21 CFR part 120) mandate the
application of hazard analysis and critical control point (HAACP)
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 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)).
In the Federal Register of May 14, 2007 (72 FR 27138), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency of Total Annual
21 CFR Sections 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 (c) 2,300 1.1 2,530 20 50,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.8(b)(7) and 120.12(a)(4)(i) and (b) 1,450 14,600 21,170,000 0.01 211,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 40886]]
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 19, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-14403 Filed 7-24-07; 8:45 am]
BILLING CODE 4160-01-S
