[Federal Register Volume 72, Number 142 (Wednesday, July 25, 2007)]
[Notices]
[Pages 40885-40886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14403]


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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.

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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 [email protected]. 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\
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                                                           No. of        Annual Frequency  of     Total Annual
                  21 CFR Sections                      Recordkeepers        Recordkeeping           Records        Hours per  Record      Total Hours
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120.6(c) and 120.12(a)(1) and (b)                                1,875                  365              684,375                0.1             68,437.5
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120.7; 120.10(a); and 120.12(a)(2), (b), and (c)                 2,300                    1.1              2,530               20               50,600
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120.8(b)(7) and 120.12(a)(4)(i) and (b)                          1,450               14,600           21,170,000                0.01           211,700
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[[Page 40886]]

 
120.10(c) and 120.12(a)(4)(ii) and (b)                           1,840                   12               22,080                0.1              2,208
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120.11(a)(1)(iv) and (a)(2) and 120.12(a)(5)                     1,840                   52               95,680                0.1              9,568
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120.11(b) and 120.12(a)(5) and (b)                               1,840                    1                1,840                4                7,360
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120.11(c) and 120.12(a)(5) and (b)                               1,840                    1                1,840                4                7,360
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120.14(a)(2), (c), and (d)                                         308                    1                  308                4                1,232
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Total                                                                                                                                          358,466
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\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