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Federal Register / Vol. 72, No.

142 / Wednesday, July 25, 2007 / Notices 40885

ANNUALIZED BURDEN HOURS


Average
Number of
Number of burden Total burden
Respondents responses per
respondents per response (in hours)
respondent (in hours)

Retail food service workers ............................................................................. 3,713 1 90/60 5,570


Food safety program regulators ...................................................................... 1,237 1 90/60 1,855
Water system operators .................................................................................. 1,781 1 90/60 2,671
Water safety program regulators ..................................................................... 594 1 90/60 891

Total .......................................................................................................... ........................ ........................ ........................ 10,987

Dated: July 18, 2007. comments be faxed to the Office of food products are safe. FDA’s mandate
Maryam I. Daneshvar, Information and Regulatory Affairs, to ensure the safety of the Nation’s food
Acting Reports Clearance Officer, Centers for OMB, Attn: FDA Desk Officer, FAX: supply is derived principally from the
Disease Control and Prevention. 202–395–6974, or e-mailed to Federal Food, Drug, and Cosmetic Act
[FR Doc. E7–14389 Filed 7–24–07; 8:45 am] baguilar@omb.eop.gov. All comments (the act) (21 U.S.C. 321, et seq.). Under
BILLING CODE 4163–18–P should be identified with the OMB the act, FDA has authority to ensure that
control number 0910–0466. Also all foods in interstate commerce, or that
include the FDA docket number found have been shipped in interstate
DEPARTMENT OF HEALTH AND in brackets in the heading of this commerce, are not contaminated or
HUMAN SERVICES document. otherwise adulterated, are produced and
FOR FURTHER INFORMATION CONTACT: held under sanitary conditions, and are
Food and Drug Administration not misbranded or deceptively
Jonna Capezzuto, Office of the Chief
[Docket No. 2007N–0165] Information Officer (HFA–250), Food packaged; under section 701 (21 U.S.C.
and Drug Administration, 5600 Fishers 371), the act authorizes the agency to
Agency Information Collection Lane, Rockville, MD 20857, 301–827– issue regulations for its efficient
Activities; Submission for Office of 4659. enforcement. The agency also has
Management and Budget Review; authority under section 361 of the
Comment Request; Hazard Analysis SUPPLEMENTARY INFORMATION: In Public Health Service Act (42 U.S.C.
and Critical Control Point Procedures compliance with 44 U.S.C. 3507, FDA 264) to issue and enforce regulations to
for the Safe and Sanitary Processing has submitted the following proposed prevent the introduction, transmission,
and Importing of Juice collection of information to OMB for
or spread of communicable diseases
review and clearance.
AGENCY: Food and Drug Administration, from one State to another State.
HHS. Hazard Analysis and Critical Control Information development and
Point Procedures for the Safe and recordkeeping are essential parts of any
ACTION: Notice.
Sanitary Processing and Importing of HACCP system. The information
SUMMARY: The Food and Drug Juice—(OMB Control Number 0910– collection requirements are narrowly
Administration (FDA) is announcing 0466)—Extension tailored to focus on the development of
that a proposed collection of FDA’s regulations in part 120 (21 CFR appropriate controls and document
information has been submitted to the part 120) mandate the application of those aspects of processing that are
Office of Management and Budget hazard analysis and critical control critical to food safety. Through these
(OMB) for review and clearance under point (HAACP) procedures to fruit and regulations, FDA is implementing its
the Paperwork Reduction Act of 1995. vegetable juice processing. HACCP is a authority under section 402(a)(4) of the
DATES: Fax written comments on the preventative system of hazard control act (21 U.S.C. 342(a)(4)).
collection of information by August 24, that can be used by all food processors In the Federal Register of May 14,
2007. to ensure the safety of their products to 2007 (72 FR 27138), FDA published a
ADDRESSES: To ensure that comments on consumers. A HACCP system of 60-day notice requesting public
the information collection are received, preventive controls is the most effective comment on the information collection
OMB recommends that written and efficient way to ensure that these provisions. No comments were received.

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


No. of Annual Frequency Total Annual Hours per
21 CFR Sections Total Hours
Recordkeepers of Recordkeeping Records Record

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
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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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40886 Federal Register / Vol. 72, No. 142 / Wednesday, July 25, 2007 / Notices

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued


No. of Annual Frequency Total Annual Hours per
21 CFR Sections Total Hours
Recordkeepers of Recordkeeping Records Record

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
1There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 1 of this document provides a DEPARTMENT OF HEALTH AND modifications of these services, based
breakdown of the total estimated annual HUMAN SERVICES on customer input; (3) to develop new
recordkeeping burden. FDA bases this services, based on customer need; and
hour burden estimate on its experience National Institutes of Health 4) to evaluate the satisfaction of various
with the application of HACCP Clinical Center customers and other
Clinical Center; Submission for OMB partners with implemented service
principles in food processing.
Review; Comment Request Customer modifications. These surveys will
The burden estimates in table 1 of this and Other Partners Satisfaction almost certainly lead to quality
document are based on an estimate of Surveys improvement activities that will
the total number of juice manufacturing
SUMMARY: In compliance with the enhance and/or streamline the Clinical
plants (i.e., 2,300) affected by the
requirement of Section 3507(A)(1)(D) of Center’s operations. The major
regulations. Included in this total are mechanisms by which the Clinical
the Paperwork Reduction Act of 1995
850 plants currently identified in FDA’s Center will request customer input is
for the opportunity for pubic comment
official establishment inventory plus through surveys and focus groups. The
on the proposed data collection projects,
1,220 very small apple juice the Clinical Center (CC) of the National surveys will be tailored specifically to
manufacturers and 230 very small Institutes of Health, (NIH) has submitted each class of customer and to that class
orange juice manufacturers. The total to the Office of Management and Budget of customer’s needs. Surveys will either
burden hours are derived by estimating (OMB) a request to review and approve be collected as written documents, as
the number of plants affected by each the information collection listed below. faxed documents, mailed electronically
portion of this final rule and This proposed information collection or collected by telephone from
multiplying the corresponding number was previously published in the Federal customers. Information gathered from
by the number of records required Register on May 9, 2007 (Volume 72, these surveys of Clinical Center
annually and the hours needed to page 26400–26401) and allowed 60- customers and other partners will be
complete the record. These numbers days for public comments. One presented to, and used directly by,
were obtained from the agency’s final comment regarding resources required Clinical Center management to enhance
regulatory impact analysis prepared for to conduct surveys was received during the services and operations of our
these regulations. the 60-day comment period. The organization. Frequency of Response:
Moreover, these estimates assume that purpose of this notice is to provide an The participants will respond yearly.
additional 30 days for public comment. Affected public: Individuals and
every processor will prepare sanitary
5 CFR 1320.5 Respondents to this households, businesses and other for
standard operating procedures and a
request for information collection profit, small businesses and
HACCP plan and maintain the organizations. Types of respondents:
should not respond unless the request
associated monitoring records and that displays a currently valid OMB control These surveys are designed to assess the
every importer will require product number. satisfaction of the Clinical Center’s
safety specifications. In fact, there are Proposed Collection: Title: Generic major internal and external customers
likely to be some small number of juice Clearance for Satisfaction Surveys of with the services provided. These
processors that, based upon their hazard Customer and Other Partners. Type of customers include, but are not limited
analysis, determine that they are not Information Collection Request: to, the following groups of individuals:
required to have a HACCP plan under Reinstatement (OMB Control Number: Clinical Center patients, family
these regulations. 0925–0458). Need and Use of members of Clinical Center patients,
Dated: July 19, 2007. Information Collection: The information visitors to the Clinical Center, National
collected in these surveys will be used Institutes of Health investigators, NIH
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Jeffrey Shuren,
by Clinical Center personnel: (1) To intramural collaborators, private
Assistant Commissioner for Policy. evaluate the satisfaction of various physicians or organizations who refer
[FR Doc. E7–14403 Filed 7–24–07; 8:45 am] Clinical Center customers and other patients to the Clinical Center,
BILLING CODE 4160–01–S partners with Clinical Center services; volunteers, vendors and collaborating
(2) to assist with the design of commercial enterprises, small

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