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27138 Federal Register / Vol. 72, No.

92 / Monday, May 14, 2007 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued


Annual Total Operating &
No. of Total Annual Hours per Total
21 CFR Section/Part Frequency per Maintenance
Respondents Responses Response Hours
Response Costs

101.36 300 40 12,000 4 48,000 0

101.42 and 101.45 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

101.79(c)(2)(ii)(D) 1,000 1 1,000 0.25 250 0

101.79(c)(2)(iv) 100 1 100 0.25 25 0

101.100(d) 1,000 1 1,000 1 1,000 0

101.105 and 101.100(h) 25,000 1.03 25,750 0.5 12,875 0

101.108 0 0 40 0 0

Total 1,109,833 $1,422,932


1There are no capital costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


Annual
No. of Total Annual Hours per Total
21 CFR Section Frequency per Rec-
Recordkeepers Records Record Hours
ordkeeping

101.12(e) 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

101.100(d)(2) 1,000 1 1,000 1 1,000

101.105(t) 100 1 100 1 100

Total 676,150
1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated annual reporting and information originally supplied by the DEPARTMENT OF HEALTH AND
recordkeeping burdens are based on Federal Government to the recipient for HUMAN SERVICES
agency communications with industry the purpose of disclosure to the public
and FDA’s knowledge of and experience is not a collection of information. Under Food and Drug Administration
with food labeling and the submission 5 CFR 1320.3(b)(2), the time, effort, and
of petitions and requests to the agency. [Docket No. 2007N–0165]
financial resources necessary to comply
Where an agency regulation implements with a collection of information are
an information collection requirement Agency Information Collection
excluded from the burden estimate if Activities; Proposed Collection;
in the act or the FPLA, only any the reporting, recordkeeping, or
additional burden attributable to the Comment Request; Hazard Analysis
disclosure activities needed to comply and Critical Control Point Procedures
regulation has been included in FDA’s are usual and customary because they
burden estimate. for the Safe and Sanitary Processing
would occur in the normal course of and Importing of Juice
No burden has been estimated for activities.
those requirements where the AGENCY: Food and Drug Administration,
information to be disclosed is Dated: May 8, 2007. HHS.
information that has been supplied by Jeffrey Shuren, ACTION: Notice.
FDA. Also, no burden has been Assistant Commissioner for Policy.
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estimated for information that is [FR Doc. E7–9219 Filed 5–11–07; 8:45 am] SUMMARY: The Food and Drug
disclosed to third parties as a usual and BILLING CODE 4160–01–S
Administration (FDA) is announcing an
customary part of a food producer’s opportunity for public comment on the
normal business activities. Under 5 CFR proposed collection of certain
1320.3(c)(2), the public disclosure of information by the agency. Under the

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Federal Register / Vol. 72, No. 92 / Monday, May 14, 2007 / Notices 27139

Paperwork Reduction Act of 1995 (the 1320.3(c) and includes agency requests HACCP procedures to fruit and
PRA), Federal agencies are required to or requirements that members of the vegetable juice processing. HACCP is a
publish notice in the Federal Register public submit reports, keep records, or preventative system of hazard control
concerning each proposed collection of provide information to a third party. that can be used by all food processors
information, including each proposed Section 3506(c)(2)(A) of the PRA (44 to ensure the safety of their products to
extension of an existing collection of U.S.C. 3506(c)(2)(A)) requires Federal consumers. A HACCP system of
information, and to allow 60 days for agencies to provide a 60-day notice in preventive controls is the most effective
public comment in response to the the Federal Register concerning each and efficient way to ensure that these
notice. This notice solicits comments on proposed collection of information, food products are safe. FDA’s mandate
recordkeeping requirements for including each proposed extension of an to ensure the safety of the Nation’s food
applying hazard analysis and critical existing collection of information, supply is derived principally from the
control point (HAACP) procedures for before submitting the collection to OMB Federal Food, Drug, and Cosmetic Act
safe and sanitary processing for for approval. To comply with this (the act) (21 U.S.C. 321, et seq.). Under
processors of fruit and vegetable juice. requirement, FDA is publishing notice the act, FDA has authority to ensure that
DATES: Submit written or electronic of the proposed collection of all foods in interstate commerce, or that
comments on the collection of information set forth in this document. have been shipped in interstate
information by July 13, 2007. With respect to the following commerce, are not contaminated or
ADDRESSES: Submit electronic collection of information, FDA invites otherwise adulterated, are produced and
comments on the collection of comments on these topics: (1) Whether held under sanitary conditions, and are
information to: http://www.fda.gov/ the proposed collection of information not misbranded or deceptively
dockets/ecomments. Submit written is necessary for the proper performance packaged; under section 701 (21 U.S.C.
comments on the collection of of FDA’s functions, including whether 371), the act authorizes the agency to
information to the Division of Dockets the information will have practical issue regulations for its efficient
Management (HFA–305), Food and Drug utility; (2) the accuracy of FDA’s enforcement. The agency also has
Administration, 5630 Fishers Lane, rm. estimate of the burden of the proposed authority under section 361 of the
1061, Rockville, MD 20852. All collection of information, including the Public Health Service Act (42 U.S.C.
comments should be identified with the validity of the methodology and 264) to issue and enforce regulations to
docket number found in brackets in the assumptions used; (3) ways to enhance prevent the introduction, transmission,
heading of this document. the quality, utility, and clarity of the or spread of communicable diseases
information to be collected; and (4) from one State to another other State.
FOR FURTHER INFORMATION CONTACT:
ways to minimize the burden of the Information development and
Jonna Capezzuto, Office of the Chief
collection of information on recordkeeping are essential parts of any
Information Officer (HFA–250), Food
respondents, including through the use
and Drug Administration, 5600 Fishers HACCP system. The information
of automated collection techniques,
Lane, Rockville, MD 20857, 301–827– collection requirements are narrowly
when appropriate, and other forms of
4659. tailored to focus on the development of
information technology.
SUPPLEMENTARY INFORMATION: Under the appropriate controls and document
PRA (44 U.S.C. 3501–3520), Federal Hazard Analysis and Critical Control those aspects of processing that are
agencies must obtain approval from the Point (HACCP) Procedures for the Safe critical to food safety. Through these
Office of Management and Budget and Sanitary Processing and Importing regulations, FDA is implementing its
(OMB) for each collection of of Juice—21 CFR Part 120 (OMB authority under section 402(a)(4) of the
information they conduct or sponsor. Control Number 0910–0466)—Extension act (21 U.S.C. 342(a)(4)).
‘‘Collection of information’’ is defined FDA’s regulations in part 120 (21 CFR FDA estimates the burden of this
in 44 U.S.C. 3502(3) and 5 CFR part 120) mandate the application of collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


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

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


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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.

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27140 Federal Register / Vol. 72, No. 92 / Monday, May 14, 2007 / Notices

Table 1 of this document provides a PRA), Federal agencies are required to validity of the methodology and
breakdown of the total estimated annual publish notice in the Federal Register assumptions used; (3) ways to enhance
recordkeeping burden. FDA bases this concerning each proposed collection of the quality, utility, and clarity of the
hour burden estimate on its experience information, including each proposed information to be collected; and (4)
with the application of HACCP extension of an existing collection of ways to minimize the burden of the
principles in food processing. information, and to allow 60 days for collection of information on
The burden estimates in table 1 of this public comment in response to the respondents, including through the use
document are based on an estimate of notice. This notice solicits comments on of automated collection techniques,
the total number of juice manufacturing the collection of information contained when appropriate, and other forms of
plants (i.e., 2,300) affected by the in the guidance entitled ‘‘Information information technology.
regulations. Included in this total are Program on Clinical Trials for Serious or
Information Program on Clinical Trials
850 plants currently identified in FDA’s Life-Threatening Diseases and
for Serious or Life-Threatening
official establishment inventory plus Conditions’’ dated March 18, 2002.
Diseases: Maintaining a Data Bank
1,220 very small apple juice DATES: Submit written or electronic (OMB Control Number 0910–0459)—
manufacturers and 230 very small comments on the collection of Extension
orange juice manufacturers. The total information by July 13, 2007.
burden hours are derived by estimating ADDRESSES: Submit electronic
In the Federal Register of March 18,
the number of plants affected by each comments on the collection of 2002 (65 FR 12022), FDA issued a
portion of this final rule and information to: http://www.fda.gov/ guidance to industry on
multiplying the corresponding number dockets/ecomments. Submit written recommendations for investigational
by the number of records required comments on the collection of new drug application (IND) sponsors on
annually and the hours needed to information to the Division of Dockets submitting information about clinical
complete the record. These numbers Management (HFA–305), Food and Drug trials for serious or life- threatening
were obtained from the agency’s final Administration, 5630 Fishers Lane, rm. diseases to a Clinical Trials Data Bank
regulatory impact analysis prepared for 1061, Rockville, MD 20852. All developed by the National Library of
these regulations. comments should be identified with the Medicine (NLM), National Institutes of
Moreover, these estimates assume that docket number found in brackets in the Health (NIH). This information is
every processor will prepare sanitary heading of this document. especially important for patients and
standard operating procedures and a their families seeking opportunities to
FOR FURTHER INFORMATION CONTACT:
participate in clinical trials of new drug
HACCP plan and maintain the Jonna Capezzuto, Office of the Chief treatments for serious or life-threatening
associated monitoring records and that Information Officer (HFA–250), Food diseases. The guidance describes three
every importer will require product and Drug Administration, 5600 Fishers collections of information: Mandatory
safety specifications. In fact, there are Lane, Rockville, MD 20857, 301–827– submissions, voluntary submissions,
likely to be some small number of juice 4659. and certifications.
processors that, based upon their hazard SUPPLEMENTARY INFORMATION: Under the
analysis, determine that they are not PRA (44 U.S.C. 3501–3520), Federal Mandatory Submissions
required to have a HACCP plan under agencies must obtain approval from the Section 113 of the Food and Drug
these regulations. Office of Management and Budget Administration Modernization Act
Dated: April 27, 2007. (OMB) for each collection of (FDAMA) of 1997 (the Modernization
Jeffrey Shuren, information they conduct or sponsor. Act) (Public Law 105–115) requires that
Assistant Commissioner for Policy. ‘‘Collection of information’’ is defined sponsors shall submit information to the
[FR Doc. E7–9220 Filed 5–11–07; 8:45 am] in 44 U.S.C. 3502(3) and 5 CFR Clinical Trials Data Bank when the
BILLING CODE 4160–01–S
1320.3(c) and includes agency requests clinical trial: (1) Involves a treatment for
or requirements that members of the a serious or life-threatening disease and
public submit reports, keep records, or (2) is intended to assess the
DEPARTMENT OF HEALTH AND provide information to a third party. effectiveness of the treatment. The
HUMAN SERVICES Section 3506(c)(2)(A) of the PRA (44 guidance discusses how sponsors can
U.S.C. 3506(c)(2)(A)) requires Federal fulfill the requirements of section 113 of
Food and Drug Administration agencies to provide a 60-day notice in the Modernization Act. Specifically,
the Federal Register concerning each sponsors should provide: (1)
[Docket No. 2007N–0182]
proposed collection of information, Information about clinical trials, both
Agency Information Collection including each proposed extension of an federally and privately funded, of
Activities; Proposed Collection; existing collection of information, experimental treatments (drugs,
Comment Request; Information before submitting the collection to OMB including biological products) for
Program on Clinical Trials for Serious for approval. To comply with this patients with serious or life-threatening
or Life-Threatening Diseases: requirement, FDA is publishing notice diseases; (2) a description of the
Maintaining a Data Bank of the proposed collection of purpose of the experimental drug; (3)
information set forth in this document. patient eligibility criteria; (4) the
AGENCY: Food and Drug Administration, With respect to the following location of clinical trial sites; and (5) a
HHS. collection of information, FDA invites point of contact for patients wanting to
ACTION: Notice. comments on these topics: (1) Whether enroll in the trial.
the proposed collection of information Senate 1789, ‘‘Best Pharmaceuticals
SUMMARY: The Food and Drug is necessary for the proper performance for Children Act’’ (Public Law 107–109)
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Administration (FDA) is announcing an of FDA’s functions, including whether (BPCA), established a new requirement
opportunity for public comment on the the information will have practical for the Clinical Trials Data Bank
proposed collection of certain utility; (2) the accuracy of FDA’s mandated by section 113 of FDAMA.
information by the agency. Under the estimate of the burden of the proposed Information submitted to the data bank
Paperwork Reduction Act of 1995 (the collection of information, including the must now include ‘‘a description of

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