27138 Federal Register / Vol. 72, No. 92 / Monday, May 14, 2007 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section/Part No. of 

Respondents 

Annual 

Frequency per 

Response 

Total Annual 

Responses 

Hours per 

Response 

Total 

Hours 

Total Operating & 

Maintenance 

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

21 CFR Section No. of 

Recordkeepers 

Annual 

Frequency per Recordkeeping 

Total Annual 

Records 

Hours per 

Record 

Total 

Hours 

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 

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 

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. 

Dated: May 8, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9219 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–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 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 92 / Monday, May 14, 2007 / Notices 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: http://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

21 CFR Sections No. of 

Recordkeepers 

Annual Frequency 

of Recordkeeping 

Total Annual 

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 

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. 


pwalker on PROD1PC71 with NOTICES
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. 

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 

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: http://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. 

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 


pwalker on PROD1PC71 with NOTICES