57962 Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Child Care and Development 

Fund Tribal Plan Preprint—ACF–118– 

A. 

OMB No.: 0970–0198. 

Description: The Child Care and 

Development Fund (CCDF) Tribal Plan 

serves as the agreement between the 

applicant (Indian Tribes, Tribal 

consortia and Tribal organizations) and 

the Federal government that describes 

how Tribal applicants will operate 

CCDF Block Grant programs. The Tribal 

Plan provides assurances that the CCDF 

funds will be administered in 

conformance with legislative 

requirements, Federal regulations at 45 

CFR parts 98 and 99 and other 

applicable instructions or guidelines 

issued by the Administration for 

Children and Families ACF). Tribes 

must submit a new CCDF Tribal Plan 

every two years in accordance with 45 

CFR 98.17. 

Respondents: Tribal CCDF programs 

(259 total). 

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

CCDF Tribal Plan ............................................................................................ 259 1 17.50 4,532.50 

CCDF Tribal Plan Amendments ...................................................................... 259 1 1.50 388.50 

Estimated Total Annual Burden Hours: ........................................................... ........................ ........................ ........................ 4,921 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: September 20, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–23826 Filed 9–22–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0357] 

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 October 25, 

2010. 

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: 

202–395–7285, or emailed to 

oira_submission@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: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850, 301–796–3793. 

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 (HACCP) 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 

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 FD&C Act) (21 U.S.C. 321, et seq.). 

Under the FD&C 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 FD&C 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 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices 57963 

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 FD&C Act (21 

U.S.C. 342(a)(4)). 

In the Federal Register of July 14, 

2010 (75 FR 40839), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No of 

Recordkeepers 

Annual Frequency per 

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. 

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 the 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 

the regulations. 

Dated: September 20, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23824 Filed 9–22–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0459] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection of 

Helicobacter pylori; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection of 

Helicobacter pylori.’’ This draft guidance 

document provides industry and agency 

staff with updated recommendations 

concerning 510(k) submissions for 

various types of in vitro diagnostic 

devices (IVDs) intended to be used for 

detecting Helicobacter pylori (H. pylori). 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by December 22, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection of 

Helicobacter pylori’’ to the Division of 


srobinson on DSKHWCL6B1PROD with NOTICES