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
57964 Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices 

Small Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Freddie M. Poole, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5520, Silver Spring, 

MD 20993–0002, 301–796–5457. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance document 

provides recommendations on 

developing studies for establishing the 

performance characteristics of in vitro 

diagnostic devices for the direct or 

indirect detection of H. pylori bacteria 

in human blood, serum, urine, stool, or 

breath specimens. FDA believes these 

recommended studies will be relevant 

for premarket notification (510(k)) 

submissions for these device types. 

Detection methods listed in this 

guidance include blood and urine 

antibody tests, stool antigen test, 

carbon-13 (13C) urea breath and blood 

tests, and the urease test. This draft 

guidance has been updated since the 

1992 guidance document entitled 

‘‘Review Criteria for Assessment of 

Laboratory Tests for the Detection of 

Antibodies to Helicobacter pylori,’’ to 

suggest information that submitters 

provide that is more appropriate given 

changes in understanding of the science 

of detection of H. pylori and to include 

technologies outside the scope of the 

old guidance, such as H. pylori urea 

breath tests and H. pylori antigen 

detection tests. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on establishing the performance 

characteristics of in vitro diagnostic 

devices for the detection of H. pylori. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection of 

Helicobacter pylori’’ you may either 

send an email request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1712 to identify the draft 

guidance you are requesting. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations 

and guidance documents. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 812 have been approved 

under OMB control number 0910–0078; 

the collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120; 

the collections of information in 42 CFR 

493.17 have been approved under OMB 

control number 0910–0607; and the 

collections of information in 21 CFR 

56.115 have been approved under OMB 

control number 0910–0130. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23644 Filed 9–22–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Ethical, Legal, and Social Research. 

Date: September 27, 2010. 

Time: 10 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Richard A. Currie, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1108, 

MSC 7890, Bethesda, MD 20892, (301) 435– 

1219, currieri@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 16, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–23849 Filed 9–22–10; 8:45 am] 

BILLING CODE 4140–01–P 


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