73106 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

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: November 17, 2010. 

Leslie Kux, 

Acting Assisitant Commissioner for Policy. 

[FR Doc. 2010–29927 Filed 11–26–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0565] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection of 

Clostridium difficile; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

document entitled ‘‘Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection of 

Clostridium difficile.’’ This draft 

guidance document describes FDA’s 

recommendations concerning 510(k) 

submissions for various types of in vitro 

diagnostic devices (IVDs) intended to be 

used for detecting Clostridium difficile 

(C. difficile). This draft guidance is not 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 on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by February 28, 2011. 

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single copies of the draft guidance 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 

Clostridium difficile’’ to the Division of 

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draft guidance to http:// 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, 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: 

Stephen Lovell, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4435, Silver Spring, 

MD 20993–0002, 301–796–6968. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance includes 

recommendations concerning 510(k) 

submissions for various types of (IVDs) 

intended to be used for detecting C. 

difficile. The document is a revision of 

‘‘Review Criteria for Assessment of 

Laboratory Tests Directed at Assisting in 

the Diagnosis of C. difficile Associated 

Disease’’ issued on May 31, 1990. It is 

updated to include new issues and 

technologies identified since the 1990 

guidance. Such methods include 

detection of C. difficile nucleic acids 

(e.g., C. difficile toxin B gene by nucleic 

acid amplification methods such as the 

Real-Time Polymerase Chain Reaction 

technique). 

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 C. difficile. 

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. 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. To 

receive ‘‘Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection of Clostridium 

difficile,’’ you may either send an e-mail 

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 1715 to 

identify the guidance you are 

requesting. 

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 807 subpart E have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 42 CFR section 493.15 

have been approved under OMB control 

number 0910–0598; the collections of 

information in 21 CFR section 50.23 

have been approved under OMB control 

number 0910–0586; and the collections 

of information in 21 CFR section 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: November 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29794 Filed 11–26–10; 8:45 am] 

BILLING CODE 4160–01–P 

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