570 Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Establishing the Performance 

Characteristics of Nucleic Acid-Based In 

vitro Diagnostic Devices for the 

Detection and Differentiation of 

Methicillin-Resistant Staphylococcus 

aureus (MRSA) and Staphylococcus 

aureus (SA).’’ The draft guidance 

document provides industry and 

Agency staff with updated 

recommendations for studies to 

establish the analytical and clinical 

performance of nucleic acid-based in 

vitro diagnostic devices (IVDs) intended 

for the detection and differentiation of 

methicillin-resistant Staphylococcus 

aureus (MRSA) and Staphylococcus 

aureus (SA). This draft guidance is not 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on the draft guidance by April 5, 2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Establishing the 

Performance Characteristics of Nucleic 

Acid-Based In vitro Diagnostic Devices 

for the Detection and Differentiation of 

Methicillin-Resistant Staphylococcus 

aureus (MRSA) and Staphylococcus 

aureus (SA)’’ 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draft guidance to http:// 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 (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: Li 

Li, Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5558, Silver Spring, MD 20993– 

0002, 301–796–6200. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing the draft guidance to 

provide industry and Agency staff with 

recommendations for studies to 

establish the analytical and clinical 

performance of nucleic acid-based IVDs 

intended for the detection and 

differentiation of MRSA and SA. These 

devices are used to aid in the prevention 

and control of MRSA/SA infections in 

healthcare settings. This document is 

limited to studies intended to establish 

the performance characteristics of 

devices that detect the MRSA/SA 

genome (nucleic acid). It does not 

address detection of MRSA/SA antigens 

or serological response from the host to 

the MRSA/SA antigens, nor does it 

address establishing performance of 

non-MRSA/SA components of multianalyte or multiplex devices. 

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 nucleic acid-based 

IVDs for the detection and 

differentiation of MRSA and SA. 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 Nucleic Acid-Based In 

vitro Diagnostic Devices for the 

Detection and Differentiation of 

Methicillin-Resistant Staphylococcus 

aureus (MRSA) and Staphylococcus 

aureus (SA),’’ 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 1722 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

The 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 21 CFR 50.23 have been 

approved under OMB control number 

0910–0586; 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: December 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–33292 Filed 1–4–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0636] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection of Antibodies 

to Borrelia Burgdorferi; 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 ‘‘Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection of Antibodies 

to Borrelia burgdorferi.’’ FDA is issuing 

this draft guidance to provide industry 

and agency staff with recommendations 

for studies to establish the analytical 

and clinical performance of in vitro 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Notices 571 

diagnostic devices (IVDs) intended for 

the detection of antibodies to Borrelia 

burgdorferi. These devices are used to 

aid in the diagnosis of Lyme disease. 

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 April 5, 2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Establishing the 

Performance Characteristics of In Vitro 

Diagnostic Devices for the Detection of 

Antibodies to Borrelia burgdorferi’’ 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 (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: 

Prasad Rao, Center for Devices and 

Radiological Health Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5508, Silver Spring, 

MD 20993–0002, 301–796–6203. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance recommends 

studies for establishing the performance 

characteristics of in vitro diagnostic 

devices for the detection of antibodies to 

B. burgdorferi in human serum, plasma, 

and blood. These devices are used to aid 

in the diagnosis of Lyme disease. This 

document does not apply to B. 

burgdorferi nucleic acid amplification 

assays. A manufacturer who intends to 

market an in vitro device for the 

detection of antibodies to B. burgdorferi 

must conform to the general controls of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) and, unless exempt, 

obtain premarket clearance or approval 

prior to marketing the device. 

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 antibodies to 

B. burgdorferi. 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 ‘‘Draft Guidance for Industry and 

Food and Drug Administration Staff; 

Establishing the Performance 

Characteristics of In Vitro Diagnostic 

Devices for the Detection of Antibodies 

to Borrelia burgdorferi,’’ 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 1721 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. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (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 801 and 21 CFR 809.10 have been 

approved under OMB control number 

0910–0485; 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 493.15 have been 

approved under OMB control number 

0910–0598; the collections of 

information 21 CFR 50.23 have been 

approved under OMB control number 

0910–0586 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: December 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–33293 Filed 1–4–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

National Advisory Council for Nursing 

Research. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the 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: National Advisory 

Council for Nursing Research. 

Date: January 18–19, 2011. 

Open: January 18, 2011, 1 p.m. to 4:45 p.m. 

Agenda: Discussion of Program Policies 

and Issues. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6C, Room 6, Bethesda, MD 20892. 


jlentini on DSKJ8SOYB1PROD with NOTICES