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This draft guidance is not final nor is it 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on the draft guidance by April 5, 2011.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single copies of the draft guidance 

document entitled ‘‘Draft Guidance for 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draft guidance to http:// 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This draft guidance recommends 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
572 Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Notices 

Closed: January 19, 2011, 9 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

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

Contact Person: Mary E. Kerr, FAAN, RN, 

PhD, Deputy Director, National Institute of 

Nursing, National Institutes of Health, 31 

Center Drive, Room 5B–05, Bethesda, MD 

20892–2178, 301/496–8230, 

kerrme@mail.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. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nih.gov/ninr/a_advisory.html, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.361, Nursing Research, 

National Institutes of Health, HHS) 

Dated: December 29, 2010. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–33331 Filed 1–4–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meetings 

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 meetings. 

The meetings 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 Institute of 

Mental Health Special Emphasis Panel K99. 

Date: February 3, 2011. 

Time: 1:30 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Megan Libbey, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd., Room 6148, MSC 9609, 

Rockville, MD 20852–9609, 301–402–6807, 

libbeym@mail.nih.gov. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel ITVC 

Conflicts. 

Date: February 9, 2011. 

Time: 10:30 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Enid Light, PhD, Scientific 

Review Officer, Division of Extramural 

Activities, National Institute of Mental 

Health, NIH, Neuroscience Center, 6001 

Executive Boulevard, Room 6132, MSC 9608, 

Bethesda, MD 20852–9608, 301–443–3599, 

elight@mail.nih.gov. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel, Conte 

Centers for Basic and Translational Mental 

Health Research. 

Date: February 25, 2011. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Ritz Carlton Hotel, 1150 22nd Street, 

NW., Washington, DC 20037. 

Contact Person: Rebecca C Steiner, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd, Room 6149, MSC 9608, 

Bethesda, MD 20892–9608, 301–443–4525, 

steinerr@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: December 29, 2010. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–33330 Filed 1–4–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; 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: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel. 

Date: March 14–16, 2011. 

Time: 6 p.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: JW Marriott, 900 W. Olympic Blvd., 

Los Angeles, CA 90015. 

Contact Person: Manana Sukhareva, PhD, 

Scientific Review Officer, National Institute 

of Biomedical Imaging and Bioengineering, 

National Institutes of Health, 6707 

Democracy Boulevard, Suite 959, Bethesda, 

MD 20892, 301–451–3397, 

sukharem@mail.nih.gov. 

Dated: December 29, 2010. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–33325 Filed 1–4–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; 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 the following meeting. 

The meeting will be open to the 

public, 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. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel. 

Date: January 19, 2011. 

Time: 2 p.m. to 4 p.m. 

Agenda: To provide concept review of 

proposed concept review. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Sathasiva B. Kandasamy, 

PhD, Scientific Review Administrator, 

Division of Scientific Review, National 


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