Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 59727 

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draft guidance to http:// 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: Haja 

Sittana El Mubarak, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5519, Silver Spring, 

MD 20993–0002, 301–796–6193. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance document 

provides recommendations on the types 

of information and data that FDA 

believes needs to be included in a 

premarket notification 510(k) 

submission for HSV types 1 and 2 

serological assays. HSV serological 

assays are devices that consist of 

antigens and antisera used in various 

serological tests to identify antibodies to 

herpes simplex virus in serum. 

Additionally, some of the assays consist 

of herpes simplex virus antisera 

conjugated with a fluorescent dye 

(immunofluorescent assays) used to 

identify herpes simplex virus directly 

from clinical specimens or tissue 

culture isolates derived from clinical 

specimens. The identification aids in 

the diagnosis of diseases caused by 

herpes simplex viruses and provides 

epidemiological information on these 

diseases. Herpes simplex viral 

infections range from common and mild 

lesions of the skin and mucous 

membranes to a severe form of 

encephalitis (inflammation of the brain). 

Neonatal herpes virus infections range 

from a mild infection to a severe 

generalized disease with a fatal 

outcome. We have revised the existing 

guidance by rewriting the method 

comparison section and the sample 

selection inclusion and exclusion 

criteria section. The revisions defined 

and differentiated the required studies 

and the study populations for the 

assessment of the safety and 

effectiveness of the different types of 

HSV 1 and HSV 2 serological assays. 

Additionally, we made several 

corrections and clarifications 

throughout the document to ensure 

accuracy, consistency, and ease of 

reading. Elsewhere in this issue of the 

Federal Register, FDA is proposing to 

designate this guidance as the class II 

special control for HSV types 1 and 2 

serological assays. If this classification 

rule is finalized, FDA intends that this 

guidance document will serve as the 

special control for this device. 

Following the effective date of any 

final classification rule based on this 

proposal, any firm submitting a 

premarket notification (510(k)) for HSV 

types 1 and 2 serological assays will 

need to address the issues covered in 

the special controls guidance document. 

However, the firm need only show that 

its device meets the recommendations 

of the guidance document or in some 

other way provides equivalent 

assurances of safety and effectiveness. 

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 HSV types 1 and 2 serological assays. 

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 ‘‘Class II Special 

Controls Guidance Document: Herpes 

Simplex Virus Types 1 and 2 

Serological Assays,’’ 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 1713 to identify the 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 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; and the collections 

of information in 21 CFR part 801 and 

21 CFR 809.10 have been approved 

under OMB control number 0910–0485. 

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. 2010–23640 Filed 9–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry (NCEH/ATSDR); 

Notice of National Conversation on 

Public Health and Chemical Exposures 

Leadership Council Meeting 

Time and Date: 9 a.m.—5 p.m. EDT, 

Tuesday, October 5, 2010. 

Location: Omni Shoreham Hotel, 2500 

Calvert Street NW., Washington, DC 

20008. 

Status: Open to the public, on a first 

come, first served basis, limited by the 

space available. An opportunity for the 

public to listen to the meeting by phone 

will be available. For information on 

observing the meeting in person or by 

phone, see ‘‘contact for additional 

information’’ below. 

Purpose: This is the sixth meeting of 

the National Conversation on Public 


srobinson on DSKHWCL6B1PROD with NOTICES
59728 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 

Health and Chemical Exposures 

Leadership Council, which is convened 

by RESOLVE, a non-profit independent 

facilitator. The National Conversation 

on Public Health and Chemical 

Exposures is a collaborative initiative 

supported by NCEH/ATSDR and 

through which many organizations and 

individuals are helping develop an 

action agenda for strengthening the 

nation’s approach to protecting the 

public’s health from harmful chemical 

exposures. The Leadership Council 

provides overall guidance to the 

National Conversation project and is 

responsible for issuing the final action 

agenda. For additional information on 

the National Conversation on Public 

Health and Chemical Exposures, visit 

this Web site: http://www.atsdr.cdc.gov/ 

nationalconversation/. 

Meeting Agenda: The purpose of the 

meeting is to discuss key themes and 

recommendations to feature in the draft 

action agenda, drawing on draft work 

group reports and the results of various 

stakeholder and public engagement 

activities. 

Contact for additional information: If 

you would like to receive additional 

information on attending this meeting in 

person or listening by telephone, please 

contact: nationalconversation@cdc.gov 

or Ben Gerhardstein at 770–488–3646. 

Dated: September 21, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–24260 Filed 9–27–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Neurodevices, Neuroimaging, and 

Bioengineering. 

Date: October 20, 2010. 

Time: 2 p.m. to 6 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: Vilen A. Movsesyan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040M, 

MSC 7806, Bethesda, MD 20892, 301–402– 

7278, movsesyanv@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Electromagnetic Devices. 

Date: October 26, 2010. 

Time: 12 p.m. to 3:30 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: Antonio Sastre, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5215, 

MSC 7412, Bethesda, MD 20892, 301–435– 

2592, sastrea@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: AIDS Predoctoral and 

Postdoctoral. 

Date: October 27–28, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Shiv A. Prasad, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5220, 

MSC 7852, Bethesda, MD 20892, 301–443– 

5779, prasads@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Dermatology, Rheumatology and 

Inflammation. 

Date: November 1, 2010. 

Time: 11:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Aftab A. Ansari, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4108, 

MSC 7814, Bethesda, MD 20892, 301–594– 

6376, ansaria@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Stem Cells 

in Cancer. 

Date: November 1, 2010. 

Time: 1 p.m. to 4 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: Nywana Sizemore, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6204, 

MSC 7804, Bethesda, MD 20892, 301–435– 

1718, sizemoren@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Tooth 

Development and Mineralization. 

Date: November 3, 2010. 

Time: 3 p.m. to 5:30 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: Priscilla B. Chen, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4104, 

MSC 7814, Bethesda, MD 20892, (301) 435– 

1787, chenp@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–08– 

147: Quick Trials on Imaging and imageGuided Intervention. 

Date: November 4, 2010. 

Time: 2 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: John Firrell, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5213, 

MSC 7854, Bethesda, MD 20892, 301–435– 

2598, firrellj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel. 

Fellowships: Neurodevelopment, Synaptic 

Plasticity and Neurodegeneration. 

Date: November 11–12, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Westin San Diego, 400 West 

Broadway, San Diego, CA 92101. 

Contact Person: Vilen A. Movsesyan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040M, 

MSC 7806, Bethesda, MD 20892, 301–402– 

7278, movsesyanv@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Digestive Sciences. 

Date: November 15–16, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Bonnie L. Burgess-Beusse, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2182, 

MSC 7818, Bethesda, MD 20892, 301–435– 

1783, beusseb@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA Panel: 

Diet and Physical Activity Methodologies. 

Date: November 16–17, 2010. 


srobinson on DSKHWCL6B1PROD with NOTICES