Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 48871 

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 

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 guidance document provides 

recommendations on the types of 

information and data that FDA believes 

needs to be included in a 510(k) for 

herpes simplex virus (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 

HSV in serum. Additionally, some of 

the assays consist of HSV antisera 

conjugated with a fluorescent dye 

(immunofluorescent assays) used to 

identify HSV directly from clinical 

specimens or tissue culture isolates 

derived from clinical specimens. The 

identification aids in the diagnosis of 

diseases caused by HSVs 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 revised the existing 

guidance by rewriting the method 

comparison section and the sample 

selection inclusion and exclusion 

criteria section. The revisions define 

and differentiate the required studies 

and the study populations for the 

assessment of the safety and 

effectiveness of the different types of 

HSV types 1 and 2 serological assays. 

Additionally, the revisions include 

several corrections and clarifications 

throughout the document to ensure 

accuracy, consistency, and ease of 

reading. The draft of this guidance 

issued on September 28, 2010 (75 FR 

59726) and the comment period closed 

on December 27, 2010. We received no 

comments on the draft guidance. 

Elsewhere in this issue of the Federal 

Register, FDA is finalizing the 

amendment of the special controls 

guidance document and designating this 

guidance as the class II special control 

for HSV types 1 and 2 serological 

assays. Following the effective date in 

the final rule finalizing the amendment 

of the special controls guidance 

document, this revised guidance 

document will serve as the special 

control for this device and supersedes 

the guidance with the same name that 

issued on April 3, 2007 (72 FR 15888). 

II. Significance of Special Controls 

Guidance Document 

FDA believes that adherence to the 

recommendations described in this 

guidance document, in addition to the 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of the HSV types 1 and 2 

serological assays classified under 21 

CFR 866.3305. In order to be classified 

as a class II device, HSV types 1 and 2 

serological assays must comply with the 

requirements of special controls; 

manufacturers must address the issues 

requiring special controls as identified 

in the guidance document, either by 

following the recommendations in the 

guidance document or by some other 

means that provides equivalent 

assurances of safety and effectiveness. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the 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 ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological 

Assays,’’ 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 1713 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act 

This 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: August 3, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20117 Filed 8–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Immunology Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Immunology Devices 

Panel of the Medical Devices Advisory 

Committee. 

General Function of the Committee: To 

provide advice and recommendations to the 

Agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on October 14, 2011, from 8 a.m. to 6 p.m. 

Location: Hilton Washington DC North/ 

Gaithersburg, salons A, B, and C, 620 Perry 

Pkwy., Gaithersburg, MD. 

Contact Person: Shanika Craig, Center for 

Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 301– 

796–6639, or FDA Advisory Committee 

Information Line, 1–800–741–8138 (301– 

443–0572 in the Washington, DC area), and 


sroberts on DSK5SPTVN1PROD with NOTICES
48872 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 

follow the prompts to the desired center or 

product area. Please call the Information Line 

for up-to-date information on this meeting. A 

notice in the Federal Register about last 

minute modifications that impact a 

previously announced advisory committee 

meeting cannot always be published quickly 

enough to provide timely notice. Therefore, 

you should always check the Agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn about 

possible modifications before coming to the 

meeting. 

Agenda: On October 14, 2011, the 

committee will discuss, make 

recommendations, and vote on a premarket 

approval application for the Progensa PCA3 

assay sponsored by Gen-Probe, Inc. The 

Progensa PCA3 assay is indicated for use in 

conjunction with other patient information to 

aid in the decision for repeat biopsy in men 

50 years of age or older who have had one 

or more previous negative prostate biopsies 

and for whom a repeat biopsy would be 

recommended based on current standard of 

care, before consideration of PCA3 assay 

results. A lower PCA3 score is associated 

with a decreased likelihood of a positive 

biopsy. 

FDA intends to make background material 

available to the public no later than 2 

business days before the meeting. If FDA is 

unable to post the background material on its 

Web site prior to the meeting, the background 

material will be made publicly available at 

the location of the advisory committee 

meeting, and the background material will be 

posted on FDA’s Web site after the meeting. 

Background material is available at http:// 

www.fda.gov/AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: Interested persons may present 

data, information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

September 30, 2011. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m., 

immediately following lunch. Those 

individuals interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of the 

general nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and an 

indication of the approximate time requested 

to make their presentation on or before 

September 22, 2011. Time allotted for each 

presentation may be limited. If the number of 

registrants requesting to speak is greater than 

can be reasonably accommodated during the 

scheduled open public hearing session, FDA 

may conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by September 23, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee meetings 

and will make every effort to accommodate 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact AnnMarie 

Williams at 301–796–5966 at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly conduct 

of its advisory committee meetings. Please 

visit our Web site at http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ucm111462.htm 

for procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2). 

Dated: August 3, 2011. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2011–20118 Filed 8–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; The Hispanic Community 

Health Study (HCHS)/Study of Latinos 

(SOL) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH) will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Hispanic 

Community Health Study (HCHS)/Study 

of Latinos (SOL). Type of Information 

Collection Request: Revision of 

currently approved collection. (OMB# 

0925–0584). Need and Use of 

Information Collection: A baseline 

examination was conducted from March 

3, 2008 to June 30, 2011. HCHS will 

follow-up new participants enrolled in 

the past year by telephone for dietary 

data, and continue to conduct annual 

follow-up of all participants by 

telephone to ascertain morbidity and 

mortality. Physicians/health care 

providers will be contacted to verify 

reported events for outcomes 

ascertainment. The Hispanic 

Community Health Study (HCHS)/Study 

of Latinos (SOL) will identify risk 

factors for cardiovascular and lung 

disease in Hispanic populations and 

determine the role of acculturation in 

the prevalence and development of 

these diseases. Frequency of Response: 

The participants will be contacted 

annually. Affected Public: Individuals 

or households; Businesses or other for 

profit; Small businesses or 

organizations. Type of Respondents: 

Individuals or households; physicians/ 

health care providers. The annual 

reporting burden is as follows: 

Estimated Number of Respondents: 

17,284; Estimated Number of Responses 

per Respondent: 1; Average Burden 

Hours Per Response: 0.3072; and 

Estimated Total Annual Burden Hours 

Requested: 5,309. The annualized cost 

to respondents is estimated at $104,718, 

assuming respondents time at the rate of 

$15 per hour and physician time at the 

rate of $55 per hour. There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

ESTIMATE OF ANNUAL HOUR BURDEN

Type of response Number of respondents 

Frequency of 

responses 

Average hours 

per response 

Annual hour 

burden 

Participant telephone Interviews: 

a. Follow-up call, Year 1 ........................................................................... 1,333 1 0.75 1,000 

b. Follow-up call, Year 2 ........................................................................... 5,333 1 0.25 1,333 

c. Follow-up call, Year 3,4,5,6 .................................................................. 9,334 1 0.25 2,334 

Non Participant Components: 

Physician, medical examiner, next of kin or other contact follow-up 1 ..... 1,284 1 0.50 642 

Total unique respondents .................................................................. 17,284 ........................ ........................ 5,309 

1Annual burden is placed on doctors and respondent relatives/informants through requests for information which will help in the compilation of 

the number and nature of new fatal and nonfatal events. 


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