2072 Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 

2011, THROUGH SEPTEMBER 30, 2011 

PMA No. 

Docket No. Applicant Trade name Approval date 

P100031, FDA–2011–M– 

0502.

Roche Diagnostics Corp. ..... ELECSYS ANTI–HBC IMMUNOASSAY & ELECSYS 

PRECICONTROL ANTI–HBC.

June 22, 2011. 

P100032, FDA–2011–M– 

0503.

Roche Diagnostics Corp. ..... ELECSYS ANTI–HBC IMMUNOASSAY, ELECSYS 

PRECICONTROL ANTI–HBC FOR USE ON THE 

ELECSYS 2010 IMMUNOASSAY ANALYZER.

June 27, 2011. 

P100001, FDA–2011–M– 

0563.

Ortho-Clinical Diagnostics, 

Inc..

VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI– 

HBE REAGENT PACK, VITROS 

IMMUNODIAGNOSTIC PRODUCTS ANTI–HBE CALIBRATOR, AND VITROS IMMUNODIAGNOSTIC 

PRODUCTS ANTI–HBE CONTROLS.

July 20, 2011. 

P110001, FDA–2011–M– 

0564.

Abbott Vascular ................... RX HERCULINK ELITE RENAL STENT SYSTEM ........... July 20, 2011. 

P100044, FDA–2011–M– 

0600.

Intersect ENT ....................... PROPEL ............................................................................. August 11, 2011. 

P110020, FDA–2011–M– 

0601.

Roche Molecular Systems, 

Inc..

COBAS 4800 BRAF V600 MUTATION TEST ................... August 17, 2011. 

P110012, FDA–2011–M– 

0630.

Abbott Molecular, Inc. .......... VYSIS ALK BREAK APART FISH PROBE KIT; VYSIS 

PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT; PROBECHEK ALK NEGATIVE CONTROL SLIDES; AND PROBECHEK ALK 

POSITIVE CONTROL SLIDES.

August 26, 2011. 

H100006, FDA–2011–M– 

0707.

Synapse Biomedical, Inc. .... NEURX DPS DIAPHRAGM PACING SYSTEM ................ September 28, 2011. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: January 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–537 Filed 1–12–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Prevalence, Incidence, 

Epidemiology and Molecular Variants 

of HIV in Blood Donors in Brazil 

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 the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection: Title: 

Prevalence, Incidence, Epidemiology 

and Molecular Variants of HIV in Blood 

Donors in Brazil. Type of Information 

Collection Request: Extension (OMB No. 

0925–0597). Need and Use of 

Information Collection: Establishing and 

monitoring viral prevalence and 

incidence rates, and identifying 

behavioral risk behaviors for HIV 

infection among donors are critical steps 

to assessing and reducing risk of HIV 

transmission through blood transfusion. 

Detecting donors with recently acquired 

HIV infection is particularly critical as 

it enables characterization of the viral 

subtypes currently transmitted within 

the screened population. In addition to 

characterizing genotypes of recently 

infected donors for purposes of blood 

safety, molecular surveillance of 

incident HIV infections in blood donors 

serves important public health roles by 

identifying new HIV infections for antiretroviral treatment, and enabling 

documentation of the rates of primary 

transmission of anti-viral drug resistant 

strains in the community. This study is 

a continuation of a previous research 

project which enrolled eligible HIV 

positive blood donors and analyzed HIV 

molecular variants and their association 

with risk. 

This previous project was conducted 

by the NHLBI Retrovirus Epidemiology 

Donor Study—II (REDS–II) International 

Brazil program and included not only 

data collection on HIV seropositive 

donors but also collection of risk factor 

data on uninfected donors. The current 

Recipient Epidemiology and Donor 

Evaluation Study—(REDS–III) research 

proposal is a continuation of the 

previous REDS–II project at the same 

four blood centers in Brazil, located in 

the cities of Sao Paulo, Recife, Rio de 

Janeiro and Belo Horizonte, but this 

time restricted to the study of HIVpositive subjects. 

The primary study aims are to 

continue monitoring HIV molecular 

variants and risk behaviors in blood 

donors in Brazil, and to evaluate HIV 

subtype and drug resistance profiles 

among HIV positive donors according to 

HIV infection status (recent versus longstanding infection), year of donation, 

and site of collection. Additional study 

objectives include determining trends in 

HIV molecular variants and risk factors 

associated with HIV infection by 

combining data collected in the 

previous REDS–II project with that 

which will be obtained in the planned 

research activities. 

Nucleic acid testing (NAT) testing for 

HIV is currently being implemented in 

Brazil. It will be important to continue 

to collect molecular surveillance and 

risk factor data on HIV infections, 

especially now that infections that 

might not have been identified by 

serology testing alone could be 

recognized through the use of NAT. 

NAT-only infections represent very 

recently acquired infections. The NAT 

assay will be used at the four REDS–III 

blood centers in Brazil during the 

planned research activities. In addition, 

in order to distinguish between recent 

seroconversion and long-standing 

infection, samples from all HIV 

antibody- dual reactive donations and/ 

or NAT positive donations will be tested 

by the Recent Infection Testing 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices 2073 

Algorithm (RITA) which is based on use 

of a sensitive/less-sensitive enzyme 

immunoassay (‘‘detuned’’ Enzyme 

Immunoassay). RITA testing will be 

performed by the Blood Systems 

Research Institute, San Francisco, 

California, USA, which is the REDS–III 

Central Laboratory. 

Subjects will be enrolled for a 5-year 

period from March 2012 through 

February 2017. According to the 

Brazilian guidelines, blood donors are 

requested to return to the blood bank for 

HIV confirmatory testing and HIV 

counseling. Donors will be invited to 

participate in the study through 

administration of informed consent 

when they return for HIV counseling. 

Once informed consent has been 

administered and enrollment has 

occurred, participants will be asked to 

complete a confidential selfadministered risk factor questionnaire 

by computer. In addition, a small blood 

sample will be collected from each HIV 

positive participant to be used for the 

genotyping and drug resistance testing. 

The results of the drug resistance testing 

will be communicated back to the HIV 

positive participants during an inperson counseling session at the blood 

center. For those individuals who do 

not return for confirmatory testing, the 

samples will be anonymized and sent to 

the REDS–III central laboratory to 

perform the recent infection testing 

algorithm (RITA). 

This research effort will allow for an 

evaluation of trends in the trafficking of 

non-B subtypes and rates of 

transmission of drug resistant viral 

strains in low risk blood donors. These 

data could also be compared with data 

from similar studies in higher risk 

populations. Monitoring drug resistance 

strains is extremely important in a 

country that provides free anti-retroviral 

therapy for HIV infected individuals, 

many of whom have low level education 

and modest resources, thus making 

compliance with drug regimens and 

hence the risk of drug resistant HIV a 

serious problem. 

The findings from this project will 

add to those obtained in the REDS–II 

study, allowing for extended trend 

analyses over a 10-year period and will 

complement similar monitoring of HIV 

prevalence, incidence, transfusion risk 

and molecular variants in the USA and 

other funded international REDS–III 

sites in South Africa and China, thus 

allowing direct comparisons of these 

parameters on a global level. 

Frequency of Response: Once. 

Affected Public: Individuals. Type of 

Respondents: Adult Blood Donors. The 

annual reporting burden is as follows: 

Estimated Number of Respondents: 100; 

Estimated Number of Responses per 

Respondent: 1; Average Burden of 

Hours per Response: 0.40 (including 

administration of the informed consent 

form and questionnaire completion 

instructions); and Estimated Total 

Annual Burden Hours Requested: 40. 

The annualized cost to respondents is 

estimated at: $260 (based on $6.50 per 

hour). There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

Estimated annual number of respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

total annual 

burden hours 

requested 

100 ............................................................................................................................................... 1 0.40 40 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and the assumptions used; 

(3) Ways to enhance the quality, utility, 

and clarity of the information collected; 

and (4) Ways to minimize the burden of 

the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Simone Glynn, 

MD, Project Officer/ICD Contact, Two 

Rockledge Center, Suite 9142, 6701 

Rockledge Drive, Bethesda, MD 20892, 

or call (301) 435–0065, or Email your 

request to: glynnsa@nhlbi.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: January 3, 2012. 

Keith Hoots, 

Director, Division of Blood Diseases and 

Resources, National Heart, Lung, and Blood 

Institute, NIH. 

Dated: January 3, 2012. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2012–571 Filed 1–12–12; 8:45 am] 

BILLING CODE 4140–01–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: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Medical Imaging 

Study Section. 

Date: February 1–2, 2012. 

Time: 7 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Serrano Hotel, 405 Taylor Street, 

San Francisco, CA 94102. 

Contact Person: Xiang-Ning Li, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5112, 

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

1744, lixiang@csr.nih.gov. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Mechanisms of 

Sensory, Perceptual, and Cognitive Processes 

Study Section. 

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