Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 21785 

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 April 25, 2012. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. 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 April 17, 

2012. 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 April 18, 2012. 

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 Martha 

Monser 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: April 5, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8701 Filed 4–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Medical Countermeasures Initiative 

Regulatory Science Symposium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

meeting: Medical Countermeasures 

Initiative Regulatory Science 

Symposium. The symposium is 

intended to provide a forum for the 

exchange of ideas for medical 

countermeasure development, highlight 

work on regulatory science as it applies 

to the development and advancement of 

medical countermeasures, facilitate 

innovative directions, and inform 

stakeholders on medical 

countermeasure-related scientific 

progress and accomplishments. 

Date and Time: This symposium will 

be held on Tuesday, June 5 and 

Wednesday, June 6, 2012, from 8 a.m. to 

5:30 p.m. Persons interested in 

attending the symposium in person or 

viewing via Web cast must register by 

Tuesday, May 29, 2012, at 5 p.m. EST. 

Location: The symposium will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503, Silver Spring, MD 20993– 

0002. 

Contact: Rakesh Raghuwanshi, Office 

of Counterterrorism and Emerging 

Threats, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

rm. 4283, 301–796–4769, FAX: 301– 

847–8615, email: Rakesh.Raghuwanshi 

@fda.hhs.gov. 

Registration: If you wish to attend the 

symposium or view via Web cast, you 

must register at http://www.fda.gov/ 

medicalcountermeasures by Tuesday, 

May 29, 2012, at 5 p.m. EST. When 

registering, you must provide the 

following information: (1) Your name, 

(2) title, (3) company or organization (if 

applicable), (4) mailing address, (5) 

phone number, and (6) email address. 

There is no fee to register for the 

symposium and registration will be on 

a first-come, first-served basis. Early 

registration is recommended because 

seating is limited. If you need special 

accommodations due to a disability, 

please enter pertinent information in the 

‘‘Notes’’ section of the electronic 

registration form when you register. 

Dated: April 6, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–8695 Filed 4–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request: Prevalence, 

Incidence, Epidemiology and 

Molecular Variants of HIV in Blood 

Donors in Brazil 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request for review and approval of the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on January 13, 2012, page 2072, 

and allowed 60 days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow an additional 30 days for public 

comment. The National Institutes of 

Health may not conduct or sponsor, and 

the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Proposed Collection: Title: 

Prevalence, Incidence, Epidemiology 

and Molecular Variants of HIV in Blood 

Donors in Brazil. Type of Information 

Collection Request: Reinstatement 

(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 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
21786 Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 

transmission of anti-viral drug resistant 

strains in the community. This study is 

a continuation of a previous research 

project which enrolled eligible HIVpositive 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—III (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 Sa ̃o 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) 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 

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 (or when OMB 

approval is received) through 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 HIVpositive participant to be used for the 

genotyping and drug resistance testing. 

The results of the drug resistance testing 

will be communicated back to the HIVpositive 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 HIV 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: Blood Donors 18 years old 

or older. 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. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. 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. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 70 / Wednesday, April 11, 2012 / Notices 21787 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: March 27, 2012. 

Keith Hoots, 

Director, Division of Blood Diseases and 

Resources, National Heart, Lung, and Blood 

Institute, NIH. 

Dated: March 30, 2012. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2012–8684 Filed 4–10–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute: 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

NHLBI Loan Repayment Grant Review. 

Date: May 4, 2012. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Chang Sook Kim, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7179, Bethesda, MD 20892–7924, 301–435– 

0287, carolko@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: April 4, 2012. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–8719 Filed 4–10–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Companion 

Diagnostics 

Date: May 22, 2012 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate contract 

proposals 

Place: National Institutes of Health, 6116 

Executive Boulevard, Room 707, Rockville, 

MD 20852 (Telephone Conference Call). 

Contact Person: Jeannette F Korczak, Ph.D., 

Scientific Review Officer, Resources and 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 6116 Executive Blvd., Room 

8115, Bethesda, MD 20892, 301–496–9767, 

korczakj@mail.nih.gov. 

Information is also available on the 

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

deainfo.nci.nih.gov/advisory/sep/sep.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: April 5, 2012. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–8721 Filed 4–10–12; 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: Center for Scientific 

Review Special Emphasis Panel; Retinal 

Biology and TBI in Developing Brain. 

Date: April 27, 2012. 

Time: 12 p.m. to 2 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: Samuel C. Edwards, Ph.D., 

IRG Chief, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 5210, MSC 7846, Bethesda, MD 

20892, (301) 435–1246, 

edwardss@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Radiation Therapeutics. 

Date: May 3, 2012. 

Time: 1 p.m. to 3 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: Careen K Tang-Toth, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6214, 

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

3504, tothct@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Nursing and 

Related Clinical Sciences Overflow. 

Date: May 8, 2012. 

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

Agenda: To review and evaluate grant 

applications. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES