78876 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices 

require more rigorous designs that 

address: The target population to which 

generalizations will be made, the 

sampling frame, the sample design 

(including stratification and clustering), 

the precision requirements or power 

calculations that justify the proposed 

sample size, the expected response rate, 

methods for assessing potential nonresponse bias, the protocols for data 

collection, and any testing procedures 

that were or will be undertaken prior to 

fielding the study. Depending on the 

degree of influence the results are likely 

to have, such collections may still be 

eligible for submission for other generic 

mechanisms that are designed to yield 

quantitative results. 

As a general matter, information 

collections will not result in any new 

system of records containing privacy 

information and will not ask questions 

of a sensitive nature, such as sexual 

behavior and attitudes, religious beliefs, 

and other matters that are commonly 

considered private. 

Request for Comments: Comments 

submitted in response to this notice will 

be summarized and/or included in the 

request for OMB approval. Comments 

are invited on: (a) Whether the 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

collection of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology; 

and (e) estimates of capital or start-up 

costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid 

Office of Management and Budget 

control number. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

1,312. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of collection Number of 

respondents 

Annual 

frequency per 

response 

Hours per 

response Total hours 

Customer outcomes and usability testing ........................................................ 888 1 40/60 592 

Customer Satisfaction and needs assessment survey ................................... 600 1 40/60 400 

Focus Groups .................................................................................................. 60 1 1 60 

Small Discussion Groups ................................................................................. 60 1 1 60 

Pilot Testing of instruments for applicability among diverse populations ....... 300 1 40/60 200 

Total ................................................................................................................. ........................ ........................ ........................ 1,312 

Dated: December 24, 2014. 

Genevieve deAlmeida, 

Project Clearance Liaison, NIDA, NIH. 

[FR Doc. 2014–30656 Filed 12–30–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60 Day Comment 

Request Prevalence, Incidence, 

Epidemiology and Molecular Variants 

of HIV in Blood Donors in Brazil 

(NHLBI) 

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. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on 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 assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

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. 

To Submit Comments and for Further 

Information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Simone Glynn, MD, 

Project Officer/ICD Contact, Two 

Rockledge Center, Suite 9142, 6701 

Rockledge Drive, Bethesda, MD 20892, 

or call non-toll-free number (301)–435– 

0065, or Email your request to: glynnsa@

nhlbi.nih.gov. Formal requests for 

additional plans and instruments must 

be requested in writing. 

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. 

Proposed Collection: Prevalence, 

Incidence, Epidemiology and Molecular 

Variants of HIV in Blood Donors in 

Brazil 0925–0597 expiration date, July 

31, 2015, Extension, National Heart, 

Lung, and Blood Institute (NHLBI), the 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: Establishing and monitoring 

viral prevalence and incidence rates, 

and identifying behavioral risk 

behaviors for HIV infection among 

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Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices 78877 

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—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 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 

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 are being enrolled for a 

5-year period from July 2012 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 are 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 are asked to 

complete a confidential selfadministered risk factor questionnaire 

by computer. In addition, a small blood 

sample is collected from each HIV 

positive participant to be used for the 

genotyping and drug resistance testing. 

The results of the drug resistance testing 

are 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. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

40. 

Form name Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hour 

Risk Factor Assessment ................... Adult Donors .................................... 100 1 24/60 40 

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78878 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices 

Dated: December 18, 2014. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2014–30657 Filed 12–30–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; Notice of 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of meetings of the National 

Center for Advancing Translational 

Sciences. 

The meetings 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 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/or 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 grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Cures Acceleration 

Network Review Board. 

Date: January 15, 2015. 

Time: 8:30 a.m. to 3:00 p.m. 

Agenda: Report from the Institute Director. 

Place: National Institutes of Health, 

Building 31, Conference Room 6, 31 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Danilo A. Tagle, Ph.D., 

Executive Secretary, National Center for 

Advancing Translational Sciences, 1 

Democracy Plaza, Room 992, Bethesda, MD 

20892, 301–594–8064, Danilo.Tagle@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to finalizing 

the agenda and scheduling of meeting topics. 

Name of Committee: National Center for 

Advancing Translational Sciences Advisory 

Council. 

Date: January 15, 2015. 

Open: 8:30 a.m. to 3:00 p.m. 

Agenda: Report from the Institute Director 

and other staff. 

Place: National Institutes of Health, 

Building 31, Conference Room 6, 31 Center 

Drive, Bethesda, MD 20892. 

Closed: 3:15 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, Conference Room 6, 31 Center 

Drive, Bethesda, MD 20892. 

Contact Person: Danilo A. Tagle, Ph.D., 

Executive Secretary, National Center for 

Advancing Translational Sciences, 1 

Democracy Plaza, Room 992, Bethesda, MD 

20892, 301–594–8064, Danilo.Tagle@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to finalizing 

the agenda and scheduling of meeting topics. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: December 23, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–30619 Filed 12–30–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of 

Meetings 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of meetings of the AIDS 

Research Advisory Committee, NIAID. 

The meetings 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: AIDS Research 

Advisory Committee, NIAID. 

Date: January 26, 2015. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: Reports from the Division Director 

and other staff. 

Place: National Institutes of Health, 

Natcher Building, Conference Rooms E1/E2, 

45 Center Drive, Bethesda, MD 20892. 

Contact Person: Mark A. Mueller, 

Executive Secretary, AIDS Research Advisory 

Committee, Division of AIDS, NIAID/NIH, 

5601 Fishers Lane, RM 8D39 Bethesda, MD 

20892, 301–402–2308, mark.mueller@

nih.gov. 

Name of Committee: AIDS Research 

Advisory Committee, NIAID. 

Date: May 18, 2015. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: Reports from the Division Director 

and other staff. 

Place: National Institutes of Health, 

Natcher Building, Conference Rooms E1/E2, 

45 Center Drive, Bethesda, MD 20892. 

Contact Person: Mark A. Mueller, 

Executive Secretary, AIDS Research Advisory 

Committee, Division of AIDS, NIAID/NIH, 

5601 Fishers Lane, RM 8D39 Bethesda, MD 

20892, 301–402–2308, mark.mueller@

nih.gov. 

Name of Committee: AIDS Research 

Advisory Committee, NIAID. 

Date: September 21, 2015. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: Reports from the Division Director 

and other staff. 

Place: National Institutes of Health, 

Natcher Building, Conference Rooms E1/E2, 

45 Center Drive, Bethesda, MD 20892. 

Contact Person: Mark A. Mueller, 

Executive Secretary, AIDS Research Advisory 

Committee, Division of AIDS, NIAID/NIH, 

5601 Fishers Lane, RM 8D39 Bethesda, MD 

20892, 301–402–2308, mark.mueller@

nih.gov. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: December 23, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–30620 Filed 12–30–14; 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 

mstockstill on DSK4VPTVN1PROD with NOTICES