Proposed Collection; 60 Day Comment Request Prevalence, Incidence, Epidemiology and Molecular Variants of HIV in Blood Donors in Brazil (NHLBI), 78876-78878 [2014-30657]

Download as PDF 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. 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. 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 ESTIMATED ANNUALIZED BURDEN HOURS Annual frequency per response Number of respondents Type of collection Hours per response Total hours Customer outcomes and usability testing ........................................................ Customer Satisfaction and needs assessment survey ................................... Focus Groups .................................................................................................. Small Discussion Groups ................................................................................. Pilot Testing of instruments for applicability among diverse populations ....... 888 600 60 60 300 1 1 1 1 1 40/60 40/60 1 1 40/60 592 400 60 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) 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 22:02 Dec 30, 2014 Jkt 235001 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, PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 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 E:\FR\FM\31DEN1.SGM 31DEN1 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices 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 78877 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. Type of respondent Number of respondents Number of responses per respondent Average burden per response (in hours) Total annual burden hour Risk Factor Assessment ................... mstockstill on DSK4VPTVN1PROD with NOTICES Form name Adult Donors .................................... 100 1 24/60 40 VerDate Sep<11>2014 22:02 Dec 30, 2014 Jkt 235001 PO 00000 Frm 00099 Fmt 4703 Sfmt 9990 E:\FR\FM\31DEN1.SGM 31DEN1 78878 Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices 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. 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 mstockstill on DSK4VPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 22:02 Dec 30, 2014 Jkt 235001 (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. PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 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 E:\FR\FM\31DEN1.SGM 31DEN1

Agencies

[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Notices]
[Pages 78876-78878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30657]


-----------------------------------------------------------------------

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

[[Page 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 
anti-retroviral 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 HIV-positive 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 long-standing 
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 self-
administered 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 in-person 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.

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Number of      Average burden
                    Form name                             Type of respondent             Number of      responses per     per response     Total annual
                                                                                        respondents       respondent       (in hours)      burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Risk Factor Assessment..........................  Adult Donors......................             100                1            24/60               40
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 78878]]

    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

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