Proposed Collection; 60-Day Comment Request: Incident HIV/Hepatitis B Virus Infections in South African Blood Donors: Behavioral Risk Factors, Genotypes and Biological Characterization of Early Infection, 67175-67177 [2013-26807]

Download as PDF TKELLEY on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices Association, pp. 1599–1611, 2007. 18. World Health Organization, ‘‘Diet, Nutrition, and the Prevention of Chronic Disease,’’ Technical Series Report 916, pp. 81–85, Geneva, 2003. 19. USDA and HHS, Dietary Guidelines for Americans, 2005, 6th ed., pp. 29 through 34, Washington, DC: U.S. Government Printing Office, January 2005. 20. USDA and HHS, Dietary Guidelines for Americans, 2010, 7th ed., pp. 24–27, Washington, DC: U.S. Government Printing Office, December 2010. 21. HHS/FDA/Center for Food Safety and Applied Nutrition Advisory Committee/ Nutrition Subcommittee Meeting, Total Fat and Trans Fat, April 27–28, 2004. 22. Lefevre, M., J. C. Lovejoy, S. R. Smith, J. P. DeLany, et al., ‘‘Comparison of the Acute Response to Meals Enriched With cis- or trans-Fatty Acids on Glucose and Lipids in Overweight Individuals With Differing FABP2 Genotypes,’’ Metabolism, 54:1652–1658, 2005. 23. Micha, R., D. Mozaffarian, ‘‘Trans Fatty Acids: Effects on Cardiometabolic Health and Implications for Policy,’’ Prostaglandins, Leukotrienes and Essential Fatty Acids, 79:147–152, 2008. 24. Teegala, S. M., W. C. Willett, D. Mozaffarian, ‘‘Consumption and Health Effects of Trans Fatty Acids: A Review,’’ Journal of AOAC International, 92:1250– 1257, 2009. 25. Riserus, U., ‘‘Trans Fatty Acids and Insulin Resistance,’’ Atherosclerosis Supplements, 7:37–39, 2006. 26. Kavanagh, K., K. L. Jones, J. Sawyer, K. Kelley, et al., ‘‘Trans Fat Diet Increases Abdominal Obesity Changes in Insulin Sensitivity in Monkeys,’’ Obesity, 15:1675–1684, 2007. 27. Morrison, J. A., C. J. Glueck, P. Wang, ‘‘Dietary Trans Fatty Acid Intake is Associated with Increased Fetal Loss,’’ Fertility and Sterility, 90:385–390, 2008. 28. Van Eijsden, M., G. Hornstra, M. F. van der Waal, T. G. M. Vrijkotte, et al., ‘‘Maternal n-3, n-6, and Trans Fatty Acid Profile Early in Pregnancy and Term Birth Weight: A Prospective Cohort Study,’’ The American Journal of Clinical Nutrition, 87:887–895, 2008. 29. Innis, S., ‘‘Fatty Acids and Early Human Development,’’ Early Human Development, 83:761–766, 2007. 30. Hornstra, G., M. van Eijsden, C. Dirix, G. Bonsel, ‘‘Trans Fatty Acids and Birth Outcome: Some First Results of the MEFAB and ABCD Cohorts,’’ Atherosclerosis Supplements, 7:21–23, 2006. 31. Innis, S. ‘‘Trans Fatty Intakes During Pregnancy, Infancy and Early Childhood,’’ Atherosclerosis Supplements, 7:17–20, 2006. 32. Brouwer, I. A., A. J. Wanders, M. B. Katan, ‘‘Effect of Animal and Industrial Trans Fatty Acids on HDL and LDL Cholesterol Levels in Humans—A Quantitative Review,’’ PLoS One, 5(3):e9434, 2010. 33. Mozaffarian, D., R. Clarke, ‘‘Quantitative Effects on Cardiovascular Risk Factors and Coronary Heart Disease Risk of Replacing Partially Hydrogenated VerDate Mar<15>2010 18:08 Nov 07, 2013 Jkt 232001 Vegetable Oils With Other Fats and Oils,’’ European Journal of Clinical Nutrition, 63:S22–S33, 2009. 34. Chardigny, J.-M., F. Destaillats, C. Malpuech-Brugere, J. Molin, et al., ‘‘Do Trans Fatty Acids From Industrially Produced Sources and From Natural Sources Have the Same Effect on Cardiovascular Disease Risk Factors in Healthy Subjects? Results of the Trans Fatty Acids Collaboration (TRANSFACT) Study,’’ The American Journal of Clinical Nutrition, 87:558–566, 2008. 35. Mensink, R. P., P. L. Zock, A. D. Kester, et al., ‘‘Effects of Dietary Fatty Acids and Carbohydrates on the Ratio of Serum Total to HDL Cholesterol and on Serum Lipids and Apolipoproteins: A MetaAnalysis of 60 Controlled Trials,’’ The American Journal of Clinical Nutrition, 77:1146–55, 2003. 36. Ascherio, A., ‘‘Trans Fatty Acids and Blood Lipids,’’ Atherosclerosis Supplements, 7:25–27, 2006. 37. Mozaffarian, D., M. B., Katan, A. Asherio, M. J. Stampfer, et al., ‘‘Trans Fatty Acids and Cardiovascular Disease,’’ The New England Journal of Medicine, 354:1601– 1613, 2006. 38. Denke, M. A., ‘‘Dietary Fats, Fatty Acids, and Their Effects on Lipoproteins,’’ Current Atherosclerosis Reports, 8:466– 471, 2006. 39. Vega-Lopez, S., L. M. Ausman, S. M. Jalbert, A. T. Erkilla, et al., ‘‘Palm and Partially Hydrogenated Soybean Oils Adversely Alter Lipoprotein Profiles Compared with Soybean and Canola Oils in Moderately Hyperlipidemic Subjects,’’ The American Journal of Clinical Nutrition, 84:54–62, 2006. 40. Leth, T., H. G. Jensen, A. A. Mikkelsen, A. Bysted, ‘‘The Effect of the Regulation on Trans Fatty Acid Content in Danish Food,’’ Atherosclerosis Supplements, 7(2):53–56, 2006. 41. Stender, S., J. Dyerberg, A. Bysted, T. Leth, et al., ‘‘A Trans World Journey,’’ Atherosclerosis Supplements, 7:47–52, 2006. 42. Bysted A., A. E. Mikkelsen, T. Leth, ‘‘Substitution of Trans Fatty Acids in Foods on the Danish Market,’’ European Journal of Lipid Science and Technology, 111:574–583, 2009. 43. Health Canada, ‘‘Trans Fat’’ (Internet address: http://www.hc-sc.gc.ca/fn-an/ nutrition/gras-trans-fats/index-eng.php). 44. Health Canada, ‘‘Fourth Set of Monitoring Data—Trans Fat Monitoring Program’’ (Internet address: http://www.hcsc.gc.ca/fn-an/nutrition/gras-trans-fats/ tfa-age_four-data_quatr-donn-eng.php). 45. Angell, S. Y., L. D. Silver, G. P. Goldstein, C. M. Johnson, et al., ‘‘Cholesterol Control Beyond the Clinic: New York City’s Trans Fat Restriction,’’ Annals of Internal Medicine, 151:129–134, 2009. 46. Memorandum from R. Bruns to M. Honigfort, November 5, 2013. Dated: November 5, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–26854 Filed 11–7–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 67175 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request: Incident HIV/Hepatitis B Virus Infections in South African Blood Donors: Behavioral Risk Factors, Genotypes and Biological Characterization of Early Infection 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 301–435–0065, or Email your request, including your address 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: Incident HIV/ Hepatitis B virus (HBV) infections in South African blood donors: Behavioral risk factors, genotypes and biological E:\FR\FM\08NON1.SGM 08NON1 67176 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices characterization of early infection, 0925New, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: South Africa has one of the highest burdens for HIV infection in the world. The HIV epidemic in South Africa is largely heterosexual, but risk factors for infections can change and so identifying factors that contribute to the recent spread of HIV in a broad crosssection of the otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in Africa. Small previous studies suggest that the risk factors for HIV among more recently acquired (incident) infections in blood donors may differ from those of more distant (prevalent) infections. Similarly risk factors for recently acquired HBV may be different than for prevalent HBV infections. The demographic and behavioral risks associated with incident HIV and incident HBV infection have, as yet, not been formally assessed in South African blood donors using analytical study designs. Due to the high rates of HIV and HBV infection in South African blood donors, a better understanding of these risk factors can be used to modify donor screening questionnaires so as to more accurately exclude high-risk blood donors and contribute to transfusion safety. Risk factor data from this research may also provide critical information for blood banking screening strategies in other countries. This study which provides a contemporary understanding of the current risk profiles for HIV and separately for HBV will also prospectively monitor genetic characteristics of recently acquired infections through genotyping and drug resistance profile testing, thus serving a US, South African, and global public health imperative to monitor the genotypes of HIV and HBV that have recently been transmitted. For HIV, the additional monitoring of drug resistance patterns in newly acquired infection is critical to determine if currently available antiretroviral medicines are capable of combating infection. Because the pace of globalization means these infections can cross borders easily, these study objectives have direct relevance for HIV and HBV control in the U.S. and globally. Further, the ability to identify recent HIV infections provides a unique opportunity to study the biology, host response and evolution of HIV disease at time points proximate to virus acquisition. Genotyping and host response information is scientifically important not only to South Africa, but to the U.S. and other nations since it will provide a broader global understanding of how to most effectively manage and potentially prevent HIV (e.g. through vaccine development). Efforts to develop vaccines funded by the National Institutes of Health and other US-based organizations may directly benefit from the findings of this study. The South African National Blood Service (SANBS) uses both individual donation Nucleic Acid Testing (ID– NAT) and serology tests (either antibody or antigen detection tests) to screen blood donors for HIV and Hepatitis-B Virus (HBV), among other infections. A positive NAT test precedes HIV antibody detection or HBV surface antigen detection by days to weeks in newly acquired HIV and HBV infections. A combined testing strategy using NAT and serology tests therefore confers the ability to detect most acute infections and discriminate between recent (incident) and more remotely acquired (prevalent) infection. Additional tests that exploit antibody maturation kinetics such as the HIV Limiting Antigen Avidity assay (LAg Avidity) can further assist to classify persons with an HIV antibody positive test as having a recently acquired (incident) or longer-term (prevalent) infection. Hepatitis B core antibody (anti-HBc) testing of NAT-positive and NAT and Hepatitis B Virus Surface Antigen (HBsAg) positive HBV infections allows classification of HBV TKELLEY on DSK3SPTVN1PROD with NOTICES Form name Type of respondent Objectives 1 and 2 consent form ............................. Objectives 1 and 2—ACASI Questionnaire ............. Objective 3 consent form *—Year 1 ........................ Objective 3—Clinical Follow-up Questionnaire— Year 1 *. Objective 3 consent form *—Year 2 ........................ Objective 3—Clinical Follow-up Questionnaire— Year 2 *. Adult Adult Adult Adult Donors Donors Donors Donors Number of respondents infections as recently acquired or prevalent infections. Infections that are anti-HBc negative are recently acquired (incident). Leveraging this ability to classify HIV and HBV infections as incident or prevalent leads to three study objectives: 1. Objective 1 consists of evaluating the risk factors associated with having an incident HIV or HBV infection. To that end, a frequency matched casecontrol study will be conducted with two case groups: incident HIV infected blood donors and incident HBV infected blood donors, respectively. Risk factors in these two case groups will be compared to the risk factors provided by a group of controls (blood donors whose infectious tests are all negative). Cases and controls will be accrued from a geographically diverse donor pool. 2. Objective 2 consists of characterizing HIV clade and drug resistance profiles and determining viral loads in all cases of incident HIV infection, as well as characterizing HBV genotype and viral load in all incident HBV infections. 3. Objective 3 consists of following persons with incident and ‘‘elite controller’’ HIV infections prospectively for three additional visits at 2, 3, and 6 months following the index positive test(s). The term ‘‘elite controllers’’ refers to those who are HIV antibody positive, but with undetectable viral RNA (NAT negative) who are believed to have a natural ability to control viral replication without therapy. These studies will be useful in identifying appropriate HIV drug therapy regimens for this condition, as well as strategies for producing an effective HIV vaccine, which has eluded 30 years of HIV research. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden for Objectives 1 and 2 will be 395 hours for 483 subjects. The total estimated annualized burden for Objective 3 will be 32 hours for 35 respondents. Number of responses per respondent Average burden per response (in hours) ............. ............. ............. ............. 483 483 35 35 1 1 1 4 15/60 34/60 15/60 10/60 121 274 9 23 Adult Donors ............. Adult Donors ............. 35 35 1 4 15/60 10/60 9 23 * The Objective 3 respondents are a subset of the respondents included in Objectives 1 and 2. VerDate Mar<15>2010 18:08 Nov 07, 2013 Jkt 232001 PO 00000 Total annual burden hour Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1 Federal Register / Vol. 78, No. 217 / Friday, November 8, 2013 / Notices Dated: October 23, 2013. Keith Hoots, Director, Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, NIH. Dated: October 24, 2013. Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2013–26807 Filed 11–7–13; 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 TKELLEY on DSK3SPTVN1PROD 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 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; Molecular Genetics B (MGB). Date: November 25, 2013. Time: 3:00 p.m. to 4:30 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: Richard A Currie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2204, MSC 7890, Bethesda, MD 20892, (301) 435– 1219, currieri@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA Panel: International Research Ethics Education and Curriculum Development. Date: December 9, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Karin F Helmers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3144, VerDate Mar<15>2010 18:08 Nov 07, 2013 Jkt 232001 MSC 7770, Bethesda, MD 20892, (301) 254– 9975, helmersk@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Macromolecular Structure and Function D. Date: December 9, 2013. Time: 8:00 a.m. to 5:00 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: James W. Mack, Ph.D., Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4154, MSC 7806, Bethesda, MD 20892, (301) 435– 2037, mackj2@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 4, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–26754 Filed 11–7–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 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: National Institute on Aging Special Emphasis Panel; Member Conflict. Date: December 18, 2013. Time: 2:00 p.m. to 3:15 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Aging, Gateway Building, Suite 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Ramesh Vemuri, Ph.D., Scientific Review Branch, National Institute On Aging, National Institutes of Health, 7201 Wisconsin Avenue, Suite 2c–212, Bethesda, MD 20892, 301–402–7700, rv23r@nih.gov. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 67177 (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: November 4, 2013. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–26750 Filed 11–7–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Biomedical Imaging Technology A Study Section, October 07, 2013, 08:00 a.m. to October 08, 2013, 05:00 p.m., Hilton Alexandria Mark Center, 5000 Seminary Road, Alexandria, VA, 22311 which was published in the Federal Register on September 10, 2013, 78 FR 175 Pgs. 55268–55270. The meeting will be held at the Hilton Rockville, 1750 Rockville Pike, Rockville, MD 20852. The meeting will start on December 10, 2013 at 6:00 p.m. and end December 11, 2013 at 5:00 p.m. The meeting is closed to the public. Dated: November 1, 2013. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2013–26753 Filed 11–7–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, Review of Neuroscience AREA Grant Applications, October 24, 2013, 08:00 a.m. to October 25, 2013, 12:00 p.m., St. Gregory Hotel, 2033 M Street NW., Washington, DC 20036, which was published in the Federal Register on October 01, 2013, 78 FR 60298. The meeting will be held on December 9, 2013 to December 10, 2013. The meeting location and time remain the same. The meeting is closed to the public. E:\FR\FM\08NON1.SGM 08NON1

Agencies

[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67175-67177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26807]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request: Incident HIV/
Hepatitis B Virus Infections in South African Blood Donors: Behavioral 
Risk Factors, Genotypes and Biological Characterization of Early 
Infection

    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 301-435-0065, 
or Email your request, including your address 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: Incident HIV/Hepatitis B virus (HBV) 
infections in South African blood donors: Behavioral risk factors, 
genotypes and biological

[[Page 67176]]

characterization of early infection, 0925-New, the National Heart, 
Lung, and Blood Institute (NHLBI), the National Institutes of Health 
(NIH).
    Need and Use of Information Collection: South Africa has one of the 
highest burdens for HIV infection in the world. The HIV epidemic in 
South Africa is largely heterosexual, but risk factors for infections 
can change and so identifying factors that contribute to the recent 
spread of HIV in a broad cross-section of the otherwise unselected 
general population, such as blood donors, is highly important for 
obtaining a complete picture of the epidemiology of HIV infection in 
Africa. Small previous studies suggest that the risk factors for HIV 
among more recently acquired (incident) infections in blood donors may 
differ from those of more distant (prevalent) infections. Similarly 
risk factors for recently acquired HBV may be different than for 
prevalent HBV infections. The demographic and behavioral risks 
associated with incident HIV and incident HBV infection have, as yet, 
not been formally assessed in South African blood donors using 
analytical study designs. Due to the high rates of HIV and HBV 
infection in South African blood donors, a better understanding of 
these risk factors can be used to modify donor screening questionnaires 
so as to more accurately exclude high-risk blood donors and contribute 
to transfusion safety. Risk factor data from this research may also 
provide critical information for blood banking screening strategies in 
other countries.
    This study which provides a contemporary understanding of the 
current risk profiles for HIV and separately for HBV will also 
prospectively monitor genetic characteristics of recently acquired 
infections through genotyping and drug resistance profile testing, thus 
serving a US, South African, and global public health imperative to 
monitor the genotypes of HIV and HBV that have recently been 
transmitted. For HIV, the additional monitoring of drug resistance 
patterns in newly acquired infection is critical to determine if 
currently available antiretroviral medicines are capable of combating 
infection. Because the pace of globalization means these infections can 
cross borders easily, these study objectives have direct relevance for 
HIV and HBV control in the U.S. and globally. Further, the ability to 
identify recent HIV infections provides a unique opportunity to study 
the biology, host response and evolution of HIV disease at time points 
proximate to virus acquisition. Genotyping and host response 
information is scientifically important not only to South Africa, but 
to the U.S. and other nations since it will provide a broader global 
understanding of how to most effectively manage and potentially prevent 
HIV (e.g. through vaccine development). Efforts to develop vaccines 
funded by the National Institutes of Health and other US-based 
organizations may directly benefit from the findings of this study.
    The South African National Blood Service (SANBS) uses both 
individual donation Nucleic Acid Testing (ID-NAT) and serology tests 
(either antibody or antigen detection tests) to screen blood donors for 
HIV and Hepatitis-B Virus (HBV), among other infections. A positive NAT 
test precedes HIV antibody detection or HBV surface antigen detection 
by days to weeks in newly acquired HIV and HBV infections. A combined 
testing strategy using NAT and serology tests therefore confers the 
ability to detect most acute infections and discriminate between recent 
(incident) and more remotely acquired (prevalent) infection. Additional 
tests that exploit antibody maturation kinetics such as the HIV 
Limiting Antigen Avidity assay (LAg Avidity) can further assist to 
classify persons with an HIV antibody positive test as having a 
recently acquired (incident) or longer-term (prevalent) infection. 
Hepatitis B core antibody (anti-HBc) testing of NAT-positive and NAT 
and Hepatitis B Virus Surface Antigen (HBsAg) positive HBV infections 
allows classification of HBV infections as recently acquired or 
prevalent infections. Infections that are anti-HBc negative are 
recently acquired (incident).
    Leveraging this ability to classify HIV and HBV infections as 
incident or prevalent leads to three study objectives: ]
    1. Objective 1 consists of evaluating the risk factors associated 
with having an incident HIV or HBV infection. To that end, a frequency 
matched case-control study will be conducted with two case groups: 
incident HIV infected blood donors and incident HBV infected blood 
donors, respectively. Risk factors in these two case groups will be 
compared to the risk factors provided by a group of controls (blood 
donors whose infectious tests are all negative). Cases and controls 
will be accrued from a geographically diverse donor pool.
    2. Objective 2 consists of characterizing HIV clade and drug 
resistance profiles and determining viral loads in all cases of 
incident HIV infection, as well as characterizing HBV genotype and 
viral load in all incident HBV infections.
    3. Objective 3 consists of following persons with incident and 
``elite controller'' HIV infections prospectively for three additional 
visits at 2, 3, and 6 months following the index positive test(s). The 
term ``elite controllers'' refers to those who are HIV antibody 
positive, but with undetectable viral RNA (NAT negative) who are 
believed to have a natural ability to control viral replication without 
therapy. These studies will be useful in identifying appropriate HIV 
drug therapy regimens for this condition, as well as strategies for 
producing an effective HIV vaccine, which has eluded 30 years of HIV 
research.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden for Objectives 1 and 2 will be 395 hours for 483 subjects. The 
total estimated annualized burden for Objective 3 will be 32 hours for 
35 respondents.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total annual
                  Form name                               Type of respondent                respondents   responses  per   response  (in    burden hour
                                                                                                             respondent       hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Objectives 1 and 2 consent form.............  Adult Donors..............................             483               1           15/60             121
Objectives 1 and 2--ACASI Questionnaire.....  Adult Donors..............................             483               1           34/60             274
Objective 3 consent form *--Year 1..........  Adult Donors..............................              35               1           15/60               9
Objective 3--Clinical Follow-up               Adult Donors..............................              35               4           10/60              23
 Questionnaire--Year 1 *.
Objective 3 consent form *--Year 2..........  Adult Donors..............................              35               1           15/60               9
Objective 3--Clinical Follow-up               Adult Donors..............................              35               4           10/60             23
 Questionnaire--Year 2 *.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The Objective 3 respondents are a subset of the respondents included in Objectives 1 and 2.



[[Page 67177]]

    Dated: October 23, 2013.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart, 
Lung, and Blood Institute, NIH.
    Dated: October 24, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-26807 Filed 11-7-13; 8:45 am]
BILLING CODE 4140-01-P