Proposed Collection; 60 Day Comment Request Characterization of Risk of HIV and HIV Outcomes in the Brazilian Sickle Cell Disease (SCD) Population and Comparison of SCD Outcomes Between HIV Sero-Positive and Negative SCD Patients (NHLBI), 32388-32389 [2015-13837]

Download as PDF 32388 Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Notices nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. National Institutes of Health DATES: Comments Due Date: Comments Proposed Collection; 60 Day Comment regarding this information collection are Request Characterization of Risk of best assured of having their full effect if HIV and HIV Outcomes in the Brazilian received within 60 days of the date of Sickle Cell Disease (SCD) Population this publication. and Comparison of SCD Outcomes Proposed Collection: Characterization Between HIV Sero-Positive and of risk of HIV and HIV outcomes in the Negative SCD Patients (NHLBI) Brazilian Sickle Cell Disease (SCD) population and comparison of SCD SUMMARY: In compliance with the outcomes between HIV sero-positive requirement of Section 3506(c)(2)(A) of and negative SCD patients 0925–NEW, the Paperwork Reduction Act of 1995, National Heart, Lung, and Blood for opportunity for public comment on Institute (NHLBI), the National proposed data collection projects, the Institutes of Health (NIH). National Heart, Lung, and Blood Need and Use of Information Institute (NHLBI), the National Collection: The National Heart, Lung, Institutes of Health (NIH), will publish and Blood Institute (NHLBI) Recipient periodic summaries of proposed Epidemiology and Donor Evaluation projects to the Office of Management Study-III (REDS–III) program conducts and Budget (OMB) for review and research focused on the safety of the approval. blood supply, the patients who are in Written comments and/or suggestions need of transfusions, and the from the public and affected agencies epidemiology of transfusionare invited on one or more of the transmissible infections such as human following points: (1) Whether the immunodeficiency virus (HIV). Sickle proposed collection of information is cell disease (SCD) is a blood disorder necessary for the proper performance of that affects thousands of people in the the function of the agency, including United States and Brazil. Many patients whether the information will have with SCD need to be chronically practical utility; (2) The accuracy of the transfused with red blood cells and the agency’s estimate of the burden of the REDS–III research program has proposed collection of information, established in Brazil a cohort of patients including the validity of the with SCD to study transfusion outcomes methodology and assumptions used; (3) and infectious diseases such as HIV in Ways to enhance the quality, utility, and the SCD population. clarity of the information to be Sickle cell disease predominantly collected; and (4) Ways to minimize the affects persons with sub-Saharan Africa burden of the collection of information and other malaria-endemic regions on those who are to respond, including ancestry because people who carry one the use of appropriate automated, sickle cell disease gene (you need 2 to electronic, mechanical, or other have sickle cell disease) have a survival technological collection techniques or advantage for malaria. Sub-Saharan other forms of information technology. Africa, where most people with SCD in the world live, remains one of the TO SUBMIT COMMENTS AND FOR FURTHER regions most severely affected by HIV, INFORMATION: To obtain a copy of the with nearly 1 in every 20 adults living data collection plans and instruments, with the virus. In the United States, HIV submit comments in writing, or request also disproportionately affects persons more information on the proposed with African ancestry. Despite the project, contact: Simone Glynn, MD, diseases’ occurrence in similar Project Officer/ICD Contact, Two populations and the fact that both HIV Rockledge Center, Suite 9142, 6701 and SCD are independent predictors of Rockledge Drive, Bethesda, MD 20892, outcomes such as stroke, there is a lack or call non-toll-free number (301) 435– 0065, or Email your request to: glynnsa@ of data to evaluate if patients with SCD mstockstill on DSK4VPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Number of respondents and HIV have different illnesses than patients who have SCD- or HIV-only. The proposed study will seek to understand the risk of HIV in the SCD population, describe HIV outcomes in patients with SCD and compare SCD complications between HIV-positive and HIV-negative patients with SCD using the infrastructure established by the REDS–III SCD Cohort study. The limited studies focused on HIV in SCD have suggested that HIV may not occur as frequently in patients with SCD as in people who do not have SCD. While it has been hypothesized that perhaps SCD pathophysiology has a unique effect on HIV infection or replication, none of the studies have adequately measured risk factors for HIV in patients with SCD. The first objective of the proposed study is to compare HIV risk factors between 150 patients with SCD (cases) randomly selected from the REDS–III SCD Cohort study and 150 individuals without SCD (controls) from a demographically similar population. An assessment that has been well validated in previous studies has been modified for the SCD population and will be used to collect data regarding HIV risk behaviors. The second objective of the proposed study will seek to enroll approximately 25 patients with SCD and HIV who consent to have detailed information regarding their diseases retrieved from their medical records. This will allow for an in-depth evaluation of how patients with both diseases fare. Additionally, patients who have SCD but not HIV will be compared to patients who have both diseases to better understand how one disease affects the other disease. Information on the HIV-negative patients with SCD has already been collected because they participated in the REDS–III SCD Cohort study. This study will provide critical information to guide the management and future research for patients with HIV and SCD in Brazil, the United States, and worldwide. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 325. Number of responses per respondent Average burden per response (in hours) Total annual burden hours Form name Type of respondents Objective 1 Risk Factor Informed Consents. Objective 2 Risk Factor Informed Consent. Adult SCD cases and controls ......... 300 1 15/60 75 Adult previously enrolled REDS–II and III HIV SCD patients. 25 1 15/60 6 VerDate Sep<11>2014 17:09 Jun 05, 2015 Jkt 235001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\08JNN1.SGM 08JNN1 32389 Federal Register / Vol. 80, No. 109 / Monday, June 8, 2015 / Notices Number of respondents Form name Type of respondents Objectives 1 and 2 Risk Factor Assessment. Adult SCD cases and controls, and Adult previously enrolled REDS–II and III HIV SCD patients. Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2015–13837 Filed 6–5–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed 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 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: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; RFA–DK–14–022: Improving Diabetes Management in Young Children with Type 1 Diabetes (DP3). Date: June 24, 2015. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Ann A. Jerkins, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 759, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, 301–594–2242, jerkinsa@niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Ancillary Studies: Kramer. Date: July 10, 2015. Time: 2:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy VerDate Sep<11>2014 17:09 Jun 05, 2015 Jkt 235001 325 Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Paul A. Rushing, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 747, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8895, rushingp@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; R13 Conference Grant Applications. Date: July 16, 2015. Time: 11:00 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Jian Yang, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 755, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7799, yangj@ extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Psychosocial and Behavioral Aspects of Bariatric Surgery (R01). Date: July 23, 2015. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Paul A. Rushing, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 747, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8895, rushingp@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Identification of Novel Targets and Pathways Mediating Weight Loss, Diabetes Resolution and Related Metabolic Disease after Bariatric Surgery in Humans (R01). Date: July 27, 2015. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Paul A. Rushing, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 747, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8895, rushingp@extra.niddk.nih.gov. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden per response (in hours) 1 Total annual burden hours 45/60 244 (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: June 2, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–13839 Filed 6–5–15; 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 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: Microbiology, Infectious Diseases and AIDS Initial Review Group; Microbiology and Infectious Diseases B Subcommittee. Date: June 30, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3F30A, 5601 Fisher Lane, Rockville, MD 20892. Contact Person: Ellen S. Buczko, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID, 5601 Fishers Lane, Bethesda, MD 20892–7616, 240–669–5028, ebuczko1@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Notices]
[Pages 32388-32389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13837]



[[Page 32388]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60 Day Comment Request Characterization of 
Risk of HIV and HIV Outcomes in the Brazilian Sickle Cell Disease (SCD) 
Population and Comparison of SCD Outcomes Between HIV Sero-Positive and 
Negative SCD Patients (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.

DATES: 
    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: Characterization of risk of HIV and HIV 
outcomes in the Brazilian Sickle Cell Disease (SCD) population and 
comparison of SCD outcomes between HIV sero-positive and negative SCD 
patients 0925-NEW, National Heart, Lung, and Blood Institute (NHLBI), 
the National Institutes of Health (NIH).
    Need and Use of Information Collection: The National Heart, Lung, 
and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation 
Study-III (REDS-III) program conducts research focused on the safety of 
the blood supply, the patients who are in need of transfusions, and the 
epidemiology of transfusion-transmissible infections such as human 
immunodeficiency virus (HIV). Sickle cell disease (SCD) is a blood 
disorder that affects thousands of people in the United States and 
Brazil. Many patients with SCD need to be chronically transfused with 
red blood cells and the REDS-III research program has established in 
Brazil a cohort of patients with SCD to study transfusion outcomes and 
infectious diseases such as HIV in the SCD population.
    Sickle cell disease predominantly affects persons with sub-Saharan 
Africa and other malaria-endemic regions ancestry because people who 
carry one sickle cell disease gene (you need 2 to have sickle cell 
disease) have a survival advantage for malaria. Sub-Saharan Africa, 
where most people with SCD in the world live, remains one of the 
regions most severely affected by HIV, with nearly 1 in every 20 adults 
living with the virus. In the United States, HIV also 
disproportionately affects persons with African ancestry. Despite the 
diseases' occurrence in similar populations and the fact that both HIV 
and SCD are independent predictors of outcomes such as stroke, there is 
a lack of data to evaluate if patients with SCD and HIV have different 
illnesses than patients who have SCD- or HIV-only. The proposed study 
will seek to understand the risk of HIV in the SCD population, describe 
HIV outcomes in patients with SCD and compare SCD complications between 
HIV-positive and HIV-negative patients with SCD using the 
infrastructure established by the REDS-III SCD Cohort study.
    The limited studies focused on HIV in SCD have suggested that HIV 
may not occur as frequently in patients with SCD as in people who do 
not have SCD. While it has been hypothesized that perhaps SCD 
pathophysiology has a unique effect on HIV infection or replication, 
none of the studies have adequately measured risk factors for HIV in 
patients with SCD. The first objective of the proposed study is to 
compare HIV risk factors between 150 patients with SCD (cases) randomly 
selected from the REDS-III SCD Cohort study and 150 individuals without 
SCD (controls) from a demographically similar population. An assessment 
that has been well validated in previous studies has been modified for 
the SCD population and will be used to collect data regarding HIV risk 
behaviors. The second objective of the proposed study will seek to 
enroll approximately 25 patients with SCD and HIV who consent to have 
detailed information regarding their diseases retrieved from their 
medical records. This will allow for an in-depth evaluation of how 
patients with both diseases fare. Additionally, patients who have SCD 
but not HIV will be compared to patients who have both diseases to 
better understand how one disease affects the other disease. 
Information on the HIV-negative patients with SCD has already been 
collected because they participated in the REDS-III SCD Cohort study. 
This study will provide critical information to guide the management 
and future research for patients with HIV and SCD in Brazil, the United 
States, and worldwide.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 325.

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Type of         Number of       Number of      burden per     Total annual
           Form name               respondents      respondents    responses per   response  (in   burden hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Objective 1 Risk Factor         Adult SCD cases              300               1           15/60              75
 Informed Consents.              and controls.
Objective 2 Risk Factor         Adult previously              25               1           15/60               6
 Informed Consent.               enrolled REDS-
                                 II and III HIV
                                 SCD patients.

[[Page 32389]]

 
Objectives 1 and 2 Risk Factor  Adult SCD cases              325               1           45/60             244
 Assessment.                     and controls,
                                 and Adult
                                 previously
                                 enrolled REDS-
                                 II and III HIV
                                 SCD patients.
----------------------------------------------------------------------------------------------------------------


Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-13837 Filed 6-5-15; 8:45 am]
 BILLING CODE 4140-01-P
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