80 FR 55142 - Submission for OMB Review; 30-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 (NHLBI)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 177 (September 14, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 177 (September 14, 2015)
| Page Range | 55142-55143 | |
| FR Document | 2015-22975 |
[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)] [Notices] [Pages 55142-55143] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22975] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-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 (NHLBI) SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 8, 2015 (80 FR 32388) and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. DATES: Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments 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. 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 [[Page 55143]] 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 Average burden Form name Type of Number of responses per per response Total annual respondents respondents respondent (in hours) burden 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. Objectives 1 and 2, Risk Adult SCD cases 325 1 45/60 244 Factor Assessment. and controls, and Adult previously enrolled REDS- II and III HIV SCD patients. ---------------------------------------------------------------------------------------------------------------- Dated: September 8, 2015. Valery Gheen, NHLBI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2015-22975 Filed 9-11-15; 8:45 am] BILLING CODE 4140-01-P
![55142 Federal Register / Vol. 80, No. 177 / Monday, September 14, 2015 / Notices
Markers for Early Cancer Detection’’) ‘‘Population Sciences Biospecimen submission is via data upload to the
and would also be directly addressing Catalog (PSBC)’’). The PSBC allows secure Web site in order to collect
four of the key recommendations that scientists in the research community information to manage and improve a
emerged in an NCI sponsored workshop and the NCI to locate specimens program and its resources for the use by
titled ‘‘Trends in 21st Century appropriate for their population based all scientists.
Epidemiology: From Scientific research projects. It is not NCI’s intent
OMB approval is requested for 3
Discoveries to Population Health’’ to collect biospecimens; rather the
(CEBP, 2013, issue 22, page 508). In collections are descriptions of the years. There are no costs to respondents
response to this, NCI DCCPS is available data that can act as a resource other than their time. The total
developing a biospecimen inventory and be shared with researchers and estimated annualized burden hours are
and online searchable catalog (or scientists who are interested. This 80.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of time per Total annual
Form name Type of respondent responses per
respondents response burden hour
respondent ( in hours)
Population Sciences Biospecimen Catalog Initial Private Sector ............... 30 1 1 30
Request.
State Government ........ 30 1 1 30
Population Sciences Biospecimen Catalog An- Private Sector ............... 30 1 20/60 10
nual Update.
State Government ........ 30 1 20/60 10
Dated: September 1, 2015. 1995, unless it displays a currently valid Study-III (REDS–III) program conducts
Karla Bailey, OMB control number. research focused on the safety of the
NCI Project Clearance Liaison, National Direct Comments to OMB: Written blood supply, the patients who are in
Cancer Institute, NIH. comments and/or suggestions regarding need of transfusions, and the
[FR Doc. 2015–23027 Filed 9–11–15; 8:45 am] the item(s) contained in this notice, epidemiology of transfusion-
BILLING CODE 4140–01–P
especially regarding the estimated transmissible infections such as human
public burden and associated response immunodeficiency virus (HIV). Sickle
time, should be directed to the: Office cell disease (SCD) is a blood disorder
DEPARTMENT OF HEALTH AND of Management and Budget, Office of that affects thousands of people in the
HUMAN SERVICES Regulatory Affairs, OIRA_submission@ United States and Brazil. Many patients
omb.eop.gov or by fax to 202–395–6974, with SCD need to be chronically
National Institutes of Health Attention: Desk Officer for NIH. transfused with red blood cells and the
DATES: Comments Due Date: Comments REDS–III research program has
Submission for OMB Review; 30-Day regarding this information collection are established in Brazil a cohort of patients
Comment Request; Characterization of best assured of having their full effect if with SCD to study transfusion outcomes
Risk of HIV and HIV Outcomes in the received within 30 days of the date of and infectious diseases such as HIV in
Brazilian Sickle Cell Disease (SCD) this publication. the SCD population.
Population and Comparison of SCD FOR FURTHER INFORMATION CONTACT: To Sickle cell disease predominantly
Outcomes Between HIV Sero-Positive obtain a copy of the data collection affects persons with sub-Saharan Africa
and Negative SCD (NHLBI) plans and instruments or request more and other malaria-endemic regions
information on the proposed project ancestry because people who carry one
SUMMARY: Under the provisions of contact: Simone Glynn, MD, Project sickle cell disease gene (you need 2 to
Section 3507(a)(1)(D) of the Paperwork Officer/ICD Contact, Two Rockledge have sickle cell disease) have a survival
Reduction Act of 1995, the National Center, Suite 9142, 6701 Rockledge advantage for malaria. Sub-Saharan
Heart, Lung, and Blood Institute Drive, Bethesda, MD 20892, or call 301– Africa, where most people with SCD in
(NHLBI), the National Institutes of 435–0065, or Email your request, the world live, remains one of the
Health (NIH) has submitted to the Office including your address to: glynnsa@ regions most severely affected by HIV,
of Management and Budget (OMB) a nhlbi.nih.gov. Formal requests for with nearly 1 in every 20 adults living
request for review and approval of the additional plans and instruments must with the virus. In the United States, HIV
information collection listed below. be requested in writing. also disproportionately affects persons
This proposed information collection Proposed Collection: Characterization with African ancestry. Despite the
was previously published in the Federal of risk of HIV and HIV outcomes in the diseases’ occurrence in similar
Register on June 8, 2015 (80 FR 32388) Brazilian Sickle Cell Disease (SCD) populations and the fact that both HIV
and allowed 60-days for public population and comparison of SCD and SCD are independent predictors of
comment. No public comments were outcomes between HIV sero-positive outcomes such as stroke, there is a lack
received. The purpose of this notice is and negative SCD patients 0925–NEW, of data to evaluate if patients with SCD
tkelley on DSK3SPTVN1PROD with NOTICES
to allow an additional 30 days for public National Heart, Lung, and Blood and HIV have different illnesses than
comment. The National Institutes of Institute (NHLBI), the National patients who have SCD- or HIV-only.
Health may not conduct or sponsor, and Institutes of Health (NIH). The proposed study will seek to
the respondent is not required to Need and Use of Information understand the risk of HIV in the SCD
respond to, an information collection Collection: The National Heart, Lung, population, describe HIV outcomes in
that has been extended, revised, or and Blood Institute (NHLBI) Recipient patients with SCD and compare SCD
implemented on or after October 1, Epidemiology and Donor Evaluation complications between HIV-positive
VerDate Sep<11>2014 18:15 Sep 11, 2015 Jkt 235001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1](https://thefederalregister.org/doc/80_FR_55319/page/1.svg)
![Federal Register / Vol. 80, No. 177 / Monday, September 14, 2015 / Notices 55143
and HIV-negative patients with SCD study and 150 individuals without SCD diseases to better understand how one
using the infrastructure established by (controls) from a demographically disease affects the other disease.
the REDS–III SCD Cohort study. similar population. An assessment that Information on the HIV-negative
The limited studies focused on HIV in has been well validated in previous patients with SCD has already been
SCD have suggested that HIV may not studies has been modified for the SCD collected because they participated in
occur as frequently in patients with SCD population and will be used to collect the REDS–III SCD Cohort study. This
as in people who do not have SCD. data regarding HIV risk behaviors. The study will provide critical information
While it has been hypothesized that second objective of the proposed study to guide the management and future
perhaps SCD pathophysiology has a will seek to enroll approximately 25 research for patients with HIV and SCD
unique effect on HIV infection or patients with SCD and HIV who consent in Brazil, the United States, and
replication, none of the studies have to have detailed information regarding
worldwide.
adequately measured risk factors for their diseases retrieved from their
HIV in patients with SCD. The first medical records. This will allow for an OMB approval is requested for 3
objective of the proposed study is to in-depth evaluation of how patients years. There are no costs to respondents
compare HIV risk factors between 150 with both diseases fare. Additionally, other than their time. The total
patients with SCD (cases) randomly patients who have SCD but not HIV will estimated annualized burden hours are
selected from the REDS–III SCD Cohort be compared to patients who have both 325.
Average
Number of
Type of Number of burden per Total annual
Form name responses per
respondents respondents response burden hours
respondent (in hours)
Objective 1, Risk Factor In- Adult SCD cases and controls .................... 300 1 15/60 75
formed Consents.
Objective 2, Risk Factor In- Adult previously enrolled REDS–II and III 25 1 15/60 6
formed Consent. HIV SCD patients.
Objectives 1 and 2, Risk Fac- Adult SCD cases and controls, and Adult 325 1 45/60 244
tor Assessment. previously enrolled REDS–II and III HIV
SCD patients.
Dated: September 8, 2015. Agenda: To review and evaluate grant Scientific Review, National Institutes of
Valery Gheen, applications. Health, 6701 Rockledge Drive, Room 6214,
Place: Marriott Wardman Park Washington MSC 7804, Bethesda, MD 20892, 301–451–
NHLBI Project Clearance Liaison, National
DC Hotel, 2600 Woodley Road NW., 3493, rahman-sesayl@csr.nih.gov.
Institutes of Health.
Washington, DC 20008. Name of Committee: Center for Scientific
[FR Doc. 2015–22975 Filed 9–11–15; 8:45 am] Contact Person: George Vogler, Ph.D.,
Review Special Emphasis Panel, PAR Panel:
BILLING CODE 4140–01–P Scientific Review Officer, Center for
Scientific Review, National Institutes of Mouse Models for Translational Research.
Health, 6701 Rockledge Drive, Room 3140, Date: October 9, 2015.
MSC 7770, Bethesda, MD 20892, (301) 237– Time: 12:00 p.m. to 5:30 p.m..
DEPARTMENT OF HEALTH AND
2693, voglergp@csr.nih.gov. Agenda: To review and evaluate grant
HUMAN SERVICES
Name of Committee: Center for Scientific applications.
National Institutes of Health Review Special Emphasis Panel, PAR14–165: Place: Renaissance Pere Marquette Hotel,
Clinical Studies of Mental Illness Not New Orleans, 817 Common Street, New
Center For Scientific Review; Notice of Involving Treatment, Development, Efficacy, Orleans, LA 70112.
Closed Meetings or Effectiveness Trials (Collaborative R01). Contact Person: Lambratu Rahman Sesay,
Date: October 5, 2015. Ph.D., Scientific Review Officer, Center for
Pursuant to section 10(d) of the Time: 8:30 a.m. to 6:00 p.m. Scientific Review, National Institutes of
Federal Advisory Committee Act, as Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 6214,
amended (5 U.S.C. App.), notice is applications. MSC 7804, Bethesda, MD 20892, 301–451–
hereby given of the following meetings. Place: Marriott Wardman Park Washington 3493, rahmanl@csr.nih.gov.
The meetings will be closed to the DC Hotel, 2600 Woodley Road NW., Name of Committee: Cell Biology
Washington, DC 20008. Integrated Review Group, Intercellular
public in accordance with the
Contact Person: George Vogler, Ph.D., Interactions Study Section.
provisions set forth in sections Scientific Review Officer, Center for
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: October 13–14, 2015.
Scientific Review, National Institutes of
as amended. The grant applications and Time: 8:00 a.m. to 2:00 p.m.
Health, 6701 Rockledge Drive, Room 3140,
Agenda: To review and evaluate grant
the discussions could disclose MSC 7770, Bethesda, MD 20892, (301) 237–
2693, voglergp@csr.nih.gov. applications.
confidential trade secrets or commercial Place: Residence Inn Bethesda, 7335
property such as patentable material, Name of Committee: Oncology 2— Wisconsin Avenue, Bethesda, MD 20814.
and personal information concerning Translational Clinical Integrated Review Contact Person: Wallace Ip, Ph.D.,
individuals associated with the grant Group, Basic Mechanisms of Cancer
Scientific Review Officer, Center for
applications, the disclosure of which Therapeutics Study Section.
Scientific Review, National Institutes of
Date: October 8–9, 2015.
would constitute a clearly unwarranted Health, 6701 Rockledge Drive, Room 5128,
tkelley on DSK3SPTVN1PROD with NOTICES
Time: 8:00 a.m. to 5:00 p.m.
invasion of personal privacy. Agenda: To review and evaluate grant MSC 7840, Bethesda, MD 20892, 301–435–
applications. 1191, ipws@mail.nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group, Place: Renaissance New Orleans Pere Name of Committee: Immunology
Behavioral Genetics and Epidemiology Study Marquette Hotel, 817 Common Street, New Integrated Review Group, Cellular and
Section. Orleans, LA. Molecular Immunology—B Study Section.
Date: October 5, 2015. Contact Person: Lambratu Rahman Sesay, Date: October 15–16, 2015.
Time: 8:00 a.m. to 6:00 p.m. Ph.D., Scientific Review Officer, Center for Time: 8:00 a.m. to 5:00 p.m.
VerDate Sep<11>2014 18:15 Sep 11, 2015 Jkt 235001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1](https://thefederalregister.org/doc/80_FR_55319/page/2.svg)
Document Created: 2018-02-26 10:15:21
Document Modified: 2018-02-26 10:15:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. | |
| Contact | To obtain a copy of the data collection plans and instruments 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, | |
| FR Citation | 80 FR 55142 |
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