Submission for OMB Review; 30-Day Comment Request; HIV Study in Blood Donors From Five Chinese Regions (NHLBI), 67176-67177 [2014-26761]

Download as PDF 67176 Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices CBER at http://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. Persons unable to download an electronic copy of ‘‘Molecular Diagnostic Instruments With Combined Functions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1763 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910–0437; and the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910–0485. V. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Dated: November 5, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–26694 Filed 11–10–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES TKELLEY on DSK3SPTVN1PROD with NOTICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; HIV Study in Blood Donors From Five Chinese Regions (NHLBI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget SUMMARY: VerDate Sep<11>2014 17:55 Nov 10, 2014 Jkt 235001 (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register in Volume 79, June 12, 2014 on page 33764 and allowed 60days for public comment. One public comment was received that was a personal opinion regarding conducting research about the Chinese blood donation system. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health (NIH) 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: NIH Desk Officer. Comment 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: HIV Study in Blood Donors From Five Chinese Regions, 0925–0596 Reinstatement With Change, National Heart, Lung and Blood Institute (NHLBI) Need and Use of Information Collection: This Study is a reinstatement with change of OMB Number: 0925– 0596 expiration date, January 31, 2012. To better understand the diversifying and changing Human Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk factors, especially those associated with recent HIV infections, this HIV risk factor study in China is proposed as part of the Recipient Epidemiology and Donor Evaluation Study–III (REDS–III). The major objectives of the study will be to evaluate the proportion of blood PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 donors in China who test positive for HIV and have acquired their infection recently or more remotely; the risk of releasing a blood product that contains HIV (HIV residual risk); and the risk factors associated with HIV infection in China. The study will also assess the frequency of distinct HIV–1 viral lineages and drug resistant mutations among HIV-positive blood donors. In 2011, there were 780,000 people infected with HIV in China and it is estimated that over 300,000 HIV infected people in China are not aware of their infection status. The large migrating population and the complexity of HIV transmission routes in China make it difficult to implement a comprehensive and effective national HIV control strategy. Risk factors for infections can change over time; thus, identifying factors that contribute to the recent spread of HIV in a broad crosssection of an otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in China. Because the pace of globalization means infections can cross borders easily, the study objectives have direct relevance for HIV control in the US and globally. Recent years have seen an increase in blood donations from repeat donors in most Chinese regions. This increase permits longer-term follow-up and testing of repeat donors which allow for calculation of new HIV infection rates and residual risks. The HIV data, for both recently and remotely acquired infections, from the proposed study will complement existing data on HIV risks obtained from general and high risk populations to provide comprehensive HIV surveillance data for China. This study will also monitor genetic characteristics of recently acquired infections through genotyping and drug resistance testing, thus serving a US and global public health imperative to monitor the genotypes of HIV 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. Genotyping and host response information are scientifically important not only to China, but to the US and other nations since they provide a broader global understanding of how to most effectively manage and potentially prevent HIV, for example through vaccine development. Efforts to develop vaccines funded by the National Institutes of Health and other US-based E:\FR\FM\12NON1.SGM 12NON1 Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices organizations may directly benefit from the findings of this study. Blood donors are tested for transfusion-transmissible infections including HIV when they present to donate, and test result information as well as demographic data will be routinely collected in a database at the five blood centers participating in REDS–III studies (located in the cities of Chongqing, Liuzhou, Luoyang, Mianyang, and Urumqi). These data will allow for calculation of HIV incidence, prevalence, and residual risk. Additionally, a case-control study will be conducted over a 2 and 1/2 year period to evaluate the risk factors associated with HIV infection among blood donors. Cases will be defined as potential donors who deny risks on the donor screening questionnaire but are found to be positive on HIV testing (their donation is discarded), HIVpositive donors who gave blood at one of the five blood centers as stated above (primary sites)or at blood centers located in the Guangxi Autonomous Region (peripheral sites, recruited through the Guangxi CDC for this study only but not other REDS–III studies) will be eligible to participate and complete a Risk Factor Questionnaire that will assess general demographic and risk factor information pertinent to HIV infection. Controls will be negative 67177 for HIV on confirmatory testing. Assuming 50% response rate, it is anticipated that 390 HIV-positive donors and 960 controls will participate in the case control study. The results of this study will contribute to global HIV surveillance and prevention, provide a broader global understanding of HIV epidemiology, and support public health efforts to most effectively manage and potentially prevent HIV transmission both worldwide and in the US. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated burden hours are 450. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Type of respondents HIV Risk factor Q .............................. Blood donors—Case Primary Sites Blood donors—Case peripheral sites. Blood donors—Control primary sites Blood donors—Control peripheral sites. Dated: October 28, 2014. Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health The National Institute of Mental Health (NIMH) Draft Strategic Plan; Request for Comments NIMH is revising its 2008 Strategic Plan to guide the Institute’s research efforts and priorities over the next five years (2015–2020). The purpose of this Notice is to seek input from the public about the draft NIMH 2015 Strategic Plan. The draft plan will be publicly available through the NIMH Draft Strategic Plan Web page (http:// www.nimh.nih.gov/about/strategicplanning-reports/review-the-draft-2015nimh-strategic-plan.shtml) for a 30-day period beginning on the publication date of this Notice. The public is invited to provide comments via the email address or postal address provided in this Notice and on the NIMH Draft Strategic Plan Web page. TKELLEY on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:55 Nov 10, 2014 Jkt 235001 20/60 20/60 70 60 540 420 1 1 20/60 20/60 180 140 SUPPLEMENTARY INFORMATION: Background The National Institute of Mental Health (NIMH) is the lead federal agency for research on mental illnesses. The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. To fulfill its mission, the NIMH supports and conducts research on mental illnesses and the underlying basic Frm 00022 Fmt 4703 Sfmt 4703 Total annual burden hours 1 1 To ensure consideration, your responses must be received within a 30day period that begins on the publication date of this Notice. ADDRESSES: Responses to this Notice should be submitted electronically using email to nimhstratplan@ mail.nih.gov. Alternatively, written responses can be submitted by mail to the Science Writing, Press, and Dissemination Branch, 6001 Executive Boulevard, Room 6200, MSC 9663. Bethesda, MD 20892–9663. FOR FURTHER INFORMATION CONTACT: Please contact our NIMH Information Specialists using the following contact information: telephone: 1–866–615– 6464 (toll-free), 1–301–443–8431 (TTY), 1–866–415–8051 (TTY toll-free). Fax: 1– 301–443–4279, Email: nimhinfo@ nih.gov PO 00000 Average burden per response (in hours) 210 180 DATES: [FR Doc. 2014–26761 Filed 11–10–14; 8:45 am] Number of responses per respondent science of brain and behavior; supports the training of scientists to carry out basic and clinical mental health research; and, communicates with scientists, patients, providers, and the general public about the science of mental illnesses. In 2008, the NIMH published a Strategic Plan to accelerate progress in basic, translational, and clinical science. The need to update the plan became clear with the increasing number of remarkable scientific advancements and the changing landscape of mental health care over the past six years. With the goals of helping individuals living with mental illnesses and promoting both prevention and cure, NIMH has revised its original four high-level Strategic Objectives as follows: (1) Define the biological basis of complex behaviors; (2) chart mental illness trajectories to determine when, where, and how to intervene; (3) develop better preventive and therapeutic interventions; and, (4) strengthen the public health impact of NIMH-supported research. These four Strategic Objectives form a broad roadmap for the Institute’s priorities over the next five years, which begins with the fundamental science of the brain and behavior, and ends with public health impact. Full implementation of these Strategies Objectives, will, we hope, transform the E:\FR\FM\12NON1.SGM 12NON1

Agencies

[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Notices]
[Pages 67176-67177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26761]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; HIV Study in 
Blood Donors From Five Chinese Regions (NHLBI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, 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 in Volume 79, June 12, 2014 on page 33764 and allowed 60-days 
for public comment. One public comment was received that was a personal 
opinion regarding conducting research about the Chinese blood donation 
system. The purpose of this notice is to allow an additional 30 days 
for public comment. The National Institutes of Health (NIH) 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: NIH Desk Officer.
    Comment 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: HIV Study in Blood Donors From Five Chinese 
Regions, 0925-0596 Reinstatement With Change, National Heart, Lung and 
Blood Institute (NHLBI)

    Need and Use of Information Collection: This Study is a 
reinstatement with change of OMB Number: 0925-0596 expiration date, 
January 31, 2012. To better understand the diversifying and changing 
Human Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk 
factors, especially those associated with recent HIV infections, this 
HIV risk factor study in China is proposed as part of the Recipient 
Epidemiology and Donor Evaluation Study-III (REDS-III). The major 
objectives of the study will be to evaluate the proportion of blood 
donors in China who test positive for HIV and have acquired their 
infection recently or more remotely; the risk of releasing a blood 
product that contains HIV (HIV residual risk); and the risk factors 
associated with HIV infection in China. The study will also assess the 
frequency of distinct HIV-1 viral lineages and drug resistant mutations 
among HIV-positive blood donors. In 2011, there were 780,000 people 
infected with HIV in China and it is estimated that over 300,000 HIV 
infected people in China are not aware of their infection status. The 
large migrating population and the complexity of HIV transmission 
routes in China make it difficult to implement a comprehensive and 
effective national HIV control strategy. Risk factors for infections 
can change over time; thus, identifying factors that contribute to the 
recent spread of HIV in a broad cross-section of an otherwise 
unselected general population, such as blood donors, is highly 
important for obtaining a complete picture of the epidemiology of HIV 
infection in China. Because the pace of globalization means infections 
can cross borders easily, the study objectives have direct relevance 
for HIV control in the US and globally. Recent years have seen an 
increase in blood donations from repeat donors in most Chinese regions. 
This increase permits longer-term follow-up and testing of repeat 
donors which allow for calculation of new HIV infection rates and 
residual risks. The HIV data, for both recently and remotely acquired 
infections, from the proposed study will complement existing data on 
HIV risks obtained from general and high risk populations to provide 
comprehensive HIV surveillance data for China. This study will also 
monitor genetic characteristics of recently acquired infections through 
genotyping and drug resistance testing, thus serving a US and global 
public health imperative to monitor the genotypes of HIV 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. Genotyping and host response information are 
scientifically important not only to China, but to the US and other 
nations since they provide a broader global understanding of how to 
most effectively manage and potentially prevent HIV, for example 
through vaccine development. Efforts to develop vaccines funded by the 
National Institutes of Health and other US-based

[[Page 67177]]

organizations may directly benefit from the findings of this study.
    Blood donors are tested for transfusion-transmissible infections 
including HIV when they present to donate, and test result information 
as well as demographic data will be routinely collected in a database 
at the five blood centers participating in REDS-III studies (located in 
the cities of Chongqing, Liuzhou, Luoyang, Mianyang, and Urumqi). These 
data will allow for calculation of HIV incidence, prevalence, and 
residual risk. Additionally, a case-control study will be conducted 
over a 2 and 1/2 year period to evaluate the risk factors associated 
with HIV infection among blood donors. Cases will be defined as 
potential donors who deny risks on the donor screening questionnaire 
but are found to be positive on HIV testing (their donation is 
discarded), HIV-positive donors who gave blood at one of the five blood 
centers as stated above (primary sites)or at blood centers located in 
the Guangxi Autonomous Region (peripheral sites, recruited through the 
Guangxi CDC for this study only but not other REDS-III studies) will be 
eligible to participate and complete a Risk Factor Questionnaire that 
will assess general demographic and risk factor information pertinent 
to HIV infection. Controls will be negative for HIV on confirmatory 
testing. Assuming 50% response rate, it is anticipated that 390 HIV-
positive donors and 960 controls will participate in the case control 
study. The results of this study will contribute to global HIV 
surveillance and prevention, provide a broader global understanding of 
HIV epidemiology, and support public health efforts to most effectively 
manage and potentially prevent HIV transmission both worldwide and in 
the US.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated burden hours are 
450.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Type of         Number of       Number of      burden per     Total annual
           Form name               respondents      respondents    responses per   response  (in   burden hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
HIV Risk factor Q.............  Blood donors--               210               1           20/60              70
                                 Case Primary
                                 Sites.
                                Blood donors--               180               1           20/60              60
                                 Case peripheral
                                 sites.
                                Blood donors--               540               1           20/60             180
                                 Control primary
                                 sites.
                                Blood donors--               420               1           20/60             140
                                 Control
                                 peripheral
                                 sites.
----------------------------------------------------------------------------------------------------------------


    Dated: October 28, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-26761 Filed 11-10-14; 8:45 am]
BILLING CODE 4140-01-P