Submission for OMB Review; 30-Day Comment Request; HIV Study in Blood Donors From Five Chinese Regions (NHLBI), 67176-67177 [2014-26761]
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Federal Register / Vol. 79, No. 218 / Wednesday, November 12, 2014 / Notices
CBER at https://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 https://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 https://
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 (https://
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
