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IT WAS ADDED 11/21/2014 BY MICHAEL LINGENFELTER AT THE NATIONAL ARCHIVES AND RECORDS ADMINISTRATION --><p align="center"><font face="Georgia, Times New Roman, Times, serif" size="4"><i><font size="2" color="#435250"><a name="top"></a>The
National AIDS Strategy</font></i></font></p>
<p align="center"><font face="Georgia, Times New Roman, Times, serif" size="4"><font size="2" color="#435250"><b><i>Appendix
B: Research<br>
</i></b></font></font> <font face="Georgia, Times New Roman, Times, serif" size="3" color="#435250"><b><i>
National Institutes of Health (HHS)</i></b></font></p>
<p><br>
</p>
<table width="75%" border="1" cellspacing="0" cellpadding="5" align="center" bordercolordark="#8A9F9C" bordercolorlight="#D2D2D2" bordercolor="#D2D2D2" bgcolor="#FFFFFF">
<tr>
<td>
<div align="center"><font size="3">NIH Research Goals</font><font size="4"><br>
<font size="3">| <a href="ns_m_xb6a.html" target="Main">1</a> | <a href="nsfs_xb6b.html" target="Main">2</a>
| <a href="nsfs_xb6c.html">3</a> | <b>4</b> | <a href="ns_m_xb6e.html" target="Main">5</a>
| <a href="ns_m_xb6f.html" target="Main">6</a> |</font></font></div>
</td>
</tr>
</table>
<p><a name="1"></a></p>
<table width="95%" border="1" cellpadding="5" bordercolor="#8A9F9C" bordercolordark="#8A9F9C" bordercolorlight="#D2D2D2" cellspacing="0" align="center">
<tr valign="top">
<td width="150" bgcolor="#D2D2D2"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>Goal
#4</b></font></td>
<td colspan="3"><font size="-1" face="Georgia, Times New Roman, Times, serif">To
conduct and support basic, preclinical, and clinical research to develop
a safe and effective preventive HIV vaccine.</font></td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>Objective
#1 </b></font></td>
<td colspan="3">
<p><font size="-1" face="Georgia, Times New Roman, Times, serif">Increase
scientific knowledge of host defense mechanisms leading to protection
against HIV infection and disease.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font size="-1" face="Georgia, Times New Roman, Times, serif"><i><b>Description</b></i></font></div>
</td>
<td colspan="3">
<p><font size="-1" face="Georgia, Times New Roman, Times, serif">More basic
knowledge is needed to define protective immune responses to HIV in order
to facilitate the development of vaccines and other immunologic strategies
to prevent and control HIV infection.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font face="Georgia, Times New Roman, Times, serif" size="-1"><b><i>Action
Steps </i></b></font></div>
</td>
<td colspan="3">
<ol>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Develop
animal models that are practical and as much as possible are representative
of the spectrum of HIV infections and AIDS; models should be amenable
to use in evaluating protection by vaccines and, where this can be demonstrated,
determining the correlates of protective immunity. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Determine
the mechanisms of immunologically mediated control of infection with
HIV and other related retroviruses, including the role of specific and
nonspecific immunity in inhibiting viral replication. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Additional
basic knowledge is needed to determine: o factors, including persistence
of antigens, that favor establishment of memory and development of long-term
protective immunity;</font>
<ul>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">
the heterogeneity of specific responses to an immunogen within distinct
compartments of the immune system; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">factors
that promote development of particular effector cell types; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">mechanisms
resulting from exposure to HIV that interfere with induction or
propagation of vaccine-induced effector responses; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">mechanisms
of virus neutralization. </font></li>
</ul>
</li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Study
acutely infected individuals, exposed/uninfected humans (and other primates),
and rapid/nonprogressors to determine viral and host factors that impact
amounts of circulating virus and disease course; ensure that plasma,
PBMC, biopsy, autopsy, and other key patient and animal samples, including
CNS samples, are accessible to qualified laboratories. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Define
and characterize viral B cell and T cell epitopes that induce protective
immunity; understand their structure and antigenicity and determine
whether and how their immunogenicity can be exploited in vaccine development;
and define epitopes in which substitutions cannot be tolerated by the
virus. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Determine
whether infection with one strain of HIV or related retroviruses confers
protection against subsequent infection with a second strain; determine
the protective mechanism and timing. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Understand
how and why HIV and related lentiviruses evade or escape from humoral
and cellular arms of the immune response. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Explore
strategies to elucidate the obligate mechanisms for protective immunity
against HIV, including amplification of selected responses by passive
transfer of Ab or immune cells and subtraction by deletion of selected
components of the immune system. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Study
chronic infection with attenuated viruses, such as SIV variants shown
to induce strong protection against virulent SIV strains in macaques,
to understand what properties of the virus and the immune system are
responsible for lack of disease induction and protection from challenge
with wild-type virus. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Explore
the molecular epidemiology and serology of HIV-1 populations relevant
to vaccine trials and collect clinical material from these populations
for scientific analysis. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Acquire
epidemiological information to assist in interpretation of these analyses.
</font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Develop
quantitative measures of HIV concentration in bodily fluids to determine
whether there is a relationship between HIV concentration and transmission
and to determine the effect of concurrent STDs on HIV shedding.</font></li>
</ol>
<p> </p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>Objective
#2</b></font></td>
<td colspan="3">
<p><font size="-1" face="Georgia, Times New Roman, Times, serif">Apply findings
from basic, epidemiologic, and clinical research to the design and evaluation
of vaccine strategies in laboratory studies and animal models, and foster
collaboration with industry in the research and development of candidate
vaccines.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font size="-1" face="Georgia, Times New Roman, Times, serif"><i><b>Description</b></i></font></div>
</td>
<td colspan="3">
<p><font size="-1" face="Georgia, Times New Roman, Times, serif">The identification
of viral antigens and vaccine delivery methods that elicit long-lasting
protective immune responses against a broad range of HIV isolates will
facilitate development of effective vaccines.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font face="Georgia, Times New Roman, Times, serif" size="-1"><b><i>Action
Steps </i></b></font></div>
</td>
<td colspan="3">
<ol>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Support
the design and development of potential vaccines, including vaccines
composed of:</font>
<ul>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">whole-killed
HIV and genetically engineered, noninfectious HIV mutants that lack
the viral RNA genome or have a defect in a critical gene necessary
for replication but contain an array of HIV genes for expression
of antigenic proteins; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">live,
recombinant viral and bacterial vectors engineered to express one
or more HIV proteins; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">naturally
occurring and genetically engineered, live-attenuated strains of
HIV; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">synthetic
peptide candidates capable of inducing and boosting both cellular
and humoral immunity; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">DNA
coding for viral proteins; o agents that stimulate mucosal immune
responses; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">a
combination of the above agents and preparations; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">other
novel agents and preparations. </font></li>
</ul>
</li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Evaluate
the efficacy of vaccine strategies in animal models of HIV and related
lentiviruses. To accomplish this:</font>
<ul>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">test
vaccine strategies in animal models that most closely mimic the
HIV infection in humans; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">determine
the effect of vaccine formulation and regimen as well as the nature,
timing, and route of vaccine challenge on the characteristics and
effectiveness of the vaccine-induced immune response; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">define
the impact of different vaccine approaches on kinetics of immune
responses, kinetics and localization of viral replication, disease
progression, and biologic characteristics of breakthrough virus
including transmissibility; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">conduct
long-term follow-up of vaccinated animals that become chronically
infected to determine the impact of vaccination on disease progression;
</font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">develop
assays to distinguish between infection and serological responses
due to immunization. </font></li>
</ul>
</li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Support
design and development of methods to improve or modulate immune responses
(qualitatively or quantitatively), including: </font>
<ul>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">novel
adjuvants and presentation methods; </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">vaccines
incorporating cytokines or other biologically active molecules;
</font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">establishment
of physical or biological reservoirs for long-term antigen presentation;
</font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">other
novel strategies. </font></li>
</ul>
</li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Encourage
development of candidate vaccines of suitable antigenic types and possessing
stability and route of administration characteristics appropriate for
international as well as domestic use. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Characterize
and evaluate the potential negative side effects of candidate vaccines,
including production antibodies enhancing neurotoxicity and oncogenicity.
</font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Develop
better in vitro methodologies to measure immune responses to primary
viral isolates. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Develop
infrastructure, and address scientific, legal, and regulatory issues
to foster and encourage participation by, and collaboration with, industry
and other agencies in the research, development, production, and clinical
testing of candidate vaccines.</font></li>
</ol>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>Objective
#3</b></font></td>
<td colspan="3">
<p><font face="Georgia, Times New Roman, Times, serif" size="-1">Select
candidate vaccines or concepts suitable for Phase I and Phase II trials
and conduct these trials.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font face="Georgia, Times New Roman, Times, serif" size="-1"><b><i>Description</i></b></font></div>
</td>
<td colspan="3">
<p><font face="Georgia, Times New Roman, Times, serif" size="-1">Suitable
candidate vaccines need to be selected and evaluated in Phase I and Phase
II trials to determine safety and immunogenicity.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font face="Georgia, Times New Roman, Times, serif" size="-1"><b><i>Action
Steps </i></b></font></div>
</td>
<td colspan="3">
<ol>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Support
the conduct of Phase I and Phase II coordinated clinical trial that
will determine long-term and short-term safety and compare immunologic
responses to preventive vaccine candidates; include a broad range of
humoral, cell-mediated, and mucosal immune parameters. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Develop
a mechanism to evaluate the suitability of vaccine candidates for entry
into Phase I and Phase II trials; evaluation criteria should include
originality and intrinsic value of the concept and animal model data.
</font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Develop
strategies at the local and national levels to reduce social and economic
risk to volunteers in Phase I and Phase II trials to facilitate broad
participation. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Design
and conduct Phase II trials using promising HIV vaccines that are also
genetically or immunologically related to HIV isolates circulating in
the proposed trial population and of an appropriate size to facilitate
decisions regarding efficacy trials. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Analyze
immune responses in vaccines and appropriate controls. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Isolate
and characterize virus and follow clinical course and immune responses
of vaccines who become HIV-infected. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Study
viral isolates from participants in HIV vaccine trials and selected
controls to explore the possible effects of vaccination on the characteristics
of transmitted viruses. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Conduct
behavioral research on trial participants to establish whether their
risk behavior has been influenced by participation in a vaccine trial,
with emphasis on individuals who become infected while participating.
</font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Closely
coordinate the evaluation of research findings on prophylactic AIDS
vaccines with preclinical research and immunotherapeutic interventions.
</font></li>
</ol>
<p> </p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>Objective
#4</b></font></td>
<td colspan="3">
<p><font size="-1" face="Georgia, Times New Roman, Times, serif">Identify
mechanisms of protective immunity to HIV in newborns and infants and support
the development of safe and effective immunologic strategies for preventing
or controlling HIV infection in this population.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font face="Georgia, Times New Roman, Times, serif" size="-1"><b><i>Description</i></b></font></div>
</td>
<td colspan="3">
<p><font size="-1" face="Georgia, Times New Roman, Times, serif">Distinct
approaches and infrastructure are needed to achieve protection of newborns
and infants because of the unique nature of their immune responses and
modes of exposure to HIV.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font size="-1" face="Georgia, Times New Roman, Times, serif"><i><b>Action
Steps</b></i></font></div>
</td>
<td colspan="3">
<ol>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Determine
what viral, immunologic, and non-immunologic host factors influence
transmission of HIV-1 from mother to infant;</font>
<ul>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Compare
virus isolates that are and are not transmitted from mother to infant;
</font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Seek
maternal and infant immune responses that might prevent transmission
to infants. </font></li>
</ul>
</li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Develop
and maintain domestic and international infrastructure necessary to
enroll mothers and infants in prospective long-term follow-up vaccine
trials and other interventions. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Determine
the safety and immunogenicity of various HIV vaccines and adjuvants
in relevant animal models of maternal-fetal and maternal-infant transmission
to evaluate safety, immunogenicity, and efficacy of candidate vaccines.
</font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Select
and evaluate antibody and/or cellular preparations in passive or passive/active
HIV prevention studies. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Establish
criteria for advancement of candidates in Phase I, Phase II, and Phase
III clinical trials in children. </font></li>
<li><font size="-1" face="Georgia, Times New Roman, Times, serif">Conduct
Phase I, Phase II, and Phase III clinical trials in children for the
most promising candidates that meet established criteria. </font></li>
</ol>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>Objective
#5</b></font></td>
<td colspan="3">
<p><font face="Georgia, Times New Roman, Times, serif" size="-1">Identify
appropriate domestic and international population and develop infrastructure
and collaborations with government, communities, and industry necessary
for ensuring adequate performance of Phase III efficacy trials.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font face="Georgia, Times New Roman, Times, serif" size="-1"><b><i>Description</i></b></font></div>
</td>
<td colspan="3">
<p><font face="Georgia, Times New Roman, Times, serif" size="-1">Preparation
for HIV vaccine efficacy trials requires development of an infrastructure
and a series of studies and planning activities to ensure their feasibility.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font face="Georgia, Times New Roman, Times, serif" size="-1"><b><i>Action
Steps</i></b></font></div>
</td>
<td colspan="3">
<ol>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Develop
domestic and international sites with access to populations at high
risk for acquiring HIV infection, where vaccine or other prevention
research activities may be feasible. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Establish
linkages with communities or community organizations where efficacy
trials might be conducted to optimize education, recruitment, and follow-up
activities and to help address community concerns related to AIDS vaccine
efficacy trials. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">For
international trials, work closely with national (host) governmental
and regulatory authorities, collaborating institutions, vaccine manufacturer(s),
and the World Health Organization to plan and conduct vaccine efficacy
trials adhering to the highest ethical and scientific standards. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Carry
out appropriate epidemiologic studies that determine the risk profiles
and infection rates of various populations in the United States and
worldwide in order to identify those groups most likely to be the participants
in vaccine trials. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Maintain
the necessary laboratory infrastructure at designated sites for conducting
domestic and international vaccine efficacy trials. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Acquire
and analyze HIV isolates from recent seroconverters representative of
potential efficacy trial populations so that genetic and antigenic information
about virus circulating in the population can be obtained. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Evaluate
other biomedical and behavioral interventions that could prove of benefit
in decreasing the incidence of HIV infection in the populations identified
for future vaccine efficacy trials and assess their potential impact
on the evaluation of vaccine efficacy. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Conduct
behavioral research in populations at high risk for HIV infection to
determine, for example, appropriate risk-reduction interventions and
to estimate risk behavior and recruitment, adherence, and retention
strategies pertinent to the design and execution of a successful efficacy
trial, especially for populations that have been historically underrepresented
in clinical trials. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Determine
possible adverse social, economic, or legal consequences of participation
in clinical trials, and develop strategies for mitigating potential
harm. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Determine
optimal methods of achieving informed consent for vaccine efficacy trials.
</font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Prepare
for adequate long-term follow-up of individuals participating in vaccine
clinical trials where it will be necessary to determine the longevity
of immune response, the correlates of immune protection, long-term safety,
the impact of participation on risk-taking behavior, and the possible
positive or negative effects of vaccine immunization against disease
progression and HIV transmission. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Encourage
linkage between vaccine preparedness studies in high-risk populations
and other research activities including research on TB and STDs; and
integrate research on vaccines against opportunistic infections as appropriate.
</font></li>
</ol>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>Objective
#6</b></font></td>
<td colspan="3">
<p><font size="-1" face="Georgia, Times New Roman, Times, serif">Select
suitable vaccine candidates and support efficacy trials when appropriate
criteria are met.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font face="Georgia, Times New Roman, Times, serif" size="-1"><b><i>Description</i></b></font></div>
</td>
<td colspan="3">
<p><font face="Georgia, Times New Roman, Times, serif" size="-1">Conduct
HIV vaccine efficacy trials of the most promising candidate vaccines in
well-characterized, high-risk populations to identify effective vaccines
for the control of HIV infection.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font face="Georgia, Times New Roman, Times, serif" size="-1"><b><i>Action
Steps</i></b></font></div>
</td>
<td colspan="3">
<ol>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Establish
criteria with concurrence of an advisory group that has the requisite
scientific, public health, government and community expertise. </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Conduct
large-scale efficacy trials of preventive vaccine candidates that have
proven promising, safe, and immunogenic in Phase II trials and that
meet appropriate criteria; </font>
<ul>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Evaluate
HIV vaccine candidate efficacy against infection and disease; </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Evaluate
additional virologic, immunologic, and behavioral outcomes, particularly
correlates of protective immunity; </font></li>
<li><font face="Georgia, Times New Roman, Times, serif" size="-1">Ensure
that trials are conducted with the highest regard for social and
ethical standards. </font></li>
</ul>
</li>
</ol>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF" rowspan="2">
<div align="right"><font size="-1" face="Georgia, Times New Roman, Times, serif"><i><b>Resources</b></i></font>
</div>
</td>
<td width="121">
<div align="center"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>FY95</b></font></div>
</td>
<td width="124">
<div align="center"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>FY96</b></font></div>
</td>
<td width="131">
<div align="center"><font size="-1" face="Georgia, Times New Roman, Times, serif"><b>FY96</b></font></div>
</td>
</tr>
<tr valign="top">
<td width="121">
<div align="right"><font size="-1" face="Georgia, Times New Roman, Times, serif">$
100.4 million</font></div>
</td>
<td width="124">
<div align="right"><font size="-1" face="Georgia, Times New Roman, Times, serif">$
109.5 million</font></div>
</td>
<td width="131">
<div align="right"><font size="-1" face="Georgia, Times New Roman, Times, serif">$
116.1 million </font></div>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font size="-1" face="Georgia, Times New Roman, Times, serif"><i><b>Populations<br>
Served</b></i></font></div>
</td>
<td width="121" colspan="3">
<p><font size="-1" face="Georgia, Times New Roman, Times, serif">All populations.</font></p>
</td>
</tr>
<tr valign="top">
<td width="150" bgcolor="#FFFFFF">
<div align="right"><font size="-1" face="Georgia, Times New Roman, Times, serif"><i><b>Constituency<br>
Involvement</b></i></font></div>
</td>
<td width="121" colspan="3">
<p><font size="-1" face="Georgia, Times New Roman, Times, serif">Researchers,
clinicians, community and patient representatives, and NIH-affiliated
advisory councils and committees.</font></p>
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