Full Text HD-94-012

ADOLESCENT MEDICINE HIV/AIDS RESEARCH NETWORK

NIH GUIDE, Volume 23, Number 7, February 18, 1994

RFA:  HD-94-012

P.T.


Keywords: 


National Institute of Child Health and Human Development
National Institute of Allergy and Infectious Diseases
Health Resources and Services Administration

Letter of Intent Receipt Date:  March 30, 1994
Application Receipt Date:  May 13, 1994

PURPOSE

The National Institute of Child Health and Human Development (NICHD)
and the National Institute of Allergy and Infectious Diseases
(NIAID), in responding to identified research needs in human
immunodeficiency virus (HIV)-infected and at risk adolescents (U.S.
Congress, Office of Technology Assessment, Adolescent Health- Volume
I; Summary and Policy Options, OTA-H-468 (Washington DC: US
Government Printing Office, April 1991)) and Public Law 103-43--
National Institutes of Health Revitalization Act of 1993, Title X,
Subtitle D, Section 1031--Prospective Longitudinal Study on
Adolescent Health, invite applications for cooperative agreements to
participate in a clinical network to plan and conduct research on the
medical, biobehavioral, and psychosocial aspects of HIV/AIDS,
including access to care and its utilization in adolescents infected
with HIV through sexual or drug-taking behaviors.  The network will
initially focus on adolescents between ages 15 and 19 years and, as
funding becomes available, expand to include adolescents between the
ages of 12 and 19 years.  The Maternal and Child Health Bureau
(MCHB), Division of Services for Children with Special Needs (DSCSN),
Health Resources and Services Administration (HRSA) will provide the
funds to support clinical sites to (1) develop the comprehensive
health care infrastructure necessary to support clinical research
where such infrastructure does not exist and (2) develop and
disseminate treatment and policy guidelines specific to HIV-infected
adolescents.

Applicants for the Basic Science Group should have research
experience pertinent to the objectives delineated in this RFA.
Applicants for the Clinical Science Group must provide health care
services to HIV-infected adolescents.  Furthermore, they must
demonstrate the proven capacity to reach sufficient numbers of
adolescents with HIV infection and provide comprehensive adolescent
HIV-related health care and support services (Track A) or submit a
plan to provide comprehensive adolescent HIV-related health care and
support services in support of clinical research (Track B).  In
addition, applicants for either Track A or Track B in the Clinical
Science Group must be willing and able to participate in a
cooperative program of research and evaluation with other successful
applicants.  Applicants are encouraged, where appropriate, to apply
as a consortium in order to satisfy site, service, and recruitment
requirements.  Existing and operational consortia are preferred to
those convened around grant requirements.  Consortia may apply in
Track A or Track B.  Track A consortium applicants must demonstrate
the capacity for comprehensive health care services at each
participating site; Track B consortium applicants must submit a plan
for using limited Track B funds to provide comprehensive health care
services in support of clinical research at all participating sites
where such service does not exist.  The network will consist of a
Basic Science Group and a Clinical Science Group; applicants may
apply for funding in either group component or both.  Applicants to
the Clinical Science Group must indicate Track A or Track B
consideration.

NICHD, NIAID, and HRSA also invite applications for a cooperative
agreement with a Data and Operations Center for the Network.  This
Data and Operations Center will manage data from surveys, studies,
and interventions at the funded sites, consult on and perform the
appropriate statistical analyses of the data, maintain the
communications link for the network, and support the activities of
research planning, protocol design, and information dissemination.
This center will be functionally independent of all research sites,
although it could be physically located at one of them.

The assistance mechanism used to support this research is the
cooperative agreement, which is similar to a traditional research
grant, but one in which NIH and HRSA scientific and program staff
participate with study investigators as partners in the research
effort.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas. This Request
for Applications (RFA), Adolescent Medicine HIV/AIDS Research
Network, is related to the priority areas of health and well-being of
special population groups and HIV infection.  Potential applicants
may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of state and local governments, and
eligible agencies of the Federal government.  Minority investigators
and women are encouraged to apply. It is expected that applicants for
the Basic Science Group have research experience pertinent to the
objectives of the network delineated in this RFA.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program
will be a cooperative agreement (U01), an "assistance" mechanism
(rather than an "acquisition" mechanism) in which substantial NIH and
HRSA scientific and/or programmatic involvement with the awardee is
anticipated during the performance of the activity. (PHS Grants
Policy Statement, DHHS (OASH) 90-50,000 (rev. October 1, 1991).
Under the cooperative agreement, the purpose of the NIH and HRSA is
to support and/or stimulate the recipient's activity by involvement
in and otherwise working jointly with the award recipient in a
partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Specifically,
members of the NICHD, NIAID, and HRSA scientific and program staff
will cooperate with principal investigators as partners in the
projects and serve as science collaborators or program managers.  All
parties will agree to accept the participatory and cooperative nature
of the group process. Details of the responsibilities, relationship,
and governance of the study to be funded under cooperative agreements
are discussed later in this document under the section "Terms and
Conditions of Award".

The total project period for applications submitted in response to
the present RFA may not exceed five years.  The anticipated award
date is September, 1994.  At this time, NICHD, NIAID, and HRSA have
not determined whether or how this solicitation will be continued
beyond the present RFA.

Awards and level of support depend on receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of NICHD, NIAID, and HRSA awards
pursuant to this RFA are contingent upon the availability of funds
for this purpose.

FUNDS AVAILABLE

NIAID funds available for the support of this program are $300,000
(total costs). The estimated NICHD funds available for support of the
entire program in Phase I (consisting of six months for planning and
base protocol/management guidelines development) and Phase II
(consisting of the subsequent six months for protocol implementation
and subject recruitment) during the first year are $2,400,000 (total
costs).  These funds will support the direct cost of activities of
the Basic Science Group, the clinical research activities of the
Clinical Science Group, and the operations/support activities of the
Data and Operations Center.  Direct costs are approximated as
follows:

(1) For all non-laboratory components of the Basic Science Group -
$235,000 (direct costs) for 8-10 awards.
(2) For the clinical research activities of the Clinical Science
Group - $875,000 (direct costs) for 8-10 awards.  This amount
includes subject encounter costs for two visits of the base protocol
in year one for all awardees in the Clinical Science Group.
(3) For the data operations and support services of the Data and
Operations Center - $450,000 (direct costs).
(4) For the support of the virology laboratory that is part of the
Basic Science Group - $120,000 (direct costs).
(5) For the support of the immunology laboratory that is part of the
Basic Science Group - $120,000 (direct costs).

In addition, the estimated HRSA funds available for support of the
Track B clinical sites in Phase II and the resource capacity of the
clinical sites are $250,000 (total costs).  It is expected that
supplemental NIH funds will be added in future years to cover costs
of full year research staff at clinical sites and special studies to
be undertaken in the assembled cohort enrolled in the base protocol.
Track B awards include additional HRSA money to support the health
care infrastructure in augmented service delivery in support of the
clinical research agenda of the Network.  It is anticipated that 8-10
Basic Science Group including one virology laboratory and one
immunology laboratory, 8-10 Clinical Science Group including
two-three Track B sites, and one Data/Operations Center awards will
be made.  This level of support is dependent on the receipt of a
sufficient number of applications of high scientific and experiential
merit.  The number of awards and actual funds awarded depend on the
overall scientific merit of the applications and the availability of
funds.

RESEARCH OBJECTIVES

Background

Through September 1993, 1,415 AIDS cases in adolescents (aged 13- 19
years) were reported to the National Centers for Disease Control and
Prevention.  Although adolescents comprise less than one percent of
all reported AIDS cases, the impact of HIV infection during
adolescence is far more profound.  First, the long incubation period
between initial HIV infection and the development of AIDS-defining
conditions suggests that the majority of AIDS cases in persons
between 20 and 29 years of age, which constitute nearly 20 percent of
all reported AIDS cases, can be attributed to infection as teenagers.
Secondly, HIV infection, and to some extent AIDS cases under the new
case definition, are not accurately estimated through reporting
mechanisms because adolescents lack easy access to medical care for
diagnosis.  Many may actually succumb to competing causes of
mortality (e.g., violence).  Recent blinded HIV serosurveys indicate
a range of estimates:  from prevalence rates of 0.34 per 1000 in
17-19 year applicants to the military, 1.7 per 1000 in the users of
student health services on selected college campuses, 3.9 per 1000 in
Job Corps applicants, to 88 per 1000 in an urban homeless youth
center.

Of the groups affected by HIV, the U.S. adolescent population is the
one in which basic biologic issues are the most poorly understood and
the one in which therapeutic and clinical management trials have not
been effectively initiated.  At the present time, it is not known how
HIV infection affects continuing development in those adolescents who
have been infected through sexual or injecting drug use practices.
It is not clear how age at infection influences the course of
maturation nor is it clear how maturation might proceed in HIV+
adolescents with repeated HIV sexual exposure, sexually transmitted
disease co-morbidity, and/or pregnancy.

The heterosexual transmission of HIV is attaining increasing
importance as a mode of HIV spread to uninfected individuals.  This
mode of HIV transmission is particularly important in the adolescent
population due to the high prevalence of high-risk behaviors.  The
factors which modulate the heterosexual transmission of HIV have not
been determined.  However, it is likely that the replication of HIV
at genital mucosal surfaces plays a major role in the likelihood of
the occurrence of viral transmission following heterosexual exposure.
Previous studies have documented the presence of HIV and antibodies
in cervical and seminal secretions. However, the prevalence of these
markers and the relationship to other microbial pathogens in the
adolescent population has not been defined.  The determination of the
prevalence of specific markers of HIV infection is an important first
step in defining the relationship between these markers and
heterosexual transmission.  Little is known about the normal range of
many routine laboratory values during the steroid-mediated phase of
growth and development, particularly in immunologic parameters.  This
deficiency makes the choice of precise and accurate clinical disease
indicators problematic for adolescent subjects in trials.

Research Goals and Scope:

This initiative calls for a descriptive examination of the full
spectrum of HIV disease and its behavioral manifestations in
adolescents who have become infected with HIV through sex and
drug-taking behaviors in order to identify and pursue HIV/AIDS-
specific research agenda in the adolescent population between the
ages of 15 and 19 years of age.  Adolescents between 12 and 15 years
of age may be incorporated in future potential expansions of the
network.  The ultimate goal of this project is to achieve a better
understanding of HIV disease progression and co-morbidity in
adolescents and thus improve health care management; this goal will
be addressed through the enrollment of approximately 200 HIV-infected
adolescents into a standardized base protocol to characterize
population-based spectrum of disease, disease progression, and the
effect of comorbidity with other sexually- transmitted diseases and
pregnancy in the adolescent population; and the standardization and
evaluation of health care services. A secondary goal involves the
resolution of remaining questions related to HIV infection in
adolescents through the development of special studies to be
undertaken in the assembled cohort enrolled in the base protocol.
These unresolved questions include, but are not limited to, the
susceptibility, infectivity, and transmissibility of HIV in
adolescents, particularly related to developing genital mucosa; the
characterization of the variation in adolescent immune function; the
identification of useful adolescent-specific clinical markers of HIV
disease progression; the effect of HIV on adolescent neuropsychologic
function and development; and the influence and effect of specific
adolescent behavioral patterns on risk-taking and health-seeking
activities.  The network will also produce and evaluate clinical
management guidelines for adolescent HIV infection that recognize the
unique biological and behavioral features of this group.  The network
will assist member units in establishing an interface with
adolescent-eligible clinical drug and vaccine trials through a
variety of mechanisms that are appropriate to the clinical research
issues facing the group and take in account particular issues facing
adolescents.

Cooperative agreements are sought to establish a research network and
permit the conduct of a wide-ranging, multi-stage series of
investigations that address one or more of the clinical facets of HIV
infection in adolescents.

SPECIAL REQUIREMENTS

The Adolescent Medicine HIV/AIDS Research Network will consist of two
interactive groups, Basic Science and Clinical Science, managed by
Steering and Executive Committees, supported by a Data and Operations
Center, and advised by a Community Advisory Board.

Organizational Components

The Basic Science Group component will provide salary support to a
group of scientists whose purpose is to set the scientific agenda for
the Adolescent Medicine HIV/AIDS Research Network.  The Basic Science
Group will consist of one NICHD and one NIAID staff collaborator,
8-10 principal investigators who would include adolescent medicine
specialist(s), immunologist(s), virologist(s), epidemiologist(s),
endocrinologist(s), behavioralist(s), and other relevant disciplines
with responsibility for setting the scientific agenda, refining the
base study protocol, and developing substudy protocols to address the
agenda and evaluation of the clinical management guidelines.  Members
of the Basic Science Group will participate in twice monthly
conference calls during year 1 and attend two meetings per year: one
specifically for the Basic Science Group and the other in conjunction
with members of the Clinical Science Group and Community Advisory
Board.

Applications to become members of the Basic Science Group must
include (1) documentation of clinical experience in adolescent health
care or professional interest in adolescent issues; (2) record of
published research relevant to adolescent health care issues; (3)
submission of an original research module designed to further the
adolescent HIV/AIDS research agenda.  This research module may focus
on any of the research areas listed in the Research Goals and Scope
Section of this RFA or address unspecified research areas relevant to
adolescent HIV infection that are consistent with the scope of this
RFA.

The Basic Science Group will hold its first meeting shortly after the
grants are awarded.  At that time, members will present briefly the
research modules that formed the basis for their competitive awards.
The purpose and scope of the cooperative agreement will be reviewed
as will the current state of knowledge about the natural history of
HIV infection in adolescents.  The members of the Basic Science Group
will prioritize the specific scientific goals and aims and construct
a base study protocol that reflects these priorities and will address
scientific questions concerning the natural history of HIV infection
and disease in adolescents.  Substudies that are also reflective of
the research modules proposed by the Basic Science Group members and
the overall goals of the cooperative agreement may be agreed upon at
this time.  Recognition that it will not be possible to implement all
the research modules proposed for purposes of technical review is
essential.  Other limiting considerations will include:  (1) studies
that are feasible to undertake in the proposed research population;
(2) the financial resources available to the Network; and (3)
strategies that are likely to be most productive and cost-effective
in addressing the research priorities of the Network.  A format for
pursuing special studies will be developed, implementation strategies
will be discussed in preparation for interaction with the Clinical
Science Group, and a timeline for submission to the Executive
Committee will be drawn up.

Laboratory support for the research network will consist of one AIDS
Clinical Trials Group (ACTG)- certified immunology laboratory and one
ACTG certified virology laboratory; both funded to support specific
study components.  Investigators from these two sites will be
included in the Basic Science Group.  ACTG certification provides an
established quality control evaluation.  Applicants for these two
reserved positions will be required to submit only a research module
as outlined above for other members of the Basic Science Group (item
3 above) as well as documentation of research experience specific to
their discipline.

The Clinical Science Group component will provide salary and program
support to clinical sites providing health care services to
adolescent populations.  The Clinical Science Group will consist of
8-10 principal investigators who are adolescent medicine specialists
at clinical sites that can enroll at least 20 HIV-positive
adolescents and 10 HIV-negative but high-risk adolescents, between
the ages of 15 and 19 years, into the base study while providing
comprehensive health care services through other funding mechanisms.
Track A sites are those with established comprehensive health care
services for adolescents through HRSA-funded Ryan White Care Act
Title IV/Pediatric Demonstration Projects or other funding
mechanisms; Track B sites are those sites with a well-developed and
operationally-supported plan for the provision of comprehensive
health care services, but require funding for its implementation.
This comprehensive care infrastructure is necessary to support the
clinical research agenda of this network.  The Clinical Science Group
will interact with the Basic Science Group and be responsible for the
generation of clinical management guidelines, enrolling adolescents
into selected substudies, and potentially enrolling adolescents into
clinical drug and vaccine trials (that are already supported through
other mechanisms, e.g., ACTG, CPCRA, AVEG, AmFAR).  Members of the
Clinical Science Group will participate in twice monthly conference
calls during Phase I and monthly thereafter and attend one annual
meeting in conjunction with members of the Basic Science Group and
one separate meeting focusing on clinical management and policy
issues.  Applications to participate in the Clinical Science Group
should include information in three areas: staff, site, and patient
population/geographic location.  Applicants should document their
ability to recruit a sufficient number of participants between the
ages of 15 and 19 years, discuss their capacity to participate in the
program and their ability to interact effectively with the Data and
Operations Center, and state their willingness to follow the common
protocol that will be produced by the Basic Science Group and to
implement subsequent protocols targeting adolescent-specific research
questions.

The Data and Operations Center will manage two meetings of the entire
Network including the Steering Committee during Phase I; one annual
scientific meeting for Basic Science Group and one annual
management/policy meeting for the Clinical Science Group during Phase
II of Year 1; twice-monthly conference calls for the Basic Science
Group during Year 1; twice monthly conference calls for the Clinical
Science Group during Phase I and monthly conference calls thereafter;
and ad hoc calls as necessary.  The Center will support protocol
development and distribution.  It will also assume responsibility for
site registration, any protocol-related training, monitoring of sites
for accurate and complete data collection, regulatory compliance, and
research subject safeguards.  The Center will provide support to the
Clinical Science Group for the development and dissemination of
treatment and policy guidelines, as well as provide resources to the
Community Advisory Board.  The Center will be responsible for the
integrity of the scientific databases by editing and entering data,
as well as designing and maintaining the study database(s).  In
addition, this center will provide statistical consultation to both
Science Groups as needed and analytic support.  Applicants should
document past experience with conducting other programs that required
responsibilities similar to those outlined above.  The applicant
should submit a detailed plan of activities with time lines that
would successfully implement the effort required to support the
research network program.

Separate applications must be made for the Clinical Science Group,
the Basic Science Group, and the Data and Operations Center, even if
a single organizational entity is applying for more than one
activity. Regardless of whether the Data and Operations Center is
located at one of the cooperating sites, it will maintain strict
independence.

Study Phases: Phase I

It is expected that Phase I (six months) will be devoted to
identification of the research agenda, the development of the base
protocol, and the development of the clinical management guidelines.
Work on these tasks will ensue at an organizational meeting of the
entire Network at which group chairs and vice chairs are elected soon
after awards. Work will continue by twice monthly conference calls,
monitored by the Executive Committee, and culminate with an
implementation meeting of the Steering Committee and the entire
Network at month six.

Study Phases: Phase II

This Phase involves the training of clinical research staff, the
recruitment of study subjects, the implementation of the base
protocol for the Clinical Science Group sites, and the further
protocol development of special studies for the Basic Science Group
members. During this phase, Basic Science Group faculty,
data/operations center staff, and NICHD and NIAID staff collaborators
will meet annually for a scientific retreat.  The Steering Committee
members in conjunction with the entire Network will meet annually for
scientific interactive sessions.

Terms and Conditions of Award

The following terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS Grants
Administration Regulations at 45 CFR Part 74 and 92 and other HHS,
PHS, and NIH grant administration policies. Business management
aspects of these awards will be administered by the NICHD Grants
Management Office in accordance with HHS, PHS, and NIH Grants
Administration policies.  It is envisioned at this time that all
awarded funds will be administered by the NICHD Grants Management
Office.

The administrative and funding instrument to be used for this program
will be a cooperative agreement (U01), an "assistance" mechanism
(rather than an "acquisition" mechanism) in which substantial NIH and
HRSA scientific and/or programmatic involvement with the awardee is
anticipated during the performance of the activity.  Under the
cooperative agreement, the NIH purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working
jointly with the award recipient in a partner role, but it is not to
assume direction, prime responsibility, or a dominant role in the
activity.  Consistent with this concept, the dominant role and prime
responsibility for the activity resides with the awardees for the
project as a whole, although specific tasks and activities in
carrying out the studies will be shared among awardees and the NICHD,
NIAID, and HRSA staff collaborators.

1.  The Primary Rights and Responsibilities of the Awardees are as
follows:

Basic Science Group:

The Basic Science Group will consist of those awardees whose
submissions were chosen on scientific merit. The Basic Science Group,
with a chair and vice chair elected by its members, will

o  Retain the primary responsibility for defining and prioritizing
the research agenda and submitting the agenda to the Steering
Committee for approval

o  Specify research objectives for the base study to characterize
population-based spectrum of disease and disease progression and
secondary special studies, develop corresponding protocols, provide
for monitoring the progress of various studies, and analyze and
interpret study protocol results. It is expected that this
responsibility will be undertaken with significant interaction with
the members of the Clinical Science Group.

o  Consult and review Clinical Science Group plans for the evaluation
of clinical management guidelines that address the unique biological,
biobehavioral and psychosocial issues of adolescence including
pharmacologic prophylaxis, the scope and frequency of medical
monitoring, and organization of services, among others.

o  Basic Science Group awardees, as a group, will retain custody of
and have primary rights to the protocol data developed under these
awards, subject to government rights of access consistent with
current HHS, PHS, and NIH policies.  Protocol development for special
studies shall be undertaken when two-thirds of the Basic Science
Group members approve the research concept.

o  Laboratory Support awardees of the Basic Science Group will be
expected to satisfy all responsibilities of Basic Science Group
members as outlined above.  In addition, these two members will
provide expertise in areas of immunology or virology to the Basic
Science Group and furnish laboratory services to the Network to
support protocol-specified evaluations.

Clinical Science Group:

The Clinical Science Group will consist of those awardees whose
submissions were chosen on clinical experience and capacity. The
Clinical Science Group, with a chair and vice chair elected by its
members, will

o  Participate in the production of the research agenda through
review and evaluation at regularly scheduled interactive Network
meetings and by submitting concepts for study (both primary or
secondary analyses).  Clinical Science Group members will be strongly
encouraged to submit research concepts to the Basic Science Group and
may participate in their subsequent protocol development.  Decisions
related to protocol development and protocol team formation are the
responsibility of the Basic Science Group.

o  Retain primary responsibility for the implementation of the base
protocol and secondary protocols where feasible and the recruitment
and monitoring of study participants, associated data collection, and
quality control.

o  Awardees will be required to accept and implement the common
protocol developed by the Basic Science Group and all procedures
approved by the Steering Committee.

o  Derive clinical management guidelines for the standardization of
health care delivery across network sites that address the unique
biological, biobehavioral, and psychosocial issues of adolescence
including pharmacologic prophylaxis, the scope and frequency of
medical monitoring, and service organization, overcoming barriers to
care, among others; and submit a corresponding evaluation plan to the
Basic Science Group for consultation and review.

o  Clinical Science awardees, as a group, will retain custody of and
have primary rights to the data specific to guidelines evaluation
developed under these awards, subject to government rights of access
consistent with current HHS, PHS, and NIH policies.  Study
development for the secondary analyses of data generated through the
clinical management guideline evaluation shall be undertaken when
two-thirds of the Clinical Science Group members approve the research
concept.

o  Clinical Science awardees, as a group, will convene consensus
panels on the dissemination of clinical management guidelines and the
definition of adolescent-specific HIV policy among other tasks
consistent with functioning as a national resource body.

o Clinical Science Group members will recruit two adolescent/family
member community representatives from each clinical site, at least
one of whom from each site must be an adolescent between 15 to 19
years to serve on the Community Advisory Board

o  Track B Awardees will be required to comply with the reporting
requirements imposed on HRSA funded Title IV/ Pediatric- Adolescent
Demonstration Projects.

2.  Program Staff Involvement

The research effort will be a cooperative venture with participation
by all awardees as outlined above, the NICHD, the NIAID and HRSA.

One NICHD, one NIAID, and one HRSA staff collaborator will:

o  Participate in the Steering Committee that oversees the
establishment and maintenance of the Network and its progress in
achieving program goals.

o  Assist Basic Science Group in the selection of research topics and
the development of protocols for specific studies and interventions.

o  Assist Clinical Science Group in the development and evaluation of
clinical management guidelines.

o  Arrange, when necessary, for the external peer review of the
protocols for the base study, special studies, and clinical
management guideline evaluation, clearing these studies for
implementation.

o  Explore mechanisms to offer study subjects the opportunity to
participate in clinical drug trials funded through mechanisms outside
the network and provide this information and organizational support
to clinical sites.

o  Assist the Executive Committee in monitoring the progress of
ongoing studies, including field data collection, standardization of
methods across study sites, and adherence to protocol and quality
control measures.

o  Assist in data analyses, interpretation and publication of study
results

One NICHD, one NIAID, and one HRSA program manager, in addition to
routine program management duties, will:

o  Assist in identifying the need to terminate or curtail the study
(or an individual award) in the event of nonparticipation in the
committee/group activities, substantial shortfall in participant
recruitment, followup, data reporting, quality control, or other
major breach of protocol, or substantive protocol changes without
prior approval from the staff collaborators and Basic Science Group.

3.  Collaborative Responsibilities:

The Research Network

The Research Network is composed of all principal investigators of
the Basic Science Group, all principal investigators of the Clinical
Science Group, all representatives of the Community Advisory Board,
the principal investigator and project coordinator from the Data and
Operations Center, and the NICHD, the NIAID, and HRSA staff
collaborators and program managers.  The entire Network will attend
interactive annual meetings to inform and review the research agenda.

The Steering Committee

The Steering Committee is the main governing body of the Network. The
Committee is composed of the Chair, Vice Chair, and two elected
representatives from the Basic Science Group; the Chair, Vice Chair,
and two elected representatives from the Clinical Science Group; the
Chair and Vice Chair of the Community Advisory Board; the principal
investigator and project coordinator from the Data and Operations
Center; and the NICHD, NIAID, and HRSA staff collaborators.  All
members will have one vote each; NICHD, NIAID, and HRSA will have one
vote each, and motions will carry with simple majority. The Chair and
Vice Chair of the Steering Committee will be elected by the entire
committee from among the principal investigators of the Basic Science
Group and the Clinical Science Group; none of the NICHD, NIAID, or
HRSA staff collaborators are eligible to serve as Chair or Vice Chair
of the Steering Committee. The Steering Committee will

o  Maintain primary responsibility for the identification of
adolescent HIV/AIDS research issues.

o  Approve the direction of the research effort, and facilitate the
conduct and monitoring of the studies.

o  Approve the research agenda specific to its feasibility and
clinical relevance and advise on the development of implementation
strategies.

o  Approve the clinical management guidelines addressing the unique
biological, biobehavioral, and psychosocial issues of adolescence
including pharmacologic prophylaxis, the scope and frequency of
medical monitoring, and service organization, among others; and the
plans for their evaluation.

The Executive Committee

An Executive Committee, composed of the Steering Committee chair, the
chair and vice-chair of the Basic Science Group, the chair and vice
chair of the Clinical Science Group, the principal investigator and
project coordinator of the Data and Operations Center, and the NICHD,
NIAID, and HRSA staff collaborators will supervise the functioning of
the network and will

o  Establish timelines for the completion of tasks and monitor
progress

o  Coordinate the integration of data collection for base protocol
and guidelines evaluation procedures

o  Oversee site participation and performance informing the
appropriate program managers

o  Define rules regarding access to data and publication and direct
the publication process.

o  The Steering Committee chair will chair the Executive Committee as
well.

4.  Arbitration Process

The specific terms and conditions above and the details of
arbitration procedures below pertaining to the scope and nature of
the interaction among NICHD, NIAID, HRSA, and participating sites
will be incorporated into the notice of grant award.  These
procedures will be in addition to the customary programmatic and
financial negotiations that occur in the administration of grants.
Arbitration procedures will be invoked only when agreement cannot be
reached on programmatic issues that may arise between awardee(s) and
the project coordinator(s) after the award has been made.  In that
event, an arbitration panel will be composed of three members-- one
selected by the executive committee (with the NICHD, NIAID, and HRSA
staff collaborators not voting) or by the individual awardee in the
event of an individual disagreement, a second member selected by the
program officers, and a third member selected by the two prior
selected members.  The decision of the arbitration panel by majority
vote will be binding.  This special arbitration procedure in no way
affects the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with the PHS Regulations at 42 CFR
Part 50, Subpart D and HHS Regulation at 45 CFR Part 16.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

It is NIH policy that applicants for NIH clinical research grants and
cooperative agreements (i.e., research involving human subjects) are
required to include minorities and women in study populations so that
research findings can be of benefit to all persons at risk of the
disease, disorder or condition under study; special emphasis must be
placed on the need for inclusion of minorities and women in studies
of diseases, disorders and conditions which disproportionately affect
them. This policy is intended to apply to males and females of all
ages. If women or minorities are excluded or inadequately represented
in clinical research, particularly in proposed population-based
studies, a clear and compelling rationale must be provided.

The composition of the proposed study population at the clinical site
must be described in terms of gender and racial/ethnic group. This
information must be included in the form PHS 398 in Sections 1-4 of
the Research Plan and summarized in Section 5, Human Subjects.
Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans [including American Indians or Alaskan Natives],
Asian/Pacific Islanders, Blacks, Hispanics). It is envisioned that
the cohort of adolescent study subjects assembled under the auspices
of this cooperative agreement  will exhibit appropriate and adequate
ethnic, racial, and geographic representation of the affected
population although individual sites may not each present the
necessary balance.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and prevention strategies), diagnosis, or treatment of
diseases, disorders or conditions, including, but not limited to,
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by the applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question addressed and the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and reflected in assigning
the priority score to the application.

All applications for clinical research submitted to the NIH are
required to address these policies.  NIH funding components will not
award grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by March 30, 1994, a
letter of intent that includes a descriptive title of the proposed
research, the name, address and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of
applications. It allows ICD staff to estimate potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Audrey Smith Rogers, Ph.D., M.P.H.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 4B11
Rockville, MD  20852
Telephone:  (301) 496-7339

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398 (rev. 9/91).  This
application form is available in the office of sponsored research at
most academic and research institutions and from the Office of Grants
Information, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda MD 20892, telephone
(301) 710-0267 and from the NIH program administrator listed under
INQUIRIES.

Additional Materials to Include in the Application

To permit evaluation of the merits of an application (peer review),
information is needed on the following topics.

Applicants to the Basic Science Group:

While the objectives of the Network specifically relate to unresolved
basic and clinical scientific questions about adolescent HIV/AIDS,
the unique behavioral features of this age group must be recognized.
Consequently, multidisciplinary representation will be sought in the
membership of the Basic Science Group while its basic and clinical
science focus is maintained.

Applications to become members of the Basic Science Group must
include:  (1) documentation of clinical experience in adolescent
health care or professional interest in adolescent issues; (2) record
of published scientific research with relevance to adolescent
medical, biological, biobehavioral, and/or behavioral issues; and (3)
submission of an original research module written to demonstrate
personal expertise in a specific area of interest consistent with the
overall research objectives of this RFA.

This research module will be used to judge the scientific and
technical proficiency of the applicant. It is not required to be a
fully-developed protocol and therefore should not include sections on
study implementation, study timelines, or budgetary considerations.
The research module must include a carefully defined statement of the
problem consistent with the overall research objectives of this RFA,
a comprehensive review of relevant literature, a detailed study
strategy including design issues and proposed analyses, and a
discussion of problems to be encountered in implementing the study
which take in account particular issues facing adolescents.

This module may address any research question consistent with the
scope of this RFA.  The research module may focus on the design of
the base protocol examining the spectrum of HIV disease to be
implemented in the first year of the study or on other areas
requiring special studies to be undertaken in the assembled cohort
enrolled in the base protocol in subsequent years.  These include,
but are not limited to:  HIV interaction with adolescent pregnancy;
co-morbidity with STDs; the susceptibility, infectivity and
transmissibility of HIV in adolescents, particularly related to
developing genital mucosa; the characterization of the variation in
adolescent immune function; the identification of useful
adolescent-specific clinical markers of HIV disease progression; the
effect of HIV on adolescent neuropsychologic function and
development; and the influence and effect of specific adolescent
behavioral patterns on risk-taking and health-seeking activities.
THIS LIST OF POTENTIAL SUBJECT AREAS IS NOT INCLUSIVE; RESEARCH
MODULES IN RELEVANT AREAS CONSISTENT WITH THE FOCUS OF THIS RFA ARE
VERY STRONGLY ENCOURAGED.  If the applicant is successful, the
proposed research module may or may not be chosen subsequently by the
constituted Basic Science Group to be incorporated into the
scientific agenda undertaken by the Adolescent Medicine HIV/AIDS
Research Network. The proposed module should, nonetheless, be
designed for implementation in the projected Network study population
(see below), and be consistent with the research objectives of the
RFA.  This part of the application should not exceed the 25 page
limit (including graphics) for the entire submission.  In the event
that the applicant is not chosen to participate in the Basic Science
Group of the Research Network or, if chosen, learns that the
applicant's submission will not be incorporated into the scientific
agenda nor implemented in the network, the applicant retains all
rights to the material and is free to pursue the funding and conduct
of such a study through other mechanisms.  The budget for Basic
Science Group members should include salary support at 0.10 FTE, flat
fee for office support services, and travel to three meetings (two
days each) in the Washington DC area for year one only; for two
meetings in Washington DC per year thereafter.

Applicants for the Basic Science Group: Immunology and Virology
Laboratory

Two positions on the Basic Science Group are restricted for
applicants who can provide currently established ACTG-certified
immunology or virology laboratory support to Network research
efforts.  Applicants for these two reserved positions will be
required to submit only a research proposal as outlined above in (3)
using and completing the PHS 398 application kit. The budget for the
immunology laboratory should include funding for the ACTG- defined
lymphocyte panel for the entire study population for two visits in
Phase II Year 1 and every six months thereafter as well as salary
support for the Basic Science Group member at 0.10 FTE, flat fee for
office support services, and travel to three meetings (two days each)
in the Washington DC area for year one only; for two meetings in
Washington DC per year thereafter.  The budget for the virology
laboratory in the first year of the grant should include funding for
the storage of samples for the entire study population at baseline
and every six months thereafter as well as salary support for the
Basic Science Group member at 0.10 FTE, flat fee for office support
services, and travel to three meetings (two days each) in the
Washington DC area for year one only; for two meetings in Washington
DC per year thereafter.

Applicants for the Clinical Science Group

Since the objectives of the Network specifically relate to unresolved
basic and clinical scientific questions about adolescent HIV/AIDS,
the proposed network must consist of established clinical sites
delivering appropriate health care and support services to
substantial adolescent populations. This RFA should not be construed
as a funding opportunity to establish an adolescent health care
delivery service. Furthermore, since adolescent participation in
research should be an opportunity presented to those for whom health
care is available and never as a means of health care or a substitute
for it, clinical sites in the network must have developed strategies
and mechanisms for providing for the health care and support needs of
their adolescent populations (Track A) or submit a well-developed and
operationally-supported plan to augment comprehensive health care and
support services requiring funding for its implementation (Track B).
HRSA funds for Track B will be available to a limited number of
established sites to augment existing services so that clinical
research may be conducted in a population of individuals receiving
adequate comprehensive health care.

Applications to participate in the Clinical Science Group should
include information in three areas: staff, site, and patient
population/geographic location.  The description of these facilities
and equipment should be provided on the Resources and Environment
page of the PHS 398 application kit.

All applicants must submit the following:

(1) Documentation of three or more years clinical experience in
adolescent health care for the physician Clinical Science Group
member applicant and the research nurse or associate (if identified
at the time of submission) to be supported by this grant.

(2) A description of the site(s) (physical structure and
administrative arrangement) in which health care and support services
are provided or arranged for, including hours of operation, provision
for off-hour coverage, and established patterns of referral.

(3) The source of funding for the delivery of health care and support
services to adolescents served by the clinic should be delineated,
particularly the proportion of services rendered for which third
party reimbursement is received.

(4) Evidence of an interdisciplinary approach to the delivery of
adolescent health care and support services is expected and the
breadth of available services and qualifications of the corresponding
providers should be listed and described.

(5) Description of the adolescent population categorized by ages
10-14 years, 15-19 years, and 20-24 years served by the clinic as
such: (a) adolescents in the catchment area of the clinic; (b)
adolescents seen within the last year by the clinic; and (c)
adolescents who regularly attend the clinic (each succeeding group
should be a subset of the former). This information will be used in
determining future expansions of the network.

(6) Descriptors of these defined groups should include (if available)
gender, race/ethnicity, socioeconomic strata, educational
achievement, blinded serosurveys of HIV infection, AIDS case numbers
(cumulative and annual), STD and pregnancy rates, substance abuse
statistics, and other evidence of high risk behaviors. If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
and compelling rationale must be provided.

(7) Evidence of ability to enroll 20 HIV-infected adolescents and 10
HIV-negative but high risk adolescents between the ages of 15 and 19
years in the six month period of Phase II.

(8) Documentation concerning adherence to clinic appointments and
referrals or other measures should be included as evidence of the
population's capacity and willingness to participate in clinical
research.

(9) The interaction between the clinic and the community it serves
should be described.  Of specific interest are community advisory or
consultative groups that have substantial adolescent participation,
efforts at parental or community education, the clinic policies for
adolescent involvement in their own care and, where relevant, for
parental involvement in adolescent care, and details of community
existing or planned outreach and prevention programs to identify
adolescents and bring them to care.

(10) Budgets for the Clinical Science Group sites should include
physician principal investigator salary support at 0.10 FTE, clinical
associate/research nurse at 1.0 FTE for Phase II only, and two
clinical visits for study subjects (examination and minimal
laboratory) for the base study during Phase II.  Travel for the
principal investigator to three meetings (two days each) in the
Washington DC area should be included.  This includes one management
policy/meeting.  In addition, budgets should include travel costs for
two adolescent/family representatives from each clinical site to the
annual Steering Committee meeting.  Track B sites should include a
clearly-marked and separate budget sheet for augmented services in
support of clinical research.

Track A Applicants must submit the following:

(1) Demonstration of availability of on-site gynecologic services and
case management, on-site or established and functioning referral
networks for mental health services, substance abuse treatment, and
enabling services such as childcare and transportation.

(2) Evidence of collaboration with other institutions, agencies, or
community-based organizations for outreach, case identification, and
access to clinical drug trials should be detailed. Every
collaborative initiative cited should be accompanied by a letter of
commitment specific to the activity of this RFA.

Track B Applicants must submit the following:

(1) Submission of a plan to provide any of the following services in
support of clinical research: on-site gynecologic services and case
management, to articulate with other institutions, agencies, or
community-based organizations for outreach, case identification,
mental health and substance abuse services, and access to clinical
drug trials.  The plan should be detailed and every collaborative
initiative cited should be accompanied by a letter of commitment
specific to the activity of this RFA.

(2) Documentation of the availability or evidence of collaboration
with other institutions, agencies, or community-based organizations
to provide services not addressed in plan required in (1).

Applicants for the Data Center should include the following
information:

(1) Expertise in the design of surveys, case control studies, cohort
studies, and interventions.  Applicants should provide a description
of their experience designing these different types of projects with
special emphasis on the required statistical expertise, as well as
examples of past or current projects requiring this expertise.  They
should also identify individuals with this expertise on staff or
available as consultants and provide their biographical sketches in
PHS 398 application kit.

(2) Documentation of understanding of the basic elements required for
a data coordinating center.  This should include an understanding of
computer logistics, programming, coding, data processing, file
building, and file maintenance.

(3) Ability to finalize research protocols and questionnaires and to
monitor quality control.  This should include prior or current
experience relative to the development of protocols, questionnaires,
other research instruments, and interacting with multi-disciplinary
teams.  An indication of procedures used for training staff in the
use of these protocols and questionnaires and quality control of data
collection across several sites would be most useful.

(4) Documentation that the personnel proposed for involvement in data
management and data processing aspects of the project have experience
in the management of large datasets, designing appropriate systems,
computer programming, data coding, data entry, data editing, quality
control, file building, file manipulation, and data analysis should
be provided.

(5) Description of facilities and equipment available, including
computer hardware and software that are intended for use by this
project, should be provided.

(6) Documentation of understanding of the basic elements required for
maintaining an operations center.  This should include an
understanding of establishing and maintaining the communications link
for the Network and supporting the activities of research planning,
protocol design, and development through team conference calls and
information dissemination.

(7) Description of resources available to support the development and
effective national dissemination of treatment and policy guidelines
specific to HIV positive adolescents.

(8) The budget for the Data and Operations Center should include 0.5
FTE salary support for a principal investigator, service costs for
data entry, management, and analysis; 0.25 FTE salary support for a
project coordinator, 1.0 FTE salary support for research nurse/site
monitor, site visit travel, conference calls, meetings, and resources
for protocol development and committee/board support.  The Center
will also assume costs of Clinical Science Group treatment and policy
guidelines development and dissemination.

The RFA label available in the PHS 398 application form must be
affixed to the bottom of the face page.  Failure to use this label
could result in delayed processing of the application such that it
may not reach the review committee in time for evaluation.  In
addition, the RFA title and number ("Adolescent Medicine HIV/AIDS
Research Network, HD-94-012") must be typed on line 2A of the face
page of the application form and the "YES" box must be marked.  In
addition to RFA title and number, applicants must further designate
on the face sheet that the application is submitted for (1) Basic
Science Group; (2) Basic Science Group- Immunology Lab; (3) Basic
Science Group- Virology Lab; (4) Clinical Science Group- Track A; (5)
Clinical Science Group -Track B; or (6) Data Center.

The signed, typewritten original of the application including the
Checklist and three signed photocopies must be sent or delivered in
one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

In addition, two copies of the application must be sent, under
separate cover to:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E01
Bethesda MD  20892

Applications must be received by close of business May 13, 1994.  If
an application is received after that date, it will be returned to
the applicant without review.  The Division of Research Grants (DRG)
will not accept any application in response to this announcement that
is essentially the same as one currently pending initial review,
unless the applicant withdraws the pending application.  The DRG will
not accept any application that is essentially the same as one
already reviewed.  This does not preclude the submission of a
substantial revision of an application already reviewed, but such an
application must follow the guidance in the form PHS 398 application
instructions for the preparation of revised applications, including
an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Pre-Review Assessment

Upon receipt, applications will be examined by the Division of
Research Grants for completeness.  The NICHD will assess the
applications for responsiveness.  Incomplete applications will be
returned to the applicant without further consideration.
Applications not responsive to the RFA will also be returned.
Applications to the Clinical Science Group will be assessed for
responsiveness by NICHD and HRSA program staff to determine their
suitability for consideration in Track A or Track B relative to other
applications received in response to this RFA.  Applicants to the
Clinical Science Group, therefore, may be notified of their ability
to compete in a Track other than the Track for which they originally
sought funding.

Review Considerations

Complete and responsive applications will be evaluated in accordance
with the criteria stated below for scientific/technical merit by a
review group specifically convened by NICHD in consultation with
NIAID and HRSA for this purpose.  Further, applications to the Basic
Science Group may be subjected to triage by an NICHD/NIAID peer
review group to determine their scientific merit relative to other
applications received in response to this RFA. The review criteria to
be used are listed below. The NIH will withdraw from further
competition those applications judged by triage to be noncompetitive
for the award and notify the applicant PI and institutional official.
Those applications, both to the Basic Science and the Clinical
Science Groups, judged to be competitive will undergo further
scientific merit review. The second level of review will be provided
by the advisory councils of the participating awarding components.

Review Criteria:

o  Scientific, technical, or medical significance and originality of
the proposed research;
o  Appropriateness and adequacy of the experimental approach and
methodology to carry out the research;
o  Qualifications and experience of the principal investigator and
staff, particularly, but not exclusively, in the area of the proposed
research;
o  Availability of the resources necessary to perform the research;
o  Appropriateness of the proposed budget and duration in relation to
the proposed research;
o  Appropriateness of plans for the inclusion of women and minorities
as subjects;
o  Appropriateness of methods and demonstrated willingness to work as
a part of the cooperative study with the NICHD, NIAID, and HRSA
scientists.

In addition to these general criteria, additional review criteria
will be used in evaluating several of the components as follows:

Basic Science Group (Including Immunology and Virology Laboratories)

o  The degree to which the propose research promises to advance
knowledge of adolescent HIV/AIDS and is concordant with current
knowledge about this age group and disease.

Clinical Science Group

o  Clinical training and experience specific to adolescent care
o  Evidence of interdisciplinary approach
o  Adequacy of site characteristics as detailed in the RFA

Data and Operations Center

o  Expertise and experience in design and statistical analysis
appropriate to this effort
o  Demonstrated ability or potential to serve as a center for
multidisciplinary, multisite collaborative studies

AWARD CRITERIA

Applications recommended by the relevant National Advisory Councils
will be considered for award based upon (a) scientific and technical
merit as reflected in the priority score; (b) program balance
including sufficient compatibility of features to make a successful
collaborative program likely; (c) availability of funds; (d)
geographic location of clinical sites; and (d) demographic and
clinical characteristics of the population at the clinical site.

Letter of Intent Receipt Date:     March 30, 1994
Application Receipt Date:          May 13, 1994
Review by NICHD Advisory Council:  September 27, 1994
Anticipated Award Date:            September 30, 1994

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Two pre-submission conferences providing the same information will be
held:

March 9, 1994 from 11:00 AM-12:30 PM
6100 Building 5th Floor Conference Room
6100 Executive Boulevard
Rockville, MD  20852

March 17, 1994 from 6:30-8:00 PM
Century Plaza Hotel and Towers - Redwood Room
2025 Avenue of the Stars
Los Angeles, CA  90067-4696

Direct inquiries regarding programmatic issues to:

Audrey Smith Rogers, Ph.D., M.P.H.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 4B11
Rockville, MD  20852
Telephone:  (301) 496-7339

Tina Johnson, M.A.
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 2A09
Rockville, MD  20852
Telephone:  (301) 496-8214

Direct inquiries regarding administrative/fiscal matters to:

Mr. E. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 8A17F
Rockville, MD  20852
Telephone:  (301) 496-1303

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.856.  Awards are made under the authorization of
the Public Health Service Act, Title IV, Part A (Public Law 78-410,
as amended by Public Law 99-158, 42 USC 241 and 285)  and
administered under PHS grants policies and Federal Regulations 42 CFR
52 and 45 CFR Part 74 and 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

.

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