Full Text AI-94-026

STRATEGIC PROGRAM FOR INNOVATIVE RESEARCH ON AIDS TREATMENT

NIH GUIDE, Volume 23, Number 25, July 1, 1994

RFA:  AI-94-026

P.T. 34

Keywords: 
  AIDS 
  0765014 
  Immunotherapy 
  Viral Studies (Virology) 


National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  September 20, 1994
Application Receipt Date:  December 8, 1994

PURPOSE

The Division of AIDS (DAIDS), National Institute of Allergy and
Infectious Diseases (NIAID), invites applications for participation
in the Strategic Program for Innovative Research on AIDS Treatment
(SPIRAT).  The objective of this Request for Applications (RFA) is to
support innovative, integrated preclinical and clinical research to
validate clinical therapeutic concepts for the treatment of HIV-1
infection.  Applications in response to this RFA can emphasize
research activities involving viral gene(s) or cellular factors
required for HIV expression, novel immunotherapeutic approaches, or
other approaches with the potential for effective therapy and disease
modulation.  Studies supported by this RFA may have greater
conceptual risk than currently exercised for treating HIV-infected
individuals, but are also expected to have greater potential for
effective, long-term therapeutic returns.  The SPIRAT program thus
complements existing, more conservative preclinical and clinical
programs for the treatment of HIV infection managed by the Division
of AIDS/NIAID [National Cooperative Drug Discovery Groups for the
Treatment of HIV Infection (NCDDG-HIV), AIDS Clinical Trial Groups
(ACTG), DAIDS Treatment Research Initiative (DATRI), Community
Program for Clinical Research on AIDS (CPCRA)].  Studies of therapies
based on anti-HIV drugs or on opportunistic pathogens associated with
AIDS are supported by other NIAID programs and are excluded from this
RFA.

Each SPIRAT will form an interdependent collaborative enterprise
between preclinical and clinical scientists in the conceptualization
and proof-of-concept of an identified therapeutic strategy.  This
will entail tightly coupled iterative research and data exchange
between preclinical and clinical studies in order to maximally refine
and improve the therapeutic concept.  The Group must, therefore,
possess the expertise necessary to (1) evaluate the proposed strategy
in preclinical systems, and (2) conduct pilot clinical study(ies) in
HIV-infected individuals (and uninfected volunteers, as appropriate)
using the proposed therapeutic approach.  Information derived from
pilot clinical studies will feed into preclinical studies to further
refine/revise the therapeutic approach.  A SPIRAT must be dedicated
to the expedited transition of advanced preclinical findings to
applied clinical setting in HIV-infected individuals.  Applications
not proposing pilot clinical study(ies) will not be considered
responsive and will be returned to the applicant without further
review.  A SPIRAT is encouraged to include investigators from
academic, non-profit, and commercial (pharmaceutical, chemical, or
biotechnological companies) organizations.

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 RFA,
Strategic Program for Innovative Research on AIDS Treatment (SPIRAT),
is related to the priority area of 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, private and public, such as universities, colleges,
hospitals, laboratories, units of State or local governments, and
eligible agencies of the Federal government.  Applications from
minority individuals and women are encouraged.  Applications from
foreign institutions will be considered.  Prospective foreign
applicants should contact Dr. Nava Sarver at the address under
INQUIRIES for additional details.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to undertake this
program will be the Cooperative Agreement (U19), an "assistance"
mechanism, rather than an "acquisition" mechanism, in which
substantial NIH scientific and/or programmatic involvement with the
awardee is anticipated during the performance of the activity.
Essential elements of the U19 mechanism include:  (1) a minimum of
three interrelated research projects organized around a central theme
for the duration of the proposed study; (2) collaborative efforts and
interaction among independent projects and their investigators to
achieve a common goal; (3) one Principal Investigator who will be
scientifically and financially responsible for the use and
disposition of funds awarded; and (4) support provided, as necessary,
for "Core" resources or facilities, each of which is expected to be
utilized by at least two research projects in order to facilitate the
overall research activities of the Group's effort.  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.  Details of the responsibilities, relationships, and
governance of a study funded under cooperative agreement(s) 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 four years.  The anticipated award
date is August, 1995.  At this time, the NIAID has not determined
whether or how this solicitation will be continued beyond the present
RFA.

FUNDS AVAILABLE

The estimated total funds (direct and indirect costs) available for
the first year of support for awards under this RFA reissuance will
be $2.5 millon; estimated total project costs (direct and indirect)
over the four-year period will be $10.6 millon.  In Fiscal Year 1995,
two to three new awards are anticipated for project periods up to
four years.

Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the size of individual
awards will vary also.  Awards are subject to a first year limit of
$1.3 millon in total costs (direct plus indirect costs).  Budget
requests should be carefully justified and commensurate with the
complexity of the project.  Applications in excess of $1.3 million
first year total cost will be returned without review.  Although this
program is provided for in the financial plans of the NIAID, awards
pursuant to this RFA are contingent upon the availability of funds
for this purpose.

The usual PHS policies governing grant administration and management
will apply.  This level of support is dependent on the receipt of a
sufficient number of applications of high scientific merit.  Funding
beyond the first and subsequent years of the grant will be contingent
upon satisfactory progress during the preceding years and
availability of funds.  In addition, recommended support beyond the
second year of each SPIRAT is subject to determination by an external
ad hoc review committee, convened by the NIAID, that stated goals
(milestones) have been sufficiently met.  The committee will
evaluate:  (1) accomplishment in executing the proposed studies as
outlined in the research proposal; (2) preclinical achievements
including quality and substance of findings; transition of such
studies to clinical research; and (3) initiation of a clinical pilot
study.  The committee's recommendation resulting from the second year
review will be used by NIAID staff to determine which groups will
continue to be funded beyond two years for the full term of the
award.  It is noted that the NIAID's ad hoc committee is distinct
from the Group's Scientific Advisory Panel (see DEFINITIONS).

RESEARCH OBJECTIVES

1.  Background

The NIAID and the PHS are currently supporting comprehensive
extramural and intramural projects for the study of the etiology,
natural history, and demographics of AIDS; determining means of
diminishing the risk of infection; screening of high risk
individuals; developing prophylactic vaccines; developing therapies
that may be useful chemopreventive or prophylactic agents; and
developing therapies to treat those with all stages of HIV disease.
Notwithstanding these efforts, effective, long-term therapies are
lacking, and the number of HIV-infected individuals and AIDS cases is
increasing.  As of December 31, 1993, 361,509 cases of AIDS had been
reported in the U.S. by the Centers for Disease Control (CDC) and
more than 220,871 of these patients (60 percent) had died.  Recent
estimates indicate that 1,000,000 to 1,200,000 individuals in the
U.S. are infected with HIV.  The World Health Organization projection
of worldwide HIV infection is placed at 30 to 40 million individuals
by the year 2000.

While significant advances in the biology and pathogenesis of HIV
disease have been made, the disease, which is associated with severe
immune dysfunction, remains intransigent.  Currently FDA-approved
therapies for HIV infection are associated with toxic side effects
and emergence of HIV drug-resistant variants that preclude long term
use.  Moreover, no treatment has been identified to eradicate or curb
HIV infection for extended time, and the disease is presently
considered fatal.  Given the emergence of reverse transcriptase and
protease drug-resistant variants, it is expected that resistance to
inhibitors directed against other viral targets will occur.  The
search for more effective and innovative therapies that may be less
susceptible to the emergence of resistant HIV variants, is one of the
highest priorities of the NIAID.

In recent years, the base of scientific information on HIV has
expanded and the number of technological breakthroughs has increased
significantly; however, the translation of that knowledge to clinical
and preventive activities has not been commensurate with this
expansion.  There is a need to apply these research advances to
clinical research studies, an effort that requires tightly coupled
research activities between preclinical and clinical investigators in
the planning and implementation of studies whose ultimate goal is an
effective clinical therapy for HIV-positive individuals.  Significant
scientific and clinical expertise exists throughout the country.  A
concerted effort to mobilize this expertise through SPIRAT can
accelerate advances in the management, and ultimately the effective
treatment, of the disease.

The SPIRAT program, launched in 1993, is specifically designed to
support refinement and proof-of-concept of innovative molecular
intervention and immunotherapy strategies for the treatment of HIV
infection.  The SPIRAT program complements and balances present
efforts pursued under existing NIAID programs, including the AIDS
Clinical Trial Groups (ACTG), the Division of AIDS Treatment Research
Initiative (DATRI), the National Cooperative Drug Discovery Groups
for the Treatment of HIV Infection (NCDDG-HIV).  Specifically
excluded from this RFA are studies on anti-viral drugs, therapies
involving the use of monoclonal antibodies, and opportunistic
infections associated with AIDS.  These efforts are supported by
other NIAID programs.

2.  Research Objectives and Scope

The principal goals of this RFA are to (1) tightly couple innovative
preclinical research with clinical proof-of concept; and (2)
implement pilot clinical studies of a therapeutic strategy in
HIV-infected individuals.  In line with this objective, applicants
for SPIRAT funding will already have an identified strategy that is
based on creative and solid scientific rationale, and for which
advanced preclinical data exist.  Efforts are to be implemented
through concerted and interdependent activities by components
constituting the group.  Each SPIRAT group will have a well-defined
central research focus consistent with the research objectives of the
Program as stated in the RFA.  A SPIRAT application can focus its
preclinical and clinical research activities on strategies directed
against a viral gene or cellular component(s) required for HIV
expression, pathogenic mechanisms of disease, novel cell-based
immunotherapeutic approaches, or other pioneering approaches.
(Studies involving traditional anti-HIV drugs or opportunistic
pathogens associated with AIDS are not supported by this RFA.)  The
following approaches are provided as examples and are not intended to
be inclusive or restrictive:

o  Strategies that target HIV gene expression via interference with
HIV cis-acting elements, viral regulatory elements, viral structural
components, or cellular factors required for HIV expression;
strategies that interrupt steps in HIV/cell interaction (entry,
subcellular transport, assembly/release); novel approaches unlikely
to be compromised by emergence of escape or resistant HIV variants;

o  Strategies that integrate current understanding of HIV accessory
proteins into a targeted therapeutic approach;

o  Intracellular delivery of genetic antagonists to curb pivotal
events in HIV life cycle (protein-based suppressors, molecular
competitors, RNA decoys, ribozymes) using ex vivo and in vivo
delivery strategies;

o  Immune system reconstitution, including infusion of genetically
modified lymphocytes, hematopoietic stem cells, xenogeneic
transplantation (e.g., bone marrow, thymic);

o  Strategies that target non-T cells (e.g., dendritic cells,
follicular dendritic cells, monocyte/macrophage, epithelial) believed
to play an essential role in cell-free virus transport, trapping,
cell-cell transmission, and general dissemination of HIV in the body;

o  Genetic immunization to augment immune response(s) via
intracellular expression of HIV immunogen(s);

o  Cell or tissue based approaches designed to modulate or curtail
the pathogenic course of infection;

o  Strategies that target the central nervous system and have the
potential to prevent or reverse AIDS-related neurologic dysfunction
and dementia

o  Innovative therapeutic strategies that specifically address
pediatric HIV disease and pathogenesis.

3.  Study components

Studies will involve advanced preclinical refinements of the proposed
strategy, evaluation and demonstration of therapeutic or immune
benefit in laboratory animals, as appropriate, and implementation of
pilot clinical studies in HIV-infected individuals.

(1) Animal studies:  Projects or cores with proposed animal models
must be integrated with and required to attain the Group's
objectives.  Funds awarded for animal models will not be made
available until the therapeutic strategy is ready for animal efficacy
studies.  Due to budgetary limitations, primate animal models should
not be requested in the original application unless they constitute a
necessary, integral component of the proposal.  Requests for
assistance in evaluation studies in primate animals may also be
directed to the NIAID for consideration in conducting such studies in
its primate model resources.  The availability of these models will
depend on the nature of the therapeutic approach.  In all other
cases, should the need for such models become evident during the
course of studies under this cooperative agreement, the Principal
Investigator may submit a competitive supplement request for the
support of primate animal models.  Funding of competitive supplements
will be from set-aside funds allocated to future RFAs for this
initiative, and is not guaranteed.  Consideration for funding will
also depend on the competitive merit and justification of the
competitive supplement relative to all other competing applications
submitted in response to the RFA.

(2) IND-related studies:  Studies required for the IND-targeted
preclinical development (formulation, toxicology) of proposed
treatments are generally beyond the scope of this RFA, but such
development through private venture capital is encouraged.
Alternatively, a Group may request that the NIH assist in these
developmental tasks using existing NIH/NIAID contract resources (see
below).

(3)  Clinical studies:  Pilot clinical studies must commence within
two years of funding.  Funds awarded for the clinical components of
the SPIRAT application will not be available until the therapeutic
strategy is ready to enter clinical phase.  Only pilot clinical
studies with limited number of patients (6 to 12) will be supported
under this program.  The NIAID has several programs for clinical
evaluation of therapies for HIV/AIDS.  These include the AIDS
Clinical Treatment Units (ACTUs) for large phase I, Phase II, and
Phase III clinical studies, and DATRI.  It is envisioned that
extended clinical studies of treatments developed by a SPIRAT group
can be accommodated under the clinical trial mechanisms available
through Division of AIDS.  Queries about these programs should be
directed to Dr. Nava Sarver, NIAID, address listed under INQUIRIES.

SPECIAL REQUIREMENTS

A.  Minimum Requirements for SPIRAT Application

Applicants for SPIRAT funding must have an identified therapeutic
strategy that is proposed for pilot clinical evaluation, and for
which advanced preclinical data already exist.  The proposed strategy
must be sufficiently advanced to permit initiation of pilot clinical
studies within two years of funding.  The proposed strategy must,
therefore, identify provisions for tightly coupled and continuous
flow of data between its preclinical and clinical components.  All
applications must consist of at least three interrelated and
interdependent projects focusing on a unifying central theme
conducted by at least three independent laboratories.  For the
purpose of encouraging new collaborations under this RFA, two (or
more) projects within a single company will not be considered
independent.  Similarly, two (or more) projects within the same
academic department will not be considered independent.  This
limitation on the number of independent projects from the same
academic or private sector organization is intended to increase the
diversity and multi-disciplinary expertise available to the Group
from other than the parent institution or organization.  A minimum 20
percent (time) effort by the Principal Investigator and each Project
Leader should be devoted  to the study.  Applications with less than
20 percent efforts for the Principal Investigator and each Project
Leader, and that do not offer compelling arguments for failing to
comply with the 20 percent requirement, will be considered
non-responsive and will be returned to the applicant without review.

B.  Definitions

ADMINISTRATIVE CORE:  An administrative facility that provides
central operations and support for the overall management of the
cooperative agreement and services shared by the Group as a whole.
The Administrative Core should have a budget separate from that of
the Principal Investigator's research project, but should be
administered by the Principal Investigator's organization.  The
Administrative Core will have in its budget for each year travel
costs for (1) two required meetings of individual members of the
Group; (2) one meeting of representative of all Groups in the SPIRAT
program; and (3) travel expenses for the Scientific Advisory Panel
(see below).  The Administrative Core will be responsible for
allocating required travel expenses to appropriate members of the
Group.  Only SPIRAT-related travel will be supported under this RFA;
travel funds to other domestic or foreign meetings is not provided
under this RFA.  (For additional details of required travel see
SPECIAL REQUIREMENTS - TERMS AND CONDITIONS OF AWARD:  C. Awardee's
Rights and Responsibilities.)

ARBITRATION PANEL:  An NIAID-convened ad hoc panel that is formed to
review scientific or programmatic activity that is impeding progress
within a Group.  It will be composed of a "Group" designee, one NIAID
designee, and a third designee with expertise in the relevant area
and chosen by the other two.  The Arbitration Panel may help resolve
both scientific and programmatic issues that develop during the
course of work that restrict progress.

COOPERATIVE AGREEMENT:  An assistance mechanism in which substantial
NIAID programmatic involvement is anticipated with the recipient
organization during the performance of the planned activity.

CORE LEADER:  The leader of one of the Scientific or Administrative
Cores of the SPIRAT.

INVENTION:  An innovative therapeutic approach that is or may be
patentable under Title 35 of the United States Code.

NIAID SPIRAT PROGRAM DIRECTOR:  A Senior Scientist of the NIAID
extramural staff who coordinates NIAID's participation in the SPIRAT
program, oversees the entire SPIRAT program, maintains the overall
scientific balance in the SPIRAT program commensurate with new
research and therapeutic findings and emerging research
opportunities, and who ensures that the SPIRAT program is consistent
with the Division of AIDS and NIAID missions and goals.

NIAID SCIENTIFIC COORDINATORS:  Scientists of the extramural staff of
the Division of AIDS, NIAID, who function as peers with the Principal
Investigators and Project Leaders and who facilitate the partnership
relationship between NIAID and each Group.  Two Scientific
Coordinators from the Division of AIDS - one from the Basic Research
and Development Program, and one from the Clinical Research Program -
will be assigned to each Group by the SPIRAT program director.  The
Scientific Coordinators are the immediate contact persons to the
Group.

PRINCIPAL INVESTIGATOR:  The person who assembles the SPIRAT, is
responsible for the performance of the Group as a whole and for that
of each of the Project Leaders, and who is responsible for submitting
the single application in response to this RFA.  The Principal
Investigator will coordinate Group activities scientifically and
administratively and should preferably be project leader of one of
the Research Projects of the Group.  The awardee (Principal
Investigator's) institution establishes and operates the Central
Operations Office that funds Group members and is legally and
fiscally accountable for the disposition of funds awarded.

PROJECT LEADER:  The leader of one of the scientific research
projects of the SPIRAT, who is responsible for the scientific conduct
of that project.

RESEARCH PROJECT:  A discrete, specified, circumscribed project that
must relate to the overall theme of the SPIRAT.

SCIENTIFIC ADVISORY PANEL:  A panel, comprised of two to three peers
from the scientific community, whose mission is to provide the
Principal Investigator with a comprehensive review of the Group's
activities and progress, consult on future goals and strategies, and
recommend alternative directions, as appropriate.  Selection and
appointment of the Panel is the responsibility of the Principal
Investigator.

SCIENTIFIC CORE COMPONENT:  Laboratory facilities for equipment and
services which are shared by two or more projects of the SPIRAT.
Examples of core components are:  biochemical, cell-based,
virological, and immunological studies; animal model studies;
pharmacology/toxicology studies; scale-up synthesis of the
therapeutic agent.  The core can be defined as a facility laboratory
with established techniques and assays which performs a service
function resulting in an economy of effort and savings in the overall
costs of the Group.  A CORE component cannot be considered toward
fulfilling the three research projects requirement.  The core unit is
to be described with the same detail as the research projects to
enable evaluation of its scientific merit.  (See details for
preparation of the budgets under "PREPARATION AND ORGANIZATION OF THE
APPLICATION).

STRATEGIC PROGRAM FOR INNOVATIVE RESEARCH ON AIDS TREATMENT (SPIRAT):
In this RFA the terms STRATEGIC PROGRAM FOR INNOVATIVE RESEARCH ON
AIDS TREATMENT (SPIRAT) and "Group" are synonymous.  Each Group may
consist of a number of scientific investigators from academic and/or
non-profit research institutions as well as scientists from
commercial organizations, performing research on interdependent
projects whose central focus is development of effective clinical
therapy for HIV-infected individuals.  A CORE component cannot be
used toward fulfillment of the three research projects requirement.

C.  Patent Coverage

Because the implementation of innovative, effective clinical
therapies for HIV/AIDS is the goal of this effort, and active
involvement by private sector laboratories is facilitated by the
existence of adequate patent coverage, it is essential that
applicants provide plans to assure such coverage.  Since several
institutions may be involved, complex patent situations may arise.
Each applicant Group must, therefore, provide a detailed description
of the approach to be used for obtaining patent coverage and for
licensing where appropriate, in particular where the invention may
involve investigators from more than one institution.  In addition
each Group must provide a detailed description of the procedures to
be followed for the resolution of legal problems that potentially may
develop.  Attention is drawn to the reporting requirements of 35
U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11.
Instructions were also published in the NIH GUIDE FOR GRANTS AND
CONTRACTS, Vol. 19, No. 23, June 22, 1990.  Note that non-profit
organizations (including universities) and small business firms
retain the rights to any patent resulting from Government contracts,
grants or Cooperative Agreements.

It is also noted that a Presidential memorandum of February 18, 1983
extended to all business concerns, regardless of size, the first
option to the ownership of rights to inventions as provided in P.L.
96-517.  As a result of this memorandum, the relationships among
industrial organizations and other participants are simplified, since
all Group members can now be full partners in the research and in any
inventions resulting therefrom.  The specific patenting arrangements
among the institutions may vary, and could include joint patent
ownership, exclusive licensing arrangements, etc.  Applicants are
encouraged to develop an arrangement that is most suitable for their
own particular circumstances.

The proposed patent plan among the institutions comprising the Group
must be submitted with the application.  This patent agreement,
signed and dated by the organizational officials authorized to enter
into patent arrangements for each Group member and member
institution, must be delivered two weeks prior to submission of the
application to Dr. Nava Sarver, Targeted Drug Discovery Section,
Developmental Therapeutics Branch, Division of AIDS, NIAID, Solar
Building Room 2C-11, 6003 Executive Boulevard, Bethesda, MD 20892.
(For express mail or courier services, the address is Rockville, MD
20852.)  Should the Group wish to place all inventions and
discoveries resulting from these studies within the public domain, a
letter to that effect must be submitted to Dr. Sarver in lieu of the
patent agreement two weeks prior to submission of the application.
The letter must be co-signed by the Principal Investigator, each of
the Project Leaders, and each of the business officials representing
the respective institutions.

Federal regulation clause 37 CFR 401 and HHS Inventions regulations
at 45 CFR Parts 6 and 8 require that NIH be informed of inventions
and licensing occurring under NIH funded research.  Invention and
licensing reports must be submitted to Extramural Invention Reports
office, Office of Extramural Research, Building 31, Room 5B41, NIH,
9000 Rockville Pike, Bethesda, Maryland 20892.

D.  Terms and Conditions of Award

The following terms and conditions will be incorporated into the
award statement and provided to the Principal Investigator as well as
the institutional official at the time of award.  The following
special terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Parts 74 and 92 [Part 92 is
applicable when State and local Governments are eligible to apply],
and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program is
the Cooperative Agreement (U19), an "assistance" mechanism (rather
than an "acquisition" mechanism), in which substantial NIH scientific
and/or programmatic involvement with the awardee is anticipated
during the performance of the activity.  The U19 must contain a
minimum of three interrelated research projects organized around a
central theme.  A Core resource or facility must be utilized by at
least two research projects.  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 awardee(s) for the project as a whole,
although specific tasks and activities in carrying out the study will
be shared among the awardees and the NIAID Scientific Coordinator.

1.  Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the details
for the project within the guidelines of the RFA and for performing
the scientific activity, and agree to accept close coordination,
cooperation, and participation of NIAID staff in those aspects of
scientific and technical management of the project as described under
"NIAID Staff Responsibilities".  Specifically, awardees have primary
responsibilities as described below:

a.  Meetings

Two Group meetings are required per year.  The Principal Investigator
and Project Leaders of the Group, and one or both of the NIAID
Scientific Coordinators, will meet twice per year to review progress,
plan and design research activities, and establish priorities within
the Group.  The Principal Investigator will be responsible for
scheduling the time and place (generally at one of the performance
sites), notifying the NIAID at least 30 days prior to the meeting
date, and preparing concise (3 to 4 pages) minutes or a summary,
which will be delivered to members of the group, including the
Scientific Coordinator, within 30 days after the meeting.  NIAID
staff will participate, but not chair Group meetings.

One mandatory meeting of the entire SPIRAT program will be held each
year (SPIRAT program annual meeting) at a site designated by the
NIAID (usually the Washington DC vicinity) during which the Principal
Investigators and Project Leaders of all the Groups will present
significant findings and progress in symposium format.  The NIAID
SPIRAT program director will consult with the Groups' key personnel
in formulating the overall agenda and in identifying key topics for
discussion, with specific focus on inter-Group interaction and
sharing information of general importance to the implementation of
clinical studies.  It is expected that NIH staff, members of
established committees and advisory boards, and others active in the
clinical application of innovative therapies for HIV/AIDS will also
be invited.

Applicants should include requests for travel funds specifically for
and restricted to the above meetings when they prepare their budgets.
Funds to cover operating costs of the SPIRAT program annual meeting
may be contributed by one or more Groups; NIAID will provide
administrative supplements for this purpose, as needed.  This RFA
will support only SPIRAT-related travel as specified above; no
additional travel funds will be provided to attend other domestic or
foreign scientific meetings under this RFA.

b.  Group's scientific advisory panel

Each Group will designate a Scientific Advisory Panel of two to three
investigators within six months of funding.  The Panel will attend
one or more of the Group's meetings.  The Scientific Coordinator(s)
will participate in all meetings of the Panel.  The Panel will review
the Groups's activities and advise the Principal Investigator on the
Group's progress, timeliness of progress in individual projects
relative to original projections, continued relevance of a given
project to Group's goals, and recommendations for new directions, as
appropriate.  The Panel will provide the Principal Investigator with
a comprehensive written review of the Group's activity in each year
of funding, as specified under DEFINITIONS:  SCIENTIFIC ADVISORY
PANEL.  A copy of the Panel's report will be submitted to the NIAID
as a supplement to the annual progress report, or within 30 days of
the report, whichever is earlier.  Members of the Panel will not be
affiliated with any of the institutions comprising the Group.

c.  Annual Progress Report

The Progress Report must include basic information as instructed with
PHS 2590 Noncompeting Continuation Application forms.  In addition,
each Progress Report must include a brief section outlining
intra-Group interactions that have augmented activities, citing
specific occurrences (e.g., construct X was made under Project 1 and
transferred to Project 2 for clinical evaluation).  Inter-Group
collaboration with other SPIRATs should be specified, where
applicable. Interaction with the Scientific Coordinator and the NIAID
during the reporting period should be described.

d.  Publications and Presentation of Findings

Early publication of major findings is encouraged.  The Principal
Investigator will be responsible for the timely submission to the
Scientific Coordinator of all abstracts, manuscripts, and reviews
(co)authored by members of the Group and supported in part or in
total under this Agreement.  The Principal Investigator and Project
Leaders are requested to submit manuscripts to the Scientific
Coordinator within three weeks of acceptance for publication so that
an up-to-date summary of program accomplishments can be maintained.

Publications or oral presentations of work done under this Agreement
are the responsibility of the Principal Investigator and appropriate
Project Leader.  All publications (abstracts, peer reviewed
manuscripts, reviews) and oral presentations of work supported in
part or in total by the SPIRAT cooperative agreement must be
acknowledged as part of the presentation and will include the
mechanism, cooperative agreement number and Institute, for example,
"This work was supported in whole (or in part) by the SPIRAT program,
cooperative agreement number U19-AI-12345, NIAID."

e.  Rights to data

While the NIAID Scientific Coordinator has a right of access to the
data, the applicant will retain custody of and rights to the data.
Information obtained from the data may be used by the Scientific
Coordinator for the preparation of internal reports on the Group's
activities.

2.  NIAID Staff Responsibilities

The NIAID shall participate as a member of the Group and shall be
represented by a Scientific Coordinator(s) or the SPIRAT program
director.  The Scientific Coordinator(s) shall be selected from the
Division of AIDS, which is an extramural programs of the NIAID.  The
NIAID Scientific Coordinator(s) will have substantial
scientific/programmatic involvement during the conduct of this
activity through technical assistance, advice and coordination such
as participating in the design of Group activities, advising in the
selection of sources or resources, coordinating or participating in
collection and/or analysis of data, advising in management and
technical performance, or participating in the preparation of
publications.  However, the role of NIAID will be to facilitate and
not to direct the activities.  It is anticipated that decisions in
all activities will be reached by consensus of the Group and that
NIAID staff will be given the opportunity to offer input to this
process.  The manner of reaching this consensus and the final
decision-making authority will rest with the Principal Investigator.

Examples of potential assistance to the Group include: (1) provision
of needed resources and information that otherwise may not be
available to the Group (e.g., reference compounds for standardization
of test systems or as analytical standards); (2) testing in NIAID
contract laboratories when the occasional need arises and when the
main research activities of the Group do not require these resources
on a regular basis (e.g., biochemical, cell-based assay, and animal
model studies).  On occasion, and under mutual agreements, NIAID may
arrange for limited preclinical evaluations at other SPIRAT sites.
The requesting Group is expected to provide sufficient material for
such testing.  Groups whose experimental approach involves studies
that require testing in animals on a regular basis must budget for
costs to be paid from award funding; (3) information concerning work
conducted in other NIAID-supported extramural projects in order to
reduce or prevent duplication of efforts; (4) further evaluation of
the therapeutic strategy under a larger phase I clinical trial be
conducted under other NIAID's sponsored clinical programs

The NIAID will retain the option to cross-file or independently file
an application for investigational clinical trial; e.g., an
Investigational New Drug (IND) application to the United States Food
and Drug Administration of any invention resulting from these
NIAID-supported Cooperative Agreements.  Reports of data generated by
the Group or any of its members required for inclusion in INDs and
Clinical Brochures and for cross-filing purposes will be submitted by
the Principal Investigator to the Scientific Coordinator upon
request.  Such reports will be in final draft form and include
background information, methods, results, and conclusions.  They will
be subject to approval and revision by NIAID and may be augmented
with test results from other Government-sponsored projects prior to
submission to the appropriate regulatory agency.

The principal end product of SPIRAT activities will be the
development of an innovative, effective clinical therapy for
HIV/AIDS. Preclinical and clinical development through private
sources is encouraged.  Alternatively, the Group may request that
further clinical studies be sponsored by NIAID.  In this case, it
will be necessary for the Principal Investigator, appropriate Project
Leaders and the NIAID Scientific Coordinators to collaborate in the
analysis, summary preparation, and subsequent presentation of data to
the Division of AIDS and other NIAID staff and NIAID advisory
committees, such as the AIDS Clinical Drug Development Committee
(ACDDC), DATRI Executive Group, or AIDS Research Advisory Committee
(ARAC).  The NIAID has several programs for clinical evaluation of
therapies for HIV/AIDS.  These include the AIDS Clinical Treatment
Units (ACTUs) for large phase I, Phase II, and Phase III clinical
studies, and DATRI.  It is envisioned that extended clinical studies
of treatments developed by SPIRAT groups can be accommodated under
the clinical trial mechanisms available through Division of AIDS.
Queries about these programs should be directed to Dr. Nava Sarver,
NIAID, address listed under INQUIRIES.

It is understood that the Government supports studies in the interest
of promoting the transition of effective, innovative therapies to the
clinic, and that identified therapies that have been derived via
government support mechanisms will be offered to the public at
reasonable costs.

3.  Arbitration Process

Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award), between award recipients and the
NIAID may be brought to arbitration.  An arbitration panel will be
composed of three members - one Group designee, one NIAID designee,
and a third designee with expertise in the relevant area and chosen
by the other two.  This special arbitration procedure in no way
affects the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulations 42 CFR Part
50, Subpart D and HHS regulation at 45 CFR Part 16.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 9, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.  Investigators also may obtain copies of the policy
from the program staff listed under INQUIRIES.  Program staff may
also provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by September 20, 1994, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address and telephone number of the
Principal Investigator, the number and title of this RFA, and a list
of the key investigators and their institution(s) and projects.
Although the letter of intent is not required, is not binding, does
not commit the sender to submit an application, and does not enter
into the review of subsequent applications, the information that it
contains allows NIAID staff to estimate the potential review workload
and to avoid conflict of interest in the review.  The letter of
intent is to be sent to Dr. Dianne Tingley at the address listed
under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on the standard research grant
application form PHS 398 (rev. 9/91).  For purposes of identification
and processing, item 2a on the face page of the application must be
marked "YES" and the RFA number and the words "STRATEGIC PROGRAM FOR
INNOVATIVE RESEARCH ON AIDS TREATMENT (SPIRAT)" must be typed in.
Applications must be received by December 8, 1994.

Applications from multi-component consortia must contain a single
face page, an overall budget page, and separate budget pages for each
institution involved.  Each consortium institution is allowed 25
pages for the research plan if different plans are proposed by the
different member institutions.  Because of the multi-institutional
nature of and the special requirements in this RFA, additional
instructions regarding format are contained in NIAID POLICY ON
MULTIPROJECT APPLICATIONS (PROGRAM PROJECT GRANTS AND MULTIPROJECT
COOPERATIVE AGREEMENTS), which is included with this package and is
also available from the program staff listed under INQUIRIES.  If a
conflict exists between instructions as presented in the program
policy guidelines and this RFA, this RFA takes precedence.  The
instruction that follow are in addition to and not in lieu of
instructions contained in the "NIAID PROGRAM PROJECT GRANTS AND
MULTIPROJECT COOPERATIVE AGREEMENTS."

The application forms may be obtained from the institution's office
of sponsored research or its equivalent 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) 435-0714. Applications must address the requirements below as
outlined in the section "SPECIAL REQUIREMENTS: Minimum Requirements
for Application."

A.  Composition of First Section of the Application

1.  The application must provide:  a clear and concise plan - in
narrative and diagrammatic form - that depicts the interrelationships
among the members of the SPIRAT Group, their relevant
experience/expertise, and the contribution of each to fulfillment of
the objectives and scope of this RFA; an organizational chart of the
SPIRAT Group showing the name, organization, and  scientific
discipline of the PI and of all key scientific, technical and
administrative personnel; and a mechanism for selecting and replacing
key professional or technical personnel.

2.  Applications are to provide a plan to ensure maintenance of close
collaboration and effective communication among members of the Group.
The application should include plans for scheduling Group meetings,
notifying Group members including the NIAID Scientific Coordinator,
and documenting and disseminating Group meeting proceedings.

3.  The application must include a written commitment to accept the
participation and assistance of NIAID Scientific Coordinators in
accordance with the guidelines outlined under "Terms and Conditions
of Award:  NIAID Staff Responsibilities."

4.  Applications are to provide a rationale for the innovative
therapeutic strategy proposed and the body of preclinical data in
support of this approach.

5.  Applications should present the anticipated unique advantages to
be expected from the Group operating within the proposed
collaborative efforts, how the projects are mutually reinforcing, and
how collectively they will further the stated goals of the proposed
research.

B.  Organizational and Administrative Structure of the SPIRAT

The application should describe in detail - in narrative and
diagrammatic form - the chain of responsibility for decision-making
and administration starting at the level of the Principal
Investigator and including the different research Project Leaders and
other investigators.  This description should indicate where in the
chain of responsibility will the advisory group be used and its role
in contributing to the quality and caliber of the research efforts.

C.  Consortium Arrangements

An application that includes research activity involving institutions
other than the sponsoring organization is considered a consortium
effort.  It is imperative that care be taken in preparing any
consortium application so that the programmatic, fiscal, and
administrative considerations are fully explained.  The policy
governing consortia is described in the NIH Guide for grants and
Contracts (Vol. 14, No. 7, June 21, 1985), which should be available
at the sponsoring institution's office of sponsored research, or in
the Office of Grants Information publication entitled "Guidelines for
Establishing and Operating Consortium Grants", January 1989, which
may be obtained by calling (301) 435-0714.

D.  Patent Coverage Agreement

1.  The application should provide a description of the Group's plan
for assuring adequate patent coverage of new inventions that may
arise as a result of Government funding of this U19.  "Invention" is
defined as a new drug or innovative treatment that is or may be
patentable under Title 35 of the United States Code.  A copy of the
proposed patent plan among the institutions comprising the Group must
be submitted with the application.  The original patent agreement,
signed and dated by the organizational officials authorized to enter
into patent arrangements for each Group member and member
institution, must be delivered two weeks prior to submission of the
application to Dr. Nava Sarver at the address listed under INQUIRIES.

2.  Should the Group wish to place all inventions and discoveries
resulting from these studies within the public domain, a letter to
that effect must be submitted to Dr. Sarver in lieu of the patent
agreement prior to submission of the application.  The letter must be
co-signed by the Principal Investigator, Project Leaders, and each of
the business officials representing the respective institutions.

E.  Individual Research Projects

1.  The strength of the complete application package will be judged
mainly on the basis of the quality of each research project.
Reviewers will expect each project to be described in the same detail
as for a regular research grant application to enable the reviewers
to judge the technical and scientific merit solely on the basis of
the written applications.

2.  The portion of the application for each component research
project should be prepared in the same manner as an R01 application,
following carefully the instructions found in the grant application
form PHS 398 (rev. 9/91).

F.  Scientific Core Support

1.  The application should describe the role and importance of the
core as a resource to the SPIRAT as a whole and the specific
service(s) such core support will provide and the projects it will
serve.  The facilities, techniques, and professional skills that the
core will provide should be described.  The role of the Core Leader
and each of the key participants should be described.  The portion of
the application describing each scientific core should be prepared
with the same level of detail as an R01 application in order for the
technical merit and appropriateness of each core to be evaluated.

2.  Core support may be provided as consortia if performed at
institutions different from that of the Principal Investigator.

3.  The budget for each scientific core should be presented according
to the instructions of the form PHS 398 (rev. 9/91); see also NIAID
POLICY ON MULTIPROJECT APPLICATIONS (PROGRAM PROJECT GRANTS AND
MULTIPROJECT COOPERATIVE AGREEMENTS).  It is highly recommended that
Dr. Nava Sarver, Chief, Targeted Drug Discovery Section, Division of
AIDS, NIAID, be contacted in the early stages of preparation of the
application.  (See program contact in INQUIRIES below.)

All components, subparts and sections of the application must be
collated into the complete application, and the packages sent to the
Division of Research Grants (DRG) and to the NIAID must each be
complete in themselves.  Applications that are not received as a
single package from the Principal Investigator and that do not
conform to the instructions contained in PHS 398 (rev. 9/91)
applications kit will be returned to the applicant.

The RFA label in the application form PHS 398 must be affixed to the
bottom of the face page of the application.  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 review.  In
addition, the RFA title and number must be typed on line 2a of the
face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including
the checklist; and three signed, exact, single-spaced photocopies in
one package to:

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

At the time of submission, also submit two additional exact copies of
the application, and five sets of the appendix and reprints directly
to Dr. Dianne Tingley at the address listed under INQUIRIES.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or Principal Investigator should be included
with the application.

Applicants from an institution receiving government funds under
General Clinical Research Center (GCRC), Center for AIDS Research
(CFAR), AIDS Clinical Trial Unit (ACTU), AIDS Vaccine Evaluation Unit
(AVEU), DATRI, and CPCRA programs, should describe how these programs
are integrated with the proposed studies, and ensure that no
scientific and budget overlap exists with the SPIRAT proposal.

Applications must be received by December 8, 1994.  If an application
is received after that date, it will be returned to the applicant
without review.  The DRG will not accept any application in response
to this RFA 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 applications must include an introduction
addressing the previous critique.

REVIEW CONSIDERATIONS

A.  General Considerations

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NIAID.  Incomplete applications will be
returned to the applicant without further consideration.  If NIAID
staff find that the application is not responsive to the RFA, it will
be returned without further consideration.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIAID in accordance with the review
criteria stated below.  As part of the initial merit review, a
process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the principal investigator/program director
and the official signing for the applicant organization will be
promptly notified.  The second level of review will be provided by
the National Advisory Allergy and Infectious Diseases Council.

All applications will be judged on the basis of the scientific and
technical merit of the proposed projects and the documented ability
of the investigators to meet the RESEARCH OBJECTIVES of the RFA.
Applications with first year total costs (direct and indirect) in
excess of $1.3 millon will be returned without review.  Applications
will also be reviewed for minimum requirement described in the SPIRAT
RFA.  Those not meeting all the requirements will be considered not
responsive and will be returned without further review.

B.  Review Criteria

Scientific Considerations

The application must be directed toward attaining the programmatic
goals as stated under RESEARCH OBJECTIVES.  The following criteria
will be used by peer review groups to evaluate these applications:

1.  The scientific and technical merit of the application as a whole
and of each individual research project and core component.  Emphasis
will be placed on the innovative aspect and uniqueness of the
proposed therapeutic strategy, and on the caliber of the preclinical
and clinical activities described to realize the overall objective.
Each project must be supportable on its own merit;

2.  The likelihood that innovative preclinical therapeutic strategies
will be refined and pilot clinical research implemented within two
years of award date;

3.  Demonstration of experience in the planning, design, and conduct
of clinical research with a small number (6 to 12) of HIV-infected
individuals (in-patient and out-patient).  Relevant prior experience
should be noted.  The plan for clinical data management and adverse
event reporting (AER) should be described;

4.  The cohesiveness, multi-disciplinary and multifaceted scope of
the program and the coordination and interdependence of the
individual projects and core(s); plans for effective intra-Group
communication and for assuring cohesiveness within the Group as a
whole;

5.  The justification for, and usefulness to the various research
projects of the core facilities.  The relationship of each core to
the central focus of the overall program.  Each core unit must
provide essential facilities or service for two or more approved
individual research projects;

6.  The leadership, scientific ability, and administrative competence
of the Principal Investigator for the development, implementation,
and management of a comprehensive preclinical and clinical research
program; and the Principal Investigator's commitment to devote
substantial time and effort to the program;

7.  The qualifications, experience, and commitment of the
investigators responsible for the individual research projects or
core(s) (Project Leaders) and their contribution to the program,
including their ability to devote adequate time and effort to the
Group.  It is anticipated that, due to the complexity and time
required to maintain a well-coordinated and productive research
effort, a minimum 20 percent (time) effort by the Principal
Investigator and each Project Leader should be devoted to the study,
unless there are compelling arguments to the contrary;

8.  Research training, experience and accomplishments of other
participating investigators and support personnel in the Group in the
research areas outlined in the RFA;

9.  Provisions for the protection of human subjects and the humane
care of animals; adequacy of biohazard containment facilities;

10.  Adequate representation of women and/or minorities in clinical
research populations;

Administrative considerations

1.  The academic, clinical, and physical environment in which the
research will be conducted, including the adequacy of space,
equipment, animal facilities, biohazard containment facilities;
access to HIV/AIDS patient care; and the potential for interaction
with active scientists from other departments and/or institutions in
relevant disciplines including infectious diseases, virology,
molecular biology, immunology, gene therapy, hematology.  The
availability of a GCRC (General Clinical Research Center) should be
noted.  The responsible IRB (Institutional Review Board) should be
identified;

2.  Documented commitment of Institutions represented by Group
members; documented capability of Principal Investigator's
Institution to serve as the Central Operations Office for the Group;

3.  Soundness of the institutional administrative and organizational
structure that facilitates attainment of the objective(s) of the
program, including fiscal responsibility and management capability to
assist the PI and staff in following PHS policy;

4.  Description of the laboratory capabilities in immunology and
virology with particular emphasis on ability to detect changes in
parameters related to HIV infection.  Pharmacological capabilities
should also be described, when relevant;

5.  Arrangements for internal quality control of on-going research,
allocation of funds, day-to-day management, contractual agreements,
and mechanism for selecting and replacing key professional or
technical personnel, if required, on an interim or permanent basis;

6.  Documented commitment of the sponsoring institution to the
cooperative agreement and willingness to accept the participation and
assistance of NIAID staff (Scientific Coordinator) as stated under
TERMS OF AWARD;

7.  Appropriateness of the budget in relation to the proposed
program.  For budgetary consideration, assume that the duration of
the annual SPIRAT meeting will be four days.  Funds to cover expenses
incurred by the Panel (see VII: SPECIAL REQUIREMENTS, Part D -
Awardee's Rights and Responsibilities, page 11) should be included in
the Administrative Core component of the application and will be
restricted solely for this purpose.

The initial review group can make recommendations regarding
appropriateness of the applicant's specific aims to programmatic
goals, deletion of projects or cores not essential to the overall
thematic objective, and administrative oversight by program staff.
The initial review group will review each project and core within the
application individually, followed by scoring of the application as a
whole.

Council Review Stage

The second level review will be conducted by the National Advisory
Allergy and Infectious Diseases Council.  Factors that will be
considered in this review include:

1.  Results of the initial scientific and technical merit review;

2.  Significance to NIAID program goals in infectious diseases,
allergy, transplantation immunology, immunologic diseases, or AIDS;

3.  National needs and NIAID program balance;

4.  Policy and budgetary considerations.

AWARD CRITERIA

Award criteria will be made on the basis of scientific and technical
merit as determined by peer review, program needs and balance, and
the availability of funds.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Nava Sarver, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Solar Building, Room 2C-11
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-8197
FAX:  (301) 402-3211

Direct the letter of intent and inquiries regarding application
preparation and review to:

Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C16
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-0818
FAX:  (301) 402-2638

Direct inquiries regarding fiscal matters to:

Ms. Pamela Greenwald
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B22
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-7075
FAX:  (301) 480-3780

For all express mail or courier services to Solar Building, use the
following address: 6003 Executive Boulevard, Rockville, MD  20852

Schedule

Letter of Intent Receipt Date:  September 20, 1994
Application Receipt Date:       December  8, 1994
Scientific Review Date:         March 1995
Advisory Council Date:          June 1995
Anticipated Award Date:         August 1995

AUTHORITY AND REGULATIONS

This program is described in the catalog of Federal Domestic
Assistance, 93.856 - Microbiology and Infectious Diseases Research
and 93.855 - Immunology, Allergy and Transplantation Research.
Awards are made under the authority 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 Part 52 and 45 CFR Parts 74 and 92.  This
program is not subject to the intergovernmental review requirements
of Executive Order 122372 or Health Systems Agency review.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

.

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