Full Text AI-93-014


NIH GUIDE, Volume 22, Number 22, June 18, 1993

RFA:  AI-93-014

P.T. 04

  Biomedical Research, Multidiscipl 
  Behavioral/Social Studies/Service 
  Disease Prevention+ 

National Institute of Allergy and Infectious Diseases
National Institute of Mental Health

Letter of Intent Receipt Date:  July 16, 1993
Application Receipt Date:  August 25, 1993


The National Institute of Allergy and Infectious Diseases (NIAID) and
National Institute of Mental Health (NIMH) invite the submission of
applications for Centers for AIDS Research/Core Support Grants
(CFAR/CSG) from institutions conducting high quality,
multidisciplinary AIDS research. The purpose of the CFAR/CSG is to
provide administrative and shared research support through Core
facilities to synergistically enhance and coordinate high quality
AIDS and AIDS-related research projects requiring resources or
services not otherwise readily obtained through more traditional
funding mechanisms.


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,
Centers for AIDS Research/Core Support Grant (CFAR/CSG), 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).


Applicant institutions

Applications may be submitted by domestic, non-profit and for-profit
research institutions including universities, colleges, units of
state and local governments and research institutes or laboratories.
Both new applicants and competing renewal applicants are eligible to
apply.  Minority individuals and women are encouraged to submit as
Principal Investigators.  Foreign institutions are not eligible to

One CFAR per institution per funding institute

CFAR/CSGs are awarded to research institutions already heavily
committed to several individual programs in AIDS and AIDS-related
research.  In general, the purpose of the CFAR/CSG award is to
enhance the impact of the unique spectrum of scientific expertise and
research projects available within an institution.  Thus, only a
single CFAR will be supported at a given institution per funding
institute, i.e., one institution may have a CFAR funded by NIAID and
one funded by NIMH, but the institution will not have more than one
CFAR funded by either institute.  It is incumbent upon the applicant
institution to demonstrate that there will be no duplication of
effort, if an institution applies for a CFAR/CSG from NIAID and one
from NIMH.  For example, the two CFARs should not have any Cores that
are the same and should not use the same grants to fulfill the Funded
Research Base requirement (see below).  The terms "applicant
institution" and "parent institution" refer to a given location
(campus).  For example, institutions that are part of a larger
system, such as UCLA and UC Davis, each a separate component of the
university system of the state of California, could each be awarded a

See the document "CFAR/CSG Guidelines" for a list of separate
organizations.  However, institutions that have significant overlap
in faculty, resources, and/or administration should submit only one

Funded Research Base

An applicant institution must have a continuing Funded Research Base
of at least $800,000 in annual direct costs of peer-reviewed AIDS or
AIDS-related research.  In order to qualify for a CFAR/CSG award by
the NIAID, the Funded Research Base must be NIAID-funded research.
In order to quality for a CFAR/CSG award by the NIMH, 60 percent of
the Funded Research Base must be from NIMH-funded research and 40
percent may be from other NIH Institutes or peer-reviewed funding
from alternate sources.  Both Institutes require that the Funded
Research Base be distributed among at least six peer-reviewed AIDS
and AIDS-related research awards when the CFAR/CSG is awarded and
throughout the award period.  The annual progress report (form PHS
2590) must include this information each year of the project period.
Funding for an existing CFAR cannot be used to achieve any portion of
the Funded Research Base.

To assist NIH in the identification of centers that may be funded by
NIAID or NIMH, applicants are urged to indicate, in the abstract that
describes the overall proposed CFAR, how many projects which comprise
the Funded Research Base are funded by NIAID and how many are funded
by NIMH.  Applicants are also encouraged to include a brief
description of the type of research included in the Funded Research
Base in the overall CFAR/CSG abstract.

Qualifying Funding

For all applicants:  AIDS and AIDS-related research supported by the
NIAID and NIMH: This includes all types of grants, cooperative
agreements, and research contracts in which proposed research has
been peer-reviewed and includes the following categories:  P01, P50,
R01, R03, R21, R29, R35, R37, U01, U10, K and F series awards, R18
(Research Demonstration and Dissemination Projects) and N01 (Research

For NIMH applicants:  AIDS and AIDS-related research supported by
other NIH Institutes and funding organizations outside of NIH:
Funding by the latter organizations, which may not exceed the
indicated percentage of the Funded Research Base (40 percent for NIMH
awards), may be included if review processes for awards are
substantially equivalent to those of NIH.  It is the responsibility
of the applying institution to demonstrate that, in these cases, the
alternative peer-review mechanisms involved are equivalent to those
in use at NIH and that the research so funded is of sufficient
quality to warrant CFAR/CSG support.  This verification may be
accomplished by attaching to the application a one page document
containing information provided by each alternate funding agency
describing their review mechanisms and criteria for awarding funds.

Excluded Funding

The following should not be included in the total AIDS Funded
Research Base

A current CFAR, training grants including Institutional Training
Grants (T32s), other P30 awards, awards from private industry,
contracts and other awards that primarily fund the production of
materials and/or services for support of research.


CFAR/CSG awards will be made under the NIH Core Support Grant (P30)
mechanism.  This RFA is a one-time solicitation.  Because the nature
and scope of the research proposed in response to this RFA will vary,
it is anticipated that the sizes of the awards will vary also.
Responsibility for the planning, direction and execution of the
proposed Center will be solely that of the applicant.  The total
project period for applications submitted in response to this RFA may
not exceed five years of support.  However, recommended support
beyond the third year of the CFAR/CSG is subject to the determination
by an ad hoc review committee that stated goals (milestones) have
been sufficiently met.  The progress report of the non-competing
continuation application (PHS 2550) for the fourth year of support
must demonstrate that stated CFAR/CSG goals have been met.  Program
staff will contact the Principal Investigator to request additional
information, if required.

The six milestones that must be met at the end of year three are:
interdisciplinary coordination and collaboration, especially between
clinical and basic research investigators; synergistic scientific
collaboration; organizational capabilities of the CFAR; institutional
commitment; developmental and educational commitment; and effective
use of the charge back system.  Additional information is provided


The NIAID has set aside a total of $7.2 million for the initial
year's funding of this RFA.  The NIAID anticipates making 9 to 11
awards.  NIMH has set aside a total of $1.5 million and anticipates
making two awards.  The final number and specific amounts of awards
will depend upon the scientific and technical merit, relevance to
programmatic priorities and availability of funds.  All applications
are limited to requests for no more than $750,000 in total costs
(direct plus indirect) in the first year.  Increases of up to four
percent are permitted for allowable recurring costs for each of the
subsequent years.



The human Acquired Immunodeficiency Disease Syndrome (AIDS) has
reached epidemic proportions:  253,448 cases of AIDS in the United
States had been reported by the Centers for Disease Control (CDC) as
of February, 1993.  A total of 169,623 individuals have died from
this disease and its sequelae.  In response to this emergency, the
NIH and other research institutes are supporting studies consisting
of basic and applied research concerning the AIDS epidemic.  It is
anticipated that these investigations will lead to achievement of
disease prevention through development of effective vaccines,
prevention and behavioral change strategies, and rational therapeutic
strategies to control viral infection and the development of
opportunistic infections and other sequelae of AIDS.

The continually expanding epidemic nature of AIDS increases the
urgency for critical basic and applied research in AIDS and
AIDS-related projects and the timely transfer of basic research
knowledge into efficacious patient treatment protocols.  The genetic
variability of HIV, the apparent complexity of its viral pathogenesis
(still not yet fully understood), as well as the unique
socio-epidemiological aspects of infection, dictate the need for
implementation of a multidisciplinary approach involving the
collaboration of teams of investigators possessing diverse and
relevant state of the art expertise in research areas most useful for
an understanding of AIDS and for the development of effective
therapies.  Most importantly, there is an imperative need for the
timely application of new knowledge obtained in the basic research
laboratory to the clinical setting as well as for the efficient
translation of observations in AIDS clinics into questions which may
be addressed and resolved by novel laboratory experimentation.  It is
precisely these aspects of AIDS research to facilitate through
CFAR/CSG awards.

During Fiscal Year 1988, the NIAID launched a new initiative intended
to establish a number of Centers for AIDS Research (CFARs) at
institutions committed to several high quality AIDS research
projects, using funds specifically appropriated by Congress.  Under
this program, thirteen CFARs were funded for the purposes of
enhancing and focusing high quality, peer-reviewed, AIDS and
AIDS-related research in a synergistic manner with a resulting
increase in the efficiency and effectiveness of a wide variety of
research programs.  In May 1992, an ad hoc Program Review Committee
organized by NIAID commended the CFAR Program, and recommended
several changes to enhance the Program's effectiveness in achieving
its stated goals.  These suggestions included:  an increased emphasis
on interdisciplinary cooperation and collaboration and the use of
Cores by multiple, interactive groups; the establishment of at least
one Clinical Core within each CFAR; maintenance of a critical level
of high quality AIDS research consisting of several peer-reviewed
awards; a continued demonstration of active support of the CFAR by
the parent institution in terms of space, personnel, and other
resources; a requirement that the CFAR Director be a Principal
Investigator of peer-reviewed funded AIDS research and a leader in
the field of AIDS research; encouragement of behavioral and
prevention research, support of the enrollment of women and
minorities in clinical trials, and support of minority investigators.

The purpose of this RFA is to request new and renewal applications
for the establishment of CFARs at parent institutions involved in
critical, high impact AIDS and AIDS-related research projects.
Funding will be provided to awardees to support the leadership and
planning activities of the Center and to develop Cores of shared
resources and services that will enhance and focus existing clinical
and basic AIDS research in a cooperative and synergistic manner.
This RFA will also provide funding for pilot projects for innovative,
high risk investigations, and developmental support for new
investigators in AIDS research.  The goal of both of these aspects of
CFAR support is to provide limited funding for development of
sufficient data to enable investigators to apply for R01-type grants.

Goals and Objectives of the Centers for AIDS Research

The goal of the CFAR/CSG is to enhance and extend the effectiveness
of groups of investigators conducting AIDS and AIDS-related research
supported by peer-reviewed funding mechanisms.  More specifically,
the CFAR/CSG is intended to:

o  Encourage activities that will initiate, consolidate and focus
high quality AIDS and AIDS-related research by establishing Core
Support Facilities for ongoing projects funded through peer-reviewed

This RFA will foster multidisciplinary collaboration among scientists
at the parent institution through coordinated administrative,
resource and service Cores:

o  Promote effective synergistic collaborations and interactions
especially among investigators participating in clinical and basic
areas of AIDS research.  Such interactions are intended to facilitate
translation of information obtained in the laboratory to specifically
address problems in the clinic and the field, and will enhance the
possibility of observations in the clinic and the field being
translated to the laboratory setting for further investigation.

o  Foster development of innovative and high quality research areas
in AIDS research by providing support for investigators new to the
field, and through the funding of pilot projects whose results can
form the basis for competitive applications.

o  Support administration of the Center including activities such as
seminars and workshops for CFAR/CSG members and AIDS investigators in
general, education at all levels including community programs, and
funding for the leadership responsible for organizing and sustaining
the Center's activities.

Scope, Restrictions and Exclusions

Specifically, the CFAR/CSG will provide funding for the types of
activities listed below.  In general, those CFARs funded by the NIAID
may have Core Facilities supporting research such as basic biology
and pathogenesis of HIV, vaccine research and development, clinical
trials and treatment research for HIV infection, drug development,
epidemiology of HIV infection, and preclinical developmental
therapeutic research for HIV and associated opportunistic infections.
Those CFARs funded by NIMH may have Core Facilities supporting
research such as CNS effects of HIV infection (neurobiological and
behavioral studies), behavior change and preventive intervention
studies, psychological and psychosocial response to HIV infection and
AIDS and psychological and psychiatric treatment of persons with HIV
infection and AIDS.  Basic research in the area of behavioral change
related to prevention of HIV infection is an area of joint interest
and either NIAID or NIMH may fund Centers having Core Facilities
supporting studies of this type.

In addition, it is strongly encouraged that by the end of year 01 of
the award and included in the non-competing, renewal application for
year 02, and subsequent non-competing renewal applications, the CFAR
will establish a plan of "Charge Back" for the remaining four years
of funding.  This will involve a gradual assumption, over the
remaining period of the grant award, of greater fiscal responsibility
by users of Core facilities through R01 funds and by the parent
institution, with a corresponding decrease in support from CFAR/CSG
funds for established Cores.

(Note that the specific examples provided below are not intended to
be all inclusive.  Applicants are strongly encouraged to contact
program staff from NIAID or NIMH listed under INQUIRIES for questions
regarding the types of Cores that will be supported by NIAID or

o  Basic Science Cores.  Centers are required to have at least three
Basic Science Cores that support basic AIDS and AIDS-related research
by investigators at the CFAR.  The basic science Cores should be
designed to foster collaboration among investigators representing
various scientific approaches or disciplines, and should especially
promote cooperation and collaboration between basic and clinical
investigators.  Applicants should indicate the mechanism that will be
used to select users of Basic Science Cores, e.g., such as through an
Internal Review Committee.

Examples of such Cores that may be supported by the NIAID include,
but are not limited to, Virus Culture in Biohazard Containment (BL3),
Mass Spectrometry, Computer Modeling, Monoclonal Antibody Facilities,
Peptide Synthesis and HPLC, DNA Synthesis and Sequencing, PCR,
Transgenic and SCID/Hu Mice Facilities, Animal Models, and Flow

Examples of such Cores that may be supported by NIMH include, but are
not limited to, Mass Spectrometry, Computer Modeling, Monoclonal
Antibody Facilities, PCR, Transgenic and SCID/Hu Mice Facilities,
Animal Models, Flow Cytometry, Tissue Banks, Cell Line Repositories,
Psychoimmunology, Neuroimmunology, and Neuroimaging.

o  Clinical Core.  Centers are required to include a Clinical Core
Support Facility that will support patient-based research.  This Core
should provide for collaborations with basic scientists and encourage
rapid development of new clinical approaches.  Activities that will
not be supported by a CFAR/CSG Clinical Core include:  routine
screening of clinical specimens, diagnosis, treatment, or
rehabilitation.  Regardless of the specific type of activity
performed within the Clinical Core, all activities should facilitate
translation between basic and clinical research.  Applicants should
indicate the mechanism that the CFAR will use for selection of users
of the Clinical Core, e.g., such as through an Internal Review
Committee.  If a Center has a clinical research entity, such as an
ACTU, AVEU, CPCRA, DATRI site, or a Clinical Center, etc., the
applicant institution must include information concerning all support
for clinical research already in place, such as, but not limited to,
biostatistical analysis, and database or repository establishment or

The types of activities that may be supported by a NIAID-funded
Clinical Core include, but are not limited to biostatistical support,
recruitment of subjects for clinical studies, support for
epidemiological studies in areas of AIDS, community outreach, or
provide modest funding for sample storage.

The types of activities that may be supported by a NIMH-funded
Clinical Core includes, but are not limited to biostatistical
support, recruitment of subjects for clinical studies, support for
epidemiological studies or behavioral epidemiological studies in
areas of AIDS, neurobehavioral or psyco-sexual or psycho-social or
treatment assessments, focus groups, ethnographic studies, community
outreach, test development, and/or provide modest funding for sample

o  Developmental Core.  CFARs are encouraged to support three
Developmental areas:  Investigators New to AIDS Research, Pilot
Projects, and Evolving Research Opportunities.

o  Administration Core.  Support for the CFAR Director, who should be
a recognized leader in the field of AIDS research and the Principal
Investigator of at least one peer-reviewed grant, which is part of
the Funded Research Base in AIDS or AIDS-related research.  Support
may also be requested for Core Directors, a senior administrator, an
office that is a clearly separate entity to which individuals may
come for information and other activities related to the CFAR, and a
modest staff for support of Center activities.

o  The CFAR may provide salaries and limited funds for research costs
for Investigators New to AIDS Research who have not previously
received individual R01-equivalent support in this field.  Funding
will be provided until the investigator achieves independent support
through a traditional research grant or equivalent, but will not
exceed three years.  Applicants should indicate the mechanism that
the CFAR will use for selection of recipients of Developmental
funding, e.g., such as through an Internal Advisory Committee.

o  Developmental funds may also be used for small feasibility
studies, often of a risky nature, preparatory to the development of
applications for independent peer-reviewed support.  Examples
include, but are not limited to, nurture of an especially innovative
idea for which other funding is not available, exploration of an
unconventional but potentially important hypothesis, and
encouragement of basic/clinical, basic/prevention, and
basic/behavioral research collaborations.  Funding for the Pilot
Projects will not exceed one year.  Applicants should describe the
mechanism they will use for identification and selection of Pilot
Projects they will support through developmental funds.

o  Funding for Evolving Research Opportunities is designed to support
rapidly arising, critical, evolving areas in the field of AIDS
research which demand a rapid resolution.  Funding for projects of
this type will not exceed six months.  Identification of a potential
project may be brought to the attention of the CFAR from CFAR
members, scientists outside of the CFAR as well as from the awarding
institute.  Applicants should describe the mechanism they will use
for identification and selection of Evolving Research Opportunities
they will support through Developmental Funds.

No more than 25 percent of the total direct costs requested in the
CFAR/CSG application may be for the combined salaries of the CFAR
Director and Core Directors.  No more than 10 percent of the total
direct costs requested in the CFAR/CSG budget application may be
allocated for all other categories in the administration core.

o  Additional Activities.  Four additional activities of CFARs are
encouraged.  Specific examples are not meant to be all inclusive:

o  Identification of a Thematic area, i.e., a general area of
scientific specialization that characterizes an individual Center and
represents its unique contribution to the overall breadth and scope
of the CFAR/CSG program.  An applicant institution may already have
an existing focus of research, such as Immune Reconstitution, X-ray
Crystallography, Specific Animal Models, Models of Cell-Based
Trafficking, Neurobehavioral Sequelae of HIV, or Behavior Change and
Prevention, that can then form the focus for a Thematic Area
encompassing AIDS or AIDS-related research.  CFAR investigators whose
AIDS or AIDS-related research is not included in the Thematic Area
will be eligible to use Core Facilities, after approval by the
standard internal review process developed by each CFAR, e.g.,
through the Internal Review Committee.

o  Development of minority scientists in the field of basic and
clinical AIDS research through support of programs that result in the
participation of minorities in high quality mainstream investigations
in this area.  The CFAR may:  (1) fund minority investigators who are
new to AIDS research as part of one or more CFAR developmental
grants, and (2) facilitate development of collaborative AIDS research
projects with minority investigators at other institutions which
could include, but not be limited to, membership in the CFAR,
training within a CFAR Core and utilization of a Core with facilities
that would not otherwise be available to the minority investigators
at their own institution;

o  The CFAR is encouraged to identify ways to use scientific
knowledge gained in the laboratory and clinic to decrease the gaps in
understanding AIDS among non-scientists.  Support could be through
Developmental funding of a project in this area.  Activities in this
area might include the development of a program similar to NIH's
"Medicine for the Layman" at the parent institution, and outreach to
community groups with information tailored to the unique needs of the
particular population, supported through Developmental funds or
through the Administration Core.

o  Finally, the CFAR is encouraged to support identification of
solutions to problems regarding enrollment and maintenance of women
and minority groups in AIDS clinical trials, an area that can be
supported through Developmental funding or through the Clinical Core.


AFFILIATED INSTITUTIONS - Affiliated Institutions are institutions
that provide one or two Core Support Facilities for the CFAR.

AIDS RESEARCH - AIDS research includes, but is not limited to,
studies of HIV and related retroviruses; studies of the mechanism(s)
by which HIV and related retroviruses infect host cells, establish
productive infections and cause disease; host genetic resistance to
HIV/AIDS; studies on in vivo and in vitro models of human HIV
infection; epidemiologic studies on HIV and related retroviruses,
including prevention and behavioral change research; preclinical
studies targeted to development of therapy for HIV infection
including drug design modeling; clinical trials involving therapy for
HIV infection or its sequelae; clinical trials involving, or studies
targeted to development of, vaccines, or other immunological or
chemotherapeutic interventions to prevent HIV infection; studies
concerned with diagnosis of HIV infection and AIDS; and viral
detection and isolation methods.

AIDS-RELATED RESEARCH - AIDS-related research refers primarily to
research on opportunistic infections associated with AIDS, research
on other sequelae of AIDS such as AIDS-related neoplasias and wasting
syndrome.  Research on opportunistic organisms must use a model
system related to HIV infection and pathogenesis in humans and may
include:  (a) mechanisms of pathogenesis; (b) virulence factors; (c)
immunoregulation, immunopathology, immunotherapy and immune
prophylaxis; (d) therapeutic methods in general, (e) host resistance
mechanisms; and (f) detection and assay.

ALTERATIONS AND RENOVATIONS - Alteration and renovation (A&R) is
defined as work required to change the interior  arrangements or
other physical characteristics of an existing facility or installed

APPLICANT INSTITUTION - The Applicant Institution refers to the
responsible university or institute applying for the CFAR/CSG award.

CFAR OR CENTER - In this RFA, the terms CFAR and "Center" are
interchangeable and refer to the organization of ongoing, innovative,
critical, peer-reviewed AIDS and AIDS-related research through the
use of Core Support Facilities.  In a CFAR, these ongoing research
projects and their scientific disciplines are united under a single
scientific and administrative structure with a common goal:  the
synergistic cooperation and collaboration between AIDS investigators
at the CFAR, and especially, between basic and clinical investigators
involved in innovative research on AIDS and its sequelae.  The
definitive feature of a CFAR is the establishment of shared Core
Support Facilities.  Through a Developmental Core, the CFAR also
supports the recruitment of new scientists into AIDS research, pilot
projects, and critical evolving research requiring an unusually
timely response.  A CFAR may also identify a thematic area to
facilitate collaboration and interaction, and may also support
community outreach projects, the organization of lecture series in
AIDS for scientists and non-scientists, and may place special
attention to the participation of women and minorities at all levels
of AIDS research and treatment through the Developmental Core.

CFAR MEMBER - Individual approved by the CFAR Internal Advisory
Committee to use Core Facility(s).

CFAR SENIOR LEADERSHIP - CFAR senior leaders are those individuals
who are involved in the overall direction of the CFAR, including the
Center Director, Associate or Assistant Director(s), Core Directors
and those Center Staff Investigators who are involved in the
planning, implementation and evaluation of Center activities
including the stimulation of scientific interactions, the recognition
and pursuit of new research opportunities, the implementation of
budgets and charge back systems in cores, the identification of new
CFAR members, the initiation of seminars and training programs and
the recruitment of faculty.

CHARGE BACK SYSTEM - CFARs are encouraged to phase in a Charge Back
System, a method of charging users of the Core Facility a fee
commensurate with their usage of equipment, time, supplies (such as
reagents) and personnel, if any, providing the service.  The charge
back costs would then be budgeted within the users' research grants,
resulting in a gradual increase in funds from this source, and a
decreased cost to the CFAR/CSG over the award period.  These freed
funds from the CFAR/CSG award, originally dedicated to establish the
Core Support Facilities proposed in the initial application, could
then be rebudgeted to the Developmental Core and/or be used to
establish new Cores as the Center evolved.  Applicants should be
aware that program income may be generated.  Institute staff will
work with grantees on this issue.

CORE SUPPORT FACILITY - A "Core Support Facility", or "Core",
consists of a functional AIDS service unit, either clinical
(including behavioral aspects) basic, developmental, or
administrative, including personnel, a responsible Core Director,
defined space, laboratory equipment, supplies, resources and services
which is able to perform experimental procedures requiring a number
of specialized techniques not available to already existing
independent research projects.  A primary function of the CFAR is to
foster multidisciplinary approaches to collaborative research.  Core
Components of a CFAR must be shared by investigators participating in
a variety of individual and collaborative projects.

CORE DIRECTORS - Core Directors shall consist of individuals
responsible for the overall technical excellence of a Core Facility
including its state of readiness, its ability to perform Core
activities in a timely and efficient manner, improvement or adoption
of new techniques as they become available, maintenance of supplies
and equipment (a function that may be delegated to appropriate
personnel), supervision of personnel providing services, supervision
of any training programs having to do with the core and provision of
advice to an Internal Advisory Committee, if appropriate, about core

EVOLVING RESEARCH OPPORTUNITIES - Evolving Research Opportunities is
a category within Developmental Funding that is designed to support
critical, evolving areas in AIDS research which demand a rapid

EXTERNAL ADVISORY COMMITTEE - An External Advisory Committee may
include established investigators in the field of AIDS and
AIDS-related research who are not members of the CFAR they advise,
one of whom may be the Director of another CFAR.  The committee
should provide advice on the overall direction and progress of the
CFAR, establishment of new Cores and whether the CFAR is maintaining
its mission.  This committee should meet at least once per year and
its report should be part of the annual CFAR progress report
submitted to the funding institute (NIAID or NIMH).

FUNDED RESEARCH BASE - The Funded Research Base is comprised of the
total amount of AIDS or AIDS-related funding received for
peer-reviewed grants awarded by the NIAID, NIMH, or alternate funding
agencies, including all other NIH Institutes, having review criteria
and mechanisms equivalent to the NIH.  See III - Eligibility

INTERNAL ADVISORY COMMITTEE - An Internal Advisory Committee of each
CFAR may be comprised of the CFAR Director, Core Directors, and other
investigators of the CFAR, as appropriate, who may review all
applications for use of Core facilities, and may be the group having
final decision upon recruitment and retention of investigators within
a Core facility.  Other functions of the Internal Advisory Committee
may include advice concerning the necessity to establish additional
Cores, and the approval of developmental grant awards.

or minority individual is defined, for the purposes of this RFA, as a
member of a recognized minority group that is either
under-represented in biomedical research or is undeserved in terms of
AIDS diagnosis and treatment.

PARENT INSTITUTION - The Parent Institution is the research
institution receiving a CFAR award.  In exceptional cases, a CFAR
award may include up to 2 core support facilities housed at a second,
affiliated institution.  It is the responsibility of the applicant
institution to clearly demonstrate the need for a Core at a second
institution.  It is expected that CFAR/CSG funding will be primarily
used to support investigators at the Parent Institution.

PEER-REVIEWED FUNDED RESEARCH - Peer-reviewed funded research
includes the following:  awarded research grants, cooperative
agreements and research contracts awarded by NIAID or NIMH including
P01, R01, R03, R18, R21, R29, R35, R37, U01, U10, K, and F series
awards, and contracts (N01).  Peer-reviewed funding also includes the
equivalent awards from other NIH institutes and awarded grants from
the National Science Foundation as well as all other government and
private institutes which meet the NIH standard for peer review. It is
the responsibility of the applying institution to demonstrate that
the latter funding sources, if projects with such support are
submitted to fulfill the requirement for a minimum level of direct
cost peer-reviewed research funding are equivalent to the NIH
standard for peer review.

THEMATIC AREA - A thematic area is a general area of scientific
specialization that characterizes an individual Center and represents
its unique contribution to the overall breadth and scope of the CFAR
Program.  If NIAID and NIMH each support a CFAR at an institution,
the themes should be distinct and non-overlapping.


Reporting Procedure

o  Progress report

As is required for all awards, Annual Progress Reports on the
progress and achievements attributable to the CFAR must be submitted
together with an expenditure report, using form PHS 2590.  Charge
back systems for the core facilities must also be clearly documented.
A progress report should demonstrate the overall value of the CFAR to
the field of AIDS research.  This would normally include brief
descriptions of the projects the CFAR/CSG has supported, the nature
of the contribution of the CFAR/CSG to the project, and the overall
significance of the research to which the CFAR/CSG contributed.

CFAR Citation

All publications including abstracts, journal articles, books, as
well as internal publications reporting on research findings
supported, at least in part, by CFAR/CSG funding must acknowledge
this as follows:  "This (project) was supported by the Center for
AIDS Research/Core Support Grant (CFAR/CSG) number XX-XXXXXX from the
NIAID (or NIMH)."  The CFAR/CSG program should also be acknowledged
in all presentations, as appropriate.

Allowable Budget Items

Items within the following categories of expenses may be allowed:

o  Shared Resources Supporting Clinical and Laboratory Research.  The
CFAR may include funds for clinical and/or laboratory facilities,
equipment, and services that will be used by multiple staff for
research supported by ongoing peer-reviewed grants and/or contracts.
Specific examples of such resources include, but are not limited to,
large shared equipment, biostatistics, animal facilities and
services, cell culture, media preparation, glassware washing,
biosafety equipment and services, photography and illustration
services, secretarial pools, centralized word processing, clinical
pharmacology and toxicology, immunology, virology, cell and molecular
biology or immunoparameter testing services, special animal colonies,
amino acid analysis, HPLC facilities, cell sorting, chemical and drug
synthesis, NMR facilities, protein chemistry, radioisotope
facilities, mass spectrometry labs, flow cytometry, electron
microscopy, neuroimaging facilities, PCR facilities, neurobehavioral

o  Alterations and Renovations.  Alteration and renovation of an
existing structure to provide suitable facilities in which to conduct
the programs of the AIDS Center may be funded by the CFAR/CSG within
the limits set by PHS grants policy if there is adequate
justification for such costs.  Requests for alterations and
renovations related to containment facilities must be consistent with
and limited to the level of containment (i.e., BL2, BL2+, or BL3)
that is actually required to conduct the research comprising the CFAR
Funded Research Base, as described in accepted NIH guidelines for
working safely with HIV.  (See HHS publication No. (NIH) 88-8395,
Biosafety in Microbiological and Medical Laboratories, J.H.
Richardson and W.E. Barkley, eds., May 1988 (or current edition)
which is available from the Government Printing Office, Washington,
DC 20402 at a cost of $4.00 per copy.  When ordering, refer to GPO
stock number 017-40-508-3.)

The policy of PHS permits up to 100 percent of the costs of
alterations and renovations to be charged to a CFAR, if there is
adequate justification for such renovation, in accordance with PHS

o  Salaries.  The requested percentage of an individual's salary may
not exceed the percentage of effort devoted specifically to the
Center.  Information substantiating this level of effort must be
included in the application.  All requested personnel costs should be
thoroughly justified in the CFAR/CSG application.

o  CFAR Director.  This grant may provide partial salary of the
Director of the CFAR.  Requests for salary support are limited to 35
percent of the total salary.

o  Core Directors.  Core Directors are CFAR members who are
responsible for the maintenance of the Core facility with which they
are charged.  Partial salaries for Core Directors may be provided by
this award.  Requests for salary support are limited to 10 percent of
the total salary.

o  Investigators Funded through Developmental Grants.  CFAR
investigators awarded a developmental grant may qualify for up to 50
percent full salary support by the CFAR Developmental award for a
period of time not to exceed three years.  Established investigators
whose research is supported by R01-type funding, and who are awarded
funding for small, pilot studies will not qualify for salary support
by this mechanism.

o  Administrative, Secretarial, and Technical Support.  A maximum of
1.5 FTE positions for a chief administrator and/or secretarial and/or
administrative assistance for the CFAR office and Director (for
matters pertaining to the CFAR) may be supported by the CFAR/CSG
award.  In addition, applicant institutions may also request salary
support for technicians providing services to maintain a Core or to
provide a service to investigators using the Core facility.

o  Other Administrative Costs

This category includes the costs necessary for the central
administration and fiscal management of the Center, including
relevant and reasonable costs for reprints, graphics and
publications, especially for developmental grantees.  As per standard
NIH policy, those costs may not duplicate or replace costs included
in the parent institution's indirect cost base or already funded by
another award.

o  Planning and Evaluation

Limited costs for planning and evaluation of center activities are
allowable, such as costs of an External Advisory Committee (see
Special Instructions document, "Centers for AIDS Research/Core
Support Grant (CFAR/CSG) - Special Instructions for Preparation of
Competing Applications"), and ad hoc scientific and technical

o  Travel

One meeting per year for all CFAR Directors and one senior scientist
per Center will be held at the NIH (or at a site designated by NIAID
and by NIMH) during which time improvements to Centers, problems,
collaborations among Centers and significant findings will be

Applicants should include travel funds specifically for this meeting
when they prepare the CFAR administration core budget request.

Applicants may request up to $5000 for travel beyond the funds
required for the Annual Directors' Meeting for investigators funded
under the Developmental Core, or other CFAR investigators.



NIH policy requires that applicants for NIH clinical research grants
and cooperative agreements 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 compelling
rationale MUST be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group, together with a rationale
for its choice.  In addition, gender and racial/ethnic issues should
be addressed in developing a research design and sample size
appropriate for the scientific objectives of the study.  This
information must be included in the form PHS 398 in items 1-4 of the
Research Plan AND summarized in item 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 U.S.
racial/ethnic minority populations [i.e., Native Americans (including
American Indians or Alaskan Natives), Asian/Pacific Islanders,
Blacks, and Hispanics].  The rationale for studies on single minority
population groups should be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
disease, 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,
clinical samples which may be coded for use by the applicant but
could be identified by another source are not excluded.  Every effort
should be made and documented 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 applicants.

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 questions 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 will be reflected in assigning the priority score to the

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

NOTE:  Peer review groups need adequate information about the
composition of proposed study populations in all applications
involving human subjects.  To avoid delays in review of such
applications, the NIAID advises that, as a minimum, the application
should contain demographic data about the clinic and/or in-patient
population from which study subjects will be drawn:  average hospital
admissions per year; percentage distribution of Black/Hispanic/other
minority/non-minority populations; gender; etc.  Studies using
non-hospital populations, such as community-based studies, should
provide similar data about populations in the area or region from
which the study subjects will be drawn.  In the absence of current
data, historical demographic information and/or previous recruitment
data for similar studies from the proposed study sites should be


Prospective applicants are requested to submit, by July 16, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the names of key members of the proposed CFAR and their
institutions, a descriptive title of each Core Components.  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 and NIMH staff to estimate the potential review workload
and to avoid conflict of interest in the review.  The letter is to be
sent to Dr. Dianne Tingley at the address listed under INQUIRIES.


Applications are to be submitted using form PHS 398 (rev. 9/91),
available in the office of sponsored research of most academic or
research institutions and from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333
Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301)

Applicants are encouraged to request the supporting document for the
GRANT (CFAR/CSG) GUIDELINES - Special Instructions for Preparation of
Competing Applications" for all information required for preparation
of the CFAR/CSG application from DAIDS program staff listed under

The RFA label available in the 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 review.  In addition, the RFA title
and number must be typed on line 2a of the face page of the
application form and "YES" must be checked.

Applicants must submit a signed, typewritten original of the
application, including the Checklist, and three signed, exact
photocopies, in one package to:

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

At time of submission, two additional copies of the application must
also be sent under separate cover to Dr. Dianne Tingley at the
address listed under INQUIRIES.


Upon receipt, applications will be reviewed by the Division of
Research Grants (DRG) for completeness.  Those judged to be
incomplete will be returned to the applicant without further
consideration.  Those considered to be non-responsive by program
staff will be returned without review.  All applications received in
response to this RFA will be assigned to the appropriate institute
based on the referral guidelines and may be reviewed by separate
scientific review groups formed by the NIAID and NIMH.

Those applications that are complete and responsive may be subjected
to a triage by a NIAID and/or NIMH peer review group to determine
their scientific merit relative to other applications received in
response to this RFA.  The NIAID and NIMH will withdraw from
competition those applications judged to be non-competitive for award
and will notify the applicant and institutional business officials.

Those applications judged to be competitive will be further reviewed
for scientific and technical merit by a review committee convened by
the Division of Extramural Activities, NIAID and/or NIMH.  The second
level of review will be provided by the National Advisory Allergy and
Infectious Diseases Council or the National Advisory Mental Health

Specific review criteria for the CFAR/CSG, as recommended by the May
1992 ad hoc Review Committee for the CFAR/CSG program include, in
order of importance:

1.  The scientific excellence of the Center's AIDS and AIDS-related,
peer-reviewed Funded Research Base (its strengths, its breadth and
depth).  This includes the following:

o  The presence of a critical mass of AIDS-related research.  The
applying institution must have a level of funding not less than
$800,000 (direct costs) which includes a minimum of six individual
awards.  This Funded Research Base must be from NIAID funded research
if the CFAR/CSG award is made by NIAID and must be 60 percent NIMH
funded research if the CFAR/CSG is made by NIMH.

2.  Interdisciplinary coordination and collaboration.  The applicant
institution should provide at least four specific examples from
existing individual basic and clinical research projects
demonstrating how the CFAR will fulfill its mandate to promote
interdisciplinary coordination and collaboration to maximize
productivity, including how the CFAR will effectively:

o  Promote the timely development of basic discoveries into
applications in the clinical setting;

o  Promote the translation of observations in the clinical
environment back into the research laboratory;

o  Encourage the use of Cores by scientists representing several
disciplines or approaches to AIDS or AIDS-related research.

3.  The commitment of the parent institution to the objectives and
goals of the CFAR.  The CFAR should be recognized as a formal
organizational component within the parent institution.  This

o  A demonstration of its institutional commitment to the success of
the Center by providing resources for the CFAR including appropriate
space and personnel.

o  A willingness to adapt the provided resources to adequately
address the changing needs of the CFAR;

4.  The qualifications, experience, and commitment of the CFAR
Director and Core Directors.  This includes:

o  The CFAR Director should currently be a Principal Investigator of
one or more peer-reviewed, AIDS or AIDS-related research projects in
the CFAR Funded Research Base.  He/she should have administrative
experience roughly equivalent to a department head.  It is strongly
suggested that the director devote at least 35 percent of his or her
time to the leadership responsibilities of the CFAR.

o  Core Directors should have sufficient knowledge and experience to
direct Core activities.

5.  The appropriateness and relevance of the proposed Cores and their
modes of operation (such as how usage will be prioritized),
facilities, and potential for contribution to ongoing research.  This

o  The mechanism the CFAR will utilize to ensure fair and appropriate
selection of Core users;

o  Documentation of the use, utility, quality control and cost
effectiveness of each Core requested to continue as part of the
Center (for competing continuation applications).

o  Progress will be judged in part on the list of publications
arising from the research supported by the Cores.  At least two users
are required to establish a Core.

However, a greater number of users generally can be evaluated as more
cost effective.

o  The willingness of the CFAR to augment a Charge Back System for
each Core by the end of year 01 of the award.  Additional information
will be provided to the awardees with the Notice of Grant Award.

6.  The appropriateness and effectiveness of the academic environment
and resources in which the activities will be conducted, including
the availability of space, equipment, facilities, and the potential
for interaction with scientists from other departments and
institutions will be reviewed.

7.  The organizational capabilities of the proposed CFAR.

o  Appropriate advisory groups should be proposed such as an External
Advisory Committee to provide appropriate advice regarding evaluation
of current and future directions, which may include requirements for
new Cores and an Internal Advisory Committee, which should have
authority to develop priority setting processes regarding CFAR
membership and recruitment, scientific directions, the use of Cores,
the development of new Cores and appropriate mechanisms for reviewing
the use of and administering of funds for the Developmental programs.

8.  The developmental and educational commitment of the proposed
CFAR.  The commitment of the CFAR to the development of investigators
new to AIDS and AIDS-related research, and the funding of pilot
projects will be evaluated.

o  The mechanism by which the CFAR will select awardees for
Developmental funding after the award is granted, such as through an
Internal Review Committee, will be evaluated for fairness and ability
to identify the candidates with most chance of this award leading to
independent funding through R01 equivalent awards.  The CFAR is
encouraged to use a mechanism which is similar to the requirements
candidates will be required to use when applying for independent
funding after termination of the Developmental award.

o  The progress of awardees who have received Developmental funding
will be reviewed in competing renewal applications: whether the
investigator has received peer-reviewed funding following the
termination of the Developmental Award, if the research has led to
publications or answers to critical issues and if the investigator
has remained in AIDS or AIDS-related research.

9.  Appropriate and effective mechanisms of fiscal administration,
procurement, property and personnel management, planning, budgeting,
internal evaluation and other appropriate capabilities will be
evaluated.  In addition, procedures for recruitment of new
individuals responsible for conducting essential CFAR functions and
maintenance of CFAR members will be reviewed.

The four optional activities of CFARs, if included as components of
the application, will be evaluated.  These elements of the CFAR/CSG
application are desirable and strongly encouraged but are not
required for the award.

o  The appropriateness of the choice of a Thematic Area will be
evaluated in terms of its ability to identify the primary focus of
the CFAR and effectiveness in promoting interdisciplinary cooperation
and collaboration, and its contribution to the CFAR/CSG program as a

o  The proposed mechanism for support of minority investigators will
be evaluated.

o  The prevention and educational commitment of the CFAR, including
seminars for scientists within and outside of the CFAR and
educational programs for non-scientists will be evaluated.

o  The commitment of the CFAR to the identification of solutions to
problems in recruitment and retention of women and minorities in AIDS
clinical trials will also be evaluated.

The following six milestones will be used to evaluate each CFAR near
the end of year three of the award to permit funding to be continued
for years four and five:

o  Interdisciplinary coordination and collaboration, especially
between clinical and basic research investigators.  The CFAR should
demonstrate active and significant scientific cooperation and
collaboration, especially between clinical (including behavioral) and
basic investigators.  Collaborative projects which involve clinical
and basic research should begin to demonstrate translation of
research findings between the clinic and the laboratory.

o  Synergistic scientific collaboration.  The CFAR should provide
four specific examples from ongoing research that demonstrates how
the CFAR has fulfilled its mandate to promote synergistic
interdisciplinary coordination and collaboration to maximize
productivity.  The Center should demonstrate that the CFAR promotes
more effective and efficient research than can be achieved with a
group of R01-equivalent grants which do not have the benefit of
CFAR/CSG support.  The CFAR should also demonstrate the equitable
usage of each Core Support Facility among CFAR members.

o  Organizational capabilities.  The CFAR should have established the
required mechanism, such as an Internal Advisory Committee, to
provide appropriate advice regarding general maintenance of the
Center, such as prioritization of Core usage, CFAR membership, and
regular exchange of scientific and administrative information.  More
global concerns, such as research directions which should also be
supported by the CFAR/CSG and establishment new Core Support
Facilities, should also be effectively addressed by the appropriate
mechanism, such as an External Advisory Committee.

o  Institutional commitment.  The parent institution should be able
to have demonstrated its commitment to the CFAR by providing required
resources such as appropriate space and personnel.  In addition, as
required, the parent institution should demonstrate active interest
in modification of the above elements should the evolving needs of
the CFAR require additional resources or services not initially
required at the beginning of the award.

o  Developmental and educational commitment.  By the end of year
three, the CFAR should be able to demonstrate significant results
from the award of developmental funds to Investigators New to AIDS
Research or Pilot Projects, and several Centers may be able to
describe scientific achievements obtained through the Evolving
Research Opportunity funding.  This might be through results leading
to applications for independent, peer-reviewed funding, or
publications.  Educational programs consisting of workshops or
seminars for AIDS investigators within and outside of the CFAR should
be established.  Educational programs for the layman and community
should also be in place as well as community outreach programs.

o  Effective use of the Charge Back System.  The CFAR should have
established Charge Back Systems for each Core Support Facility by the
end of year one of the CFAR/CSG and at the end of year three these
should be functioning efficiently.  CFAR funds that are no longer
being used to support Cores established at the beginning of the award
could then be available for Developmental funding or may be applied
toward the development of new Core Support Facilities.


The NIAID anticipates making 9 to 11 P30 awards as a result of this
RFA, while NIMH anticipates making two awards.  The final number and
specific amounts of awards to be made will depend upon consideration
of the following:  initial scientific and technical merit review as
judged by peer review; significance and relevance to NIAID or NIMH
program goals in microbiology, infectious diseases, immunologic
diseases, behavior change and prevention, psychological aspects of
HIV infection and AIDS; national needs and program balance; evidence
and degree of collaboration in proposed work; and policy and
budgetary considerations, including availability of funds.


It is essential that prospective applicants carefully review the RFA
and accompanying instructions on preparation of the application.
Prior to preparing an application, prospective applicants are
strongly encouraged to contact NIAID or NIMH staff.

Direct inquiries regarding programmatic issues and RFA requirements

Dr. Robert H. Bassin or Dr. Janet M. Young
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 2B31
Bethesda, MD  20892
Telephone:  (301) 402-0755
FAX:  (301) 480-5703

Dr. Leonard Mitnick or Dr. Willo Pequegnat
Office on AIDS
National Institute of Mental Health
5600 Fishers Lane, Room 15-99
Rockville, MD  20857
Telephone:  (301) 443-7281
FAX:  (301) 443-9719

Inquiries regarding fiscal matters may be addressed to:

Ms. Jane Unsworth
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

Ms. Diana Trunnell
Grants Management Branch
National Institute of Mental Health
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-3065
FAX:  (301) 443-6885

Inquiries regarding review matters, the letter of intent, and two
copies of the application are to be addressed to:

Dr. Dianne Tingley
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


Letter of Intent Receipt Date:  July 23, 1993
Application Receipt Date:       September 17, 1993
Scientific Review:              December 1993
Review by NAAIDC and NMHAC:     February 1994
Anticipated Award Date:         March 1994


This program is described in the Catalog of Federal Domestic
Assistance Nos. 93.856 - Microbiology and Infectious Diseases
Research, 93.855 - Immunology, Allergic and Transplantation Research,
and 93.242 - Mental Health Research Grants.  Grants are awarded 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 the PHS grants policies and Federal
Regulations, most specifically in 42 CFR 52 and 45 CFR Part 74.
Under authority of Section 301 of the Public Health Service Act, as
amended PL 78-410, 42 U.S.C. 241, the National Institute of Mental
Health provides support for Clinical Research Centers.  This program
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.


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