Full Text AI-93-05

INTERNATIONAL COLLABORATIONS IN INFECTIOUS DISEASE RESEARCH

NIH GUIDE, Volume 22, Number 1, January 8, 1993

RFA:  AI-93-05

P.T. 34

Keywords: 
  Infectious Diseases/Agents 
  Tropical Medicine 


National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  April 12, 1993
Application Receipt Date:  July 13, 1993

PURPOSE

The National Institute of Allergy and Infectious Diseases (NIAID)
plans to continue its efforts in international health through a
program of collaborative biomedical research on infectious diseases
that are primarily endemic in or profoundly impact upon the health of
people living in the tropics.  The Parasitology and Tropical Diseases
(PTD) Branch of the Division of Microbiology and Infectious Diseases
(DMID), NIAID, therefore invites cooperative agreement applications
for International Collaborations in Infectious Diseases Research
(ICIDR).  The intent of this program is to bring together relevant
biomedical knowledge and technology to develop new approaches for the
detection, prevention and treatment of infectious diseases of
recognized relevance to the health of people living in tropical
countries; to increase relevant research experience for both U.S. and
foreign investigators; and to enhance opportunities for scientific
linkages and interaction between U.S. and foreign investigators
through regularly scheduled meetings coordinated by the PTD Branch.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), International Collaborations in Infectious
Disease Research, is related to the priority area of immunization and
infectious diseases.  Potential applicants may obtain a copy of a
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-O) 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 non-profit and for-profit
organizations, public and private, such as universities, medical
colleges, hospitals, laboratories.  Minority individuals and women
are encouraged to participate as Principal Investigators.  The U.S.
applicant institution is responsible for developing an affiliation(s)
with an established institution (e.g., university, research
institute, federal or state health department, hospital) in the host
country.  Research activities on this project conducted at the
foreign affiliate must be supported by the award made to the
U.S.-based institution.  For the application to be considered, the
domestic applicant institution must include proof of having an
off-site component as a foreign base of operations and one or more
specified employees of the foreign institution(s) as
co-investigators.  The proposed research programs must be acceptable
to the resident (foreign) scientists and to the advisory group(s) of
their particular institution.  The application will not be reviewed
unless proof of such a foreign affiliation is included.

In addition, it will be necessary to establish a working agreement
with the government of the host country to expedite deputation of
personnel, equipment, and supplies from the U.S. to the off-site
facility.  The agreement may be developed directly between the
domestic applicant institution and representatives of the foreign
government, or it may be more convenient for the domestic component
to arrange such an agreement through a regional organization such as
the Pan American Health Organization or the relevant office of the
World Health Organization.  Proof of such an agreement must be
submitted to Dr. Olivia Preble, at the address listed under
INQUIRIES, no later than two months after the application receipt
date in order to assure its availability prior to review.

MECHANISM OF SUPPORT

Successful applicants funded under this RFA will be supported through
cooperative agreements (U01).  This type of funding mechanism is
utilized when it is desired to encourage investigator-initiated
research projects in areas of special importance to NIAID and when
substantial programmatic involvement by NIH staff is anticipated.
This RFA represents a single competition with a specified deadline
for receipt of applications.

A.  Support for this program will be through the cooperative
agreement (U01) funding instrument.  These are interactive assistance
relationships in which an ongoing collaborative relationship exists
between NIAID staff and the investigators.  The nature of NIAID
Program involvement is further described under "Terms of Award:
Awardee Rights and Responsibilities; Nature of Participation of NIAID
Staff".  The awardee will be responsible for the planning, direction
and execution of the proposed project and interrelated activities.
Except as otherwise stated in this RFA, the award will be
administered under PHS grants policy as stated in the Public Health
Service Grants Policy Statement, DHHS Publication No. (OASH)
90-50,000, revised October 1, 1990.  The total project period for
applications submitted in response to this RFA may not exceed five
years.  The earliest possible award date is May 1, 1994.

Reissuance of this RFA is uncertain.  If, by the end of the third
year of the award, NIAID has not announced its intent, due to budget
uncertainties, to reissue the RFA, incumbents of multicomponent U01s
should contact program staff before preparing a recompeting
application to seek advice on the most appropriate method of
application submission.

B.  The cooperative agreement (U01) funding instrument can support
projects of either a multicomponent (program project-like) or single
component nature, and both types of applications will be considered
by NIAID.  Single component applications should focus on a discrete,
circumscribed objective.  Multicomponent programs consist of a
minimum of three interrelated research projects.  Multicomponent
programs should be multidisciplinary and have a central research
focus to which each component is related and makes a contribution.
For the purpose of this RFA, ICIDR Directors are defined as Program
Directors of the multicomponent programs and as Principal
Investigators of the single project programs.

Applications for multicomponent programs should describe in detail
their organizational and administrative structure.  Multicomponent
programs may take advantage of the "core" mechanism to provide
support for common resources (e.g., laboratory or clinical
facilities).  It is understood that support for such facilities will
be included in the budget of a single component application as
required.  Because the nature and scope of the research proposed in
response to this RFA may vary, it is anticipated that the size of the
award will vary also.  Applications for multicomponent programs
should not exceed $500,000 in annual direct costs, while single
component applications should not exceed $175,000 in direct costs
annually.

C.  Research at the foreign affiliate institution will be supported
by the U.S. applicant institution through a consortium arrangement,
and the programmatic, fiscal and administrative agreements involved
should be described within the application.  The applicant
organization's administrative support must provide the necessary
management for the transfer of funds and material to the off-site
component.  Indirect costs will not be paid on any expense incurred
by the foreign institution(s).  Travel, salaries, and fringe benefits
will be subject to the applicant institution's rules and regulations.

Regarding travel, it is expected that scientists from the U.S.
institution will travel to the foreign affiliate for long-term
collaborations (involving periods of at least six months each) with
the resident scientists in research on problems of local health
importance.  Senior scientists with major institutional
responsibilities in the U.S. may spend shorter periods of time, e.g.,
one to two months several times a year, working at the foreign site
with their associates.

It is permissible to travel and support foreign professionals and
selected technical staff for short visits to the U.S. institution to
obtain relevant research experience and training.  Provision should
also be made for the ICIDR Director to travel to the annual meetings
of the NIAID International Centers for Tropical Disease Research
(ICTDR), to be held in the Washington, DC area.  Such anticipated
travel costs should be identified in advance and built into the
budget of the ICIDR proposal.

Applications must also include a Visiting Investigator constituent,
under which a pool of funds will be set aside and restricted to cover
costs for the exchange of scientific personnel to conduct short-term
research projects or to learn new technology related to the
objectives of the ICIDR project.  Conditions qualifying for these
funds would include:  (1) unanticipated requirement for travel of
ICIDR personnel between the domestic and foreign component
institutions, (2) travel of ICIDR personnel to other laboratories,
including but not restricted to other ICIDR projects or other members
of the ICTDR network; and (3) travel of other U.S. investigators,
including but not restricted to other members of the ICTDR network,
to the foreign component of the ICIDR project.  Visiting investigator
funds should be used for projects of no longer than three months
duration.  In multicomponent program applications, the visiting
investigator program should be treated as a "core" and should not
exceed $30,000 per year to cover the costs of travel, housing and
research supplies.  In single component applications, the Visiting
Investigator program should reside in the travel portion of the
budget, and should not exceed $10,000 per year.  This portion of the
ICIDR application will be reviewed primarily on the basis of the
methods proposed for soliciting and selecting nominees.  The ultimate
nomination process will involve submission to NIAID by the ICIDR
Director of a one-page description of the project to be carried out.
Each nomination will be reviewed by a committee composed of the NIAID
Program Officer and Scientific Coordinators, who will advise the
ICIDR director and his collaborators on final approval of selections.
It is the NIAIDs intent under the Visiting Investigator program to
provide a flexible means to enhance scientific exchange between the
ICIDR projects and other investigators working in the area of
tropical disease research and to increase opportunities to obtain
research experience in endemic areas.

FUNDS AVAILABLE

The estimated funds (total costs) available for the first year of
support for all ICIDR awards are $3.5 million.  It is anticipated
that at least five awards will be made under this mechanism.
Applications for multicomponent programs should not exceed $500,000
in annual direct costs, while single component applications should
not exceed $175,000 in direct costs annually.

RESEARCH OBJECTIVES

Background

Tropical diseases constitute major public health problems
disproportionately affecting populations residing in developing
countries.  Diseases caused by protozoan and helminth parasites
plague billions of people, killing millions annually and inflicting
irreversible debilitating injuries such as blindness and
disfiguration on additional millions.  Their economic impact is
enormous, and is often cited as a key impediment to further social
and economic progress in these regions.  According to a recent report
of the World Health Organization, at least 500 million people, the
equivalent of one person in ten worldwide, are estimated to be
infected with one or more of the five major tropical parasitic
diseases malaria, schistosomiasis, filariasis, trypanosomiasis, and
leishmaniasis.

Bacterial, viral and fungal infections are also of concern in
tropical regions, resulting in such important health problems as
measles, AIDS, diarrhea, tuberculosis and other respiratory diseases,
leprosy and hemorrhagic fevers.  Some of these bacterial and viral
illnesses also occur commonly in developed countries, however, and in
contrast to diseases caused by parasites, effective prevention
methods already exist for some of them.

The magnitude of many tropical disease problems in endemic areas is
generally increasing, due to changing ecological patterns and
development of resistance to previous methods of control.  Tropical
diseases are of increasing global concern as tourism, trade, business
travel, immigration and military activities extend their impact into
industrialized countries.  The number of U.S. citizens traveling
overseas is increasing annually.  While most cases of tropical
diseases currently reported in this country are imported, affecting
people who have traveled in endemic regions, the potential for
transmission of some of these infections continues to exist within
the U.S.

Fulfillment of its mission to control such diseases requires that
NIAID have the capacity to carry out research on tropical infectious
diseases in endemic areas.  The improvement of scientific linkages
between U.S. and foreign investigators also stimulates
self-sufficiency of the collaborating foreign institution and
strengthens the scientific infrastructure for further international
collaborative arrangements.

Scope of Research

The purpose of this RFA is to stimulate high quality collaborative
tropical disease research.  Basic and clinical research appropriate
to this RFA would apply the disciplines of biochemistry, immunology,
genetics, pharmacology, molecular biology, microbiology, zoology and
medical entomology, as well as infectious diseases, pathology,
epidemiology or other clinical or public health specialties relevant
to a specific tropical disease.

The research to be supported by this RFA will focus on those
infectious diseases primarily endemic in or profoundly impacting upon
people living in the tropics, including but not limited to protozoan
and helminth infections, mycobacterial diseases, bacterial and viral
enteric infections, and arboviral infections.  Studies of human
immunodeficiency virus (HIV) infection in developing countries are
supported by other NIAID activities, and will not be considered in
response to this solicitation.  Studies of the impact of HIV
infection on the clinical course and outcome of these other tropical
diseases will, however, be considered.

The overall research goals of this RFA are:  (1) to obtain increased
information on the factors influencing distribution of infection and
resulting clinical outcome and (2) to develop and test new
intervention strategies that will contribute to the control of these
diseases.  It is the intent of the program to support the conduct of
biomedical research that can only be performed outside the U.S., and
thus, an emphasis on population-based studies would be appropriate.
It is anticipated that these studies may involve such topics as
diagnosis and natural history of infection (including the role of
vectors and reservoir hosts), chemo-or immunotherapy, chemo- or
immunoprophylaxis, pathogenesis and vector control.

Investigators will choose the tropical disease agent(s) that they
prefer to study, and U.S. applicant institutions will make their own
arrangements for a mutually acceptable affiliation with one or more
collaborating foreign institutions located in or near regions where
tropical diseases are endemic.  The majority of the research effort
must take place in the endemic area.  Investigators from the foreign
institution(s) must be substantially involved, inasmuch as it is
intended that there be active collaboration between domestic staff
and scientists of the foreign affiliate(s).

SPECIAL REQUIREMENTS

Awardee Rights and Responsibilities; Nature of Participation of NIAID
Staff

Successful applicants (ICIDRs) will be designated as components of
the NIAID International Centers for Tropical Disease Research
(ICTDR), which constitutes a network of NIAID-supported activities in
tropical diseases (ICIDRs, Tropical Disease Research Units, Tropical
Medicine Research Centers and Intramural NIAID Center for Tropical
Disease Research (see Appendix).  Each ICIDR director will serve as a
member of the ICTDR Coordinating Committee, which is composed of the
directors of these tropical disease programs.  ICIDR directors will
represent their program at annual centers meetings organized by
NIAID.  These meetings will be held to share advances in tropical
disease research among the ICIDR projects and other NIAID-tropical
disease units, to discuss research needs and opportunities in this
arena, and to facilitate the development of new collaborative
protocols that may include multi-center studies.  To encourage
cross-fertilization of ideas and facilitate exchange of scientific
personnel, a Visiting Scientist component will be included in these
applications to provide for short-term travel of ICIDR personnel to
other research institutions, or of other U.S. investigators to ICIDR
facilities for the purpose of conducting specific research projects.
The members of the ICTDR Coordinating Committee plan the agenda in
consultation with NIAID staff, and following the meeting, make
recommendations to the Institute concerning needs in the area of
tropical disease research.

Under the cooperative agreement, a partnership relationship exists
between the recipient of the award and NIAID according to the
guidelines and conditions set forth in the RFA.  Investigators are
expected to define research objectives and methods in accord with
their own interests and perceptions of novel and exploitable
approaches to research that ultimately is likely to contribute to the
prevention and control of tropical diseases.

Terms and Conditions

It is the primary responsibility of each Principal Investigator to
define objectives and approaches, and to plan, conduct, analyze, and
publish results, interpretations, and conclusions of their studies.
NIAID may periodically review and generate internal reports from data
and progress reports developed under this cooperative agreement.  The
data obtained will, however, be the property of the awardee.

It is the responsibility of the awardee to maintain a mutually
acceptable arrangement with the foreign affiliate institution and
host country.  It is intended that publications resulting from
collaborative research supported under this award will be co-authored
by the involved foreign scientist(s) and that the data will be made
readily available to the government of the host country.  The awardee
should ensure that all requirements for the protection of human
subjects, including the negotiation of human subject assurances for
clinical studies performed at the foreign institution, are adhered to
as described in 45 CFR Part 46.  Studies involving human subjects
which are conducted at the foreign site must adhere to current
guidelines and policies in effect within the United States.
Questions regarding these policies may be directed to the Office of
Protection from Research Risk (OPRR).  (See INQUIRIES for address and
phone numbers).

Normal programmatic and stewardship responsibilities will be assumed
by the NIAID International Tropical Disease Research Program Officer.
In addition, NIAID anticipates substantial programmatic involvement
during the performance of a Cooperative Agreement.  NIAID staff will
work closely with the ICIDR investigators.  However, the role of
NIAID will be to facilitate and not to direct the activities.  For
each ICIDR, NIAID will be represented by a Scientific Coordinator,
who will be a Program Officer within DMID.  During performance of
this award, the NIAID Scientific Coordinator may work with the ICIDR
to provide appropriate assistance, advice and guidance in:

o  the overall design and planning of ICIDR research activities,
including suggestion of studies within the scope of the ICIDR's
objectives and research activities;

o  selection of sources or resources, including provision of
biological supplies, or reagent production and clinical testing
facilities available through NIAID sources;

o  replacement of staff, including authorization of key personnel
changes;

o  coordination, collection and/or evaluation of data;

o  technical and management performance of ICIDR activities;

o  preparation of publications;

o  selection of candidates for award of visiting investigator funds.

NIAID will support and enhance coordination among the ICIDRs through:

o  facilitation of information exchange between ICIDRs, other members
of the ICTDR network as well as other investigators and agencies
engaged in tropical disease research;

o  provision of new research reagents and technologies or of other
important resources and information that may not otherwise be
available to the individual ICIDRs;

o  mechanisms to reduce of duplication of efforts both between ICIDRs
and with other extramural projects.

The NIAID will coordinate annual meetings of the ICIDR directors in
the context of the yearly ICTDR meetings in the Washington, DC area.
These meetings will provide a forum for the ICIDR directors to share
research advances, discuss needs and opportunities in tropical
disease research with NIAID staff and other investigators, and
develop collaborations and multicenter studies.  Applicants should
include a statement indicating their willingness to participate in
these activities, and include plans to attend these meetings in their
budget requests.

NIAID staff are responsible for preparing and disseminating
information on the most recent advances in the field resulting from
the meeting.  At the annual meeting, NIAID Scientific Coordinators
are able to meet with their specific ICIDR units and to provide
assistance and advice.  Additional ad hoc meetings or workshops for
ICTDR network participants will also be organized by NIAID staff, as
requested by the Coordinating Committee, in conjunction with other
major national meetings.  NIAID scientific coordinators serve a staff
function for the ICTDR Coordinating Committee; they do not have a
vote on matters pending before the Coordinating Committee.

In the event that research supported by the Cooperative Agreement
results in development of a therapeutic or other medical
intervention, NIAID will retain the option to cross-file or
independently file an application for investigational clinical trial,
i.e., an Investigational New Drug Application (INDA) to the United
States Food and Drug Administration.  Reports of data generated by
the ICIDR that are required for inclusion in the INDAs and for
cross-filing purposes will be submitted in final draft form by the
ICIDR director to the Scientific Coordinator upon request.

Arbitration Panel

It is anticipated that decisions in all activities outlined within
this RFA will be reached by consensus of the investigators and that
the 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 ICIDR director.  Should
any difference of opinion arise, an arbitration panel, composed of
one NIAID designee, one ICIDR designee and a third member selected by
these two, will be established to review any scientific or
programmatic issue that is significantly restricting progress.  This
arbitration process in no way affects the right of an award recipient
to appeal post award administrative decisions in accordance with PHS
regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45
CFR Part 16.

These 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 Part 74, and other HHS, PHS, and
NIH grant administration policy statements.  NIH reserves the right
to withhold funds should any of the terms of the award not be
implemented.

Applicants should describe plans to accommodate these stated program
requirements, criteria and staff involvement.

STUDY POPULATIONS

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

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

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must 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
(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in
Section 5, Human Subjects.  Applicants are urged to assess carefully
the feasibility of including the broadest possible representation of
minority groups.  However, NIH recognizes that it may not be feasible
or appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority populations
(i.e., Native Americans [including American Indians or Alaskan
Natives], Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups must
be provided.

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

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

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

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

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

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

LETTER OF INTENT

Prospective applicants are asked to submit, by April 12, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the names and affiliations of proposed key investigators,
and the number and title of the RFA in response to which the
application may be submitted.  The letter of intent is requested in
order to provide an indication of the number and scope of
applications to be reviewed.  This does not commit the sender to
submit an application, nor is it a requirement for submission of an
application.

The letter of intent is to be sent to Dr. Olivia Preble at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398 (rev. 9/91).
Application kits are available at most institutional offices of
sponsored research and may be obtained from the Office of Grants
Inquiries, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone
(301) 496-7441.  Applicants must adhere to the format and
requirements specified in the PHS 398 application kit.  In addition,
applicants for multicomponent programs are strongly advised to read
the information brochure "Program Project and Center Grants, NIAID"
which accompanies each RFA.  The brochure describes the format for
large multidisciplinary grants, outlines review criteria for such
programs, and includes other important information that will aid in
preparation of the application.

For purposes of identification and processing, mark "yes" in item 2a
on the face page of the application and type in the RFA number
AI-93-05 and the title, INTERNATIONAL COLLABORATION IN INFECTIOUS
DISEASES RESEARCH.  The RFA label available in the form PHS 398 must
be affixed to the bottom of the face page of the original
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.

The signed, typewritten original of the application, including the
Checklist, and three exact copies must be sent to:

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

At the time of submission, two additional copies must be sent to:

Dr. Olivia Preble
Chief, Microbiology and Immunology Review Section
Program and Project Review Branch
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C-20
Bethesda, MD  20892

To ensure their review, applications must be received by both the
Division of Research Grants (DRG) and Dr. Olivia Preble by July 13,
1993.  Applications not received on the official date will be
considered non-responsive and will be returned to the applicant.  The
DRG will not accept any application in response to this announcement
that is essentially the same as one currently pending initial review
by any other NIH awarding unit, unless the applicant withdraws the
pending application.

REVIEW CONSIDERATIONS

Review Procedures

Applications will be reviewed by DRG staff for completeness and by
NIAID staff to determine administrative and programmatic
responsiveness to the RFA.  Those judged to be incomplete or
nonresponsive will be returned to the applicant without review.
Those considered complete and responsive may be subjected to a triage
review by an NIAID peer review group to determine their scientific
merit relative to the other applications submitted in response to
this RFA.  This triage may be conducted before or during the initial
review committee meeting.  The NIH will withdraw from competition
those applications judged by the triage peer review group to be
noncompetitive for award and will so notify the applicant
investigator and the institutional business official.

Those applications judged to be competitive for award will be
reviewed for scientific and technical merit by a Review Committee
convened by the Division of Extramural Activities, NIAID.  The second
level of review will be provided by the National Advisory Allergy and
Infectious Diseases Council.

Review Criteria

The factors to be considered in scientific review of the application
are:

1.  Scientific merit of research approach, design, and methodology as
well as the potential scientific, technical or medical significance
of the proposed research.

2.  Scientific appropriateness and administrative adequacy of the
proposed affiliation with the foreign institution(s) and host
country.

3.  Research experience and competence of the Principal
Investigator(s) and other staff to conduct the proposed studies.

4.  Adequacy of the time (effort) which the Principal Investigator(s)
and staff would devote to the proposed studies.

5.  Adequacy of facilities, both at the domestic and foreign
institutions, including, if relevant to the proposed research,
adequacy of the clinical facilities and patient availability for
clinical studies.

6.  Adequacy of mechanisms proposed for visiting investigator
component.

AWARD CRITERIA

It is the desire of the NIAID to fund a group of applications that
together will provide research opportunities on the broadest possible
spectrum of tropical diseases.  While scientific merit is a prime
consideration in the selection of applications for awards, program
balance will also be considered.  Insofar as possible, every effort
will be made to achieve a geographic distribution of ICIDR
cooperative agreements that adequately reflects the occurrence of
tropical diseases.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Dr. Michael Gottlieb
Parasitology and Tropical Diseases Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A-37
Bethesda, MD  20892
Telephone:  (301) 496-7115
FAX:  (301) 402-0804

Send the letter of intent and direct any questions regarding review
procedures to:

Dr. Olivia Preble
Chief, Microbiology and Immunology Review Section
Scientific Review Branch
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C-20
Bethesda, MD  20892
Telephone:  (301) 496-8208
FAX:  (301) 402-2638

Direct inquiries regarding fiscal matters to:

Mr. Todd Ball
Chief, Microbiology Grants Management Section
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A-37
Bethesda, MD  20892
Telephone:  (301) 496-7075
FAX:  (301) 480-3780

Questions concerning policies for studies involving human subjects
may be directed to:

Chief, Assurance Branch
Office for Protection from Research Risks
National Institutes of Health
Bethesda, MD  20892
Telephone:  (301) 496-7041
FAX:  (301) 402-0527

Schedule

Letter of Intent Receipt Date:      April 12, 1993
Application Receipt Date:           July 13, 1993
Scientific Review Date:             November 1993
Council Meeting Date:               February 1994
Earliest Award Date:                May 1, 1994

AUTHORITY AND REGULATIONS

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

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