Release Date:  January 24, 2000

RFA:  AI-00-009 (This RFA has been reissued and modified, see RFA-AI-06-006)

National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date: May 1, 2000
Application Receipt: June 27, 2000



The National Institute of Allergy and Infectious Diseases (NIAID), 
National Institutes of Health (NIH) invites applications for 
multiproject center grants from institutions in geographic areas where 
tropical infectious diseases are endemic. It is the NIAID's objective 
to develop a flexible tropical disease research network that can be 
responsive to emerging scientific needs and challenges in the field of 
tropical infectious diseases. The purpose of the Tropical Medicine 
Research Centers (TMRCs) program is to support high quality centers for 
research that will lead to or result in prevention, amelioration, 
and/or treatment of tropical infectious diseases and thus improve the 
health and quality of life of individuals in endemic areas. It is 
envisioned that this program will enhance opportunities for relevant 
experience in tropical disease research and will promote scientific 
linkages and interaction between U.S. and foreign investigators.  Each 
TMRC will be included as a component of the NIAID's network of 
International Centers of Tropical Disease Research (ICTDR).


The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a 
PHS-led national activity for setting priority areas.  This Request for 
Applications (RFA), Tropical Medicine Research Centers, is related to 
the priority areas of immunization and infectious diseases.  Potential 
applicants may obtain a copy of "Healthy People 2010" at


Non US and non-European organizations and institutions located in the 
tropics in or near an area endemic for tropical infections are eligible 
to apply. Applications may be submitted by for-profit and non-profit 
organizations, public and private institutions, such as universities, 
colleges, hospitals, laboratories and government agencies in the host 
country.  To achieve the goals identified in the application, 
subcontract or consortium arrangements are permitted with other 

It will be necessary for each TMRC to demonstrate a working 
relationship with the appropriate government organization in the host 
country.  It may also be convenient to develop a collaborative 
association with an organization such as the Pan American Health 
Organization or the World Health Organization.

Only institutions with strong ongoing research programs will be 
considered for TMRC support under the provisions of this RFA.  
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.


The mechanism of support will be the specialized center grant (P50). 
This mechanism supports all phases of research ranging from basic and 
developmental aspects to applied field and clinical research. The 
spectrum of activities comprises a multidisciplinary attack on a 
specific disease entity or biomedical problem area.  Unless 
specifically stated to the contrary herein, all policies and 
requirements that normally govern the grant programs of the NIH will 

The responsibility for leadership of each TMRC rests with the Program 
Director (PD) who must possess demonstrated scientific and 
administrative competence.  The PD should be located at and affiliated 
with the institution at which the TMRC will reside.  The PD is expected 
to contribute at least 40% effort to the program and exercise 
leadership in program development and integration, quality control, 
administration, and scientific collaboration within the program.  If 
desired, an U.S. Co-PD may be designated.  Participation of a US 
investigator is not a requirement of the program.

Each TMRC must consist of three or more scientifically meritorious 
projects whose interrelationships will result in a greater contribution 
to the program goals than if each project were pursued individually.  
There must be a unifying, well-defined goal or problem area of research 
to which each project relates and contributes, thereby producing a 
research environment that allows each project to benefit from the 
creative strengths of the others. Each research project included in the 
application must, as assessed by peer review, stand on its own 
independent scientific merit, as well as complement the other projects.  
Each of the individual projects within the TMRC will be under the 
leadership of an established, non-US or non-European, investigator who 
will be the principal investigator (PI) for the specific project.  
Principal investigators are expected to expend at least 25% effort on 
their individual projects.  All investigators must contribute to, and 
share in, the responsibilities of fulfilling the objectives of the 
TMRC.  To enhance the individual projects as well as the program goals 
it is envisioned that each TMRC, under the direction of the Program 
Director, will schedule regular bi-weekly or monthly meetings to foster 
scientific cooperation and collaboration.  Common shared resources 
e.g., laboratory or clinical service facilities will be requested as 
cores.  Such cores should be utilized by two or more projects within 
the TMRC.  In addition provision for an administrative core with 
detailed arrangements for financial management is a requirement of the 
Responsibility for the planning, direction, and execution of the 
proposed research plan will be solely that of the applicant.  The total 
requested period of support may not exceed five years. These P50 
applications should not request budgets in excess of $600,000 total 
costs per year.  It is the policy of the NIH that facilities and 
administrative (F&A) costs will not be paid to organizations located 
outside of the territorial limits of the United States.  The earliest 
anticipated award date is June 2001.


The estimated total funds available for the first year of support for 
this RFA will be $1.75 million.  In fiscal year 2001, the NIAID plans 
to fund approximately three center grants related to this RFA.  This 
level of support is dependent on the receipt of a sufficient number of 
applications of high scientific merit.  Although this program is 
provided for in the financial plans of the NIAID, awards pursuant to 
this RFA are contingent upon the availability of funds for this 
purpose.  Funding beyond the first and subsequent years of the grant 
will be contingent upon satisfactory scientific progress during the 
preceding years and availability of funds.  Satisfactory progress will 
be assessed by NIAID staff, including review of material presented in 
annual reports and at a required annual reverse site visit.  At this 
time, the NIAID has not determined whether or how this solicitation 
will be continued beyond the present RFA.



Infectious diseases represent a tremendous public health threat for 
people living in tropical and subtropical regions of the world and are 
responsible for limiting individual productivity and socioeconomic 
development.  Infectious diseases remain a major cause of death in 
developing countries. It is estimated that 20 percent of the world's 
population carries a helminthic parasite infection, and that 10 percent 
are infected with those parasites causing malaria, schistosomiasis, 
filariasis, leishmaniasis or trypanosomiasis. Greater than 70% of 
deaths in children less than five years of age and greater than 40% of 
deaths in developing countries are due to infectious and parasitic 
infections.  Enteric infections, caused by viruses, bacteria and 
protozoa, including mycobacterial infections such as leprosy, are 
responsible for immeasurable global morbidity and mortality.  Childhood 
mortality rates in tropical developing countries are five times higher 
than those in industrialized countries.  This difference is to a large 
extent attributable to the prevalence of diarrheal and acute 
respiratory diseases.

The morbidity and mortality of many tropical disease problems in 
endemic areas are increasing, due to changing ecological patterns 
leading to an increase in incidence and prevalence as well as new 
pathogens, drug resistance, and failure of currently available control 
measures. Moreover, tropical diseases are of increasing global concern 
as tourism, trade, business travel, immigration and military activities 
extend the range of infectious agents and invertebrate vectors.  

Many fundamental questions about host pathogen interaction remain 
unanswered.  Moreover, advances in biomedical technology and genomics 
have opened up exciting possibilities for the development of vaccines, 
chemo- and immuno- therapeutics, and transmission control methodologies 
for all the major tropical diseases.  The need for sustained research 
support in these areas persists, especially for those clinical and 
field efforts dependent upon access to populations of pathogens, 
patients and invertebrate vectors.   To address these needs the NIAID 
initiated the competitive TMRC program in 1991. Currently there are 
three TMRCs.

Scope of Research

Projects to be supported by this RFA will focus on infectious diseases 
primarily endemic in or profoundly impacting people living in the 
tropics and emphasize research requiring access to human, pathogen, and 
vector populations.  Diseases of interest include, but are not limited 
to, those resulting from infection with protozoa and helminth 
parasites, enteric bacteria and viruses, arboviruses, and bacterial 
meningitis.  Emphasis is placed on those diseases for which recent 
discoveries and developments require facilities and infrastructure for 
further testing and evaluation in the field and in the clinic.  Studies 
focusing on human immunodeficiency virus (HIV) infections and 
tuberculosis in developing countries are supported by other NIAID 
activities, and will not be considered in response to this 

Each TMRC should bring together relevant biomedical knowledge, 
technology, and expertise in tropical infectious diseases with the 
ultimate goal to develop and test new diagnostic and intervention 
strategies.  The TMRC program is intended to support research requiring 
access to populations.  Relevant research activities include projects 
on clinical, epidemiological and field aspects of tropical diseases as 
well as supportive basic research related to the biology of host-
infectious agent interactions.  Relevant disciplines include but are 
not limited to genetics, immunology, pharmacology, bacteriology, 
virology, parasitology, clinical science, and medical entomology.  The 
goals of the research projects should support the development and 
evaluation of diagnostic tests, immunotherapeutic and 
immunoprophylactic measures, chemotherapeutic and chemoprophylactic 
methods, and vector and other control strategies that may be deployed 
as part of national control efforts.

Projects may involve collaboration among investigators at several 
institutions.  Consortium arrangements should follow the NIH Guide 
outlined in "Guidelines for Establishing and Operating Consortium 
Grants, January 1989."  These are available from the program staff 
listed under INQUIRIES.


Research at the applicant institution in the endemic area will be 
supported directly by NIAID.  Fiscal and administrative arrangements 
for the transfer of funds and materials to the applicant institution 
and for the management of these funds and materials must be described 
in detail in the application under a required administrative core.  
Applications should budget approximately $50,000 for the 
administrative/fiscal core that should focus on financial management 
and accounting. Fiscal core funds can be utilized to purchase the 
appropriate hardware and software for required accounting procedures. 
Applicants must work with a U.S. University or the NIAID in the 
administrative core, as funds must be first distributed to a United 
States Bank. The NIAID Grants Management Office must approve final 
arrangements before an award is made and will be available to answer 
inquiries regarding these arrangements (see Inquires). An initial start 
up meeting of the TMRC program directors will be required early in year 
one at the time of the 2001 ICTDR network meeting to convey information 
on NIH requirements for human subject research and fiscal arrangements. 

Successful TMRCs 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. Each TMRC program director will represent his/her TMRC at the 
annual meeting of the ICTDR network organized by NIAID.  These meetings 
will be held to share advances in tropical disease research among the 
TMRC projects and other NIAID supported tropical disease research 
programs and activities, to discuss research needs and opportunities in 
this arena, and to facilitate the development of new collaborative 
protocols that may include multi-center studies.  Each TMRC will have a 
required annual reverse site visit at the NIH in Bethesda.  Thus, 
provision should be made for the TMRC Program Director to make two 
trips to Bethesda each year.  Such anticipated travel costs should be 
identified in advance and built into the budget of the TMRC 
application.  Other TMRC personnel are encouraged, but not required, to 
attend the ICTDR meetings, and travel support will be at the discretion 
of the TMRC.

Applications must also include a Visiting Investigator component, which 
should be described as a separate Core constituent.  Under the terms of 
this Core, provision will be made by the TMRC for visiting 
investigators to spend up to one year in residence to study tropical 
disease problems of their own interest or participate in ongoing 
programs of the TMRC. This provision is intended to afford 
opportunities for tropical disease research experience at the TMRC 
primarily to U.S. scientists or other members of the ICTDR network.  
The application should detail: the facilities available at the 
applicant institution to host visiting investigators, the procedures to 
be used to advertise the program and to recruit such visiting 
investigators, and the method by which their research projects will be 
evaluated and approved.  Those selected will require the approval of 
NIAID program staff.  Funds allotted to the visiting investigator core 
should not exceed $50,000 per year to cover the anticipated costs of 
travel, supplies, and salary.  Funds initially designated for this core 
are restricted for this purpose and cannot be re-budgeted to other 
programs within the Center.  The TMRC Program Director is expected to 
include plans for the visiting scientist in his/her annual reverse site 
visit at the NIAID.

Applicants must be aware of policies and procedures for the conduct and 
oversight of clinical research studies and of clinical trials.  NIH 
defines all biomedical and behavioral research involving human subjects 
as clinical research.  All human subject research is subject to the 
NIAID’s terms of award requirements (see appendix), which include 
requirements for protocol review, safety and site monitoring.  Clinical 
protocols involving human subjects will be reviewed at two stages of 
development, early (during the concept stage) and later close to 
protocol completion, for: scientific content, design, safety, 
feasibility, statistical and regulatory issues such as adverse 
experience reporting mechanisms and informed consent. 

All TMRC protocol documents for clinical trials should, at minimum, 
include the following sections: an introduction, including background 
and rationale; a statement of the study objectives; criteria for 
selection of subjects, and enrollment procedures; clinical and 
laboratory evaluations to be performed; plans for data management, 
collection, and monitoring, and for reporting of adverse events; a 
complete description of the study treatment; and statistical 
considerations, including general design issues, endpoints, sample 
size, accrual and power, monitoring and analysis, and stopping rules. 
An ICTDR Data Safety and Monitoring Board, to be selected and overseen 
by NIAID, will monitor all Phase III TMRC clinical trials.  All phase I 
and II clinical trails will be monitored by interim monitoring boards 
that will be established jointly by NIAID program staff and the TMRC 


It is the policy of the NIH that women and members of minority groups 
and their sub-populations must be included in all NIH supported 
biomedical and behavioral research projects involving human subjects, 
unless a clear, compelling rationale, and justification are provided 
that inclusion is inappropriate with respect to the health of the 
subjects or the purpose of the research.  This policy results from the 
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should 
read the "NIH Guidelines for Inclusion of Women and Minorities as 
Subjects in Clinical Research", published in the Federal Register of 
March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and 
Contracts, Vol. 23, No. 11, March 18, 1994 which is available via the 
WWW at:


It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research, conducted or 
supported by the NIH, unless there are scientific and ethical reasons 
not to include them.  This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines on the Inclusion of Children as 
Participants in Research Involving Human Subjects" that was published 
in the NIH Guide for Grants and Contracts, March 6, 1998, and which is 
available at the following URL address:

Investigators may obtain copies from these sources or from Elizabeth 
Higgs, (listed in INQUIRIES below) who may also provide additional 
relevant information concerning the policy.


Prospective applicants are asked to submit, by the date listed on the 
face page of this RFA, a letter of intent that includes a descriptive 
title of the overall proposed research, the name, address and telephone 
number of the Principal Investigator, and the number and title of this 
RFA.  Prospective applicants are also asked to submit a list of the key 
investigators and their institution(s). The information in the letter 
of intent allows NIAID staff to estimate the potential review workload 
and to avoidance conflict of interest in the review. The letter of 
intent is neither required nor binding. It does not commit the sender 
to submit an application, nor does it enter into the review. 

All potential applicants are encouraged to contact Dr. Elizabeth Higgs 
listed under INQUIREIES to discuss intended projects.

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


Applicants for P50 grants must follow special application guidelines in 
PROJECT AWARDS (April 1999); this brochure is available via the WWW at:

The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants. Application kits are available at most 
institutional offices of sponsored research and from the Division of 
Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, 
telephone (301) 710-0267, email: Applications are 
also available on the World Wide Web at

For purposes of identification and processing, item 2a on the face page 
of the application must be marked "YES" and the RFA number "AI-00-009" 
and the words "TROPICAL MEDICINE RESEARCH CENTERS" must be typed in.

The RFA label and line 2 of the application should both indicate the 
RFA number.  The RFA label 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.

The sample RFA label available at: has been modified 
to allow for this change.  Please note this is in pdf format.

Applications must be received by the Receipt Date listed on the face 
page of this RFA.  Applications that are not received as a single 
package on the receipt date or that do not conform to the instructions 
contained in PHS 398 (rev. 4/98) Application Kit (as modified in, and 
APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive 
and will be returned to the applicant.  

It is highly recommended that the appropriate NIAID program contact be 
consulted before submitting the letter of intent and during the early 
stages of preparation of the application.  (See program contact under 

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

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express mail or courier service)

At the time of submission, two additional exact copies of the grant 
application and all five sets of any appendix material must be sent to 
Dr. Peter Jackson at the address listed under INQUIRIES.
Concurrent submission of an R01 and a Component Project of a Multi-
project Application: Current NIH policy permits a component research 
project of a multi-project grant application to be concurrently 
submitted as a traditional individual research project (R01) 
application.  If, following review, both the multi-project application 
and the R01 application are found to be in the fundable range, the 
investigator must relinquish the R01 and will not have the option to 
withdraw from the multi-project grant.  This is an NIH policy intended 
to preserve the scientific integrity of a multi-project grant, which 
may be seriously compromised if a strong component project(s) is 
removed from the program.  Investigators wishing to participate in a 
multi-project grant must be aware of this policy before making a 
commitment to the Principal Investigator and awarding institution.


Applicants for P50 grants must follow special application guidelines in 
PROJECT AWARDS (April 1999); this brochure is available via the WWW at:

The brochure presents specific instructions for sections of the PHS 398 
(rev. 4/98) application form that should be completed differently than 
usual.  For all other items in the application, follow the usual 
instructions in the PHS 398 REVIEW CONSIDERATIONS

Review Procedures

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NIAID. Incomplete and/or non-responsive 
applications will be returned to the applicant without further 

Applications that are complete and responsive to the PA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by NIAID in accordance with the review criteria 
stated below. As part of the initial merit review, a process will be 
used by which applications receive a written critique and undergo a 
process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under 
review, will be discussed, and assigned a priority score.  A second 
level of review will be provided by the National Advisory Allergy and 
Infectious Diseases Council.

Review Criteria

The review criteria for P50 center grant applications are the same as 
review criteria for large, multicomponent, interdisciplinary program 
projects as outlined in the brochure, NIAID PROGRAM PROJECT GRANTS AND 

The distinguishing features of a multiproject center grant include:

o  A unifying well-defined goal or problem area of research to which 
each project relates and contributes, thereby producing a research 
environment that allows each research effort to share the creative 
strengths of others.

o  A program director who possesses recognized scientific and 
administrative competence; he/she must show a 40% commitment of time 
and effort to the center and exercise leadership in its quality 

o  Each research project must, as assessed by peer review, stand on its 
own independent scientific merit, as well as complement other projects 
whenever feasible.

o  These multiple projects require the participation of established 
investigators in several disciplines, or investigators with special 
expertise in several areas of one discipline.  All investigators must 
contribute to and share in the responsibilities of fulfilling the 
center's objective.

In addition, the following criteria will be considered in the 
scientific review of the application:

o  Relevance of research approach, design, and methodology to the 
development and evaluation of intervention strategies for the 
prevention, treatment, and control of tropical diseases.

o  Major emphasis on  research requiring access to human, pathogen, and 
vector populations.

o  Adequacy of administrative and financial core.

o  Adequacy of appropriate facilities for laboratory, field and 
clinical studies.  

o  Mechanisms proposed for the visiting investigator component.


Funding decisions will be made on the basis of scientific and technical 
merit as determined by peer review, program needs and balance, and the 
availability of funds.  It is the desire of NIAID to fund a group of 
applications that together will provide a broad spectrum of research 
opportunities for the development, evaluation and deployment of 
intervention strategies for the control of tropical infectious 


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

Requests for the NIAID Information Brochure "NIAID Program Project 
Grants and Multiproject Cooperative Agreements" and for the new "NIH 
CLINICAL RESEARCH" as well as inquiries regarding programmatic issues 
may be directed to:

Dr. Elizabeth S. Higgs
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive, MSC 7630
Bethesda, MD  20892-7630
Telephone:  (301) 496-7115
FAX:  (301) 402-0804

Direct inquiries regarding review issues, address the letter of intent 
to, and mail two copies of the application and all five sets of 
appendices to:

Dr. Peter Jackson
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive, Room 2154 MSC 7616
Bethesda, MD  20892-7616
Telephone:  (301) 496-8426
FAX:  (301) 402-2638

(Fed-Ex Mailings use: Bethesda, MD 20817-7613)

Direct inquiries regarding fiscal matters to:

Ms. Lesia Norwood
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive
Bethesda, MD  20892-7610
Telephone:  (301) 402-6581


Letter of Intent Receipt Date:  May 1, 2000
Application Receipt Date:       June 27, 2000
Scientific Review Date:         October, 2000 
Advisory Council Date:          February, 2001
Earliest Date of Award:         June, 2001


This program is described in the Catalog of Federal Domestic 
Assistance, No. 93.856 - Microbiology and Infectious Diseases Research.  
Awards are made under authorization of the Public Health Service Act, 
Sections 301 and 405 as amended (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.

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
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Bethesda, Maryland 20892
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