Full Text AI-92-09


NIH GUIDE, Volume 21, Number 19, May 22, 1992

RFA:  AI-92-09

P.T. 34

  Sexually Transmitted Diseases 
  Biology, Molecular 

National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  August 7, 1992
Application Receipt Date:  November 18, 1992


The Sexually Transmitted Diseases Branch of the Division of
Microbiology and Infectious Diseases (DMID) of the National Institute
of Allergy and Infectious Diseases (NIAID) invites grant applications
for program project grants to conduct basic research on the molecular
nature of the human immune response to sexually transmitted diseases
(STDs).  The NIAID wishes to expand research in this area to develop
molecular strategies to prevent infection, transmission, disease, and
disease progression by immunization.  Of particular interest is the
integration of the disciplines of immunology and microbiology leading
to productive interdisciplinary approaches that elucidate the basis of
protective immunity to sexually transmitted infections.


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), Research on Molecular Immunology of Sexually
Transmitted Diseases, is related to the priority area of sexually
transmitted diseases.  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. 017-001-10473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).


Applications may be submitted by domestic non-profit and for-profit
research institutions; public and private organizations such as
universities, colleges, hospitals, laboratories, units of State and
local governments, and eligible agencies of the Federal Government.
Applications from minority individuals and women are encouraged.


Successful applicants funded under this RFA will be supported through
a National Institutes of Health (NIH) program project grant (P01).
This type of funding mechanism is utilized to encourage
interdisciplinary investigator-initiated research designed to elucidate
various aspects or components of a central research objective, in areas
of high priority to the NIAID.  This RFA solicitation represents a
single competition with a specified deadline for receipt of
applications.  Although there are no present plans to reissue this RFA
at any future time, the NIAID may invite competitive renewal
applications upon expiration of the initial funding period, contingent
upon the availability of funds for this purpose.  If the NIAID does not
solicit competitive renewal of the program project, the participating
project Principal Investigators should consider the submission of
discrete but interactive R01s sharing a common theme.


The NIAID anticipates making two program project grant awards as a
result of this RFA.  The final number of awards to be made is dependent
upon the availability of funds.  The budget request for the initial
year's total costs (direct and indirect) may not exceed $1 million for
each application.  Applicants may request budgets of up to five years
of support.  Although the current NIAID policy is to limit the duration
of program projects to four years, it is possible that the duration may
be extended.  The earliest possible award date is July 1993.  Funding
beyond the first and subsequent years of the award will be contingent
upon satisfactory progress during the preceding years and upon
availability of funds.



Despite control efforts to prevent spread of STDs, including human
immunodeficiency virus (HIV) infection, both bacterial and viral STDs
remain epidemic in many areas of the United States.  Current estimates
predict that in 1992 there will be 10 to 13 million new cases of STDs.
Related health care costs are likely to exceed $5 billion.

Although curative therapy is available for some of these acute
infections, many individuals go on to develop serious complications and
chronic disease.  Furthermore, sexually transmitted infections have
also been implicated in increased risk of HIV transmission.  Recent
studies indicate that the more prevalent non-ulcerative STDs, as well
as ulcerative diseases, increase the risk of HIV transmission at least
three to five-fold.

Three strategies are central to the prevention and control of STDs:
diagnosis and treatment, behavioral intervention, and vaccination.
Since each of these strategies has limitations both in efficacy and
implementation, a comprehensive control program utilizing all three
components is necessary. Vaccines are strategically important for
preventing both viral diseases for which there is no curative treatment
and bacterial diseases for which antibiotic resistance is common or for
which symptoms are so indolent that the patient neither seeks nor
receives effective therapy.  Most desirable are vaccines that prevent
infection; however, vaccines may play a critical role in reducing
transmission, ameliorating disease, or interrupting disease

Unfortunately, except for Hepatitis B, there are no vaccines for STDs.
STD vaccine development is extremely difficult and complex for reasons
related primarily to (1) the nature of the host-pathogen relationship,
and (2) the consequences of co-infection with more than one sexually
transmitted pathogen.  As obligate pathogens of humans, the etiologic
agents of these diseases have evolved to effectively avoid, subvert, or
ignore the immunodominant host response through strategies including:

o  phase variation:  the ability to turn on and off the synthesis of a
surface component/antigen;

o  antigenic variation:  the ability to synthesize a particular antigen
from a large repertoire of antigenic types;

o  surface microheterogeneity:  the ability to vary surface immuno-
accessibility of antigens among organisms within a population, e.g.,
the sporadic distribution of the H.8 antigen on gonococci within a
single bacterial colony or within microcolonies in urethral exudate;

o  elicitation of immunodominant responses that are not protective:
the ability to present surface antigens that do not result in
protective immunity.  Instead, the immune response often results in
avoidance or subversion of host defenses.  For example, the generation
of blocking antibodies during gonococcal infection, or the generation
of detrimental humoral or cellular responses to heat shock protein
during chlamydial infection.

Furthermore, the presence of several infections in the reproductive
tract is likely to complicate vaccine development as pre-existing STDs
compromise epithelial barriers through tissue fragility, induction of
inflammatory cytokines, and the recruitment of target cells, such as
lymphocytes (in the case of HIV), thereby lowering the infectious dose
and compromising vaccine

Programmatic Interests and Requirements for ROMIS Program Projects

Research Objectives

A fundamental objective of the Institute's STD research program is to
develop vaccines effective in preventing and controlling STDs.  This
requires focused interdisciplinary research to create effective
molecular level strategies for eliciting protective immunity.
"Molecular" is used here in the broadest sense to mean the interaction
between molecules of the pathogen and the host; this is not limited to
molecular genetics.

Research Scope

A wide range of research questions must be answered in order to meet
this programmatic objective.  Research issues and areas of high
priority to the NIAID and to this RFA include, but are not limited to,
the following:

1.  Molecular specificity and function of immune responses

What is the function of the immune response to infection?  Does
protective immunity occur as the result of infection?  Since the
surface of any given pathogen is a mosaic of antigens, and any given
antigen is a mosaic of epitopes, it is essential to separate and
characterize the specificity of protective and non-protective humoral
and cellular immune responses occurring in sexually transmitted

2.  Immunity of the reproductive tract

How can protective immunity be induced in the reproductive tract?
Given that protection against infection is absolutely dependent upon
functional (i.e., protective), neutralizing antibodies at mucosal
surfaces, the phenotype (including isotype), source, and specificity of
these antibodies must be described.  The role of CD4, CD8, and CD16
cells as well as other effector cells in protective immunity must be

Can humoral and/or cellular immunity be induced that offers partial
protection, i.e., reduces transmission, ameliorates disease, or
prevents disease progression?

What are the kinetic parameters of protective immune responses and how
can protective immunity be enhanced both in terms of efficacy and
longevity?  It is necessary to characterize and compare protective
immunity stimulated by direct inoculation of regional mucosal surfaces,
other mucosal surfaces (e.g., oral), and parenteral routes.  The role
of cellular immunity in this process must be delineated.

What are the differences between the immune responses of the male and
female reproductive tract?  How do reproductive hormones influence
infectivity and the host response to infection?  What is the role of
regional immunity in prevention or manifestation of sexually
transmitted infections?  Currently, little is known about the
immunology of the female reproductive tract, and even less is known
about the male reproductive tract.  Does partial immunity play a role
in asymptomatic disease, and if so, can this be correlated with the
higher prevalence of silent infections in women compared to men?

3.  Diseases of interest

Applicants are strongly encouraged to submit research projects that
address the following diseases of high scientific priority to the NIAID
and to this RFA:

Chlamydial infection and gonorrhea:  As etiologic agents of PID,
development of vaccines for chlamydial infection and gonorrhea are of
the highest priority.  This urgency is in recognition of the high rates
of morbidity and the significant socio-economic costs associated with
pelvic inflammatory disease (PID).  Special emphasis is placed on
chlamydial infections because they are often silent in women and
chlamydial PID more often results in tubal scarring and related

Human papillomavirus infection:  The development of vaccines for the
relatively limited number of sexually transmitted HPV types associated
with progression to serious disease, (e.g., types 16, 18, 31, and 33),
is a priority because of the widespread prevalence and marked increase
of HPV-related disease in the last decade.

Syphilis:  Of all the STDs, syphilis should be one of the easiest to
control because the cases are clustered, and good diagnostic tests as
well as effective treatments are available.  However, the epidemic of
the eighties underscores the need to develop effective vaccines and
behavioral interventions.  The epidemiology of syphilis suggests that
protective immunity does occur, although the specific mechanisms are
unknown.  Furthermore, there is evidence to suggest that the immune
system also plays a significant role in the pathogenesis of syphilis;
additional research must be conducted to delineate the role of the
immune response in this disease.

Genital Herpes:  Human studies involving three different herpes
vaccines suggest that it may be possible to ameliorate disease
frequency and severity through vaccination.  Special emphasis should be
placed on delineating the role of the immune system in preventing
primary infection, preventing the establishment of latency, and
preventing transmission to neonates.

4.  Emphasis on populations at risk - women, minorities and adolescents

Applicants are strongly encouraged to characterize the immune response
in women both because of the gaps in our understandings of the female
reproductive tract and because of the disproportionate burden of STD
morbidity (e.g., infertility, ectopic pregnancy, cervical cancer, fetal
wastage, low birth weight, and congenital/perinatal infection) that is
borne by women and their perinatally infected children.

Additionally, STDs greatly impact the health of minority populations
and youth in the United States.  Both the incidence of STDs and the
incidence of the long-term and potentially fatal sequelae are
consistently higher among African and Hispanic Americans than among
white Americans.  Moreover, numerous epidemiological studies have
documented high prevalence of STDs and STD sequelae in youth -- of the
projected 10 to 13 million cases of STDs occurring this year, 63
percent are expected to occur in people younger than 25 years old.  For
these reasons, applicants are strongly encouraged to study STDs in
populations that are at greatest risk; these populations include women,
inner city minorities, adolescents, and infants.


To facilitate effective research approaches to further the
understanding of protective immunity leading to vaccine development,
specific application requirements and constraints for structuring
Research on Molecular Immunology of Sexually Transmitted Diseases
(ROMIS) program projects are as follows:

1.  Collaborative interdisciplinary approach

Because one of the primary objectives of this RFA is to stimulate
collaboration between microbiologists and immunologists, each proposed
project must combine microbiological and immunological approaches.
Microbiological disciplines to be drawn from include bacteriology,
parasitology, and/or virology.

2.  Central focus on human immune response

Because virtually all STD pathogens are obligate pathogens of a single
host (human beings), and because our understanding of the specific
nature of the relationship of these microbes with their human host is
incomplete, the central focus of all ROMIS program projects must be
study of the human immune response to sexually transmitted infections.

3.  Clinical Facility and Study Population

The program project must have a strong clinical facility with an
accessible patient population that is appropriate to answering STD
research questions.  This population must be characterized with respect
to other sexually transmitted pathogens including, but not limited to,
Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema palladium, HPV,
HSV, and HIV.  Costs for establishing and/or maintaining the study
population should be included as a separate clinical core within the
proposed budget.

4.  Required number of diseases or syndromes

Research may be designed to focus on several STD pathogens, or may
focus entirely on a single STD pathogen.  Interdisciplinary study of
several pathogens presents opportunities to design projects that
reflect the high frequency of co-infection within patient populations
as well as the potential to understand the interactive nature of co-
infections in the context of immune response.  It is also recognized,
however, that interdisciplinary, in-depth study of a single pathogen
may provide unique opportunities for accelerated advances in scientific
understanding of immune function.  Therefore, the number of pathogens
proposed for study is less important than the quality of the science
that is proposed within applications.

5.  Study of HIV

HIV is not a pathogen of interest under this RFA, although study of the
natural history of STDs in an HIV-positive population is permissible if
the emphasis is on the role of the altered immune system on the course
of the STD(s) under investigation.

6.  Epidemiological and Biostatistical Aspects of Study Design

Detailed description of the epidemiological characteristics of the
study population including demographics and relevant clinical profiles
is necessary.  Statistical power considerations and data analysis plans
should be detailed.  The use of multivariate techniques to look at
independent variables such as race and gender, controlling for possible
confounders and considering possible interaction with other factors, is

7.  Structure of Program Projects

The required structure and format of P01 applications is found in the
NIAID Program Projects and Center Grants Brochure that is available
from Dr. Olivia Preble at the address listed under "LETTER OF INTENT".

further clarification.)  At a minimum, two of these projects, and
preferably three, must involve the study of some aspect of the humoral
or cellular immune response in humans.  It is permissible for the third
project (or additional projects) to involve study of relevant STD
animal models; however, emphasis on comparison to the human immune
response is encouraged.

Role of Program Director and Organization of Projects:  The Director of
the Program Project will be responsible for the overall direction and
administration of the total program project.  It is the Program Project
Director's responsibility to promote effective coordination and strong
interaction among the research staff of individual projects.

Each project should have clearly defined research objectives, a
separately identifiable budget, and a research staff headed by a
project leader.  It is the primary responsibility of the project leader
to clearly state the objectives and approaches of the project, to plan
and conduct the research stipulated in the application, and to ensure
that the results obtained are analyzed and published in a timely

8.  Allowable Costs

Award funds may be utilized to support the following research-related

Scientific and Professional Personnel Costs:  The requested percentage
of an individual's salary may not exceed the percentage of effort
devoted specifically to activities associated with the ROMIS program
project grant. Information substantiating this level of effort must be
included in the application.

Administrative Costs:  This category includes the costs necessary for
the central administration and fiscal management of the program
project, such as salaries of the Chief Administrator and secretarial
support.  Those costs may not duplicate or replace costs included in
the institution's indirect cost base.

Shared Research Resources (Cores):  Shared Research Resources or cores
must serve at least two research projects.  The ROMIS program project
grant may include core funds for equipment, supplies, and services to
expand and/or maintain clinical, laboratory, or biostatistical

Study Population Costs:  The costs necessary for establishing,
characterizing and/or maintaining a study population appropriate for
answering the proposed STD research questions should be requested as
clinical core funding.  This clinical core will include monies for
clinic personnel, supplies/equipment, study-related patient care,
patient reimbursement and ancillary costs, laboratory-related
microbiological, and immunological diagnostic tests and analyses.  As
with other cores, this shared research resource should serve at least
two research projects.

Other Costs:  In addition to the above categories, budget requests
within each project may include research-related costs for supplies,
funds for limited investigator travel, and costs of publication.  Since
the program project cannot provide funds for new construction, adequate
physical facilities must be available to meet the primary needs of the

General Clinical Research Center (GCRC):  An applicant whose
institution has an NIH-supported GCRC funded by the NIH National Center
for Research Resources may wish to utilize the GCRC for conducting the
proposed research.  In such a case, a letter of agreement from either
the GCRC program director or Principal Investigator must be included
with the application.



NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 under Research
Plan items 1-4 and 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 United States racial/ethnic
minority populations [i.e., Native Americans (including American
Indians or Alaskan Natives], Asian and Pacific Islanders, Blacks,

The rationale for studies on single minority population groups must be

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.

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 will be 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.  (For
further specifics see "Research Scope" item 4 -- Populations at Risk)


Prospective applicants are asked to submit, by August 7, 1992, a letter
of intent that includes a descriptive title of the overall proposed
research program and the name, address, and telephone number of the
Principal Investigator, the names of the proposed project leaders and
other key personnel and participating institutions, 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.  The letter of
intent is not binding, 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
Chief, Microbiology and Immunology Review Section
Scientific Review Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
9000 Rockville Pike
Solar Building, Room 4C-20
Bethesda, MD  20892
Telephone:  (301) 496-8208


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these program project grant awards.  These forms are
available at most institutional business offices and the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD  20892, telephone

Before preparing the application, the brochure entitled "Information
Brochure on NIAID Program Projects and Center Grants" should be
carefully read.  It contains instructions on formatting program project
applications, review criteria, and other useful information.  Requests
for the brochure and questions concerning instructions are to be
addressed to Dr. Olivia Preble at the address indicated above.

The RFA label available in the PHS 398 application form must be affixed
to the bottom of the face page of the application. Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee in time for review.  In addition,
"Research on the Molecular Immunology of Sexually Transmitted Diseases,
RFA AI-92-09" must be typed on line 2a of the face page of the
application form and the "YES" box must be marked.

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

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

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

Dr. Olivia Preble
Chief, Microbiology and Immunology Review Section
Scientific Review Branch
Division of Extramural Affairs
National Institute of Allergy and Infectious Diseases
9000 Rockville Pike
Solar Building, Room 4C-20
Bethesda, MD  20892

Dr. Preble, is 6003 Executive Blvd., Room 4C-20, Rockville, MD  20852.

Applications must be received by both the Division of Research Grants
(DRG) and Dr. Preble by November 18, 1992. Applications received after
November 18, 1992 will be returned to the applicant without review.
The DRG will not accept any application in response to this
announcement that is the same as one currently pending initial review,
unless the applicant withdraws the pending application.  The DRG will
not accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an introduction addressing the previous critique.  Nor does it
preclude the concurrent submission of component projects as independent
R01s; however, should both the P01 and the R01 applications be
recommended for funding, the R01 must be relinquished in favor of the
P01, to preserve the latter's strength and integrity.



Applications will be received and reviewed for completeness by DRG.
Incomplete applications will be returned to the applicant without
review.  Applications will be reviewed by NIAID staff to determine
administrative and programmatic responsiveness to this RFA; those
judged to be non-responsive will be returned to the applicant without

Those applications considered responsive to the RFA may be subjected to
a triage review by an NIAID peer review group, before or during the
initial review committee meeting, to determine the scientific merit
relative to the other applications submitted in response to the RFA.
The NIAID will withdraw from further competition those applications
judged by the triage peer review group to be non-competitive for award,
and will notify the Principal Investigator and institutional official.

Those applications judged to be competitive will be reviewed for
scientific and technical merit by a review committee convened by the
NIAID in March 1993.  The second level of review will be provided by
the National Advisory Allergy and Infectious Diseases Council in May
1993.  The earliest award date is July 1993.

Summary of Application Requirements:  General Review Considerations

PROJECTS.  It should be emphasized that for a program project
application to be considered for funding, NIH requires a minimum of
THREE research projects in that application to have been judged by the
peer review group as having "significant and substantial merit."  Each
individual research project must be scientifically meritorious in its
own right and must also demonstrate the essential elements of unity of
theme, interdependence, and synergy.  A project intended primarily to
establish, characterize, and maintain the study population will not be
considered a research project, and funds to support such activity
should be requested in the "Core."

Particular attention must be given to the following areas when
preparing applications:

1.  The detailed description of each research project should
demonstrate how it contributes to the attainment of the program project
objectives. Furthermore, in addressing the organization and
administrative structure of the program project grant, the mutually
reinforcing inter-relationships among the investigators must be clearly
described.  This section must include an organizational chart showing
the name, the organization, and the scientific discipline of the
Principal Investigator, the Project Leaders, and the key personnel for
the projects and cores.

2.  In describing the clinical and laboratory facilities available to
conduct each project, specific information should be included on the
institution's present STD patient load and projections for patient
involvement, diagnostic laboratory capabilities, and on the
availability of appropriate biohazard facilities and safety procedures.

3.  Included in information under the "Other Support" section must be
an explicit written plan that explains how applicant Principal
Investigators who also hold Principal Investigator status on other
grants and contracts from any source (particularly on Center, Training,
or other program project grants) will be able to successfully and fully
meet the responsibilities demanded by all endeavors.

4.  The application must include a signed letter of agreement from each
collaborator and/or consultant to the program project indicating (1)
willingness to participate in the program, and (2) the exact nature of
the participation.  In addition, a letter co-signed by the Principal
Investigator, the Institution's Budget Official, and the Dean must
detail a specific plan by which indirect costs and/or shared resources
will be distributed to institutions collaborating with the awardee

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

Summary of Application Requirements:  Specific Review Considerations

In addition to the minimum requirements for applications stated above,
applications must satisfy the specific programmatic requirements that
are summarized below.  These requirements appear in greater detail in
PROJECTS" section, and applicants are urged to review this section.

1.  Collaborative interdisciplinary approach:

Each proposed project must combine microbiological and immunological

2.  Central focus on human immune response:

Minimally two, and preferably three, of the proposed projects must
involve the study of some aspect of the human humoral or cellular
immune response to sexually transmitted infections.

3.  Clinical facility and study population:

All ROMIS program project applications must have a strong clinical
facility with an accessible patient population appropriate to answer
STD research questions.  Characterization of the patients must include
a microbiological evaluation of sexually transmitted infections,
including, but not limited to, Chlamydia trachomatis, Neisseria
gonorrhoeae, Treponema palladium, HPV, HSV, and HIV.

4.  Study design:

Study design must reflect epidemiological/biostatistical expertise
including statistical power considerations and data analysis.

Applicants are strongly encouraged to consider the following within
ROMIS program project applications:

1.  Diseases of interest:

Chlamydial infection, gonorrhea, HPV, syphilis, and HSV.  HIV is not a
pathogen of interest under this RFA unless the emphasis is on the role
of the altered immune system on the course of the STD(s) under

2.  Populations at risk:

Special emphasis should be placed on studying STDs in populations that
are disproportionately affected:  women, inner city minorities,
adolescents, and infants.


Scientific merit and technical proficiency, based on the demonstrated
and projected capabilities described in the application in response to
the RFA, will be the predominant criteria for determining funding
priorities.  It should be emphasized that NIH policy limits
consideration of funding of program projects to those with no less than
three research projects that have been judged by a peer review group to
have "significant and substantial" merit.  After applications have been
reviewed by the National Advisory Allergy and Infectious Diseases
Council, NIAID staff reserves the right to give consideration to the
following additional factors in the final selection of applications to
be funded:  pathogen(s) that are proposed for study; the potential
impact on health of women, minorities, and adolescents; and geographic
distribution of the awards.


Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcomed.  Investigators seeking information about
programmatic issues may contact:

Dr. Penelope J. Hitchcock
Acting Chief, Sexually Transmitted Diseases Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
9000 Rockville Pike
Solar Building, Room 3A-21
Bethesda, MD  20892
Telephone:  (301) 402-0443

Questions regarding fiscal matters may be addressed to:

Mr. Todd Ball
Grants Management Branch
National Institute of Allergy and Infectious Diseases
9000 Rockville Pike
Solar Building, Room 4B-22
Bethesda, MD  20892
Telephone:  (301) 496-7075

Questions regarding review policies and procedures may be addressed to
Dr. Olivia Preble at the address and telephone number given in the


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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