SEXUALLY TRANSMITTED DISEASES COOPERATIVE RESEARCH CENTERS

Release Date:  April 1, 1998

RFA:  AI-98-007

P.T.

National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  May 8, 1998
Application Receipt Date:  September 15, 1998

APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED
USING SPECIFIC INSTRUCTIONS IN AN NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR
APPLICATIONS FOR MULTI-PROJECT AWARDS" (September 1997).

PURPOSE

The purpose of this RFA is to stimulate multidisciplinary, collaborative research
to further understanding of sexually transmitted diseases (STDs) and effective
approaches to their prevention and control.  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 recompetition of the Sexually Transmitted Diseases Cooperative
Research Centers (STD CRCs).  The Institute recognizes that although each STD
presents unique diagnostic, therapeutic, and prevention challenges, all STDs
share a common mode of transmission, populations at risk for one STD are at risk
for others, comorbidity is common, and  the presence of one infection may
influence the acquisition and natural history of another.  Therefore, a research
program that addresses these diseases as a group is likely to be highly
productive.  The CRCs (1) provide a multi-disciplinary approach to STD research
by bridging biomedical, clinical, behavioral, and epidemiological research; (2)
foster interaction among STD investigators; and (3) facilitate
intervention-oriented research.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This RFA, Sexually Transmitted Diseases
Cooperative Research Centers (STD CRCs), is related to the priority areas of
sexually transmitted diseases and HIV infection.  Potential applicants may obtain
a copy of "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325 (telephone
202-512-1800).

ELIGIBILITY REQUIREMENTS

Research grant applications may be submitted by domestic for-profit and non-
profit organizations, public and private institutions, such as universities,
colleges, hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  Foreign organizations are not
eligible to apply; however, applications may include an international component. 
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to undertake this program
will be the Multiproject Cooperative Agreement (U19), an "assistance" mechanism,
rather than an "acquisition" mechanism.  Under the cooperative agreement, the NIH
purpose is to support and/or stimulate the recipient's activity by involvement
in and otherwise working jointly with the award recipient in a partner role, but
it is not to assume direction, prime responsibility, or a dominant role in  the
activity.  Essential elements of the multiproject cooperative agreement mechanism
also include: (1) a minimum of three interrelated individual research projects
organized around a central theme; (2) collaborative efforts and interaction among
independent projects and their investigators to achieve a common goal; (3) a
single Principal Investigator who will be scientifically and administratively
responsible for the group effort; (4) a single applicant institution that will
be legally and financially responsible for the use and disposition of funds
awarded; and (5) support provided, as necessary, for "Core" resources or
facilities, each of which is expected to be utilized by at least two research
projects in order to facilitate the research effort.  Details of the
responsibilities, relationships and governance of a study funded under a
cooperative agreement are discussed later in this document under the section
"Terms and Conditions of Award."

The total project period for an application submitted in response to this RFA may
not exceed five years.

FUNDS AVAILABLE

The estimated total funds (direct and indirect) available for the first year of
support for this RFA will be $7.7 million.  In fiscal year 1999, the NIAID plans
to make approximately seven awards related to this RFA.  This level of support
is dependent on the receipt of a sufficient number of applications of high
scientific merit.

Applications may not request budgets in excess of $1.1 million total (direct and
indirect) costs in the first year.  The usual PHS policies governing grants
administration and management will apply.  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 progress
during the preceding years and availability of funds.

At this time, the NIAID has not determined whether or how this solicitation will
be continued beyond the present RFA.

RESEARCH OBJECTIVES

Background

In 1995, an estimated 14 million cases of STDs occurred in the United States. 
Approximately 65% occurred in people under 24 years of age; three million
occurred in teenagers.  Associated health care costs exceeded $ 8 billion.  Women
and their infants bear a disproportionate share of disease burden and long term
sequelae of STDs, including infertility, ectopic pregnancy, cervical cancer,
fetal wastage, low birth weight, and congenital/perinatal infection. 
Additionally, STDs disproportionately impact the health of some minority
populations.  Both the incidence of STDs and their long-term and potentially
fatal sequelae are consistently higher among African and Hispanic Americans than
among white Americans.

-  Chlamydial infection is the most prevalent bacterial STD in the U.S. and a
major cause of pelvic inflammatory disease (PID); over four million cases are
diagnosed annually.  In virtually all studies, adolescents appear to have greater
risk for infection compared to older women.  Cross-sectional studies and data
collected from adolescent and family planning clinics have documented that
adolescents 15-19 years have the highest rates of infection irrespective of
socioeconomic status.  Due to delays in diagnosis or inadequate therapy, 10 to
40 percent of these young women with chlamydial cervicitis develop PID.

-  Gonorrhea, the other major cause of PID, occurs at an annual rate of
approximately 0.5 million new cases, 25 percent of which occur in teenagers. 
Although rates of infection have been steadily decreasing in the last decade,
gonorrhea rates have declined slowly in adolescent populations compared to older
age groups.

-  During the syphilis epidemic of the 1980s, the rate of syphilis increased in
African-American adolescent males and females.  Congenital syphilis rates were
particularly high among pregnant adolescent women because perinatal care is less
frequent in younger women.

-  Trichomoniasis affects over three million American women; in the US and
throughout the world, it is not uncommon to find 25% of these infections in
adolescents.

-  In the U.S., as many as 40 million people are believed to be infected with
human papillomavirus (HPV).  High-risk HPV types are causally associated with
cervical cancer.  Globally, cervical cancer is the most common cause of
cancer-related death in women.  The attack rate for HPV infection in college-aged
women during their first year of sexual activity is 25%, with fewer than two
partners.  In another study of female college students 50% of the young women had
HPV infection.

-  Approximately 65 million Americans are afflicted with genital herpes, caused
by herpes simplex viruses 1 & 2 (HSV).  Genital herpes is a painful, recurrent,
incurable disease with annual costs estimated to exceed $96 million.  Serological
evidence of genital herpes infection suggests that rates increase rapidly during
adolescence.  Estimated annual cases of genital herpes in teenagers and young
adults in the U.S. increased from 15,000 yearly visits in 1966 to about 100,000
by 1995.

-  Both ulcerative and non-ulcerative STDs increase the risk of human
immunodeficiency virus (HIV) transmission approximately 3-5 fold, independent of
the effect of sexual behavior; and HIV infection, which decreases immune
function, may alter the natural history and increase the prevalence of some STDs. 
One in five cases of AIDS is diagnosed in young people 20-29 years of age; given
the length of the incubation period between HIV infection and onset of AIDS,
arguably all of these people became infected as teenagers.

Research Objectives and Scope

In spite of decades of STD prevention and control programs and STD research,
rates of infection continue to grow. The alarming dimensions of STDs and related
health problems described above point to the need for more effective research
that will lead to essential tools for preventing and controlling STDs, especially
in adolescent populations.  The 1996 report of the Institute of Medicine,  "The
Hidden Epidemic -  Confronting Sexually Transmitted Diseases" identified
adolescents as an under-served population that requires special emphasis in both
STD research and STD service delivery.  The report encourages efforts in
prevention that are dependent upon the development of new biomedical tools
(vaccines, topical microbicides and diagnostic tests), interventions and
paradigms that are likely to be more effective for prevention and control of STDs
in adolescent populations.  The STD CRCs have been developed as multi-
disciplinary research efforts that integrate clinical observations into basic
biomedical research; apply the findings of basic research to the development of
improved diagnostics, therapeutics, vaccines and topical microbicides; and
integrate behavioral and epidemiological research needed to ensure the optimal
utilization of these tools.

The purpose of this RFA is to stimulate multi-disciplinary, collaborative
research to further understanding of STDs and to develop and evaluate effective
approaches to STD prevention and control.  The scientific complexity of the STD
problems is such that coordinated, multi-disciplinary research is required to
solve these problems.  This will be accomplished through collaborations among
scientists from various disciplines working in the scientific areas of
biomedical, clinical, behavioral, and epidemiological research.  In this RFA, the
term scientific area refers to the four broad categories of investigation:  (1)
biomedical, (2) clinical, (3) behavioral, and (4) epidemiological research.  The
term discipline refers to investigators' specialized areas of expertise or
training.  Some examples of disciplines associated with the four scientific areas
include but are not limited to (1) reproductive endocrinology, immunology,
virology, and molecular  biology; (2) gynecology, infectious diseases, and
adolescent medicine; (3) psychology, sociology, and anthropology; (4)
epidemiology, biostatistics, and computer modeling.  Research on HIV infection
is supported by the Division of Acquired Immunodeficiency Syndrome (DAIDS) and
is not included in the scope of this RFA except in studies where it is directly
linked to research on STDs as risk factors for HIV transmission or in alteration
of the natural history of STDs.

In order to attain these goals, applications must include:

-  at least three projects, one of which should be in behavioral or
epidemiological research (of particular interest is research on social networks;
special attention should be paid to methods and evaluation outcomes that would
be useful in characterizing social networks and in designing interventions for
social networks);

-  two projects that link disciplines within a single scientific area and at
least one project that links disciplines in two different areas (disciplines and
scientific areas are defined above);

-  research on two or more STD pathogens or syndromes selected from Diseases,
Syndromes, and Areas of Interest listed below;

-  a strong clinical capability in sexually transmitted diseases with accessible,
appropriate populations to participate in the clinical and behavioral/
epidemiological research projects; and

-  provisions for the Principal Investigator of each CRC (also known as the CRC
Director) to attend meetings with NIAID staff twice each year and for all CRC
Project Leaders to attend CRC workshops twice during the program period.

Diseases, Syndromes, and Areas of Interest

Applicants are encouraged to consider research projects  in the following areas:

-  Pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, Haemophilus ducreyi,
Treponema pallidum, bacteria that cause bacterial vaginosis, Trichomonas
vaginalis, genital herpes viruses (herpes simplex viruses 1 and 2), (sexually
transmitted) human herpes virus 8, and human papillomavirus.  In designing
specific projects, use of human material to address basic research questions is
highly recommended.

-  Adverse Outcomes of Pregnancy:  Research is needed to define the epidemiology,
pathogenesis, and immunology of STD-related adverse outcomes of pregnancy in at-
risk populations.

-  Human Papillomavirus Infection: The NIAID's priorities in HPV include research
on the epidemiology, natural history, pathogenesis, and immunology of infection,
diagnosis and treatment.

-  Pelvic Inflammatory Disease (PID):  Additional research is needed in a number
of areas, including diagnosis, epidemiology, pathogenesis, treatment, and long
term sequelae.  Of particular interest are age-related host factors that
influence disease progression including tubal scarring.

-  Inter-Relatedness of Sexually Transmitted Infections: Because of the HIV
epidemic, it is now recognized that infection with one sexually transmitted
infection can alter susceptibility to and natural history of other STDs. 
Understanding the molecular bases of these interactions is needed, especially
those that are age-related.  For example, research is needed to examine the role
of classical STDs in the acquisition and progression of HIV infection and on the
role of HIV in alterations of the natural history, diagnosis, or response to
treatment of STDs.  One project on HIV infection may be included.

-  Reproductive Endocrinology:  The role of reproductive hormonal changes, both
endogenous (puberty) and exogenous, on the biology of susceptibility and
resistance to infection is a high priority.

-  Immunology:  Basic immunological research related to vaccine development for
any of the pathogens or syndromes listed above is of  interest.  In order to make
critical advances in this area, functional collaborations between immunologists
and microbiologists focused on the immune response in STD populations will be
extremely important.  Work on non-specific defense mechanisms including the role
of defensins, normal flora (lactobacilli), mucus and pH is encouraged, especially
in the context of changes associated with puberty and the use of hormonal
contraceptives.

-  Behavioral/Epidemiological Research: Behavioral research is needed to decrease
risk-associated behaviors and to increase health behaviors, specifically those
related to seeking early diagnosis, treatment, and immunization.  Also of 
interest is research on social networks; special attention should be paid to
methods and evaluation outcomes that would be useful in characterizing social
networks and in designing interventions for social networks.  STD CRCs, because
of their multi-disciplinary approach, are in a unique position to assess
behavioral measures and evaluate interventions.

-  Topical Microbicides:  Basic biomedical and clinical research leading to
topical microbicide development to prevent sexually transmitted infections is
needed.  Topical microbicides are products for intravaginal use that are
microbicidal (virucidal and/or bactericidal) but not necessarily spermicidal;
they are used by women to prevent sexually transmitted infections (HIV and other
STDs).  Examples of such research include, but are not limited to, identifying
early events in the infectious process, characterizing vaginal physiology and
normal flora in adolescent populations, developing methods to measure and assess
clinical significance of vaginal/cervical inflammation and comparing changes
induced by microbicides.

-  Adolescents from all segments of society are at extremely high risk for STDs.
Furthermore there are unique biomedical and behavioral factors that underlie the
risk of STD acquisition and transmission in adolescents.  Therefore, research
projects that specifically focus on STDs in this young, at-risk populations are
encouraged.

Clinical Capability

As stated earlier, applications must have a strong clinical capability in
sexually transmitted diseases and access to appropriate populations to serve the
clinical and behavioral/epidemiological research projects.  In describing the
clinical and laboratory facilities, the application should include specific
information on the institution's present patient load, projections for patient
involvement in future clinical investigations, history of recruitment of
subjects, and disease prevalence as well as on the availability of appropriate
biohazard facilities and safety procedures.

Optional Developmental Component

Applications may include a Developmental Fund Core to provide support for new
investigators or pilot projects.  Eligible investigators are individuals in the
early or mid stages of their career who have NOT held an NIH grant including an
R29, R01, P01, U01, any research career or training grant (K or T awards), or any
other type of grant or contract with annual direct costs in excess of $37,500 for
research in STDs.

Potential awardees and specific research projects to be pursued need not be
identified in the CRC application.  However, the application should include a one
page description of the kind of project that might be funded under this mechanism
and how it interdigitates with CRC research projects.  In addition, the
application must provide a description of review process and selection criteria
for proposed projects.  Approval of the developmental funds portion of the
application does not in any way commit the investigators to the execution of the
sample project.

Budget Issues

Budget requests within each project may include research-related costs for
supplies, patient involvement and medical care, funds for limited investigator
travel, and costs of publication.  Proposals for studies that do not receive the
majority of funding through the CRC will not be counted as a project.  There must
be concordance between the science proposed and the budget requested. 
Furthermore, if additional sources of funding have been identified for a project,
then letters documenting a funding commitment must be included in the
application.

STD and HIV Meeting.  The STD CRC should budget funds ($8,000 per year) to co-
sponsor an annual information-based meeting on STDs and HIV infection.  NIAID
Program staff will assist the STD CRC directors in coordinating this meeting.

STD CRC award funds may be utilized to support the following research-related
activities:

-  PI Level of Effort:  The applicant Principal Investigator (STD CRC Director)
must allot 15% of time to the administration of the CRC.  If less effort is
indicated, justification must be provided, including a written plan explaining
how they will be able to successfully and fully meet the responsibilities
demanded by these endeavors.  Effort on scientific projects would be additional.

-  Shared Research Resources (Cores):  The STD CRC may include funds for
equipment, supplies, and services to expand and/or maintain clinical, laboratory,
biostatistical, or behavioral facilities shared by research staff from at least
two research projects.

-  Advisory group activities:  The STD CRC funds may be used to support
activities related to acquiring scientific advise from experts in the field. 
These advisory groups should be constituted after the grant award has been made
and should not be named in the application.

-  Developmental Funds Core for New Investigators:  This optional core sets aside
and restricts funds solely to cover salaries and research costs for new
investigator or pilot projects.  There is no ceiling on the total dollar amount
of the developmental funds pool, but once identified as developmental funds these
monies constitute a restricted portion of the total CRC budget and will not be
available for other CRC activities.  The annual total amount for each
developmental award may not exceed $40,000 and may be used for salary, technical
support, laboratory supplies, and equipment.  Supplies and equipment expenditures
for each award may not exceed $20,000 annually.  Projects and investigators
funded under the developmental core may not receive subsequent awards from this
pool.  The duration of developmental support is limited to three years.  If the
investigator achieves independent funding through a traditional research grant
(R01) prior to the end of the developmental award, the award must be terminated,
and unexpended funds must be returned to the developmental funds pool.

In general, the CRC should try to advance learning experiences in STD research
and to make medical students, house staff and postdoctoral candidates more aware
of STD research opportunities in the clinical, biomedical, and behavioral
sciences.  It is permissible for projects to include post-residency personnel who
spend a maximum of one third of their time in clinical activities related to the
research focus of the project.  Formal training programs in clinical or basic
sciences that include stipends for these students are supported by other funding
mechanisms at the NIH, such as the National Research Service Awards (T-32s) and
do not, therefore, fall within the purview of this request.

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

SPECIAL REQUIREMENTS

Collaborative Organization

The application should include a plan to maintain close collaboration and
communication among members this STD CRC (and potentially among of the seven
other STD CRCs) and 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.  The application must also
include a signed letter of agreement from each collaborator and/or consultant to
the program indicating willingness to participate in the program and a
description of the exact nature of the participation.

TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the award statement
and provided to the Principal Investigator as well as the institutional official
at the time of award.

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 92, and other HHS, PHS, and NIH Grant Administration policy
statements.

The administrative and funding instrument used for this program is the
multiproject cooperative agreement (U19), an "assistance"  mechanism (rather than
an "acquisition" mechanism), in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated  during the performance
of the activity.  Under the cooperative agreement, the NIH purpose is to support
and/or stimulate the recipient's activity by involvement in and otherwise working
jointly with the award recipient in a partner role, but it is not to assume
direction, prime responsibility, or a dominant role in the activity.  Consistent
with this concept, the dominant role and prime responsibility for the activity
resides with the awardees for the project as a whole, although specific tasks and
activities in carrying out the research will be shared among the awardees and the
NIAID Scientific Coordinator.

1.  Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the research objectives,
approaches and details of the projects within the guidelines of the RFA and for
performing the scientific activity. Specifically, awardees have primary
responsibility as described below.

Under the Cooperative Agreement, a partnership relationship exists between the
recipient of the award and NIAID in which successful applicants are responsive
to the guidelines and conditions set forth in the RFA.  At the same time,
investigators are expected to define research objectives and approaches in accord
with their own interests and perceptions of novel and exploitable approaches to
the research which ultimately is likely to result in improved prevention and
control of STDs.

It is the primary responsibility of the Principal Investigator to clearly state
the objectives and approaches of the research, to plan and conduct the research
stipulated in the proposal, and to ensure that the results obtained are analyzed
and published in a timely manner.  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.

The multi-disciplinary and collaborative nature of the STD CRCs creates an
extraordinary opportunity for information exchange and scientific advancement in
STD research.  Principal Investigators are expected to take advantage of this
opportunity by participation in both formal events established expressly for this
purpose and informal investigator-initiated dialogues

2.  NIAID Staff Responsibilities

NIAID staff assistance will be provided by a Program Officer who will serve as
NIAID's Scientific Coordinator.  The NIAID Scientific Coordinator will have
substantial scientific/programmatic involvement during the conduct of this
activity through technical assistance, advice and coordination above and beyond
normal program stewardship for grants, as described below. The Scientific
Coordinator will be a program officer in the STD Branch of NIAID.  During the
award period, the NIAID Scientific Coordinator may provide appropriate
assistance, advice, and guidance in:  design of research activities; coordination
and facilitation of information, technology, and reagent exchange between STD
CRCs; data collection and analysis; assistance in review and selection of
developmental fund applicants; and technical and administrative activities of
CRCs.  However, it is again emphasized that the role of NIAID will be to
facilitate and not to direct the activities of the STD CRC.  It is anticipated
that decisions in all activities outlined within this RFA will be reached by
consensus of the investigators and that the NIAID Scientific Coordinator will be
given the opportunity to offer input to this process.

Collaborative Responsibilities

The CRC Principal Investigators and the NIAID Scientific Coordinator will meet
twice a year to review progress of the CRCs at the NIH in Bethesda, Maryland (or
at a site designated by NIAID).  The first such meeting will be a Post Award
Meeting.  In addition, two workshops for the Principal Investigators and CRC
Project Leaders will be convened during the project period to share STD research
advances, and to discuss STD research needs and opportunities, to develop
collaborations.  It is likely that workshops will be convened in Year 1 and Year
3 of the project period at the NIH in Bethesda, Maryland (or at a site designated
by NIAID).  Applicants should be aware that there are no additional travel monies
available.

4.  Arbitration

Any disagreement that may arise on scientific or programmatic matters (within the
scope of the award) between award recipients and the NIAID may be brought to
arbitration.  An arbitration panel will be composed of three members -- one
selected by the Steering Committee or by the individual awardee in the event of
an individual disagreement, a second member selected by the NIAID, and the third
member with expertise in the relevant area and selected by the two prior members
will be formed to review any scientific or programmatic issue that is
significantly restricting progress.  While the decisions of the Arbitration Panel
are binding, these special arbitration procedures will in no way affect the
awardee's right to appeal an  adverse action in accordance with PHS regulations
at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 16.

Cooperative agreements are subject to the administrative requirements outlined
in OMB circulars A-102 and A-110.  All pertinent HHS, PHS, and NIH grant
regulations, policies and procedures, with particular emphasis on PHS regulations
at 42 CFR Part 52 and HHS regulations at 45 CFR Part 74, are applicable. These
special terms and conditions pertaining to the scope and nature of the
interaction between the NIAID and the investigators will be incorporated in the
Notice of Grant Award.  However, these terms will be in addition to, not in lieu
of, the customary programmatic and financial negotiations that occur in the
administration of cooperative agreements.

STUDY POPULATIONS

A strong emphasis is placed on studying STDs in populations that are
disproportionately affected.  These populations include adolescents, women and
minorities.  Subjects may be recruited or specimens obtained from domestic sites
or through collaborations with foreign institutions in developing countries if
the collaboration is beneficial to the foreign country and offers the potential
for collection of STD data that are pertinent to U.S. populations and could not
be generated as effectively in the United States.

As stated later under AWARD CRITERIA, program balance takes into account
geographic distribution of the STD CRCs (of particular interest is access to
populations that are not being studied in other STD CRCs).

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification are provided that inclusion is inappropriate with
respect to the health of the subjects of 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", which have been 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.

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

LETTER OF INTENT

Prospective applicants are asked to submit, by May 8, 1998, 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.  Although the letter of intent is not required, is not
binding, does not commit the sender to submit an application, and does not enter
into the review of subsequent applications, the information that it contains
allows NIAID staff to estimate the potential review workload and to avoid
conflict of interest in the review.  The letter of intent is to be sent to Dr.
Madelon Halula at the address listed under INQUIRIES.

APPLICATION PROCEDURES

Applicants for U19 cooperative agreements must follow special application
guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR
MULTI-PROJECT AWARDS (September 1997); this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm

Applications are to be submitted on the research grant application form PHS 398
(rev. 5/95).  Application kits are available at most institutional offices of
sponsored research and may be obtained 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:
asknih@od.nih.gov.

For purposes of identification and processing, item 2 on the face page of the
application must be marked "YES" and the RFA number "AI-98-007" and the words
"Sexually Transmitted Diseases Cooperative Research Centers" must be typed in.

Applications must be received by September 15, 1998.  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. 5/95) Application Kit (as modified in,
and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR
MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the
applicant.  The RFA label available in the application form PHS 398 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.

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

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 listed under INQUIRIES).

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/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. Madelon Halula 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.

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA

Applicants for U19 cooperative agreements must follow special application
guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR
MULTI-PROJECT AWARDS (September 1997); this brochure is available from NIAID
listed under INQUIRIES via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm

This brochure presents specific instructions for sections of the PHS 398 (rev.
5/95) application form that should be completed differently than usual.

REVIEW CONSIDERATIONS

Review Procedures

Upon receipt, applications will be reviewed for completeness by the NIH Center
for Scientific Review and for responsiveness by NIAID staff.  Incomplete and/or
non-responsive applications will be returned to the applicant without further
consideration.

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

Review Criteria

The general criteria for U19 multiproject cooperative agreement applications are
presented in the NIAID BROCHURE.  Additional review criteria specific to this RFA
are:

o  documentation of a strong capability in sexually transmitted diseases,
adequate and appropriate patient populations, disease prevalence, and historical
success of recruitment and retention of subjects;

o  documentation of the sponsoring institution's commitment to the cooperative
program and willingness to accept the participation and assistance of NIAID
staff;

o  adequacy of proposed plan for coordination and communication within the
applicant STD CRC and with NIAID and other STD CRCs; and

o  adequacy of review plan and selection criteria for new investigators making
application to the optional Developmental Funds.

In addition, applications from existing STD CRCs must include a comprehensive
progress report (as stated above under Objectives and Scope) and demonstrate
successful collaborative activities supported through their CRC.  Applicants who
have not had an STD CRC should explain how they will establish successful
collaborative efforts.

AWARD CRITERIA

Funding decisions will be made on the basis of scientific and technical merit as
determined by peer review, program priorities and balance, and availability of
funds.  Program balance takes into account pathogen(s) proposed for study, the
potential impact on health of women, minorities and adolescents, as well as
geographic distribution of the CRCs (of particular interest is access to
populations that are not being studied in other STD CRCs).

INQUIRIES

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

Requests for the NIAID brochure "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT
AWARDS" as well as inquiries regarding programmatic (research scope and
eligibility) issues, may be directed to:

Dr. Penelope J. Hitchcock
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A-24
Bethesda, MD  20892
Telephone:  (301) 402-0443
FAX:  (301) 402-1456
Email:  ph22k@nih.gov

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

Dr. Madelon Halula
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4C16
Bethesda, MD  20892-7610
Telephone:  (301) 402-2636
FAX:  (301) 402-2638
Email:  mh30x@nih.gov

Direct inquiries regarding fiscal matters to:

Todd C. Ball
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, MSC 7610
Bethesda, MD  20892-7610
Telephone:  (301) 402-5512
FAX:  (301) 480-3780
Email:  tb22j@nih.gov

Schedule

Letter of Intent Receipt Date:  May 8, 1998
Application Receipt Date:       September 15, 1998
Scientific Review Date:         February 1, 1999
Advisory Council Date:          May 24, 1999
Earliest Date of Award:         July 1, 1999

AUTHORITY AND REGULATIONS

This program is supported under authorization of the Public Health Service Act,
Sec. 301 (c), Public Law 78-410, as amended.  The Catalogue of Federal Domestic
Assistance Citation is Sec. 93.856, Microbiology and Infectious Diseases
Research.  Awards will be administered under PHS grants policies and Federal
Regulations 42 CFR Part 52 and 45 CFR Part 74.  This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or Health
Systems review.

The Public Health Service (PHS) strongly encourages all grant and contract
recipients to provide a smoke-free workplace and promote the non-use of all
tobacco products.  In addition, Public Law 103-227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care, health care
or early childhood development services are provided to children.  This is
consistent with the PHS mission to protect and advance the physical and mental
health of the American people.

Return to Volume Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.