Full Text AI-94-016

SEXUALLY TRANSMITTED DISEASES COOPERATIVE RESEARCH CENTERS

NIH GUIDE, Volume 23, Number 18, May 13, 1994

RFA:  AI-94-016

P.T. 34

Keywords: 
  Sexually Transmitted Diseases 
  Biomedical Research, Multidiscipl 
  Epidemiology 


National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  August 5, 1994
Application Receipt Date:  November 17, 1994

PURPOSE

The purpose of this Request for Applications (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 research grant applications for recompetition of the Sexually
Transmitted Diseases Cooperative Research Centers (STD CRCs).  The
NIAID 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 STDs and acquired
immunodeficiency syndrome (AIDS).  Potential applicants may obtain a
copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications will be limited to domestic institutions, but may
include an international component.  Applications may be submitted by
domestic for-profit and non-profit research institutions; public and
private organizations, such as universities, colleges, hospitals,
laboratories, units of State or local governments; and eligible
agencies of the Federal government.  Applications from minority
individuals and women are encouraged.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to undertake this
program will be the 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 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.  Details of the responsibilities, relationships, and
governance of the study funded under cooperative agreement(s) are
discussed later in this document under the section Terms and
Conditions of Award.

The total project period for each application submitted in response
to this RFA may not exceed five years.  At this time, the NIAID has
not determined whether and how this solicitation will be continued
beyond the present RFA.

The anticipated award date is July 1, 1995.

FUNDS AVAILABLE

The estimated total funds (direct and indirect costs) available for
the first year of support for awards under this RFA will be $6.2
million.  In Fiscal Year 1995, the NIAID plans to fund five STD CRCs
or more if additional money becomes available.  The final number of
awards to be made is dependent upon the availability of funds.  The
initial year's total costs, including direct and indirect costs,
should not exceed $1.2 million for each award.  The usual PHS
policies governing grants administration and management will apply.
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 progress during the
preceding years and availability of funds.

RESEARCH OBJECTIVES

Background

In 1993, an estimated 12 million cases of STDs occurred in the United
States. Approximately 65 percent occurred in people under 24 years of
age; three million occurred in teenagers.  Associated health care
costs exceeded $6 billion.  Women and infants bear a disproportionate
share of disease burden and 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.

o  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.  Due to delays in
diagnosis or inadequate therapy, 10 to 40 percent of women with
chlamydial cervicitis develop PID.

o  Gonorrhea, the other major cause of PID, occurs at an annual rate
of approximately 1.4 million new cases, 25 percent of which occur in
teenagers.  Antibiotic resistance has increased within the last
decade; up to 10 percent of isolates may be resistant to one or more
antibiotics.

o  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.

o  In the 1990s, infectious syphilis reached the highest level in 40
years.  Syphilis rates among African-Americans are reported to be 56
times higher than in whites.  Increases in women were echoed by
five-fold increases in congenital/perinatal cases.

o  Approximately 65 million Americans are afflicted with genital
herpes (HSV).  HSV is a painful, recurrent, incurable disease with
annual costs estimated to exceed $96 million.

o  Both ulcerative and non-ulcerative STDs increase the risk of human
immunodeficiency virus (HIV) transmission approximately three- to
five-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.

Objectives and Scope

In spite of decades of STD prevention and control programs and STD
research, rates of infection continue to grow.  This is now
complicated by the emergence of a new fatal STD, HIV infection.  The
alarming dimensions of STDs and related health problems described
above point to the need for more effective research approaches that
will lead to essential tools for preventing and controlling STDs.
The 1986 report of the NIAID Study Group on STDs and Congress have
recommended a multidisciplinary approach to research programs seeking
to prevent and control STDs.  By contrast, STD research historically
has not been conducted by multidisciplinary, collaborative teams of
scientists.  Each scientific area tended to build its own empirical
base and report findings to peers.  In response to both the dimension
of the problem and advice provided to the NIAID, the STD CRCs were
created to achieve the following goals: 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 epidemiologic research needed to ensure the optimal
utilization of these tools.

The purpose of this RFA is to stimulate multidisciplinary,
collaborative research to further understanding of STDs and effective
approaches to their prevention and control.  The scientific
complexity of the STD problems is such that coordinated,
multidisciplinary 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)
epidemiologic 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) immunology, virology, and molecular biology; (2)
gynecology, infectious diseases, and adolescent medicine; (3)
psychology, sociology, and anthropology; (4) epidemiology,
biostatistics, and computer modeling.

In order to attain these goals, applications should include:

o  at least three projects, one of which should be in behavioral or
epidemiologic research (behavioral/epidemiologic research must
include both behavioral or epidemiologic outcomes and
microbiologic/disease outcomes as described in the next section);

o  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);

o  a strong clinical capability (described below) with accessible
patient populations to participate the clinical and
behavioral/epidemiologic research projects; and

o  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

In designing specific projects, applicants are encouraged to consider
research proposals in the following areas of programmatic interest.
Biomedical research projects are encouraged to use human material to
address research questions.

o  Pathogens:  C. trachomatis, N. gonorrhoeae, H. ducreyi, T.
pallidum, T. vaginalis, herpes simplex virus 1 and 2, and human
papillomavirus.

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

o  Human Papillomavirus Infection: The NIAID's priorities in HPV
include research on the epidemiology, natural history, pathogenesis,
and immunology of infection as well as the development of a culture
system and improved diagnosis and treatment.

o  Pelvic Inflammatory Disease (PID):  Additional research is needed
in a number of areas, including diagnosis, epidemiology,
pathogenesis, treatment, and long term sequelae.

o  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.  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.  If this area
is selected, the application should include only one project on STDs
and HIV infection.

o  Immunology:  Basic immunological research related to vaccine
development for any of the pathogens or syndromes listed above is of
programmatic interest.  In order to make critical advances in this
area, functional collaborations between immunologists and
microbiologists focused on pathogenesis will be extremely important.

o  Behavioral/Epidemiologic Research:  Much STD research to date has
focused on diagnosis, treatment, and vaccine development without
integrating approaches to modify the sexual and other behaviors
associated with acquisition and transmission STDs or development of
their sequelae.  Behavioral research is needed to decrease
risk-associated behaviors and to increase health behaviors,
specifically those related to seeking early diagnosis, treatment, and
immunization.  STD CRCs, because of their multi-disciplinary
approach, are in a unique position to assess behavioral measures and
evaluate interventions because, as stated earlier, behavioral and
epidemiologic research projects in the STD CRCs must include both
behavioral and microbiologic and/or disease outcomes.  (For more
information on areas of programmatic interest, see Program
Announcement Number PA-93-108, NIH Guide, Volume 22, Number 32,
September 3, 1993.)

o  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, developing methods to measure
and assess clinical significance of vaginal/cervical inflammation.
(See also RFA AI-94-013.)

Clinical Capability

As stated earlier, applications should have a strong clinical
capability and access to patient populations to serve the clinical
and behavioral/epidemiologic 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 including HIV.

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.  Approval of the developmental funds portion
of the application does not in any way commit the investigators to
the execution of the sample project.  In addition, the application
must provide a description of the review process and selection
criteria for proposed projects.

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

o  PI Level of Effort:  Each applicant Principal Investigator must
allot at least 15 percent of time to the administration of the CRC.
If less effort is indicated, justification must be provided,
including a written plan explaining how the responsibilities demanded
by these endeavors will be met fully and successfully.

o  Shared Research Resources (Cores):  The STD CRCs 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.

o  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 support is limited
to three years.  If the investigator achieves independent funding
through a traditional research grant (R01) or a FIRST (R29) award
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 CRCs 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.

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.

STD CRCs can serve as important resources to increase awareness of
the prevention, diagnosis, and treatment of STDs in the public
health, the lay and the local medical communities.  The NIAID has
been involved with the Centers for Disease Control's (CDC)
Accelerated Research Program in STDs.  Several proposed projects for
this CDC program involve collaborations between the existing STD CRCs
and state and local health departments.  Applicants with interest in
this area should contact the Division of STDs/HIV, National Center
for Prevention Services, CDC for information on support of outreach
projects.

SPECIAL REQUIREMENTS

Collaborative Organization

The application should include a plan to maintain close collaboration
and communication among members of the STD CRC and an organizational
chart showing the name, the organizational affiliation 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 Condition 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 Parts 74 and 92, and other HHS,
PHS, and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is
the 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.

Awards will be made to an institution on behalf of a Principal
Investigator who will be responsible for the coordination of STD CRC
scientific and administrative activities.  Support of all CRC
activities will be coordinated through a Central Operations Office
located within the applicant organization.

1.  Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the details
for the project within the guidelines of the RFA and for performing
the scientific activity, and agree to accept close coordination,
cooperation, and participation of NIAID staff in those aspects of
scientific and technical management of the project described in 2.
below.  Specifically, awardees have primary responsibilities as
described below.

Under the Cooperative Agreement, a partnership relationship exists
between the recipient of the award and the 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, plan and
conduct the research stipulated in the application, and ensure that
the results obtained are analyzed and published in a timely manner.
The 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

The NIAID 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 NIAID will work closely with the Principal Investigators and
shall be represented by a Scientific Coordinator (Program Officer).
The Scientific Coordinator will be a program officer in the STD
Branch of the 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
the 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.

3.  Collaborative Responsibilities

The CRC Principal Investigators and 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 the 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, discuss STD research needs and opportunities, and 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 the NIAID).  Applicants should be aware
that there are no additional travel monies available.  Funds for
travel to all meetings must be included in applicant's budget.

A critical element of the STD CRCs' success is the degree of
communication among its members.  Therefore, additional informal
meetings among participants from different CRCs as well as regular
telephone and written communication will be encouraged.

4.  Arbitration

Any disagreement that may arise on scientific/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 Principal
Investigator, a second member selected by the NIAID, and the third
member selected by the two prior members.  This special arbitration
procedure in no way affects the awardee's right to appeal an adverse
action that is otherwise appealable in accordance with PHS
regulations at 42 CFR part 50, subpart D, and HHS regulation at 45
CFR part 16.

In the event that research supported by the Cooperative Agreement
results in development of a therapeutic or other medical
intervention, the NIAID will retain the option to cross-file or
independently file an application for investigational clinical trial
(i.e., an Investigational New Drug Application [INDA]) to the United
States Food and Drug Administration.  Reports of data generated by
the CRC or any of its members that are required for inclusion in INDs
and Clinical Brochures and for cross-filing purposes will be
submitted by the Principal Investigator to the Scientific Coordinator
upon request.  Such reports will be in final draft form and include
background information, methods, results, and conclusion.  They will
be subject to approval and revision by the NIAID and may be augmented
with test results from other Government sponsored projects prior to
submission to the appropriate regulatory agency.

STUDY POPULATIONS

A strong emphasis is placed on studying STDs in populations that are
disproportionately affected.  These populations include women,
adolescents, 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.

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 is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  The application should
include a description of the proposed outreach for recruiting women
and minorities as participants.  This new policy results from the NIH
Revitalization Act of 1993 (Section 492B of Public Law 103-43) and
supersedes and strengthens the previous policies (Concerning the
Inclusion of Women in Study Populations, and Concerning the Inclusion
of Minorities in Study Populations) which have been in effect since
1990.  The new policy contains some new provisions that are
substantially different from the 1990 policies.  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 reprinted in the NIH GUIDE
FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

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

LETTER OF INTENT

Prospective applicants are asked to submit, by August 5, 1994, a
letter of intent that includes a descriptive title of the overall
proposed research; the name, address, and telephone number of the
Principal Investigator; the number and title of this RFA; and a list
of the key investigators and their institution(s).  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 avoid
conflict of interest in the review.  The letter of intent is to be
sent to Dr. Olivia Preble at the address listed under INQUIRIES.

APPLICATION PROCEDURES

Before preparing an application, the applicant should carefully read
the information brochure, "NIAID Program Project Grants and
Multiproject Cooperative Agreements."  Instructions for formatting
the application as outlined in the brochure should be followed
carefully.  Failure to follow the instructions may result in
unnecessary delays in the review process.

Applications are to be submitted on the standard research grant
application form PHS 398 (rev. 9/91).  These application forms may be
obtained from the institution's office of sponsored research or its
equivalent and from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, 5333 Westbard Avenue,
Room 449, Bethesda, MD 20892, telephone (301) 435-0714.  For purposes
of identification and processing, item 2a on the face page of the
application must be marked "YES" and the RFA number and the words
"SEXUALLY TRANSMITTED DISEASES COOPERATIVE RESEARCH CENTERS (STD
CRCs)" must be typed in.

Applications from multi-component consortia must contain a single
face page, an overall budget page, and separate budget pages for each
institution involved.  Each consortium institution is allowed 25
pages for the research plan if different plans are proposed by the
different member institutions.  For additional information, refer to
page 8 of the PHS 398 application form.

The RFA label available in the PHS 398 (rev. 9/91) 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.

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 exact copies of the grant
application and five sets of appendix material must also be sent to
Dr. Olivia Preble at the address listed under INQUIRIES.

Applications must be received by November 17, 1994.  All components,
subparts and sections of the application must be collated into the
application and the packages sent to the DRG and the NIAID must each
be complete in themselves.  Applications that do not conform to the
instructions contained in PHS 398 (rev. 9/91) application kit will be
judged nonresponsive and will be returned to the applicant.

Current NIH policy permits a component research project of a
multiproject grant application to be concurrently submitted as a
traditional individual research project (R01) application.  If,
following review, both the multiproject 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 multiproject grant.  This is an NIH policy intended to preserve
the scientific integrity of a multiproject grant, which may be
seriously compromised if a strong component project(s) is removed
from the program.  Investigators wishing to participate in a
multiproject grant must be aware of this policy before making a
commitment to the Principal Investigator and awarding institution.

The three copies of the applications that are sent to the DRG must be
received as a single package from the Principal Investigator and
conform to the instructions contained in PHS 398 (rev. 9/91)
application kit otherwise the application will be judged
non-responsive and will be returned to the applicant.

REVIEW CONSIDERATIONS

Review Method

Upon receipt, applications will be reviewed for completeness by the
Division of Research Grants (DRG) and for completeness and for
responsiveness by NIAID staff.  Incomplete and non-responsive
applications will be returned to the applicant without further
consideration or review.

Those applications that are complete and responsive may be subjected
to a triage by a peer review group to determine their scientific
merit relative to other applications received in response to this
RFA.  The NIAID will remove from competition those applications
judged to be non-competitive for award and will notify the Principal
Investigators and institutional business officials.  For applications
found non-competitive, summary reports will be very brief and will
only highlight the major reason(s) for the non-competitive rating.

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

Review Criteria

The review criteria are stated in the NIAID Program Project Grants
and Multiproject Cooperative Agreements brochure, which is available
rom program staff listed under INQUIRIES.  In addition, applicants
are expected to address research priorities, objectives, and other
requirements stated in this RFA, as well as the following:

o  the scientific and technical significance, merit, and originality
of the research projects and anticipated contributions to the
prevention and control of STDs;

o  the scientific expertise and experience of the Principal
Investigator, the Project Leaders and key project and core personnel;

o  documentation of a strong clinical capability, 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.

INQUIRIES

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

Inquiries regarding programmatic issues may be directed to:

Dr. Heather Miller
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A-26
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 402-0443
Internet Address:  heather@exec.niaid.pc.niaid.nih.gov

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. Olivia Preble
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C-20
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-8208
Internet Address:  op2t@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Katherine Phillips
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B-33
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-7075

Schedule

Letter of Intent Receipt Date:  August 5, 1994
Application Receipt Date:       November 17, 1994
Scientific Review Date:         February/March 1995
Advisory Council Date:          June 1995
Earliest Award Date:            July 1, 1995

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.855 Immunology, Allergic and Immunological Diseases
Research and 93.856 Microbiology and Infectious Diseases Research.
Grants are awarded under the authority of the Public Health Service
Act, Section 301 (42 USC 241) and administered under PHS grants
policies and Federal Regulations, most specifically at 42 CFR Part 52
and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of the Executive Order 12372 or
Health Systems Agency review.

The Public Health Service 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 people.

.

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