Full Text AI-97-003
 
ADOLESCENTS AND STD COOPERATIVE RESEARCH CENTER
 
NIH Guide, Volume 26, Number 29, August 29, 1997
 
RFA:  AI-97-003
 
P.T.


Keywords: 

 
National Institute of Allergy and Infectious Diseases
 
Letter of Intent Receipt Date:  October 15, 1997
Application Receipt Date:  January 8, 1998
 
PURPOSE
 
The purpose of this Request for Applications (RFA) is to stimulate
multi-disciplinary, collaborative research to further understanding
of sexually transmitted diseases (STDs) in adolescent populations and
to develop and evaluate 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 an Adolescents and Sexually Transmitted Diseases Cooperative
Research Center (STD CRC). The STD CRC will provide a multi-
disciplinary approach to STD research by bridging biomedical,
clinical, behavioral, and epidemiological research; will foster
interaction among STD investigators; and will 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,
Adolescents and Sexually Transmitted Diseases Cooperative Research
Center (STD CRC), is related to the priority areas of STDs and AIDS.
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
 
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 requested project period for applications submitted in
response to this RFA may not exceed 5 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 August 1, 1998.
 
FUNDS AVAILABLE
 
The estimated total funds (direct and indirect costs) available for
the first year of support for awards under this RFA will be $1.2
million.  In Fiscal Year 1998, the NIAID plans to fund one
Adolescents and STD CRC.  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 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.  Because of infections acquired during
adolescence, 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.
 
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.  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.
 
o  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.
 
o  During 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.
 
o  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.
 
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.  In one
study, the incidence rate for HPV infection in college-aged women
during their first year of sexual activity with a single partner was
25%.  Another study of female college students found a 50% prevalence
of the young women had HPV infection.
 
o  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.
 
o  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, virtually
all of these people became infected as teenagers.
 
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 underserved 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 in adolescent
populations 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.
 
Applications must include:
 
o  at least three research projects:  one should be in behavioral or
epidemiological research in adolescent populations (of particular
interest is research on social networks; and two or more 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  research on two or more STD pathogens or syndromes selected from
Diseases, Syndromes, and Areas of Interest listed below;
 
o  a strong clinical capability in adolescent medicine (described
below) with accessible adolescent populations to participate in the
clinical and behavioral/epidemiological 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
 
Applicants are encouraged, but not limited, to consider research
projects  in the following areas:
 
o  Pathogens:  Chlamydia trachomatis, Neisseria gonorrhoeae,
Haemophilus ducreyi, Treponema pallidum, Trichomonas vaginalis,
herpes simplex viruses 1 and 2, and human papillomavirus.  In
designing specific projects, use of human material to address basic
research questions is highly recommended.
 
o  Adverse Outcomes of Pregnancy:  Research is needed to define the
epidemiology, pathogenesis, and immunology of STD-related adverse
outcomes of pregnancy in adolescent populations.
 
o  Human Papillomavirus Infection: The NIAID's priorities in HPV
include research on the epidemiology, natural history, pathogenesis,
and immunology of infection , diagnosis and treatment in adolescent
populations.
 
o  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.
 
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, 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.
 
o  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.
 
o  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 vis a vis
adolescent populations, functional collaborations between
immunologists and microbiologists focused on the immune response in
adolescent 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 .
 
o  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.
 
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 in adolescent populations,
developing methods to measure and assess clinical significance of
vaginal/cervical inflammation and comparing changes induced by
microbicides in adolescent versus adult women.
 
Clinical Capability
 
As stated earlier, applications must have a strong clinical
capability in adolescent medicine and access to adolescent
populations to serve the clinical and behavioral and/or
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, RO1, PO1, UO1, 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.  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 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:  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.
 
o  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.
 
o  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.
 
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 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 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 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. Awardees will retain custody of and have primary rights to
the data developed under this award, subject to Government rights of
access consistent with current HHS, PHS, and NIH policies.
 
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 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.
 
3. Collaborative Responsibilities
 
The CRC Principal Investigator of the Adolescents and STDs CRC and
the other seven STD CRCs 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 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.  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 other STD 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, NIAID will retain the option to cross-file or
independently file an application for investigational clinical trial
(i.e., an Investigational New Drug Application [IND]) to the United
States Food and Drug Administration.  Reports of data generated by
the CRC or any of its members which 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 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 adolescent
populations that are disproportionately affected.  These populations
include 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.
 
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 the
program staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by October 15, 1997, a
letter of intent that includes a descriptive title of the overall
proposed research; the name, address, and telephone number of the
Principal Investigator; a list of the key investigators and their
institution(s), and the number and title of the RFA in response to
which the application may be submitted.  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
 
Before preparing an application, the applicant should carefully read
the new information brochure accompanying the RFA, "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. 5/95).  Application forms are
available at most institutional offices of sponsored research and
from the Division of Extramural Outreach Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone (301) 710-0267, email:
[email protected].
 
Applications from multi-component consortia must contain a single
face page, an overall budget page, and separate budget pages for each
institution involved.
 
The RFA label available in the PHS 398 (rev. 5/95) 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, the RFA title and number must be typed on
line 2 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
6701 ROCKLEDGE DRIVE - 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 five sets of appendix material must also be sent to:
 
Dr. Madelon Halula
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases 6003 Executive
Boulevard, Room 4C-16
Bethesda, MD  20892
Rockville, MD  20852 (for express/courier service)
 
Applications must be received by the January 8, 1998.  All
components, subparts and sections of the application must be collated
into the application, and the packages sent to the DRG and to the
NIAID must each be complete in themselves.  Applications that do not
conform to the instructions contained in PHS 398 (rev. 5/95)
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 R0l 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.
 
REVIEW CONSIDERATIONS
 
Review Method
 
Upon receipt, applications will be reviewed for completeness by the
Division of Research Grants (DRG) and for responsiveness by NIAID
staff.  Incomplete and non-responsive applications will be returned
to the applicant without further consideration or review.
 
As part of the initial merit review, a process 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 assigned
a priority score.  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 accompanies
the RFA.  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 capability in adolescent medicine,
adequate and appropriate patient populations, disease prevalence, and
historical success of recruitment and retention of subjects;
 
o  inclusion of populations that are not currently represented in
existing STD CRCs;
 
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 existing CRCs (of particular interest is access
to populations that are currently 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.
 
Direct inquiries regarding programmatic issues to:
 
Dr. Penelope J. Hitchcock
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases 6003 Executive
Boulevard, Room 3A-24
Bethesda, MD  20892
Bethesda, MD  20852 (for express/courier service
Telephone:  (301) 402-0443
Email:  [email protected]
 
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. Madelon Halula
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases 6003 Executive
Boulevard, Room 4C-16
Bethesda,  MD  20892
Bethesda, MD  20852 (for express/courier service
Telephone: (301) 402-2636
FAX:  (301) 402-2638
Email:  [email protected]
 
Direct inquiries regarding fiscal matters to:
 
Ms. Sharie Bernard
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases 6003 Executive
Boulevard, Room 4B-33
Bethesda, MD  20892
Telephone:  (301) 496-7075
 
Schedule
 
Letter of Intent Receipt Date:  October 15, 1997
Application Receipt date:       January 8, 1998
Scientific Review Date:         April 1998
Advisory Council Date:          June 1998
Earliest Award Date:            August 1998
 
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 PHS and EPA strongly encourage all grant 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 EPA and PHS missions to
protect
and advance the physical and mental health of the American people.
 
ADDENDUM
 
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.
 
.

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