kristoff@NET.BIO.NET (Dave Kristofferson) (10/12/89)
Vol. 18, No. 36, October 13, 1989 - Page 12
FULL TEXT OF RFAs FOR ONLINE ACCESS
THE DEVELOPMENT AND USE OF SENSITIVE, SPECIFIC, RAPID DIAGNOSTIC
TESTS FOR CLINICALLY IMPORTANT MICROBIAL AGENTS
RFA AVAILABLE: 90-AI-01
P.T. 34; K.W. 0755010, 0715125, 0715165, 0715182, 0745020
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Letter of Intent Receipt Date: December 1, 1989
Application Receipt Date: January 16, 1990
The National Institute of Allergy and Infectious Diseases
(NIAID) invites grant applications for basic research which
will lead to the improvement or development of rapid,
sensitive and specific diagnostic tests for clinically
significant viruses, bacteria, and other microorganisms.
The targeted infectious diseases include, but are not
limited to: respiratory diseases, cytomegalovirus,
hepatitis and other enteric diseases, and sexually
transmitted diseases (STDs). Research on diagnostic tests
for HIV are supported by a separate program.
Successful applicant(s) funded under this Request for
Applications (RFA) will be supported through Cooperative
Agreements. Cooperative Agreements are awarded to both
nonprofit and for-profit organizations and institutions.
This type of solicitation is utilized when it is desired to
encourage investigator-initiated research projects in areas
of special importance to the National Institutes of Health
(NIH) and where substantial programmatic involvement by
staff is anticipated. This RFA solicitation represents a
single competition, with a specified deadline for receipt of
applications. There are no present plans to reissue this
RFA at any future time. The NIAID intends to invite
competitive renewal applications upon expiration of the
initial funding period, contingent on the continued
availability of funds for this purpose, and the continued
need to stimulate research in this area. All applications
received in response to the RFA will be reviewed by the same
NIAID Initial Review Group (IRG) and by the National
Advisory Allergy and Infectious Diseases Council. The
deadline for the receipt of applications in response to this
RFA is January 16, 1989. Applications should be prepared
and submitted in accordance with the aims and requirements
as set forth in the remainder of this document.
BACKGROUND INFORMATION
The rapid and accurate diagnosis of infectious disease is
crucial to appropriate patient management and to the
epidemiological surveillance required for public health
control. As antiviral drugs become available, both for
prophylactic and therapeutic use, it is essential to
diagnose quickly the diseases for which these drugs provide
benefits. Furthermore, diagnostic tests are needed that can
evaluate the drug sensitivity of the infecting microbe.
Improved diagnostic techniques are urgently needed for a
number of clinical infections. Difficulty in diagnosing
some viral infections, such as those caused by CMV, is due
to the virus' slow growth in tissue culture. Some viruses,
such as the papillomaviruses and the Norwalk agent, don't
replicate in tissue culture and therefore require extremely
sensitive diagnostic methods. Other viruses, which grow
quickly in vitro, may still require a test with improved
sensitivity. An example of a need is to be able to detect
the presence of HSV in the genital tract of pregnant women
at delivery. Some currently available diagnostic tests,
such as brain biopsy for herpes simplex encephalitis, are
undesirably invasive. Consequently, physicians may elect to
treat a patient with acyclovir and not biopsy.
Unfortunately, more than half of the patients clinically
diagnosed as having herpes encephalitis actually have
encephalitis due to other causes, some of them treatable.
The failure to obtain a correct diagnosis may thus prevent
or delay initiation of an effective therapy. For diseases
such as diarrhea and respiratory infections, rapid tests
that allow differential diagnosis of the various possible
etiologic agents are highly desirable.
In the area of STDs, improved, inexpensive diagnostics are
essential to successful control of acute infection and
long-term sequelae. Syndromic diagnosis of cervicitis and
urethritis currently relies heavily on Gram stain evidence
of polymorphonuclear leukocytes in endocervical or urethral
secretions. Particularly in women (among whom failure to
diagnose lower tract infection may lead to pelvic
inflammatory disease), this approach is neither sensitive
nor specific. Advances in organism-specific diagnostics for
STDs are equally important. Screening for chlamydial
infection, for example, remains too costly to be offered
routinely in most STD, antenatal, or family planning clinics
in the United States. Yet because of the indolence of
chlamydial disease, detection of asymptomatic infection is
vital to reducing the incidence of infertility, ectopic
pregnancy, fetal wastage, low birth weight, and congenital
infection in this country.
RESEARCH GOALS AND SCOPE
The purpose of this RFA is to stimulate basic research that
is expected to lead to the development of novel diagnostic
tests. The research proposed should select strategies that
will lead to improvements in sensitivity, specificity or
speed in the diagnosis of a clinically important infectious
disease. The tests should be valid for individuals of
either sex and various ethnic populations. Specifically the
research should be targeted towards diagnostic tests for:
1. Infectious diseases that are currently difficult to
diagnose; especially for diseases for which there is
clinical urgency to select an appropriate therapy.
2. Infections for which only cumbersome or invasive
diagnostic methods are available. Non-invasive procedures
and simpler tests are needed.
3. Infectious diseases for which the current tests lack
suitable specificity, sensitivity, or rapidity.
4. Infectious diseases for which more economical tests are
needed.
5. Diagnosis of numerous agents in the same specimen at the
same time.
The targeted infectious diseases include but are not limited
to respiratory diseases, cytomegalovirus, hepatitis and
other enteric infections, and sexually transmitted diseases
(excluding AIDS).
Inclusion of women and minorities are encouraged. If they
are excluded, reasons for this exclusion must be included in
the application.
MECHANISM OF SUPPORT
Award(s) will be made as Cooperative Agreements. These are
assistance relationships with substantial involvement of
NIAID staff, as outlined under Part IV, "Terms of Award".
Universities, medical colleges, hospitals, and laboratories
or other public, private, or for-profit institutions are
eligible.
NIAID anticipates making four awards as a result of this
request. However the number of awards to be made is
dependent upon receipt of a sufficient number of
applications of high scientific merit and upon the
availability of funds. If appropriate, collaboration with
other investigators or institutions by way of consortium
agreements is encouraged. It is expected that the initial
year's award for successful applications will average
$125,000 in direct costs. However individual awards may be
higher or lower. Awards will be made for a project period
of up to five years. [When the applicant institution is
outside the United States, awards will be limited to three
years.] The earliest possible award date is June 1, 1990.
It is the intent of the Program to fund applications in a
manner which will ensure a variety of approaches to the
diagnosis of a variety of diseases caused by viruses and/or
other microorganisms.
TERMS OF AWARD: AWARDEE RIGHTS AND RESPONSIBILITIES; NATURE
OF PARTICIPATION OF NIAID STAFF
Under the Cooperative Agreement, a negotiated partner
relationship between the recipient of the award and NIAID
exists in which the applicant is responsive to the
requirements and conditions set forth in the RFA.
Specifically, the Principal Investigator defines the details
for the project within the guidelines of the RFA, retains
primary responsibility for the performance of the scientific
activity, and agrees to accept close coordination,
cooperation, and participation of NIAID staff in all aspects
of scientific and technical management of the project in
accordance with the terms formally negotiated and mutually
agreed upon prior to the award. The applicant must define
the research objectives and approaches in accord with
his/her own interests and perceptions of novel and
exploitable approaches to the development of rapid,
specific, sensitive diagnostic tests for infectious diseases
and must develop the details of the research design
following the guidance given in this RFA. The awardee is to
plan and conduct the research stipulated in the application
and to ensure that the results obtained are analyzed and
published in a timely manner. The data obtained will be the
property of the awardee.
Assistance via Cooperative Agreement differs from the
traditional research grant in that, in addition to the
normal programmatic and administrative stewardship
responsibilities, the component awarding the Cooperative
Agreement anticipates substantial programmatic involvement
during performance of the project. It is presently
envisioned that the NIAID will be actively engaged in the
coordination of all components including assisting the
awardees in:
* collaborative participation in overall research planning
and data analysis;
* prior approval of changes of key personnel including the
Principal Investigator and co-investigators;
* facilitation of evaluation of the experimental tests for
some pathogens by coordination of acquisition of pedigreed
patient specimens, i.e. specimens (sera, stools, CSFs) from
patients with definitively diagnosed diseases;
* coordination of exchange of reagents when appropriate;
* reduction of duplication of efforts conducted in other
extramural projects.
The staff involvement mandated by the cooperative agreement
mechanism will permit NIAID staff to participate in, but not
direct, the research to ensure that important disease
targets are addressed. A member of the NIAID staff will
serve as Scientific Coordinator and will participate as a
member of the research team. The Scientific Coordinator
will be the Chief, Antiviral Research Branch, DMID, or a
staff member designated by the Chief. The Scientific
Coordinator will interact closely with the Principal
Investigators and Co-investigators in the overall research
planning and in data analysis. During performance of the
award the NIAID Scientific Coordinator may provide
appropriate assistance, advice, and guidance by
participating in the design of research group activities;
advising in the selection of sources or resources,
replacement of staff; coordinating or participating in
collection and/or analysis of data; and, advising in
management and technical performance. The Scientific
Coordinator may organize the exchange of reagents to
validate results from a test developed by one of the
awardees. However, the role of NIAID will be to facilitate
and not to direct the activities.
It is anticipated that decisions in all activities outlined
below as well as changes in research direction will be
reached by consensus of the investigators and the NIAID
Scientific Coordinator. Such changes may be occasioned by
the emerging clinical importance of different infections or
the suitability of developed approaches for diagnosis of
other infections. The manner of reaching this consensus and
the decision-making authority will rest with the Principal
Investigator. However, if a dispute should arise, the
decision of a three-member arbitration team will be binding.
One member of this team will be chosen by the Principal
Investigator and the second will be chosen by the NIAID
Scientific Coordinator. These two members of the
arbitration team will select the third member.
NIAID staff will coordinate an annual symposium in Bethesda,
Maryland, at which the principal investigators will discuss
their progress. This will facilitate overall program
planning and development, the evaluation of the feasibility
of the attempted approaches and will promote productive
interactions among the successful applicants. Funds for
travel to this meeting should be included in the budget. In
addition, Staff will interact informally with the principal
investigators through additional meetings, averaging once a
year, at the Principal Investigator's institution as well as
by regular telephone and written communication.
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
other HHS, PHS, and NIH grant administration policy
statements.
METHOD OF APPLICATION
LETTER OF INTENT
Prospective applicants are asked to submit, by December 1,
1989, a short letter of intent that includes a descriptive
title of the proposed research, and the names and
affiliation(s) of proposed key investigators. The letter of
intent is requested in order to provide an indication of the
number and scope of applications to be reviewed. The letter
of intent does not commit the sender to submit an
application, nor is it a requirement for submission of an
application.
The letter of intent should be sent to:
Dr. Olivia Preble
Acting Chief
Microbiology and Immunology Review Section
Program and Project Review Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Westwood Building - Room 3A10
Bethesda, Maryland 20892
Telephone: (301) 496-8208
Format of Applications
Applications must be submitted on form PHS 398 (Rev.
10/88), the application form for research grants.
Application kits are available at most institutional
business offices, or may be obtained from the Office of
Grants Inquiries, Room 449, Westwood Building, Division of
Research Grants, NIH. The format and detail applicable to
regular research grant applications should be followed, and
the requirements specified under Review Criteria (below)
must be fulfilled.
For purposes of identification and processing, mark "yes" in
item 2 on the face page of the application and type in the
words DIAGNOSTIC TESTS FOR CLINICALLY IMPORTANT MICROBIAL
AGENTS and the RFA number 90-AI-01.
The research proposed should describe plans to accommodate
the RFA research program requirements and NIAID staff
involvement. Note that the applications will be judged by
the stated review criteria.
Application Procedure
The completed original application and four (4) exact copies
should be sent or delivered to:
Division of Research Grants
National Institutes of Health
Westwood Building - Room 240
Bethesda, Maryland 20892**
TWO (2) ADDITIONAL COPIES MUST BE SENT TO:
Dr. Olivia Preble
Acting Chief, Microbiology and Immunology
Review Section
Program and Project Review Branch
National Institute of Allergy and
Infectious Diseases
National Institutes of Health
Westwood Building - Room 3A10
Bethesda, Maryland 20892
Telephone: (301) 496-8208
CONSEQUENCES OF LATE APPLICATIONS AND DUPLICATE SUBMISSIONS
To ensure their review, applications must be received by
both DRG and Dr. Olivia Preble by January 15, 1990.
Applications received after the above date will be returned
without review. The DRG will not accept any application in
response to this announcement that is the same as one
currently being considered by any other NIH awarding unit.
REVIEW PROCEDURES AND CRITERIA
Assignment of Applications: Applications will be received
by the NIH Division of Research Grants (DRG) and assigned to
NIAID.
Review Procedures: Applications will be reviewed by NIAID
staff to determine administrative and programmatic
responsiveness to this RFA; those judged to be
non-responsive will be returned to the applicant without
review. Those applications considered responsive to the RFA
may be subjected to a triage review by an NIAID peer review
group to determine their scientific merit relative to the
other applications in response to the RFA. The NIAID will
withdraw from competition those applications judged by the
triage peer review group to be noncompetitive and will
notify the applicant and the institutional business
official.
Those applications judged to be competitive for award will
be reviewed for scientific and technical merit by a Review
Committee convened by the Division of Extramural Activities,
NIAID during April 1990. The second level of review will be
provided by the National Advisory Allergy and Infectious
Diseases Council in May 1990.
Review Criteria:
The factors to be considered in scientific evaluation of the
applications are:
Originality and scientific merit of research approach,
design, and methodology as well as the potential scientific,
technical, or medical significance of the proposed research.
Research experience and competence of the Principal
Investigator and staff to conduct the proposed studies.
Adequacy of time (effort) which the Principal Investigator
and staff would devote to the proposed studies.
Adequacy of facilities.
Reasonableness of proposed costs.
In addition to the customary criteria listed above,
applications will be evaluated for programmatic relevance
and importance. It is anticipated that at least two awards
will be made for research on viral pathogens and that no
more than one award will be made for research on any one
pathogen.
FUTURE FUNDING
This is a one-time request for applications. NIAID has no
plans to reissue this announcement at any future date;
however the NIAID intends to invite competitive renewal
applications upon expiration of the initial funding period,
contingent on the continued need for this research and the
availability of funds for this purpose.
INQUIRIES
Investigators seeking information relevant to this RFA
should contact Dr. Catherine Laughlin at the address below.
Questions regarding review procedures should be addressed to
Dr. Preble, at the address given in the Section on METHOD OF
APPLICATION.
Dr. Catherine Laughlin
Acting Chief, Antiviral Research Branch
Division of Microbiology
and Infectious Diseases
National Institute of Allergy
and Infectious Diseases
Westwood Building, Room 753
Bethesda, Maryland 20892
Telephone: (301) 496-8285
This program is supported under authorization of the Public
Health Service Act, Sec. 301(c), Public Law 78-410; as
amended. The catalog of Federal Domestic Assistance
citation is Sec. 13.856, Microbiology and Infectious
Diseases Research. Awards will be administered under PHS
grant 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 Agency review.
DIGESTIVE DISEASES CORE CENTERS
RFA Available: 90-DK-01
P.T. 04; K.W. 0715085, 0710030, 0785035, 0715026
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Letter of Intent Receipt Date: December 16, 1989
Application Receipt Date: February 15, 1990
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) invites applications for Digestive Diseases
Core Center Grants to be awarded in Fiscal Year 1991. NIDDK
anticipates the award of up to four competitive Digestive
Diseases Core Center Grants in Fiscal Year 1991.
OBJECTIVE AND SCOPE
The objectives of the Core Center are to bring together, on
a cooperative basis, clinical and basic science
investigators in a manner which enhances and extends
research being conducted in the field of digestive diseases.
Within the research activities of the Core Center should be
research that is relevant to the underlying cause(s),
mechanism(s), diagnosis, early detection, prevention,
control and treatment of digestive diseases and related
physiological, pathophysiological, congenital or metabolic
disorders resulting from such diseases. The focus of the
research program in the center can be a disease such as
inflammatory bowel disease, functional bowel disease,
pancreatitis chronic hepatitis; an organ such as liver,
esophagus, large bowel; a process such as absorption,
secretion, motility or an appropriate combination thereof
which may also include areas of relevant technology. A
major area of programmatic interest in digestive diseases at
NIDDK is inflammatory bowel disease including Crohn's
disease and ulcerative colitis. Accordingly, as a part of
this request for applications, NIDDK intends to fund at
least one digestive disease center whose focus of research
is inflammatory bowel disease.
The Core Center Grant is a mechanism designed to extend the
effectiveness of a group of related projects that are
already funded through other mechanisms such as individual
research grants or program project grants. In this respect
the Core Center mechanism builds upon an established base of
research excellence. The Core Center Grant may provide
funds for:
(1) Core resources such as a tissue culture laboratory,
immunoassay or biostatistics units; each core facility must
be utilized by two or more center participants;
(2) Pilot/feasibility projects to encourage new
investigators or investigators from other fields to pursue
new and innovative ideas to a point where they can compete
for independent support; in addition, temporary salary
support for one named new investigator in a specified area
of research and with a defined pilot/feasibility project may
be requested for up to 24 months, with subsequent
individuals to be proposed by the Core Center PI and
reviewed by the Core Center's Advisory Committee and the
NIDDK; and
(3) Program enrichment funds to provide for small
conferences or symposia, advisory committee expenses and
special consultants.
Institutions that have the necessary foundation of
multidisciplinary digestive diseases-related research are
encouraged to apply for a Digestive Diseases Core Center
Grant. Each applicant must show that at least fifty percent
of the fiscal support for the ongoing research projects in
areas relevant to digestive diseases is from the NIDDK and
that the remainder of the research projects to be included
in the center research base is relevant to the overall goals
of the Core Center. Foreign institutions are not eligible
to apply.
MECHANISM OF SUPPORT
NIDDK expects to award up to four Digestive Diseases Core
Center Grants in Fiscal Year 1991 on a competitive basis.
The receipt of four competitive continuation applications is
anticipated and they will be in competition for the awards
together with other applications received in response to
this announcement. An average Center may include about 5 to
7 pilot/feasibility projects and about 6 core units with a
total direct cost of up to approximately $500,000. However,
the actual cost of the Center will vary depending on the
needs of the Center. The anticipated award will be for five
years and is contingent upon the availability of
appropriated funds. The general description of a Core
Center and Core Center Guidelines as well as consultation
may be obtained from:
Maria H. Sjogren, M.D., Director
Digestive Diseases and Nutrition
Centers Program
National Institute of Diabetes
and Digestive and Kidney Diseases
Bethesda, Maryland 20892
Telephone: (301) 496-9717
REVIEW PROCEDURES
Applications for the Core Center Grant will be evaluated in
a national competition by the NIH Grant peer review process.
Applications will be reviewed initially by a special review
committee convened by the NIDDK and subsequently by the
National Diabetes and Digestive and Kidney Diseases Advisory
Council.
METHOD OF APPLYING
Potential applicants are urged to submit a letter of intent
by December 16, 1989. The letter of intent is non-binding
and is not a precondition for an award. The letter of
intent should include the name(s) of the principal
investigator and principal collaborators, descriptive titles
of the core facilities and pilot/feasibility projects, and
the organization(s) involved.
The special single receipt date for submissions in response
to this announcement is February 15, 1990, with earliest
funding in December 1990. Applications received after
February 15 are unacceptable and will be returned to the
applicant. Applications are unlikely to be reviewed by a
site visit team; therefore, the written application should
be complete so as to facilitate review without a site visit.
Extensive additional material submitted subsequent to the
stated receipt date will not be accepted.
Applications must be submitted using PHS 398 (rev. 10/88).
Check the "YES" box on line 2 of the application face page
and type in "DIGESTIVE DISEASES CORE CENTERS, RFA 90-DK-01."
THE RFA LABEL (FOUND IN THE 10/88 REVISION OF APPLICATION
FORM PHS 398) MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE
OF THE ORIGINAL COPY OF THE APPLICATION. FAILURE TO USE
THIS LABEL COULD RESULT IN DELAYED PROCESSING OF AN
APPLICATION SUCH THAT IT MAY NOT REACH THE REVIEW COMMITTEE
IN TIME FOR A REVIEW.
Mail the completed application (original and four copies) to:
Application Receipt Office
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, Maryland 20892**
Simultaneously two copies of the application are to be sent to:
Review Branch, NIDDK
5333 Westbard Avenue
Westwood Building, Room 406
Bethesda, Maryland 20892
The NIDDK anticipates that the next announcement (RFA) for
Digestive Diseases Core Center applications will be in
September 1991.
This program is described in the Catalog of Federal Domestic
Assistance No. 13.848, Digestive Diseases and Nutrition.
Awards will be made under the authority of the Public Health
Service Act, Title IV, Section 431(b), (Public Law 99-158;
42 USC 285c-5) and administered under PHS Grant Policies and
Federal Regulations 42 CFR Part 52 and CFR Part 74. This
program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems
Agency review.