Subject: RFA AI-9l-03 2/8/91 NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 07 Feb 91 08:32 EST

Hello,
   Three of six.  Please post this one to the Listserver as:
RFAAI-91-03.910208
   Thanks.   Dottie
 ---------------------------- Text of forwarded message -----------------------
 
REQUEST FOR APPLICATIONS
 
RFA AVAILABLE:  AI-91-03
 
IMPROVED STRATEGIES FOR DIAGNOSIS OF LYME DISEASE
 
P.T. 34; K.W. 0745020, 0715125, 0710070, 0785035, 0710030, 0755010
 
National Institute of Allergy and Infectious Diseases
 
Letter of Intent Receipt Date:  March 15, 1991
Application Receipt Date:  May 3, 1991
 
PURPOSE
 
The National Institute of Allergy and Infectious Diseases (NIAID)
invites applications for research that applies an understanding
of the biology of Borrelia burgdorferi and host responses to
infection by this organism to studies that will lead to the
development of reliable and sensitive diagnostic tests for the
detection of Lyme disease.  Detection of infections by the
etiologic agent of Lyme disease, B. burgdorferi, can
theoretically be executed by antigen detection, detection of an
immune response, or by detection of some non-antigenic component
of the infectious agent such as a specific genomic sequence.
Research focusing upon the development of one or more of these
approaches is an appropriate subject for an application.
 
Successful applications funded under this Request for
Applications (RFA) will be supported through traditional research
project grants (R01) that can be awarded to both nonprofit and
for-profit organizations and institutions.  This RFA solicitation
represents a single competition with a specified deadline for
receipt of applications.  There are no plans to reissue this RFA.
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 May 3,
1991.  Applications should be prepared and submitted in
accordance with the aims and requirements set forth in the
remainder of this document.
 
BACKGROUND INFORMATION
 
Currently, Lyme disease is the most common vector-borne disease
in the United States.  It has been reported in forty-six states
and has become a subject of great public concern in the United
States and other countries, especially those in Europe.  The
Division of Microbiology and Infectious Diseases (DMID) has
targeted Lyme disease as an area of high priority.  DMID sponsors
research programs on:  epizootiology and transmission of Lyme
disease; basic biology of the etiologic agent, B. burgdorferi;
mechanisms of pathogenesis; host interactions with B.
burgdorferi; and immune response to infection.  The long range
goal is the effective control, prevention, and treatment of Lyme
disease.
 
A major impediment to effective treatment of Lyme disease is the
lack of sensitive and reliable diagnostic tests that will allow
attending physicians to determine the presence of Lyme disease
with a high degree of confidence.  Lyme disease is difficult to
diagnose on the basis of symptoms alone, because they tend to be
protean manifestations and present inconsistently.  Therefore,
supplementary information, such as culture of the etiologic agent
or other diagnostic test results, are often critical in the
decision-making process as to whether one treats for Lyme disease
or not.  Most bacterial diseases are confirmed by culturing the
etiologic agent.  Unfortunately, B. burgdorferi is very difficult
to recover from patients.  At present the most likely way to
improve our ability to diagnose cases of Lyme disease is to
develop better approaches for detection of the etiologic agent or
of the host response to it.
 
RESEARCH OBJECTIVES
 
The goal of this RFA is to stimulate programs of
multidisciplinary basic and clinical research focused upon
determining the most effective approach(es) for diagnosis of Lyme
disease.  Applications submitted in response to this RFA are
expected to focus upon developing and testing new diagnostic
strategies that should result in a more reliable and sensitive
approach to the detection of Lyme disease in patients.
 
Applications should include innovative approaches to the
following:
 
o Identification and characterization of antigens, antibodies,
and DNA sequences that are good candidates as reagents, probes,
or targets for use as a basis for a Lyme disease diagnostic test.
 
o Identification and recruitment of three patient populations
(patients that have a firm diagnosis of Lyme disease, patients
that have no history or signs of Lyme disease, and patients that
have symptoms of Lyme disease but test negative using a defined
set of diagnostic tests currently available);
 
o Evaluation of the sensitivity and specificity of candidate
diagnostic assays relative to one another and to selected
commercially available diagnostic kits using a standard panel of
clinical specimens from each of the individuals in the recruited
patient populations described above.
 
However, alternative approaches or additional components may be
included in applications if they are directly related to the
overall objective of this RFA which is the development of
improved strategies for the diagnosis of Lyme disease.
 
MECHANISM OF SUPPORT
 
The support mechanism for this program will be the traditional
individual research grant (R01).  Responsibility for planning,
direction, and execution of the proposed project will be solely
that of the applicant.
 
NIAID anticipates making two 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 is
encouraged.  NIAID staff anticipates that each application would
be a comprehensive single project (i.e., not a multiproject
application).  It is expected that the initial year's awards for
successful applications will average $500,000 in total (direct
plus indirect) costs for each award, although individual awards
may be slightly higher or lower.  Awards will be made for a
project period of up to five years.  (Awards to applicant
institutions outside the United States will be limited to three
years.) The earliest possible award date is September 30, 1991.
NIAID has no plans to reissue this announcement.  At the end of
the award period, awardees may apply for continuation through the
normal competing renewal process for R01 grants.
 
SPECIAL REQUIREMENTS
 
NIAID program staff will organize semi-annual meetings at which
the Principal Investigators, and other key members (as designated
by the Principal Investigators) of the projects, will discuss
their progress.  This will facilitate overall program planning
and development, evaluation of the feasibility of planned
approaches, and will promote productive interactions among the
awardees.  NIAID program staff will also ensure the participation
in these meetings of investigators from other NIAID-supported
Lyme disease research projects in order to further promote
relevant interactions.  Funds for travel to these meetings should
be included in the budget.
 
GENERAL REQUIREMENTS
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to
include minorities and women in study populations so that
research findings can be of benefit to all persons at risk of the
disease, disorder or condition under study; special emphasis
should be placed on the need for inclusion of minorities and
women in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy is intended to apply
to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear
compelling rationale should be provided.
 
The composition of the proposed study population must be
described in terms of gender and racial/ethnic group, together
with a rationale for its choice.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives
of the study.  This information should be included in the form
PHS 398 in Section 2, A-D of the Research Plan AND summarized in
Section 2, E, Human Subjects.
 
Applicants/offerors are urged to assess carefully the feasibility
of including the broadest possible representation of minority
groups.  However, NIH recognize that it may not be feasible or
appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority
populations (i.e., Native Americans [including American Indians
or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics).
The rationale for studies on single minority population groups
should be provided.
 
For the purpose of this, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention and (preventive strategies), diagnosis, or treatment
of diseases, disorders or conditions, including but not limited
to clinical trials.
 
The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.
However, every effort should be made to include human tissues
from women and racial/ethnic minorities when it is important to
apply the results of the study broadly, and this should be
addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States'
populations, including minorities.
 
If the required information is not contained within the
application, the review will be deferred until the information is
provided.  (For RFAs, change to read:  If the required
information is not contained within the application, the
application will be returned.)
 
Peer reviewers will address specifically whether the research
plan in the application conforms to these policies.  If the
representation of women or minorities in a study design is
inadequate to answer the scientific question(s) addressed AND the
justification for the selected study population is inadequate, it
will be considered a scientific weakness or deficiency in the
study design and will be reflected in assigning the priority
score to the application.
 
All applications for clinical research submitted to NIH are
required to address these policies.  NIH funding components will
not award grants or cooperative agreements that do not comply
with these policies.
 
ELIGIBILITY REQUIREMENTS
 
Domestic universities, medical colleges, hospitals, and other
public or private research institutions, including State and
local government units, are eligible.  Applications from minority
investigators and women are encouraged.
 
REVIEW PROCEDURES
 
Applications will be received by the NIH Division of Research
Grants (DRG) and assigned to NIAID.  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.
By mutual agreement between the applicant and NIAID staff, a
non-responsive application may also be retained at NIH and
processed as an unsolicited R01 application for the next review
cycle.  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 for award and will notify the
applicant Principal Investigator 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
July 1991.  The second level of review will be provided by the
National Advisory Allergy and Infectious Diseases Council in
September 1991.
 
REVIEW CRITERIA
 
The factors to be considered in scientific evaluation of the
applications are:
 
o Originality and scientific merit of research approach, design,
and methodology as well as the potential scientific, technical,
or medical significance of the proposed research.
 
o Relevance of the proposed research to the stated objectives of
this RFA.
 
Specifically, the proposed research should be focused upon the
development of a diagnostic assay for Lyme disease with greater
reliability and sensitivity than currently available.
 
o Research experience and competence of the Principal
Investigator and staff to conduct the proposed studies.  The
Principal Investigator and key personnel must exhibit appropriate
experience and competencies (with respect their specific roles in
the research proposed) to conduct research studies on Lyme
disease.
 
o Adequacy of time (effort) that the Principal Investigator and
staff would devote to the proposed studies.
 
o Adequacy of facilities and access to an appropriate patient
population.  The applicant must demonstrate access and ability to
study adequate numbers of patients to achieve statistically
meaningful answers regarding the reliability and specificity of
the diagnostic procedures to be evaluated in the proposed
research.
 
o Reasonableness of proposed costs.
 
The review criteria listed above will be those used by the
initial review group, which will base their evaluation primarily
on scientific merit.  In selecting applications for funding,
while scientific merit is of prime consideration, applications
also will be evaluated for programmatic relevance and importance.
 
METHOD OF APPLICATION
 
Letter of Intent:  Prospective applicants are asked to submit, by
March 15, 1991, a letter of intent that includes a descriptive
title of the proposed research, and the names and affiliation(s)
of the principal investigator and other key nvestigators.  The
letter of intent is requested in order to provide review staff
with 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
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, MD  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 and may be obtained from the Office of Grants Inquiries,
Room 449, Westwood Building, Division of Research Grants, NIH.
The format and detail applicable to research grant applications
should be followed, and the requirements specified under Review
Criteria (VII.C.) 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
IMPROVED STRATEGIES FOR DIAGNOSIS OF LYME DISEASE and the RFA
number AI-91-03.
 
The RFA label available in the form PHS-398 (rev.  10/88) must be
affixed to the bottom of the face page of the original signed
application.  Failure to use this label could result in delayed
processing of the application such that it may not reach the
committee in time for review.
 
The research proposed should describe plans to accommodate the
RFA research program requirements.
 
Application Procedure:  The completed original application and
four (4) exact copies must be sent or delivered to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
TWO (2) ADDITIONAL COPIES MUST BE SENT TO:
 
Dr. Olivia Preble
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, MD  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 May 3, 1991.  Applications received
after the above date will be returned without review.  If the
application submitted in response to this RFA is substantially
similar to a research grant application already submitted to the
NIH for review, but has not yet been reviewed, the applicant will
be asked to withdraw either the pending application or the new
one.  Simultaneous submission of identical applications will not
be allowed, nor will essentially identical applications be
reviewed by different review committees.  Therefore, an
application cannot be submitted in response to this RFA that is
essentially identical to one that has already been reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include
an introduction addressing the previous critique.
 
FUTURE FUNDING
 
This is a one-time RFA.  NIAID has no plans to reissue this
announcement at any future date.  Continuation of research
projects funded through this RFA, beyond the time period awarded,
can be applied for through the usual competitive renewal process
for R01 research grants.
 
INQUIRIES
 
Investigators seeking information relevant to
scientific/programmatic aspects of this RFA should contact Dr.
Robert L. Quackenbush at the address below.  Questions of a
business or administrative nature should be directed to Todd Ball
at the address below.  Questions regarding review procedures
should be addressed to Dr. Preble, at the address given above.
 
Dr. Robert L. Quackenbush
Chief, Bacteriology and Mycology Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Westwood Building, Room 738
Bethesda, MD  20892
Telephone:  (301) 496-7728
 
Mr. Todd Ball
Chief, Microbiology and Infectious Diseases Grants Management Section
Westwood Building, Room 718
GMB, DEA, NIAID, NIH
Bethesda, MD  20892
Telephone:  (301) 496-7075
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.856 - Microbiology and Infectious Disease
Research.  Grants are awarded under the authority of the Public
Health Service Act, Title IV, Section 301 as amended, Public Law
78-410; Public Law 97-219; Public Law 99-158; Public Law 99-500;
and Report 99-711 to accompany HR 5233 and administered under PHS
grant policies and Federal Regulations 42 CFR 52 and 45 CFR Part
74.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.