Subject: NIH GUIDE - RFA NS-92-01 - V20(35) 09/20/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 20 Sep 91 12:34 EST

Hi Paul,
This is the last part of this week's NIH Guide.  Please post this
one to the NIH Listserver as:
RFANS-91-01.910920
Please let us know when they are posted so we can notify the
listserver.
Thanks,  M. G. Broaddus
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA NS9201 NS-92-01 P1O1 *****************************************
 
FEASIBILITY GRANTS FOR BRAIN-TUMOR RESEARCH CENTERS
 
RFA:  NS-92-01
 
P.T. 34; K.W. 0705010, 0715035, 1002030, 071085, 0785120, 0745020
 
National Institute of Neurological Disorders and Stroke
 
Letter of Intent Receipt Date:  November 15, 1991
Application Receipt Date:  January 15, 1992
 
PURPOSE
 
The National Institute of Neurological Disorders and Stroke (NINDS)
invites applications for feasibility (exploratory) grants for the
development of brain-tumor research centers.  The major purpose of
this Request for Applications (RFA) is to develop additional research
capabilities that will lead to improved diagnosis and management of
patients with brain tumors and to foster an environment that would
enhance the research skills of investigators in specialized methods
relevant to the study of brain tumors.
 
BACKGROUND
 
In response to House Joint Resolution 174, which declared the 1990s
the "Decade of the Brain," the NINDS developed the Implementation
Plan for the Decade of the Brain that identifies the most compelling
neurological disease areas and research issues in which the
opportunity exists to make practical advances during the next several
years.  Among these highest priority issues is the recommendation
that new ways of management of primary brain tumors be developed
through an understanding of the highly specialized biology of brain
tumors.  This recommendation is based on the recognition that tumors
of the brain are a devastating occurrence and that the expanding
tumor mass interferes in several ways with the most delicate organ in
the body.  In addition, brain tumor is the second most common
malignancy of childhood.  In a second incidence peak at the age of
55, brain tumors cause the death of over 35,000 patients a year, a
third of whom succumb to primary tumors of the brain.
 
In The Labor-HHS Appropriations Act for Fiscal Year 1992, the
Congress responded to knowledge that the incidence of brain tumors
continues to increase and that this disease process is especially
tragic because many of the victims are children and young adults.
The Congress, therefore, urged the NINDS to establish several
additional brain-tumor research centers with research training
capabilities, and provided funds for feasibility grants to develop
future capacities in this important area.
 
RESEARCH GOALS AND SCOPE
 
The overall purpose of this RFA is to award feasibility grants that
will lead, ultimately, to several additional centers with
investigators capable of generating complex research initiatives,
developing essential pilot data, and answering important research
questions about a variety of types of brain tumors, processes
associated with malignant tumors, the management of spreading brain
tumors, and other confounding effects of brain tumors.
 
Areas of research appropriate to this RFA include, but are not
limited to:
 
o  fundamental biological research on brain tumors, including such
areas as tumor development, promoters and inhibitors of brain tumor
growth, the specific genetic codes that regulate brain-cell growth to
maturity, the sites at which these messengers act, the genetic
markers that define the premalignant through the highly invasive
stages of a tumor, the chromosomal abnormalities that
neurogenetically link several tumor disorders (such as
neurofibromatosis, bilateral acoustic neurons, meningiomas, and
astrocytomas), the function of the basement membrane and the
extracellular matrix of brain cells, the hormonal modulation of brain
tumors, and factors that regulate tumor angiogenesis;
 
o  development of diagnostic and therapeutic monoclonal antibodies
with a high degree of specificity and sensitivity toward brain
tumors, including the basic developmental and clinical research
required for these activities;
 
o  preclinical testing of pharmacological agents directed towards
specific molecular characteristics of brain tumor cells;
 
o  development of new therapeutic approaches; and
 
o  refinement of existing forms of therapy for the treatment of brain
tumors, such as systems for directly introducing vectors into tumors
that can down-regulate their metabolic activity.
 
Since applicants for the feasibility grant are at an early stage of
developing the scope of a research program that would eventually
qualify for center support, applications must be based on the goal of
creating a clinical research center that would, at the end of the
feasibility grant, conform to the "Application Guidelines: Program
Project and Clinical Research Center Grants" (revised October 1989)
that is available from the NINDS staff contact listed below.
Therefore, the format for these feasibility grant applications must
address at least the following essential components of the future
center:
 
o  the feasibility of developing a research program centered around a
unifying theme relevant to brain-tumor research and treatment;
 
o  a component devoted to fundamental brain-tumor research;
 
o  a component devoted to clinical research on brain tumors,
including plans for research that may lead to the development of new
therapeutic interventions, the refinement of existing forms of
therapy, and the preclinical testing of these forms of therapy; and
 
o  an administrative core devoted to the integration and coordination
of activities within the research center and among the several
research centers selected for funding.
 
Recognizing that the goal of this program is to develop the
capabilities of the awardee investigators and institutions,
applicants must emphasize the existing and the potential strengths of
the applicant organization as related to the development of a
clinical research center. Appropriate areas may include, but are not
limited to: development of additional research capabilities for
basic, applied, and clinical research; potential arrangements for
improved capabilities for preclinical testing of new or refined
methods of treatment of brain tumors; plans for collaborations that
would strengthen existing research interests; identification of
personnel that would be considered essential for the future of the
center and possibilities for their successful recruitment;
development of plans for acquiring or providing special research and
clinical skills; and possible collaborations that would ensure the
availability of patients for clinical studies.
 
DISCIPLINES AND EXPERTISE
 
The Center Director or Principal Investigator must be active in a
discipline related to the study and/or treatment of brain tumors,
such as neuro-oncology, neurosurgery, neurology, neurobiology,
tumor-cell biology, immunology, neurophysiology, neuroanatomy,
neuroradiology, radiation oncology, or neuropharmacology, and have
demonstrated the potential for developing and directing a research
program.  Interrelated biomedical research projects included in the
interdisciplinary research centers must be conducted by scientists
who represent a variety of disciplines within basic, applied, and
clinical science and who are willing and able to relate to each other
so that new scientific leads may be readily developed and effectively
utilized by others.  For purposes of planning, it is important to
recognize that the content of the individual components of a research
center is critical; the research center program must be organized
around a central research theme and must encompass a sufficient
number of scientifically meritorious research activities (from a
minimum of three to a maximum of five or more) to permit an effective
collaborative effort among the participating investigators.
 
SPECIAL INSTRUCTIONS REGARDING WOMEN AND MINORITIES IN CLINICAL
RESEARCH
 
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 or 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 and compelling rationale
for non-conformance to the policy should be provided.
 
The composition of the proposed study population must be described in
terms of gender and racial or ethnic group. In addition, gender and
racial or 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 are urged to assess carefully the
feasibility of including the broadest possible representation of
minority groups; however, the NIH recognizes that it may not be
feasible or appropriate in all research projects to include
representation of the full array of United States racial or ethnic
minority populations (American Indians or Alaskan Natives, Asian or
Pacific Islanders, Blacks, and Hispanics).
 
The rationale for studies on single minority population groups should
be provided.
 
For the purpose of this policy, 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 or ethnic minorities when it is important to apply the results
of the study broadly, and this should be addressed by applicants.
 
If 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 being asked, it will be considered a weakness or
deficiency in the study design and will be reflected in the
assignment of 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 or
do not have an approved, compelling rationale for non-compliance.
 
ELIGIBILITY
 
To be eligible for competition under this RFA, applicants must
document the existence of, or potential for, ongoing basic, applied,
and clinical research related to brain tumors; research resources in
the encompassing fields of neuro-oncology and the neurological
sciences; clinical facilities that demonstrate the ability to
adequately receive and track patients who have brain tumors;
cooperation among investigators within the represented disciplines so
that scientific leads may be effectively implemented; and a plan for
the further development of individual investigators, fellows, or
clinicians in specialized techniques or procedures relevant to
research on brain tumors.
 
MECHANISM OF SUPPORT
 
The support mechanism for this program will be the exploratory
(feasibility) grant (P20).  Applicants are requested to furnish their
own estimates of the time required to achieve the objectives of the
proposed developmental program.  Feasibility grants will be awarded
for up to three years (not renewable).
 
The NINDS expects to make up to four awards for exploratory grants,
depending upon availability of funds.  No exploratory grant (P20) may
exceed annual direct costs of $250,000 for each of three years.  The
current policies and requirements that govern the research grant
programs of the NIH will prevail.
 
NOTE:  Although this RFA specifically invites applications for
feasibility grants only, there may be applicants who are beyond the
feasibility stage and who would be more appropriately judged as
eligible for center status. Applications for clinical research
centers are also welcome, but they must be submitted for any of the
three annual receipt dates (February 1, June 1, and October 1). Such
applications must conform to the application format as described in
the NINDS pamphlet, "Application Guidelines: Program Project and
Clinical Research Center Grants" (revised October 1989), which may be
obtained from the individual to whom inquiries and letters of intent
are directed (address below).
 
REVIEW PROCEDURES AND CRITERIA
 
Review Method.  Upon receipt, applications will be reviewed by NINDS
staff to determine responsiveness to this RFA.  Applications judged
unresponsive will be returned to the applicant.  NOTE: APPLICATIONS
THAT DO NOT CONFORM TO THE INSTRUCTIONS CONTAINED IN THE PHS 398
(rev.9/88, reprinted 10/89) APPLICATION KIT WILL BE JUDGED
NON-RESPONSIVE AND WILL BE RETURNED TO THE APPLICANT.
 
All applications that are complete and responsive to this RFA may be
subjected to a triage by an NINDS peer review group to determine
relative scientific merit among the applications.  The NINDS will
administratively withdraw those applications judged to be
noncompetitive for award and will notify the applicant Principal
Investigator and institutional business official.
 
Those applications judged to be competitive for award will be further
reviewed for scientific and technical merit by an initial review
group convened by the Division of Extramural Activities, NINDS.  A
second level of review will be by the National Advisory Neurological
Disorders and Stroke Council in May 1992.
 
Review Criteria.  The factors to be considered in the evaluation of
the merit of each application will focus on the potential for the
applicant institution to develop into a full clinical research
center; potential access to appropriate patient populations; presence
of facilities for basic, applied, or clinical research, with the
potential to develop other areas; plans for future development in
innovative areas of research and recruitment of needed personnel;
planned collaborations to strengthen existing facilities; plans for
further development of existing research personnel and exchange of
ideas and techniques; and feasibility of the planned research within
the time and budget requested.
 
METHOD OF APPLYING
 
Letter of Intent.   The NINDS urges applicants to submit a letter of
intent that includes the name and address of the Principal
Investigator, the names and addresses of co-investigators who will be
responsible for the planning of research projects and required
components within the center, a descriptive title of each anticipated
areas of research, if possible, and each required component for which
support will be requested, and the identification of any
collaborating institutions, if known at the time.  A letter of intent
is not binding, is not entered into the review of a subsequent
application, and is not a precondition for an award.  The information
provided will be used by the NINDS staff in planning for the review
of applications, to estimate the potential workload, and to avoid
possible conflict of interest.  The letters are requested by November
15, 1991, and are to be sent to Dr. George N. Eaves at the Division
of Stroke and Trauma, NINDS (complete address below).
 
Format of Applications.  All applicants will submit applications on
form PHS 398, the application form for the traditional research
project grant.  This form is available in an applicant institution's
office of sponsored research or business office and from Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 449, Bethesda, MD  20892, Telephone:
(301) 496-7441.
 
Applicants must use the application format as described in the NINDS
pamphlet, "Application Guidelines: Program Project and Clinical
Research Center Grants" (revised October 1989), that may be obtained
from the individual to whom inquiries and letters of intent are
directed.
 
To identify the application as a response to this RFA, check "yes" on
item 2 of page 1 of the application and enter the title "NINDS:
FEASIBILITY GRANTS FOR BRAIN-TUMOR RESEARCH CENTERS" and the RFA
number NS-92-01.  The RFA label available in the application form PHS
398 must be affixed to the bottom of the face page.  Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review.
 
Application Procedure.  Send or deliver the completed application and
four signed, exact photocopies to:
 
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, MD  20892
 
In addition, send two exact photocopies to Dr. George N. Eaves at the
address below.
 
This RFA is a one-time solicitation with an APPLICATION DEADLINE OF
January 15, 1992.  An application not received by close of business
on this date will be ineligible for consideration.  The review for
scientific and technical merit of applications judged responsive to
the RFA will take place during Spring 1992.  THERE WILL BE NO SITE
VISITS.  Review by the National Advisory Neurological Disorders and
Stroke Council will be in May 1992.  Awards will be made on or before
September 30, 1992.
 
INQUIRIES
 
Inquiries regarding this announcement may be directed to:
 
Dr. George N. Eaves
Division of Stroke and Trauma
National Institute of Neurological Disorders and Stroke
Federal Building, Room 8A13
Bethesda, MD  20892
Telephone:  (301) 496-4226
 
For fiscal and administrative matters, contact:
 
Mr. King P. Bond, Jr.
Grants Management Specialist
National Institute of Neurological Disorders and Stroke
Federal Building, Room 1004
7550 Wisconsin Avenue
Bethesda, MD  20892
Telephone:  (301) 496-9203
 
AUTHORITY AND REGULATIONS
 
The program to which the intended grants relate is described in the
Catalog of Federal Domestic Assistance, No. 93.853, Clinical Research
Related Neurological Disorders and 93.854, Biological Basis Research
in the Neurosciences.  Grants will be awarded under the authority of
the Public Health Service Act, Title IV, Section 301 (Public Law
78-410, as amended; 42 USC 241) and administered under PHS grants
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.