kristoff@GENBANK.BIO.NET (Dave Kristofferson) (10/06/90)
NIH GUIDE - Vol. 19, No. 36, October 5, 1990
NOTICES
FISCAL YEAR 1991 BUDGET ISSUES ......................(84/119)............... 1
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
NEW NIH/ADAMHA PEER REVIEW CONSULTANT FILE ..........(122/150).............. 1
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
THANK YOU TO PHS 398 RESPONDENTS ....................(161/174).............. 2
Division of Research Grants
Index: DIVISION OF RESEARCH GRANTS
E-GUIDE ACCESS - REPORT OF THE MEETING ..............(177/252).............. 2
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
NOTICES OF AVAILABILITY (RFPs AND RFAs)
DEVELOPMENT OF NOVEL DRUG FORMULATION AND DELIVERY SYSTEMS FOR
ANTI-TUMOR AND ANTI-AIDS AGENTS (RFP) ...............(258/311).............. 3
National Cancer Institute
Index: CANCER
CLINICAL CENTERS FOR A CHILDHOOD ASTHMA MANAGEMENT PROGRAM (RFP) ........... 4
National Heart, Lung, and Blood Institute (321/367)
Index: HEART, LUNG, BLOOD
EPIDEMIOLOGY OF CANCER IN U.S. ETHNIC/MINORITY POPULATIONS (RFA CA-91-02) .. 4
National Cancer Institute (370/457, 804/1080)
Index: CANCER
AIDS-LYMPHOMA NETWORK (RFA CA-91-01) ................(460/591, 1083/1557)... 5
National Cancer Institute
Index: CANCER
ONGOING PROGRAM ANNOUNCEMENTS
STROKE IN BLACKS, OTHER MINORITIES, AND WOMEN (PA-91-01) ..(597/733)........ 7
National Institute of Neurological Disorders and Stroke
Index: NEUROLOGICAL DISORDERS AND STROKE
NOTICES
FISCAL YEAR 1991 BUDGET ISSUES
P.T. 34; K.W. 1014006
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
The purpose of this notice is to provide the National Institutes of Health
(NIH) and the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA)
research grantees and contractors with information on the potential impact of
the Gramm-Rudman-Hollings (GRH) Act on the Fiscal Year (FY) 1991 budget and
associated grant and contract funding.
The GRH Act requires that appropriations for each fiscal year be consistent
with the need to reduce the national budget deficit to a predetermined amount.
If actions on the appropriation do not satisfy the requirements of the GRH
Act, a process called "sequestration" automatically begins. This process
results in mandatory across-the-board spending reductions for Federal
agencies.
There are several key dates in the sequestration process. An initial
sequester order was issued on August 25 and specified a spending cut of 32.4
percent between October 1 and 15. A final sequester order must be issued on
October 15 to specify the spending cuts required from October 15, 1990,
through September 30, 1991. These sequester orders will be cancelled, or
become unnecessary, if the Congress passes--and the President signs--
legislation that meets the deficit reduction requirements.
All Federal agencies are now faced with the necessity of developing
contingency plans in the event that these sequesters do occur. What this
means, in more specific terms, is that some restrictions on Federal spending
may be imposed, and most agencies will be required to reduce their costs for
numerous activities including grants and contracts.
As further details regarding operating budgets for FY 1991 are obtained, the
NIH and ADAMHA will broadly disseminate them to the scientific community.
NEW NIH/ADAMHA PEER REVIEW CONSULTANT FILE
P.T. 34; K.W. 1014002
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
The National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and
Mental Health Administration (ADAMHA) have established a new consultant file
of peer reviewers. Reviewers will be selected from a national pool of
scientists who are engaged in basic or applied research. Data from qualified
respondents will be entered into a new computerized NIH/ADAMHA data base.
This unique data base will be used as one source from which candidates for
membership on NIH/ADAMHA committees and for other peer review activities are
drawn. All qualified scientists are requested to participate. Qualified
women and minority scientists are encouraged to apply.
A Consultant File Information Form has been sent to every PHS grantee and the
solicitation announcement will appear in major journals. Other scientists who
are interested in participating should respond by letter requesting a copy of
the NIH/ADAMHA Consultant File Information Form. Since the new file will be
established based solely on positive responses, your response is needed even
if you are already a consultant or are a member of a Reviewer's Reserve. This
file is independent of other consultant files. Your request should be sent
to:
NIH/ADAMHA Consultant File
4733 Bethesda Avenue, Suite 725, Dept. 02
Bethesda, MD 20814
NIH GUIDE - Vol. 19, No. 36, October 5, 1990 - Page 1
THANK YOU TO PHS 398 RESPONDENTS
P.T. 34; K.W. 1014002
Division of Research Grants
The staff of the Public Health Service would like to thank the many
individuals who responded to the March 30 and April 27, 1990 NIH Guide
Announcements inviting comments and suggestions to improve the Public Health
Service Grant Application Kit (Form 398). The response from the scientific
community was substantial and many useful and constructive comments were
received. These comments have been carefully analyzed and many are being
incorporated into the new version of the Form PHS 398 which should be
available in late 1991.
E-GUIDE ACCESS - REPORT OF THE MEETING
P.T. 16; K.W. 1014002
National Institutes of Health
On September 7, nearly one hundred people from institutions located across the
United States and Canada attended a meeting concerning the electronic version
of the NIH Guide for Grants and Contracts (E-Guide). Attendees had a wide
range of technical and administrative backgrounds and came from academic and
medical institutions, large and small. The meeting was intended to bring
people together for information exchange about receiving and dealing with the
E-Guide, as well as to identify changes that should be made in its format
which would maximize its usefulness to users. It included didactic
presentations, discussion, and on-line demonstrations.
Hope was expressed at the meeting that the E-Guide could be developed to the
point that it is truly an electronic document, rather than an electronic
version of a paper document. Efforts will be dedicated toward accomplishing
this goal but may be limited by the extent to which the NIH can provide
financial resources. Attendees expressed the desire that the electronic
format as transmitted by the NIH be kept simple, with most of the manipulation
performed at the receiver end.
There seemed to be consensus that unobtrusive delimiters for individual items
and the various sections of the Guide would be useful if they did not
interfere with clarity. A test of such delimiters will be enacted in the near
future. In addition, some attendees asked that standards be developed and a
manual be provided that describes the standards and other relevant
characteristics of the files so that institutional users can maximize their
use. This is a point that will be considered for future implementation.
Institutions use a variety of approaches for local distribution, the list
server being a popular one that seems likely to see expanded use.
Considerable interest was expressed in the distribution systems and software
that were demonstrated by representatives from the University of California at
San Francisco, Johns Hopkins University, and the University of North Carolina.
Attendees felt that the publication of an up-to-date list of designated
institutional recipients of the E-Guide would facilitate inter- and
intra-institutional communication, including the exchange of ideas and
information on methods of internal distribution.
Questions arose as to the length of time that individual issues of the E-Guide
should be retained. Key policy announcements are republished approximately
every six months, and most requests for applications or for proposals have a
specific receipt date, but some program announcements might be effective for a
very long time. Back E-Guide issues probably always will be attainable from
the NIH in electronic and/or hard copy. Nevertheless, archival maintenance
should receive additional attention, policy development, and implementation.
Comments also illustrated the need for tutorials in the use of the E-Guide, as
well as identification of approaches to help faculty and staff to use the
electronic format effectively and frequently. In order to be fully
successful, the E-Guide must offer advantages that do not exist for the paper
version. The potential for such advantages exists but further development is
necessary before it can be fully realized.
Attendees generally found the meeting to be very useful, and most felt that it
should be held again, perhaps on a regional basis or in conjunction with other
meetings, or with better and larger facilities so that several individuals can
attend from a single institution for better coordination in use of the
E-Guide.
NIH GUIDE - Vol. 19, No. 36, October 5, 1990 - Page 2
Three handouts were made available at the meeting: (1) "Using the NIH Guide
List Server Archives," (2) "Indexes to the NIH Guide for Grants and
Contracts," and (3) "Electronic Transmission of NIH Extramural Program
Information, Two Principal Modes of Operation." They can be obtained from:
Ms. Claire Blados
Institutional Liaison Office
Building 31, Room 5B31
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-5366
BITNET: Q2C@NIHCU
NOTICES OF AVAILABILITY (RFPs AND RFAs)
DEVELOPMENT OF NOVEL DRUG FORMULATION AND DELIVERY SYSTEMS FOR ANTI-TUMOR AND
ANTI-AIDS AGENTS
RFP AVAILABLE: NCI-CM-17527-49
P.T. 34; K.W. 0715008, 0715035, 0740020
National Cancer Institute
The National Cancer Institute (NCI), Division of Cancer Treatment,
Developmental Therapeutics Program, Pharmaceutical Resources Branch, is
interested in receiving proposals from organizations that have innovative
research ideas concerning improving intravenous delivery and other routes of
administration of chemotherapeutic agents. A workload-per-year of 1-2
compounds having diverse chemical structures of either natural or synthetic
origin is anticipated. The contractor's studies will be directed towards
resolving specific deliverability and/or stability problem(s) culminating in
an acceptable dosage form prepared on laboratory scale. The contractor will
deliver to the NCI, small quantities (less than 50 units) of the
experimentally formulated products for preliminary evaluation for efficacy and
toxicity in rodents.
The Principal Investigator should possess a Ph.D. in chemistry, pharmacy, or a
related discipline, and have extensive experience with the development of
novel drug delivery systems. The contractor should be experienced with drug
analysis procedures including UV, NMR and infrared spectroscopy, plus the
development of stability indicating assays using high performance liquid
chromatography (HPLC).
The contractor should have access to the necessary analytical equipment to
perform the required work, including animal facilities for biologic
evaluation.
This procurement is unrestricted. The Standard Industrial Classification
(SIC) code is 8731.
This RFP will be available on or about October 23, 1990, and will be due
approximately seven (7) weeks thereafter. It is anticipated that two (2)
cost-reimbursement, incrementally funded type contracts for a period of three
(3) years each, beginning approximately June 1991, will be awarded. Requests
for the solicitation should reference the RFP number and be sent to the
address below. No collect calls will be accepted.
Requests for this RFP should be addressed to:
Ms. Sandra A. Lehner, Contracts Specialist
National Cancer Institute
Research Contracts Branch
Treatment Contracts Section
Executive Plaza South, Room 602
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-8620
NIH GUIDE - Vol. 19, No. 36, October 5, 1990 - Page 3
CLINICAL CENTERS FOR A CHILDHOOD ASTHMA MANAGEMENT PROGRAM
RFP AVAILABLE: NHLBI-HR-90-13
P.T. 34, AA, FF; K.W. 0715013, 0715026, 0785035
National Heart, Lung, and Blood Institute
The purpose of this solicitation is to establish clinical centers for a
collaborative study of a Childhood Asthma Management Program (CAMP). The
objective of this program is to determine, in a population of 5-9 year old
children with asthma, if regular use of either of two types of
antiinflammatory medications (inhaled corticosteroids or cromolyn sodium),
compared to regular bronchodilator medication and to each other, results in
greater lung function and less bronchial hyperresponsiveness over a five-year
period. The program will require a clinical coordinating center (CCC) to
collect data from approximately 8 participating clinical centers, each
studying a minimum of 132 children with asthma aged 5-9 years, including 44
from minority groups, e.g., Blacks, Hispanics and Native Americans, over a 6
1/2-year period. The clinical centers will be responsible for: 1)
participating in the development and preparation of the study protocol,
reporting forms, and manual of operations; 2) training staff to conduct the
study as outlined in an approved study protocol and manual of operations; 3)
during an 18-month period recruit 132 children (of both sexes) with asthma
aged 5-9 years, including 44 from minority groups, e.g., Blacks, Hispanics,
and Native Americans; 4) performing follow-up assessment of the subjects in
the manner specified in an approved manual of operations; 5) collecting and
forwarding subject data to the CCC; 6) interacting with the CCC to provide
data and information necessary for data analysis; and 7) working with other
study investigators in the preparation and writing of reports and manuscripts
for publication.
This announcement is for clinical centers only, and the Institute expects to
make 8 awards. A separate Request for Proposals (RFP) for the coordinating
center will appear later.
This announcement is not an RFP. It is anticipated that RFP NHLBI-HR-90-13
will be available on or about October 1, 1990, with proposals due on February
28, 1991. Copies of the RFP may be obtained by submitting a written request
along with three (3) self-addressed mailing labels to the address identified
below.
Pamela S. Randall
Contracts Operations Branch, DEA
Westwood Building, Room 654, 5333 Westbard Avenue
National Heart, Lung, and Blood Institute
Bethesda, MD 20892
EPIDEMIOLOGY OF CANCER IN U.S. ETHNIC/MINORITY POPULATIONS
RFA AVAILABLE: CA-91-02
P.T. 34, FF; K.W. 0715035, 0785055, 1002019, 0411005
National Cancer Institute
Application Receipt Date: February 15, 1991
INTRODUCTION
The Division of Cancer Etiology of the National Cancer Institute invites grant
applications for epidemiologic studies of possible causes of cancer in U.S.
ethnic/minority populations.
RESEARCH GOALS AND SCOPE
The purpose of this Request for Applications (RFA) is to stimulate analytical,
site-specific studies of cancer etiology in ethnic/minority populations of the
United States. Research strategies may involve cohort, case-control, or
genetic epidemiology designs as well as laboratory methodology. Innovative
approaches that involve new inter-disciplinary collaboration, or include the
application of diagnostic or exposure measurements, are particularly
encouraged. Whenever possible, studies should make cost-efficient use of
existing resources such as population-based cancer registries or specimen
repositories. Emphasis should be placed on etiologic studies of the more
common cancers affecting the U.S. population, or on cancer sites with rising
NIH GUIDE - Vol. 19, No. 36, October 5, 1990 - Page 4
incidence rates. Projects will be evaluated on their potential for impact on
the overall understanding of cancer etiology and means of prevention.
The initiative permits a wide range of epidemiologic investigations of cancer
in U.S. ethnic/minority populations including, but not limited to, the
following:
o Cross-cultural studies of cancers with striking ethnic disparities
in incidence rates, among groups residing in the same or different
geographic areas, to identify more specifically the etiologic
factors, and to study their relationship with biomarkers of
exposure.
o Analytic studies of specific cancer sites to determine the impact
of age-specific changes in exposures over time, due to waves of
migration within the U.S. as well as from other countries, and/or
to secular changes in lifestyle, occupation, and environment.
o Studies among Hispanics with special consideration given to the
subgroups within the population.
o Studies of ethnic differences in the histologic and cytologic
parameters of particular cancers that may reflect differences in
exposures or susceptibility.
o Meta-analysis of previous studies to further refine known
associations or yield new information on risk factors.
o Studies addressing methodological issues related to the
heterogeneity of ethnic groups, especially dietary and genetic
parameters.
o Molecular epidemiologic studies exploring differences in genetic
predisposition to cancer due to variations in carcinogen
metabolism, DNA repair activities, response to tumor promoters,
measures of immune function, chromosome sensitivity to mutagens, or
other factors.
o Genetic epidemiologic studies of polymorphisms associated with
ethnic differences in cancer risk.
In any studies involving human subjects, where feasible and appropriate, women
should be included in the study population; otherwise a clear rationale for
their exclusion must be provided in the application. Minority institutions
are encouraged to apply, and other institutions are encouraged to establish
collaborative arrangements with minority institutions.
Copies of the RFA may be obtained from:
Dr. A. R. Patel
Extramural Programs Branch
Epidemiology and Biostatistics Program
Division of Cancer Etiology
National Cancer Institute
Executive Plaza North, Suite 535
Rockville, MD 20892
Telephone: (301) 496-9600
AIDS-LYMPHOMA NETWORK
RFA AVAILABLE: CA-91-01
P.T. 34; K.W. 0715008, 0715035, 0755015
National Cancer Institute
Application Receipt Date: January 16, 1991
The Division of Cancer Treatment (DCT) of the National Cancer Institute (NCI)
invites applications (R01 mechanism) from interested investigators to
participate in an AIDS-Lymphoma Network. The AIDS-Lymphoma Network will be
composed of those institutions who successfully compete for funding in this
Request for Applications (RFA) to perform new therapeutic AIDS-lymphoma
clinical trials, or AIDS-lymphoma clinical trials with correlative laboratory
studies. The purpose of the AIDS-Lymphoma Network is to foster interchange
among different institutions and to coordinate activities of the different
institutions working towards a common goal.
NIH GUIDE - Vol. 19, No. 36, October 5, 1990 - Page 5
BACKGROUND
Adult and pediatric acquired immunodeficiency syndrome (AIDS) patients are
surviving longer due to improved retroviral and opportunistic infection
treatment and care. As a result, acquired immunodeficiency
syndrome-associated malignancies have become more prevalent and are now a
major concern. Lymphomas and Kaposi sarcomas are the malignancies most
frequently seen in AIDS patients. Both non-Hodgkin's lymphoma (NHL) and
Hodgkin's disease (HD) have been described in these patients. The etiology of
NHL in AIDS patients remains unclear. The most prominent clinical features of
NHL in HIV-positive patients are the aggressive nature and course of the
disease and the presence of unusual extralymphatic disease in sites such as
the CNS or bowel. Results of treatment using standard intensive multi-agent
chemotherapy have been disappointing, with median survival of less than one
year in treated patients, and difficult because conventional aggressive
combination chemotherapy exacerbates the patient's immunodeficient state. The
choice of therapy must be based on the nature of the disease and the overall
condition of the patient. The precise relationship of HD to the underlying
immunodeficient state in patients with HIV infection also remains unclear.
Clinical observations suggest that HD in this setting may have a different
natural history and therapeutic outcome when compared with HD in the general
population. Patients with HIV infection and HD are likely to have a poor
therapeutic outcome and to develop AIDS-associated opportunistic infections
during therapy.
The NCI recognizes that research in AIDS-lymphoma is technically difficult to
conduct because of the complexity of this disease and the relatively limited
availability of study subjects at any single institution. Thus it is
encouraging conduct of research relevant to this RFA in the context of an
AIDS-Lymphoma Network. The AIDS-Lymphoma Network will serve as a resource of
information and will work to facilitate patient accrual, obtaining tissue
samples, and exchange of information and materials between involved
investigators.
RESEARCH GOALS AND SCOPE
The major goal of this RFA is to develop more effective management and
therapies for AIDS-lymphoma. This goal can be accomplished by supporting (1)
the development of AIDS-lymphoma therapeutic clinical trials or (2)
AIDS-lymphoma clinical trials with correlative laboratory studies.
Both adult and pediatric AIDS-lymphoma studies involving non-Hodgkin's and
Hodgkin's disease are encouraged. The therapeutic clinical trials (pilot,
phase I, or phase II) will usually involve a patient population ranging
between 5-40 patients with survival, response, and/or quality of life end
points. NCI does not envision the establishment of multi-institutional
collaborative therapeutic clinical trials by the AIDS-Lymphoma Network at this
time. Some examples of potential correlative laboratory studies could deal
with the following: (1) What is the clinical significance of the abnormal
patterns of distribution of disease sites? (2) What factors are involved in
the different clinical responses observed in AIDS-lymphomas? (3) What are the
potentially exploitable features with respect to etiology and pathogenesis of
AIDS-lymphoma? (4) What is the clinical significance of the molecular and
cytogenetic alterations specifically associated with AIDS-lymphoma? (5) What
alterations occur in growth factors or oncogenes in AIDS-lymphoma patients
that may potentially lead to new therapies? Investigators are not limited to
the above categories of potential studies. Other scientific approaches may be
proposed.
MECHANISM OF SUPPORT
This RFA will use the NIH grant-in-aid R01 mechanism. Approximately
$3,000,000 in total costs per year for three years will be committed to
specifically fund applications that are submitted in response to this RFA. It
is anticipated that 10 to 15 awards will be made. This funding level is
dependent on the receipt of a sufficient number of applications of high
scientific merit. The earliest feasible start date for the initial award will
be July 16, 1991. Although this program is provided for in the financial
plans of the NCI, the award of grants pursuant to this RFA is contingent upon
the availability of funds appropriated for fiscal year 1991.
ELIGIBILITY REQUIREMENTS
Applicant organizations should be located in the United States and Canada.
Non-profit and for-profit organizations and institutions, and government
agencies are eligible to apply.
NIH GUIDE - Vol. 19, No. 36, October 5, 1990 - Page 6
LETTER OF INTENT
Prospective applicants are asked to submit by December 16, 1990, a letter of
intent that includes a descriptive title of the proposed research, the name
and address of the principal investigator, the names of other key personnel,
the participating institutions, and the number and title of this RFA. The
letter of intent is requested in order to provide an indication of the number
and scope of applications to be reviewed. This letter of intent does not
commit the sender to submit an application, nor is it a requirement for
submission of an application.
INQUIRIES
A copy of the complete RFA describing the research goals and scope, the review
criteria and the method of applying can be obtained by contacting:
Dr. Roy S. Wu
Health Scientist Administrator
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD 20892
Telephone: (301) 496-8866
FAX: (301) 496-9384
Written or telephone inquiries concerning the objectives and scope of this RFA
or inquiries about whether or not specific proposed research would be
responsive are encouraged and should be directed to Dr. Roy S. Wu at the above
address. The program director welcomes the opportunity to clarify any issues
or questions from potential applicants.
ONGOING PROGRAM ANNOUNCEMENTS
STROKE IN BLACKS, OTHER MINORITIES, AND WOMEN
PA: PA-91-01
P.T. 34, FF, II; K.W. 0715200, 0785055, 0745020, 0745070, 0745027, 0411005
National Institute of Neurological Disorders and Stroke
The Division of Stroke and Trauma (DST), National Institute of Neurological
Disorders and Stroke (NINDS), invites applications for support of research
that will increase our knowledge and understanding of cerebrovascular disease
in blacks, other minorities, and women.
BACKGROUND
The Report of the Secretary's Task Force on Black and Minority Health
discusses the continuing disparity in the burden of death and illness
experienced by blacks and other minority Americans compared with the
population as a whole. In the United States, stroke remains a leading cause
of death and a prime cause of disability. Nearly half a million Americans
each year are known to suffer an acute stroke. The overall problem is even
more imposing than annual incidence and mortality figures would indicate,
since many strokes are not fatal and recurrent strokes are common in nearly
all forms of cerebrovascular disease. Additionally, many transient attacks
(TIA) and minor strokes frequently remain unreported. In the black
population, age-adjusted death rates for stroke are almost twice that of the
white population. Dramatic differences between the extent of the various
cerebrovascular risk factors are thought to exist among minority populations
as a whole. Women appear to comprise an important population at risk for
stroke. Previous assumptions regarding the hormonal protection against heart
disease and stroke are now being brought into question. Recent changes in
employment patterns and lifestyles of women may be placing them in high-risk
categories in a manner previously unrecognized. Whereas some factors, such as
transient ischemic attacks, are well known, the existence of other factors and
the interrelationship between various predisposing factors remain unclear.
Limited information is available regarding differences between stroke
subtypes, although clinical evidence suggests that such differences may exist.
RESEARCH GOALS AND SCOPE
The Division of Stroke and Trauma is seeking investigator-initiated research
grant applications for basic, applied, and clinical studies related, in the
NIH GUIDE - Vol. 19, No. 36, October 5, 1990 - Page 7
broadest sense, to the etiology, prevention, early diagnosis, and treatment of
stroke, including rehabilitation, as these may relate to blacks, other
minorities, and women.
Examples of important research topics for consideration might include, but
should not necessarily be limited to:
o longitudinal epidemiology of the distribution and inter-relation
between risk factors;
o relation of outcome from stroke to the differences in diagnostic
methodology, acute management, post-stroke care, rehabilitation,
and recurrent stroke;
o evaluation of treatment factors, including treatment compliance, in
these special populations;
o special problems of blacks, other minorities, or women that may
have an impact on the identification, diagnosis, treatment,
management, follow-up, or long-term outcome;
o evaluation of emerging techniques for the analysis, diagnosis,
treatment, and prevention of cerebrovascular disease; and
o comparative studies of identifiable populations at risk for stroke.
MECHANISM OF SUPPORT
The support mechanism for grants in this area will be the usual
investigator-initiated research project grant (R01), the program project grant
(P01), and the center grant (P50). Under these mechanisms, the principal
investigator and any participating investigators will plan, direct, and
perform the research. Applicants for program project grants should contact
the NINDS representative listed below as early as possible in the planning
stages.
APPLICATION AND REVIEW PROCEDURES
Applications must be prepared on form PHS 398 (rev. 10/88) according to the
instructions included in the application kit. These kits are available from
the business offices of most institutions eligible to receive Federal grants
or from the Division of Research Grants, NIH. Applications for program
project grants should request, from the address below, a copy of the NINDS
GUIDELINES FOR THE PREPARATION OF A PROGRAM PROJECT GRANT APPLICATION.
Receipt dates for new research project grant (R01) applications and for
program project grant (P01) and center grant (P50) applications are February
1, June 1, and October 1.
On page 1 of form PHS 398, check "yes" in item 2 and Type: "STROKE IN BLACKS,
OTHER MINORITIES, AND WOMEN, PA-91-01."
Use the mailing label provided in the application kit to mail the signed
original and six exact copies to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
If the application is for a program project or center grant, please send the
original and four copies to the Division of Research Grants. An additional
two copies sent to the address below would be useful for expediting the
processing of applications for these multidisciplinary efforts. Any questions
concerning this should be directed to:
Dr. Patricia A. Grady
Division of Stroke and Trauma, NINDS
Federal Building, Room 8A13
Bethesda, MD 20892
Telephone: (301) 496-4226
Research project grant (R01) applications will be reviewed for scientific and
technical merit by an appropriate study section in the Division of Research
Grants. Program project grant (P01) and center grant (P50) applications will
be reviewed according to the assigned Institute's prevailing practice.
Secondary review will be by an appropriate National Advisory Council.
NIH GUIDE - Vol. 19, No. 36, October 5, 1990 - Page 8
This program is described in the Catalog of Federal Domestic Assistance,
Number 93.853, Clinical Research Related to 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 grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74.
This program is not subject to Health Services Agency review of the
intergovernmental review requirements of Executive Order 12372.
This announcement is a revision of the Ongoing Program Announcement entitled,
"Cerebrovascular Disease in Blacks and Other Minorities," that appeared in the
NIH GUIDE For Grants and Contracts, Volume 16, Number 10, March 13, 1987,
pages 5-6.
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE
CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO
USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S
REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD
BUILDING IS:
5333 Westbard Avenue
Bethesda, Maryland 20816
NIH GUIDE - Vol. 19, No. 36, October 5, 1990 - Page 9
------------------------Full Text of RFAS ------------------------------------
REQUEST FOR APPLICATIONS
RFA NUMBER: CA-91-01
RFA TITLE: AIDS-Lymphoma Network
P.T. 34; K.W. 0715008, 0715035, 0755015
NATIONAL CANCER INSTITUTE
Letter of Intent Receipt Date: December 7, 1990
Application Receipt Date: January 16, 1991
TABLE OF CONTENTS
I. Introduction
II. Purpose
III. Research Goals and Scope
IV. Mechanism
V. Special Requirements
A. Requirements of Grantees
B. Requirements of the AIDS-Lymphoma Network
VI. Eligibility Requirements
VII. Special Instructions for Preparation of Applications
VIII. Review Procedures and Criteria
A. Review Procedures
B. Review Criteria
C. Study Population
IX. Method of Applying
X. Letters of Intent
XI. Inquiries
I. INTRODUCTION
The Division of Cancer Treatment (DCT) of the National Cancer
Institute (NCI) invites applications (R01 mechanism) from
interested investigators to participate in an AIDS-Lymphoma
Network. The AIDS-Lymphoma Network will be composed of those
institutions who successfully compete for funding in this
Request for Applications (RFA) to
perform new therapeutic AIDS-lymphoma clinical trials, or AIDS-
lymphoma clinical trials with correlative laboratory studies. The
purpose of the AIDS-Lymphoma Network is to foster interchange among
different institutions and to coordinate activities of the
different institutions working towards a common goal.
This RFA is designed to promote
collaborations and interactions among researchers from a variety of
basic and clinical disciplines to facilitate better treatment and
management of AIDS-lymphoma patients. Both adult and pediatric
AIDS-lymphoma studies involving non-Hodgkin's or Hodgkin's disease
are encouraged. Basic science investigators should collaborate
with AIDS Clinical Trial Centers, Cancer Centers, Cooperative
Groups or their equivalent to obtain AIDS-lymphoma tumor specimens
and set up collaborative interdisciplinary studies.
The present RFA announcement is for a single solicitation with one
specified deadline January 16, 1991, for receipt of applications.
Applications should be prepared and submitted in accordance with
the aims and requirements described in the RFA.
II. PURPOSE
Adult and pediatric acquired immunodeficiency syndrome (AIDS)
patients are surviving longer due to improved retroviral and
opportunistic infection treatment and care. As a result, acquired
immunodeficiency syndrome-associated malignancies have become more
prevalent and are now a major concern. Lymphomas and Kaposi
sarcomas are the malignancies most frequently seen in AIDS
patients. Both non-Hodgkin's lymphoma (NHL) and Hodgkin's disease
(HD) have been described in these patients. The etiology of NHL in
AIDS patients remains unclear. The most prominent clinical
features of NHL in HIV-positive patients are the aggressive nature
and course of the disease and the presence of unusual
extralymphatic disease in sites such as the CNS or bowel. Results
of treatment using standard intensive multi-agent chemotherapy have
been disappointing, with median survival of less than one year in
treated patients, and difficult because conventional aggressive
combination chemotherapy exacerbates the patient's immunodeficient
state. The choice of therapy must be based on the nature of the
disease and the overall condition of the patient. The precise
relationship of HD to the underlying immunodeficient state in
patients with HIV infection also remains unclear. Clinical
observations suggest that HD in this setting may have a different
natural history and therapeutic outcome when compared with HD in
the general population. Patients with HIV infection and HD are
likely to have a poor therapeutic outcome and to develop AIDS-
associated opportunistic infections during therapy.
The NCI recognizes that research in AIDS-lymphoma is technically
difficult to conduct because of the complexity of this disease and
the relatively limited availability of study subjects at any single
institution. Thus it is encouraging conduct of research relevant
to this RFA in the context of an AIDS-Lymphoma Network. The AIDS-
Lymphoma Network will serve as a resource of information and will
work to facilitate patient accrual, obtaining tissue samples, and
exchange of information and materials between involved
investigators. It is NCI's assessment that such collaboration
between investigators will permit achievement of the goals of this
RFA in the most rapid and efficient manner.
The purpose of this RFA and the resultant AIDS-Lymphoma Network is
to foster collaborative interactions between laboratory scientists
and clinicians to more precisely characterize the molecular and
genetic characteristics of AIDS-lymphoma or to devise more
effective treatment of this disease. Laboratory research efforts
and new therapies ready to be applied in clinical situations are
solicited. The results obtained from studying AIDS-lymphoma
patients will increase our understanding of the biology of
lymphomas and will assist the development of more effective
treatment in the general population of lymphoma
patients as well as those infected with HIV.
III. RESEARCH GOALS AND SCOPE
The major goal of this RFA is to develop more effective management
and therapies for AIDS-lymphoma. This goal can be accomplished by
supporting (1) the development of AIDS-lymphoma therapeutic
clinical trials or (2) AIDS-lymphoma clinical trials with
correlative laboratory studies. Applications should be focused on
integrating research areas with clinical goals. Support will be
provided to institutions with established clinical and/or
laboratory resources. Both adult and pediatric AIDS-lymphoma
studies involving non-Hodgkin's and Hodgkin's disease are
encouraged.
This RFA envisions funding therapeutic clinical trials (pilot,
phase I, or phase II). These therapeutic clinical trials will
usually involve a patient population ranging between 5-40 patients
with survival, response, and/or quality of life end points. NCI
does not envision the establishment of multi-institutional
collaborative therapeutic clinical trials by the AIDS-Lymphoma
Network at this time. Examples of clinical questions worth
considering are the following: (1) What is the best method of
combining retroviral and antitumor therapies? (2) What clinical
approach affords the least toxicity with the best therapeutic
index?
This RFA has a second research goal of funding clinical trials with
correlative laboratory studies. Examples of scientific questions
worth considering are the following: (1) What is the clinical
significance of the abnormal patterns of distribution of disease
sites? (2) What factors are involved in the different clinical
responses observed in AIDS-lymphomas? (3) What are the potentially
exploitable features with respect to etiology and pathogenesis of
AIDS-lymphoma? (4) What is the clinical significance of the
molecular and cytogenetic alterations specifically associated with
AIDS-lymphoma? (5) What alterations occur in growth factors or
oncogenes in AIDS-lymphoma patients that may potentially lead to
new therapies?
Investigators are not limited to the above categories of potential
studies. Other scientific approaches may be proposed. All
institutions must have adequate statistical expertise and be
prepared to serve as a source of tumor specimens for other
institutions in the AIDS-Lymphoma Network. Where feasible and
appropriate, applications for the proposed clinical studies should
include a suitable representation of minorities and women. If the
applicant cannot comply, a clear rationale for their exclusion must
be provided. The laboratory studies must have been demonstrated to
be applicable to tissue samples and/or bodily fluids from human
subjects. A discussion of statistical methodology and significance
pertaining to laboratory data is essential.
IV. MECHANISM OF SUPPORT
Awards will be made as investigator-initiated research grants
through the National Institutes of Health (NIH) grant-in-aid, in
accordance with Public Health Service (PHS) policies applicable to
research project grants. This mechanism is used when the NCI
wishes to stimulate investigator-initiated research projects in
areas of special interest to the National Cancer Program.
Responsibility for the planning, direction, and execution of the
proposed research will be solely that of the applicant. Except as
otherwise stated in this RFA, awards will be administered under PHS
grants policy as stated in the Public Health Service Grants Policy
Statement, DHHS Publication No.(OASH) 82-50,000, revised January 1,
1987.
This RFA is a one-time solicitation. Applications received after
the deadline will be returned. Generally, future unsolicited
competing continuation applications will compete as traditional
research project applications with all other investigator-initiated
applications and be reviewed by the Division of Research Grants
(DRG). However, should the NCI determine that there is a
sufficient continuing program need, a request for renewal
applications will be announced. Only recipients of awards under
this RFA will be eligible to apply.
Approximately $3,000,000 in total costs per year for three years
will be committed to specifically fund applications which are
submitted in response to this RFA. It is anticipated that 10 to 15
awards will be made. This funding level is dependent on the
receipt of a sufficient number of applications of high scientific
merit. The total project period for applications submitted in
response to the present RFA should not exceed three (3) years. The
earliest feasible start date for the initial award will be July 16,
1991. Although this program is provided for in the financial plans
of the NCI, the award of grants pursuant to this RFA is contingent
upon the availability of funds appropriated for fiscal year 1991.
V. SPECIAL REQUIREMENTS
It is essential that there be good liaison between basic scientists
and clinicians, as the goal of this RFA is to apply the knowledge
and techniques of basic science to the treatment and management of
AIDS-lymphoma. NCI representatives will assist the AIDS-Lymphoma
Network by facilitating the coordination of the activities and the
exchange of information among the research groups within the AIDS-
Lymphoma Network.
A. REQUIREMENTS OF GRANTEES
The grantees are required to participate in the AIDS-Lymphoma
Network. Participation in the AIDS-Lymphoma Network is defined as,
but not limited to, attendance at the annual meeting of the AIDS-
Lymphoma Network by the Principal Investigator (PI) or a
representative of each research group and the sharing of
appropriate tumor tissue with other participating research groups
of the AIDS-Lymphoma Network. Grantees conducting clinical trials
are required to accrue patients into approved clinical protocols.
Grantees and PIs are required to comply with all FDA monitoring and
reporting requirements for investigational agents. Grantees are
required to meet the requirements for the protection of human
subjects and the protection of investigators working with AIDS
materials/patients.
B. REQUIREMENTS OF THE AIDS-LYMPHOMA NETWORK
The AIDS-Lymphoma Network will be composed of those institutions
who successfully compete for funding in this RFA. The PIs of the
grants will be members of the Network and will elect a chairman to
serve as the Chairman of the AIDS-Lymphoma Network. The Chairman
will set the agenda for all meetings and coordinate all Network
activities. The members of the Network will review procedures for
patient accrual, quality control, and study monitoring and
procedures for tissue acquisition, processing, distribution,
storage, and methods of histopathological diagnosis for uniformity
among the institutions. There will be a meeting shortly after the
award of the grants to organize the AIDS-Lymphoma Network.
Subsequent annual meetings of the AIDS-Lymphoma Network will review
progress, plan future research activities, coordinate tissue
utilization, and establish priorities. Travel funds for the
organizational meeting and subsequent annual meetings are to be set
aside as a budget line item in each project budget. Funds for
travel to these meetings will be restricted for this purpose only.
Staff from the NCI and the National Institute of Allergy and
Infectious Diseases may attend these meetings. NCI staff may serve
in a liaison role whenever possible, however, substantial
programmatic involvement is neither anticipated nor implied.
VI. ELIGIBILITY REQUIREMENTS
Applicant organizations should be located in the United States
and Canada. Non-profit and for-profit organizations and
institutions, and government agencies are eligible to apply.
VII. SPECIAL INSTRUCTIONS FOR PREPARATION OF APPLICATIONS
General instructions for the preparation of investigator-initiated
grants are contained in the Grant Application Form PHS 398 (revised
10/88).
Because of the Special Requirements discussed in Section V above,
it is critical that each applicant include specific plans for
responding to these requirements. Investigators proposing new
clinical trials should submit a draft protocol with their
application, and address all issues related to clinical trials.
Investigators utilizing on-going clinical trials should also
include the clinical protocol. Institutions with correlative
laboratory studies should clarify whether their clinical trials
will provide them with sufficient AIDS-lymphoma tumor specimens or
whether they will be dependent upon the AIDS-Lymphoma Network for
additional specimens.
All investigators should address issues in communication,
collaboration, tissue procurement, and how these studies would
contribute toward the development of new therapies or management
strategies for AIDS-lymphoma. A discussion of statistical
methodology and significance pertaining to laboratory and clinical
studies is essential.
VIII. REVIEW PROCEDURES AND CRITERIA
A. REVIEW PROCEDURES
Upon receipt, applications will be reviewed initially by the
Division of Research Grants (DRG)
for completeness. Evaluation for responsiveness to the RFA is an
NCI program staff function. Applications will be judged to
determine whether they comply with the goals, scope, and objectives
of the program as described in the RFA (Section III). Incomplete
and non-responsive applications will be returned to the applicant
without further consideration. Applications that are non-
responsive will be inactivated administratively, but may be
submitted as regular investigator-initiated research grant
applications at the next grant application receipt date. Questions
concerning the responsiveness of proposed research to the RFA
should be directed to program staff as described in section XI.
In cases where the number of applications is large compared to the
number of awards to be made, the NIH will conduct a preliminary
scientific peer review to eliminate those which are clearly not
competitive. The NIH will administratively withdraw from
competition those applications judged to be noncompetitive and
notify the applicant and institutional business official. Those
applications judged to be both competitive and responsive will be
further evaluated, using the review criteria shown below, for
scientific and technical merit by an appropriate peer review group
convened by the Division of Extramural Activities, NCI. The second
level of review by the National Cancer Advisory Board considers the
application in light of the special needs of the Institute and the
priorities of the National Cancer Program.
B. REVIEW CRITERIA
The factors considered in evaluating the scientific merit of each
response to this RFA will be:
1. Extent to which the proposed research addresses the goals of
the RFA.
2. The scientific merit of the proposed approach, including
adequacy and quality of the methodological approach, the research
design, the ability to serve as a source of tumor specimens, and a
discussion of statistical methods.
3. Experience, training, time availability, clinical and research
competence of the investigators involved.
4. Adequacy of plans for effective collaboration and communication
between laboratory, clinical, and statistical investigators within
their research institution. For new clinical trials, adequacy of
draft protocols.
5. Adequacy of available facilities, statistical collaboration,
and data management resources.
6. Adequacy of patient population and plans for inclusion of women
and minorities in clinical trials.
7. Provision for the adequate protection of human subjects and the
humane treatment of animals.
8. Appropriateness of the budget and period of support for the
scientific effort proposed.
C. STUDY POPULATION
NCI requires the applicant to recruit women and minorities into
their study population. Applicants must address the study
population issue in their application.
IX. METHOD OF APPLYING
The USPHS research grant application form PHS-398 (revised 10/88)
must be used in applying for these grants. These forms are
available at most institutional business offices; or from the
Office of Grant Inquiries, Division of Research Grants, National
Institutes of Health, Room 449, Westwood Building, 5333 Westbard
Avenue, Bethesda, MD 20892; or from the NCI Program Director named
below.
The RFA label available in the 10/88 revision of Application Form
398 must be affixed to the bottom of the face page. Failure to use
this label could result in delayed processing of your application
such that it may not reach the review committee in time for review.
In addition, the RFA number and title (to the extent that space
permits) should be typed on line 2 of the face page of the
application form.
Submit a signed, typewritten original of the application, including
the Checklist, and four (4) signed, exact photocopies, in one
package to the Division of Research Grants at the address below.
The photocopies must be clear and single sided.
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
At the time of submission, two (2) additional copies of the
application should also be sent to:
REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD 20892
Applications should be received by January 16, 1991. If an
application is received after the indicated dates, it will be
administratively withdrawn.
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.
X. LETTER OF INTENT
Prospective applicants are asked to submit by December 7, 1990, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the principal investigator, the
names of other key personnel, the participating institutions, the
number and title of the RFA in response to which the application is
being submitted. Although a letter of intent is not required, is
not binding, and does not enter into the review of subsequent
applications, the information which it contains is extremely
helpful in planning for the review of applications. It allows
NCI staff to estimate the potential review workload and to avoid
possible conflict of interest in the review. In follow-up phone
conversations, Program staff may be able to assist applicants as
well as ascertain whether they have understood the objectives of
the RFA and opted for an appropriate funding mechanism. Therefore,
NCI would like to emphasize the benefits to the applicant and to
staff of having a principal investigator submit a letter of intent.
The letter establishes communication between the potential
applicant and program staff initiating the RFA. Program staff may
be able to assist prospective applicants in several areas such as
scientific content and objectives of the application, and
appropriate use of consultants.
The letter of intent should be sent to:
BY US POSTAL
Dr. Roy S. Wu
Health Scientist Administrator
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
Bethesda, MD 20892
Telephone: (301) 496-8866
FAX: (301) 496-9384
BY DIRECT DELIVERY
Dr. Roy S. Wu
Health Scientist Administrator
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza North, Room 734
6130 Executive Blvd.
Rockville, MD 20852
Telephone: (301) 496-8866
FAX: (301) 496-9384
XI. INQUIRIES
Written or telephone inquiries concerning the objectives and scope
of this RFA or inquiries about whether or not specific proposed
research would be responsive are encouraged and should be directed
to Dr. Roy S. Wu at the above address. The program director
welcomes the opportunity to clarify any issues or questions from
potential applicants.
This program is described in the Catalog of Federal Domestic
Assistance No. 93.395, (Clinical Treatment Research). Awards are
under authorization of the Public Health Service Act, Title IV,
Part A (Public Law 78-410 as amended: 42 USC 241) 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.
EPIDEMIOLOGY OF CANCER IN U.S. ETHNIC/MINORITY POPULATIONS
RFA Available: CA-91-02
P.T. 34, FF; K.W. 0715035, 0785055, 1002019, 0411005
NATIONAL CANCER INSTITUTE
Letter of Intent Receipt Date: January 15, 1991
Application Receipt Date: February 15, 1991
INTRODUCTION
The Division of Cancer Etiology of the National Cancer
Institute (NCI) invites grant applications for epidemiologic studies
of possible causes of cancer in U.S. ethnic/minority
populations.
PURPOSE
The racial and ethnic diversity of the U.S. population offers a
challenging opportunity for epidemiologic studies of cancer
etiology. Cancer incidence rates, as reported by numerous
population-based registries, vary strikingly across population
subgroups. The wide spectrum of variability in risk for
certain cancer sites (viz. stomach, prostate, multiple myeloma)
suggests a particular need for analytic, cross-cultural
studies. Factors representing a common denominator of risk or
of protection may become identifiable for certain ethnic
groups. In addition, underlying pathogenetic mechanisms may be
hypothesized and tested.
Epidemiologic studies have provided clues on the influence of
environmental exposures and cultural/lifestyle factors in
cancer causation. However, the specific role of dietary
practices and nutritional status in host susceptibility needs
to be clarified. It is also unknown whether dietary
interactions with other exposures, such as cigarette smoke or
occupational substances, influence cancer development.
There is an increasing awareness of the genetic heterogeneity
present within racial and ethnic subgroups. An example is the
mix of ancestry among Hispanic individuals derived from Mexico,
South or Central America, and the Caribbean areas. These groups
may vary significantly in environmental exposures and gene-
environmental interactions, and provide opportunities for a
better understanding of cancer risk factors.
RESEARCH GOALS AND SCOPE
The purpose of this Request for Applications (RFA) is to
stimulate analytical, site-
specific studies of cancer etiology in ethnic/minority
populations of the United States. Research strategies may
involve cohort, case-control, or genetic epidemiology designs,
as well as laboratory methodology. Innovative approaches that
involve new inter-disciplinary collaboration, or include the
application of diagnostic or exposure measurements, are
particularly encouraged. Whenever possible, studies should
make cost-efficient use of existing resources such as
population-based cancer registries or specimen repositories.
Emphasis should be placed on etiologic studies of the more
common cancers affecting the U.S. population, or on cancer
sites with rising incidence rates. Projects will be evaluated
on their potential for impact on the overall understanding of
cancer etiology and means of prevention.
The initiative permits a wide range of epidemiologic
investigations of cancer in U.S. ethnic/minority populations
including, but not limited to, the following:
o Cross-cultural studies of cancers with striking ethnic
disparities in incidence rates, among groups residing in the
same or different geographic areas, to identify more
specifically the etiologic factors, and to study their
relationship with biomarkers of exposure.
o Analytic studies of specific cancer sites to determine the
impact of age-specific changes in exposures over time, due to
waves of migration within the U.S. as well as from other
countries, and/or to secular changes in lifestyle, occupation,
and environment.
o Studies among Hispanics with special consideration given to
the subgroups within the population.
o Studies of ethnic differences in the histologic and
cytologic parameters of particular cancers that may reflect
differences in exposures or susceptibility.
o Meta-analysis of previous studies to further refine known
associations or yield new information on risk factors.
o Studies addressing methodological issues related to the
heterogeneity of ethnic groups, especially dietary and genetic
parameters.
o Molecular epidemiologic studies exploring differences in
genetic predisposition to cancer due to variations in
carcinogen metabolism, DNA repair activities, response to tumor
promoters, measures of immune function, chromosome sensitivity
to mutagens, or other factors.
o Genetic epidemiologic studies of polymorphisms associated
with ethnic differences in cancer risk.
In any studies involving human subjects, where feasible
and appropriate, women must be included in the study
population; otherwise a clear rationale for their exclusion
must be provided in the application. Minority institutions
encouraged to apply, and other institutions are
encouraged to establish collaborative arrangements with
minority institutions.
MECHANISM OF SUPPORT
This program will be supported through the National Institutes
of Health (NIH) traditional research project grant (R01).
Responsibility for the planning, direction, and execution of
the proposed research will be solely that of the applicant.
Awards will be administered under Public Health Service grants
policy as stated in the PHS Grants Policy Statement, DHHS
Publication No. (OASH) 82-50,000 revised January 1, l987.
This RFA is a one-time solicitation. The total project period
for applications submitted in response to the present RFA
should not exceed five years. The intent is to fund several
individual research project grants. Approximately $2.0 million
in total costs will be committed for the first year to
specifically fund applications that are submitted in response
to this RFA. This funding level 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 NCI, the award of grants pursuant to
this RFA is also contingent upon the availability of funds for
this purpose. Non-profit and for-profit and foreign and
domestic institutions are eligible to apply.
Competitive continuation applications will compete with all
other unsolicited applications and be reviewed by a standing
Division of Research Grants study section. However, should the
NCI determine that there is a sufficient continuing program
need, NCI may announce a request for renewal applications.
REVIEW PROCEDURES AND CRITERIA
Review Procedures: Upon receipt, applications will be reviewed
initially by the Division of Research Grants (DRG) for
completeness. Incomplete applications will be returned to the
applicant without further consideration. Preliminary
evaluation for responsiveness to the RFA is an NCI program
staff function. If an application is judged to be
nonresponsive, the applicant will be contacted and given an
opportunity to have it considered along with other unsolicited
grant applications received by NIH for this cycle.
Proposals responsive to this solicitation will be reviewed by
an appropriate review group convened by the Division of
Extramural Activities, NCI. The initial review will be for
scientific merit. The second level of review by the National
Cancer Advisory Board considers the special needs of the
Institute and the priorities of the National Cancer Program.
Review Criteria: Applications should be responsive to the RFA
and, therefore, relevant to the program goals of the NCI.
Those factors considered to be important for
review include a demonstrated knowledge of the applicable
science, adequacy of facilities and personnel commitment,
availability of subject populations and in-depth knowledge of
the state-of-the-art to which the RFA is directed. The
application will be judged upon the overall scientific merit,
adequacy of methodology, facilities and resources, commitment
of time and cost effectiveness of proposal, and quality of
collaborations.
METHOD OF APPLYING
Applications must be submitted on form PHS-398, revised 10/88,
available at most institutional business offices, or from the
Office of Grants Inquiries, Division of Research Grants, NIH,
Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda,
Maryland 20892. The format and instructions applicable to
regular research grant applications should be followed.
The RFA label available in the 10/88 revision of Application
Form 398 must be affixed to the bottom of the face page.
Failure to use this label could result in delayed processing of
your application such that it may not reach the review
committee in time for review. In addition, the number and
title of the RFA should be typed on line 2 of the face page of
the application and YES must be checked.
Submit a signed, typewritten original of the application,
including the Checklist, and four (4) signed, exact
photocopies, in one package to the Division of Research Grants
at the address below. The photocopies must be clear and single
sided.
DIVISION OF RESEARCH GRANTS
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
At time of submission, two (2) additional copies of the
application should also be sent to:
REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD 20892
Applications must be received by February 15, l991. If an
application is received after that date, it will be returned.
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 which 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.
Letter of Intent
Prospective applicants are requested to submit, by January 15,
1991, a letter of intent that includes a descriptive title of
the proposed research, the name and address of the principal
investigator, the names of other key personnel, the
participating institutions, and the number and title of the RFA
in response to which the application is being submitted.
Although a letter of intent is not required, is not binding,
and does not enter into the review of subsequent applications,
it allows NCI staff to estimate the potential review workload.
The letter of intent should be sent to:
Dr. A. R. Patel
Extramural Programs Branch
Epidemiology and Biostatistics Program
Division of Cancer Etiology
National Cancer Institute
Executive Plaza North, Suite 535
Rockville, MD 20892
Telephone: (301) 496-9600
INQUIRIES
Written or telephone inquiries concerning the objectives and
scope of this RFA or inquiries about whether or not specific
proposed research would be responsive are encouraged and should
be directed to Dr. A. R. Patel at the above address.
THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE
DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE
WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE
NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL
OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S
REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS OF THE
WESTWOOD BUILDING IS 5333 WESTBARD AVENUE, BETHESDA, MARYLAND
20816.
This program is described in the Catalog of Federal Domestic
Assistance No. 93.393, Cancer Cause and Prevention Research.
Awards are under authorization of the Public Health Service
Act, Section 301(c) and Section 402 (Public Law 78-410, as
amended; 42 USC 241; 42 USC 282) and 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.