CZJ%NIHCU.BITNET@CUNYVM.CUNY.EDU (09/13/88)
Attached is the Table of Contents and articles of interest from the
NIH Guide to Grants and Contracts 9/2/88
Jim Cassatt
====================================================================
Vol. 17, No. 28, September 2, 1988
NOTICES
REVISED GUIDELINES FOR CORE GRANTS ........................(84/111)......... 1
National Eye Institute
Index: EYE
REVISED GUIDELINES FOR INSTITUTIONAL TRAINING GRANTS ......(114/146)........ 1
National Eye Institute
Index: EYE
DATED ANNOUNCEMENTS (RFPs AND RFAs)
STATISTICAL AND DATA ANALYSIS CENTER FOR THE AIDS CLINICAL
TRIALS GROUP (RFP) ........................................(164/255)........ 2
National Institute of Allergy and Infectious Diseases
Index: ALLERGY AND INFECTIOUS DISEASES
CANCER CENTER MINORITY ENHANCEMENT AWARDS (RFA) ...........(258/279)........ 3
National Cancer Institute
Index: CANCER
NATIONAL COOPERATIVE NATURAL PRODUCTS DRUG DISCOVERY GROUPS (RFA) (282/369). 3
National Cancer Institute (964/2042)
Index: CANCER
IDENTIFICATION AND EVALUATION OF MOLECULAR PROBES FOR PATHOLOGICAL
CLASSIFICATION OF HUMAN ASTROCYTOMAS ...............(372/454, 2045/2606).... 4
National Cancer Institute
Index: CANCER
SEXUALLY TRANSMITTED DISEASES RESEARCH UNITS (RFA) ...(457/547, 2609/2930).. 5
National Institute of Allergy and Infectious Diseases
Index: ALLERGY AND INFECTIOUS DISEASES
BEHAVIORAL RESEARCH ON THE USE OF CONDOMS TO PREVENT AIDS (RFA) (540/704)... 6
National Institute of Child Health and Human Development (2933/3224)
Index: CHILD HEALTH AND HUMAN DEVELOPMENT
ONGOING PROGRAM ANNOUNCEMENTS
TYPE II OSTEOPOROSIS (PA) ...................................(710/867)...... 8
National Institute on Aging
National Institute of Arthritis and Musculoskeletal and
Skin Diseases
Index: AGING, ARTHRITIS, MUSCULOSKELETAL AND SKIN DISEASES
ERRATUM
RESEARCH ON AIDS AND THE AMERICAN TEENAGER (RFA) ............(884/900)......11
National Institute of Child Health and Human Development
Index: CHILD HEALTH AND HUMAN DEVELOPMENT
NOTICES
REVISED GUIDELINES FOR CORE GRANTS
P.T. 34; K.W. 1002046, 0710030, 0715100
National Eye Institute
The National Eye Institute (NEI) has recently revised its application
guidelines for Core Grants for Vision Research (P30). The objectives of the
NEI Core Grant Program are: (1) to enhance an institution's environment for
vision research; (2) to attract scientists of diverse disciplines to engage in
vision research; and (3) to facilitate multidisciplinary and/or collaborative
studies of the visual system and its disorders. To be eligible for Core
Grants, institutions must have at least four NEI-supported investigators, each
with at least two years of committed support remaining on a regular research
grant (RO1), FIRST award (R29), or MERIT award (R37) at the time of submission
of the application. The NEI currently provides up to $750,000 direct costs
over a 5-year period in support of a Core Grant. An exception to this limit
may be made for applications requesting a Clinical Vision Research Development
module. Applications that specifically include such a module may request up
to $1,050,000 direct costs over a 5-year period. The NEI has one receipt date
for Core Grants; June 1 of each year. Copies of the new guidelines may be
obtained by writing to:
NEI Core Grant Program Director
National Eye Institute
Building 31, Room 6A48
Bethesda, Maryland 20892
Telephone: (301) 496-5884
REVISED GUIDELINES FOR INSTITUTIONAL TRAINING GRANTS
P.T. 44; K.W. 0720005, 1014002
National Eye Institute
The National Eye Institute (NEI) has recently revised its application
guidelines for National Research Services Award (NRSA) Institutional Training
Grants (T32). Emphasis is placed on: (1) enhancing fundamental training in
basic disciplinary areas at the predoctoral level, where an introduction to
vision research opportunities would be expected; and (2) using more
specialized fundamental training at the postdoctoral level to help meet
national research priorities in vision research. NEI research priorities are
described in "Vision Research -- A National Plan: 1983-1987" and the recently
published "1987 Evaluation and Update". Copies of these documents are
available from:
Associate Director for Planning and Reporting
National Eye Institute
Building 31, Room 6A27
Bethesda, Maryland 20892
The NEI has one receipt date for institutional training grants; January 10 of
each year. The revised institutional training grant guidelines are available
from:
NEI Training Program Director
National Eye Institute
Building 31, Room 6A48
Bethesda, Maryland 20892
Applicants are encouraged to contact the NEI Training Program Director at
301/496-5884 prior to submission of an application.
Vol. 17, No. 28, September 2, 1988 - Page 1
DATED ANNOUNCEMENTS (RFPs AND RFAs)
STATISTICAL AND DATA ANALYSIS CENTER FOR THE AIDS CLINICAL TRIALS GROUP
RFP AVAILABLE: RFP-NIH-NIAID-AIDSP-89-8
P.T. 34; K.W. 1004008, 1010013, 0755015
National Institute of Allergy and Infectious Diseases
The Treatment Research Branch of the AIDS Program, National Institute of
Allergy and Infectious Diseases, NIH, is planning to recompete the current
AIDS Clinical Trials Coordinating Center contract. The emphasis of this
activity is changing from a data collection and management activity to a
statistical and data design and analysis activity. The purpose of the new
five-year contract is to provide extensive biostatistical expertise and data
management coordination to the AIDS Clinical Trials Group (ACTG).
ACTG clinical trials are currently being conducted by 34 funded sites
designated as AIDS Clinical Trials Units (ACTUs). Some of the awards are to
groups of institutions, with a total of over 55 clinical sites located
throughout the United States participating in ACTG trials. These sites are
each involved in the evaluation of potential therapies for HIV infection. As
of July 1, 1988, 37 protocols were active, an additional 39 protocols were
pending or in development, and over 4,000 patients had been enrolled in ACTG
clinical trials, including a number of large-scale multicenter Phase III
studies. It is anticipated that the ACTG will continue to expand over the
next several years. The number of clinical sites may increase significantly,
possibly to a total of 85 to 90 participating sites. By 1990 it is expected
that over 10,000 patients will be enrolled in approximately 100 active
protocols at any given time, with about 75 percent of the patients enrolled in
Phase III studies.
Necessary functions relevant to this activity include the ability to: provide
scientific leadership with regard to experimental design, sample size,
protocol feasibility, data analysis, and other statistical issues involving
protocol development, implementation and analysis; perform interim and final
statistical analyses and be substantially involved in the writing of
scientific papers; conduct methodological research on the efficient design,
conduct and analysis of ACTG clinical trials; perform cross-study analyses to
identify new leads regarding prognostic factors and late treatment effects;
give formal presentations at each ACTG national meeting on issues related to
the design, conduct and analysis of ACTG studies; serve on relevant ACTG
committees; provide for central registration of patients and for randomization
where appropriate; identify information to be included in protocol-specific
research records, develop study forms, and define the computerized database;
provide for computer processing, storage and retrieval of data at a central
data management facility using a commercial (nonproprietary) database
management system based on the relational model of database management and
incorporating the industry-standard SQL language; design and implement quality
assurance procedures to evaluate the validity and completeness of data
collected; design and implement data entry procedures to provide for the
efficient transfer of data to a central facility using either a distributed
and/or centralized approach; provide for electronic mail to facilitate
communication among ACTG participants; provide appropriate training; prepare
operations manuals and related material; and develop a detailed work plan for
the transition phase.
To perform the required work, the contractor must be able to provide:
experience serving as a statistical and data analysis center for complex
multicenter, multi-protocol clinical trial research efforts; Ph.D.-level
statisticians with experience and expertise in sophisticated statistical
techniques required for the analysis of clinical trials; experience in active
collaborations with clinicians in the design, conduct and analysis of clinical
trials; experience in AIDS-related research studies; access to a
large-capacity computer facility; and experience in the various activities
described above.
This NIAID-sponsored project will take approximately five years to complete.
A cost-reimbursement contract is anticipated. NIAID expects to make one
award.
This is an announcement for an anticipated Request for Proposal (RFP).
RFP-NIH-NIAID-AIDSP-89-8 shall be issued on or about October 10, 1988, with a
closing date tentatively set for December 13, 1988.
Vol. 17, No. 28, September 2, 1988 - Page 2
Requests for the RFP shall be directed in writing to:
Brenda Velez
Contract Management Branch
Westwood Building, 5333 Westbard Avenue, Room 707
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, Maryland 20892
Telephone: (301) 496-7117
To receive a copy of the RFP, please supply this office with three
self-addressed mailing labels. All responsible sources may submit a proposal
which will be considered.
This advertisement does not commit the Government to award a contract.
CANCER CENTER MINORITY ENHANCEMENT AWARDS
RFA: 88-CA-11
P.T. 04, FF; K.W. 0715035, 0710030, 0745020, 0745055, 0415000, 0710095
National Cancer Institute
CHANGE IN RECEIPT DATE: September 15, 1988
The April 29 issue of the NIH Guide for Grants and Contracts (Vol. 17, No.
16) included a notice of availability of a request for applications (RFA) on
the above topic. Please note that the receipt date for applications in
response to this RFA should be September 15, 1988 instead of August 2.
Questions and requests for the complete RFA may be addressed to:
Lemuel A. Evans, Ph.D.
Director, Comprehensive Minority Biomedical Program
Building 31, Room 10A04
9000 Rockville Pike
Bethesda, Maryland 20892
Telephone: (30l) 496-7344
NATIONAL COOPERATIVE NATURAL PRODUCTS DRUG DISCOVERY GROUPS
RFA AVAILABLE: 88-CA-17
P.T. 34; K.W. 0740020, 0755025, 0750025, 0755020
National Cancer Institute
Letter of Intent Date: October 21, 1988
Application Receipt Date: December 9, 1988
In FY 1983 and 1984 NCI requested applications for National Cooperative Drug
Discovery Groups whose goal was the discovery of improved cancer treatment on
the basis of novel mechanism of drug action (Vol. 12, No. 7, July 1983, and
Vol. 13, No. 9, August 3, 1984). In 1986, the program requested applications
focused on exploitation of specific and unique characteristics of lung and
colon cancer (Vol. 15, No. 20, October 3, 1986). The NCDDG approach to
modern anticancer treatment discovery was broadened further in August 1987 by
RFAs inviting applications for the creation and evaluation of both general
mechanism of action based and specific disease-oriented anticancer treatments
as well as for the development of innovative preclinical models for
determining antitumor selectivity.
SUMMARY
The National Cancer Institute (NCI) announces the availability of an RFA for
the funding of National Cooperative Natural Products Drug Discovery Groups
(NPDDGs) to stimulate the scientific community to select and isolate on a
rational basis, new potential anticancer treatments from natural sources and
to evaluate them in preclinical models designed to select those with the most
favorable prognosis for clinical usefulness. This program is designed to
assist leading investigators in diverse scientific disciplines to interact as
a unit, regardless of their individual institutional affiliations or prior
direct involvement in cancer related research. The purpose is to mobilize,
with NCI support, the outstanding talents required for exploitation and
extrapolation of leads from fundamental studies to the discovery of improved
Vol. 17, No. 28, September 2, 1988 - Page 3
anticancer treatment. An NPDDG is envisioned as being composed of a Principal
Investigator and a number of Program Leaders who will conduct interdependent
and synergistic preclinical laboratory programs to identify and isolate novel
anticancer leads from natural sources, conduct preclinical tasks required to
select materials worthy of development based on activity in pertinent
laboratory models as perceived by the Group, and provide the basis for
identifying new agents and strategies for development to clinical trial. A
NPDDG may be made up of scientists in academic, non-profit research, and
commercial organizations.
Awards will be made as cooperative agreements. Assistance via cooperative
agreement differs from all research grants in that the cooperative agreement
funding mechanism anticipates substantial NCI staff participation during
performance. However, the applying Group must define its objectives in accord
with its own interests and perceptions of approaches to the discovery of new
models. The role of NCI as a member of the Group is described in the RFA.
Essentially, the extramural NCI staff concerned with the administration of
grants and contracts will apply its experiences and appropriate resources to
facilitate and stimulate the realization of Group objectives. The active
participation of industry is encouraged because it will allow this segment of
the scientific community to contribute its considerable intellectual and
material resources.
The Principal Investigator's (PI's) institution will be responsible for the
Group's application. Awards will be made to the applicant institution on
behalf of the Group as a whole and not to individual Laboratory Programs
within the Group. The PI's institution will provide a Central Operations
Office for the Group and will be responsible for the performance of the entire
Group and be accountable for the funds awarded.
NCI plans to make multiple awards for project periods of up to five years and
has set aside three million dollars for the initial year's funding.
The RFA label obtained from the NCI staff person named below or from grant
application Form PHS 398 (Revised 9/86) 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.
For further information and a copy of the RFA contact:
J.A.R. Mead, Ph.D.
Program Director, NPDDGs
Executive Plaza North, Suite 832
Grants and Contracts Operations Branch
Developmental Therapeutics Program
Division of Cancer Treatment
National Cancer Institute
Bethesda, Maryland 20892
IDENTIFICATION AND EVALUATION OF MOLECULAR PROBES FOR PATHOLOGICAL
CLASSIFICATION OF HUMAN ASTROCYTOMAS
RFA FOR COOPERATIVE AGREEMENT AVAILABLE: 88-CA-18
P.T. 34; K.W. 1002058, 1002015, 1002008, 1002004, 0710075
National Cancer Institute
Application Receipt Date: January 16, 1989
Letter of Intent Receipt Date: October 17, 1988
The Diagnosis Research Program of the Division of Cancer Biology and Diagnosis
at the National Cancer Institute (NCI) invites applications for Cooperative
Agreements from institutions interested in identifying and evaluating
molecular probes to improve the pathologic classification of astrocytomas.
Astrocytomas are the most common primary tumors of the central nervous system
(CNS), but precise pathologic diagnosis is often difficult, and the current
classification scheme does not permit reliable predictions of clinical
outcome. Recent advances in the field of molecular biology suggest that
opportunities exist to develop a classification scheme using molecular probes.
This should lead to a better understanding of the disease and hopefully to
improved therapy. This Request for Applications (RFA) is designed to promote
collaborations and interactions among researchers from a variety of basic
scientific and clinical disciplines (e.g. molecular biology, cell biology,
immunology, biochemistry, cytogenetics, neuropathology, clinical medicine) to
Vol. 17, No. 28, September 2, 1988 - Page 4
facilitate correlation of results using molecular probes with results using
standard histopathological analysis and with patient response to specific
therapies.
Awards will be made as Cooperative Agreements. These create an assistance
relationship in which substantial involvement of NCI staff is anticipated
during performance of the project, as outlined in the detailed RFA. This
mechanism is used when the NCI wishes to stimulate investigator interest and
proposes to advise or assist in planning in an important and opportune area of
research. Applicants will be responsible for the planning, direction and
execution of the proposed project. 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 clinic in the areas of
diagnosis and prognosis. Each group responding to this RFA should describe
existing and proposed collaboration/cooperation between basic scientist(s) and
clinician(s).
NCI anticipates making 3 to 5 awards for project periods of up to 5 years;
total direct costs of $750,000 have been set aside for the initial year's
funding. Although this program is provided for in the financial plans of the
NCI, the award of Cooperative Agreements pursuant to this RFA is contingent on
the availability of funds appropriated for fiscal year 1989.
This RFA is a one-time solicitation with a specified deadline of January 16,
1989, for receipt of applications.
The RFA label available in the 9/86 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.
A copy of the complete RFA describing the research goals and scope, the
Cooperative Agreement mechanism, the review criteria and the method of
applying can be obtained by contacting:
Doris Balinsky, Ph.D.
Program Director for Biochemistry and Immunodiagnosis
Division of Cancer Biology and Diagnosis
National Cancer Institute
Room 10A10, Westwood Building
5333 Westbard Avenue
Bethesda, Maryland 20892
Telephone: (301) 496-1591
Inquiries concerning this RFA are encouraged and should be directed to Dr.
Balinsky at the above address or telephone number.
This program is described in the catalog of Federal Domestic Assistance no
13.394, Cancer Detection and Diagnosis 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 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.
SEXUALLY TRANSMITTED DISEASES RESEARCH UNITS
RFA AVAILABLE: 88-AI-14
P.T. 34; K.W. 0715220, 1002027, 0785035, 0785055, 0710030
National Institute of Allergy and Infectious Diseases
Application Receipt Date: November 28, 1988
BACKGROUND INFORMATION
The National Institute of Allergy and Infectious Diseases (NIAID) invites
applications for program project grants to be initiated during FY 1989 for a
continuing program of research on the spectrum of Sexually Transmitted
Diseases (STD).
RESEARCH GOALS AND SCOPE
The goal of the program is to encourage investigators to undertake research
that will provide the clinical, behavioral, epidemiological and
microbiological information needed for the eventual control of sexually
Vol. 17, No. 28, September 2, 1988 - Page 5
transmitted diseases. The NIAID wishes to broaden the scope of its program of
research in this area so that the knowledge gained may be applied to
improvement in the means of prevention, diagnosis, and therapy of these
infections.
As one means of achieving the stated goals, the NIAID proposes to maintain
support of a number of STD Research Units. These units are funded as program
project grants, function as centers of excellence in STD research and serve as
foci for research and training. The research to be considered for emphasis in
this program can be on any or on all of the STDs that are currently recognized
as significant public health problems with the exception of ectoparasites. A
strong clinical component should be a major part of the program project
application. Several distinguishing characteristics that must be considered
in developing these applications for STD Research Units and the specific areas
of research being encouraged are detailed in the full RFA.
Only institutions with demonstrated strong ongoing research programs and
resources that can focus on a multidisciplinary and multifaceted team effort
to study STD infections in depth will be considered for program project
support under the provisions of this program.
MECHANISM OF SUPPORT
Eligibility: Domestic universities, medical colleges, hospitals, laboratories
and other public or private research institutions, including state and local
governmental units, are eligible.
Length of Support: The project can be supported up to a maximum of five years
without additional competition contingent upon availability of funds.
Expected Number of Awards: Competition is open for two or three program
projects in STD research. Two currently funded STD Research Units may be
competing for renewal of their support. Support for each STD Research Unit is
estimated at $450,000 per year, direct costs.
APPLICATION PROCEDURES
All applications in response to this RFA must be submitted on Application Form
398 Rev. 9/86. On line 2 of the application form, insert the title of this
RFA "Sexually Transmitted Diseases Research Units" and the RFA number
88-AI-14. The RFA label contained in the application kit 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.
All inquires and requests for the full text of this RFA should be directed to:
William P. Allen, Ph.D., Chief
Bacteriology and Virology Branch
NIAID, NIH, WB-738
Bethesda, Maryland 20892
Telephone: (301) 496-7728
Interested investigators are requested to submit a letter of intent or call by
September 30, 1988 the Institute contact person. The letter of intent should
include a descriptive title, the principal investigators and the individual
subprojects under consideration for the program project. The letter of intent
is not binding and is not a requirement.
BEHAVIORAL RESEARCH ON THE USE OF CONDOMS TO PREVENT AIDS
RFA AVAILABLE: 88-HD-16
P.T. 34; K.W. 0404000, 0715120, 0745055
National Institute of Child Health and Human Development
Application Receipt Date: January 16, 1989
BACKGROUND INFORMATION
The Center for Population Research (CPR) of the National Institute of Child
Health and Human Development (NICHD) invites scientists to submit grant
applications for the support of research on behavioral aspects of condom use.
CPR comprises four branches which support research on all aspects of
contraception and related behaviors. Applications submitted in response to
this announcement will be assigned to the most appropriate branch within the
center.
Vol. 17, No. 28, September 2, 1988 - Page 6
The purpose of this RFA is to solicit research on factors affecting the use of
condoms. Findings should be useful in efforts to encourage the use of condoms
among groups for whom this method is appropriate and to modify the
characteristics of condoms and the ways in which they are made available in
order to increase their use among people who should be using them to prevent
infection.
RESEARCH GOALS AND SCOPE
Proposed research should include one or both of two general approaches: (1)
to collect and analyze the experiences and perceptions of men and women who
have used condoms and (2) to collect and analyze the attitudes of those who
have not used condoms. Both positive and negative features of condoms should
be considered. These include awareness of condoms through friends,
advertising, or other means; their availability in stores, vending machines or
clinics; their cost; any embarrassment during purchase; difficulty in
unwrapping them in the situations in which they are used; ease of transport in
pocket or purse; ease of application; real or perceived effectiveness in
preventing pregnancy and sexually transmitted disease; and enhancement or
reduction of pleasure. In addition, research is needed relating to different
kinds of condoms: with or without lubricant; whether spermicides are included
in the lubricant; whether or not contoured, textured, or colored; whether
fitted with reservoir tip; varying degrees of thickness, length, and
circumference; whether supplied with applicator; and any other features that
the investigators may consider relevant to effective and consistent use.
These experiences and perceptions should be related to the social, economic,
psychological, and, where relevant, physiological characteristics of the
respondents and their partners. Attention should be given to the experience
and perceptions of men and women who have used condoms, but no longer do so,
as well as current users. Proposed research should determine whether condoms
are used intermittently and the reasons for omitting use. If other methods
are used in addition to condoms, research should determine whether they are
used in combination with condoms or separately.
Condom use should also be related to the various kinds of sexual activity in
which the respondent engages, their duration and frequency, whether they are
associated with alcohol or drug use, and to the nature of the relationship
with partners. Special attention should be given to the circumstances under
which condoms break or leak.
The populations proposed for study should include members of groups for whom
condom use is essential for preventing the spread of AIDS and other sexually
transmitted diseases. These groups include young sexually active men and
women, male homosexuals, prostitutes and their clients, intravenous drug users
and their sexual partners, and any other groups identified by the investigator
as being at high risk of sexually transmitted diseases. In addition, studies
may include men and women in monogamous relationships, whether married or not,
if their experience and perceptions are considered to be valuable in
identifying factors affecting the use of condoms. It is not necessary for
samples to be national in scope, but they should represent carefully defined
populations in specific localities so that the findings of research can be
considered applicable to one or more high-risk groups.
MECHANISM OF SUPPORT
The support mechanism for this program is the individual research project
grant. Although this solicitation is included in the plans for Fiscal Year
1989, the support of grants to be awarded as a result of this RFA is
contingent upon the receipt of funds for this purpose. It is anticipated that
four to six grants will be awarded, depending on the overall merit of the
applications and the availability of funds. After projects are underway,
meetings will be held to foster the sharing of work in progress. Principal
and co-investigators will be encouraged to attend these meetings; funds should
be included in the budget for one two-day meeting per year in Bethesda,
Maryland to discuss the research with other investigators. The current
policies and requirements that govern the research grant programs of NIH will
prevail (Code of Federal Regulations, Title 42, Part 52 and Title 45, Part
74).
REVIEW PROCEDURES AND CRITERIA
NICHD staff will review applications for responsiveness to the RFA; those
judged to be nonresponsive will be returned. The applicant may resubmit the
application and have it assigned for review in the same manner as unsolicited
grant applications during the next review cycle. An application will be
considered nonresponsive to this RFA if it is identical to one already
submitted to the NIH for review, unless the previous application is withdrawn.
Vol. 17, No. 28, September 2, 1988 - Page 7
Responsive applications will be reviewed within six months of receipt. They
may be subjected to triage by a peer-review group to determine their
scientific merit relative to the other applications received in response to
this RFA. NIH will withdraw from competition those applications judged to be
noncompetitive and notify the applicant and institutional business official.
Those applications judged to be competitive will be further evaluated for
scientific merit by a review panel convened solely for this purpose by the
Scientific Review Program, NICHD. Criteria for the initial review include the
significance and originality of research goals and approaches; the feasibility
of research and adequacy of the experimental design; the research experience
and competence of the investigator(s) to conduct the proposed work; the
adequacy of investigator(s) effort devoted to the project; and the
appropriateness of the project duration and cost relative to the work
proposed. Following review by the Initial Review Group, applications will be
evaluated by the Institute's Advisory Council for program relevance and policy
issues before awards are made. After scientific review, NIMH and other
Institutes may participate in funding meritorious applications received in
response to this RFA. The anticipated award date is July 1, 1989.
METHOD OF APPLYING
Applications should be submitted on Form PHS 398 (revised 9/86) which is
available in most institutional business offices or from the Division of
Research Grants, NIH (301/496-7441). Applications should be identified by
checking the "yes" box in Item No. 2 on the face page of the application and
by typing in the words, "In Response to RFA 88-HD-16." The RFA label
available in Form 398 must be affixed to the bottom of the face page of the
original application. The signed original (topmost) and four (4) copies of
the application must be received by January 15, 1989. Late applications will
not be accepted. Applications should be sent or delivered to:
Grant Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, Maryland 20892**
It is extremely important for the timely review of your application that two
(2) additional copies be sent under separate cover to:
Laurance S. Johnston, Ph.D.
Deputy Director, Scientific Review Program
National Institute of Child Health and Human Development
Executive Plaza North, Room 520
6130 Executive Boulevard
Bethesda, Maryland 20892
Inquiries regarding this announcement may be directed to:
Arthur A. Campbell
Deputy Director, Center for Population Research
National Institute of Child Health and Human Development
Executive Plaza North, Room 604
6130 Executive Boulevard
Bethesda, Maryland 20892
Telephone: (301) 496-1101
This program is described in the Catalog of Federal Domestic Assistance No.
13.864, Population Research. Awards will be made under the authority of the
Public Health Service Act, Title III, 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 Part 74. This program is not subject to
the intergovernmental review requirements of Executive Order No. 12372 or to
Health Systems Agency review.
ONGOING PROGRAM ANNOUNCEMENTS
TYPE II OSTEOPOROSIS
P.T. 34; K.W. 0705050, 0715135
National Institute on Aging
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Vol. 17, No. 28, September 2, 1988 - Page 8
BACKGROUND
Osteoporosis and associated fractures constitute a major public health problem
affecting more than 20 million Americans. Osteoporosis can be defined as an
absolute decrease in the amount of bone, leading to fractures after minimal
trauma. While women are disproportionately vulnerable to this debilitating
disease, both men and women lose bone mineral with age and are at increasing
risk for fracture as they grow older. One third of women over 65 years of age
will suffer vertebral fractures. By age ninety, one third of the women and
approximately 17 percent of the men will have experienced a hip fracture.
Although the fundamental pathogenesis of osteoporosis remains unclear,
clinical evidence suggests that there are two types of the syndrome. Type I,
which occurs mainly in women within 15 to 20 years after menopause, is
manifested by vertebral crush fracture and Colles' fracture of the distal
forearm. Type II osteoporosis occurs in both men and women over the age of 70
and is associated mainly with hip, pelvic, proximal femur, and wedge type
vertebral fractures.
Clinically, type I and II are not readily distinguishable and both often occur
in the same patient. However, there are a number of characteristics which
help to distinguish them. Type I osteoporosis is associated with excessive
and disproportionate loss of trabecular bone, but the rate of cortical-bone
loss is only slightly above usual age-related rates. It is also closely
related to factors associated with menopause, and the most effective method to
date of reducing postmenopausal bone loss is estrogen therapy.
In the type II form of osteoporosis, bone loss is proportionate for both
cortical and trabecular bone and is only slightly greater for patients with
fracture than for the remainder of the aging population. As bone is lost,
increasing numbers of older people have bone densities that fall below the
fracture threshold. Age-related risk factors include decreased osteoblast
function and impaired 1,25(OH)2D, leading to decreased calcium absorption and
secondary hyperparathyroidism. At present, there is no established
universally effective therapy for type II osteoporosis.
GOALS AND SCOPE
Much recent osteoporosis research has been directed toward the postmenopausal,
type I form. Both epidemiologic and clinical findings suggest that type II
and type I osteoporosis may be related but they are not identical. The goal
of this announcement is to encourage research to determine whether these two
syndromes of osteoporosis have different etiologic mechanisms and to develop
theories of pathogenesis which can lead to the prediction, prevention, and
treatment of type II osteoporosis. This research lends itself to
interdisciplinary collaboration in the areas of cell biology, biochemistry,
endocrinology, physiology, biophysics, epidemiology, and aging. The NIA/NIAMS
encourages collaborative proposals from experimental gerontologists,
geriatricians, bone endocrinologists and related biomedical researchers.
The NIH urges applicants for grants to give added attention (where feasible
and appropriate) to the inclusion of minority groups and/or women in the study
populations for research.
SPECIFIC OBJECTIVES
The NIA/NIAMS invite grant applications to test hypotheses and elucidate
mechanisms including, but not limited to, the following general areas:
Etiologic mechanisms underlying type II osteoporosis in men and women.
Suspected factors include parathyroid function, calcium absorption, vitamin D
metabolism, bone remodeling, prostaglandin and growth factor activity, and
osteoblast function.
The role of age-related changes in bone biochemistry, bone turnover, bone
cells, endocrine function, mineral absorption, and other aging changes in
contributing to age-related bone loss in men and women.
Improved techniques for measuring bone density and bone strength, and their
validation in old and very old persons.
Epidemiologic studies designed to determine risk factors for type II
osteoporosis in men and women. Longitudinal studies are particularly
encouraged. Incidence and prevalence studies among races and ethnic groups
which may offer mechanistic explanations of type II osteoporosis are also
encouraged.
Vol. 17, No. 28, September 2, 1988 - Page 9
Interventions that may prevent or retard age-related osteoporosis in men and
women including exercise, diet, drug and/or hormonal therapy as well as other
factors that are linked to type II disease.
MECHANISMS OF RESEARCH SUPPORT
The primary mechanisms for support of this program are:
Research Project Grant (RO1)
FIRST Award (R29)
Career grants, which include:
Special Emphasis Research Career Award (K01) in
Nutritional and Metabolic Factors in Aging
Research Career Development Award (K04)
Clinical Investigator Award (KO8)
Academic Award (K08)
REVIEW PROCEDURES
Applications will be evaluated in accordance with the usual NIH peer review
procedures, based on scientific merit. Following study section review, the
applications will be evaluated by the National Advisory Council on Aging and
the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council.
Awards will be based on available funds.
METHOD OF APPLYING
Applications should be submitted on the PHS 398 (Revised 9/86) application
form. Application deadlines are February 1, June 1, or October 1. Under item
2, on the face page of the application, Response To Specific Program
Announcement, type NIA/NIAMS, TYPE II (AGE-RELATED) OSTEOPOROSIS. If your
institution does not have NIH research grant application kits, copies may be
obtained by writing:
Office of Grant Inquiries
Division of Research Grants
National Institutes of Health
Westwood Building, Room 449
Bethesda, Maryland 20892
Telephone: (301) 496-7441
Forward the original + 6 copies of the completed application to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, Maryland 20892**
INQUIRIES AND CORRESPONDENCE
Potential applicants interested in obtaining further information may call:
Ann W. Sorenson, Ph.D.
Osteoporosis and Rheumatology Program Director
National Institute on Aging
Bethesda, Maryland 20892
Telephone: (301) 496-1033
Stephen L. Gordon, Ph.D.
Musculoskeletal Diseases Program Director
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
Westwood Building, Room 405
Bethesda, Maryland 20892
Telephone: (30l) 496-7326
Vol. 17, No. 28, September 2, 1988 - Page 10
ERRATUM
RESEARCH ON AIDS AND THE AMERICAN TEENAGER
RFA: 88-HD-13
P.T. 34, AA; K.W. 0715120, 0411005, 0750020, 0404000
National Institute of Child Health and Human Development
Correction to RFA-88-HD-13, RESEARCH ON AIDS AND THE AMERICAN TEENAGER, NIH
Guide for Grants and Contracts, Vol. 17, No. 26, August 12, 1988. Sentence 1
of Paragraph 1 under IV. REVIEW PROCEDURES AND CRITERIA should read as
follows:
Applications submitted in response to this RFA will be reviewed for scientific
merit by an initial review group (IRG) which will be convened by the
Scientific Review Program of the National Institute of Child Health and Human
Development (NICHD) to review only these applications.
Vol. 17, No. 28, September 2, 1988 - Page 11
FULL RFAs FOR ONLINE ACCESS
REQUEST FOR APPLICATIONS FOR COOPERATIVE AGREEMENT
88-CA-17
P.T. 34; K.W. 0740020, 0755025, 0750025, 0755020
NATIONAL COOPERATIVE NATURAL PRODUCTS DRUG DISCOVERY GROUPS
NATIONAL CANCER INSTITUTE (NCI)
Letter of Intent Date : October 21, 1988
Application Receipt Date: December 9, 1988
The NCI invites applications for the establishment of
"National Cooperative Natural Products Drug Discovery
Groups" for the discovery of new effective anticancer
treatments from natural sources.
There are no plans to reissue this Request for Applications
at any future time.
LETTER OF INTENT
Prospective applicants are asked to submit, by October 21,
1988, a short letter of intent that includes a descriptive
title of the proposed research, and if possible, names of
members of the proposed Group and their institutions. The
letter of intent is requested in order to provide an
indication of the number and scope of applications to be
reviewed. The letter of intent does not commit the sender
to submit an application, nor is it a requirement for
submission of an application. Letters of intent should be
sent directly to:
J.A.R. Mead, Ph.D.
Executive Plaza North, Suite 832
Developmental Therapeutics Program
Division of Cancer Treatment
National Cancer Institute
Bethesda, MD 20892
Telephone No.: (301) 496-8783
*This program is described in the Catalog of Federal
Domestic Assistance number 13.395. Cancer Treatment
Research. Awards will be made under the authority of the
Public Health Service Act, Sections 301, Public Law 78-410,
as amended, 42 U.S.C. 241, as amended by Public Law 99-158,
42 U.S.C. and 285(a), and by Sections 410 and 411, Small
Business Innovation Development Act, Public Law 97-219.
This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems
Agency review.
CONTENTS
SUMMARY
MECHANISM OF SUPPORT
DEFINITIONS
COMPOSITION
RESEARCH GOALS AND SCOPE
PATENT COVERAGE
TERMS OF AWARD: NATURE OF NCI STAFF PARTICIPATION
MINIMUM REQUIREMENTS FOR APPLICATION
REVIEW METHOD AND PEER REVIEW CRITERIA
METHOD OF APPLYING
INQUIRIES
SUMMARY
The search for better cancer treatments is a dynamic process
dependent on the availability of new agents and strategies
coupled with the development and use of more predictive
models. Recent advances in modern biomedical research
provide unprecedented opportunities for the discovery of
novel and highly sophisticated cancer treatments.
Exploitation of these exciting leads for development of more
effective cancer therapy requires the organization of
outstanding scientists from diverse scientific disciplines
within the biological, chemical, biochemical, and
pharmacological sciences into highly synergistic research
teams regardless of institutional affiliation. To realize
this objective as well as to utilize facilitating resources
of the NCI's drug development program within these teams,
the NCI established the National Cooperative Drug Discovery
Group (NCDDG) program as a result of Request for
Applications (RFAs) issued in July 1983 and August 1984 for
the exploitation of mechanistically based differences
between normal and cancer cells. October 1986 reissuances
established groups focused on exploitation of specific and
unique characteristics of lung and colorectal cancers. The
NCDDG approach to modern drug discovery was broadened
further in August 1987 by RFAs inviting applications for the
creation and evaluation of both general mechanism of action
based and specific disease-oriented anticancer treatments as
well as for the development of innovative preclinical models
for determining antitumor selectivity.
The present RFA is for the discovery of new therapies for
cancer from the universe of natural substances, historically
a fruitful source of agents effective against a wide variety
of human diseases.
The "RESEARCH GOALS AND SCOPE" of this RFA require that a
National Cooperative Natural Products Drug Discovery Group
has the capacity within itself to discover and evaluate new
entities from natural sources for the treatment and cure of
cancer. Subsequent studies required for development of new
treatments to clinical trial (e.g., formulation development,
classical toxicology, etc.) are beyond the scope of this
RFA. Considering the rich diversity of chemical entities
with medicinal potential to be found in nature (many
providing host defenses against infectious diseases,
parasitism, or predation) as well as recent advances in
analytical sciences, approaches to realization of the goals
of this RFA are broad and limited only by the creativity and
ability of the applying Group. Programs appropriate to
fulfillment of Group objectives could include, but are not
limited to, discovery of natural products which elicit
selective toxicity against tumor cells via as yet
unexploited mechanisms, or which inhibit specific tumor
types selectively; products that may affect oncogene
expression in tumors, or the actions of hormones or growth
factors on proliferation. Projects for random collection
and screening of natural products without strong rationales
for material selection or testing models and projects
designed to produce analogs or derivatives of known
antitumor natural products are not responsive to this RFA.
Each group is envisioned as containing a number of
laboratory programs whose cooperative activities may, for
example, include: (1) implementation of strategies to
support the selection and acquisition of natural sources of
NOVEL agents; (2) preparation of crude materials for
testing; (3) development and use of discriminating
laboratory tests to select crude materials for further
study; (4) development and use of biological assays and
physical/chemical methods leading to the efficient
isolation, purification and structure elucidation of
antitumor selective moieties and; (5) suitable preclinical
models for identifying and setting priorities for the
development of new agents to clinical trial. A cohesive
National Cooperative Natural Products Drug Discovery Group
should include all of the Laboratory Programs needed to
attain Group objectives. Since it is unlikely that all of
the required laboratory capabilities will be found in any
single institution, it is probable that most proposed Groups
will be multi-institutional as well as multidisciplinary in
nature. The specialized research competencies required
could include scientists (e.g., ecologists, botanists,
chemists, molecular biologists, and others) who have not
been working primarily in cancer research. The
participation of highly creative scientists from any
scientific discipline appropriate to the Group objectives is
encouraged.
MECHANISM OF SUPPORT
o Awards will be made as COOPERATIVE AGREEMENTS. Assistance
via Cooperative Agreement differs from the research grant in
that the Government component (NCI) awarding the Cooperative
Agreement anticipates substantial involvement during
performance of the award. This partnership relationship
will facilitate technology transfer from Government owned
data-bases and the use of appropriate contract resources to
enhance the efficiency and effectiveness of a Group's
efforts. The nature of NCI staff participation is described
in this RFA under "TERMS OF AWARD: NATURE OF NCI STAFF
PARTICIPATION." There is no intent, real or implied, for
NCI staff to direct Group activities or to limit the freedom
of investigators. A Group is expected to consist of a
single consortium of multidisciplinary and/or
multi-institutional Laboratory Programs from academic,
non-profit, or commercial organizations. The interaction of
academic and non-profit research institutions with
commercial (including industrial) organizations and
Government will favor the efficient invention of new agents
or treatment strategies for cancer. It should be mentioned
that all industrial companies are now eligible to apply for
grants and Cooperative Agreements (see NIH Guide for Grants
and Contracts, Volume 11, Number 5, April 23, 1982, page 3).
The active participation of industry is encouraged because
it will allow this segment of the scientific community to
contribute its considerable intellectual and material
resources. Further, the interaction of academic and
non-profit research institutions with industry and
Government will facilitate subsequent development and
marketing of new therapies, although these latter activities
are not within the scope of this RFA.
o NCI plans to make multiple awards for project periods up
to five years and has set aside three million dollars total
costs for the initial year's funding. Although this program
is provided for in the financial plans of the National
Cancer Institute, awards pursuant to this RFA are contingent
upon continuing availability of funds. The starting date
for the initial annual period will be on or before September
30, 1989. This RFA is a one-time solicitation. Generally,
future unsolicited competing renewal applications will
compete as research project applications with all other
investigator initiated applications. However should the NCI
determine that there is continuing program need, competing
renewal applications for Cooperative Agreements from the
then current awardees will be invited.
(When the applying institution is outside the United States,
awards must be limited to three years; this special
provision does not apply when the applying institution is
within the United States and the application contains
proposed Laboratory Programs in a foreign country.)
o Each award will be made only to the Principal
Investigator's institution. All Group activities will be
coordinated through a Central Operations Office located at
the Principal Investigator's institution.
o Under the Cooperative Agreement, a partner relationship
between the recipient of the award and NCI exists in which
the Group is responsive to the requirements and conditions
set forth in the RFA. Specifically, the Principal
Investigator defines the details for the project within the
guidelines of the RFA, retains primary responsibility for
the performance of the activity, and agrees to accept close
coordination, cooperation, and assistance of NCI extramural
staff in all aspects of scientific and technical management
of the project in accordance with the terms formally
negotiated and mutually agreed upon prior to the award.
o All policies and requirements that govern the grant
program of the U.S. Public Health Service apply.
DEFINITIONS
o COOPERATIVE AGREEMENT - An assistance mechanism in which
substantial NIH programmatic involvement with the recipient
during performance of the planned activity is anticipated.
o NATIONAL COOPERATIVE NATURAL PRODUCTS DRUG DISCOVERY GROUP
- A number of Laboratory Programs representing diverse
scientific disciplines and organizations which join together
under guidance and direction of a single Principal
Investigator and which function as a unit with a common
goal: the rational selection, isolation, and evaluation of
new entities from natural sources for treatment and cure of
cancer. In this RFA the terms National Cooperative Natural
Products Drug Discovery Group, NPDDG, and "Group" are used
synonymously.
o CENTRAL OPERATIONS OFFICE - An administrative unit located
at the Principal Investigator's institution that coordinates
all Group activities and is legally and fiscally accountable
for the disposition of funds awarded.
o NATURAL PRODUCT - In the context of the NPDDG program, a
term used broadly to encompass any naturally occuring
chemical or biological entity selected and evaluated
preclinically against cancer. This, of course, excludes
materials which are synthesized de novo by the investigator
and also excludes semi-synthetic derivatives of known
antitumor agents.
o PRINCIPAL INVESTIGATOR - The person who assembles the
NPDDG, submits the single application in response to this
RFA and who is responsible for performance of the Group as a
whole and of each Program Leader. The Principal
Investigator may lead one of the Laboratory Programs of the
Group, and in addition, coordinate Group activities
scientifically and administratively.
o PROGRAM LEADER - The Director of one of the scientific
Laboratory Programs of the NPDDG.
o NCI PROGRAM DIRECTOR - A member of the NCI extramural
staff who provides leadership and guidance for the overall
NPDDG program within the NCI.
o NCI COORDINATOR - A member of the NCI extramural staff,
appointed by the Program Director, who interacts
scientifically with the Group and facilitates the role of
NCI as partner in the NPDDG. The Program Director also may
serve as the NCI Coordinator for a Group.
o PATENTABLE INVENTION - Any new and useful process,
machine, manufacture or composition of matter, or any new
and useful improvements thereof, as defined under the U.S.
Patent Statute (35 USC 101).
COMPOSITION
o The composition of an NPDDG is envisioned as follows:
A Principal Investigator.
Laboratory Programs, each headed by a Program Leader, in
diverse scientific disciplines, such as microbiology,
molecular and cell biology, immunology, biochemistry,
chemistry, botany, ecology, pharmacology, etc., that may be
appropriate to realization of Group objectives.
An NCI Coordinator designated from the NCI extramural staff
(to be appointed by the NCI Program Director after award).
o The Principal Investigator, in addition to providing
scientific and administrative leadership, may contribute a
Laboratory Program. Laboratory Program Leaders will be
directly responsible to the Principal Investigator. The
formation of the Group, the application in response to this
RFA, the overall management of the Group, and the allocation
of funds to the various Laboratory Programs based on
performance and overall Group needs at any given time will
be the responsibility of the Principal Investigator and the
Principal Investigator's institution in accordance with PHS
policies.
o The constituency of the Group and its Laboratory Programs
should depend on the talents required to accomplish its
scientific and technical objectives as perceived by the
Principal Investigator and Program Leaders. The major
consideration in structuring an NPDDG should be the
mobilization of maximum intellectual strength and the
ability to carry out the proposed research. If the Group
includes more than one Laboratory Program in a specific
scientific area, each should be capable of contributing high
quality, necessary, and non-overlapping talents.
o An individual scientist may be proposed as a Principal
Investigator or a Program Leader in more than one
application. If so, the Principal Investigator must
demonstrate in the application that there is no scientific
or budgetary overlap or proprietary conflict with each
individual's proposed activities. Likewise, individuals
currently receiving funding via contracts, grants, or
Cooperative Agreements may be funded under this RFA as long
as there is no scientific or budgetary overlap or
proprietary conflict in funded activities. Any Program
Leader who proposes to be a Group member must complete an
application form in detail even if no funds are requested.
An NIH intramural scientist may participate in an NPDDG as a
collaborator or consultant, but may not submit a formal
application as a Program Leader or receive funds from this
program. The intramural scientist must provide a letter of
commitment and current curriculum vitae and obtain
appropriate NIH clearances prior to submission of the
application. The Principal Investigator must incorporate
into the application, in the usual grant format, a full
description of the collaborative project, including
technical details and methodology. The participation of an
intramural scientist is independent of and unrelated to the
role of the NCI Program Director and Coordinator as
described in "TERMS OF AWARD: NATURE OF NCI STAFF
PARTICIPATION."
o More than one member of an NPDDG might be derived from a
single institution. However, the varied talents and
commitment required for effective drug discovery, as
described in this RFA, are not usually present in most
single institutions and it is anticipated that the Program
Leaders within a Group will be derived from several
institutions.
o No minimum or maximum number of Laboratory Programs per
Group is stipulated. However, the Principal Investigator
could experience difficulty in providing the desirable level
of guidance, and Program Leaders might communicate and
collaborate less efficiently if the Group were to contain
more than five or six Laboratory Programs.
o In forming Groups, potential Principal Investigators
should remain cognizant of the need for communication,
including regular meetings of members. While it is not a
requirement of this RFA, the formation of Groups on a
geographically regional basis may be advantageous.
Applicants from outside the United States or applications
who propose Laboratory Programs in foreign countries must
specifically address how effective communication will be
maintained.
o Under the provisions of assistance via Cooperative
Agreement, the NCI Coordinator will participate as a member
of the Group in a manner specified in "TERMS OF AWARD:
NATURE OF NCI STAFF PARTICIPATION." The NCI Program
Director will carry out the normal programmatic and
scientific responsibilities required for guidance of the
NPDDG program. The NCI Program Director or Coordinator will
not conduct Laboratory Programs.
RESEARCH GOALS AND SCOPE
o The goals of the NATURAL PRODUCTS DRUG DISCOVERY GROUP
PROGRAM are:
The search for, discovery and isolation from natural sources
of novel agents to treat cancer effectively and their
evaluation in appropriately developed and/or selected
preclinical models.
The development or use of preclinical models based on their
ability to discriminate for antitumor activity and their
ability to test the rationale for natural product selection
and isolation.
The recommendation of presumptively curative treatments for
development to clinical trial.
The conduct of biological, biochemical, and pharmacological
studies that will permit the most enlightened subsequent
clinical evaluation supported by the most sophisticated
technology, and which may provide information leading to the
future discovery of even more effective treatments.
o Applications for funding as an NPDDG should stress
creative approaches to the discovery of effective anticancer
therapies and should emphasize the following:
Objectives of the proposed NPDDG.
Research approaches to the realization of objectives and the
provision of comprehensive information (including citations)
in support of the rationale(s) for the proposed approaches.
Specific pertinence to cancer treatment.
The scientific and technical areas of expertise (Program
Leaders) required to attain Group objectives.
PATENT COVERAGE
Since the discovery of new and improved anticancer
treatments is the objective of this effort and active
involvement by industrial laboratories is facilitated by the
existence of adequate patent coverage, it is essential that
applicants provide plans to assure such coverage. The
situation could be complicated since multiple institutions
are involved. Each applicant Group must, therefore, provide
a detailed description of the approach to be used for
obtaining patent coverage and for licensing where
appropriate, in particular where the invention may involve
investigators from more than one institution. Procedures
must be described for resolution of legal problems should
they arise. Your attention is drawn to P.L. 96-517 as
amended by P.L. 98-6230 and 37 CFR Part 401. Note that
non-profit organizations (including universities) and small
business firms retain the rights to any patent resulting
from government contracts, grants, or Cooperative
Agreements. Your further attention is drawn, however, to a
Presidential memorandum of February 18, 1983 (Attachment 1),
which extends to all business concerns, regardless of size,
the first option to the ownership of rights to inventions as
provided in P.L. 96-517. As a result of this memorandum,
the relationships among industrial organizations and other
participants are simplified, since all Group members can now
be full partners in the research and in any inventions
resulting therefrom. The specific patenting arrangements
among the institutions may vary and could include joint
patent ownership, exclusive licensing arrangements, etc.
Applicants are encouraged to develop an arrangement that
best suits their own particular circumstances.
The proposed patent plan among the institutions comprising
the Group must be included as part of the application. It
should be inserted following the overall Group budget
section. A formal patent agreement signed and dated by the
organizational official authorized to enter into patent
arrangements for each Group member and member institution
must be on file at the Division of Extramural Activities,
NCI prior to peer review. (See "MINIMUM REQUIREMENTS FOR
APPLICATION.")
TERMS OF AWARD: NATURE OF NCI STAFF PARTICIPATION
Assistance via Cooperative Agreement differs from that of
research grants in that, in addition to the normal
programmatic and administrative stewardship
responsibilities, the component awarding the Cooperative
Agreement anticipates substantial scientific involvement
during performance of the project. However, the Group must
define its objectives and its approaches to attain these
objectives in accord with its own interests and perceptions
of novel and exploitable ways to discover effective
anticancer treatments and must develop the details of the
research design following the guidance given in this RFA.
It is the primary responsibility of the Principal
Investigator to state clearly the objectives of the Group,
to direct the research stipulated in the proposal and to
ensure that the results obtained are published in a timely
manner.
NCI shall assist the Group and will be represented by a
Coordinator. The NCI Coordinator will be selected from the
scientific staff that manages extramural programs but not
from the NCI intramural program staff. During performance
of the award, NCI may provide appropriate assistance,
advice, and guidance by participating in the design of
activities; advising in the selection of sources for
resources, staff, etc., coordinating or participating in
collection and/or analysis of data; advising in management
and technical performance; or participating in the
preparation of publications. However, the role of NCI will
be to assist and facilitate and not to direct activities.
It is anticipated that decisions in all activities outlined
below will be reached by consensus of the Group under the
leadership of the Principal Investigator and that the NCI
Coordinator will have the opportunity to offer input to this
process.
o NCI Assistance in Design of Group Activities, Development
of Research Protocols and Evaluation of Results
The Principal Investigator, Program Leaders, and NCI
Coordinator will meet periodically to review progress, plan
and design research activities, and establish priorities.
The frequency of meetings, but not fewer than two per year,
will be determined by the Principal Investigator who will be
responsible for scheduling the time and place (generally at
one of the performance sites) and for preparing concise
proceedings or minutes which will be delivered to the
members of the Group within 60 days of the meeting. NCI
staff may not chair Group meetings.
A critical determinant of Group success will be the degree
of communication among its members. Therefore, additional
informal meetings among all participants as well as regular
telephone and written communications will be important.
The NCI Coordinator, as well as any Group member, may assist
in research planning; may suggest studies within the scope
of the Group's objectives and research activities; may
present to the Group experimental findings from published
sources or from contract projects in support of these
suggestions; may participate in the design of experiments
agreed to by the Group; and may participate in the analysis
of results.
o NCI Assistance in Implementation and Management of
Research Activities
Upon recommendation of the NCI Coordinator, NCI may utilize
its contract based resources in support of Group research
activities when such resources may be required on an
occasional basis. The following is a list of some resources
that might be supplied if they become desirable during
performance, are not anticipated as a continuing need, and
are readily available:
Reference compounds for standardization of test systems, as
analytical standards, and for related purposes.
Needed resources such as test materials and information that
may not otherwise be available to the Group.
Data from testing conducted in resource contract
laboratories.
Laboratory testing capacity, whenever appropriate and
possible, in the current NCI contract based preclinical
therapy-related laboratory testing program. The Group is
expected to provide sufficient test material for such
testing.
Searches of computer files of materials, chemical structures
and biological activity, if requests for such searches are
sufficiently focused to avoid excessive costs. Information
given to an NPDDG will be restricted by any standard
confidentiality agreements between the Government and
suppliers of test materials to the Government.
Experimental animals and cultured cells, if available, to
Groups whose main research activities do not require these
materials on a regular basis. Groups whose experimental
approach involves studies that require animals on a regular
basis must budget for costs in their application.
Computer processing and statistical evaluations if costs are
not excessive.
o NCI Assistance in Collection and Analysis of Data,
Procedures for Submission of Results to NCI, and Preparation
of Group Findings for Presentation and Publication.
In addition to the special reports and stipulations
described below, reporting requirements will be identical to
those currently in existence for awardees of program project
grants.
The principal end product of NPDDG activities will be the
discovery of new treatments for development to clinical
trial. Subsequent developmental work through private
resources is encouraged. Alternatively, the Group may
recommend that development be sponsored by NCI. In the
latter case, it will be necessary for the Principal
Investigator and NCI Coordinator to cooperate in the
analysis, summarization, preparation, and presentation of
data to the appropriate NCI staff.
NCI will retain the option to cross-file or independently
file an application for investigational clinical trial
(e.g., an Investigational New Drug Application [INDA] to the
United States Food and Drug Administration) of any invention
resulting from these NCI supported Cooperative Agreements.
Reports of data generated by the Group or any of its members
required for inclusion in INDAs and Clinical Brochures and
for cross-filing purposes will be submitted by the Principal
Investigator to the NCI Coordinator upon request. Such
reports will be in final draft form and include background
information, methods, results, and conclusions. They will
be subject to approval and revision by NCI and may be
augmented with test results from other Government sponsored
projects prior to submission to the appropriate regulatory
agency.
The Government, via the NCI Coordinator, will have access to
data generated under this Cooperative Agreement and may
periodically review the data. However, the awardee will
retain rights to the data, and timely publication of major
findings by the Group members is encouraged. Publication or
oral presentation of work done under this agreement will
require appropriate acknowledgement of NCI support.
Dissemination of information on synthetic or natural
substances supplied to the Group by NCI (e.g., for
comparative testing purposes, as reference materials, etc.)
will require clearance by NCI to assure conformity to
existing confidentiality agreements with suppliers.
o These "TERMS OF AWARD" require that NCI staff approve
changes in the Principal Investigator or Program Leaders;
reports intended for inclusion in INDAs and Clinical
Brochures; redistribution, outside the NPDDG, of biological
and chemical materials received from the Government; and
dissemination of research findings resulting from the use of
such materials. Disagreements arising pursuant to these
approvals will be arbitrated by a panel composed of one
Group designee, one NCI designee, and a third designee with
expertise in the relevant area chosen by the other two.
These special arbitration procedures in no way affect the
awardee's right to appeal an adverse action in accordance
with PHS regulations at 42 CFR Part 50, Subpart D, and HHS
regulations at 45 CFR Part 16.
o These special "TERMS OF AWARD: NATURE OF NCI STAFF
PARTICIPATION" described in this section are in addition to,
and not in lieu of, otherwise applicable OMB administrative
guidelines, HHS Grant Administration Regulations at 45 CFR
Part 74, and other HHS, PHS, and NIH grant administration
policy statements.
MINIMUM REQUIREMENTS FOR APPLICATION
Applications seeking funding as a NATIONAL COOPERATIVE
NATURAL PRODUCTS DRUG DISCOVERY GROUP must meet the
following requirements:
o Name a SINGLE Principal Investigator who will be
responsible for the application, for Group research
activities, and for the dispersal of funds for the support
of Group activities.
o Identify the Principal Investigator's organization
(institution) that will provide the Central Operations
Office and assume legal and financial responsibility and
accountability for the use and disposition of funds awarded
on the basis of this RFA; show availability of personnel and
facilities capable of performing and supporting the
administrative functions of this NPDDG.
o Provide a description of the Group's plan for assuring
adequate patent coverage of new inventions that may issue as
a result of Government funding of the proposed work.
Note: A formal statement of Patent Agreement among all
Group members and their institutions as well as a detailed
description of procedures to be followed for resolution of
legal problems which may develop, signed and dated by the
organizational official authorized to enter into patent
arrangements for each Group member and member institution is
preferred with the application. If this signed agreement is
not included in the application, it must be submitted to the
Executive Secretary prior to peer review.
o Provide from the Principal Investigator and from each
Program Leader a signed statement of acceptance of the
assistance of NCI staff during performance of project as
outlined under "TERMS OF AWARD: NATURE OF NCI STAFF
PARTICIPATION."
o Provide a clear, concise plan in narrative and
diagrammatic form that depicts the interrelationships among
the members of the Group and the contribution of each to
fulfillment of Group objectives; provide an organizational
chart of the Group showing the name, organization, and
scientific discipline of the Principal Investigator and
Program Leaders; provide an organizational chart for each
Laboratory Program within the Group showing relationships
among the key personnel.
o Provide a plan to assure the maintenance of close
collaboration and effective communication among members of
the Group which will include letters of commitment to this
plan by all Program Leaders.
o Demonstrate that the Principal Investigator and the
Program Leaders possess the outstanding scientific skills
and leadership qualities to conduct the proposed research
successfully; include relevant research programs,
experience, unique competencies, and pertinent publications.
o Demonstrate the competence of the Principal Investigator
to manage comprehensive research projects and to coordinate
and integrate research activities of diverse Laboratory
Programs.
o Demonstrate that each component Laboratory Program is
required for the attainment of the Group's objectives and
that each has available the professional and technical
personnel to permit efficient and successful conduct of the
proposed research; show that total personnel of the Group
are sufficient in quality and quantity to assure successful
conduct of the proposed research.
Note: Other activities which are essential to maintaining
or achieving the objectives of the stated research programs
(e.g., routine assays, scale-up of materials, shared
equipment, shared services, animal maintenance, etc.) should
be under the budget for core resources. Anticipated
payments to third parties for such activities should be
shown as subcontracts under the core budget.
o Demonstrate for all key personnel the time available for
this project and show for all key professional personnel (1)
title, identifying number, percentage of effort devoted to
the project, direct costs, and project period of all awarded
and pending grants, Cooperative Agreements, contracts, and
industrial commitments regardless of source of funding; (2)
identify and explain areas of potential scientific and/or
budgetary overlap with active and pending grants, contracts,
and Cooperative Agreements and what support would be
relinquished if this Cooperative Agreement award is made.
o Demonstrate that each component Laboratory Program and the
Group as a whole have available the facilities (including
appropriate biohazard facilities) required for conduct of
the proposed research. Funds will not be provided for
alteration or renovation of facilities under this
Cooperative Agreement.
REVIEW PROCEDURES AND CRITERIA
o Review Procedure
Upon receipt, applications will be reviewed by the Division
of Research Grants for completeness. Incomplete
applications will be returned to the applicant without
further consideration. Evaluation for responsiveness to
this RFA is an NCI program staff function. Applications
will be judged to determine how well they meet the goals and
objectives of the program as described in the RFA.
Applications which are judged non-responsive will be
administratively withdrawn, and the proposed Principal
Investigator and institutional business official will be
notified. Questions concerning the relevance of proposed
research to the RFA should be directed to program staff as
described in "INQUIRIES."
In cases where the number of applications is large compared
to the number of awards to be made, the NIH may conduct an
initial peer review to eliminate those which are clearly not
competitive for award. The NIH will withdraw from further
competition those applications judged to be noncompetitive
and notify the Principal Investigator 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 special
needs of the Institute and the priorities of the National
Cancer Program.
o Review Criteria
Extent of relevance of applicant's (Group) objectives to the
discovery of NOVEL approaches for developing new anticancer
treatments.
Scientific merit and originality of proposed research.
Technical merit of proposed methods for producing or
obtaining test materials and for their evaluation.
Adequacy of the scientific disciplines and specific
competencies represented by the Principal Investigator and
Program Leaders; research experience, competence,
commitment, and time availability of Principal Investigator,
Program Leaders, and other key personnel.
Administrative experience and competence of Principal
Investigator in the development, implementation, and
management of comprehensive research programs.
Adequacy of existing physical facilities and resources of
the Principal Investigator and Program Leaders.
Evidence of approval and commitment of institutions
represented by Group members to Group goals.
Evidence of availability and competence of the applying
institution to serve as the Central Operations Office for
the Group.
Commitment to accept NCI assistance in accordance with the
guidelines outlined under "TERMS OF AWARD: NATURE OF NCI
STAFF PARTICIPATION."
Adequacy of plans for effective intra-Group communication
and for assuring Group cohesiveness.
The review group will recommend an appropriate budget and
period of support for each approved application.
METHOD OF APPLYING
o Receipt Date
The deadline for receipt of application is December 9, 1988.
APPLICATIONS RECEIVED AFTER THIS DATE WILL BE CONSIDERED AS
NOT RESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT
REVIEW.
2. General
The regular research grant application Form PHS-398 (Rev.
9/86) must be used in applying. These forms are available
at most institutional business offices or from the Division
of Research Grants, National Institutes of Health, 9000
Rockville Pike, Bethesda, Maryland 20892. One original and
six (6) copies are requested.
Submit a signed, typewritten original of the application,
including a single Checklist, and four (4) signed, exact
single sided photocopies in one package to:
The Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Send the remaining two (2) copies of your application
directly to:
Mr. Hernon Fox
Referral Officer
National Cancer Institute
Westwood Building, Room 848
Bethesda, MD 20892
Telephone: (301) 496-3428
To expedite the review of your application, and to assure
its identification with this RFA:
The application form should have "NATIONAL COOPERATIVE
NATURAL PRODUCTS DRUG DISCOVERY GROUPS (RFA 88-CA-17) on
line 2 of the face page of the application form;
personalized titles more fitting for your application should
be listed on line 1 and not on line 2.
The RFA label available in the 9/86 revision of 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 your application such that it may not
reach the review committee in time for review.
o Organization of Application and Suggested Modifications of
Form PHS-398 (Revised, 9/86)
This RFA requires the submission of a single application for
the proposed NATIONAL COOPERATIVE NATURAL PRODUCTS DRUG
DISCOVERY GROUP.
Because of the multi-institutional nature of an NPDDG and
the special requirements in this RFA, additional suggestions
regarding format and some modifications seem desirable to
provide a comprehensive yet readily reviewable application.
Each application should have one INTRODUCTION SECTION
(described below) and Sections for each of the scientific
Laboratory Programs including the LABORATORY PROGRAM of the
proposed Principal Investigator and that these be identified
as "Laboratory Programs" and be numbered consecutively. Use
Form PHS-398 for each LABORATORY PROGRAM but omit the face
page for the individual program. A single face page should
apply to the entire application. Insert the INTRODUCTION
after the Table of Contents. It is suggested that the title
"Program Leader" (Retain the title "Principal Investigator"
for the section describing the LABORATORY PROGRAM of the
Principal Investigator) be substituted for "Principal
Investigator/Program Director" and that the Abstract of
Research Plan for each of the Laboratory Programs, in
addition to describing the work proposed, provide a
statement of relevance to the overall objectives of the
proposed NPDDG. A single checklist should be provided for
the overall application. Do not include a checklist for
each Laboratory Program. The 20 page limitation stipulated
in the PHS-398 kit applies to each of the individual
Laboratory Programs. The overall Introductory Section
should also be limited to 20 pages.
Sections pertaining to Laboratory Programs should provide a
Detailed Budget for the First Twelve Month Budget Period
INCLUDING APPLICABLE INDIRECT COSTS and a Budget for the
Entire Proposed Project Period.
Often the various research tasks necessary to reach the
Group's goals may need to be phased in, at least in part, in
sequential fashion. In such cases, the budgets for the
individual Laboratory Programs should, logically, reflect an
appropriate change in relative emphasis among tasks until an
operational steady state situation is attained.
The package containing the proposed research plan of the
Principal Investigator and each Program Leader should be
preceded by an INTRODUCTORY SECTION bearing the title
NATIONAL COOPERATIVE NATURAL PRODUCTS DRUG DISCOVERY GROUP
and the phrase, "Prepared in Response to RFA No. 88-CA-17."
Form PHS-398 should be used for this Introductory Section
and should describe the proposed NPDDG as a whole with
respect to goals, objectives, and overall research plan. In
this Introductory Section, list the Program Leaders as "Key
Personnel Engaged on Project." Other key personnel should
be listed in the proposed research plan for each individual
Laboratory Program. It is important to discuss any prior
collaborative efforts among investigators in the Group as
well as advantages expected from the Group effort, e.g., how
the projects are mutually reinforcing, how collectively they
will further the goals of the proposed research, etc.
In the Introductory Section, budget sheets should reflect
the consolidated total DIRECT COSTS of the entire proposed
NPDDG. This should include the direct and indirect costs at
cooperating institutions. The Introductory Section should
also provide, from the applicant institution, a Detailed
Budget for the First Twelve Month Period and a Budget for
the Entire Proposed Project Period for Direct Costs for each
of the following:
The Principal Investigator's Laboratory Program.
Management and coordination of Group activities.
Maintenance of the Central Operations Office.
Inasmuch as the Principal Investigator may also function as
a Program Leader for his/her Laboratory Program, parts of
Form PHS-398 that duplicate information provided in the
section describing the Principal Investigator's laboratory
work need not be included in the Introductory Section. The
Introductory Section should, however, contain any additional
information about the proposed Principal Investigator or
his/her institution as evidence of capability to carry out
the scientific and administrative duties required in this
RFA and the functions of the Central Operations Office.
In addition, Form PHS-398 constituting the Introductory
Section must include the following elements to be considered
responsive to minimum requirements (see "MINIMUM
REQUIREMENTS FOR APPLICATION" of this RFA):
o The name of a single Principal Investigator in accordance
with "MINIMUM REQUIREMENTS FOR APPLICATION."
o The name of the Principal Investigator's organization that
will provide and operate the Central Operations Office in
accordance with "MINIMUM REQUIREMENTS FOR APPLICATION."
o A statement assuring adequate patent coverage of new
inventions that may issue as a result of Government funding
in accordance with "MINIMUM REQUIREMENTS FOR APPLICATION"
and as described in "PATENT COVERAGE."
o A statement of acceptance of the provision of "TERMS OF
AWARD: NATURE OF NCI STAFF PARTICIPATION" in accordance
with "MINIMUM REQUIREMENTS FOR APPLICATION."
o A description of the inter-relationships among members of
the Group and organizational charts in accordance with
"MINIMUM REQUIREMENTS FOR APPLICATION."
o A plan to assure maintenance of close collaboration and
effective communication among members of the Group in
accordance "TERMS OF AWARD:
"NATURE OF NCI STAFF PARTICIPATION."
The application will be reviewed as a whole as well as
project by project; therefore, prepare a detailed Table of
Contents that will enable reviewers to find specific
information readily and number all pages consecutively after
the face page, which is page 1. Complete all items on the
face page of the application (only one per application) as
in a regular research grant proposal. Identify projects by
number, title and Program Leader, Identify cores by letter,
title and Program Leader.
If internal or external advisory groups will be used,
list their membership and describe their roles. Include a
signed letter of agreement from each advisor.
List in a separate table all consultants, both paid and
unpaid. Include a signed letter of agreement from each
consultant.
INQUIRIES
Inquiries may be addressed to:
J.A.R. Mead, Ph.D.
Executive Plaza North, Room 832
Developmental Therapeutics Program
Division of Cancer Treatment
National Cancer Institute
Bethesda, MD 20892
Telephone No.: (301) 496-8783
RFA - NATIONAL COOPERATIVE NATURAL PRODUCTS DRUG DISCOVERY
GROUPS
ATTACHMENT 1
A Presidential memorandum of February 18, 1983 directed a
revision in policy respecting allocation of rights in
inventions that are products of Government-funded research
and development. The memorandum directs the adoption and
implementation of the same or substantially the same
policies for all federally-funded R and D contracts, grants,
or cooperative agreements as those set forth in P.L. 96-517
(H.R. 6933, "Patent and Trademark Laws, Amendment," December
12, 1980) for small businesses and non-profit organizations.
Under the new policy, the Government would retain "march-in"
rights and require licensing if the inventing organization
fails to pursue development of the invention.
The text of the President's memorandum:
[Text] To the extent permitted by law, agency policy with
respect to the disposition of any invention made in the
performance of a federally-funded research and development
contract, grant, or Cooperative Agreement award shall be the
same or substantially the same as applied to small business
firms and nonprofit organizations under Chapter 38 (now
Chapter 18) of Title 35 of the United States Code.
In awards not subject to Chapter 38 (now Chapter 18) of
Title 35 of the United States Code, any of the rights of the
Government or obligations of the performer described in 35
U.S.C. 202-204 may be waived or omitted if the agency
determines (1) that the interests of the United States and
the general public will be better served thereby as, for
example, where this is necessary to obtain a uniquely or
highly qualified performer, or (2) that the award involves
co-sponsored, cost sharing, or joint venture research and
development, and the performer, cosponsor or joint venturer
is making substantial contribution of funds, facilities or
equipment to the work performed under the award.
In addition, agencies should protect the confidentiality of
invention disclosure, patent application and utilization
reports required in performance or in consequence of awards
to the extent permitted by 35 U.S.C. 205 or other applicable
laws. [End Text]
In the basis of the President's memorandum the General
Services Administration has issued a Temporary Regulation
which prescribes revised guidance regarding the rights of
the Government and recipients of federally-funded R and D
contracts, grants, and Cooperative Agreements. (Federal
Register, Vol 48, No. 74, Friday, April 15, 1983, GSA, 41
CFR Ch.1. FPR Temporary Regulation 69.) The intended effect
is to extend in principle the current implementation of
Public Law 96-517 beyond small businesses and non-profit
organizations.
REQUEST FOR APPLICATIONS FOR COOPERATIVE AGREEMENT: RFA 88-
CA-18
IDENTIFICATION AND EVALUATION OF MOLECULAR PROBES FOR
PATHOLOGICAL CLASSIFICATION OF HUMAN ASTROCYTOMAS
P.T. 34; K.W. 1002058, 1002015, 1002008, 1002004, 0710075
NATIONAL CANCER INSTITUTE
Application Receipt Date: January 16, 1989
Letter of Intent Receipt date: October 17, 1988
The Diagnosis Research Program of the Division of Cancer
Biology and Diagnosis at the National Cancer Institute (NCI)
invites applications for Cooperative Agreements from
institutions interested in identifying and evaluating
molecular probes to improve the pathologic classification of
astrocytomas. Astrocytomas are the most common primary
tumors of the central nervous system (CNS), but precise
pathologic diagnosis is often difficult, and the current
classification scheme does not permit reliable predictions of
clinical outcome. Recent advances in the field of molecular
biology suggest that opportunities exist to develop a
classification scheme using molecular probes. This should
lead to a better understanding of the disease and hopefully
to improved therapy. This Request for Applications (RFA) is
designed to promote collaborations and interactions among
researchers from a variety of basic scientific and clinical
disciplines (e.g. molecular biology, cell biology,
immunology, biochemistry, cytogenetics, neuropathology,
clinical medicine) to facilitate correlation of results using
molecular probes with results using standard
histopathological analysis and with patient response to
specific therapies.
Awards will be made as Cooperative Agreements. These create
an assistance relationship in which substantial involvement
of NCI staff is anticipated during performance of the
project, as outlined in this RFA. This mechanism is used
when the NCI wishes to stimulate investigator interest and
proposes to advise or assist in planning in an important and
opportune area of research. NCI anticipates making 3 to 5
awards for project periods of up to 5 years; total direct
costs of $750,000 have been set aside for the initial year's
funding. Although this program is provided for in the
financial plans of the NCI, the award of Cooperative
Agreements pursuant to this RFA is contingent on the
availability of funds appropriated for fiscal year 1989.
___________________________
This program is described in the catalog of Federal Domestic
Assistance no 13.394, Cancer Detection and Diagnosis
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 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.
This RFA is a one-time solicitation. Generally future
unsolicited competing renewal applications will compete as
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, the NCI
will invite recipients of awards under this RFA to submit
competing renewal cooperative agreement applications for
review according to the procedures described in Section G.
Funding in response to this RFA is dependent on the receipt
of a sufficient number of applications of high scientific
merit. The earliest feasible start date for the initial
awards will be 7/1/89.
CONTENTS
Background
Rationale for this Initiative
Mechanism of Support - Cooperative Agreement
Terms of Cooperation
Organization and Role of the Coordinating Committee
Role of NCI Representative
Arbitration Procedures
Responsibilities of Awardees
Eligibility Requirements
Special Instructions for Preparation of Cooperative Agreement
Applications
Review Procedures and Criteria
Application
Letter of Intent
Inquiries
BACKGROUND
The majority of CNS tumors arise from astrocytes, one of the
classes of glial cells. There are three major groups of
astrocytic tumors. The first and least malignant are the
well-differentiated astrocytomas. While these tumors can
recur, they are often manageable by surgery if not located in
an essential part of the brain. Glioblastoma multiforme is
the most malignant type; these tumors are uniformly fatal and
no effective therapy is available. The anaplastic
astrocytomas are intermediate between the well-differentiated
astrocytomas and the glioblastoma multiforme. About half the
patients with anaplastic astrocytoma respond well to
radiotherapy and some also respond to chemotherapy. By
current diagnostic techniques, it is not possible to predict
which of the patients with anaplastic astrocytomas will
respond to treatment. To maximize the chance of a response,
some protocols include treatment with both radiotherapy and
chemotherapy, but there are many patients who fail to respond
even to combined modality therapy. Because of potential
complications to the patient of these therapeutic modalities,
it would be extremely valuable to be able to identify those
patients likely to respond to a specific treatment regimen.
Methods other than standard histopathological examination are
needed for an informative classification of astrocytomas,
particularly the anaplastic astrocytomas.
Current CNS tumor nosologies are based almost exclusively on
the histological appearance of tumor tissue and the
morphology of neoplastic or putatively neoplastic cells (1-
3). This current scheme for classification of
neuroectodermal tumors has remained largely unchanged for
several decades (4-6). Experienced neuropathologists vary
considerably in how they assign biopsied specimens to these
categories. In the case of the anaplastic astrocytomas, the
classification fails primarily as a result of the highly
variable clinical behavior of many of these tumors currently
placed within a single diagnostic category (1). The
unpredictable response to therapy suggests that there may be
unique subgroups among these tumors (7,8). Thus, there is a
need for uniform methods of classification and diagnosis
which will be of value in determining the course of therapy.
Application of molecular biological techniques to studies of
CNS tumors can be expected to enhance our understanding of
tumor behavior and to provide tools which will allow
identification of biological subgroups of anaplastic
astrocytomas. Preliminary results from other areas of
oncology, including investigations of lymphoid neoplasms (9)
and peripheral nervous system tumors (neuroblastomas)
(10,11), have demonstrated that molecular probes can
distinguish subtypes of tumors which are often
morphologically identical. This initiative would require
collaboration between neuropathologists, clinicians and basic
scientists in order to correlate results using molecular
probes with those from standard histopathologic analysis and
with response to specific therapies.
REFERENCES
1 Burger, P.C., et al. Malignant astrocytic neoplasms:
classification, pathologic anatomy, and response to
treatment. Sem Oncol. 13:16-26, 1986.
2 Zulch, K.J. Histologic Typing of Tumours of the Central
Nervous System. WHO, Geneva, 1979.
3 Rubinstein, L.J. Tumors of the Central Nervous System.
Armed Forces Institute of Pathology, Atlas of Tumor
Pathology, Second series, Fascicle 6., AFIP, Wash., D.C.
1972.
4 Dolman, C.L. Ultrastructure of Brian Tumors and Biopsies.
A Diagnostic Atlas. Praeger, N.Y., 1984.
5 Svien, H.J., Mabon, R.F., Kernohan, J.W., et al:
Astrocytomas. Symposium on a new and simplified concept of
gliomas. Proc. Staff Meet. Mayo Clinic 24:54-64, 1949.
6 Ringertz, N.: Grading of Gliomas. Acta Pathol. Microbiol.
Scand. 27:51-64, 1950.
7 Caputy, A.J., McCullough, D.C., Manz, H.J., Patterson, K.
and Hammock, M.K.: A review of the factors influencing the
prognosis of medulloblastoma. The importance of cell
differentiation. J. Neurosurg. 66:80-87, 1987.
8 Packer, R.J., Sutton, L.N., Rorke, L.B., Littman, P.A.,
Sposto, R., Rosenstock, J.G., Bruce, D.A. and Schut, L.:
Prognostic importance of cellular differentiation in
medulloblastoma of childhood. J. Neurosurg. 61:296-301, 1984.
9 Rosen, N. and Israel, M.A.: Genetic abnormalities as
biological tumor markers. Sem. Oncol. 14:213-231, 1987.
10 Israel, M.A., Helman, L.J. and Miser, J.: Patterns of
proto-oncogene expression: a novel approach to the
development of tumor markers. In: Important Advances in
Oncology, De Vita, V.T., Hellman, S. and Rosenberg, S.A.
(eds.). Philadelphia: J.B. Lippincott Co., pp. 87-104, 1987.
11 Brodeur, G.M., Seeger, R.C. and Schwab, M.: Amplification
of N-myc in untreated human neuroblastomas correlates with
advanced disease stage. Science 224:1121-1124, 1984.
RATIONALE FOR THIS INITIATIVE
The extent of variation in the diagnosis of anaplastic
astrocytomas by experienced neuropathologists and the poor
correlation of diagnosis with therapeutic response has led
the National Cancer Institute to examine opportunities that
may help to improve CNS tumor classification. There is a
growing body of knowledge suggesting that molecular probes
may be of diagnostic and prognostic value. It is recognized
that although several laboratories are currently engaged in
one or more aspects of related research, progress towards
clinically useful diagnostic probes for this disease has been
slow. It is the purpose of this initiative to promote
collaborations among investigators to take advantage of
recently developed methodologies as well as to develop new
methodologies, to share rare tumor tissues, and to coordinate
the analyses of data in order to improve the classification
and make more specific the diagnosis of these tumors.
Information gained from these studies will be disseminated to
as wide a community of investigators and clinicians as
possible.
MECHANISM OF SUPPORT - COOPERATIVE AGREEMENT
Support of this program will be through the Cooperative
Agreement, an assistance mechanism in which substantial NCI
programmatic involvement with the recipients is anticipated
during performance of the planned activity, as outlined in
this RFA. Applicants will be responsible for the planning,
direction and execution of the proposed project. Except as
otherwise stated in the 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 1987.
The purpose of the proposed awards is to enhance and expand
multidisciplinary/interdisciplinary approaches to improved
methods of astrocytoma classification. The cooperative
agreement funding mechanism has been selected because NCI
anticipates substantial programmatic involvement in
coordination of activities among several laboratories working
on a common problem. The requirement for sharing data will
avoid duplication of effort and will maximize the possibility
of developing new, more effective tests for diagnosis and
prognosis of anaplastic astrocytomas. Sharing of rare tumor
tissues will also be required to allow correlation of results
obtained using different approaches. A set of
histopathological diagnostic criteria should initially be
established to permit comparison of data obtained on a single
tissue specimen by different laboratories using different
techniques and the same or different molecular probes.
TERMS OF COOPERATION
The Cooperative Agreements will require cooperation between
an NCI representative and the principal investigators of the
individual projects in several broad areas of basic science
and clinical medicine. 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 clinic in the areas of diagnosis and
prognosis. Each group responding to this RFA should describe
existing and proposed collaboration/cooperation between basic
scientist(s) and clinician(s). The NCI Representative will
assist in coordinating the activities of the research groups,
and in facilitating exchange of data, tissue, etc.
1 Organization and Role of the Coordinating Committee
The NCI and the participating research groups will be
responsible for forming a Coordinating Committee as defined
below. Operating policies will be developed by the
Coordinating Committee and submitted to NCI for concurrence
prior to implementation. NCI will facilitate the review of
operating policies. Results of the NCI review will be
discussed with the Coordinating Committee and an arbitration
system, as detailed below, will be available to resolve
disagreements between investigators and the NCI.
The Coordinating Committee will review the operating
procedures proposed by the individual research groups to
insure that they are compatible with the overall goals of the
RFA; will develop uniform procedures for tissue acquisition,
processing, distribution and storage; will develop uniform
methods of histopathological diagnosis; will collaborate in
the analyses of data, and will discuss their
significance/usefulness.
The Coordinating Committee will consist of 2 members from
each research group, one of whom is a basic scientist and one
a clinician (one of the two will be the principal
investigator). The NCI representative will be Dr. Doris
Balinsky, appointed by the Chief of the Cancer Diagnosis
Branch, Division of Cancer Biology and Diagnosis. The
Coordinating Committee will be responsible for electing a
chairperson (who may not be the NCI representative). This can
be a rotating position. The Chairperson of the Coordinating
Committee will be responsible for coordinating the Committee
activities, for preparing meeting agendas, and for scheduling
and chairing meetings. The NCI representative will attend
and participate in all meetings of the Coordinating Committee
and should be informed of major inter-group interactions.
The Coordinating Committee will prepare an annual progress
report which will include individual reports from each
participating research group; each group is responsible for
timely preparation of its report.
The Coordinating Committee will meet initially to plan basic
operating procedures and integration of the participating
programs, and will meet at least twice a year thereafter.
These meetings are aimed at planning research activities,
coordinating the tissue utilization, establishing priorities
and reviewing progress. The NCI representative shall
participate in the discussions at these meetings. Travel
funds for Coordinating Committee meetings are to be set aside
as a budget line item in each project budget. Locations of
the meetings will be decided by the Coordinating Committee;
they may rotate among the participating research
imstitutions.
2 Role of NCI Representative
The NCI Representative will coordinate and facilitate the
research programs supported by these Cooperative Agreements,
will attend and participate in all meetings of the
Coordinating Committee, and will provide liaison between the
Coordinating Committee and participating research groups. The
NCI representative will assist the Coordinating Committee in
developing operating policies, quality control procedures and
consistent policies for dealing with recurring situations
that require coordinated action. To assure consistency and
quality, NCI must concur in operating policies and procedures
prior to their implementation. The NCI staff member may
review the operations of individual research groups for
compliance with quality control standards and with operating
policies developed by the Coordinating Committee. The NCI
representative may recommend withholding of support,
suspension or termination of an award for lack of progress or
failure to adhere to policies established by the Coordinating
Committee.
3 Arbitration Procedures
An arbitration panel of external consultants will be created
as needed to resolve any irreconcilable differences of
opinion between the NCI and the Coordinating Committee with
respect to implementation of a proposed operating policy.
The panel will include one member selected by the partipating
researchers on the Coordinating Committee, one member
selected by the NCI, and a third member chosen by the other
two members of the arbitration panel. The NCI arbitration
process for the Cooperative Agreement in no way affects the
rights of awardees to appeal selected postaward
administrative decisions in accordance with PHS regulations
at 42 CFR part 50, subpart D and HHS regulations at 45 CFR
part 16.
RESPONSIBILITIES OF AWARDEES
Two members of each research group are required to attend
meetings of the Coordinating Committee (as detailed above),
to help formulate the Coordinating Committee's policies
(which will be submitted to the NCI for approval), to
implement the policies and to participate in analysis of the
data submitted by the various research groups. Awardees are
required to have access to appropriate tumor tissue and to
share it with other participating research groups. They are
required to submit annual progress reports to the
Coordinating Committee. Awardees are required to publish
worthwhile research results in appropriate peer-reviewed
scientific/clinical journals in a timely fashion.
ELIGIBILITY REQUIREMENTS
Applicant organizations should be located in the United
States. Non-profit organizations and institutions, and
government agencies are eligible to apply. For profit
organizations are also eligible.
SPECIAL INSTRUCTIONS FOR PREPARATION OF COOPERATIVE AGREEMENT
APPLICATIONS
General instructions for the preparation of the Cooperative
Agreement application are contained in the Grant Application
Form PHS 398 (revised 9/86).
Because the Terms of Cooperation discussed in Section D above
will be included in all awards issued as a result of the RFA,
it is critical that each applicant include specific plans for
responding to these terms. Plans should describe the
applicant's approaches to tissue collection, preparation and
distribution; histopathologic diagnosis; and coordination of
data collection and analysis. Applicants should describe how
they will comply with NCI Program Staff involvement, how they
will fulfil their responsibilities in the Cooperative
Agreement, and how they plan to interact with the other
grantees involved in these Cooperative Agreements.
REVIEW PROCEDURES AND CRITERIA
Review Procedures
Upon receipt, applications will be reviewed initially by the
Division of Research Grants for completeness. Incomplete
applications will be returned to the applicant without
further consideration. Evaluation for responsiveness to the
program requirements and criteria stated in the RFA is an NCI
program staff function. Applications judged to be
nonresponsive to this RFA will be inactivated
administratively, but may be submitted as regular
investigator-initiated research grant applications at the
next grant application receipt date.
In cases where the number of applications is large compared
to the number of awards to be made, the NIH may 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
according to the review criteria stated 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 special needs of the Institute and the
priorities of the National Cancer Program.
Review Criteria
Reviewers will be asked to review the grant applications by
considering the following criteria:
o Extent of relevance of the proposed research to the
overall goals and objectives of the RFA.
o Scientific merit and originality of the proposed research.
o The proposed techniques and methodologies to be used to
achieve the required goals; demonstrated expertise in both
the appropriate basic science and clinical techniques.
o Proposed collaborations between basic scientists and
clinicians.
o Demonstration of availability of and access to tissue from
an appropriate patient population.
o Qualifications, experience and proposed responsibilities
of the principal investigators and key support personnel.
o Facilities and resources, and their availability for this
project.
o Plans for effective cooperation and coordination among
projects and with NCI.
o Plans to protect the rights of human subjects.
The review group will critically examine the submitted budget
and will recommend an appropriate budget and period of
support for each approved application.
APPLICATION
Complete applications are due no later than 1/16/89 and must
address all requirements in the RFA. Applications received
after this date will not be accepted. Also, the Division of
Research Grants will not accept any application in response
to this announcement that is the same as one currently being
considered by any other review group or NIH awarding unit.
Applications should be as concise as possible.
1 The regular research grant application form PHS 398
(Revised 9/86) must be used in applying for these grants.
These forms are available at most institutional business
offices or from:
Office of Grants 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 9/86 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.
2 To expedite the review of your application, and to assure
its identification with this RFA:
The application form should have "Molecular Probes for
Astrocytomas" and RFA 88-CA-18 typed on line 2 of the face
page of the application form; and
You should submit a signed typewritten original of the
application, including the checklist, and four signed exact
photocopies, in one package to:
Division of Research Grants
Room 240, Westwood Building
Bethesda, Maryland 20892-4500**
The photocopies must be clear and single sided.
In addition, two copies should also be sent to:
Referral Officer
Division of Extramural Activities, NCI
Room 848 Westwood Building
5333 Westbard Avenue
Bethesda, MD 20892.
LETTER OF INTENT
Prospective applicants are asked to submit, by 10/17/88, 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, the NCI would like to emphasize the benefits to
the applicant of having the principal investigator submit a
letter of intent. First, it allows NCI staff to estimate the
potential review workload and to avoid possible conflict of
interest in the review. In addition, program staff may be
able to assist prospective applicants in clarifying
scientific content and objectives of an application, size and
focus of a research program, organization of an application,
and appropriate use of consultants. Should it appear that
the potential applicant has misunderstood the requirements
and objectives of the RFA or opted for an inappropriate
funding mechanism, NCI staff will be able to so inform the
applicant.
The letter of intent should be sent to:
Doris Balinsky, Ph.D.
Program Director for Biochemistry and Immunodiagnosis
Division of Cancer Biology and Diagnosis
National Cancer Institute
Room 10A10, Westwood Building
5333 Westbard Avenue
Bethesda, Maryland 20892
Telephone: (301) 496-1591
INQUIRIES
Written or telephone inquiries concerning the objectives and
scope of the RFA, or inquiries about whether or not specific
proposed research would be responsive, are encouraged and
should be directed to Dr. Doris Balinsky at the above
address. The program director welcomes the opportunity to
clarify any issues or questions from potential applicants.
REQUEST FOR RESEARCH GRANT APPLICATIONS: RFA
NIH-NIAID 88-AI-14
SEXUALLY TRANSMITTED DISEASES RESEARCH UNITS
P.T. 34; K.W. 0715220, 1002027, 0785035, 0785055, 0710030
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Application Receipt Date: November 28, 1988
BACKGROUND INFORMATION
The National Institute of Allergy and Infectious Diseases (NIAID) invites
applications for program project grants to be initiated during FY 1989 for a
continuing program of research on Sexually Transmitted Diseases (STD).
Support for applications for a STD Research Unit by the program project
mechanism will be on a competitive basis. This RFA will not be issued again
during FY 1988.
One of the major health problems in the United States today is that of
sexually transmitted diseases. The accelerated rise in STD in the last
decade, for example, has been alarming. It has been estimated
conservatively that over two million cases of gonorrheal and chlamydial
infections occur each year with the majority being unreported to public
health agencies. Also, many other diseases are now known to be transmitted
by the sexual route and illness caused by them are being recognized with
increasing frequency including acquired immunodeficiency disease syndrome
(AIDS). Nongonococcal urethritis, caused primarily by Chlamydia trachomatis
and genital herpes currently are among the most common of all the STD
infections. A rapid increase in the frequency of genital warts is also of
major concern, especially since human papilloma viruses can be transmitted
to neonates and are associated with cervical dysplasia, neoplasia and
cancer. It is estimated that 5 to 15 percent of sexually active women are
infected with human papilloma viruses. Not only is there a tremendous
impact of these infections in terms of the acute illnesses they cause, but
many of these infections produce some long-term sequelae. Pelvic
inflammatory disease (PID) is a major long-term complication of gonococcal
and chlamydial infections. The cost of treating PID exceeds $1 billion per
year, and the disease renders thousands of women of childbearing age
sterile. Genital herpes infections and Group B streptococcal infections in
pregnant women at term pose a most serious hazard to the neonates. There is
now convincing evidence that some sexually transmitted diseases, such as
syphilis, chancroid or other infections, result in open genital lesions
which predispose an individual to infection with human immunodeficiency
virus (HIV). More definitive studies relating other STD infections to HIV
infection are needed.
Support is authorized by the Public Health Service Act, Public Law 78-410,
as amended. The Catalog of Federal Domestic Assistance citation is Sec.
13.856, Microbiology and Infectious Diseases Research. Awards will be
administered under PHS grant policies and Federal Regulations 42 CFR Part 52
and 45 CFR Part 74. This program is not subject to the intergovernmental
review of Executive Order 12372 or health system agency
review. The burden of identifying and treating STDs is a
serious and costly public health problem. The hidden costs
of STDs in family disruption, absence from education or
gainful employment, ill health and individual misery can not
be fully described. Research offers one positive means of
eventually controlling this vast public health problem. The
NIAID has been in the forefront in support of research on
STD since 1971. Currently, research in this area is
supported by a number of different mechanisms: program
projects (STD Research Units); individual research projects;
contracts; institutional training grants and individual
postdoctoral fellowships.
RESEARCH GOALS AND SCOPE
The goal of the program is to encourage investigators to undertake research
that will provide the clinical, epidemiological, microbiological and
behavioral information needed for the eventual control of STDs. NIAID
proposes to broaden the scope of its program of research in this area so
that the knowledge gained may be applied to improve prevention, diagnosis,
and therapy of these infections.
REQUIREMENTS OF THE RESEARCH PROGRAM PROJECT
As one means of achieving the stated goals, the NIAID proposes to maintain
support of a number of STD Research Units. These program projects function
as Research Units of Excellence in STD research and serve as foci for
research and training. The units are funded as program project grants.
Research to be considered for emphasis in this program can be on any or on
all of the STDs that are currently recognized as significant public health
problems such as those listed under "RESEARCH SCOPE."
A strong clinical component should be a major part of the program project
application. Several distinguishing characteristics must be considered in
developing these program projects or Research Units of Excellence in STD:
1. The program project will be based at a teaching hospital, a university
or medical school, a medical school affiliated hospital or a research
institute;
2. The program project will be multidisciplinary, combining efforts of
investigators in clinical, social and basic science disciplines to focus on
different facets of the overall problem of STD infections;
3. Integration and coordination of different departments within an
institution will be necessary for adequate program development. Different
collaborating institutions may also be involved as a consortium. Close
coordination and cooperation with a public venereal disease clinic (e.g., a
city or county clinic) is of prime importance for successful functioning of
the research unit.
4. The program project will consist of a number of individual subprojects,
each with a clearly identified research task, and each with its principal
investigator, staff and budget. The program director of the Unit will be
responsible for the overall direction and administration of the total
program project. It is expected that the principal investigators of the
subprojects will act as members of a strong and coordinated research team,
the whole team directed toward resolving some of the many problems in STDs.
The team concept is an especially important aspect in developing and
managing these program projects (Research Units).
5. It is suggested that efforts be made to advance learning experiences in
STD and to make medical students and doctoral candidates more aware of the
needs and opportunities in STD research, at both the clinical and basic
levels. A program of training that involves student stipends, however, will
not be considered as part of this program. Training programs that include
stipends for both pre- and postdoctoral trainees are supported by separate
NIH funding mechanisms, such as an institutional training program grant.
Only institutions with strong ongoing research programs and resources that
can coordinate a multidisciplinary and multifaceted team effort to attack
STD infections will be considered for program project support under the
provisions of this program.
RESEARCH SCOPE
The research efforts in this program will focus on, but are not limited to,
the following diseases:
Gonorrhea; syphilis; nongonococcal urethritis caused by chlamydial agents
alone or in combination (e.g., ureaplasma); trichomonad infections; genital
herpes; genital warts; hepatitis B viruses; nonspecific vaginitis; group B
streptococcal colonization of the vagina; parasitic infestations; enteric or
other diseases that may be recognized as transmitted by the sexual route.
The program will not focus on AIDS nor its putative agent, HIV, but studies
on STDs as they relate to AIDS or susceptibility to HIV infection will be
considered.
The specific areas of research interest for the above STD problems will be
on:
o Biology of the causal organisms; e.g., growth, nutrition, physiology,
genetics,metabolism, antigenic structure and chemical composition;
o Virulence factors of the microorganisms involved;
o Antibody development and the role of humoral and cell mediated immune
responses in the host to the infecting organisms;
o Immunopathology of the diseases;
o Pathogenesis and mechanisms of recovery and resistance; latent or
recurrent infections or reinfections;
o Animal model systems for any facet of the diseases worthy of study;
o Immunodiagnosis and antigen detection, identification, specificity;
o Development of candidate vaccines or antisera, of more useful
antimicrobial therapeutic modalities and studies of antibiotic resistance;
o Epidemiology of any of the STD's including mathematical or computer
modeling for useful control strategies; and
o Introduction of behavioral and social science approaches into studies on
epidemiology, natural history and intervention strategies of STDs.
Clinical and fundamental studies involving any or all of the above
categories will be considered relevant to this program. Applicants are
urged to consider the inclusion of women in the study populations, whenever
possible, for all clinical research efforts.
An educational component for enhanced learning experience of medical staff
and fellows, as well as a community outreach program, can be considered an
appropriate part of the STD Research Unit.
MECHANISM OF SUPPORT
Eligibility: Domestic universities, medical colleges, hospitals,
laboratories and other public or private research institutions, including
State and local governmental units, are eligible.
Length of Support: The project can be supported up to a maximum of five
years without competition. Additional years of support are subject to the
competitive review procedure and the availability of funds.
Expected Number of Awards: Competition is open for two (2) or three (3)
program projects in STD research. Although no specific level of available
funding can be cited, the project can expect to receive support in the range
of $450,000 direct costs annually. Two currently funded STD research Units
may be competing for renewal of their support.
REVIEW PROCEDURES AND CRITERIA
All applications will receive an initial technical review by the
Microbiology and Infectious Diseases Research Committee, a chartered
Institute review committee. Final review will be by the National Advisory
Allergy and Infectious Diseases Council; applicants will be notified of the
outcome of the review following the May 1989 Advisory Council meeting. The
earliest possible funding date for approved new or competing renewal
applications, if in a fundable category, will be July 1, 1989.
The reviewing groups will evaluate the entire program project as well as
each of the individual subprojects involved. Special consideration will be
given to overall scientific merit of the total project and of each of the
subprojects, to innovative research approaches, and to the research team
concept. The expertise of each investigator and his or her past
productivity in this or in closely related research areas will also be
considered. The facilities available including access to patients or to
clinical material will also form part of the evaluation. Finally, budget
requests for each subproject and for the total program project will be
carefully reviewed. Budgetary adjustments may be made by the reviewers and
by Institute staff. A priority score will be given to the overall program
project application by the initial review group. Other factors in addition
to the priority score, however, also may be taken into consideration for
possible support of the project.
Applications received later than the announced receipt date, and those
considered by NIAID staff to be not responsive to the terms outlined in this
RFA will be returned to the investigator. Unsuccessful applicants may wish
to consider revising their applications and resubmitting as regular (R01)
research grant applications. It is permissible for a subproject of the
program project to be concurrently submitted as an R01 application.
However, should both be eligible for immediate funding, the R01 must be
relinquished in favor of the P01 subproject.
All policies and requirements that govern the research grant programs of the
Public Health Service/NIH will apply.
METHOD OF APPLYING
The NIAID information brochure entitled: "Information Brochure: The Program
Project Grant, NIAID" should be requested from NIAID staff by prospective
applicants prior to preparation of an application. The development of a
program project application is clearly detailed in this brochure. The
application should include:
1. A table of contents;
2. Description of the integrated program project with rationale and
justification and with a description of available laboratory and clinical
facilities as well as appropriate patient populations;
3. Complete description of each subproject;
4. An abstract of the entire program project (on page 2 of the application)
and an abstract of each of the subprojects;
5. Collaborative arrangements with other departments or with other
institutions, if applicable; and
6. A consolidated first year budget for the total project as well as first
year budgets for each of the individual subprojects and the program cores,
if applicable. Budgets for future year's support of the total project and
for each individual subproject are to be included.
Applications must be submitted on Application Form 398 Rev. 9/86. The RFA
LABEL in the application kit 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.
For purposes of identification and processing, the "Yes" box should be
checked in item 2 on the face page of the application and the words SEXUALLY
TRANSMITTED DISEASES RESEARCH UNITS should be typed.
LETTER OF INTENT:
It is strongly recommended that Institute staff be contacted by a letter of
intent when development of a program project grant application is being
considered, prior to formal submission. The letter of intent should contain
a descriptive title, including a list of principal
investigators and the title of each subproject. This letter of intent should
be received no later than September 30, 1988. However, the letter of intent
is not binding and is not a requirement. Inquiries should be directed to:
William P. Allen, Ph.D., Chief
Bacteriology and Virology Branch
MIDP, NIAID, NIH, WB-738
Bethesda, Maryland 20892
Phone: (301) 496-7728
Form 398 application kits may be obtained from the applicant institution
business office. If not available there, they may be obtained from:
Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
WB-449
Bethesda, Maryland 20892
SUBMISSION OF APPLICATION:
Forward the original application and four (4) copies to:
Division of Research Grants
National Institutes of Health
WB-240
Bethesda, Maryland 20892**
In order to expedite review send two (2) copies of the application directly
to:
Dr. Sayeed Quraishi
Executive Secretary
Microbiology and Infectious Diseases
Research Committee
NIAID, NIH, WB-3A-07
Bethesda, Maryland 20892
(301) 496-7465
IDENTIFICATION OF CONTACT POINTS
For questions of programmatic nature contact Dr. William P. Allen. For
questions regarding review procedures contact Dr. Sayeed Quraishi.
RFA 88-HD-16
BEHAVIORAL RESEARCH ON THE USE OF CONDOMS TO PREVENT AIDS
P.T. 34; K.W. 0404000, 0715120, 0745055
NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
Application Receipt Date: January 16, 1989
BACKGROUND INFORMATION
The Center for Population Research (CPR) of the National
Institute of Child Health and Human Development (NICHD)
invites scientists to submit grant applications for the
support of research on the behavioral aspects of condom use.
CPR is composed of four branches which support research on
all aspects of contraception and related behaviors such as
sexual behavior.(1) Applications submitted in response to
this announcement will be assigned to the most appropriate
branch within the center.
A major element in the fight against AIDS and other sexually
transmitted diseases is the effort to encourage the use of
condoms in sexual activities that may endanger the
participants. In one sense this effort is supported by a
widespread familiarity with condoms among the U. S. public.
In 1982, 52 percent of a nationally representative sample of
sexually active women (interviewed in the National Survey of
Family Growth) reported that their partners had used
condoms. However, only 10 percent reported that their
partners were using this method in the month preceding
interview. The proportions ever using and currently using
are even lower among those with low educational attainment
and low income, groups that include people whose sexual
behavior and sexual partners place them at high risk of AIDS
and other sexually transmitted diseases. Further evidence
that condoms are not used in high-risk situations is
supplied by recent findings from a San Francisco study that
shows that although sexually active adolescents regard the
use of condoms as important for preventing disease, "females
continued not to intend to have their partners use condoms
and the males' intentions to use condoms decreased." (Susan
M. Kegeles, Nancy E. Adler, and Charles E. Irwin, Jr.,
"Sexually Active Adolescents and Condoms: Changes over
One Year in Knowledge, Attitudes, and Use," American Journal
of Public Health, Vol. 78, No. 4, April 1988, pp. 460-461.)
The purpose of this RFA is to solicit research on factors
affecting the use of condoms. The resulting findings should
be useful in efforts to encourage the use of condoms among
groups for whom this method is appropriate and to modify the
characteristics of condoms and the ways in which they are
made available in order to increase their use among people
who should be using them to prevent sexually transmitted
diseases.
RESEARCH GOALS AND SCOPE
Proposed research should include one or both of two general
approaches: (1) to collect and analyze the experiences and
perceptions of men and women who have used condoms and (2)
to collect and analyze the attitudes of those who have not
used condoms. Both positive and negative features of
condoms should be considered. These include awareness of
condoms through friends, advertising, or other means; their
availability in stores, vending machines or clinics; their
cost; any embarrassment during purchase; difficulty in
unwrapping them in the situations in which they are used;
ease of transport in pocket or purse; ease of application;
real or perceived effectiveness in preventing pregnancy and
sexually transmitted disease; and enhancement or reduction
of pleasure. In addition, research is needed relating to
different kinds of condoms: with or without lubricant;
whether spermicides are included in the lubricant; whether
or not contoured, textured, or colored; whether fitted with
reservoir tip; varying degrees of thickness, length, and
circumference; whether supplied with applicator; and any
other features that the investigators may consider relevant
to effective and consistent use.
These experiences and perceptions should be related to the
social, economic, psychological, and, where relevant,
physiological characteristics of the respondents and their
partners. Their fear of contracting AIDS and other sexually
transmitted diseases should also be taken into account. We
know that there have been strong relationships between
condom use and socioeconomic characteristics, such as
education, income, religion, race, Hispanic background, and
marital status. However, we do not know how these
differentials have changed as people have become aware of
the danger of AIDS, and we have virtually no information on
the psychological or physiological characteristics that may
impede or facilitate the use of condoms.
Attention should be given to the experience and perceptions
of men and women who have used condoms in the past, but no
longer do so. Did they stop using condoms because of
perceived negative features, did they switch to other
methods because of their more attractive features, or did
they stop using any method of contraception because they
became unable to conceive, because they changed the nature
of their sexual activities, because they began a
relationship with another partner, or other reasons? If
they have tried other methods, did they encounter the same
problems in using them that they had with condoms? For
example, did they occassionally neglect use of other methods
or was this problem related solely to condoms?
Proposed research should determine the extent to which
condoms are used intermittently and the reasons for omitting
use. Condom use should also be related to the various kinds
of sexual activity in which the respondent engages, their
duration and frequency, whether they are associated with
alcohol or drug use, and to the nature of the relationship
with partners (for example, whether the relationships are
long-term, casual, or one-time). Other important factors
include the ways in which condoms are stored, how long they
are stored, whether they are used more than once, whether
more than one condom is used during any single sexual act,
and the specific ways in which condoms are used during
sexual activity - for example, the timing of their use,
whether they are fully unrolled, and whether and what kind
of additional lubrication is used. Special attention should
be given to the circumstances under which condoms break or
leak.
Research should also take into account methods of
contraception that are used in combination with condom. In
the 1982 National Survey of Family Growth, 45 percent of the
female respondents who reported using condom in the month
preceding interview also reported using other methods in the
same month - predominantly foam, calendar rhythm, and
diaphragm. Research should determine whether other methods
are used at the same time as condom for additional
protection against pregnancy or whether they are used
separately.
The populations proposed for study should include members of
groups for whom condom use is essential for preventing the
spread of AIDS and other sexually transmitted diseases.
These groups include young sexually active men and women,
male homosexuals, prostitutes and their clients, intravenous
drug users and their sexual partners, and any other groups
identified by the investigator as being at high risk of
sexually transmitted diseases. In addition, studies may
include men and women in monogamous relationships, whether
married or not. Even though they are at low risk of STDs,
their experience and perception of condoms may be valuable
in identifying factors affecting their use. It is not
necessary for samples to be national in scope, but they
should represent carefully defined populations in specific
localities so that the findings of research can be
considered applicable to one or more high-risk groups.
MECHANISM OF SUPPORT
The support mechanism for this program is the individual
research project grant. Although this solicitation is
included in the plans for Fiscal Year 1989, the support of
grants to be awarded as a result of this RFA is contingent
upon the receipt of funds for this purpose. It is
anticipated that four to six grants will be awarded,
depending on the overall merit of the applications and the
availability of funds.
Applicants should furnish estimates of the time required
to conduct the proposed research. Ordinarily, grants are
supported from one to five years, but may be renewed
according to the conventional processes available through
the NIH grant program. The current policies and
requirements that govern the research grant programs of NIH
will prevail (Code of Federal Regulations, Title 42, Part 52
and Title 45, Part 74).
After projects are underway, meetings will be held to foster
the sharing of work in progress. Principal and
co-investigators will be encouraged to attend these
meetings, and funds should be included in the application
budget for one two-day meeting per year in Bethesda,
Maryland to discuss the research with other investigators.
REVIEW PROCEDURES AND CRITERIA
Applications will be reviewed by NICHD staff for
responsiveness to the RFA. Applications judged to be
nonresponsive will be returned. The applicant may resubmit
the application and have it assigned for review in the same
manner as unsolicited grant applications during the next
review cycle. An application will be considered
nonresponsive to this RFA if it is identical to one already
submitted to the NIH for review, unless the previous
application is withdrawn.
Responsive applications will be reviewed within six months
of receipt on a schedule designated for research relating to
AIDS. They may be subjected to triage by a peer-review
group to determine their scientific merit relative to the
other applications received in response to this RFA. NIH
will withdraw from competition those applications judged to
be noncompetitive and notify the applicant and institutional
business official. Those applications judged to be
competitive will be further evaluated for scientific merit
by a review panel convened solely for this purpose by the
Scientific Review Program, NICHD. Criteria for the initial
review include the significance and originality of research
goals and approaches; the feasibility of research and
adequacy of the experimental design; the research experience
and competence of the investigator(s) to conduct the
proposed work; the adequacy of investigator(s) effort
devoted to the project; and the appropriateness of the
project duration and cost relative to the work proposed.
Following review by the Initial Review Group, applications
will be evaluated by the Institute's Advisory Council for
program relevance and policy issues before awards for
meritorious proposals are made. After scientific review,
NIMH and other Institutes may participate in funding
meritorious applications received in response to this RFA.
METHOD OF APPLYING
Applications should be submitted on Form PHS 398 (revised
9/86) which is available in most institutional business
offices or from the Division of Research Grants, NIH
(301/496-7441). Applications should be identified by
checking the "yes" box in Item No. 2 on the face page of the
application and by typing in the words, "In Response to RFA
88-HD-16." The RFA label available in Form 398 must be
affixed to the bottom of the face page of the original
application. 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. The signed
original (topmost) and thirty (30) copies of the application
must be received by January 16, 1989. Applications should
be sent or delivered to:
Grant Application Receipt Office
Division of Research Grants
National Institutes of Health
Room 240, Westwood Building
Bethesda, Maryland 20892**
It is extremely important for the timely review of your
application that one (1) additional copies of the
application be sent under separate cover to:
Laurance S. Johnston, Ph.D.
Deputy Director, Scientific Review Program, NICHD
Room 520, Executive Plaza North
6130 Executive Boulevard
Bethesda, Maryland 20892
Also, send one copy to:
Arthur A. Campbell
Deputy Director, Center for Population Research, NICHD
Room 604, Executive Plaza North
6130 Executive Boulevard
Bethesda, Maryland 20892
Applications must be received by January 16, 1989. Late
applications will not be accepted.
TIMETABLE
Application Receipt Date January 16, 1989
Initial Review Date February/March 1989
Review by NICHD Advisory Council June 1989
Anticipated Award Date July 1, 1989
Inquiries regarding this announcement may be directed to:
Arthur A. Campbell
Deputy Director, Center for Population Research, NICHD
Room 604, Executive Plaza North
6130 Executive Boulevard
Bethesda, Maryland 20892
Telephone: (301) 496-1101
_____________________
(1) This program is described in the Catalog of Federal
Domestic Assistance No. 13.864, Population Research. Awards
will be made under the authority of the Public Health
Service Act, Title III, 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
Part 74. This program is not subject to the
intergovernmental review requirements of Executive Order No.
12372 or to Health Systems Agency review.
**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