NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR CANCER
RELEASE DATE: January 16, 2004
RFA Number: RFA-CA-05-001
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.395
LETTER OF INTENT RECEIPT DATE: April 19, 2004
APPLICATION RECEIPT DATE: May 19, 2004
This RFA is a reissue of RFA-CA-99-010, which was published in the NIH
Guide on April 14, 1999.
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The Developmental Therapeutics Program, Division of Cancer Treatment
and Diagnosis, National Cancer Institute (NCI) invites applications to
continue the National Cooperative Drug Discovery Group (NCDDG) Program
for the discovery of new and more effective anticancer treatments.
This program will further the NIH Roadmap Initiatives
(http://nihroadmap.nih.gov) and the NCI goal of eliminating the
suffering and death due to cancer by the year 2015. For this Request
for Applications (RFA), the term NCDDG will apply, whether the products
are from natural sources or of synthetic or biological origin.
Applications are sought from both new and re-competing NCDDGs (also
called Groups).
This RFA will support broad, innovative, interdisciplinary, multi-
project approaches to the discovery of new, rationally based or
natural-source derived anticancer treatments or strategies. The
initiative provides a framework for interactions that will reduce the
time from concept to product. A multi-institutional, public-private
partnership approach involving academic, nonprofit, and/or
commercial/industrial institutions with Government staff participation
is envisioned because the creative talents in the required scientific
disciplines are rarely available in a single institution. Although not
required, 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. Biological or molecular targets for drug
discovery and the sources and types of natural products to be
investigated will be selected by the applying Group.
Subsequent studies required for development of new treatments (e.g.,
formulation development, large-scale production for clinical trials, or
toxicology in support of Investigational New Drug Applications, etc.)
as well as the clinical trial itself, are beyond the scope of this RFA.
However, a timely evaluation of products is encouraged. The
development of analogs of established or well-studied anticancer agents
is not responsive to this RFA.
RESEARCH OBJECTIVES
Background
Important discoveries in molecular biology, cell biology, chemistry and
related fields, together with major technological advances, permit the
design of highly selective and specific approaches to discovery of new
cancer therapies. Harnessing these exciting advances for development of
more effective cancer therapy requires the organization of outstanding
scientists from diverse scientific disciplines within the biological,
chemical, and pharmacological sciences into highly synergistic research
teams without regard to institutional affiliation. To realize this
objective as well as to make use of facilitating resources of NCI's
Developmental Therapeutics Program within these teams, the NCI acted on
the advice of the former Division of Cancer Treatment's Board of
Scientific Counselors and established the NCDDG program in 1982. Since
then the NCDDG program has been recompeted several times. For
additional information on history and past accomplishments of NCDDGs,
visit the web site: http://dtp.nci.nih.gov/ (under Grants and
Contracts).
NCDDGs are peer-reviewed, multi-component, interdisciplinary projects
focused on discovery of new approaches for treatment of cancer. An NIH
intramural laboratory or a foreign institution may participate as a
Laboratory Program or a Scientific Core in an NCDDG submitted by a
domestic institution. NCDDGs are funded as cooperative agreements, a
mechanism in which the NCI, through its extramural staff, is an active
partner in the Group. NCI staff, represented by a Project Coordinator
appointed after award, provides advice and guidance in the area of drug
discovery and development and facilitates access to NCI resources
including repositories, chemical searches, and screens. Resources for
development include, but are not limited to, scale-up synthesis,
formulation, pharmacology, toxicology, and Investigational New Drug
Applications (INDAs) to the Food and Drug Administration (FDA).
Information can be found at the DTP web site: http://dtp.nci.nih.gov/.
Clinical trials support may be made available through the Cancer Therapy
Evaluation Program (CTEP): http://ctep.info.nih.gov/. Additional pre-
clinical developmental support may be obtained though the Rapid Access
to Intervention Development (RAID) or Drug Discovery Group (DDG)
mechanisms (http://dtp.nci.nih.gov/).
Objectives and Scope
The purpose of this RFA is to encourage the discovery of novel
treatments or strategies to eliminate suffering and death due to cancer.
Groups should use innovative approaches to drug discovery based on
recent advances in tumor biology and the molecular understanding of
cancer. Projects directed at molecular targets and regulatory pathways
specifically altered in tumor cells are encouraged, whereas approaches
based solely on inhibition of cellular proliferation without regard to
exploitation of alterations in cancer cells are discouraged. Specific
approaches may encompass a wide range of topics such as gene therapies,
monoclonal antibodies, and vaccines; biological response modifiers;
design of agents to interfere with transcription factors, signal
transduction, cell adhesion factors, angiogenesis, hormone or other
receptors; and other novel targets involved in the initiation and/or
maintenance of the transformed state and for which a strong rationale
can be provided. Development and use of new chemical libraries,
structural biology, proteomics or computer modeling of receptor targets
should be considered. Non-mammalian models may be used if appropriate
to the goals of the project. Applications related to treatment of
childhood cancers as well as AIDS-related malignancies are encouraged.
It should be emphasized that approaches to realization of the goals of
this RFA are broad and limited only by the creativity and scientific
abilities of the applicants. For more information on the research
priorities of NCI in cancer prevention and treatment, visit
http://cancer.gov/pdf/nci_2005_plan.
NCDDGs focused on the discovery and evaluation of new entities from
natural sources should emphasize the novelty of the natural product
sources and use molecular target-based screening assays. Biosynthetic
approaches are considered within the scope of the RFA. The development
or use of pre-clinical models based on their ability to discriminate for
antitumor activity and to test the rationale for natural product
selection and isolation is encouraged.
Programs for collection and screening of natural product extracts or
existing combinatorial libraries without strong rationales for material
selection or testing models, and projects designed to produce analogs of
extensively studied natural products or their derivatives are not
responsive to this RFA. To be considered responsive to this RFA, natural
product discovery Groups must include lead optimization strategies, such
as modern combinatorial chemistry technology. If appropriate, Group
projects could include analysis of new and relevant procedures to
evaluate in vivo efficacy that will facilitate decisions regarding
potential clinical utility. Approaches could include development of
molecular end points or non-invasive agent imaging for tumor and organ
distribution analysis. Development and use of assays that can be
applied to clinical evaluation following completion of NCDDG-supported
research are especially encouraged. Funds for projects or cores which
depend on the successful completion of other activities, such as the
availability of certain reagents or scale-up synthesis, may be included,
but use of such phase-in funds will be restricted and released only on
specific written approval by the NCI.
Definitions:
AWARDEE. The institution to which the NCDDG U19 is awarded.
BIOLOGICAL RESPONSE MODIFIER. Agent that alters the relationship
between the tumor and its host by altering the host's response to the
tumor cells.
CORE, ADMINISTRATIVE. An administrative unit located at the Principal
Investigator's institution that coordinates all Group activities. It is
separately budgeted from the PI's Laboratory Program (if any) and
budgets for activities pertinent to the Group as a whole, such as travel
for intra-Group meetings.
CORE, SCIENTIFIC. A separately budgeted scientific service component
which provides essential facilities or services to two or more of the
proposed Laboratory Programs. Core components typically use established
procedures or protocols rather than generating new research. An NIH
intramural laboratory or foreign institution may participate as a
Scientific Core.
CORE LEADER. The director of a scientific core component who is
responsible for the conduct of that core.
DRUG. In the context of this RFA, a term used broadly to encompass
synthetic agents, natural products and biological products, as well as
novel therapeutic strategies and inventions designed to treat and cure
cancer. Strategies also encompass creative methods to maximize
antitumor selectivity.
GROUP. See NCDDG below.
LABORATORY PROGRAM. A research component headed by a Program Leader
within an NCDDG with a separate, detailed research plan and budget. An
NIH intramural laboratory or foreign institution may participate as a
Laboratory Program.
NATIONAL COOPERATIVE DRUG DISCOVERY GROUP (NCDDG). A unit consisting of
a Principal Investigator, Program Leaders, Core Leaders (if any), their
respective programs (at least three laboratory programs), and an NCI
Coordinator (from the NCI extramural staff, appointed after award) that
functions as a unit with a common goal: the conceptualization,
invention, and evaluation of new entities and strategies or rational
selection, isolation, and evaluation of new entities from natural
sources for treatment and cure of cancer. In this RFA, the terms NCDDG
and Group are used synonymously.
NATURAL PRODUCT. In the context of the NCDDG program, a term used
broadly for any naturally occurring chemical or biological entity of
non-human origin selected and evaluated pre-clinically against cancer.
NCI COORDINATOR. A scientist from the NCI extramural program staff who
is appointed by the NCI Program Official just before award, who
participates as a member of the Group, interacts scientifically with the
Group and facilitates the role of NCI as partner in the Group. The
Program Official also may serve as the NCI Coordinator for a Group.
NCI PROGRAM OFFICIAL. The senior staff member of the Grants and
Contracts Operations Branch, Developmental Therapeutics Program,
Division of Cancer Treatment and Diagnosis who provides leadership and
guidance for the overall NCDDG Program within the NCI, maintains overall
scientific balance for the NCDDG Program, and ensures that the NCDDG
Program is consistent with the NCI mission for treatment research.
PRINCIPAL INVESTIGATOR. The scientist who is designated by the
applicant institution to direct the NCDDG. The PI will assume
responsibility and accountability to the applicant institution and to
the NCI for the performance and proper conduct of the NCDDG in
accordance with the terms and conditions specified in this RFA. An NIH
intramural scientist or a scientist from a foreign institution may not
serve as a Principal Investigator.
PROGRAM LEADER. A senior scientist with proven independent research
capabilities who serves as director of one of the scientific Laboratory
Programs of the Group and is responsible for the scientific conduct of
that program. The Principal Investigator of the Group may be a Program
Leader. An NIH intramural scientist or a scientist from a foreign
institution may serve as a Program Leader.
MECHANISM OF SUPPORT
This RFA will use the NIH cooperative agreement (U19) award mechanism.
As an applicant you will be primarily responsible for planning,
directing, and executing the proposed project. This RFA is a one-time
solicitation. Future unsolicited, competing-continuation applications
based on this project will compete with all investigator-initiated
applications and will be reviewed according to the customary peer
review procedures. The earliest anticipated award date is May 2005.
Applications that are not funded in the competition described in this
RFA may be resubmitted as NEW investigator-initiated applications using
the standard receipt dates for NEW applications described in the
instructions to the PHS 398 application.
This RFA uses just-in-time concepts. It uses the non-modular budgeting
formats. Applicants should follow the instructions for non-modular
budget research grant applications. This program does not require cost
sharing as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
The NIH U19 is a cooperative agreement award mechanism. In the
cooperative agreement mechanism, the Principal Investigator retains the
primary responsibility and dominant role for planning, directing, and
executing the proposed project, with NIH staff being substantially
involved as a partner with the Principal Investigator, as described
under the section "Cooperative Agreement Terms and Conditions of
Award. Plans for future competitions of this RFA are currently
indefinite.
FUNDS AVAILABLE
NCI intends to commit approximately $12 million in FY 2005 to fund 10
to12 new and/or competitive continuation grants in response to this
RFA. An applicant may request a project period of up to 5 years and a
budget for total costs of up to $1.2 million per year. Because the
nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award
will also vary. Although the financial plans of the NCI provide support
for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of
meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic institutions/organizations
o Foreign institutions are not eligible to apply. Foreign
collaborators are allowed as Leaders of Programs or Cores.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
A. The Group's objectives and goals should be relevant to and
compatible with the NCI's mission in cancer treatment as stated in this
RFA. Applicants should describe their plans to accommodate the stated
NCDDG requirements, criteria, and NCI involvement.
B. All proposed Groups must consist of at least three
interdisciplinary Laboratory Programs with each complementing the
others expertise. While no maximum number of programs is stipulated,
when a consortium exceeds five programs the overall Group may become
difficult to manage. Groups may also have Scientific and/or
Administrative Cores that provide essential services to two or more
Laboratory Programs, but a Core cannot serve as one of the three
required Laboratory Programs.
C. The Principal Investigator and each Program Leader must provide a
signed statement of acceptance of the participation of NCI staff during
performance of the award as outlined under "NCI Staff Responsibilities"
below.
D. A plan should be described for decision-making regarding
identification and evaluation of promising agents for development. A
plan should be provided for developmental activities not supported by
this RFA but required for introduction of an agent into clinical trial.
E. For projects involving natural products, a plan for lead
optimization should be included.
F. Participation by pharmaceutical companies and biotechnology firms
is strongly encouraged. Industrial partners should include key
personnel who have authority within the company to allocate resources
to ensure successful completion of the proposed discovery and
development efforts.
G. INTELLECTUAL PROPERTY AND 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 successful
applicants (those likely to receive awards) provide plans to assure
such coverage. The situation could be complicated since multiple
institutions are likely to be involved. Following peer review of the
application, each successful 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 country and
institution. Procedures must be described for resolution of legal
problems should they arise. Your attention is drawn to the NIH
Extramural Technology Transfer Policies and Documents at
http://ott.od.nih.gov/NewPages/602-rev2.htm.
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, must
be developed. The signed agreement must be submitted after review and
prior to award to the assigned NCI Coordinator.
For applications involving natural products, a formal statement of
agreement must be provided and signed by authorized representatives of
all institutions in the Group, assuring that an equitable sharing of
royalties or profits arising from the discovery, if any, will be
returned to indigenous peoples, research collaborators, research
institutions or Governmental entities as appropriate, in the country of
origin of the natural product sample from which the lead or drug was
derived. The signed document must be submitted prior to award to the
assigned NCI Coordinator.
A plan must be developed for disposition of natural product samples,
compound libraries, etc., that are generated over the course of the
award in conformance with TERMS AND CONDITIONS OF AWARD, Item 1.,
listed below. The signed document must be submitted prior to award to
the assigned NCI Coordinator.
The three documents listed above will be considered confidential and
should not be included with the application. These documents must be
provided after the peer review of applications but before award to the
assigned NCI Coordinator. However, awards will not be made until these
documents are received and approved by NCI.
H. Funds from this RFA can be used for sample acquisition only from
locations, domestic or foreign, where the Investigators have secured
signed documents of Memorandum of Understandings and have obtained
collection permits.
I. An NIH intramural scientist (IMS) may not serve as the Principal
Investigator of an NCDDG but may participate in a Group as a Program
Leader, Scientific Core Leader, collaborator, or consultant. However,
an IMS may not receive salary, equipment, supplies, or other
remuneration from this RFA. The IMS must obtain approval of his/her
NIH Institute Scientific Director to allocate resources to the project.
This letter must specify that no more than $500,000 direct costs of
intramural resources will be allocated to the project and provide
assurance that the conduct of the project will comply with the DHHS
regulations for research involving human subjects (if applicable) and
with the PHS policy of vertebrate animal research. The participation of
an intramural scientist is independent of and unrelated to the role of
the NCI Program Official and Coordinator as described below in TERMS
AND CONDITIONS OF AWARD. For NCDDG applications that include NIH
intramural components, the intramural resource level will be accounted
for in the total cost of the overall application.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
The following terms and conditions will be incorporated into the award
statement and provided to the Principal Investigator as well as the
institutional official at the time of award. Failure to abide by any of
the Terms and Conditions of Award pertaining to awardee responsibilities
stipulated in this Section may result in a reduction of funding,
withholding of support, suspension or termination of the award.
These special Terms and Conditions of Award are in addition to and not
in lieu of otherwise applicable OMB administrative guidelines, DHHS
Grant Administration Regulations at 45 CFR parts 74 and 92, and other
DHHS, PHS, and NIH Grant Administration policy statements.
The administrative and funding instrument used for this program is a
cooperative agreement (U19), an "assistance" mechanism (rather than an
"acquisition" mechanism) in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during
performance of the activity. To qualify as an NCDDG, the overall
program must include a minimum of three laboratory programs. Under the
cooperative agreement, the NIH purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working jointly
with the award recipient in a partner role, but it is not to assume
direction, prime responsibility, or a dominant role in the activity.
Consistent with this concept, the dominant role and prime responsibility
for the activity resides with the awardee for the project as a whole,
although specific tasks and activities in carrying out the studies will
be shared between the awardee and the NCI Coordinator.
1. Awardee Rights and Responsibilities
a. The Principal Investigator will have primary authority and
responsibility to define objectives and approaches and to plan
and conduct the proposed research. She/he will assume
responsibility and accountability to the applicant organization and to
the NCI for performance and proper conduct of the research supported in
the NCDDG, including the NIH intramural component, if applicable, in
accordance with the TERMS AND CONDITIONS OF AWARD.
b. 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, 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 (two or three pages) which will be delivered to
the members of the Group within 60 days of the meeting. NCI Coordinator
or Program Official may not chair Group meetings.
c. The Government, via the NCI Coordinator, will have access to data
generated under this cooperative agreement and may periodically review
the data consistent with current DHHS, PHS, and NIH policies. However,
the awardee will retain primary custody of and have primary rights to
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 acknowledgment of NCI support,
including the assigned cooperative agreement award number.
Dissemination of information on synthetic or natural substances supplied
to the Group by NCI (e.g., for comparative testing purposes, as
reference material, etc.) will require clearance by NCI to assure
conformity with existing confidentiality agreements with suppliers.
d. Ownership of natural product samples and combinatorial libraries
acquired during the course of the research rests with the Group. The
Group must follow its policy, approved by NCI, for final disposition of
the samples and ownership rights in the event that the samples are
transferred to other parties who use them to make discoveries.
e. In order that samples be fully evaluated for anticancer potential
after the Group has concluded its evaluation, but before the samples are
transferred to other parties for evaluation in other therapeutic areas,
it is requested that the Group provide lists of completed samples to the
NCI Coordinator, who may facilitate additional biological evaluation in
NCI's contract-based screening facilities or at an additional testing
resource of mutual agreement to NCI and the Group.
f. The NCI recognizes that most countries retain interest in samples
collected within their domains. All applicants who propose foreign
collections of natural products must provide a formal statement of
agreement to NCI prior to award, signed by authorized representatives of
all Group member institutions, for equitable return of a portion of any
profits or royalties derived from NCDDG discoveries to indigenous
peoples, research collaborators, cooperating institutions or
Governmental entities in the countries of origin, as appropriate to
their contributions.
g. Foreign trips for collection purposes must be itemized separately.
These funds will be restricted by NCI and require prior approval for
release. Written approval for release of funds will be granted only
after appropriate clearance documentation from the source country is
provided.
2. NCI Staff Responsibilities
NCI will participate as a member of the Group and will be represented by
an NCI Coordinator, who will have substantial scientific programmatic
involvement during the conduct of this activity that is above and beyond
the normal stewardship for grant awards. In all cases, the role of NCI
will be to assist and facilitate and not to direct activities.
The NCI Coordinator, as well as any other 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. However, the NCI Coordinator will not conduct laboratory
studies.
Upon recommendation of the NCI Coordinator, NCI may utilize its drug
development resources (http://www.dtp.nci.nih.gov/) in support of Group
research activities when such resources may be required on an occasional
basis. The following is a list of resources that may be supplied if
they become desirable during performance, are not anticipated as a
continuing need, and are readily available:
a. Reference compounds for standardization of test systems, as
analytical standards, and for related purposes.
b. Needed resources such as test materials and information that may not
otherwise be available to the Group.
c. Data from testing conducted in resource contract laboratories.
d. Laboratory testing capacity, whenever appropriate and possible, in
the current contract- based preclinical therapy-related laboratory
testing program. The Group is expected to provide sufficient test
material for such testing.
e. Searches of computer files for information about materials, chemical
structures and biological activities, if requests for such searches are
sufficiently focused to avoid excessive costs. Information given to a
Group will be restricted by any standard confidentiality agreements
between the Government and suppliers of test materials to the
Government.
f. 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 these costs in their
application.
These "Terms and Conditions of Award" require that the NCI Coordinator
approve the following: changes in the Principal Investigator or Program
Leaders; reports intended for inclusion in Investigational New Drug
Applications (INDAs) and Clinical Brochures; redistribution, outside the
NCDDG, of biological and chemical materials received from the
Government; and dissemination of research findings resulting from the
use of such materials.
3. Collaborative Responsibilities
The following Collaborative Responsibilities are based on the premise
that the NCDDG is a unit consisting of a Principal Investigator, Program
Leaders, Core Leaders, and their respective programs, and an NCI
Coordinator which functions as a unit as specified in this RFA. Foreign
institutions and NIH intramural laboratories may be participants as
Programs or Scientific Cores but not as the awardee institution, and
their scientists may not serve as the Principal Investigator.
a. The principal end product of NCDDG activities will be the discovery
of new entities and strategies 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.
b. 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 shall be submitted promptly by the
Principal Investigator to the NCI Coordinator upon request. Such
reports shall 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.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award, including the NIH intramural component)
between the awardee and the NCI may be brought to arbitration. An
arbitration panel will be composed of three members: one Group designee,
one NCI designee, and a third designee with expertise in the relevant
area chosen by the other two. This special arbitration procedure in no
way affects the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with PHS regulations at 42 CFR Part
50, Subpart D, and DHHS regulations at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to
Mary K. Wolpert, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 8153, MSC 7456
Bethesda, MD 20892-7456
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8783
FAX: (301) 402-5200
Email: wolpertm@exchange.nih.gov
For specific information related to chemistry or structural biology
contact:
Dr. Ronald Dubois
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 8153, MSC 7456
Bethesda, MD 20892-7456
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8783
FAX: (301) 402-5200
Email: duboisro@mail.nih.gov
For specific information related to natural products research, contact:
Dr. Yali Hallock
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 8153, MSC 7456
Bethesda, MD 20892-7456
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8783
FAX: (301) 402-5200
Email: hallocky@mail.nih.gov
o Direct your questions about peer review issues to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
o Direct your questions about financial or grants management matters
to:
Ms. Jill Rogers
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8796
FAX: (301) 496-8601
Email: jr261m@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows NCI staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent to by the date listed at the
beginning of this document. The letter of intent should be sent to:
Mary K. Wolpert, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPS Room 8153, MSC 7456
Bethesda, MD 20892-7456
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8783
FAX: (301) 402-5200
Email: wolpertm@exchange.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/ . The DUNS number should be entered
on line 11 of the face page of the PHS 398 form. The PHS 398 document
is available at:
http://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact Grants Info,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS: The submission of a single application for
a proposed NCDDG is required (that is, all parts of the application
must be packaged together and submitted by the applying organization).
Because of the interdisciplinary and usually multi-institutional nature
of an NCDDG, the special requirements of the RFA, and the special
provisions which must be followed when NIH intramural laboratories are
participants, the following guidance is provided to help the applicant
include all necessary information and still provide a document that can
be readily reviewed. Applications that are incomplete will be returned
without review. Information about the NCDDG program can be found at
http://dtp.nci.nih.gov.
FORMAT OF APPLICATION
General instructions for the preparation of applications are contained
in the Grant Application Form PHS 398 (revised 5/2001) and can be found
at http://grants.nih.gov/grants/funding/phs398/phs398.html. These
instructions are designed primarily for traditional research project
(R01) applications. NCDDG applications require additional information
as outlined below. Page limitations are presented in the PHS 398
instructions and these should be followed for each individual
Laboratory Program and Core unless otherwise noted. Please note that
an NCDDG is headed by a Principal Investigator and includes research
components called Laboratory Programs headed by Program Leaders and may
include Cores headed by Core Leaders. Programs are equivalent to R01
projects as far as the PHS 398 Instructions are concerned and the
instructions are the same except as noted below.
Description, Performance Sites, and Key Personnel (PHS 398 Form Page 2
and Continuation Pages: This section should concisely state the
overall goals of the NCDDG and clearly state the contribution of each
component to the overall goals. Key personnel for the entire Group
including consultants and consortium collaborators should be listed
alphabetically. Use the terms "Program Leader" and "Core Leader" as
appropriate to identify personnel performing these roles.
Research Grant Table of Contents (PHS 398 Form Page 3 and Continuation
Pages: The application is reviewed as a whole as well as Program by
Program; therefore, prepare a detailed Table of Contents that enables
reviewers to find specific information readily. Identify Laboratory
Programs by number, title, and responsible investigator. Identify
Cores by letter, title and responsible investigator. A sample table of
contents is included at the end of these special instructions to show
the order and format in which the application should be organized.
Agreement to Accept NCI Participation (PHS 398 Continuation Pages):
The agreement to accept NCI participation in the NCDDG as described in
the RFA text, and signed by all parties, must be inserted in the
application after the Table of Contents.
Budget Instructions for Initial Budget Period: Follow the Detailed (not
modular) Budget Instructions for Initial Budget Period (PHS 398 Form
Page 4. Items in this section of the PHS 398 Instructions must be
followed carefully in preparing the total NCDDG budget. Budgetary
information is also required for each grant component as part of the
write up for that component (Laboratory Program or Core). Specify and
justify personnel effort even if no salary support is requested.
Present a detailed composite budget for all requested support for the
first year, using page 4 of the PHS 398 application form. If
collaborative efforts or "purchased services" involving other
institutions or organizations are anticipated, itemize all costs
associated with such third party participation, including any
applicable Facilities and Administrative (F&A) costs on a separate
budget page and enter the total under the "Consortium/Contracted Costs"
direct costs budget category. For details on consortium budgets, see
the NIH Grants Policy Statement (03/01) at
http://grants.nih.gov/grants/policy/nihgps_2001/index.htm. Under
NIHGPS (03/01) in the left hand corner of the screen, scroll down to
Part II: Other Terms then click Consortiums.
Travel costs for Group meetings should be included in the budget for
the Administrative Core. All other scientific travel should be
included in the budget for each individual Program or Scientific Core.
Budget Instructions for Entire Proposed Period of Support (PHS 398 Form
Page 5 and Continuation Pages: Present a composite summary budget for
all years of requested support for the overall Group by category, i.e.,
personnel, equipment supplies, etc. All increases for future years,
whether standard cost of living or projected special requirements,
should be stated explicitly and clearly justified. 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. Detailed justification
for phase-in budgets must be provided. Costs for Group meetings and
intra-Group communications should be budgeted in the Administrative
Core taking care not to duplicate these costs in the budgets for
individual Programs. Budgetary provision should be made for items such
as scale-up synthesis; actual use of funds for these purposes will be
restricted by the NCI to the purposes stated and funds will be released
if and as needed only on specific recommendation of the NCI Program
Official.
Foreign trips for collection purposes must be itemized separately.
These funds will be restricted by NCI and require prior approval.
Approval for release of funds will be granted only after appropriate
clearance documentation from the source country is provided.
Biographical Sketches (PHS 398 Format page "BIOGRAPHICAL SKETCH" and
Continuation Page; PHS 398 Instructions): Biographical sketches as
described in this section of the instruction sheet must not exceed four
pages. Therefore, cite only the most relevant publications. Place the
biographical sketches in alphabetical order by last name immediately
after the budget sections. Do not repeat biographical sketches in each
Program component. Biosketches are required for all professional
personnel participating in individual Laboratory Programs and cores and
for all consultants. Include all biosketches in the application and
not in an appendix.
Overall NCDDG Description (PHS 398 Continuation Pages): The overall
NCDDG description should explicitly provide the required information in
the order noted below. This description should not exceed 25 pages,
excluding publications.
o Goals: Present the general problem area to be studied, the overall
long-term objectives of the research described in this application and
the hypotheses to be tested. Discuss the relationship of your goals to
the discovery of new treatments for cancer.
o Interrelationships: The NCDDG is a confederation of interrelated and
interdependent Laboratory Programs. It is important to address the
integration of the components, demonstrating how each individual
program and core benefits from and contributes to the overall Group as
well as how the Group intends to interact with the NCI. A diagram
illustrating the effective interactions between components may be
helpful to reviewers. Details should be provided about Group meetings
which are expected to be held at least twice per year and how frequent
communication between Group meetings will be maintained. The agreement
to accept NCI participation should be discussed in this section.
o Research Plan: This section delineates the research addressed by the
Group as a whole and explains the strategic approach to the problem,
briefly mentioning each component (Laboratory Program or Scientific
Core) as it relates to the overall NCDDG. Descriptions of prior
collaborative efforts among investigators in the Group, as well as the
sequence of events leading to the current application may also be
included in this section. It is important to discuss the advantages
expected from a group effort, and how they will further the goals of
the research.
o Lead Optimization: Discuss how the Group plans to optimize lead
structures discovered in Group research.
o Development Plan: As required in the RFA, discuss how the Group
intends to pursue leads discovered in the research towards advanced
pre-clinical and clinical development.
o Preliminary Studies (for new applications): This section should
focus on research already underway and current accomplishments of the
investigators. More detailed preliminary results are to be included
separately under each individual Laboratory Program or Core. Items to
be included are a summary of major accomplishments attributed to the
participating investigators that relate to the overall theme of the
Group and a list of all publications and manuscripts accepted for
publication already produced by the interactions of the participating
investigators.
o Progress Report (for competing renewal applications): This section
should describe the achievements of the Group since the last
competitive review with emphasis on the discovery of new anticancer
treatments and new leads. Separate progress reports are included in
the individual Laboratory Programs, so this section should focus on the
overall Group rather than reiterating information provided in each
component. Include the following:
Summarize the major accomplishments that can be attributed to the
Group. Identify which components were involved in these
accomplishments.
Discuss the role of the NCI in your accomplishments.
Discuss any changes in the composition of the Group and the reasons for
the changes.
Provide a list of all publications and completed manuscripts that have
resulted from the award. Indicate those which involved participation
of more than one Group component.
o Institutional Environment and Resources: Discuss the overall
resources that are available to the Group, particularly those which
relate to the overall Group and provide special opportunities. These
could include resources of industrial collaborators, consultants, etc.
The resources and environments specific to the laboratory components
and cores are to be detailed in their individual parts of the
application.
o Organization and Administrative Structure: Describe in detail and by
diagram the chain of authority for decision making and administration,
beginning at the level of the Principal Investigator. Include all
investigators responsible for individual Laboratory Programs and cores
and detail how the tasks are planned, coordinated, and evaluated. If
internal or external advisory groups are to be used, list the
membership (actual but not proposed members) and describe the role of
each. List in a separate table all consultants, both paid and unpaid.
o Literature Cited: While this section is not included in the page
limitation, it is important to be concise and to select only those
literature references pertinent to the overall description. List
complete literature citations as directed in the PHS 398 Instructions.
o Appendix: Again, this section is not included in the page
limitations. Organize appendix materials in the following sequence:
Appendix material for the overall NCDDG, followed by appendix material
for numbered Laboratory Programs, if needed, followed by appendix
material for lettered Cores, if needed. Limit the appendix to those
few most essential publications necessary to document your application
o Laboratory Programs: Describe each Laboratory Program (term used to
describe an individual research project in a Group) in sufficient
detail to enable reviewers to judge the scientific merit from the
written application. Use the outline below. In each Laboratory
Program, sections A-D of the Research Plan should not exceed 25 pages.
Cover Page (Use a PHS 398 Continuation Page and NOT form page 1, FACE
PAGE from PHS 398). Clearly denote the Laboratory Program number, the
title of the Laboratory Program, the name of the Program Leader, and
the Program Leader's Institution.
Key Personnel (PHS 398 Form page 2). The title of Principal
Investigator is reserved for the director of the overall Group. The
directors of the individual Laboratory Programs should be referred to
as "Program Leaders".
Omit Table of Contents (already included in OVERALL section).
Budget. Use detailed budget formats even if no more than $250,000
direct costs per year are requested for an individual program. Use PHS
398 Form Pages 4 and 5 and PHS 398 Instructions, Pages 10-14. A
detailed budget is required for the first year and the budget summary
for each additional year. The budget justifications are to be
explicit, including those for changes for future years.
Omit Biographical Sketches as these are included elsewhere in the
application.
Resources and Environment: List only those specific to the Laboratory
Program. Clearly explain the position of Program Leaders from
pharmaceutical companies. The Program Leader should be responsible for
allocation of resources required for the research. No page limitation.
Research Plan:
Laboratory Program aspects - Include Sections A, B, C and D. Limited to
25 pages.
Relation of Laboratory Program to overall NCDDG: (This item is not
included in PHS 398 Instructions.) Describe in this section the
relevance of the Laboratory Program to the primary theme of the Group
and the collaborations with other investigators within the Group.
Limited to one page.
Human Subjects: If any organizational component within an NCDDG uses
human subjects, this information must be noted on the face page for the
overall application.
If human subjects are involved in the application, be sure to address
all aspects including Gender and Minority Inclusion for Research
Involving Human Subjects and Inclusion of Children as Participants in
Research Involving Human Subjects. HS 398 Instructions, Pages 17-2.
There are no page limitations here but be succinct and address the four
points for each laboratory program that uses human subjects.
Vertebrate Animals: If any organization within a NCDDG uses vertebrate
animals, this information must be noted on the face page for the
overall application. Again, there are no page limitations but be
succinct, and address the five points for each laboratory program that
uses vertebrate animals.
Consultants/Collaborators: (PHS 398 Continuation Pages). List only
those consultants or collaborators who are specific to this Laboratory
Program. No page limitation.
Literature Cited: (PHS 398 Continuation Pages; PHS 398 Instructions,
Page 28). List complete literature citations at the end of each
Laboratory Program. Each citation must include the names of all
authors, full title, name of book or journal, volume, pages and year of
publication. No page limitation but select only pertinent references.
Do NOT include a checklist for each Laboratory Program. There should
be only one checklist at the very end of the entire application, and
that should come from the organization submitting the overall NCDDG.
Cores: (PHS 398 Continuation Pages). The Cores within a Group may
include laboratory facilities, equipment, and services which will be
shared by two or more Laboratory Programs. A core may also include
support of administration, such as the costs of business management,
consultants, and secretarial services associated with the Group where
these items are not included in the institution's indirect cost rate.
Using a Form PHS 398 Continuation Page, denote "Core Component"
(followed by a letter if there is more than one core), the title of the
core, and the name and institution of the Core Leader.
The Administrative Core at the Principal Investigator's institution
must be designated as "Core A", followed by Scientific Cores, if any.
An Administrative Core may be omitted in special circumstances, such as
an application from a single institution.
For each Scientific Core component, follow the specific instructions
and page limitations for the Laboratory Program, above, except that in
place of the item "Research Plan", describe the role of the core
component as a resource to the NCDDG as a whole. Clearly present the
facilities, resources, services, and professional skills that the core
component provides.
Checklist for overall application (Use PHS 398, CHECKLIST FORM PAGE:
Self-explanatory.
Additional documentation of a legal and proprietary nature, described
in the RFA under SPECIAL REQUIREMENTS, will need to be sent to the NCI
Coordinator assigned to the application before an award can be made.
This information will be considered confidential and will not be
provided to reviewers as part of the application material. This
documentation must be signed by authorized representatives of all Group
participants. The three documents include a Patent Agreement (required
by all Groups), a formal statement providing assurance that an
equitable portion of profits will be returned to indigenous people from
the country of origin (required by Groups discovering drugs from
natural products obtained from foreign sources), and a plan for
ownership and use of natural product extracts or chemical libraries
after the Group has decided that they are no further value to the Group
Programs (required by Groups generating these products). Although this
documentation is to be sent when requested by NCI staff after the peer
review of applications but before award, applicant organizations would
be well advised to have this information ready to be supplied.
Incumbent applicants can state on an appropriate continuation page that
there are no changes from previously submitted information, if this is
the case.
SAMPLE TABLE OF CONTENTS: IN ORDER TO AID THE REVIEW OF APPLICATIONS,
PLEASE ORGANIZE YOUR MATERIALS IN THE ORDER SHOWN IN THIS SAMPLE TABLE.
SECTION I
Face Page
Table of Contents
Agreement to Accept NCI Participation
Detailed Group budget for First 12-Month Period
Budget Estimate for Each Year of Funding
Biographical Sketches (alphabetical order by last name)
SECTION II
Overall NCDDG Description:
Goals
Interrelationships
Research Plan
Development Plan
Preliminary Studies/Progress Report
Institutional Environment and Resources
Organization and Administrative Structure
Literature Cited with complete titles and authors
Laboratory Program 1 (Title):
Cover Page
Description of Research Plan/ List of Key Personnel
Detailed budget for First 12-Month Period
Budget Estimate for Each Year of NCDDG
Resources and Environment
Research Plan
(Human Subjects)
(Vertebrate animals)
Consultants/Collaborators
Literature Cited with complete titles and authors
Laboratory Program 2 (Title):
Cover Page
Description of Research Plan/ List of Key Personnel, etc.
Core Component A (Title) (Administrative Core, if present):
Cover Page
Description of Core/List of Key Personnel
Detailed budget for First 12-Month Period
Budget Estimate for Each Year of NCDDG
Resources and Environment
Role and Justification for the Core Component
Core Component B (Title) (Scientific Core, if Present):
Cover Page
Description of Core/List of Key Personnel
Detailed budget for First 12-Month Period
Budget Estimate for Each Year of NCDDG
Resources and Environment
Role and Justification for the Core Component
(Human Subjects)
(Vertebrate animals)
Literature Cited with complete titles and authors
Check List
Appendix (if appendix is needed, put documents in following sequence):
Overall Group Description
Numbered Laboratory Programs
Lettered Cores
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to us
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf .
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center For Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0715
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
Appendices should be comprised of single-sided, unbound materials, with
separators between documents.
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER
INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to
courier deliveries (i.e. FEDEX, UPS, DHL, etc.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)
This policy is similar to and consistent with the policy for
applications addressed to Centers for Scientific Review as published in
the NIH Guide Notice
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received on or before the
application receipt listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS:
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NCI. Incomplete and/or nonresponsive applications
will not be reviewed.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the Division of Extramural Activities of the
NCI in accordance with the review criteria stated below. As part of
the initial merit review, all applicants will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NCI National Cancer Advisory
Board (NCAB).
REVIEW CRITERIA
Review Criteria for NCDDG as a Whole
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting them
as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
All applications will be judged on the basis of the scientific merit of
the proposed project and documented ability of the investigators to
meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit
of the proposed studies is important, the likelihood of identifying a
clinical trial candidate and the plan for pre-clinical development
activities beyond the scope of the RFA will be part of the evaluation.
Within this framework the specific goal of this RFA is the discovery
and pre-clinical analysis of new agents to treat cancer. The reviewers
will address the following criteria in assigning priority scores,
weighting them as appropriate for each application. Individual
Programs and Cores within the NCDDG, as well as the NCDDG as a whole,
will be evaluated. Note that each Program within the NCDDG does not
need to be strong in all categories as long as it contributes a
necessary function to the goals of the Group.
Each application will be evaluated for the extent of progress on prior
award (RECOMPETING GROUPS) or preliminary results (NEWAPPLICANTS).
Groups will be evaluated for extent of effectiveness of cooperation
with the NCI (RECOMPETING GROUPS) and adequacy of plans for cooperation
with the NCI (ALL APPLICANTS).
SIGNIFICANCE: Does the applicant address an important problem in
anticancer drug discovery and/or development? If the aims of the
application are achieved, what is the likelihood of a new cancer
therapy or strategy for clinical evaluation? Is the development plan
adequate to bring the agent to clinical trial?
APPROACH: Are the overall conceptual frameworks, designs, methods, and
analyses adequatelydeveloped, well-integrated, and appropriate? Are
the scientific disciplines represented in Programs and Scientific Cores
adequate to achieve Group objectives? Does the applicant acknowledge
potential problem areas and consider alternate tactics? Are targets and
screens relevant to the neoplastic process? Are plans adequate for
ensuring effective intra-Group communication and for assuring Group
cohesiveness? Is the plan to optimize lead structures, from both
synthetic and natural sources, adequate to ensure that the most
efficacious drug will result? Are plans for decision-making regarding
identification and pursuit of lead candidates reasonable and
appropriate?
INNOVATION: Does the NCDDG employ novel concepts, approaches, or
methods? Are the aims original and innovative? Does the NCDDG
challenge existing paradigms or develop new methodologies or
technologies? Is the target under investigation for drug discovery
novel? Will new paradigms for drug discovery emerge?
INVESTIGATORS: Are the Principal Investigator and Program/Core Leaders
appropriately trained and well suited to carry out this work? Is the
time commitment for each sufficient to achieve goals? Has the
Principal Investigator demonstrated leadership in development,
implementation and management of comprehensive research programs?
ENVIRONMENT: Does the scientific environment in which the Programs will
be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
expertise and foster effective collaborations? Is there evidence of
institutional support and competence of the applying Institution to
serve as the Administrative Core for the Group?
Review Criteria for Programs SIGNIFICANCE: Does this program address
an important problem in anticancer drug discovery and/or development?
If the aims of the program are achieved, how will scientific knowledge
be advanced? What will be the effect of these studies on the concepts
or methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the program? Does the applicant acknowledge potential problem areas
and consider alternative tactics?
INNOVATION: Does the program employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the program
challenge existing paradigms or develop new methodologies or
technologies?
INVESTIGATOR: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the Program Leader and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
Review Criteria for Cores
The utility of the Core to the NCDDG. Each Core must provide essential
facilities or services for two or more programs judged to have
substantial merit.
The quality of the facilities or services provided by the Core
(including procedures, techniques, and criteria for prioritizing
activities).
The qualifications, experience, and commitment of the personnel
involved in the Core.
For an Administrative Core: Resources and plans provided for Group
communication and coordination of Group activities.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below). The four items
described in PHS 398 must be included in each program or core that uses
human subjects.
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in any program or core, the five items described under
Section f of the PHS 398 research grant application instructions (rev.
5/2001) will be assessed. The five items must be included in each
program or core that uses animals.
ADDITIONAL REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in
direct costs in any year of the proposed research must include a data
sharing plan in their application. The reasonableness of the data
sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the
proposed data sharing plan into the determination of scientific merit
or priority score. Instructions concerning this policy are listed
below under REQUIRED FEDERAL CITATIONS.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: April 19, 2004
Application Receipt Date: May 19, 2004
Peer Review Date: October 2004
NCAB Review: February 2005
Earliest Anticipated Start Date: May 1, 2005
AWARD CRITERIA:
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
SHARING RESEARCH DATA: Starting with the October 1, 2003, receipt
date, investigators submitting an NIH application seeking $500,000 or
more in direct costs in any single year are expected to include a plan
for data sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing Investigators should
seek guidance from their institutions on issues related to
institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data sharing plan but will not factor the plan into
the determination of the scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing clinical research should read the NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research Amended, October 2001 , published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH
definition of clinical research; updated racial and ethnic categories
in compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all
initial (Type 1) applications submitted for receipt dates after
October 1, 1998.
All investigators proposing research involving human subjects should
read the NIH Policy and Guidelines on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
A continuing education program in the protection of human participants
in research is available online at: http://cme.nci.nih.gov/
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the
NIH Human Embryonic Stem Cell Registry will be eligible for Federal
funding (see http://escr.nih.gov). It is the responsibility of the
applicant to provide, in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s) to be used in the proposed research. Applications that do not
provide this information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
VERTEBRATE ANIMALS: The PHS Policy on Humane Care and Use of Laboratory
Animals requires that applicant organizations proposing to use
vertebrate animals file a written Animal Welfare Assurance with the
Office for Protection from Research Risks, establishing appropriate
policies and procedures to ensure the humane care and use of live
vertebrate animals involved in research activities supported by the
PHS. The PHS policy stipulates that an applicant organization, whether
domestic or foreign, bears responsibility for the humane care and use
of animals in PHS-supported research activities. Additional
information in outlined in the PHS 398 instructions and available at:
http://grants.nih.gov/grants/olaw/references/phspol.htm.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement that can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
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