ACADEMIC PUBLIC PRIVATE PARTNERSHIP PROGRAM (AP4) PLANNING GRANT
RELEASE DATE: July 30, 2003
RFA Number: RFA-CA-04-005
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.394 and 93.395
LETTER OF INTENT RECEIPT DATE: October 21, 2003
APPLICATION RECEIPT DATE: November 20, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Academic Directors
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE
The Developmental Therapeutics Program (DTP), Division of Cancer
Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) invites
academic cancer researchers to participate in the Academic Public
Private Partnership Program (AP4). The purpose of the AP4 initiative
is to provide support for the formation of new partnerships or
significant expansions of existing partnerships among academia,
industry, non-profit institutions, and government entities. The
partnerships will conduct novel cancer therapeutic, prevention,
diagnostic, and imaging intervention-directed research. The goal of
the research will be to speed the translation of newly discovered
cancer interventions to clinical trials. The NCI is assisting the
formation of these partnerships by offering to academic and non-profit
researchers a one-year planning grant, which is the subject of this
RFA. The planning grant will be utilized by the academic or non-profit
cancer researcher to study the feasibility of developing the
pharmaceutical/non-profit/academic interaction necessary to establish
and support a partnership, to hold a meeting of potential partners and
select research projects for the potential AP4 Center.
The research focus of these partnerships should take advantage of the
latest discovery and development technologies and include projects
which focus on cancers that meet the definition of orphan disease
(those that affect less than 200,000 people per year in the United
States) using a multidisciplinary approach. Biologically defined
subsets of more common tumor types could also be defined as having
"orphan" status. The research will occur at the AP4 Center with the
advice and intellectual and financial support of industrial, academic,
non-profit institute, other government partners and the NCI. The goal
of the research conducted in the AP4 center is to generate novel
interventions, development of which for human clinical trials will be
supported by other financial resources.
The impetus behind the creation of such a program is to promote public-
private partnerships that will advance our basic knowledge of the
molecular biological events that lead to cancer, and to apply that
knowledge to the development of novel cancer interventions. The
strategy addresses an important issue: how to bring together the
necessary multidisciplinary expertise to discover new, more effective
treatment, diagnostic, and prevention interventions for cancer, and
shorten the time required to bring these new interventions to clinical
trials.
A number of recent NCI initiatives aim to support key steps in the
intervention discovery and development process (see: Rapid Access to
NCI Discovery Resources (R-A-N-D); Rapid Access to Intervention
Development (RAID); Flexible System to Advance Innovative Research
(FLAIR); and Molecular Target Drug Discovery grants (MTDDs)at:
http://dtp.nci.nih.gov). The above initiatives provide assistance for
the most part to individual researchers.
The present initiative has a very different organizational focus. We
wish to bring together the basic research skills inherent in the
academic institutions, the scientific expertise of industry, the
interests of disease-oriented charities and non-profit groups, and the
administrative support, resources, and years of discovery and
development expertise of the DTP, DCTD, NCI.
RESEARCH OBJECTIVES
Background
The cost of discovering and developing a drug to the point of filing a
New Drug Application (NDA), which allows sale to the public, has been
estimated to be as high as $800 million, and requires up to 15 years of
research, clinical trials, and marketing. At the same time, scientific
breakthroughs have revealed that many, if not all, human cancers can be
classified into genetic subtypes, potentially decreasing the population
of patients who may benefit from a rationally designed, targeted drug,
diagnostic or imaging technology. This raises the possibility of
creating "orphan status" markets, traditionally of less interest to
large pharmaceutical companies. This concern, that "big pharma" may
stand back from research in an "orphanized" cancer market, might be
addressed by creating partnerships in which NCI leverages the risks of
cancer intervention discovery and development for academic and
industrial researchers. The NCI desires to catalyze the creation of
these partnerships to realize the promise of the molecular revolution
in cancer biology.
In the Fall of 2001, the Office of Scientific Planning and Assessment
(OSPA) convened a committee of NCI staff charged with outlining an
implementation plan which would make the public-private partnership
concept a reality. OSPA identified a potential model for NCI
activities in the Industrial/University Cooperative Research Center
(I/UCRC), an initiative originally developed by the National Science
Foundation (NSF).
The NSF I/UCRC Program was initiated in 1973 to catalyze the formation
of long term partnerships among industry, academia, and government,
particularly focused on engineering and materials science initiatives.
The NSF invests in academic centers, which are the focus of these
partnerships, to promote research programs of mutual interest to the
members forming each partnership. The goals of this program are to
contribute to the Nation's basic research infrastructure, and to
enhance the intellectual capacity of the engineering workforce through
the integration of research and education.
The Centers are catalyzed by a small investment from NSF, which then
adopts a supporting role in their development. The primary financial
support for each Center comes from Center "members," derived mainly
from the industrial sector. The NSF program offers five-year awards to
Centers. This five-year period allows for the development of a strong
partnership between the academic researchers and their industrial and
government members. There are currently more than 50 Centers involving
750 faculty and almost 1,000 students. The Centers are supported by
more than 700 partners (http://www.eng.nsf.gov/iucrc/).
The NCI modification of the NSF I/UCRC, the Academic Public-Private
Partnership Program (AP4), constitutes a novel cooperative agreement
mechanism for the NCI. AP4 features will include:
o. An AP4 Center Director located at a United States university or non-
profit institution applies for and coordinates the planning grant
effort, and if successful in the subsequent Center application,
coordinates all aspects of the Center. The Director will consult with
Center members to define a research agenda focused on shared research
interests, needs, and opportunities.
o Biotechnology, pharmaceutical, non-profit, university and/or state
and local government partners who are members of the Center, and who
contribute financially to the operation of the Center.
o A Steering Committee for each Center comprised of the membership of
the Center which approves ongoing activities and recommends new
projects, responding to current dynamic opportunities.
o A membership agreement which serves as a formal operations document,
and which specifies the structure and policies of the Center, including
how the Center is governed, as well as the prospective management of
intellectual property issues, publication procedures, and membership
fees and rights. Different Centers may have substantially different
agreements.
o development of scientific expertise in research relevant to cancer
intervention discovery and development at the academic level.
o A strong research team capable of developing and operating an AP4.
o Annual formal evaluations of the organization of the partnership
compiled by an individual evaluator who works with the AP4 Director but
is independent of the Center.
o Facile access to the development contract resources of the
Developmental Therapeutics Program (DTP) (formulation, bulk synthesis,
pharmacology, toxicology) for promising lead compounds approved by the
Center Steering Committee which meet NCI criteria for interest.
Criteria for NCI interest would follow the same guidelines as those
compounds or biological constructs presented to the Drug Development
Group (DDG) (See: http://dtp.nci.nih.gov/docs/ddg/ddg_descript.html).
o Investigational New Drug (IND)-filing assistance through the Cancer
Therapy Evaluation Program (CTEP) for an NCI-based clinical trial or a
Principal Investigator-based trial will be afforded on a case-by-case
basis. This may involve assistance in putting together IND's when held
by the originating Center or assumption of the IND if the agent is to
be studied more broadly in NCI's existing early clinical trials groups.
The AP4 Center must be based at an academic or non-profit institution,
and will include a combination of biotech, pharmaceutical, non-profit
organizations, the NCI, and other government agencies as partners, each
with an interest in translating novel anticancer therapeutic,
prevention, diagnostic, and imaging interventions from the laboratory
to the clinic. Each Center partner might contribute expertise in a
different functional area of the intervention discovery and development
process. Alternatively, partners with expertise in overlapping
disciplines could agree to support one aspect of a discovery and
development program; the actual roles and goals of each Center's
members will be articulated by the AP4 Center Director and included in
the membership agreement. There will be three or more selected
research projects, which are new collaborative efforts, of interest to
the partners, to be conducted at the institution, and upon which review
of the Center application will be partially based. Existing
partnerships may apply provided that the selected projects are new to
the partnership. Major criteria for review will encourage that the
research approach take advantage of the latest technologies, and
include projects with a focus on malignancies that are underserved or
on biologically defined subsets of more common tumor types. The goal
of each selected project will be the development of a new anticancer
therapeutic, preventive, diagnostic or imaging agent.
AP4 Center awards will be for a period of five years. The Centers will
be funded initially with $450,000 per year (total direct costs
including third party F and A) by NCI, with a minimum of $300,000 per
year (total) funds coming from Center members. For Centers with
combined funds from partners of at least $450,000, the NCI's annual
contribution will increase to $600,000 (total direct costs including
third party F and A). NCI expects the awardees will be able to compete
for a second five-year award of $100,000 - $200,000 (direct costs) per
year, which could be made to Centers successful in meeting their
established goals. After ten years, it is expected that Centers which
continue to operate would be fully supported by industrial, non-profit,
academic, other (non-NIH) Federal agency, and/or state and local
government partners. For more details on funding and other aspects of
the AP4 Center, please refer to
http://dtp.nci.nih.gov/docs/ap4/ap4-index.jsp
Objectives and Scope
The One-year Planning Grant for an AP4 Center
This RFA requests applications for the one-year planning grant. The
$50,000 (total direct costs including third party F and A) one-year
planning grant, which will be competitive and peer-reviewed, will be
used by the proposed AP4 Director to study the feasibility of developing
the pharmaceutical/non-profit/academic interaction necessary to
establish or significantly expand existing partnerships, and will lead
to a determination of whether or not to apply for an AP4 Center. The
planning grant period will include a meeting that brings together
potential members to explore opportunities, discuss how intellectual
property issues will be handled, and establish a research plan.
The ideal planning grant applicant will be based at an academic or non-
profit institution with a clear track record of funded research in
cancer biology. The application should identify the overall theme
and/or the disease(s) to be studied. Letters of interest in a
potential Center from at least two potential members must be included
in the application for the planning grant. These letters will not be
viewed as full or formal commitments, but as a basis for further
discussion. NCI recognizes that the final AP4 Center application may
contain commitments of a subset of these, or additional potential
members.
Only awardees of a planning grant will be eligible to submit an
application for the AP4 Center.
Elements of a successful planning grant application will include:
o A description of the scientific and managerial experience of the
proposed AP4 Director, and the names and research expertise of
participating researchers;
o A brief description of the capabilities of the institution, including
faculty and infrastructure, and the commitment of the institution to
the proposed Center;
o A brief description of the proposed organization of the Center:
management plans, staffing, budget, and operational procedures;
o The description of the process and criteria that will be used during
the planning period to recruit partners and select projects for the
Center application.
o A description of the process to be used to select the Center
evaluator. The evaluator will be responsible for conducting surveys on
Center performance, and the progress of projects. Evaluators must be
external to the Center and may be retained on a contractual basis;
o A one to two page summary for each of at least three sample initial
projects involving orphan malignancies, addressing how the projects
would impact the diagnosis, prevention, imaging or treatment of a
specific cancer, and how the areas of research are appropriate to the
institutional environment;
o Letters from at least two potential Center members from biotech,
pharmaceutical, academic, non-profit organization, or non-NIH
government agencies stating that the proposed research agenda of the
Center is concordant with the organization and that the organization
would consider joining if the Center were formed.
The AP4 Center Application
It is anticipated that the actual Center application will be written
during the one-year planning grant period and will be submitted at the
end of this period It is anticipated that several months will elapse
in between the submission of the Center application and the award.
Details on the requirements of the AP4 Center application can be found
at: http://dtp.nci.nih.gov/docs/ap4/ap4-index.jsp
Definitions
Awardee The academic or non-profit institution to which the AP4 U56
is awarded.
Academic Public Private Partnership Program (AP4) a partnership based
at an academic or non-profit institution comprised of academic,
industrial, NCI, state and local government entities, and non-profit
groups engaged in the discovery and development for eventual clinical
evaluation of novel anticancer therapeutic, prevention, diagnostic, and
imaging interventions.
AP4 Director (AD) The scientist who conceives of and administers the
Center. The AD is responsible for and accountable to the applicant
institution and to the NCI for the performance and proper conduct of
the AP4 Center in accordance with the terms and conditions specified in
this RFA.
Center Application successful awardees of a planning grant will be
eligible to submit an application for an AP4 Center.
Center Evaluator an individual who is independent of the Center and
who is responsible for surveying, collecting and distributing member
feedback regarding their satisfaction with the Center and reporting on
the status of all Center projects as presented to the Steering
Committee.
Membership Agreement a document that establishes a framework for the
relationship between all partners. All partners must agree to terms of
the agreement that spells out issues of intellectual property,
publication rights, membership fees, changes in membership, creation of
the Steering Committee, and evaluation metrics for the Center
NCI Program Coordinator A scientist from the NCI extramural program
staff, appointed after award, who participates as a member of the
Steering Committee, interacts scientifically with the Center and
facilitates the role of NCI as a partner in the Center.
Orphan Disease - The disease or condition for which the intervention is
intended affects fewer than 200,000 people in the United States per
year as defined by the FDA. (See paragraph 8i in:
http://www.fda.gov/orphan/designat/apply.htm)
Planning Grant the planning grant supplies funding for a period of
one year to the proposed AP4 director's institute to study the
feasibility of developing the interactions necessary to establish and
support an AP4 Center. One activity during the planning grant year is
the planning and holding of a meeting which brings together potential
partners to discuss research opportunities and define a research plan
for each of the proposed projects.
Partner a biotech, pharmaceutical company, academic or non-profit
organization or non-NIH government agency that contributes financially
to the AP4 Center. Each partner furthermore contributes to the success
of the Center by selecting a representative to actively participate in
Steering Committee meetings.
Project a scientific study supported by the AP4 involving a cancer-
relevant molecular target or an intervention such as a therapeutic,
diagnostic, preventive or imaging agent.
Steering Committee (SC) comprised of representatives from the Center
membership, the NCI Program Coordinator, and chaired by the AP4
Director. The SC reviews all project status reports and makes go/no go
decisions and recommends new projects. The SC may shift funds from one
project to another, and select candidate molecules for possible
clinical development.
MECHANISM OF SUPPORT
This RFA will use the NIH (U56) award mechanism. As an applicant you
will be responsible for planning, directing, and executing the proposed
project. The anticipated award date is June 2004.
This RFA uses just-in-time concepts. It also uses the modular format
budget (see http://grants.nih.gov/grants/funding/modular/modular.htm).
The NIH (U56) is a cooperative agreement award mechanism in which 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"
FUNDS AVAILABLE
The NCI intends to commit approximately $1.125 Million in FY 2004 to
fund up to 15 new planning grants in response to this RFA. An
applicant may request a project period of one year and a budget of
$50,000 total direct costs which includes third party F and A.
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) only if your institution has the
following characteristic:
o Public or private domestic degree-granting academic institutions,
such as universities and colleges;
o Non-profit domestic organizations;
o Foreign institutions are not eligible.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, experience in cancer
intervention discovery and development, 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
The proposed Center's objectives and goals should be relevant to and
compatible with the NCI's mission in cancer intervention as stated in
this RFA. The application shall include letters from at least two
potential partners and address at least three new potential projects.
Partnerships already in existence are eligible to apply provided the
potential projects are new to the partnership. Applicants should
describe their plans to accommodate the stated AP4 Center requirements,
criteria, and working with NCI staff. Non-profit applicants should
either have a formal relationship, such as joint faculty appointments,
with degree-granting academic institutions or identify a degree-granting
institution as a partner. Planning grant recipients shall organize and
hold a meeting of potential AP4 Center partners to explore
opportunities, discuss how intellectual property issues will be handled,
and establish a research plan.
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 (U56), 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. 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 Program Coordinator.
1. Awardee Rights and Responsibilities
The AP4 Director will have primary authority and responsibility to
define objectives and approaches. She/he will assume responsibility and
accountability to the applicant organization and to the NCI for
performance and proper conduct of the activities supported in the AP4
planning grant in accordance with the TERMS AND CONDITIONS OF AWARD.
2. NCI Staff Responsibilities
NCI will participate as a partner in the planning grant and will be
represented by an NCI Coordinator, who will have substantial
scientific/programmatic involvement during the conduct of the project
that is above and beyond normal program stewardship, as described
below.
The NCI Program Coordinator is a scientist from the NCI extramural
program staff, appointed after award, who participates as a member of
the Steering Committee, interacts scientifically with the Center and
facilitates the role of NCI as a partner in the Center. During
performance of the award, NCI may provide appropriate assistance by
participating in the design of activities; advising in the selection of
sources for resources, staff, etc.; and advising in management and
technical performance. It is not NCI's role to assist in the writing
of the AP4 application, to assist in the actual planning or conduct of
the partnering meeting, or to identify potential partners. In all
cases, the role of NCI will be to facilitate but not to direct
activities.
An NCI Program Director will perform normal program stewardship
responsibilities for this award.
3. Collaborative Responsibilities
The Collaborative Responsibilities are based on the premise that the
AP4 is a unit consisting of an AP4 Director, Principal Investigators,
their respective programs, and an NCI Coordinator, which functions as a
unit as specified in this RFA. Foreign institutions may be
participants as potential Center members but not as the awardee
institution, and their scientists may not serve as the AP4 Director.
A Steering Committee (SC), comprised of the AP4 Director,
representatives from the Center membership, and the NCI Program
Coordinator as voting members, is the governing body of the AP4,
reviews all project status reports and makes go/no go decisions and
recommends new projects. The SC may shift funds from one project to
another, and select candidate molecules for possible clinical
development. The SC is chaired by the AP4 Director.
WHERE TO SEND INQUIRIES
We highly recommend that applicants for an AP4 planning grant review
the requirements for the AP4 Center application found at
http://dtp.nci.nih.gov/docs/ap4/ap4-index.jsp. We also strongly
encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants and their potential
partners. 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:
Jill Johnson
Developmental Therapeutics Program, DCTD
National Cancer Institute
Building EPN, Room 8020
Bethesda, MD 20892
Telephone: (301) 496-8720
FAX: (301) 402-0831
Email: johnsoji@mail.nih.gov
o Direct your questions about peer review issues to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
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. Kelli Oster
Grants Administration Branch
Office of Management, OD, NCI
Executive Plaza South - Room 243
6120 Executive Boulevard
Bethesda, Maryland 20892
Telephone: (301) 496-8627
Fax: (301) 496-8601
E-mail: osterk@gab.nci.nih.gov
LETTERS 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 AP4 Director
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 by the date listed at the beginning
of this document. The letter of intent should be sent to:
Jill Johnson
Developmental Therapeutics Program, DCTD
National Cancer Institute
Building EPN, Room 8020
Bethesda, MD 20892
Telephone: (301) 496-8720
FAX: (301) 402-0831
Email: johnsoji@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level
of budgetary detail. Applicants request direct costs in $25,000
modules. Section C of the research grant application instructions for
the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
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 use
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/label-bk.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)
At the time of submission, two additional copies of the application
must be sent to:
Referral Officer
National Cancer Institute
6116 Executive Blvd, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
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 change in practice is effective immediately. 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 date 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. While the investigator may
still benefit from the previous review, the RFA application is not to
state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NCI. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.
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 applications will:
o Receive a written critique
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
REVIEW CRITERIA
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 discuss the
following aspects of the application in order to judge the likelihood
that the proposed plan will have a substantial impact on the pursuit of
these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning the application's overall score, weighting them
as appropriate for each application. 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.
SIGNIFICANCE: Does the application demonstrate the ability to plan and
organize an AP4 Center within the one-year planning period? Does the
application propose new partnerships and/or significant expansion of
existing partnerships? Do the sample proposed projects address one or
more orphan malignancies as defined in this RFA?
APPROACH: Are the proposed strategies for the planning year, including
the potential partners meeting, appropriate and adequately developed
for establishing new partnerships and/or significantly expanding
existing ones? Are the proposed processes and criteria for organizing
the future Center and selecting partners and projects adequate, well
integrated, and appropriate for the orphan cancer diseases(s) to be
addressed? Do letters of interest from potential AP4 Center members
support the priorities and objectives of the proposed planning process?
Are the proposed methods for securing resources (space, budget,
staffing) for the future Center adequate?
INNOVATION: Does the proposed AP4 Center involve novel concepts,
approaches, or methods? Does it involve new partnerships or new
projects for an existing partnership?
INVESTIGATOR: Does the proposed AP4 director have strong scientific
and administrative leadership abilities? Are the roles of other
proposed researchers appropriate to their qualifications and
experience? Are the sample projects appropriate to the experience
level of the AP4 director and other researchers (if any)? Do the
researchers involved in the planning grant represent an appropriate
range of disciplines?
ENVIRONMENT: Does the scientific environment in which the proposed
work will be done contribute to the probability of success? Is there
evidence of strong institutional commitment and support?
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: October 21, 2003
Application Receipt Date: November 20, 2003
Peer Review Date: February 2004
Earliest Anticipated Start Date: June 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
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 PA 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.
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. The NIH Grants Policy Statement 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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