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) 435-0714, 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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