This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED


COOPERATIVE PLANNING GRANT FOR COMPREHENSIVE MINORITY INSTITUTION/CANCER 
CENTER PARTNERSHIP

Release Date:  March 28, 2002

RFA:  CA-03-008

National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

Letter of Intent Receipt Date:  July 17, 2002  
Application Receipt Date:       August 14, 2002  

This RFA is a reissue of RFA-CA-02-007, which was published in the NIH Guide on April 9, 2001.

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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE

The National Cancer Institute (NCI) invites cooperative agreement applications 
(i.e., U56) for the planning and development of Comprehensive Minority 
Institution/Cancer Center Partnerships between Minority-Serving Institutions 
(MSIs) and NCI-designated Cancer Centers (or groups of Centers) in order to 
develop a stronger national cancer program aimed at understanding the reasons 
behind the significant cancer disparities and impact on minority populations.

The lack of significant training opportunities for minority scientists in 
cancer research and the low level of involvement of MSIs in competitive cancer 
research have represented two major obstacles to developing a stronger 
national cancer research effort aimed at understanding the reasons behind the 
significant disparities of cancer impact on minority populations. The NCI has 
created a potentially powerful approach that can help MSIs and Cancer Centers 
integrate and take maximum advantage of their expertise and experience to work 
together in areas that are mutually beneficial.  

This new initiative, the Minority Institution/Cancer Center Partnership 
(MI/CCP) program, offers  two cooperative agreement assistance mechanisms, a 
U56 and a U54.  The Cooperative Planning Grant for Comprehensive Minority 
Institution/Cancer Center Partnership (U56) is to be used by those 
institutions that are in the initial stages of planning for a comprehensive 
partnership.  The Comprehensive Minority Institution/Cancer Center Partnership 
(U54) is to be used by those institutions who have had considerable prior 
planning and evaluation and are ready to begin implementing a more broadly 
focused partnership having inter-institutional cancer research projects and/or 
cancer training and career development, education or outreach programs.  

The sole purpose of the MI/CCP program is to provide support for a various 
collaborative activities that will lead to the submission of specific 
competitive grant applications traditionally supported by the NCI and other 
funding organizations. 

The purpose of this initiative for a (U56) Cooperative Planning Grant for 
Comprehensive Minority Institution/Cancer Center Partnership is to help 
potential partners develop plans and initiate activities that will enable them 
to become competitive for a U54 grant and achieve the following long-term 
objectives: 

1. Build and stabilize the independent, competitive cancer research projects 
and cancer research training and career development programs at MSIs;

2. Create stable, long-term collaborative relationships between MSIs and 
Cancer Centers in the areas of cancer research, cancer training and career 
development, cancer education and/or cancer outreach that increase the 
emphasis on problems and issues relevant to the disproportionate cancer 
incidence and mortality in minority populations; 

3. Improve the effectiveness of the Cancer Center research, training and 
career development, cancer education and cancer outreach activities 
specifically designed to benefit minority populations in the region the Cancer 
Center serves.

OBJECTIVES

Background

Since the War on Cancer was initiated, the disparities in cancer incidence, 
morbidity and mortality in underserved racial and ethnic minorities have 
continued to rise.  For example, the incidence of colon and lung cancers in 
Alaska Native and African-American men and women is higher than that of other 
ethnic groups; five-year survival rates in Native American, African American, 
Hawaiian, and Hispanic Americans are lower than those of Japanese and White 
Americans; and patterns of prostate cancer among African American males 
compared with White males, seen in the Southeastern U.S., particularly in 
rural areas still remain higher http://www.nci.nih.gov/atlasplus/.  Clearly, 
more research is needed that specifically addresses these and other 
disparities if they are to be eliminated by 2010 (Presidents Initiative on 
Race and Health Disparities).

Minority-Serving Institutions conduct high quality programs for educating 
minorities and they represent a rich source of talent with appropriate 
cultural sensitivity and perspectives needed in cancer research. However, they 
have had difficulties developing and sustaining independent programs in 
biomedical research, and there is a paucity of minority scientists who are 
pursuing successful biomedical research careers.  Despite various initiatives, 
progress in realizing a significant increase in the number of minority 
scientists who are competitive for NIH research grants has been slow.  More 
specifically, there remains a serious shortage of well-trained minority 
scientists who can conduct independent cancer research, who can focus research 
efforts on the disproportionate burden of cancer in minority populations, and 
whose cultural perspectives are essential to the successful conduct of many 
forms of research involving minority patients and populations.  

The NCI-designated Cancer Centers are geographically dispersed, research 
intensive organizations with well-organized programs for training cancer 
scientists.  They are the only organized units supported by the NCI that 
conduct research; sponsor research training in the basic, clinical and 
population sciences; provide information services; and develop and sustain 
educational and outreach programs that benefit their communities. Yet, the 
progress of Cancer Centers in focusing on research issues of particular 
importance to cancer in minorities, in training minority scientists, in 
reaching out to and partnering with different racial and ethnic minority 
populations in their communities, and in bringing the benefits of cancer 
research to these populations has been slow and often disappointing.

Objectives and Scope

The (U56) Cooperative Planning Grant for Comprehensive Minority 
Institution/Cancer Center Partnership offers four broad areas to target for 
development:

1. Cancer Research: Joint cancer research projects must be the most 
significant component of a U56 Comprehensive Minority Institution/Cancer 
Center Partnership. Joint pilot and full research projects may be in any area 
of basic, clinical, prevention, control, behavioral or population research.  
Research projects conducted primarily at the MSI may be in any area of cancer 
research, but research projects conducted primarily at the Cancer Center must 
specifically address areas of cancer disparity in minority populations. Joint 
cancer research projects at MSIs might focus, for example, on general areas of 
environmental carcinogenesis, molecular epidemiology, and behavioral issues 
related to cancer prevention, treatment and control. The expectation is that 
successful pilot research projects will become full research projects and that 
full research projects will become competitively funded grants (e.g., R03, 
R01; project on a P01; project on a P50). 

2. Cancer Training and Career Development: Cancer training and career 
development programs are highly encouraged and must focus on joint programs 
between MSI and Cancer Center(s) that place an emphasis on the training of 
minority scientists and on educating majority trainees to appreciate the 
issues and problems associated with cancer disparities in minority 
populations.  The NCI particularly encourages training of minority scientists 
in clinical, behavioral and population research; there is a huge deficit of 
minority scientists engaged in these research areas, areas which are highly 
dependent for their success on the cultural sensitivity of the researchers.  
These training programs must represent true collaborations that function 
seamlessly across the institutional boundaries of the MSI and the Cancer 
Center.  For example, new training programs might provide graduate students in 
MSIs the opportunity to fulfill their research requirements in Cancer Center 
laboratories using state-of-the-art equipment and mentoring by Cancer Center 
investigators; or masters programs in an MSI might be linked formally to 
doctoral training programs in Cancer Centers. Clinical research training 
programs at MSIs might also include rotations dealing with minority cultural 
issues for majority trainees and clinical training programs at the Cancer 
Center might offer the use of current methodologies for national and 
international electronic communication on diagnosis and treatment of cancer 
for minority trainees.  Successful activities in this area may lead to the 
submission of a competitive training grant application (e.g. T32, K12, R25T).

3. Cancer Education: Cancer education programs could focus on any effort to 
augment existing or create new curricula in the MSI and/or the Cancer Center 
that would apprise and culturally sensitize graduate and postdoctoral students 
in research, medicine and public health of the need to reduce disproportionate 
cancer burden in minority populations.  A successful effort may result in the 
submission of a competitive NCI education grant application (R25E) and later 
to institutional commitments to make these curricula an inherent component of 
their educational systems.

4. Cancer Outreach: Cancer outreach programs may be defined as proactive 
efforts to help minority communities develop and manage their own culturally 
sensitive programs for educating their populations about cancer risk, early 
detection, screening, prevention, and treatment. MSIs and Cancer Centers would 
be expected to combine their expertise in working with minority leaders and 
organizations in the community to develop outreach programs that effectively 
reach individuals and physicians and that increase the recruitment and 
retention of racial and ethnic minorities into clinical trials and prevention 
protocols.  The U56 MI/CCP could help communities develop activities such as: 
(a) utilizing church networks to reach and educate the citizens of minority 
communities about prevention, early detection and treatment of cancer; (b) 
working with civic organizations to develop programs that encourage life-style 
changes important for cancer prevention and that emphasize the importance of 
early detection and diagnosis; (c) developing continuing education programs 
for community health care providers to ensure that they are providing state-
of-the-art care and advice to their patients; and (d) training communities to 
use and link their communities to the electronic information systems that can 
educate individuals about cancer and help them make informed decisions about 
their health.

MECHANISM OF SUPPORT

This RFA will use NIH U56 award mechanism.  As an applicant you will be solely 
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 (when appropriate).  The anticipated award date is April 1, 
2003. 

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"  

This RFA is a one-time solicitation. If it is determined that there is a 
continuing program need, the NCI will either reissue this RFA for re-
competition or invite recipients of awards under this RFA to submit 
competitive continuation cooperative agreement applications for review. 

The Principal Investigators on behalf of the institutions are responsible for 
the conduct of this activity with strong continuing commitments from the MSI 
and the Cancer Center enabling the success of the partnership.

ALLOWABLE COSTS

The U56 will provide support for:

1. Administrative costs (not to exceed 20% of the total direct costs per year 
per partner) for managing the partnership, such as salaries for key personnel; 
equipment and supplies to support an administrative structure.

2. Planning and Evaluation should be constantly ongoing and the bases for 
initiating and terminating the investment of resources into developmental 
projects, programs, resources and recruitment below.  This may include the 
costs for travel for internal and external activities (key personnel; travel 
and per diem for Program Steering Committee members), workshops, seminars, 
retreats and other forums to strengthen, stabilize and consolidate 
interactions and cooperation in areas of existing high priority; to merge 
existing cancer programs into consolidated collaborations; to identify new 
areas of opportunity and high priority as the partnership evolves; and for 
reviewing pilot projects/programs, recruitments and resources.

3. Developmental costs for:

a. Pilot cancer research projects or pilot cancer training and career 
development, cancer education and/or cancer outreach program (not to exceed 
$100,000 in direct costs per year per project/program of the partnership for 
no more than three years).  These activities cannot be self-contained and must 
have the potential to become long-term efforts.
b. Resources and infrastructure (e.g., tissue resources) that augment the 
cancer research capability of the MSI, the collaborative research of the MSI 
and the Cancer Center, and/or specifically enhance research focused on 
minority issues. Shared infrastructure could be placed in either the MSI or 
the Center or in both locations.
c. Start-up packages for newly recruited investigators in areas prioritized 
for development and stabilization.

FUNDS AVAILABLE

NCI anticipates making up to 12 (six pair) 5-year awards and intends to commit 
approximately $5.0 million (including direct costs and costs for facilities 
and administration) for the initial year's funding of the program.  The 
maximum combined direct cost budget of the MSI and the cancer center together 
is $500,000.  Third party sub-contractual facilities and administration costs 
will not be counted toward the maximum combined direct costs of $500,000.  
Applications exceeding the $500,000 direct costs limit will be considered 
unresponsive to the RFA and will be returned without further consideration. 
Funding in response to this RFA is dependent upon the receipt of a sufficient 
number of meritorious applications. Although this program is provided for in 
the financial plans of NCI, the award of grants pursuant to this RFA is 
contingent upon the anticipated availability of funds for this purpose. Awards 
are not renewable.  The NCI will make a commitment for funding a partnership 
for the full term of the award.  The total project period for applications 
submitted in response to this RFA may not exceed five years.  The anticipated 
award date is April 1, 2003.

ELIGIBLE INSTITUTIONS

Applications will only be accepted from Minority-Serving Institutions (MSIs) 
[e.g., Historically Black Colleges and Universities (HBCUs), Hispanic-Serving 
Institutions (HSIs) and Tribal Institutions (e.g., Colleges)] either in the 
United States or in territories under U.S. jurisdiction, and from institutions 
that are NCI-designated Cancer Centers (or groups of centers) that wish to 
develop comprehensive partnerships. MSIs are defined as those in which 
students of minority groups, who are underrepresented in the biomedical 
sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan 
Natives, Native Hawaiians, Pacific Islanders), comprise a significant 
proportion of the enrollments AND that have a track record of commitment to 
the special encouragement of minority faculty, students and investigators.  
Both MSIs with medical schools and MSIs with more focused education and 
research programs (e.g., Masters and Ph.D. Programs) are invited to 
participate in this initiative.  MSIs that offer only baccalaureate degrees, 
and Tribal Colleges are also invited to participate in this initiative as sub-
contractual partners in Minority Institution/Cancer Center Partnerships. A 
partial list of eligible Minority-Serving Institutions can be found at the 
following website address: http://www.sciencewise.com/.  Other 
institutions that meet MSI qualifications may not be listed on the website but 
they are also eligible to apply.  A list of NCI-designated Cancer Centers can 
be found at the following website address: 
http://www.nci.nih.gov/cancercenters/.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

The Principal Investigators must be U.S. citizens, non-citizen alien 
nationals, or permanent residents of the United States.

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

There are a number of Special Requirements and Provisions that each 
Cooperative Planning Grant for Comprehensive Minority Institution/Cancer 
Center Partnership must comply with:

1. Each MSI and Cancer Center is limited to applying for no more than ONE 
Comprehensive Minority Institution/Cancer Center Partnership application 
(either a U56 or a U54). 

2. Of the four areas being targeted by this initiative, (i.e., cancer 
research, cancer training and career development, cancer education and cancer 
outreach) cancer research must represent 50 percent or more of the proposed 
activities.

3. There must be written "Letters of Commitment" from the MSI leadership and 
the Cancer Center leadership that are fully supportive of this activity and 
that commit the additional resources necessary to ensure that these 
partnerships will have the maximum chance of success.  Additional resources 
would include protected faculty time (i.e., release time with grant funds), 
provisions for recruitment of new faculty, space and facilities for new 
projects/programs, capital improvements, etc.

4. Each U56 MI/CCP planning activity must be submitted as a clear partnership 
between the MSI and the Cancer Center.  This must be done by submitting two 
separate applications, one from the MSI and one from the Cancer Center.  The 
Principal Investigator of the MSI grant application must be the Co-
Investigator of the Cancer Center grant application and vice versa.  The 
overall priorities and objectives for implementation of the two applications 
must be the same, but the actual activities and budgets of the two 
applications should demonstrate how the MSI and the Cancer Center requests 
both differ and complement each other in achieving these priorities and 
objectives. 

5. The two planning applications must not only complement each other, but 
clearly outline the mutual benefits to be gained by the MSI and the Cancer 
Center as a result of the partnership.  For example, both the MSI and Cancer 
Center benefit from a broader range of resources and approaches than are 
available at any one institution, however, the MSI will be exposed to state-
of-the-art technology and have greater access to information services while 
the Cancer Center benefits by having a greater diversity of students, faculty 
and researchers participating in cancer related activities and more access to 
minority patients for clinical protocols.

6. The direct costs of the two applications together cannot exceed $500,000 
per year.  If there is a third party subcontract, only the direct costs of the 
subcontract will count against this cap.

7. No more than 20% of the total direct costs of the partnership can be used 
for Administrative Core expenses.

8. There must be a common Planning and Evaluation Core shared between the MSI 
and the Cancer Center(s) proposals with:  

a. Internal Processes for workshops and other forums to identify areas of 
new opportunity as well as for strengthening, stabilizing and merging existing 
projects/programs.  Internal processes must also have an evaluation and 
prioritization process in place for reviewing internal proposals for Pilot 
projects/programs, recruitment of research associates, new investigators and 
establishment of resources and infrastructure on the basis of their merit and 
potential to contribute effectively to achieving high priority goals and 
objectives.
b. External Processes, in which a Program Steering Committee evaluates 
overall progress on an annual basis, make recommendations for establishing 
priorities, changing direction and identifying areas of new opportunity to 
accomplish mutual objectives more successfully.  The evaluation and 
recommendations must be in the form of a written report and must be included 
as part of the Non-Competing Continuation Application submitted to the NCI 
each year.

The rationale for using Developmental Core funds would have to be based on 
these planning and evaluation processes.

9. In using Developmental Core funds to support pilot projects/programs, each 
activity must be co-lead by individuals from both the MSI and the Cancer 
Center.  No pilot project/program of the partnership can exceed $100,000 in 
direct costs per year or continue for more than three years.  Third party 
facilities and administrative costs may be requested in addition to the direct 
costs requested.

10. Any new project/program and shared resources for development must be 
totally new activities that do not overlap in purpose or intent with existing 
grants and shared resources (e.g. P30; P50; National Center for Research 
Resources' Infrastructure Grants, National Institute of General Medical 
Sciences Minority Biomedical Research Support Grants or any other peer-
reviewed funded programs).  Resources should augment the research capability 
of the MSI, the collaborative research between the MSI and the Cancer Center, 
and/or specifically support and enhance research focused on minority issues.  
Resources can augment existing Cancer Center resources, or they can be 
entirely new resources, as long as they are tailored to the common objectives 
and priorities of the partnership.  Resources can be located either at the MSI 
or the Cancer Center or divided but shared between the MSI and the Cancer 
Center.

11. All recipients of U56 MI/CCP awards will be required to participate in an 
annual MI/CCP workshop sponsored by the Comprehensive Minority Biomedical 
Branch of the NCI for the purpose of sharing information and strategies.  
Travel expenses for this purpose must be included in the grant applications 
for the MSI and the Cancer Center.

12. If the application includes participation of Native America (American 
Indian) or similar populations, a formal letter of support for the study from 
the Tribal Nation Leader or equivalent authority must be included.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD

Cooperative agreements are assistance mechanisms and are subject to the same 
administrative requirements as grants.  The following Terms and Conditions of 
Award are in addition to, and not in lieu of, otherwise applicable OMB 
administrative guidelines, HHS grant administration regulations in 45 CFR Part 
74 and 92 and administered under the NIH Grants Policy Statement. 

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(s) for the project as a whole, although 
specific tasks and activities in carrying out the studies will be shared among 
the awardees and the NCI Program Coordinator. These are summarized below:

1.  AWARDEE RIGHTS AND RESPONSIBILITIES 

a. Awardees will have primary responsibility for the project as a whole, 
including research design and conduct, data collection, data quality control, 
data analysis and interpretation and preparation of publications, as well as 
collaborations with other awardees. Awardees will retain primary rights to the 
data developed under these awards, subject to government rights of access 
consistent with current HHS, PHS, and NIH policies.  However, awardees must be 
committed to making the research tools and research materials they develop 
available to the cancer research community.
b. Awardees agree to follow the advice and recommendations of the Program 
Steering Committee, whenever possible, in meeting the intent of this 
initiative.
c. Each partnership should plan regular meetings (no less than monthly) to 
discuss the progress and direction of its activities and to ensure that the 
necessary interactions are taking place.  For partnerships including members 
from other institutions, plan and extend meetings via teleconferencing, 
videoconferencing or web conferencing (for more frequent meeting), as well as 
face-to-face meetings (semiannually or quarterly) should be described.
d. The Co-Investigators and other designated investigators will attend an 
Annual MI/CCP Workshop for the purpose of sharing information and strategies 
to be organized by NCI staff. In addition, the Co-Investigators will be voting 
members of the Program Steering Committee which meets once year.
e. Each partner will submit annual progress reports (including the PSC 
annual meeting recommendation) to the NCI that describes activities and 
accomplishments during the previous funding period as part of the Non-
Competing Continuation Renewal.
f. Intellectual Property.  Each applicant must provide a detailed 
description of the approach to be used for obtaining patent coverage and for 
licensing where appropriate, in particular where the invention may involve 
investigators from more than one institution. Procedures must be described for 
resolution of legal problems should they arise. Your attention is directed to 
P.L. 96-517 as amended by P.L. 98-620 and 37 CFR Part 401. Instructions were 
also published in the NIH Guide for Grants and Contracts (NIH Guide, Vol. 19, 
No. 23, June 22, 1990). 

All Awardees must adhere to the policy for distribution of unique research 
resources produced with PHS funding, published in the NIH Guide for Grants and 
Contracts (NIH Guide, Vol. 25, No. 23, July 12, 1996). The Guide can be 
accessed electronically at http://grants.nih.gov/grants/guide/index.html. All 
awardees must also adhere to the Principles and Guidelines for Recipients of 
NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical 
Research Resources (64 Federal Register 72090).  The Principles and Guidelines 
can be accessed electronically at: 
http://www.nih.gov/od/ott/RTguide_final.htm. Procedures must be described, 
that address how awardees will approach such distribution/dissemination, 
including acknowledgment of the terms of any related technology licenses or 
sponsored research agreements which Institution may have. Awardees shall 
include the following terms concerning intellectual property rights, or 
provide an alternative plan.  NCI acknowledges that some commercial 
collaborators that are members of applicant partners, or who provide agents to 
applicant partners, may require that Institution agree to grant to them 
certain intellectual property rights, as described by the terms below.  If an 
Institution voluntarily agrees to the described terms, then they should appear 
in the Institution's partner application. NCI recognizes that Institutions' 
ability to access agents from commercial collaborators for this effort may be 
limited absent such a voluntary agreement, or a substantially similar 
independent agreement between Institution and commercial collaborators 
providing agents.  However, in no event will the award of a cooperative 
agreement be dependent upon the described terms' being part of an 
Institution's partner application. Rather, Institution's partner application 
may provide Institution's own plan for accessing agents from commercial 
collaborators. In no event, however, will an award be made absent 
incorporation of either the terms below, or Institution's own plan.

Institution agrees to grant to commercial collaborator: (i) a paid-up 
nonexclusive, nontransferable, royalty-free, world-wide license to all 
Institution Inventions for research purposes only; and (ii) a time-limited 
first option to negotiate an exclusive, world-wide royalty-bearing license for 
all commercial purposes, including the right to sub-license, to all 
Institution Inventions on terms to be negotiated in good faith by the 
collaborator and Institution. The collaborator shall notify Institution, in 
writing, of its interest in obtaining such an exclusive license to any 
Institution Invention within six (6) months of the collaborator's receipt of 
notice of such Institution Invention(s). In the event that a collaborator 
fails to so notify Institution, or elects not to obtain an exclusive license, 
then the collaborator's option shall expire with respect to that Institution 
Invention, and Institution will be free to dispose of its interests in such 
Institution Invention in accordance with Institution's policies. If 
Institution and collaborator fail to reach agreement within ninety (90) days, 
(or such additional period as collaborator and Institution may agree) on the 
terms for an exclusive license for a particular Institution Invention, then 
for a period of six (6) months thereafter Institution shall not offer to 
license the Institution Invention to any third party on materially better 
terms than those last offered to collaborator without first offering such 
terms to collaborator, in which case collaborator shall have a period of 
thirty (30) days in which to accept or reject the offer.

Institution agrees that notwithstanding anything contained herein to the 
contrary, any inventions, discoveries or innovations, whether patentable or 
not, which are not Subject Inventions as defined in 35 USC 201(e), arising out 
of any unauthorized use of the collaborator's agent and/or any modifications 
to the agent, shall be the property of the collaborator (hereinafter 
"Collaborator Inventions"). Institution will promptly notify the collaborator 
in writing of any such Collaborator Inventions and, at collaborator's request 
and expense, Institution will cause to be assigned to collaborator all right, 
title and interest in and to any such collaborator inventions and provide 
collaborator with assignment or other documents). Institution may also be 
conducting other research using the agent under the authority of a separate 
Material transfer Agreement (MTA) with the collaborator. Inventions arising 
thereunder shall be subject to the terms of the MTA, and not to this clause.

g. Protection of Proprietary Data. The ability to publish new results in a 
timely and intellectually unconstrained manner is fundamental to the academic 
enterprise. This need must be balanced with the legitimate requirements of 
commercial collaborators to protect the proprietary or confidential 
information that they provide concerning their proprietary agents. Commercial 
collaborators also may require exclusive access to the raw and primary data 
generated in studies of their agents. Therefore, NCI urges that the following 
statement also be incorporated in Partner applications:

"Raw and primary data may be provided exclusively to the NCI, industrial 
collaborators, and the FDA, as appropriate. This provision shall not affect 
the investigators' right to disseminate their research findings through 
publications or presentations."

2. NCI STAFF RESPONSIBILITIES 

The NCI Program Coordinator will be responsible for normal stewardship of the 
award and may recommend the termination or curtailment of an investigator or 
project/program (or an individual award) in the event the partnerships fail to 
evolve within the intent and purpose of this initiative.  The NCI Program 
Coordinator will also:

a. Serve as full participating and voting member of the Program Steering 
Committee.
b. Work closely with individual investigators and partners to facilitate 
collaborations.
c. Assist the partnership efforts by facilitating access to fiscal and 
intellectual resources provided by NCI, NIH, industry, private foundations and 
federal funding agencies.
d. Ensure that activities proposed for development or implementation do not 
overlap or duplicate activities supported by Cancer Center Support Grants, 
Research Centers at Minority Institutions Infrastructure Grants, Minority 
Biomedical Research Support Grants or other peer reviewed funding mechanisms.
e. Interact with each partner, coordinate approaches between partners, and 
contribute to the adjustment of projects/programs or approaches as warranted.  
f. Provide assistance in reviewing and commenting on all major transitional 
changes of an individual partner's activities prior to implementation to 
assure consistency with the goals of this RFA.
g. Coordinate activities with other ongoing studies supported by NCI to 
avoid duplication of effort and encourage sharing and collaboration in the 
development of new clinically useful agents and methodologies.
h. Coordinate access to other resources from NCI including NCI sponsored 
agents for pre-clinical and clinical testing, assistance in IND filing, etc.
i. Link the approaches developed from these partnerships to each other and 
to other NCI Cancer Centers and NCI-supported networks to ensure that 
information is shared and utilized on the widest basis possible. 
j. Help reprogram efforts within the peer reviewed scope of work, including 
options to modify projects/programs when projects/programs are not making 
headway relative to the time-line for achieving the objectives of the RFA.
k. Assist the Program Steering Committee in the evaluation of new pilot and 
full projects/programs when requested as replacements for ongoing activities.
l. Monitor institutional commitments and resources to ensure that the 
partnership receives the maximum chance of stabilization and success.
m. Recommend the approval of new faculty recruits to ensure that they fall 
within the bounds of the areas prioritized for development and stabilization.
n. Organize and recommend an agenda for an annual workshop that engages all 
of the partnerships and other participants as needed. This meeting will be 
held for all funded investigators to share progress and research insights that 
may benefit all of the projects.
o. Call additional meetings/workshops of the participants to address 
emerging areas of high priority to the NCI and/or the problems of high cancer 
incidence and mortality in minority populations. 

The dominant role and prime responsibility for the activity resides with the 
awardee(s) for the project as a whole, although specific tasks and activities 
in carrying out the projects/programs will be shared among the awardees and 
the NCI Staff.

3. COLLABORATIVE RESPONSIBILITIES OF THE PROGRAM STEERING COMMITTEE 

A Program Steering Committee (PSC) must be composed of the Co-Principal 
Investigators of each partnership, NCI Program Coordinator, and up to six 
external advisors with the scientific expertise necessary to provide 
appropriate advice relative to the objectives of the U56 and for providing the 
most objective advice. The PSC will meet once a year and serve as the primary 
advisory board of the U56 Program and will have the responsibility of making 
recommendations for establishing priorities, changing direction and 
identifying areas of new opportunity based on continuing evaluation.   The 
PSC's recommendations, in the form of a written annual report, are to be 
submitted to the leaders of the MSI and the Cancer Center and the NCI and are 
to be used by the Principal Investigators to guide and direct the development 
of the U56 program.  The Principal Investigators and the NCI Program 
Coordinator will each have one vote.  The chairperson, who will be someone 
other than the Principal Investigators or NCI staff, will be selected by the 
PSC. Subcommittees with additional ad hoc advisors may be established by the 
PSC as necessary in order to meet its planning, priority setting and 
evaluation responsibilities.  Awardees generally will be expected to accept 
and implement the recommendations of the PSC; in those situations where the 
recommendations are not feasible to implement, the Co-Principal Investigators 
must provide a thorough explanation and rationale to the NCI.

4. ARBITRATION 

Any disagreement that may arise on scientific/programmatic matters (within the 
scope of the award), between award recipients and the NCI may be brought to 
arbitration.  An arbitration panel will be composed of three members -- one 
selected by the Program Steering Committee (with the NCI member not voting), a 
second member selected by NCI, and the third member selected by the two prior 
selected members. This special arbitration procedure in no way affects the 
awardee's right to appeal an adverse action that is otherwise appealable in 
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS 
regulation 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:

Sanya A. Springfield, Ph.D.
Chief, CMBB, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 7013
Bethesda, MD 20892-8347
Rockville, MD 20852 (express courier)
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: springfs@mail.nih.gov

Nelson Aguila, D.V.M.
Program Director, CMBB, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 7013
Bethesda, MD 20892-8347
Rockville, MD 20852 (express courier)
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: aguilah@mail.nih.gov

Or

Brian Kimes, Ph.D.
Director, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 7000
Bethesda, MD 20892-8347
Rockville, MD  20852 (express courier)
Telephone: (301) 496-8537
Fax: (301) 402-0181
Email: kimesb@mail.nih.gov

o Direct your questions about financial or grants management matters to:

Ms. Barbara Fisher
Grants Administration Branch
1003 West 7th Street
Suite 300
Frederick, Maryland 21701
Telephone: (301) 846-1015
Fax: (301) 496-8601
Email: fisherb@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:  ncidearefof@mail.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 U56 partnership
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 peer 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:

Sanya A. Springfield, Ph.D.
Chief, CMBB, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 7013
Bethesda, MD 20892-8347
Rockville, MD  20852
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: springfs@mail.nih.gov

PREAPPLICATION TECHNICAL ASSISTANCE WORKSHOP

The NCI strongly encourages all potential applicants to attend a pre-
application Technical Assistance Workshop (TAW) on June 4-5, 2002.  Since this 
is a new concept for the NCI and for the applicant population, it will give 
staff the opportunity to clarify any perceived ambiguities in the RFA and help 
applicants to present their strongest case for support.  If one is unable to 
attend the technical assistance workshop, the results of the workshop can be 
accessed at the Web site http://minorityopportunities.nci.nih.gov. 

In addition, NCI encourages pre-application consultations with individual 
partnerships either as telephone conference calls, videoconference meetings, 
or as face to face meetings.  In order to make these arrangements contact Dr. 
Sanya A. Springfield by email at springfs@mail.nih.gov or by phone at (301) 
496-7344 or Dr. Brian Kimes by email at kimesb@mail.nih.gov or by phone at 
(301) 496-8537.

SUBMITTING THE APPLICATION

The following procedures apply to both the MSI and the Cancer Center 
applications:

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/01).  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. 

SUPPLEMENTAL INSTRUCTIONS

1. Face Page: Use Form Page 1 as instructed in the Form PHS 398 (rev. 5/01).  
On line 1 provide a title that is representative of your partnership.  This 
title should be the same for both the MSI and the Cancer Center institution's 
applications.  For line 2 enter the title "U56 MI/CCP " and the number of this 
RFA, RFA CA-03-008.  Remember to affix the RFA label that comes with the Form 
PHS 398 to the bottom of the Face Page.

2. Description, Performance Sites and Key Personnel:  Use Form Page 2 of the 
Form PHS 398 to list the Principal Investigator first and next the Co-
Principal Investigator for the partnership.  Then list all Key Personnel for 
the Administrative Core, Planning and Evaluation Core, Developmental Core (all 
Pilot projects/programs), and Resources. Follow the instructions provided in 
the Form PHS 398.

3. Table of Contents:  NOTE: The Table of Contents and Research Plan of the 
PHS 398 (rev. 5/01) application are not specifically tailored to the unique 
objectives of the MI/CCP application.  Therefore organize the Table of 
Contents exactly as described below:

Face Page
Description, Performance Sites and Key Personnel
Table of Contents
Detailed Budget for Initial Budget Period:
a. Total Initial Budget for all Cores
b. b. Administrative Core
c. Planning and Evaluation Core
d. Developmental Core
Budget for Entire Proposed Period of Support:
a. Total Entire Budget for all Cores
b. b. Administrative Core
c. Planning and Evaluation Core 
d. Developmental Core
Budgets Pertaining to Consortium/Contractual Arrangements
List of all participating members 
Biographical Sketch(s) and Other Support:
a. Principal Investigator 
b. Co-Principal Investigator 
c. All Key Personnel in alphabetical order
d. Program Steering Committee Members 
Resources
Implementation Plan: (replaces Research Plan in PHS 398 application 
instructions)  
  Special Introduction to Revised Application (if applicable)
a. Background and Objectives
b. "Letter of Commitment" from the MSI or Cancer Center
c. Chronological Review of Planning and Priority-setting Processes
d. Scientific and Administrative Leadership
e. Administrative Core
f. Planning and Evaluation Core:
1) Internal Processes
2) External Processes
g. Development Core:
1) Pilot projects/programs 
2) Resources and infrastructure 
3) Recruitment(s)
h. Human Subjects
i. Vertebrate Animals
j. Literature Cited
k. Consortium/Contractual Arrangements
l. Intellectual Property
Appendix  
Checklist
Personal Data

4. Detailed Budget for Initial Budget Period: Use Form Page 4 of the Form PHS 
398 application kit.  Separately break out the budget into three sections 
using different Page 4s as follows:
a. Total Initial Budget for all Cores
b. Administrative Core: Denote the costs for personnel, supplies, travel 
etc. needed to provide administrative oversight, coordination and cohesion of 
the partnership.
c. Planning and Evaluation Core: Delineate the costs separately for:
    1) Internal processes, e.g., workshops, retreats, committees, seminar 
series, and ad hoc consultants to strengthen, stabilize and merge existing 
programs and the process for evaluating and prioritizing the use of 
developmental funds and the process for deciding which areas using 
developmental funds should be continued or be discontinued.  
    2) External processes should include the Program Steering Committee, 
which must meet once a year and evaluate the progress of the partnership as a 
whole toward accomplishing its objectives and make recommendations for 
changing direction or strategy to accomplish mutual objectives more 
successfully.  External processes could also include special seminar series 
inviting experts to make presentations to partnership participants that relate 
to the objectives of the partnership and then serve as ad hoc advisors in 
areas under development.

d. Developmental Core: Separately delineate the funds being requested for 
all Pilot projects/programs, Resources, Research Associates and Recruitment.  
Remember that individual Pilot projects/programs cannot exceed $100,000 in 
direct costs per year of the partnership.

5. Budget for Entire Proposed Period of Support: Using Form Page 5 of the Form 
PHS 398, break out the total budgets separately for (provide justifications 
for costs in future years only when there are specific items requested in 
future years that exceed standard cost-of-living increases.
a. Total Entire Budget for all Cores 
b. Administration Core
c. Planning and Evaluation Core
d. Developmental Core Funds

6. Budgets Pertaining to Consortium/Contractual Arrangements: Use this 
category if more than one MSI or Cancer Center is being linked in the 
partnership.  In either case, one of the MSIs or Cancer Centers would have to 
serve as the primary grantee and subcontract for the consortia involvement of 
the other MSI or Cancer Center.

7. List all participating faculty/members of the MSI or the Cancer Center 
alphabetically by last name.  Include for each their degree, department 
affiliation or equivalent, and research or other interest (e.g., research 
area, training, education, or outreach).

8. Biographical Sketches and Other Support. Use Biographical Sketch Format 
Page and follow the instructions in the Form PHS 398 application kit for:
a. Principal Investigator
b. Co-Principal Investigator
c. Key Professional Personnel of the MSI or Cancer Center.  This section 
should include all professional individuals who serve in middle leadership 
roles.  The biographical sketches of those Co-Leaders of Pilot 
projects/programs and resources, as well as any named individuals who are 
going to be recruited, should be provided in the appropriate sections of this 
application.
d. Program Steering Committee Members

9. Resources: Using Resources Format Page, follow the instructions in the 
Form PHS 398 application kit.

10. Implementation Plan 

The Research Plan of the PHS 398 (rev. 5/01) application is not specifically 
tailored to the unique objectives of the MI/CCP application.   Therefore, 
applicants should follow the outline below:

Special Introduction for Revised Applications(if applicable): 

This section should be the same for both the MSI and Cancer Center U56 
applications and limited to three pages.  Include a summary of the additions, 
deletions, and changes in the revised application, placing particular emphasis 
on responses to the criticisms and issues raised in the previous summary 
statement. Include a chronological description of activities since the 
original submission (meetings, research activities, etc.). The changes in the 
full text must be clearly marked by appropriate bracketing, indenting, or 
changing the type setting, unless the changes are so extensive as to include 
most of the text. 

A. Background and Objectives:

This section should be the same for both the MSI and the Cancer Center U56 
applications and limited to two to three pages.  It should (1) discuss the 
general rationale and the mutual benefits that the MSI and the Cancer Center 
expect to derive from the partnership and the ways in which the MSI and the 
Cancer Center believe they can help each other develop stronger cancer 
programs, (2) clearly outline the immediate priorities of the partnership 
derived from a careful planning process that relates to mutual benefits, (3) 
present focused objectives in the areas of cancer research, cancer training 
and career development, cancer education and/or cancer outreach that the 
partnership believes can be achieved during the grant period for each 
priority, (4) present a projected time-line for achieving each objective and 
(5) discuss other areas of opportunity that the partnership will consider as 
the relationship between the partners evolves.

B. Letter of Commitment:

This section should be different for the MSI and the Cancer Center application 
and limited to two to three pages.  The MSI institutional leadership (e.g., 
Dean, President) and the Cancer Center leadership (e.g., Center Director, 
Dean), repectively, should include a detailed statement of their long-term 
commitment by noting the specific resources that will be dedicated to the 
priorities of this partnership as outlined in the Background and Objectives 
section above. These resources could be in the form of protected time for 
faculty to participate in and focus on the objectives of this grant, faculty 
appointments that will be made available in those areas where recruitment will 
be needed, space that will be dedicated to this effort, discretionary 
resources that will be made available to the Principal and Co-Investigators 
and purchase of sophisticated equipment for critical infrastructure needs.  
The letter should clearly explain how the MSI and the Cancer Center leadership 
would be responsible and accountable for following the progress of this effort 
and doing what is needed to sustain it.

C. Chronological Review of the Prior Planning and Priority-setting Processes:

This section should be the same for both the MSI and Cancer Center 
applications and limited to five pages.  It should provide a clear indication 
that this partnership was derived from careful planning and priority-setting 
processes based on each partner's strengths and weaknesses and potential to 
complement each other and help each other become stronger in areas of 
opportunity.

In chronological order present each process used in planning for and setting 
the priorities and objectives for this application.  Briefly describe the 
nature of each planning activity (e.g., meetings of higher institutional 
officials, planning committees, steering committees in areas of opportunity, 
workshops of MSI faculty and Cancer Center members, retreats of MSI faculty 
and Cancer Center members), its purpose, the individuals that participated 
from the MSI and the Cancer Center, and its outcome. 

D. Scientific and Administrative Leadership:

This section should be different for each application and limited to two to 
three pages.  Briefly describe how the Principal Investigator was chosen in 
terms of the qualifications and experience to provide leadership and cohesion 
for this effort and to promote collaboration and cooperation in achieving the 
common objectives as outlined in the Background and Objectives section above.  
Also, if there are other mid-level leaders who will play a significant role in 
determining the success of this partnership, provide the same information for 
them.

E. Administrative Core:

This section should be different for each application and limited to ten 
pages.  Describe the leadership and specific functions of the administrative 
core to provide the necessary day-to-day oversight, coordination, support, and 
logistical services needed to make this partnership function effectively. This 
might include organizing meetings, workshops, and retreats; documenting the 
results of activities; providing critical secretarial services, etc.

F. Planning and Evaluation Core 

This section must be the same for each application and limited to five pages.

1. Internal Processes: Document each internal planning and evaluation activity 
(e.g., regular forums and seminars, workshops, retreats etc.) in which the 
objectives (or issues to be addressed) are identified, activities described, 
and participating individuals from the MSI and the Cancer Center.  (Face-to-
face informal meetings between collaborators have been found to be the most 
effective method of communication.  In instances where there is a problem of 
distance between partners, applicants are encouraged to consider other methods 
of communication including e-mail, teleconferences, and videoconferences). 
This should include how the progress of the partnership will be reported to 
institutional leaders and must include a review and evaluation process for 
initiating and closing all pilot and full projects and programs based on their 
merit and potential for achieving the objectives of the partnership and their 
actual progress.  This process must also be used to determine which resources 
and infrastructure needs of the partnership will be established and which 
kinds of recruitment of faculty will be implemented.

2. External Processes: Program Steering Committee:

Excluding the Co-Principal Investigators and the NCI Program Coordinator, 
describe how each Program Steering Committee member was chosen to provide 
unbiased, rigorous, expert evaluation of progress, to provide recommendations 
for improvement based on the objectives and priorities of the implementation 
plan of the partnership and to provide insights and advice for taking 
advantage of new objectives and initiatives as they emerge during the course 
of the grant period.

NOTE: THE USE OF DEVELOPMENTAL FUNDS IN PART G BELOW IS INTENDED TO BE VERY 
FLEXIBLE AND RESPONSIVE TO THE PLANNING AND PRIORITY SETTING ACTIVITIES OF THE 
MSI AND THE CANCER CENTER DURING THE COURSE OF THE GRANT

G. Developmental Core

This section should be different for each application.

1. Pilot Projects/Programs: 

Pilot Projects/Programs proposed for funding, which cannot exceed $100,000 per 
project/program in direct costs per year of the partnership or continue for 
longer than three years, should be provided in the following format:

Title
Names of the Co-Leaders from the MSI and the Cancer Center
One paragraph abstract stating the objectives of the project/program
Specific Aims
One paragraph describing how this pilot project/program relates to the overall 
priorities
Detailed budget page for initial budget period using Form Page 4 of the Form 
PHS 398.
Budget for entire proposed period of support using Form Page 5 from the Form 
PHS 398 
Proposal (up to five pages), include experimental methods and design, and any 
preliminary data if available indicating the role played by the MSI and the 
Cancer Center investigators in the collection of data.
Describe which aspects of the pilot project/program will be conducted at the 
MSI/Cancer Center
Human Subjects**
Vertebrate Animals
Literature Cited
Consortium/Contractual 
Consultants

**NOTE:  (1) All NIH-supported biomedical or behavioral research projects 
involving human subjects must consider appropriate inclusion of Gender and 
Minorities and Children as noted on pages 17 - 27 the Form PHS 398 
instructions; (2) Research dealing with Human Subjects and Vertebrate Animals 
must be accompanied by appropriate documentation as described on page 27 of 
the Form PHS 398 instructions; (3) Research components involving clinical 
trials must include provisions for rigorous data management, quality 
assurance, and auditing procedures.  Funds should be budgeted for these 
activities and should be justified.  The proposed provisions should not 
duplicate review and monitoring systems already in place at the institution.  
For any cancer treatment protocol supported directly or indirectly by the U56, 
informed consent forms, early stopping rules and procedures to detect and 
monitor adverse drug reactions (ADR) must be provided in the application, or 
in the case of protocols subsequent to funding of a U56, to the NCI Program 
Coordinator.

2. Resources/Infrastructure:

Resources and Infrastructure needs (e.g., minority tissue resource, minority 
patient accrual core, clinical research management core) of the partnership 
should be presented in the following format:

Title
Co-Leaders from the MSI and Cancer Center who lead the activity
The experience of key technical personnel, if applicable, who will be 
responsible for the day-to-day operation.
Detailed budget for the initial budget period using Form Page 4 from the Form 
PHS 398
Budget for entire proposed period of support using Form Page 5 from the Form 
PHS 398
Biographical Sketches of Co-Leaders
Description of the resource/infrastructure and how it will further the 
priorities
Commitment of space for the resource(s).
Justification for the location of the resource(s) at the MSI, the Cancer 
Center or both.

3. Recruitment to be supported with Developmental Funds:

Individuals who are known: 

Provide the biographical sketch of the individual.
Describe how the individual fulfills the priorities and objectives of the 
partnership as described in the Background and Objectives section above.
Describe the nature of the position that provides the necessary stability 
(e.g., tenure track) and resources (e.g., space) to promote success.
Identify a mentor and describe a career development plan if the individual is 
a less experienced investigator
Describe the location of the individual at the MSI or the Cancer Center and 
how this location will best achieve the needs of the partnership.

Individuals who are planned for:

Describe the number and expertise of the individuals that the partnership 
plans to recruit over the five-year period of this grant in order to 
strengthen its capabilities (e.g., epidemiology, prostate cancer, breast 
cancer, behavioral research, outcomes research, community outreach, molecular 
genetics) in those areas needed to fulfill its priorities and objectives.

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:  A cover letter must be attached to the 
application clearly defining the MSI or Cancer Center partner and the Co-
Principal Investigator; this will allow the NCI to assemble the two 
applications as one package for peer review.  Submit signed, typewritten 
originals of the cover letters, MSI application and the Cancer Center 
application with their checklists, and three signed photocopies to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040
MSC 7710
Bethesda, MD 20892-7710 or
Bethesda, MD 20817-7710 (for express/courier service)

At the time of submission, two additional copies of the applications must be 
sent to:  

NCI Referral Officer
Division of Extramural Activities
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/notices-
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 by the application receipt date listed in the 
heading of this RFA.  If an application is received after the date, it will be 
returned to the applicant without review.

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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the Center for 
Scientific Review and responsiveness to ELIGIBILITY REQUIREMENTS and 
responsiveness to the SPECIAL REQUIREMENTS AND PROVISIONS OF COOPERATIVE 
PLANNING GRANT FOR COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER 
PARTNERSHIP 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.  The initial review will 
first evaluate the applications for meeting the criteria in the General 
Features below.  Those applications that meet the criteria in the General 
Features (intent of the RFA) will be further evaluated for scientific and 
technical merit in accordance with the other 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
o Those that receive a priority score will undergo a second level review by 
the National Cancer Advisory Board.

The application from the MSI and the application from the Cancer Center will 
be reviewed together as ONE partnership.

REVIEW CRITERIA:

This initiative is quite broad in scope and may include objectives ranging 
from cancer research to cancer training, to cancer education to cancer 
outreach.  Under these circumstances, the review criteria are not organized 
under the traditional headings of Significance, Approach, Environment, 
Investigator and Innovation typically used for NIH research grants.  Reviewers 
will have to use considerable flexibility in determining the merit of a broad 
range of possibilities that can strengthen the research capabilities of 
minority institutions, expand training and career development opportunities 
for minority scientists and increase the effectiveness of cancer centers in 
developing programs with the potential to reduce disproportionate cancer 
incidence and mortality in minority populations. 

INDIVIDUAL SUBCOMPONENTS:

(1) SCIENTIFIC AND ADMINISTRATIVE LEADERSHIP:

a. The adequacy of the qualifications and experience of the Co-
Investigators and other key personnel from the MSI and the Cancer Center to 
provide strong programmatic (e.g., scientific) and administrative leadership.  
b. b. If applicable, the adequacy of the qualifications and experience of 
other key personnel in both the MSI and the Cancer Center to successfully plan 
for and achieve the objectives of the implementation plan of the partnership.

(2) LETTERS OF COMMITMENT FROM THE LEADERSHIP OF THE MSI AND THE CANCER 
CENTER:

a. The degree to which the letters of commitment from the leadership of the 
MSI and the Cancer Center address and fully support the priorities and 
objectives of the implementation plan of the partnership. 
b. The level of authority of officials committing to this joint effort at 
the MSI and the Cancer Center that gives confidence that these commitments 
will be stable and long-lasting.  
c. Adequacy of the plans to remain responsible and accountable for 
monitoring and sustaining the priorities and objectives of this partnership. 
d. The adequacy of the resources (e.g., discretionary resources, space, 
faculty positions, protected time for research, etc.) that the MSI and the 
Cancer Center will provide to promote the successful achievement of the 
priorities and objectives of this partnership.

(3) ADMINISTRATIVE CORE:

a. The quality of an appropriate organizational and administrative 
structure for effective attainment of U56 priorities and objectives that 
considers arrangements for internal quality control of ongoing activities, the 
allocation of funds, day-to-day oversight and management, support and 
logistical services, contractual agreements, (if applicable), and internal 
communication among investigators.  
b. The qualifications, experience and time commitment of Co-Investigators 
and key personnel in the services provided by the administrative core unit.
c. The appropriateness of the use of the administrative core services by 
the budgeted activities and projects/programs.

(4) PLANNING AND EVALUATION CORE:

a. The adequacy of the design and quality of each of the internal planning 
and evaluation processes proposed to achieve the objectives and priorities of 
the implementation plan.
b. The adequacy of the review and evaluation process and criteria for 
initiating and closing pilot projects/programs based on their merit and 
potential for achieving the objectives of the partnership and on their actual 
progress. 
c. The appropriateness and adequacy of the specific faculty and others 
identified who will participate together in each aspect of the planning and 
evaluation effort.  
d. The adequacy of the qualifications and experience of each proposed 
member of the Program Steering Committee to evaluate and monitor the progress 
of the partnership in achieving its priorities and objectives, to recommend 
mid-course changes in approaches and tactics, and to help the partnership 
evaluate and take advantage of new opportunities.  
e. If applicable, the appropriateness and adequacy of the process and 
criteria for identifying and implementing the resource and infrastructure 
needs of the partnership, and the appropriateness and strategic adequacy of 
the actual and proposed recruitment over the five-year period of the grant to 
strengthen the partnership's capabilities in areas of high priority for 
implementation.
f. The adequacy of the experience and qualifications of the individuals who 
take part in evaluating specific proposals (e.g., pilot projects, pilot 
programs, recruitment) for using Developmental funds.  

(5) DEVELOPMENTAL CORE:

a. Evaluation Criteria for Pilot Projects/Programs:

1) The qualifications of the Co-Leaders from the MSI and the Cancer 
Center to develop the proposed project/program.
2) The merit of the proposed Pilot Project/Program, and the degree to 
which it contributes to the priorities and objectives of the partnership.
3) Potential to develop into a Full project/program in three years or 
less.  

The options will be either to score and recommend support at the recommended 
budget levels or to Not Recommend for Further Consideration (NRFC) because it 
has either: (1) low merit; (2) low relevance to the objectives of the 
partnership; (3) low potential to develop into a Full project/program in a U54 
application; and/or (4) low potential to become funded through competitive 
peer review.

b. Evaluation Criteria for Resources/Infrastructure: (if applicable)

1) The degree to which the proposed resource/infrastructure proposed will 
contribute to the overall priorities and objectives of the implementation 
plan.  
2) The degree to which the proposed resource/infrastructure will provide 
long-term stability to the activities of the partnership supported by current 
pilot and full projects/programs and potential future funded grants.  
3) The qualifications of key personnel to operate the proposed 
resource/infrastructure activity, and the merit of the resource as proposed.   

The options will be either to score and recommend support at the recommended 
budget levels or to recommend support with specific modifications in the 
operation of the resources or to Not Recommend for Further Consider (NRFC) 
because it has either: (1) low merit; and/or (2) low relevance to the 
objectives of the partnership.

c. Evaluation Criteria for Recruitment: (if applicable)

1) The quality of each specific individual recruitment proposed relative 
to background and ability of the individual to contribute substantially to 
strengthening areas of high priority to the implementation plan.  
2) The quality of plans to recruit individuals with the kinds of 
qualifications that will satisfy the most important strategic needs in 
strengthening the future capability of the partnership to fulfill its 
priorities and objectives.

(6) EVALUATION OF PROGRESS BY THE PROGRAM STEERING COMMITTEE:

a. The adequacy of the plan for using the Program Steering Committee 
effectively.

(7) INTELLECTUAL PROPERTY: (if applicable)

a. The adequacy of the intellectual property plan (if applicable), 
including provision for sharing of research tools/materials, and the accession 
of agents from commercial collaborators.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  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 included in the 
section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data. (include, if 
appropriate)

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

OTHER REVIEW CRITERIA:

The overall degree of merit for the partnership, as reflected by one priority 
score that will be assigned to the MSI and the Cancer Center applications, 
will be determined considering the following:

1. The quality of the seven individual sub-components, additional and other 
review criteria as proposed in the MSI and Cancer Center U56 applications; 
and.

2. The extent to which the MSI and the Cancer Center applications together 
satisfy the following General Features above (i.e., overall intent of this 
initiative):

GENERAL FEATURES:

1. Have the MSI and the Cancer Center established priorities and objectives 
for implementation after a careful and thorough planning process and have they 
shown that they worked closely together in the preparation of these 
applications?

2. Have the MSI and the Cancer Center clearly identified the mutual benefits 
to be gained from this partnership?

3. Can the applicants achieve the priorities and objectives for this 
partnership within the five-year grant period?

4. If fully successful, will the implementation plan result in a stable cancer 
research capability for the MSI and/or result in the significant, successful 
training of more minority cancer researchers?

5. If fully successful, will the ability of the Cancer Center be enhanced 
through research and/or training and career development and education and/or 
outreach to more directly and successfully address the disproportionate cancer 
burden in minority populations?.

RECEIPT AND REVIEW SCHEDULE

Preapplication Technical Assistance Workshop Date:    June 4-5, 2002 
Letter of Intent Receipt Date:                        July 17, 2002
Application Receipt Date:                             August 14, 2002
Peer Review:                                          November/December, 2002
Review by NCAB:                                       February, 2003
Earliest Anticipated Award Date:                      April 1, 2003

NON-COMPETING CONTINUATION APPLICATION

For those applications that are funded, the NCI will provide special 
instructions for submitting the Non-Competing Application.

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.

The set of two applications from an MSI and a Cancer Center will compete for 
funds with all other partnerships in response to this RFA.

REQUIRED FEDERAL CITATIONS

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

Clinical trials supported or performed by NCI require special considerations.  
The method and degree of monitoring should be commensurate with the degree of 
risk involved in participation and the size and complexity of the clinical 
trial.  Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety 
Monitoring Board (DSMB).  These monitoring activities are distinct from the 
requirement for study review and approval by an Institutional Review Board 
(IRB).  For details about the Policy for the NCI for Data and Safety 
Monitoring of Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  See NIH Guide 
Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II 
Trials" for additional information: http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-00-038.html.  Information concerning essential elements of data 
safety monitoring plans for clinical trials funded by the NCI is available:  
http://www.cancer.gov/clinical_trials/

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS:  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 AMENDMENT "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
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 in now 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://grants.nih.gov/grants/stem_cells.htm 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 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.

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 No. 93.398, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and 
administered under NIH grants policies described at: 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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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