COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIP

Release Date:  April 25, 2000

RFA:  CA-01-002

National Cancer Institute
Office of Research on Minority Health

Letter of Intent:          June 8, 2000
Application Receipt Date:  July 26, 2000

PURPOSE

The National Cancer Institute (NCI) and the NIH Office of Research on 
Minority Health (ORMH) invite cooperative agreement applications (i.e., U54s) 
for the establishment of Comprehensive Minority Institution/Cancer Center 
Partnerships (CMI/CCP) between Minority-Serving Institutions (MSIs) and 
NCI-designated Cancer Centers. 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. The long-range goals 
of the partnerships are to increase the cancer research capabilities at the 
MSIs; to increase the number of minority scientists engaged in cancer 
research and other related cancer activities; and to improve the 
effectiveness of NCI-designated Cancer Centers in developing and sustaining 
activities focused on the disproportionate incidence, mortality and morbidity 
in minority populations in the region the cancer center serves. To achieve 
these goals, CMI/CCP activities are expected to lead to the development of 
long-term comprehensive partnerships that will strengthen competitive cancer 
research, research training and career development, education and outreach 
capabilities at MSIs and in Cancer Centers. 

The purpose of this request for application (RFA) is to solicit cooperative 
agreements (U54s) that would implement comprehensive partnerships between 
MSIs and NCI-designated Cancer Centers (or groups of centers) that will 
achieve goals that are of clear mutual benefit.  The comprehensive 
partnership must be predominantly focused on cancer research and one or more 
of the following target areas: cancer research training and career 
development, education or outreach programs to minority communities. The 
partnership application must be based on extensive planning and priority 
setting activities, whether supported by a CMI/CCP U20 cooperative planning 
grant or not.  CMI/CCP U54 applicants are expected to achieve the following 
objectives in whole or in part: 			

1. Build and stabilize the independent and collaborative, competitive 
research and research training projects and programs at MSIs;
2. Create stable, long-term collaborative relationships between MSIs and 
NCI-designated Cancer Centers (or groups of centers) in the areas of cancer 
research, research training and career development, education and/or 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 Cancer Center research, education and 
outreach activities specifically designed to benefit racial and/or ethnic 
minority populations in the region the Cancer Center serves;
4. Export successful approaches in addressing disproportionate cancer 
incidence and mortality rates in minority populations to other NCI Cancer 
centers, as well as to other key networks supported by the NCI (e.g., Cancer 
Genetics Network, Clinical Cooperative Groups, Early Detection Research 
Network, and the Special Populations Network). 

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, Comprehensive 
Minority Institution/Cancer Center Partnership, is related to the priority 
area of cancer.  Potential applicants may obtain a copy of "Healthy People 
2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications will only be accepted from MSIs, 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. Minority-Serving Institutions are 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.  A 
list of the eligible Minority-Serving Institutions can be found at the 
following website address: http://www.sciencewise.com/.  A list of 
NCI-designated Cancer Centers can be found at the following website address: 
http://www.nci.nih.gov/cancercenters/ 

Each partnership must be submitted as two applications, one from the MSI and 
one from the Cancer Center (or group of Cancer Centers), but with separate, 
complementary budgets to achieve priorities, common goals and objectives.  
Each Principal Investigator must be listed as a Co-Investigator on the 
complementary application (See below for further instructions).  Each 
applicant should specify the Co-Investigator and partnering institution in a 
cover letter.

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

Each MSI and Cancer Center is limited to participate in no more than ONE 
Comprehensive Minority/Institution Cancer Center Partnership (U54) 
application. 

MECHANISM OF SUPPORT 

This RFA will use the National Institutes of Health (NIH) cooperative 
specialized center (U54) award mechanism.  The U54 mechanism may support any 
part of a full range of research development from very basic to clinical.  
The U54 is a cooperative agreement, an assistance mechanism (rather than an 
acquisition mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during the 
performance of the activities. Under a cooperative agreement, the NIH's 
purpose is to support and stimulate the recipient's activities by involvement 
in and otherwise working jointly with the award recipient in a partner role. 
NCI/ORMH staff will work cooperatively with the award recipients in a partner 
role and do not assume direction, prime responsibility, or a dominant role in 
the activity. Details of the responsibilities, relationships, and governance 
of the activities to be funded under the cooperative agreements awarded for 
this Program are discussed below under "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.  If 
the NCI does not continue the program, awardees will be able to submit grant 
applications through existing investigator-initiated grant programs. 

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 U54 will provide support for:

1. An Administrative Core activity (not to exceed 20% of the total direct 
costs) for
a. Salaries of key personnel
b. Equipment and supplies to support an administrative structure
2. Planning and Evaluation Core activities that may include the costs for 
a. Travel for key personnel
b. Travel and per diem for Program Steering Committee members
c. Workshops, seminars, retreats and other forums to strengthen, stabilize 
and consolidate interactions and cooperation between the MSI and the Cancer 
Center in areas of existing high priority; to merge existing cancer programs 
of the MSI and the Cancer Center to consolidate collaborations; and to 
identify new areas of opportunity and high priority as the partnership 
evolves.
3. Developmental Core Funds for: 
a. Pilot research projects or pilot programs in research training and career 
development, education and outreach (not to exceed $100,000 in direct costs 
per year per project/program or a duration of three years). 
b. Up to three Full Projects/Programs per year in research, research training 
and career development, outreach and education may be funded (not to exceed 
$250,000 in direct costs per year per project/program or a duration of three 
years) in areas prioritized for development and stabilization through 
subsequent competitive funding (e.g., R01, K12, P01, SPORES, T32, R25). One 
of one, one of two, or two of three Full projects/programs must be focused 
primarily on research. The partnership would have the flexibility to 
discontinue projects and start new projects based on the regular evaluation 
of progress; the funding of Full projects/programs through other competitive 
sources; and identification of new opportunities through formalized planning, 
evaluation and priority setting activities. 
c. 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.
d. Support for research assistants and research associates in various stages 
of their career development as independent scientists.
e. Start-up packages for newly recruited investigators in areas prioritized 
for development and stabilization.

FUNDS AVAILABLE

This RFA is a one-time solicitation. NCI/ORMH anticipate making two (one 
pair) 5-year awards and plan to set aside an estimated total of $2.5 million 
(including direct costs and costs for facilities and administration) for the 
initial year's funding of the program.  An annual budget in the range of $1 
million - 1.5 million in direct costs is suggested.  Third party 
sub-contractual F & A costs will not be counted toward the maximum combined 
direct costs of $1.5 million. Applications exceeding the $1.5 million in 
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/ORMH, 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/ORMH will make a commitment for funding a partnership for the full 
term of the award.  The anticipated award date is March 1, 2001.

OBJECTIVES

Background:

Twenty-eight years have passed since the War on Cancer was initiated, and 
during this period, the disparities in cancer incidence and mortality in 
underserved racial and ethnic minorities have continued to rise. The 
incidence of large bowel and lung cancers in Alaska Native and African 
American men and women is higher than that of other ethnic groups.  Five-year 
survival rates by selective sites among racial or ethnic groups in the U.S., 
for example in Native American, African American, Hawaiian, and Hispanic 
Americans, are lower than those of Japanese and White Americans.  The cancer 
mortality rates for lung, trachea, bronchus, and pleura for minority males 
and females differ widely when measured by state economic area. Examples of 
geographical differences are seen in a pattern of excessive prostate cancer 
among African American males in the Southeastern U.S., particularly in rural 
areas. High rates of esophageal cancer in the District of Columbia and in the 
Coastal area of South Carolina appear to be related to alcohol consumption, 
tobacco use and dietary deficiencies. More research is needed that 
specifically addresses these disparities if they are to be eliminated.  
Information about cancer incidence and mortality rates in different racial 
and ethnic U.S. populations can be obtained at the following website address: 
http://www.nci.nih.gov/atlas

Minority-Serving Institutions (MSIs) [e.g., Minority Medical Schools, 
Historically Black Colleges and Universities (HBCUs), Hispanic-Serving 
Institutions (HSIs), Tribal Colleges] 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, MSIs 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 by the community and the NIH, 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 incidence and mortality rates 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 engage in extensive outreach and education programs 
designed to reduce cancer incidence and mortality in the communities they 
serve. Cancer centers 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.

The low level of involvement of MSIs in cancer research and lack of 
significant training of minority scientists in cancer research represent 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 potentials for identifying and 
training minority students and faculty in areas of cancer research have not 
been fully explored.  One untried and potentially powerful approach for 
addressing these difficult issues is to create collaborations and 
partnerships between MSI's and NCI Cancer Centers that integrate and take 
maximum advantage of their respective expertise and experience.  MSIs and 
Cancer Centers can help each other get better and collaborate in areas that 
neither could do as well alone. 

Through long-term comprehensive partnerships that are mutually beneficial to 
MSIs and NCI-designated Cancer Centers, the objectives of NCI and ORMH are to 
increase the participation of MSIs in the nation's cancer research and 
research training enterprise; to increase the involvement and effectiveness 
of the cancer centers in research and research training relating to 
minorities; and to develop more effective research, outreach and education 
programs that will have an impact on minority populations. 

Within this objective, four broad areas are targeted for development:

1. Cancer Research: Cancer research projects must be the most significant 
component of a Comprehensive Minority Institution Cancer Center Partnership. 
Joint 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 NCI-designated 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 and control.  
2. Cancer Research Training and Career Development: Cancer research training 
and career development programs can be in any of the research areas above but 
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 
incidence and mortality disparities in minority population.  The need to 
train minority scientists in clinical research and population research is a 
recognized deficit in many areas of cancer research 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(s).  For 
example, new research 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 a MSI might be linked formally to 
doctoral training programs in Cancer Centers. Clinical research training 
might also include the use of current methodologies for national and 
international electronic communication on diagnosis and treatment of cancer.
3. Cancer Education: Cancer education programs could focus on any efforts to 
augment existing or create new curricula in the MSI and/or the Cancer Center 
that would apprise and culturally sensitize graduate students and 
postdoctoral students in research, medicine and public health of the need to 
reduce disproportionate cancer incidence and mortality in racial and ethnic 
minority populations.  A successful effort may result in an R25 education 
grant and later to institutional commitments to make these curricula an 
inherent component of their educational systems.
4. Cancer Outreach: Outreach programs may be defined as proactive effort 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 to develop community education 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 MSI Cancer Center Partnership could help communities develop activities 
such as the following: (a) utilize church networks to reach and educate the 
citizens of minority communities about prevention, early detection and 
treatment of cancer; (b) work 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) develop 
continuing education programs for community health care providers to ensure 
that they are providing state-of-the-art care and advice to their patients; 
(d) train communities to use and link these communities to the electronic 
information systems that can educate individuals about cancer and help them 
make informed decisions about their health.
      
SPECIAL REQUIREMENTS AND PROVISIONS OF COMPREHENSIVE MINORITY 
INSTITUTION/CANCER CENTER PARTNERSHIPS (CMI/CCP)

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

1. Each MSI and Cancer Center is limited to participating in no more than ONE 
U54 Comprehensive Minority Institution Cancer Center Partnership application.
2. Of the four areas being targeted by this initiative (i.e., cancer 
research, cancer research training and career development, cancer education 
and outreach), cancer research must be the major component.
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), 
recruitment of new faculty, space and facilities, capital improvements, etc.
4. The CMI/CCP activity must be submitted as a clear partnership between the 
MSI and the Cancer Center.  This must be done by submitting two applications, 
one from the MSI and one from the NCI Cancer Center (or Cancer Centers).  The 
Principal Investigator of the MSI grant must be the Co-Investigator of the 
Center grant and visa 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 grants should demonstrate how the MSI and 
the Cancer Center requests complement each other in achieving these 
priorities and objectives. 
5. The two applications must clearly outline the mutual benefits to be gained 
by the MSI and the Cancer Center (or Centers) as a result of the partnership.
6. The total direct costs of the two applications together cannot exceed $1.5 
million.  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 
devoted to Administrative Core expenses.
8. In using Developmental Funds to support Pilot or Full research projects or 
Pilot or Full programs (research training and career development, education 
or outreach), each activity must be co-led by individuals from both the MSI 
and the Cancer Center.
9. Cancer research training programs must be joint programs designed to 
function seamlessly across institutional boundaries and to share trainees, 
faculty and mentors.
10. Research projects supported by the U54 and primarily conducted at the MSI 
can be any research area relevant to cancer but research primarily conducted 
at the NCI-designated Cancer Center must be focused on cancer disparity in 
minority populations.
11. There must be a common planning and evaluation component shared between 
the MSI and the Cancer Center(s) proposals:  
a. A Program  Steering Committee with NCI/ORMH staff as a voting member(s) 
must meet once-a-year to evaluate progress and make recommendations for mid-
course corrections as needed.  The progress 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.
b. The partnerships must have a process in place for reviewing internal 
proposals for Pilot and Full projects/programs, recruitment of new 
investigators and establishment of infrastructure on the basis of their merit 
and potential to contribute effectively to achieving high priority goals and 
objectives and this process must serve as the basis for distributing 
Developmental Funds.  The rationale for using all Developmental Funds would 
have to be based on careful planning and evaluation activities conducted by 
the U54 CMI/CCP program. The expectation is that successful pilot 
projects/programs will become full projects/programs and that full 
projects/programs will become competitively funded grants (e.g., R01; R25; 
SPORES; T32; P01; K12). No full project/program can exceed $250,000 in direct 
costs or continue for a duration longer than 3 years
c. Other internal planning and evaluation methods for assuring progress of 
the partnership.
12. Any new project/program and shared resources for development must not 
overlap in purpose and intent with existing projects/programs and shared 
resources funded by the NCI Cancer Center Support Grant, National Center for 
Research Resources Infrastructure Grants, National Institute of General 
Medical Sciences Minority Biomedical Research Support Grant 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.
13. All recipients of U54 CMI/CCP Awards will be expected to participate in 
an annual meeting sponsored by the Comprehensive Minority Biomedical Branch 
(CMBB) of the NCI.  Travel for this purpose must be included in the grant 
applications from the both MSI and the Cancer Center institutions.
14. Successful Partnerships are expected to participate in exporting their 
approaches to other NCI Centers and Networks and MSIs.
15. Once a U54 CMI/CCP grant is funded, specific guidelines for Non-Competing 
Renewal applications will be provided to the grantees.
 
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 (U54), 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/ORMH Program staff. 
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 directions of its activities and to insure that the 
necessary interactions are taking place. For partnerships including members 
from other institutions, plans to extend meetings via teleconferencing, 
videoconferencing or web conferencing (for more frequent meetings) 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 Meeting to be organized by NCI staff in Washington D.C.  In addition, 
the Co-Investigators will be voting members of the Program Steering Committee 
which meets once a year.
e. Each partner will submit annual progress reports to the NCI that describe 
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 drawn 
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.ott.nih.gov/policy/rt_guide_final.html. Procedures must be described, 
which 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 

Program staff consists of the NCI Program Director and an additional 
representative from the ORMH. The NCI/ORMH Program staff will have 
substantial scientific-programmatic involvement during conduct of this 
activity, through technical assistance, advice and coordination above and 
beyond normal program stewardship for grants  (which includes evaluating 
progress),  as described below. The NCI/ORMH staff will have substantial 
involvement in identifying new areas of opportunity, recommend making mid-
course corrections on an annual basis and generally ensuring that the U54 
CMI/CCP remains focused on the intent of this initiative.  NCI/ORMH staff 
will be involved in the following ways:
a. Serve as full participating and voting member(s) 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, ORMH, industry, private 
foundations and federal funding agencies. 
d. Ensure that activities proposed for the 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. Will assist the Program Steering Committee in the evaluation of new pilot 
and full projects/programs when requested as replacements for ongoing 
activities.
l. Terminate or curtail 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.
m. Monitor institutional commitments and resources to ensure that the 
partnership receives the maximum chance of stabilization and success.
n. Prior approval of new faculty recruits to ensure that he/she falls within 
the bounds of the areas prioritized for development and stabilization.
o. Organize and make final decisions on the 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.
p. Call additional meetings/workshops of the participants to address emerging 
areas of high priority to the NCI and ORMH and/or the problems of high cancer 
incidence and mortality in minority populations. 

The dominant role and prime responsibility for the activity reside 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/ORMH Staff. 

3.  Collaborative Responsibilities of Program Steering Committee    

A Program Steering Committee (PSC) must be composed of the Co-Principal 
Investigators of each partnership, no more than two NCI/ORMH Program Staff, 
and up to six external advisors with the scientific expertise necessary to 
provide appropriate advice relative to the objectives of the U54 CMI/CCP.  
The Co-Principal Investigators and the six external advisors are responsible 
for providing the most objective advice. The PSC will meet once a year and 
serve as the primary advisory board of the U54 CMI/CCP Program and will have 
the responsibility to make recommendations for establishing priorities, 
changing directions 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 used by the Principal Investigators in guiding and 
directing the development of the U54 CMI/CCP program.  The Principal 
Investigators from the MSI and the Cancer Center and the NCI/ORMH Program 
staff will have one vote.  The chairperson, who will be someone other than 
the Principal Investigators and NCI/ORMH staffs, will be selected by the PSC.  
Subcommittees with additional ad hoc advisors can 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 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/ORMH may be 
brought to arbitration.  An arbitration panel will be composed of three 
members -- one selected by the External Steering Committee (with the NCI/ORMH 
member not voting), a second member selected by NCI/ORMH, 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. 

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 subpopulations must be included in all NIH-supported biomedical 
research projects involving human subjects, unless clear and compelling 
rationale and justification is provided that the 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 research involving human subjects should read the 
"NIH Guidelines for Inclusion of Women and Minorities as subjects in Clinical 
Research", which have been published in the federal register of March 20, 
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contract, Volume 
23, Number 11, March 18, 1994 available on the web at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted and supported by 
the NIH, unless that are clear and compelling scientific and ethical reasons 
not to include them. This policy applies to all initial (Type I) 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

PREAPPLICATION MEETING

The NCI/CMBB and the ORMH strongly encourage all potential applicants to 
attend a pre-application technical assistance workshop (TAW) on May, 12-13, 
2000 in New Orleans, LA.  Since this is an entirely 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://deainfo.nci.nih.gov/cmbs/index.htm. These results will be posted 
by July 1, 2000.

In addition, NCI encourages pre-application consultations with individual 
partnerships either as telephone conference calls 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 at by email at kimesb@mail.nih.gov or by phone at (301) 
496-8537.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit by June 8, 2000, a letter of 
intent (LOI) that includes a descriptive title of the proposed CMI/CCP U54 
partnership, address, and telephone number of the Co-Investigators, the 
identities of other key personnel and participating institutions, and the 
number and title of the RFA in response to which application may be 
submitted. 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 allow NCI staff to estimate the potential review workload 
and plan the review. The letter of intent is to be sent to the program staff 
members listed under INQUIRIES by the letter of intent receipt date.  

APPLICATION PROCEDURES

The following procedures apply to both the MSI application and the NCI Cancer 
Center(s) application:

Applications are to be submitted using the Form PHS 398 (rev. 4/98) using the 
SUPPLEMENTAL INSTRUCTIONS provided below and at 
http://deainfo.nci.nih.gov/cmbs/index.htm on or before July 26, 2000. A Form 
PHS 398 application kit is available at most institutional offices of 
sponsored research and from the Division of Extramural Outreach and 
Information Resources, National Institutes of Health, 6701 Rockledge Drive, 
MSC 7910, Bethesda, MD 20892-7910, Phone: (301) 435-0714; FAX: (301) 
480-0525; Email: grantsinfo@nih.gov.  Forms are also available on the 
following NIH website: 
http://grants.nih.gov/grants/funding/phs398/phs398.html

NOTE:  The RFA label available in the PHS 398 (rev. 4/98) application form 
must be affixed to the bottom of the face page of the application and title 
"U54 CMI/CCP" must be typed on line 2 of the face page of the application 
form and the YES box must be marked.  Type the RFA number on the label.   
Failure to do so could result in delayed processing of the application such 
that it may not reach the review committee in time for the review.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change. Please note this is in pdf format.

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

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8062
MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)

As noted above the instructions for the Form PHS 398 do not entirely apply to 
the submission of a U54 CMI/CCP grant application.  Accordingly, NCI strongly 
recommends that you follow the SUPPLEMENTAL INSTRUCTIONS below which have 
been adapted to accommodate the Form PHS 398 and the special needs of this 
U54 CMI/CCP RFA.  These instructions include all of the information needed by 
peer reviewers of your applications.

SUPPLEMENTAL INSTRUCTIONS

1. Face Page: Use page AA as instructed in the Form PHS 398.  On line 1 
provide a title that is representative of your partnership.  This title 
should be the same for both the MSI application and the Cancer Center 
institution's application.  For line 2 enter the title "U54 CMI/CCP " and the 
number beginning with RFA....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 page 2 of the Form 
PHS 398 and follow the instructions provided in the Form PHS 398.
3. Table of Contents:  Organize the Table of Contents exactly as described 
below:

                 Content	                       Page Number              
     
Face Page
Description, Performance Sites and Key Personnel
Table of Contents
Detailed Budget for Initial Budget Period:
a. Administrative Core
b. Planning and Evaluation Core
c. Developmental Core
Budget for Entire Proposed Period of Support
a. Administrative Core
b. Planning and Evaluation Core 
c. Developmental Core
Budgets Pertaining to Consortium/Contractual Arrangements (e.g., more than 
one MSI/Cancer Center is involved)
Biographical Sketches of Principal Investigator and the Co-Investigator (not 
to exceed two pages for each individual)
Biographical Sketches of Key Professional Personnel of the MSI or Cancer
Center (not to exceed two pages for each individual)
Biographical Sketches of Program Steering Committee Members (not to exceed 
two pages for each individual)
List of the participating members of the MSI or the Cancer Center
Other Support of Principal Investigator, Co-Investigator and Key Personnel
Resources
Implementation Plan for the Partnership:
a. Background and Objectives
b. "Letter of Commitment" from the Institution or Cancer Center
c. Chronological review of Planning and Priority-setting processes
d. Scientific and Administrative Leadership
e. Administrative Core
f. Planning and Evaluation
1) Internal Processes
2) Program Steering Committee
g. Proposed Pilot projects/programs to be supported with Developmental Funds
h. Proposed Full projects/programs to be supported with Developmental Funds
i. Proposed resources and infrastructure to be supported with Developmental 
Funds
j. Proposed Recruitment to be supported with Development Funds
k. Human Subjects
l. Vertebrate Animals
m. Consortium/Contractual Arrangements
n. Intellectual Property
o. Checklist

4. Detailed Budget for Initial Budget Period: Use DD (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) Administrative Core; b) 
Planning and Evaluation Core; and c) Developmental Core.
a) For the Administrative Core, denote the costs for personnel, supplies, 
travel etc. needed to provide administrative oversight, coordination and 
cohesion of the partnership.
b) For Planning and Evaluation Core, delineate the costs separately for 
Internal processes (e.g., workshops, retreats, committees, seminar series, ad 
hoc consultants) and the Program Steering Committee.  Internal processes 
should include the process for evaluating and prioritizing the use of 
developmental funds and the process for deciding which areas using 
developmental funds should continue or be discontinued.  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 who make presentations 
to partnership participants that relate to the objectives of the partnership 
and then serve as an ad hoc advisor in areas under development.
c) For the Developmental Core, separately delineate the funds being requested 
for all Pilot projects/programs, Full Projects/programs, resources and 
recruitment.  Remember that individual Pilot projects/programs cannot exceed 
$100,000 in direct costs and Full projects/programs cannot exceed $250,000 in 
direct costs.
5. Budget for Entire Proposed Period of Support: Using page EE (Form page 5) 
of the Form PHS 398, break out the total budgets separately for 
Administration, Planning and Evaluation and Developmental Funds.  Provide 
justifications for costs in future years only when there are specific items 
requested in future years that exceed standard cost-of-living increases.
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, the MSI or Cancer Center would have to serve 
as the primary grantee and subcontract costs would go to the other MSI or 
Cancer Center involved.
7. Biographical Sketches of the Principal Investigator and the 
Co-Investigator (not to exceed two pages).  Use Form FF (Form page 6) of the 
Form PHS 398 and follow the instructions in the application kit.
8. Biographical Sketches of Key Professional Personnel of the MSI or Cancer 
Center (not to exceed two pages for each individual). Use Form FF as above. 
This section should include all professional individuals who serve in middle 
leadership roles. The biographical sketches of those Co-Leaders of Pilot 
projects/programs, Full 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.
9. Biographical Sketches (not to exceed two pages for each individual) of 
Program Steering Committee Members other than the Principal Investigators of 
the MSI and Cancer Center and NCI/ORMH staff.  Use form FF as above.
10. List all participating faculty/members of the MCI or the Cancer Center 
alphabetically by name.  Include for each individual their degree, department 
affiliation or equivalent, and research or other interest (e.g., research 
area, training, education, or outreach).
11. Other Support: Use Page GG of the Form PHS 398 kit for the Principal 
Investigator, Co-Investigator and all other key professional personnel noted 
in item 8 above.
12. Resources: Using Page HH, follow the instructions in the Form PHS 398 
application kit.
13. IMPLEMENTATION PLAN FOR THE PARTNERSHIP 
a. Background and Objectives:
This section should be the same for both the MSI and the Cancer Center U54 
applications.  It should (1) discuss the general rationale for 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 research, research training, education and/or 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 and potential of the partners to work together 
evolves.
b. Letter of Commitment:
The MSI institutional leadership (e.g., Dean, President) and the Cancer 
Center leadership (e.g., Center Director, Dean) 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 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 Planning and Priority-setting Process:
This section should be the same for both U54 CMI/CCP applications.
This section is to provide to the reviewers of your application a clear 
indication that this partnership was derived from a careful planning and 
priority-setting process based on each partner's strengths and weakness 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:
Briefly describe how the Principal and Co-Investigators were chosen in terms 
of their 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: (no more than 10 pages)
Describe the leadership and specific functions of the administrative core to 
provide the necessary regular day-to-day oversight, coordination, support, 
and logistics 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: 
This section must be the same for each U54 application:
1) Internal Planning and Evaluation Activities:
Document each internal planning and evaluation activity (e.g., steering 
committees, regular forums and seminars, workshops, retreats etc.) and 
include the individuals from the MSI and the Cancer Center who will be 
involved. This should include how the progress of the partnership will be 
reported to institutional leaders and the Cancer Center Director 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) Program Steering Committee:
Not including the Co- Principal Investigators and the NCI/ORMH staff, 
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 PARTS g., h., i., and j. 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. Proposed Pilot Projects/Programs: 
Pilot Projects/Programs proposed for funding, which cannot exceed $100,000 in 
direct costs per year or continue for longer than three years, should be 
provided in the following format:
1. Title
2. Names of the Co-Leaders from the MSI and the Cancer Center
3. One paragraph abstract stating the objectives of the project/program
4. One paragraph describing how this pilot project/program relates to the 
overall priorities and objectives of the partnership as described in the 
Background and Objectives section above.
5. Detailed budget page for initial budget period using page DD from the Form 
PHS 398. 
6. Biographical Sketches of Co-Leaders
7. Proposal (no more than two pages)
8. Describe what aspects of the pilot project/program will be conducted at 
the MSI and the Cancer Center
9. Human Subjects**

**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 16 and 17 and 27-33 of the Form PHS 
398 instructions; (2)  Research dealing with Human Subjects and Vertebrate 
Animals must be accompanied by appropriate documentation as described on 
pages 17 and 18 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 U54 CMI/CCP, 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 U54 CMI/CCP, to the NCI program director.

h. Proposed Full Projects/Programs:
Full Projects/Programs proposed for funding, which cannot exceed $250,000 in 
direct costs per year or continue for longer than three years, should be 
prepared in the following format:
1. Title
2. Names of the Co-Leaders from the MSI and the Cancer Center
3. One paragraph abstract describing the purpose and objective of the 
project/program
4. One paragraph describing how the project/program relates to the overall 
priorities and objectives of the partnership as described in the Background 
and Objectives section above.
5. Detailed budget for initial budget period using Page DD from the Form PHS 
398.
6. Biographical Sketches of Co-Leaders
7. Proposal prepared in the same detail as any research, training or 
education grant proposal following the specific instructions, page 
limitations (no more than 25 pages) and guidelines provided in the Form PHS 
398.

**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 16 and 17 and 27-33 of the Form PHS 
398 instructions; (2)  Research dealing with Human Subjects and Vertebrate 
Animals must be accompanied by appropriate documentation as described on 
pages 17 and 18 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 U54 CMI/CCP, 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 U54 CMI/CCP, to the NCI program director.

i. Proposed 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:
1. Title
2. Co-Leaders from the MSI and Cancer Center who lead the activity
3. The experience of key technical personnel, if applicable, who will be 
responsible for the day-to-day operation.
4. Detailed budget for the initial budget period using page DD from the Form 
PHS 398
5. Budget for entire propose period of support using page EE from the Form 
PHS 398
6. Biographical Sketches of Co-Leaders
7. Description of the resource/infrastructure and how it will further the 
priorities and objectives of the partnership (no more than one page)
8. Commitment of space for the resource.
9. Justification for the location of the resource at the MSI, the Cancer 
Center or both.
j. Recruitment:
1. Individuals who are known:
a. Provide the Biographical sketch of the individual
b. Describe how the individual fulfills the priorities and objectives of the 
partnership as described in the Background and Objectives section above
c. Describe the nature of the position that provides the necessary stability 
(e.g., tenure track) and resources (e.g., space) to promote success.
d. 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.
2. 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.
3. Budget:
The budget can provide salary and start-up packages for new recruitment. 
Provide a five year budget plan that relates to the costs expected to be 
incurred by this grant in years 1 through 5 using page EE of the Form PHS 398 
for recruitment and plans to incorporate these individuals  into the 
permanent faculty of the MSI and/or the faculty/membership of the Cancer 
Center.
 
k. Annual External Evaluation of Progress:
This planning activity is required to use a Program Steering Committee (PSC) 
shared by the MSI and the Cancer Center to evaluate annual progress.  An NIH 
or NCI staff person must be voting members of this committee.  Each year a 
written report must be submitted to the NCI that summarizes the PSC’s 
evaluation and its recommendations for improvement.

This section will be the same for the MSI and the Cancer Center grant 
applications.  Describe the expertise of the individual external advisors and 
the rationale for their selection as a group that can effectively evaluate 
this activity relative to its objectives and provide recommendations for mid-
course corrections as necessary.

l. Human Subjects:
Follow the directions and instructions provided in the Form PHS 398 
application kit.
m. Vertebrate Animals:
Follow the directions and instructions provided in the Form PHS 398 
application kit.
n.  Intellectual Property - See instruction in the Form PHS 398 application 
kit.
14. Checklist - See instruction in the Form PHS 398 application kit.
15. Appendix Materials


REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness to ELIGIBILITY REQUIREMENTS and responsiveness to the SPECIAL 
REQUIREMENTS AND PROVISIONS OF COMPREHENSIVE MINORITY INSTITUTION/CANCER 
CENTER PARTNERSHIPS by the NCI. Incomplete and/or non-responsive applications 
will be returned to the application without further consideration.
                     
Applications that are complete and responsive to the RFA will be evaluated by 
the 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 
application 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 receive a written critique but 
only those applications deemed to have the highest scientific merit, 
generally the top half of the applications under review, will be discussed, 
assigned a priority score, and receive a second level review by the National 
Cancer Advisory Board (NCAB).

Both 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 can 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. 

1.  General Features:
a.  Strength of the evidence that MSI and the Cancer Center established 
priorities and objectives for implementation after a careful and thorough 
planning process and that they worked closely together in the preparation of 
these applications.
b. Strength of the evidence that the MSI and the Cancer Center have clearly 
identified the mutual benefits to be gained from this partnership.
c. Feasibility of achieving the priorities and objectives for this 
partnership within the five-year grant period.
d. Degree to which this implementation plan, if fully successful, will result 
in a stable cancer research capability for the MSI and/or result in the 
significant, successful training of more minority cancer researchers.
e. Degree to which this implementation plan, if fully successful, will 
enhance the ability of the Cancer Center through research and/or training and 
education and/or outreach to more directly and successfully address the 
disproportionate incidence and mortality rates in minority populations. 

Those applications satisfying the criteria listed under “General Features” 
will be evaluated according to the following criteria.  Each criterion 
includes additional guidance to reviewers.

2.  Scientific and Administrative Leadership:
The adequacy of the qualifications and experience of the Co-Investigators 
from the MSI and the Cancer Center to provide strong programmatic (e.g., 
scientific) and administrative leadership.  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.

3. Letters of Commitment from the MSI and the NCI-designated Cancer Center:
The degree to which the letters of commitment from the MSI and the Cancer 
Center address and fully support the priorities and objectives of the 
implementation plan of the partnership. 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.  Adequacy 
of the plans to remain responsible and accountable for monitoring and 
sustaining the priorities and objectives of this partnership.  If applicable, 
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.

4.  Administrative Core:
The quality of an appropriate organizational and administrative structure for 
effective attainment of U54 CMI/CCP 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 
logistic services, contractual agreements, (if applicable), and internal 
communication among investigators.  The qualifications, experience and 
commitment of Co-Investigators and key personnel in the services provided by 
the administrative core unit, as well as their ability to devote the required 
time and effort in providing services.  The appropriateness of the use of the 
administrative core services by the budgeted activities and 
projects/programs.

5.  Planning and Evaluation Activities:
The adequacy of the design of and quality of each of the internal planning 
and evaluation processes proposed to achieve the objectives and priorities of 
the implementation plan.  The adequacy of the review and evaluation process 
and criteria for initiating and closing pilot and full projects/programs 
based on their merit and potential for achieving the objectives of the 
partnership and on their actual progress. The appropriateness and adequacy of 
the specific faculty and others identified who will participate together in 
each aspect of the planning and evaluation effort.  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.  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.

6.  Method of Evaluating and Prioritizing the Use of Developmental Funds:
The adequacy of the experience and qualifications of the individuals who take 
part in evaluating specific proposals (e.g., pilot/full projects, pilot/full 
programs, recruitment) for using Developmental funds.  The adequacy of the 
criteria used for selecting pilot/full projects, pilot/full programs, 
recruitment etc. for funding based on their merit and their potential to meet 
the proposed priorities and objectives of the partnership.  The adequacy of 
the evidence based on any specific pilot/full projects, pilot/full programs, 
recruitment, etc. proposed for support with Developmental Funds that the 
process for allocating developmental funds works effectively.

7.  Proposed Pilot Projects/Programs:
The qualifications of the Co-Leaders from the MSI and the Cancer Center to 
develop the project/program.  The merit of the Pilot Project/Program, and the 
degree to which it contributes to the priorities and objectives of the 
partnership.  Potential to develop into a Full project/program in three years 
or less.  The options will be either to recommend support at the recommended 
budget levels or to recommend no support because it has either: a) low merit; 
b) low relevance to the objectives of the partnership and/or c) low potential 
to develop into a Full project/program.

8.  Proposed Full Projects/Programs:
The qualifications of the Co-Leaders to conduct the project/program as 
proposed.  The merit of the Project/Program and the degree to which the 
project will fulfill the priorities and objectives of the partnership.  The 
potential to become a competitively funded project (e.g., R01, T32, R25) in 
three years or less.  The options will be either to recommend support at 
recommended budget levels or to recommend no support because it has either: 
a) low merit; b) low relevance to the objectives of the partnership; and/or 
c) low potential to become funded through competitive peer review.

9. Proposed Resources/Infrastructure: (if applicable)
The degree to which the proposed resource/infrastructure proposed will 
contribute to the overall priorities and objectives of the implementation 
plan.  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 and potential future funded grants.  The 
qualifications of key personnel to operate the resource/infrastructure 
activity, and the merit of the resource as proposed.   The options will be 
either to recommend support either at the recommended budget levels, or to 
recommend support with specific modifications in the operation of the 
resources, or to recommend no support and the development of a more 
appropriate resource because of either: a) low merit; and/or b) low relevance 
to the objectives and priorities of the partnership.

10.  Proposed Recruitment: (if applicable)
The quality of each specific individual recruitment proposed relative to 
background and ability to contribute substantially to strengthening areas of 
high priority to the implementation plan.  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.

11.  Evaluation of Progress by Program Steering Committee:
The adequacy of the expertise and qualifications of each of the Program 
Steering Committee members to provide appropriate evaluation and advice and 
recommendations for making mid-course corrections based on the objective of 
this planning effort.  The adequacy of the plan for using the Program 
Steering Committee effectively.

12.  Intellectual Property: (if applicable)
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.

13. Other Considerations:
The initial review group will also examine: the appropriateness of the 
proposed budgets and duration; the adequacy of plans to include both genders 
and minorities and their subgroups as appropriate for the scientific goals of 
the research and plans for the recruitment and retention of subjects; the 
adequacy of plans for including children as appropriate for the scientific 
goals of the research, or justification for exclusion; the provisions for the 
protection of human and animal subjects; and the safety of the research 
environment.   

Overall Evaluation and Scoring of Application:

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 extent to which the MSI and Cancer Center applications together 
satisfy the General Features above (i.e., overall intent of this initiative).
2. Taken together, the quality of the individual sub-components as proposed 
in the MSI and Cancer Center U54 CMI/CCP applications.

AWARD CRITERIA

Each set of two applications from an MSI and a Cancer Center will compete for 
funds with all other partnerships in response to this RFA. Applications 
recommended by the NCAB will be considered for award based upon (a) 
scientific and technical merit as determined by peer reviewers; (b) the 
program priorities of the NCI and the ORMH; and (c) availability of funds. 

SCHEDULE

Preapplication Meeting Date:      May 12-13, 2000 
Letter of Intent Receipt Date:    June 8, 2000
Application Receipt Date:         July 26, 2000
Peer Review:                      October/November, 2000
Review by NCAB:                   February, 2001
Earliest Anticipated Award Date:  March 1, 2001

NON-COMPETING CONTINUATION APPLICATION

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

INQUIRIES

Written, telephone, fax and e-mail inquiries concerning this RFA are 
encouraged especially during the planning phase of these applications.  Below 
is a listing of program (i.e., scientific management), grants administration 
(i.e. fiscal management) and review (i.e., management of peer review process) 
staff of the National Cancer Institute who are available to for inquiries:

Direct inquiries regarding scientific or programmatic issue to:

Sanya A. Springfield, Ph.D.
Chief, CMBB, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 700
Bethesda, MD 20892-8347
Telephone: (301) 496-7344
Fax: (301) 402-4551
Email: springfs@mail.nih.gov
 
	Or

Brian Kimes, Ph.D.
Director, OCTR, ODDES
National Cancer Institute
6116 Executive Blvd.
Suite 700
Bethesda, MD 20892-8347
Telephone: (301) 496-8537
Fax: (301) 402-0181
Email: kimesb@mail.nih.gov

Direct inquiries regarding fiscal or budget matters to:

Ms. Barbara Fisher
Grants Management Specialists
National Cancer Institute
6120 Executive Blvd.
EPS/243
Bethesda, MD 20892
Telephone (301) 496-8626
Email: Bf18m@nih.gov.

Direct inquiries regarding review matters to:

Ms Toby Friedberg
Referral Officer
Division of Extramural Activities
6116 Executive Boulevard, Room 8062, MSC 8239 
Rockville, MD 20852 (express service) 
Bethesda, MD 20892-8239
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.398, Cancer Research Manpower. 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 and Federal Regulations 
42 CFR Parts 52 and 45 CFR Parts 74 and  92. This program is not subject to 
the intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review. 

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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