COOPERATIVE PLANNING GRANT FOR COMPREHENSIVE MINORITY INSTITUTION/CANCER 
CENTER PARTNERSHIP

Release Date:  April 25, 2000

RFA:  CA-01-008

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 planning grant applications (i.e., 
U56s) for the development of Comprehensive Minority Institution/Cancer Center 
Partnership (cMI/CCP) planning programs between Minority-Serving Institutions 
(MSIs) and NCI-designated Cancer Centers (or groups of centers).  Both MSIs 
with medical schools and MSIs with more focused research and education 
programs (e.g., Masters, and Ph.D. programs) are invited to participate in 
this initiative. The long range goals of these collaborations are to increase 
the cancer research capabilities of MSIs; to increase the number of minority 
scientists engaged in cancer research and other cancer related 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 cancer among minority populations. 
These U56 cMI/CCP planning activities are expected to lead to the development 
of long-term collaborations and 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 applications (RFA) is to solicit cooperative 
planning grants (U56s) that would establish comprehensive planning 
partnerships between MSIs and NCI-designated Cancer Centers (or groups of 
centers) that would achieve goals that are of clear mutual benefit.  This U56 
cMI/CCP represents a first step before achieving a Comprehensive Minority 
Institution/Cancer Center Partnership grant (U54 cMI/CCP), and it must be 
focused on cancer research and, one or all of the following targeted program 
areas: research training and career development, education and outreach to 
minority communities. 

Cooperative planning grant (U56 cMI/CCP) applicants are expected to achieve 
the following objectives all or in part: 

1. Build and stabilize independent and collaborative, competitive cancer 
research projects, and/or cancer research training and career development in 
MSIs;

2. Establish priorities for and initiate 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 address 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.

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, Cooperative 
Planning Grant For Comprehensive Minority Institution/Cancer Center 
Partnerships, 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 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 collaboration or partnership must be submitted as two separate 
applications, one from the MSI and one from the Cancer Center (or group of 
Cancer Centers) but with separate complementary budgets to achieve common 
priorities, goals and objectives. Each Principal Investigator must be listed 
as a Co-Investigator on the complementary application (See below for further 
instructions).

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 no more than ONE Comprehensive 
Minority Institution Cancer Center Partnership (U56) planning grant 
application. 

MECHANISM OF SUPPORT

This RFA will use the National Institute of Health (NIH) cooperative planning 
grant (U56) award mechanism.  The U56 mechanism may support any part of a 
full range of research development from very basic to clinical research.  The 
U56 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 works cooperatively with the award recipients in a partner 
role and does 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 U56 will provide support for:

1. Administrative Core activity (not to exceed 20% of the total direct costs) 
for:
a. Salaries for 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; to identify 
new areas of opportunity and high priorities the planning 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 duration of three years). Pilot 
projects/programs are expected to lead to full research projects/programs in 
the Comprehensive Minority Institution/Cancer Center Partnership (U54 
cMI/CCP) application. 
b. Resources and infrastructure (e.g., tissue bank 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 cancer center or in both locations.  
c. Support for research assistants and research associates in various stages 
of their career development.
d. Start-up packages for newly recruited investigators in areas for 
development and stabilization.

Funds may NOT be used to purchase equipment (unless part of a start-up 
package for a faculty recruitment. In this case, the maximum allowable costs 
for such equipment items can not exceed $10,000) for research purposes 
without prior approval by the NCI. 

FUNDS AVAILABLE

This RFA is a one-time solicitation. NCI/ORMH anticipate making approximately 
12 (six pair)5-year awards, and plan to set aside $5.0 million including 
direct costs and costs for facilities and administration for the initial 
year's funding.  Annual budgets in the range of $300,000 - $500,000 direct 
costs are suggested.  Third party sub-contractual F & A costs will not be 
counted toward the maximum combined direct costs of $500,000. Applications 
exceeding the $500,000 direct cost 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 total project period for 
applications submitted in response to this RFA may not exceed five years. 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 ethnic minorities have continued to rise. The incidence of colon 
and rectum, and lung and bronchus cancers in Alaska Natives 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. 
(e.g., Native Americans, African Americans, Hawaiian, and Hispanic Americans) 
are lower than the 5-year survival rates 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 these trends are 
going to be reduced and brought into balance with the rest of the population.  
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 ethnic 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 National Institutes of Health (NIH) and other 
agencies, 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 independently 
funded 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 research 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 and career development 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 minority 
populations in their communities, and in bringing the benefits of biomedical 
research to these populations has been slow and often disappointing.

The low involvement of MSIs in cancer research and lack of significant 
training of minority scientists in cancer research must be addressed if we 
are to develop a stronger national cancer research effort aimed at 
understanding the disparities of cancer incidence and mortality in minorities 
compared to majority 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-designated 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 planning activities dedicated to developing stable, long-term 
comprehensive partnerships that are mutually beneficial to MSIs and NCI 
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 and career development related to 
minorities, and to develop more effective research, education and outreach 
and programs that will have an impact on minority populations. 

Within these objectives, four broad areas are targeted for development:

1. Cancer Research: Cancer research is a required component of the U56 
cMI/CCP planning cooperative activity.  Joint pilot 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 pilot research projects conducted 
primarily at the NCI 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 majority trainees to 
appreciate the issues and problems associated with cancer incidence and 
mortality disparities in minority populations. The need to train minority 
scientists in clinical research and population research, however, 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 and career development programs might provide 
graduate students with the opportunity to fulfill their research requirements 
in cancer center laboratories using state-of-the art equipment and mentoring 
by cancer center investigators.  
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 appraise 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
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 leaders and 
organizations in the community to develop 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 and Cancer Center Partnerships 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 COOPERATIVE PLANNING GRANTS FOR 
COMPREHENSIVE MINORITY INSTITUTION/CANCER CENTER PARTNERSHIPS (U56) 

There are a number of Special Requirements and Provisions that each U56 
cMI/CCP Cooperative Planning Grant Application must comply with: 

1. Each MSI and Cancer Center is limited to participating in no more than ONE 
U56 cMI/CCP planning grant application. 
2. Of the four targeted areas for development in this initiative (i.e., 
cancer research, research training and career development, education and 
outreach), cancer research is a required component.
3. There must be written "Letters of Commitment" from the MSI leadership and 
the Cancer Center Leadership that are fully supportive of this planning 
activity and that commit the additional resources necessary to ensure that 
these planning activities will have the maximum chance of success.  
Additional resources would include protected faculty time, recruitment of new 
faculty, space and facilities, capital improvements, etc.
4. The U56 cMI/CCP planning 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-designated Cancer Center 
(or groups of 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 the 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 planning 
effort. 
6. The total direct costs of the two applications together cannot exceed 
$500,000.  If there are third party subcontract costs, only the direct costs 
of the subcontract will count against this cap.
7. No more than 20% of the total costs of the collaboration can be devoted to 
Administrative Core expenses.
1. In using Developmental Funds to support pilot research projects or pilot 
research training and career development, education or outreach programs, 
each activity must be co-led by individuals from both the MSI and the Cancer 
Center.
2. Cancer research training programs must be joint programs designed to 
function seamlessly across institutional boundaries and share trainees, 
faculty and mentors.
3. Pilot research projects supported by the U56 cMI/CCP and primarily 
conducted at the MSI can be any research relevant to cancer, but research 
projects primarily conducted at the NCI-designated Cancer Center must be 
focused on problems related to areas of cancer disparity in minority 
populations.
4. 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 an 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 planning partnerships must have a process in place for reviewing 
internal proposals for pilot 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 U56 cMICCP program.  No pilot project/program can exceed $100,000 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.
5. Any new project/program and shared resources for development must not 
overlap in purpose and intent with existing projects/program 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 program.  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.
6. All recipients of cMI/CCP U56 Planning Grant 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 can be included 
in the grant applications from the MSI and the Cancer Center institutions.
7. Once a cMI/CCP U56 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 (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/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 the 
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 
the 
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 evaluation of 
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 U56 
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 form NCI including NCI sponsored 
agents for pre-clinical and clinical testing, assistance in IND filing, etc.
i. 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.
j. Will assist the Program Steering Committee in the evaluation of new pilot 
projects/programs when requested as replacements for on-going activities.
k. Terminate or curtail an investigator or pilot project/program (or an 
individual award) in the event the partnerships fail to evolve within the 
intent and purpose of this initiative.
l. Monitor institutional commitments and resources to ensure that the 
partnership receives the maximum chance of stabilization and success.
m. Prior approval of new faculty recruits to ensure that he/she falls within 
the bounds of the areas prioritized for development and stabilization.
n. 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.
o. 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 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/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 U56 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 U56 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 U56 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 external 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 Principal Investigator 
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 developing an application. 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 
planning partners 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 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 U56 
planning 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 below and provided 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 
"U56 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 review. Submit signed, typewritten originals 
of the of the cover letter, MSI application and the NCI 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 application 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 U56 cMI/CCP grant application.  Accordingly, the NCI 
strongly suggests that you follow the SUPPLEMENTAL INSTRUCTIONS below which 
have been adapted to accommodate the Form PHS 398 and the special needs of 
this U56 cMI/CCP RFA.  These instructions include all of the information that 
will be needed by the peer reviewers of your application.
 
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 collaboration or 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 "U56 CMI/CCP" 
and the number beginning with RFA....Remember to fix 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. Developmental Core
Budget for Entire Proposed Period of Support
a. Administrative Core
b. Developmental Core
Budgets Pertaining to Consortium/Contractual Arrangements (e.g., more than 
one MSI/Cancer Center is involved)
Biographical Sketch of Principal Investigator (not to exceed two pages)
Biographical Sketch of Co-Investigator (not to exceed two pages)
Biographical Sketches of Key Professional Personnel of the MSI or Cancer 
Center  (not to exceed two pages each for each individual)
Biographical Sketches of External Advisors (not to exceed two pages each)
List of participating members of the MSI or the Cancer Center
Other Support of Principal Investigator, Co-Investigator and Key Personnel
Resources
Plan for Developing the Collaboration or Partnership:   
a. Background and Objectives
b. "Letter of Commitment" from the MSI or Cancer Center
c. Overall Planning Objectives with Expected Times for Completion (these 
should be the same in both the MSI and the Cancer Center applications)
d. Scientific and Administrative Leadership
e. Planning Activities
f. Method of Evaluating and Prioritizing Pilot Research Projects, Pilot 
Programs, Resources, Faculty Recruitment that will use Developmental Funds
g. Proposed Pilot Projects to be supported with Developmental Funds
h. Proposed Pilot Programs to be supported with Developmental Funds
i. Proposed Resources to be initiated with Developmental Funds
j. Faculty Recruitment to be supported with Development Funds
k. Annual Evaluation of Progress
l. Human Subjects
m. Vertebrate Animals
n. Consortium/Contractual Arrangements
o. Intellectual Property
p. Check List
4. Detailed Budget for Initial Budget Period: Use DD (Form page 4) of the 
Form PHS 398 application kit.  Separately break out the budget using 
different Page 4s under the headings: a) Administrative Core and b) 
Developmental Core.
a) For the Administrative Core denote all the costs for salaries of both 
scientific and administrative personnel; travel and per diem for scientific 
and administrative personnel and outside advisors; and equipment and supplies 
to support the administrative needs of the planning effort.  The 
corresponding Principal Investigator of the partner U56 cMI/CCP application 
should be listed as the Co-Investigator with no salary.
b) For the Developmental Core use separate page 4s for costs for each of the 
following:
1) Developmental Funds/Workshops and Retreats: within this budget 
specifically denote the workshop, retreat, etc. by title and break out the 
costs by category
2) Developmental Funds/Pilot Research Project 1 with title, Pilot Research 
Project 2 with title etc.
3) Developmental Funds/Pilot Program 1 (e.g., training, education, and/or 
outreach) with title; Pilot Program 2 with title etc.
4) Developmental Funds/Specialized Resources 1 with title; Specialized 
Resources 2 with title etc.
5) Developmental Funds/Faculty Recruitment 1 with title etc.
5. Budget for Entire Proposed Period of Support: Using Page EE (Form Page 5) 
of the Form PHS 398, follow the instructions in the Form PHS 398 application 
kit. Provide specific justifications for costs in the first year but only 
provide costs for future years only when there are specific items requested 
in future years that exceed standard costs 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 these 
planning activities.  In either case, the MSI or Cancer Center would have to 
serve as the primary grantee and subcontract for the consortia involvement of 
the other MSI or Cancer Center.
7. Biographical Sketch of Principal Investigator: Use Page FF (Form page 6) 
of the Form PHS 398 and follow the instructions in the application kit.
8. Biographical Sketch of the Co-Investigator: Use Page FF and follow the 
instructions in the Form PHS 398 application kit.
9. Biographical Sketch of Key Professional Personnel of the MSI or the Cancer 
Center (not to exceed two pages for each individual).  Use Page FF as above. 
This section should include all professional individuals who serve in middle 
leadership roles.  The biographical sketches for those co-leaders of pilot 
projects/programs and resources, as well as nay named individuals who are 
going to be recruited, should be provided in the appropriate sections of this 
application.
10. Biographical Sketches of External Advisors: Use Page FF and follow 
instructions in the Form PHS 398 application kit.  The same advisors will 
also be included in the partner application.
11. List of participating faculty/members of the MSI or 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).
12. Other Support: Using Page GG, provide other support only for the 
Principal Investigator, Co-Investigator and other key professional personnel 
at either the MSI or the Cancer Center and follow the instructions in the 
Form PHS 398 application kit.
13. Resources:  Using Page HH, follow the instructions in the Form PHS 398 
application kit.
14.  PLAN FOR DEVELOPING THE COLLABORATION/PARTNERSHIP:
a. Background and Objectives:  
This section should be the same for MSI and Cancer Center U56 cMI/CCP 
applications.  It should describe the characteristics of the MSI and the 
Cancer Center that will contribute to a planning effort resulting in specific 
mutual benefits and complementation of each partners strengths and weakness 
to accomplish goals and objects that neither could achieve as successfully 
alone.  It should clearly denote the nature of the interactions and 
deliberations that occurred and the individuals involved between the MSI and 
the Cancer Center during the preparation of these applications.
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 each stage of this planning effort outlined in the 
Background and Objectives section above.  These resources could be in the 
form of protected time (i.e., release time from grant funds) for faculty to 
participate in and focus on the objectives of this grant, faculty 
appointments that will be dedicated to this effort, discretionary resources 
that will be made available to the Principal and Co-Investigators to achieve 
objectives that will build a stronger institutional culture dedicated to this 
effort, and purchase of sophisticated equipment for critical infrastructure 
needs.  This letter should clearly explain how the MSI and the Cancer Center 
would be responsible and accountable for following the progress of this 
planning effort and doing what is needed to sustain it.
c. Overall Planning Objectives with Expected Times for Completion:
This section should be the same for the MSI and the Cancer Center 
application.  Each application should list the specific interim and final 
objectives that are expected to be achieved in chronological order with the 
expected times (e.g., months, years) for completion during the period 
requested in this grant.  For each objective, a brief statement should be 
made about the separate contributions of the cancer center and the MSI in 
order to achieve success and realize mutual benefits. The final objective in 
planning for a comprehensive partnership must be the submission of a 
Comprehensive Minority Institution /Cancer Center Partnership (U54 CMI/CCP) 
grant.
d. Scientific and Administrative Leadership: 
Briefly describe how the Principal Investigator and Co-Investigator 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 planning grant, 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.
f. Planning Activities:
Describe the kinds of planning activities that the MSI and the Cancer Center 
will conduct to ensure a highly interactive and integrated effort between the 
faculty and scientists of the MSI and the faculty and scientists of the 
Cancer Center.  Relate each planning activity (e.g., workshop, retreat, 
executive meeting) to specific objectives above and denote the specific 
faculty by name and their interests (training clinical oncology researchers, 
research in prostate cancer, establishing new curriculum in nutrition, etc.) 
who will participate in each activity.  Describe what advice and oversight 
role for planning will be asked of the Program Advisory Committee.
g. Method of Evaluating and Prioritizing Pilot Research Projects, Pilot 
Programs, Resources, Faculty Recruitment that will use Developmental Funds:
Describe how the Developmental Funds will be allocated based on the merit of 
proposals and their potential to successfully achieve the objectives of this 
planning effort.  Describe the shared role of MSI and the Cancer Center 
faculty by name and expertise in accomplishing this task.  Do not forget the 
requirement for co-leadership of developmental activities (e.g., pilot 
research projects).

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

h. Proposed Pilot Research Projects to be Supported with Developmental Funds:
Pilot research projects must have co-leadership by individuals from the MSI 
and the Cancer Center.  Each Pilot Project should include the following:
1. Title
2. Names of the Co-Investigators from the MSI and the Cancer Center
3. One paragraph abstract
4. One paragraph describing how this pilot project relates to the overall 
objectives of the collaboration as described in the Background and Objectives 
section above.
5. Detailed budget page for initial budget period using page DD from form PHS 
398.
6. Biographical Sketches of Co-Leaders
7. Research Proposal (no more than two pages)
8. Describe what aspects of the research proposal will be conducted at the 
MSI or 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 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 cMI/CCP, to the NCI program director.

i. Proposed Pilot Programs to be Supported with Developmental Funds:
Pilot Programs require co-leadership by individuals from the MSI and the 
Cancer Center.  Use a format adapted from the Pilot Research Project format 
above.  See NOTE above for Pilot Research Projects in case this applies to 
any Pilot Program using human subjects that will be funded by this grant.
j. Proposed Resources to be Supported with Developmental Funds:
Resources and Infrastructure needs (e.g. minority tissue resources, minority 
patient accrual core, clinical research management core) of the planning 
effort 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 proposed period of support using EE from the Form PHS 
398
6. Biographical Sketches of Co-Leaders
7. Description of the resources/infrastructure and how it will further the 
objectives of the planning grant (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.
k. Specific Faculty Recruitment to be Supported with Developmental Funds: 
Depending upon the nature of the proposed planning activity, recruitment of 
faculty or additional mentored research of existing faculty may be necessary 
to build the Research capability of a MSI.  The following information should 
be provided for Faculty Recruitment:
Individual who are known:
1. Provide the Biographical sketch of the individual
2. Describe how the individual fulfills the objectives of the planning grant 
as described in the Background and Objectives section above
3. Describe the nature of the position that provides the necessary stability 
(e.g. tenure track) and resources (e.g. space) to promote success.
4. Describe the location of the individual at the MSI or the Cancer Center 
and how this location will best achieve the objectives of the planning grant.
Individual who are planned:
1. Describe the number and expertise of the individuals to be recruited 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 objectives.
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 pages 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.
l. 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 planning 
grant applications.  Describe the expertise of the individual external 
advisors and the rationale for their selection as a group that can 
effectively evaluate this planning activity relative to its objectives and 
provide recommendations for mid-course corrections as necessary.

m. Human Subjects:  
Follow the directions and instructions provided in the Form PHS 398 
application kit.
n. Vertebrate Animals:
Follow the directions and instructions provided in the Form PHS 398 
application kit.
o.  Intellectual Property - See instructions in the Form PHS 398 application 
kit.
15. Checklist  - See instructions in the Form PHS 398 application kit.
16. 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 PLANNING GRANT FOR 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 group will 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 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 this planning effort. 

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 effort at the MSI and 
the Cancer Center that gives confidence that these commitments will be stable 
and long-lasting.  If applicable, the adequacy of the resources (e.g., 
discretionary resources, space, faculty positions, protected time for 
research) that the MSI and the Cancer Center will provide to promote the 
successful achievement of the objectives of this partnership. The adequacy of 
the MSI's and the Cancer Center's plans to remain responsible and accountable 
for monitoring and sustaining the priorities and objectives of this 
partnership.

4.  Administrative Core:
The quality of an appropriate organizational and administrative structure for 
effective attainment of U56 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. If applicable: the appropriateness 
and adequacy of the process and criteria for identifying and implementing the 
resource and infrastructure needs of the planning partnership; 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, and the 
appropriateness and adequacy of the specific faculty and others identified 
from the MSI and the Center 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.

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 objectives of the planning effort. 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 the pilot project/program contributes to the priorities and 
objectives of the partnership. The 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 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. The options will be either to recommend support either at the 
recommended budget levels, 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.

9.  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.

10.  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.

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

12.  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 satisfy the 
General Features outlined 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 U56 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:

Pre-application 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 7008
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
Fax: (301) 496-8601
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)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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