Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov)

Title: Cooperative Planning Grant for Comprehensive Minority Institution/Cancer Center Partnership (U56)

Announcement Type
This is a reissue of RFA-CA-05-022, which was previously released November 2, 2004.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-CA-06-012 

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.396, 93.398, 93.399

Key Dates 
Release Date: March 6, 2006
Letters of Intent Receipt Date(s): March 20, 2006
Application Receipt Dates(s): April 19, 2006
Peer Review Date(s): June-July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: December 1, 2006
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Expiration Date: April 20, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives
   A. Descriptio
   B. Scope
   C. Target Areas

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
   A. Allowable Costs
   B. Developmental Costs

Section III. Eligibility Information
1. Eligible Applicants
   A. Eligible Institutions
   B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
   A. Special Requirements and Provisions

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
   A. Receipt and Review and Anticipated Start Dates
     1. Letter of Intent
   B. Sending an Application to the NIH
   C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
   A. Application Requirements
   B. Additional Instructions
   C. Sharing Plan and Intellectual Property Plan

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
   A. Additional Review Criteria
   B. Additional Review Considerations
   C. Sharing Research Data
   D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
   A. Cooperative Agreement Terms and Conditions of Award
     1. Principal Investigator Rights and Responsibilities
     2. NIH Responsibilities
     3. Collaborative Responsibilities
     4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Since the War on Cancer was initiated in 1971 through passage of the National Cancer Act by the U.S. Congress and President, the disparities in cancer incidence, morbidity, and mortality in underserved racial and ethnic minority populations and among the socio-economically disadvantaged have continued to rise.   For example, the incidences of colon and lung cancers in Alaska Native and African-American men and women are higher than that of other ethnic groups; 5-year survival rates in Native American, African American, Hawaiian, and Hispanic American populations are lower than those in the Japanese and White American populations; and patterns of prostate cancer among African American males compared with White males, seen in the Southeastern U.S., particularly in rural areas, still remain higher (http://www.nci.nih.gov/atlasplus/).  Clearly, more research is needed that specifically addresses these and other disparities if they are to be eliminated by 2010 (President’s Initiative on Race and Health Disparities). This initiative is also in line with the priority recommendations for the U.S. Department of Health and Human Services (DHHS) to lead the Nation in eliminating cancer health disparities (Making Cancer Health Disparities History).

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

The NCI-designated Cancer Centers are geographically dispersed, research-intensive organizations with well-organized programs for training cancer scientists.  They are the only organized units supported by the NCI that conduct research; sponsor research training in the basic, clinical, and population sciences; provide information services; and develop and sustain educational and outreach programs that benefit their communities.  Yet, the progress of Cancer Centers in focusing on research issues of particular importance to cancer in minorities, in training underrepresented 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.

1.A.  Description

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

MSIs are defined as institutions at which students of minority groups that 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 at which there have been documented records of commitment to the special encouragement of minority faculty, students, and investigators.

The lack of significant training opportunities for minority scientists in cancer research and the low level of involvement of MSIs in competitive 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 NCI has created a potentially powerful approach that can help MSIs and Cancer Centers integrate and take maximum advantage of their expertise and experience to work together in areas that are mutually beneficial.

The MI/CCP program utilizes two cooperative agreement assistance mechanisms, i.e., the U56 and U54 mechanisms.  The Cooperative Planning Grant for Comprehensive Minority Institution/Cancer Center Partnership (U56) is to be used by those institutions that are in the initial stages of planning for a comprehensive partnership.  The Comprehensive Minority Institution/Cancer Center Partnership (U54) is to be used by those institutions which have already conducted considerable prior planning and evaluation and are ready to begin implementing a partnership that involves inter-institutional cancer research projects, cancer training, and/or education or outreach programs.

This initiative for a U56 Cooperative Planning Grant for Comprehensive MI/CCP is to help potential partners develop plans and initiatives that will enable them to become competitive for a U54 cooperative agreement and achieve the following objectives:

1) Build and stabilize the independent competitive cancer research capacity at the MSIs;

2) Improve the effectiveness of the NCI-designated Cancer Center in conducting activities specifically designed to address the cancer disparities in underserved racial and ethnic minority populations and among the socio-economically disadvantaged; and

3) Create stable, long-term collaborative relationships between MSIs and Cancer Centers in all areas of cancer research, training, outreach and education.

1.B. Scope

The Minority Institution Cancer Center Partnership program is about building and sustaining excellence.  In its most simplistic rendering, other than long-term support for cancer research infrastructure (e.g., key personnel recruitment, equipment, clinical accrual cores, tissue cores, etc.), the MI/CCP does not sustain any type of the activities listed below in the broad target areas of development (e.g., research projects, training, education and outreach programs) indefinitely.  All of these activities are intended to generate competitively funded, peer-reviewed support.  This is a nurturing program that will provide longer incubation times while projects/programs are being developed and stable support for projects/programs while they are being submitted as competing grants to NIH or equivalent agencies.

Career and professional development activities must be developed for Co-Leaders, junior investigators and post-doctoral scientists involved in the partnerships.  For the purpose of this RFA, a junior investigator is a scientist or faculty member with no prior independent research funding from NIH or equivalent agencies.  The proposed plan of action for the career and professional development as well as mentorship must be integrated into every target area of the U56 (cancer research, training, education, and outreach) as well as administration.  When necessary, career development plans should be established for the Co-Principal Investigators (Co-PIs).  The objective of this endeavor is to nurture the junior investigator into developing the research skills and abilities needed to work in a collaborative environment and to become a successful independent cancer researcher.  The career plan should identify mentor(s) who will be responsible for career and professional development of the individuals.  Mentorship should involve senior faculty member(s) with research competence and/or experience appropriate for the role. Mentors must be individuals with relevant research experience who have an appreciation of the cultural, socioeconomic, and research backgrounds of the junior investigators.  When appropriate, experienced senior faculty within MSIs, but outside the junior investigator’s research area, may be chosen as consultants or co-mentors.  This approach is of particular significance when junior investigators with relevant research experience from the Cancer Centers become mentors for less experienced senior faculty from the MSIs.  The mentor(s) and the junior investigator will be responsible for planning, directing and executing a tailored career development plan similar to the ones used in NIH career development awards.  The mentoring process should be such that the expected outcomes are clear to mentors and trainees.  The career development plan should ensure that mentors and advisors are available to provide appropriate guidance throughout the duration of the program.  The MI/CCP application should provide compensation for mentors, co-mentors, and/or consultants.

1.C. Target Areas

The U56 MI/CCP grant must address three target areas: Cancer Research, Cancer Training, and Cancer Outreach.  The fourth target area, Cancer Education, is an option.

1) Cancer Research: Joint cancer research is a required component of a U56 Cooperative Planning Grant for Comprehensive MI/CCP.  Joint pilot research projects may be in any area of basic, clinical, prevention, control, behavioral, and/or population research.  Research projects conducted primarily at the MSI may be in any area of cancer research, but research projects conducted primarily at the Cancer Center must specifically address areas of cancer disparity in minority and underserved populations.  Joint cancer research projects at MSIs might focus, for example, on general areas of environmental carcinogenesis, molecular epidemiology, and/or behavioral issues related to cancer prevention, treatment, and/or control.  The expectation is that successful pilot research projects will become full research projects in the U54 and/or become competitively funded grants (e.g., R03, R01, project in a P01, project in a P50).

2) Cancer Training: Cancer training is a required component.  Joint training programs that link the faculty and students of the MSI and the Cancer Center are the most productive ways to sustain each long-term effective partnership.  These programs must place an emphasis on the training of minority scientists and on educating majority trainees to appreciate the issues and problems associated with cancer disparities in minority populations.  The NCI particularly encourages training of underrepresented minority scientists in clinical, behavioral, and population research; there is a huge deficit of underrepresented minority scientists engaged in these research areas, which are highly dependent for their success on the cultural sensitivity of the researchers.  These training programs must represent true collaborations that function seamlessly across the institutional boundaries of the MSI and the Cancer Center.  For example, new training programs might provide graduate students in MSIs opportunities to fulfill their research requirements in Cancer Center laboratories using state-of-the-art equipment and mentoring by Cancer Center investigators; or masters programs in an MSI might be linked formally to doctoral training programs in Cancer Centers.  Clinical research training programs at MSIs might also include rotations for medical students and residents in Cancer Center laboratories.  Other training programs may deal with minority cultural issues for majority trainees and clinical training programs at the Cancer Center might offer the use of current methodologies for national and international electronic communication on diagnosis and treatment of cancer for minority trainees.  Successful activities in this area may lead to full programs in the U54 or to the submission of a competitive training grant application (e.g., T32, K12, R25T) as well as individual predoctoral fellowships (F31), career development awards (e.g., K01, K08, K23, K22) and research supplements for trainees.

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

4) Cancer Education: Cancer education programs could focus on any effort to augment existing or create new curricula in the MSI and/or the Cancer Center that would apprise and culturally sensitize graduate and postdoctoral students in research, medicine, and public health of the need to reduce the disproportionate cancer burden in minority populations.   A successful effort may result in the submission of a full program in the U54 or a competitive NCI education grant application (R25E) and later to institutional commitments to make these curricula an inherent component of their educational systems.

See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the National Institutes of Health cooperative agreement specialized center (U56) award mechanism.  The U56 mechanism may support any part of a full range of research, training, education, and outreach development from very basic to clinical.  As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  This RFA is a one-time solicitation.

This funding opportunity uses just-in-time concepts.  It also uses the non-modular format as described in the PHS 398 instructions (http://grants.nih.gov/grants/funding/modular/modular.htm).

The NIH U56 is a cooperative agreement award mechanism.  In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award.

2. Funds Available

The NCI intends to commit approximately $800,000 dollars in FY 06 to fund up to two (one partnership) new grants in response to this RFA.  An applicant may request a project period of up to 5 years and a budget for direct costs up to 5 years up to $525,000 (per pair) per year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.  Although the financial plans of the NIH IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

2.A. Allowable Costs

1) The U56 MI/CCP will provide support for administrative costs (which may be higher in the early stage of development and lower in the later stages) for managing the partnership, such as salaries for key personnel; equipment, and supplies to support an administrative structure.

2) Planning and Evaluation should be constantly ongoing and the outcomes of those processes will constitute the basis for initiating and terminating the investment of resources, into developmental projects, programs, resources and recruitments.  These resource allocations may include the costs for internal activities of the Internal Advisory Committee (IAC), key personnel, and ad hoc committee members, as well as external activities (e.g., per diem costs for travel and consultant costs for Program Steering Committee [PSC] members, consultant costs for focus groups).  They may also include costs associated with the identification and conduct of strategic planning sessions, workshops, seminars, retreats, and other forums to strengthen, stabilize, and consolidate interactions and cooperation in areas of existing high priority.

3) Developmental Core funds are expected to escalate each year and the rationale for not using escalating Developmental Core funds would have to be based on the documentation of prior planning and evaluation processes.  It is conceivable that in the first years of the grant, greater commitment would be devoted to the administrative and planning and evaluation cores for the identification of the talent pool (student, faculty); team building and program identification; and developing IAC processes.  Developmental Core funds would increase in subsequent years of the grant for the funding of projects/programs, especially for those projects with human subjects and special training requirements.

2.B. Developmental Costs

1) Pilot projects/programs that are not recommended for funding in the initial review but that are pursuing important, high-risk, and promising ideas may be recommended as pre-pilots by the IAC/PSC.  The allowable cost for pre-pilot must not exceed $25,000 in direct cost per project/program.   Approved pre-pilot project/program cannot be funded for more than 1 year.

2) Pilot cancer research projects or pilot cancer training and career development, cancer education, and/or cancer outreach programs (not to exceed $120,000 in direct costs per year per project/program for no more than 3 years) are allowable costs.

3) Interim support for pilot projects, which have been submitted as competitive grant applications (e.g., K-series, R-series, or equivalent), which are in the process of revision for resubmission (funding level not to exceed $120,000 per year in direct costs for no more than the duration needed for three grant review cycles), and which are expected to become full projects in the U54, are allowable costs.

4) Resources and infrastructure (e.g., tissue resources, specialized equipment) 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 cancer health disparities issues are allowable costs.  Shared infrastructure can be placed in either the MSI or the Center or in both locations.

5) Start-up packages for newly recruited investigators in areas prioritized for development and stabilization are allowable costs.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions


 You may submit (an) application(s) if your organization has any of the following characteristics:

In addition, applications will only be accepted from Minority-Serving Institutions (MSIs) (e.g., Historically Black Colleges and Universities [HBCUs], Hispanic-Serving Institutions [HSIs] and Tribal Institutions [e.g., Colleges]) either in the United States or in territories under U.S. jurisdiction, and from institutions that are NCI-designated Cancer Centers (or groups of centers) that wish to develop long-term comprehensive partnerships.  Three or more institutions (e.g. triads, groups of Cancer Centers) may apply in response to this announcement only when approved by the NCI prior to submission.

MSIs are defined as institutions at which students of minority groups that are underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, and Pacific Islanders) comprise a significant proportion of the enrollments AND at which there have been documented records of commitment to the special encouragement of minority faculty, students, and investigators.  Both, MSIs with medical schools and MSIs with more focused education and research programs (e.g., Masters and Ph.D. programs) are invited to participate in this initiative.  MSIs that offer only baccalaureate degrees and Tribal Colleges are also invited to participate in this initiative.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

The PIs 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.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.   The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

3.A. Special Requirements and Provisions

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

1) Each MSI and Cancer Center is limited to applying for no more than ONE U56.  The MI/CCP U56 is not renewable.

2) Each U56 MI/CCP program must be submitted as a clear partnership between the MSI and the Cancer Center.  This must be done by submitting two (or three) separate applications, one from the MSI and one from the Cancer Center.  The PI of the MSI grant application must be the Co-Principal Investigator (Co-PI) of the Cancer Center grant application and vice versa.  The Co-PI should be a mid-to-senior-level scientist who has established records of obtaining competitively-funded grants who will serve as role models and mentors to the partnership participants and who must commit a minimum of 10 percent effort to the partnership.  If a Co-PI is not an established, competitively funded investigator, the other more experienced Co-PI must work with him/her to develop a career and professional development plan that sets a high priority on working toward the goal of his/her becoming a well-rounded, competitively funded PI.  The overall priorities and objectives for implementation of the two applications must be the same, but the actual activities and budgets of the two applications should demonstrate how the MSI and the Cancer Center requests both differ and complement each other in achieving these priorities and objectives.

3) Of the four areas being targeted by this initiative, cancer research, cancer training, and cancer outreach must be included.

4) The application must include 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.  Letters must specifically address:

a. A specific statement detailing the per cent effort of release/protected time (minimum of 25 percent for MSI faculty and 10 percent for the Cancer Center faculty) as well as the activities that each faculty involved are being released from (e.g., teaching, clinical, administrative duties).

b. Provisions for recruitment of new faculty, space and facilities for new projects/programs, capital improvements, etc.

Note: When the institutional leadership changes during the course of the award, new letters-of-commitment must be sent addressing the issues stated above.  This letter must be received by NCI no later than 90 days after the change.

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

6) The direct costs of the applications together cannot exceed $525,000 per year.  The future years may include a COLA of 3 percent over the maximum combined direct cost budget limit for each institution in the partnership.  If there is a third/fourth party subcontract, only the direct costs of the subcontract will count against this cap.

7) There must be a common Planning and Evaluation Core shared between the MSI and the Cancer Center(s) proposals that will have as objectives the evaluation of:

a. Internal Activities -- Internal Advisory Committee (IAC) will be composed by the Co-PIs and must have equal representation from the MSI and the Cancer Center.  In addition, the Program Managers of each partnership will serve as ex-officio members. The NCI Project Scientist will not be a participant of the IAC. The expertise of the IAC members should be relevant to the objectives and goals of the partnership.  If the committee lacks the scientific expertise to evaluate a proposal, ad hoc reviewers either from within or outside the partnering institutions may be added to the IAC.  The responsibilities of the IAC are detailed below

(1) Evaluation of New Pilot and Pilot Projects/Programs -- Each new pilot and pilot project/program should be evaluated for scientific merit, relevance to the partnership objectives, potential to generate publishable data for peer reviewed journals, and potential of the pilot project/program to develop into a competitive grant application to be submitted to NCI/NIH or other equivalent funding agencies.  When a project/program co-leader is identified as a junior investigator, the application should also be evaluated for the appropriateness of the career development and mentorship plan as stated in the Section I.1 of this RFA.  Each reviewer should prepare a detailed written critique and assign a numerical score to the application according to the NIH system.

The IAC will prioritize the applications and either:  recommend the project/program be funded as is; recommend that only the most important, high-risk, and promising part of the project/program be allotted a smaller amount of funds (not to exceed $25,000 in direct costs for no more than 1 year); or not recommend the project/program due to low scientific merit, low relevance to partnership goals and objectives, low potential to generate publishable data, and/or low potential to become a competitive grant application.

(2) Evaluation of Ongoing Pre-Pilot, Pilot, and Projects/Programs-- The IAC will also perform an annual evaluation of existing pre-pilot, pilot, project/programs.

The following recommendations are possible: (1) convert pre-pilot to pilot  project/program; or (2) terminate funding of pilot project/program based on low scientific merit, low relevance to partnership goals and objectives, low potential to generate publishable data, and/or low potential to become a competitive grant application.

(3) Evaluation of Other Activities -- The IAC will make recommendations and provide guidance for workshops, retreats, focus groups and other forums to identify areas of new opportunity as well as for strengthening, stabilizing, and merging existing projects/ programs.  In addition, the committee will also evaluate and recommend other key partnership activities, such as the recruitment of new investigators, and research associates and the establishment of resources and infrastructure on the basis of their merit and potential to contribute effectively to achieving high priority goals and objectives.

The IAC evaluations and recommendations for new pilot projects/programs, ongoing pre-pilot, pilot projects/programs and other activities will be forwarded to the Program Steering Committee (PSC) for concurrence.  If the IAC recommendations change the scope of the partnership objectives, those recommendations must be reviewed and approved by the PSC.  The Co-PIs must make minutes of the IAC meetings conducted throughout the year, available to the PSC.

b. External Activities, in which a PSC evaluates overall progress on an annual basis, makes recommendations for establishing priorities, changing direction and identifying areas of new opportunities to accomplish mutual objectives more successfully.

8) In using Developmental Core funds to support pilot projects/programs, each activity must be co-led by individuals from both the MSI and the Cancer Center.  No pilot project/program can exceed $120,000 in direct costs per year of the partnership or continue for more than 3 years.  The expectation is that successful pilot projects/programs will become either full projects/programs in the U54 application or become competitively funded grants (e.g., R03, R21, R01, R25T, R25E, P50, T32, P01, K12).  Third/fourth party facilities and administrative costs are in addition to the direct costs requested.

9) Any investigator turnover (replacement of Co-Principal Investigator, Co-leader, project and/or program) must be fully documented and approved by the PSC and NCI.  Documentation should include institutional support letters, rationale for replacement in ensuring that they fall within the bounds of the areas prioritized for development and stabilization and the goals and objectives of the partnership, biographical sketches, and transition plans (when appropriate).

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

11)  All recipients of U56 MI/CCP awards must participate in a biennial MI/CCP Workshop for the purpose of sharing information and strategies.  A planning Committee will be convened by the NCI to develop an agenda for the workshop.  Travel expenses for this purpose must be included in the applications from the MSI and the Cancer Center.

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

13) Successful Partnerships are expected to participate in exporting their approaches to other NCI Centers, Networks, and MSIs.

14) No institution can have two MI/CCP cooperative agreements (U grants) simultaneously.  Institutions funded with a U56 cooperative planning grant cannot submit a U54 application to NCI before the last year of funding (fifth year).

15) The PSC must have concurrence with any U54 application that is derived from the activities of the U56 before sending the application to NCI for review.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  Applicants must use the currently approved version of the PHS 398.  For further assistance, contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms.  Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements.  The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.  The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date(s): March 20, 2006
Application Receipt Dates(s): April 19, 2006
Peer Review Date(s): June-July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: December 1, 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

H. Nelson Aguila, D.V.M.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard., Suite 7028, MSC 8350
Bethesda, MD 20892-8350 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7344
Fax (301) 402-4551
Email: Aguilah@mail.nih.gov

Technical Assistance Workshop

The NCI strongly encourages all potential applicants to attend a pre-application Technical Assistance Workshop (TAW).  Since this is a relatively 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 http://minorityopportunities.nci.nih.gov.

The NCI encourages interested applicants planning a proposal, to schedule pre-application consultations either as telephone conference calls, videoconference meetings, or as face-to-face-meetings.  To make these arrangements, contact Dr. H. Nelson Aguila at aguilah@mail.nih.gov, Dr. Peter O. Ogunbiyi at ogunbiyp@mail.nih.gov, or Ms. Belinda Locke at Lockeb@mail.nih.gov, or by telephone at (301) 496-7344. 

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application.  Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application.  Type the RFA number on the label.  Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review.  In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.).  If an application is received after that date, it will be returned to the applicant without review.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the NCI.  Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.  However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application.  That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.  The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable.  A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval.  If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred.  NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.  See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

6.A. Application Requirements

1) Face Page: Use Form Page 1 as instructed in the Form PHS 398 (rev. 9/04).  On line 1 provide a title that is representative of your partnership.  This title should be the same for both the MSI and the Cancer Center institution's applications.  On line 2 enter the title "U56 MI/CCP" and the number of this RFA, RFA CA-06-012.  Remember to affix the RFA label that comes with the Form PHS 398 to the bottom of the Face Page.

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

3) Table of Contents:  NOTE: The Table of Contents and Research Plan of the PHS 398 (rev. 9/04) applications are not specifically tailored to the unique objectives of the MI/CCP application.  Therefore, organize the Table of Contents exactly as described below:

a. Face Page

b. Description, Performance Sites and Key Personnel

c. Table of Contents

d. Detailed Budget for Initial Budget Period

(1) Total Initial Budget for all Cores

(2) Administrative Core Budget

(3) Planning and Evaluation Core Budget

(4) Developmental Core Budget

e. Budget for Entire Proposed Period of Support

(1) Total Entire Budget for all Cores

(2) Administrative Core Budget

(3) Planning and Evaluation Core Budget

(4) Developmental Core Budget

f. Budgets Pertaining to Consortium/Contractual Arrangements

g. List of all participating members

h. Biographical Sketch(s) and Other Support

(1) Principal Investigator

(2) Co-Principal Investigator

(3) All Professional Personnel in alphabetical order

(4) Internal Advisory Committee Members

(5) Program Steering Committee Members

i. Resources

j. Introduction to Revised Application (if applicable)

k. Implementation Plan: (replaces Research Plan in PHS 398 application instructions)

(1) Background and Objectives

(2) Letter-of-Commitment from the MSI or Cancer Center

(3) Chronological Review of Planning and Priority-setting Processes

(4) Scientific and Administrative Leadership

(5) Administrative Core

(6) Planning and Evaluation Core

(i)  Internal Activities

(ii)  External Activities

(7)  Development Core

(i)  Pilot projects/programs

(ii)  Resources and infrastructure

(iii)  Recruitment(s)

(8) Human Subjects

(9) Vertebrate Animals

(10) Literature Cited

(11) Consortium/Contractual Arrangements

(12) Intellectual Property

 l.  Appendix 

m. Checklist

n. Personal Data

4) Detailed Budget for Initial Budget Period - Use Form Page 4 of the Form PHS 398 application kit.  Separately break out the budget into three sections using different Form Page 4s as follows:

a. Total Initial Budget for all Cores.

b. Administrative Core - Denote the costs for personnel, supplies, travel, etc., needed to provide administrative oversight, coordination and cohesion of the partnership.

c. Planning and Evaluation Core - Delineate the costs separately for:

(1) Internal Activities should include IAC meetings, partnership workshops, retreats, committees, seminar series, and the use of ad hoc consultants to strengthen, stabilize, and merge existing programs and the processes for evaluating, prioritizing, and recommending the use of developmental funds and the process for deciding which areas the use of developmental funds should be continued or be discontinued.

(2) External activities should include the PSC (consultant costs and travel costs), which must meet once a year to evaluate the progress of the partnership as a whole toward accomplishing its objectives and make recommendations for changing direction or strategy to accomplish mutual objectives more successfully.  External processes could also include special seminar series inviting experts to make presentations to partnership participants that relate to the objectives of the partnership and then serve as ad hoc advisors in areas under development.

d. Developmental Core - Separately delineate the funds being requested for all pilot projects/programs, Resources and Infrastructure, and Recruitment.  Remember that individual Pilot projects/programs cannot exceed $120,000 in direct costs.

5) Budget for Entire Proposed Period of Support-Using Form Page 5 of the Form PHS 398, break out the total budgets separately for:

a. Total Entire Budget for all Cores;

b. Administration Core;

c. Planning and Evaluation Core; and

d. Developmental Core.

(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 as a subcontract and not as an equal partner in the partnership.  In either case, one of the MSIs or Cancer Centers would have to serve as the primary grantee and subcontract for the consortia involvement of the other MSI or Cancer Center.

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

8) Biographical Sketches and Other Support - Use Biographical Sketch Format

Page and follow the instructions in the PHS form 398 application kit for:

a. Principal Investigator;

b. Co-Principal Investigator;

c. All Key Personnel of the MSI or Cancer Center -- This section should include all professional individuals who serve in leadership roles as well as the biographical sketches of those Co-Leaders of Pilots, and Resources, as well as any named individuals who are going to be recruited, should be provided in the appropriate sections of this application;

d. Internal Advisory Committee Members; and

e. Program Steering Committee Members.

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

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

11) Implementation Plan

6.B. Additional Instructions

The Research Plan of the PHS 398 (rev. 9/04) application is not specifically tailored to the unique objectives of the MI/CCP application.  Therefore, applicants should follow the outline below:

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

2) Letters-of-Commitment: This section should be different for the MSI and Cancer Center applications and is limited to two to three pages.  The MSI institutional leadership (e.g., President, Dean) and the Cancer Center leadership (e.g., Center Director, Dean), respectively, 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/release 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 leadership must specify a minimum of 25 percent MSI faculty or a minimum of 10 percent time Cancer Center faculty that will be freed up for each investigator and must specify what current duties, (e.g., teaching, clinical duties, administrative duties) will be eliminated to allow the faculty member(s) to spend adequate time on the MI/CCP.  In addition, the institution should specify how these duties will be accommodated by others in the institution or by additional recruitments.  The institution must clearly demonstrate that it will be completely committed to a certain number of positions that will be dedicated to cancer research.  The letter should also clearly explain how the MSI and the Cancer Center leadership would be responsible and accountable for following the progress of this effort and doing what is needed to sustain it.

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

In chronological order present each process used in planning and setting the priorities and objectives for this application.  Briefly describe the nature of each completed 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, and the individuals that participated from the MSI and the Cancer Center, and its outcome.

4) Scientific and Administrative Leadership: This section should be different for each application and limited to two to three pages.  Briefly describe how the Principal Investigator was chosen in terms of the qualifications and experience to provide leadership and cohesion for this effort and to promote collaboration and cooperation in achieving the common objectives as outlined in the Background and Objectives section above.  If the Co-Principal Investigator is not an established competitively funded investigator, the partnership must include a professional development plan which outlines the activities through which he/she will become a well-rounded competitively funded principal investigator on an NIH-funded research grant (e.g., R01, P01, or equivalent).  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.

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

6) Planning and Evaluation Core:  This section must be the same for each application and limited to five pages.

a. Internal Activities - List the names of the IAC members and document each internal planning and evaluation activity (e.g., IAC meetings, regular forums and seminars, workshops, retreats, etc.) in which the objectives (or issues to be addressed) are identified, activities are described, and participating individuals from the MSI and the Cancer Center are named.  (Face-to-face informal meetings between collaborators have been found to be the most effective method of communication.  In instances where there is a problem of distance between partners, applicants are encouraged to consider other methods of communication including e-mail, teleconferences, and videoconferences). This should include how the progress of the partnership will be reported to institutional leaders.  This section must also include the IAC review and evaluation process for initiating and closing all pre-pilot, pilot 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.

b. External Activities - Excluding the Co-PIs and the NCI Project Scientist, describe how each PSC 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 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

7) Developmental Core

This section should be different for each application.

a. Pilot Projects/Programs

Pilot Projects/Programs proposed for funding, which cannot exceed $120,000 per project/program in direct costs per year of the partnership or continue for longer than three years, should be provided in the following format:

**NOTE:  (1) All NIH-supported biomedical or behavioral research projects involving human subjects must address the instructions under the Research Plan, Section E, Human Subjects of  the PHS 398 instructions; (2) Research dealing with Vertebrate Animals must be accompanied by appropriate documentation as described under the Research Plan, Section F, Vertebrate Animals of the PHS 398 instructions; (3) Research components involving clinical trials must include a data and safety monitoring plan as described in the PHS 398 instructions.  Funds should be budgeted for these activities and should be justified.  The proposed provisions should not duplicate review and monitoring systems already in place at the institution.  For any cancer treatment protocol supported directly or indirectly by the U56, early stopping rules and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application, or in the case of protocols subsequent to funding of a U56, to the NCI Program Director.

b. Resources/Infrastructure

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

c. Recruitment to be supported with Developmental Funds

The recruitment will depend on the planning, in the existing partnerships, the mechanism provides basic resources for new hires, most of the commitment, as described in the letter of support, is granted by the institutions.

For individuals who are known:

For individuals who are planned for:

Describe the number and expertise of the individuals that the partnership plans to recruit over the 5-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.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data.  Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave).  Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement.  References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application.  The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers.  However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant  recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm  and at http://ott.od.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications.  The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

6.C. GUIDANCE FOR PREPARATION OF RESEARCH TOOLS SHARING PLAN AND INTELLECTUAL PROPERTY PLAN

Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research.  The NIH is interested in ensuring that the research resources developed through this grant also become readily available to the broader research community in a timely manner for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public health.

Investigators conducting biomedical research frequently develop unique research resources.  The policy of the NIH is to make available to the public the results and accomplishments of the activities that it funds.  To address this interest in ensuring research resources are accessible, NIH expects applicants who respond to this RFA to submit a plan: (1) for sharing the research resources generated through the grant (e.g., human biospecimens and novel cancer biomarkers); and (2) addressing how they will exercise intellectual property rights, should any be generated through this grant, while making such research resources available to the broader scientific community consistent with this initiative.  Therefore, any such research resources sharing and intellectual property management plans would make unique research resources readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/ and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 http://ott.od.nih.gov/NewPages/64FR72090.pdf) (“NIH Research Tools Policy”).  These documents also: (1) define terms, parties, and responsibilities; (2) prescribe the order of disposition of rights and a chronology of reporting requirements; and (3) delineate the basis for and extent of government actions to retain rights.  Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page (http://www.iedison.gov); see also, 35 USC § 210(c); Executive Order 12591, 52 FR 13414 (Apr. 10, 1987); and Memorandum on Government Patent Policy (Feb. 18, 1983).  If applicant investigators plan to collaborate with third parties, any research resources sharing plan submitted would explain address how such collaborations will not restrict their ability to share research materials produced with NIH funding.

Reviewers will comment, as appropriate, on the adequacy and feasibility of any sharing of research resources plan and the intellectual property plan.  Comments on the plans and any concerns will be presented in an administrative note in the Summary Statement.  These comments will not affect the priority score of the application.  NIH program staff will consider the adequacy of the plans in determining whether to recommend an application for award.  The approved plans will become a condition of the grant award and Progress Reports must contain information on activities for the sharing of research resources and intellectual property.

Where it is anticipated that there will be an exchange of collections of human tissues, consideration should also be given to obtaining the appropriate assurances from the DHHS Office of Human Subject Protections (http://www.hhs.gov/ohrp) and necessary institutional review board (IRB) approvals and/or exemptions.  In addition, issues pertaining to the protection of patient identifiable information under the Privacy Rule of the Health Insurance Portability and Accountability Act of 1976 (HIPAA) should be addressed.  For more information concerning the HIPAA Privacy Rule, see the HIPAA web site at http://www.hhs.gov/ocr/hipaa.

In the development of the research resource sharing and intellectual property management plans, applicants should confer with their institutions’ office(s) responsible for handling technology transfer related matters and/or sponsored research.  If applicants or their representatives require additional guidance in preparing these plans, they are encouraged to make further inquiries to the appropriate contacts listed above for such matters.  Furthermore, applicants may wish to independently research and review examples of approaches considered by other institutions such as those described on the NCI Technology Transfer Branch web site (http://ttc.nci.nih.gov/intellectualproperty/).  The foregoing guidance is provided by way of example to assist applicants in preparing the research resources sharing and intellectual property management plans in a manner that encourages partnerships with industry.  While these approaches will likely suit most situations, these approaches are not exclusive and applicants should feel free to submit alternative versions for consideration.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NCI.  Incomplete and/or non-responsive applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCI in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

The following will be considered in making funding decisions:

This initiative is quite broad in scope and equally emphasizes cancer research, cancer training, and cancer education objectives.  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.  The review criteria below includes merit evaluation of possibilities that can expand research, training, and career development opportunities for underserved scientists and students.

Summary of Review Criteria  

1) SCIENTIFIC AND ADMINISTRATIVE LEADERSHIP:

a. Do the qualifications and experience of the Co-PIs, Co-Leaders, and other key personnel from the MSI and the Cancer Center provide strong scientific and administrative leadership that will help achieve the objectives of the partnership?

b. If applicable, is the plan to address the competitiveness of the Co-Principal investigator adequate?

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

a. What is the level of authority of officials committing to this joint effort?

b. To what degree do the letters of commitment fully support the priorities and objectives proposed for the partnership?

c. Are the resources (e.g., discretionary resources, space, faculty positions, protected time for research, etc.) committed to the partnership, adequate?

3) ADMINISTRATIVE CORE:

a. Is the proposed quality of the organizational and administrative structures, adequate for the effective attainment of U56 priorities and objectives?

b. Are the qualifications, experience and time commitment of all key personnel, adequate?

c. Is the use of the administrative core services by the budgeted activities and projects/programs, appropriate?

4) PLANNING AND EVALUATION CORE:

a. Are the qualifications and experience of each member of the Internal Advisory Committee, adequate?

b. Is the design and quality of each of the internal planning and evaluation processes, adequate?

c. Are the qualifications and experience of each member of the Program Steering Committee, adequate?

d. Is the plan for using the Program Steering Committee, effective?

e. Is the process and criteria for identifying and implementing the resource and infrastructure needs, adequate?

f. Is it appropriate and strategically adequate the actual and proposed recruitment over the 5-year period?

5) DEVELOPMENTAL CORE:

a. Evaluation Criteria for Pilot Projects and Programs (i.e. training, education, and outreach).

?      Are the qualifications of the Co-Leaders and quality of the institutional environment, adequate?

?      What is the merit and importance of the proposed pilot project/program?

?      Is the Career Development and Mentorship plan, adequate?

?      What is the potential of the Pilot project and program to develop into a competitive grant proposal in 3 years or less?

b. Evaluation Criteria for Resources/Infrastructure:

?      What is/are the contribution(s) of the proposed resource/infrastructure to the overall priorities and objectives of the partnership?

?      Are the qualifications of key personnel to operate the resource/infrastructure activity, adequate?

c. Evaluation Criteria for Recruitment:

?      What is the quality of recruitment plans and the potential of individual recruitment proposed to contribute substantially to the program?

6) OVERALL EVALUATION AND SCORING OF THE PARTNERSHIP

a. The overall degree of merit for the partnership will be based on:

?      Quality of the individual sub-components; and

?      Extent to which the two applications together :

(1) have established priorities and objectives for the partnership?

(2)  have demonstrated they worked together in preparing the application?

(3)  have clearly identified the mutual benefits for the partnership?

(4)  have shown that they can achieve the priorities/objectives within a 5-year period?

(5) have shown that if fully successful, will the implementation plan result in a stable cancer research capability for the MSI and/or result in the significant, successful training of more competitive minority cancer researchers?

(6) have shown that if fully successful, will the ability of the Cancer Center be enhanced to more directly and successfully address the disproportionate cancer burden in minority populations?

b.     The two applications will be assigned one priority score.

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed.  Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards:  If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.  The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers.  However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.  The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).  Program staff will be responsible for the administrative review of the plan for sharing research resources.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html).  Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications.  Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application.  The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant.  The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590).  See Section VI.3. Reporting.

3.  Anticipated Announcement and Award Dates: 
Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document.  Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page).  If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NoA are at the recipient's risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
 
2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other DHHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U56), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

a. The Principal Investigator will have the 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 DHHS, 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. An Internal Advisory Committee (IAC) will be responsible for internal planning and evaluation activities.  The membership and chair of the IAC will be determined by the co-Principal Investigators.  The IAC will also be responsible for establishing a process for IAC review and evaluation for initiating and closing all pre-pilot, pilot projects and programs based on their merit and potential for achieving the objectives of the partnership and their actual progress.  The IAC evaluations and recommendations will be forwarded to the Program Steering Committee (PSC) for concurrence.  The IAC should meet regularly but not less than quarterly.

c. Upon receiving the Notice of Award, the Co-PIs will convene a teleconference of the PSC to select a chair, determine the date/time of the first PSC meeting and identify the most critical elements for an effective agenda.  Once a meeting date is determined, the Co-PIs must distribute all materials that are to be evaluated within 48 hours to the PSC.  The PSC chair will make assignments for other PSC members based on their expertise and experience.  The first draft of the PSC's recommendations, in the form of a written annual report will be prepared by all members at the PSC meeting.  The PSC report should be as critical as possible and should be prepared with reasonable detail, identifying weaknesses and recommending ways to correct them.  The PSCs should pay close attention to the commitment of the leadership to the partnership and the faculty members involved.  No later than 2 weeks after the adjournment of the meeting, the final PSC report must be submitted to the Co-PIs and is to be used by the Co-PIs to guide and direct the development of the U56 program.  The PSC report must be included as part of the Non-Competing Grant Progress Report (PHS 2590).

d. Awardees will respond to the advice and recommendations of the PSC report and this response must also be included in the Non-Competing Grant Progress Report (PHS 2590).

e. Each partnership should plan regular meetings (no less than monthly) to discuss the progress and direction of its activities and to ensure that the necessary interactions are taking place.  These meetings may be in the form of teleconferencing, videoconferencing or web conferencing as well as face-to-face meetings.

f. The Co-PIs and Program Managers will attend a Biennial MI/CCP Workshop to be organized by a Planning Committee composed of participants of all the MI/CCP programs for the purpose of sharing information and strategies.

g. Each partner will submit annual progress reports (including the PSC annual meeting report and program response) to the NCI that describes activities and accomplishments during the previous funding period as part of the Non-Competing Grant Progress Report (PHS 2590).

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

a. Serve as a participating non-voting member of the PSC;

b. Work closely with individual investigators and partners to facilitate collaborations;

c. Assist the partnership efforts by facilitating access to fiscal and intellectual resources provided by NCI, NIH, industry, private foundations and federal funding agencies;

d. Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by Cancer Center Support Grants, Research Centers at Minority Institutions Infrastructure Grants, Minority Biomedical Research Support Grants or other peer reviewed funding mechanisms;

e. Interact with each partner, coordinate approaches between partners, and contribute to the adjustment of projects/programs or approaches as warranted;

f. Provide assistance in reviewing and commenting on all major transitional changes of an individual partner's activities prior to implementation to assure consistency with the goals of this RFA;

g. Coordinate activities with other ongoing studies supported by NCI to avoid duplication of effort and encourage sharing and collaboration in the development of new clinically useful agents and methodologies;

h. Coordinate access to other resources from NCI, including NCI-sponsored agents for pre-clinical and clinical testing, assistance in IND filing, etc.;

i. Link the approaches developed from these partnerships to each other and to other NCI Cancer Centers and NCI-supported networks to ensure that information is shared and utilized on the widest basis possible;

j. Help reprogram efforts within the peer reviewed scope of work, including options to modify projects/programs when projects/programs are not making headway relative to the time-line for achieving the objectives of the RFA;

k. Assist the PSC in the concurrence of new/replacement pilot projects/programs when requested for ongoing activities;

l. Monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success;

m. Recommend the approval of new Co-PIs, Co-Leaders, projects/programs, faculty recruits to ensure that they fall within the bounds of the areas prioritized for development and stabilization;

n. Select members of the Workshop Planning Committee to organize a biennial workshop that engages all of the partnerships and other participants as needed (this meeting will be held for selected funded investigators to share progress and research insights that may benefit all of the projects); and

o. Call additional meetings/workshops of the participants to address emerging areas of high priority to the NCI and/or the problems of high cancer incidence and mortality in minority populations.

The dominant role and prime responsibility for the activity resides with the awardees 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 Project Scientist.

Additionally, an agency program official or IC Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The NCI Program Director may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative.  The NCI Program Director may also serve as the NCI Project Scientist.

2.A.3. Collaborative Responsibilities

A Program Steering Committee (PSC) must be composed of up to six external advisors with the scientific expertise necessary to provide appropriate advice relative to the objectives of the U56 and for providing the most objective advice.  The Co-PIs of each partnership and the NCI Project Scientist will be participating, non-voting members.  The chairperson, who will be someone other than the PIs or NCI staff, will be selected by the PSC members.  Subcommittees with additional ad hoc advisors may be established by the PSC as necessary in order to meet its planning, priority setting and evaluation responsibilities.

The PSC will meet once per year and serve as the primary advisory board of the U56 Program and will have the responsibility of making recommendations for establishing priorities, changing direction and identifying areas of new opportunity based on continuing evaluation.  Awardees generally will be expected to accept and implement the recommendations of the PSC; in those situations where the recommendations are not feasible to implement, the Co-PIs must provide a thorough explanation and rationale in the Program Response to the PSC report section in the Non-Competing Grant Progress Report.

Each full member will have one vote.  Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process
 
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration.  An Arbitration Panel composed of three members will be convened.  It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee.  This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.  For those applications that are funded, the NCI will provide special instructions for submitting the Non-Competing Grant Progress Report.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

H. Nelson Aguila, D.V.M.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028, MSC 8350
Bethesda, MD 20892-8350 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7344
FAX: (301) 402-4551
Email: aguilah@mail.nih.gov

Peter O. Ogunbiyi, D.V.M., Ph.D.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028, MSC 8350
Bethesda, MD 20892-8350 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7344
FAX: (301) 402-4551
Email: ogunbiyp@mail.nih.gov

Belinda M. Locke, M.S.
Office of Center, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028, MSC 8350
Bethesda, MD 20892-8350 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-7344
FAX: (301) 402-4551
Email:  Lockeb@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3428
FAX: (301) 496-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Ms. Barbara Fisher
Grants Administration Branch
National Cancer Institute
1003 West 7th Street, Suite 300
Frederick, MD 21701
Telephone: (301) 846-1015
FAX: (301) 496-8601
Email: fisherb@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); and efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk.  The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule.  Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).  At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).  All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible.  This will permit other researchers to benefit from the resources developed with public funding.  The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.  This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community.  The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:

The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.  All investigators proposing research involving human subjects should read the “NIH Policy and Guidelines” on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm.

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel.  The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov).  It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.  Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH.  The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects; or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies.  The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings.  Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution.  The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas.  This funding opportunity is related to one or more of the priority areas.  Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.  The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products.  In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children.  This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas.  The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt.  Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged.  The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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