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: Feasibility Studies for Collaborative Interaction for Minority Institution/Cancer Center Partnership (P20)

Announcement Type
New

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

Program Announcement (PA) Number: PAR-07-230

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

Key Dates
Release Date: February 22, 2007
Letters of Intent Receipt Date(s):
March 13, 2007, March 15, 2008, March 15, 2009
Application Receipt or Submission Date(s): April 13, 2007; April 15, 2008; April 15, 2009
Peer Review Date(s): July 2007, July 2008, July 2009
Council Review Date(s): October 2007, October 2008, October 2009
Earliest Anticipated Start Date(s): December 2007, December 2008, December 2009
Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: April 16, 2009

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

Section II. Award Information
 1. Mechanism(s) of Support
 2. Funds Available

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

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

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
 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

Purpose

The National Cancer Institute (NCI) invites linked award applications for feasibility studies to help researchers and faculty at Minority-Serving Institutions (MSIs) establish collaborative partnerships with the researchers and faculty of NCI-designated Cancer Centers (or other institutions with highly-organized, integrated research efforts focused on cancer). The awards (using the NIH P20 mechanisms) are designed to facilitate planning and implementation of focused collaborations in cancer-related research, training, career development, education, and/or outreach. The sole intent of these P20 partnership awards is to provide support for cancer projects and programs for a limited time to perform feasibility studies and obtain preliminary data that will lead to the submission of specific competitive grant applications for support by the NCI and/or other sources of peer-reviewed funding.

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.

Feasibility Studies for Collaborative Interactions must be focused on promoting and conducting collaborative activities between the MSI and the Cancer Center in one or more of the targeted areas:

1)       Collaborative cancer research project(s);

2)       Collaborative training and career development programs designed to train students and scientists;

3)       Collaborative cancer education programs designed to create new curriculum to apprise and culturally sensitize high school, undergraduate, and/or graduate students in cancer health disparities and motivate them to pursue cancer research careers; and

4)       Collaborative cancer outreach programs designed 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.

The ultimate objective of the programs proposed for the P20 linked awards must be the submission of competitive applications to the NIH/NCI for funding by mechanisms such as:

Background

The disparities in cancer incidence, morbidity, and mortality in racial and ethnic minority populations and among the socio-economically disadvantaged have continued to rise over several decades, despite the progress in other aspects of the “War on Cancer” that began” in 1971. 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. The 5-year survival rates in the Native American, African American, Hawaiian, and Hispanic American populations are lower than in the Japanese and White Americans populations; and patterns of prostate cancer among African American males compared with White males, seen in the Southeastern United States (U.S.), particularly in rural areas, 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 (http://www.healthypeople.gov/default.htm). This initiative is also in line with the priority recommendations for U.S. Department of Health and Human Services (DHHS) to lead the Nation in eliminating cancer health disparities (Making Cancer Health Disparities History, http://www.hhs.gov/chdprg) and The NCI Strategic Plan (http://strategicplan.nci.nih.gov).

MSIs conduct high quality programs for educating minorities and they represent a rich source of talent with appropriate cultural sensitivity and perspectives needed in cancer research. However, they have had difficulties developing and sustaining independent programs in biomedical research, and there is a paucity of minority scientists 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 National Institutes of Health (NIH) research grants has been slow. More specifically, a serious shortage of well-trained underrepresented minority scientists who can conduct independent cancer research, and focus research efforts on the disproportionate burden of cancer in racial and ethnic minority and socio-economically disadvantaged populations, and whose cultural perspectives are essential to the successful conduct of research involving these populations still exist.

The NCI-designated Cancer Centers are geographically dispersed, research-intensive organizations with well-organized programs for training cancer scientists. They are the major organized units supported by the NCI to conduct cancer research; sponsor cancer-related 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, Cancer Centers can (and should) play a greater role in facilitating the following activities: (1) research pertinent to cancer in racial and ethnic minorities and socio-economically disadvantaged groups; (2) training underrepresented minority scientists; (3) reaching out to and partnering with different racial, ethnic minority populations in their communities; and (4) bringing the benefits of cancer research to these populations.

Scope

The Minority Institution/Cancer Center Partnership program is about building excellence. The feasibility studies program sponsored by this Funding Opportunity Announcement (FOA) will stimulate and support (albeit not indefinitely) the activities in the broad target areas listed below. ALL of these activities are intended to eventually generate competitively funded, support through peer-reviewed funding mechanisms.

Career and professional development activities must be developed for less experienced investigators from the MSI and Cancer Center, in particular junior investigators, and post-doctoral scientists involved in the partnerships. For the purpose of this PA, a junior investigator is a scientist and/or faculty member with no prior independent research funding from NIH or equivalent agencies. Appropriate career development plans must be proposed for individual researchers from the MSI and Cancer Center, for example for scientists designated to serve as non-lead PIs or lead PIs. The objective of this endeavor is to increase the chances that junior investigators develop the research skills and abilities needed to work in a collaborative and competitive environment and will eventually become successful independent cancer researchers. The career plan should identify mentor(s) who will be responsible for career and professional development of these individuals. Mentorship should involve senior faculty member(s) with research competence and/or experience appropriate for the role. Mentors must be individuals from the cancer center(s) 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 Cancer Center investigators with relevant research experience become mentors for less experienced senior faculty from the MSIs. The mentor(s) and the junior investigator are expected to closely interact during planning, developing, and realizing of a tailored career development plan similar to the model used in NIH career development awards. The mentoring process should include defining the expected outcomes in a way clear to both mentors and mentees. The career development plan should ensure that mentors are available to provide appropriate guidance throughout the duration of the program. The Minority Institution/Cancer Center Partnership (MI/CCP) application should provide compensation for mentors, co-mentors, and/or consultants.

Target Areas

The P20 MI/CCP grant offers four broad target areas for focused planning, development, and implementation, which are described below. The application must propose at least one joint project/program in any of these four targeted areas:

1) Cancer Research: A joint pilot research project may be in any area of basic, clinical, prevention, control, behavioral, and/or population research. A research project conducted primarily at the MSI may be in any area of cancer research, but a research project conducted primarily at the Cancer Center must specifically address one or more 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. Applicants are encouraged to consider joint research projects that involve emerging technologies such as genomics, proteomics, and nanotechnology. The expectation is that successful pilot research projects will become competitively funded grants (e.g., R03, R01, project on a P01, project on a P50).

2) Cancer Training: Joint training programs that link the faculty and students of the MSI and the Cancer Center are the most productive ways to sustain long-term effective partnerships. 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, and training that incorporates methods and tools of emerging technologies such as genomics, proteomics, and nanotechnology; there is a huge deficit of underrepresented minority scientists engaged in these research areas, areas which are highly dependent for their success on the cultural sensitivity of the researchers and in these leading edge technologies. 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 at 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 degree programs at an MSI might be linked formally to doctoral training programs at Cancer Centers. Clinical research training programs at MSIs might also include rotations for medical students and residents working 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 the submission of competitive training grant applications (e.g., T32, K12, R25) as well as individual predoctoral fellowships (F31), career development awards (K01, K08, K23, K22), and research supplements for trainees.

3) Cancer Education: Cancer education programs could focus on any effort to augment existing or create new curricula in the MSI and/or the Cancer Center that would apprise and culturally sensitize high school, undergraduate, graduate, and postdoctoral students in research, medicine, and public health of the need to reduce the disproportionate cancer burden in minority populations. Education programs that focus on informing students about emerging technologies such as genomics, proteomics, and nanotechnology that emphasize their use in cancer research are encouraged. A successful effort may result in the submission of a competitive NCI education grant application (R25) and that later should yield to institutional commitments to make these curricula an inherent component of their educational systems.

4) Collaborative Cancer Outreach: Cancer-related outreach programs in the context of this FOA are 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.

Period of Support

Applicants may apply for up to 4 years of support under the P20 MI/CCP FOA. Applicants requesting 4 years of support must clearly describe three stages of partnership development: (i) a planning stage; (ii) a priority setting stage; and (iii) an implementation stage. Applicants requesting shorter periods of support should have already identified areas of potential collaboration through planning. These applicants must document prior planning activities and clearly describe a priority-setting stage and an implementation stage.

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 NIH Exploratory Grant (P20) mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

MSI and cancer Center applicant institutions are required to submit linked applications and request linked awards for one joint partnership program.

2. Funds Available

Applicants may request a project period of up to 4 years. The combined direct costs budgeted in the two linked applications from the MSI and the Cancer Center together cannot exceed $275,000 per year, depending upon prior progress in planning and setting priorities for partnership. The amount requested should be appropriate to the stage of partnership development, and take into account that the planning and priority-setting stages are not as costly as the implementation stage. Budget requests would be expected to escalate progressively from year 1 to year 4. If there is a third/fourth party subcontract, only the direct costs of the subcontract will count against the limit of $275,000. Future years may include cost of living adjustments of 3 percent over the maximum direct cost budget limit for each institution in the partnership.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

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. Depending on the availability of funds and the number and quality of applications received, the NCI may support up to three or four new partnerships per year under this announcement.

The P20 award will provide support for:

1) Administrative costs (which may be higher in the early stage of development and lower in the late stages) for managing the planning effort, such as salaries for key personnel, travel for key personnel, equipment, and supplies to support an administrative structure.

2) Developmental costs for:

a. Initial Planning Stage, which should be focused on developing and organizing workshops, seminars, retreats, and other forms of communication to explore potential opportunities in cancer research, cancer training and career development, or cancer education;

b. Priority-Setting Stage, which should be focused on selecting the areas of greatest promise for implementation as specific types of pilot projects or programs based on merit and potential to result in a successful grant application. Pilot projects/programs cannot exceed $120,000 in direct costs per year, and may not exceed 3 years; and

c. Implementation Stage, which should be focused on implementing pilot research projects or pilot programs in training and career development, education or outreach for the explicit purpose of obtaining preliminary data for the submission of a specific grant application(s).

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Given additional requirements specified below, you may submit (an) application(s) if your organization has any of the following characteristics:

In addition, applications will only be accepted from MSIs (e.g., Historically Black Colleges and Universities [HBCUs], Hispanic-Serving Institutions [HSIs] and Tribal Institutions [e.g., colleges]) either in the U.S. or in territories under U.S. jurisdiction, and from institutions that are NCI-designated Cancer Centers (or groups of centers) that wish to develop comprehensive partnerships.

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 support.

More than one PI, or multiple PIs, may be designated on the applications from either MSI, cancer center, or both. Additional information on the implementation plans and policies and procedures to formally allow more than one PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The PI(s) 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.

Applicants who choose to designate more than one PI per component must follow the special procedures and consider additional factors explained below.

If the multiple PIs option is used, one PI from each partnering institution must be designated “contact PI.”

The decision of whether to designate a single PI or multiple PIs from each partnering organization is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PI awards will require additional information, as outlined in the instructions below. A weak or inappropriate PI can have a negative effect on the review. Multiple PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of all required reports. For further information on multiple PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 MI/CCP grant application must comply:

1) Number of concurrent applications/awards. In addition to this FOA using the P20 mechanism, there are other funding opportunities for MI/CCP programs that use the U54 and U56 mechanisms (see respective links for the latest MI/CCP FOAs using these mechanisms: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-07-045.html http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-06-012.html). Each MSI and Cancer Center must not exceed the limits of the following combinations of applications and awards for MSI/CC partnership programs: no more than two P20 applications (or awards), or one P20 application (award) and one U56 application (award), or one P20 application (award)and one U54 application (award) simultaneously. The Feasibility Studies for Collaborative Interaction for MI/CPP (P20) mechanism of support is not renewable. If two applications are submitted, they must have a different PI and must be distinctly different proposals.

2) Partnership Structure and Leadership. Each collaborative planning grant application must be submitted as a clear partnership between the MSI and Cancer Center. For each partnership, two separate applications must be submitted: one from the MSI and one from the Cancer Center. The overall objectives 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 their common objectives.

Each application may have multiple PIs but one PI from each partnering institution is expected to be designated “lead PI”. Even if there are no additional PIs from the same institution, the lead PI on the application from the MSI should be listed as the PI on the linked application from the Cancer Center and the lead PI on the application from the Cancer Center should be listed as the PI on the linked application from the MSI. When the PI from the MSI or Cancer Center is an individual with no prior experience as a PI on a peer reviewed grant, there must be a written "Letter-of-Support" from a senior member (e.g., Department Chair, Dean, Cancer Center Director) of the MSI or Cancer Center. In the letter, the senior member is expected to indicate his/her qualifications and the willingness to provide guidance to the inexperienced PI..

Any investigator turnover (replacement of a PI or a Co-Leader of project/program) must be fully documented and approved by the NCI. Documentation should include institutional commitment and 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).

3) Targeted Areas. The Feasibility Studies for Collaborative Interaction must include any of the following targeted areas:

a.       cancer research;

b.       cancer training and career development;

c.        cancer education; and

d.       cancer outreach.

4) Letters-of-Commitment. Each application must include written "Letters-of-Commitment" from the MSI leadership and the Cancer Center leadership that are supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum chance of success. A complete and specific description of such resources should include the following items:

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

b.       Provisions for space and facilities availability for new projects/programs, capital improvements, recruitment of new faculty, and other resources that may contribute to the success of the partnership.

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 Program Director/Project Scientist no later than 90 days after the change.

5) Collaborative Planning Process. Depending upon prior experience, interactions, and progress in planning, the two applications must clearly describe a collaborative planning process that includes all of the following components:

a.       Initial Planning Stage, for which the participants must describe appropriate means of communicating and identifying areas of potential collaborations and clearly explain the participation and specific roles of the Internal Advisory Committee (IAC, see below);

b.       Priority-Setting Stage, for which the participants must select the areas of greatest promise for implementation as specific types of pilot projects or programs based on merit and potential to result in a successful grant application (the PIs from both partnering components should describe the process used by the IAC to evaluate new and ongoing pilot project/programs); and

c.        Implementation Stage, for which the participants acquire preliminary data from pilot project/programs for the purpose of submitting a specific competitive grant application (in any of the target areas to the NCI or other funding agencies).

6) Nature of Projects/Programs for Development.  The applicants are required to propose at least one joint project/program in any of the four targeted areas. To qualify, pilot projects and pilot programs must represent totally new activities that do not overlap in purpose or intent with existing funded grants (e.g., P30, P50, P01, R01, National Center for Research Resources' Research Infrastructure Grants, National Institute of General Medical Sciences' Minority Biomedical Research Support Grants, EXPORT grants, Community Network Program grants, and other peer-reviewed funded programs).

For each proposed joint project/program, two project/program co-leaders must be designated (one investigator from the MSI and one from Cancer Center).

7) Internal Advisory Committee (IAC).  The PIs from both partnering components will convene a common Internal Advisory Committee (IAC) that will be made up of the PIs and other key personnel, as appropriate, from both the MSI and the Cancer Center. The IAC must have equal numerical representation from the MSI and the Cancer Center. The expertise of the IAC members should be relevant to the objectives and goals of the collaboration/partnership. If the committee lacks the scientific expertise to evaluate application for specific projects/programs, ad hoc reviewers either from within or outside the partnering institutions may be added to the IAC.

Evaluation of Projects/Programs by IAC. Each new project/program should be evaluated for scientific merit, relevance to the partnership objectives, potential to generate publishable data for peer-reviewed journals, and potential 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 a junior investigator, the application must be evaluated for the appropriateness of the career development and mentorship plan. In addition to reviewing and prioritizing new pilot projects/programs, the IAC will also evaluate ongoing pilot projects/programs and advise the PIs from both partnering components as to the general activities of the partnership and how they may contribute effectively to achieving high priority goals and objectives.

8) The Role of the NCI Program Staff. The NCI Program Director will:

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

b.       Verify 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, and/or other peer reviewed funding mechanisms;

c.        Help disseminate the approaches developed by individual partnerships across the MI/CCP and other NCI Cancer Centers and NCI-supported community networks; and

d.       Verify that participating institutions fulfill their institutional commitments and provide the partnership with the promised resources.

9) MI/CCP Workshop. All recipients of P20 MI/CCP awards will be expected to participate in a biennial MI/CCP Workshop for the purpose of sharing information and strategies. Travel expenses for this purpose must be included in the grant applications from the MSI and the Cancer Center.

10) Studies Involving Native Americans (if applicable). If an application includes participation of Native American (American Indian) or similar defined populations, a formal letter-of-support from the Tribal Nation Leader or equivalent must be included.

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 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.C) for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): March 13, 2007; March 15, 2008; March 15, 2009
Application Receipt Date(s): April 13, 2007; April 15, 2008; April 15, 2009
Peer Review Date(s): July 2007, July 2008, July 2009
Council Review Date(s): October 2007, October 2008, October 2009
Earliest Anticipated Start Date(s): December 2007, December 2008, December 2009

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 institute and/or center (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 (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

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms 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 (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 appendix materials in the pdf format (on a single CD) 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

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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

The standard PHS 398 instructions (http://grants.nih.gov/grants/funding/phs398/phs398.html) and the standard PHS398 Forms should be followed unless specific exceptions and/or additional requirements are noted below.

Face Page (PHS398 Form Page 1).The title of the partnership (Item 1) should be the same for both the MSI and the Cancer Center linked applications. The title should be unique to specific partnership (do not repeat the title of this PA) and should include the suffix “(1 of 2)” or “(2 of 2)” for applications from MSI and cancer center, respectively. Attach additional Form Page 1 sheets for each additional PI.

Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (PHS398 Form Page 2). List the lead PI first followed by the other PIs (the lead PI on the partnering application should be included as one of the PIs). Then list all Key Personnel for the Administrative Core and all Pilot projects/program in this application in alphabetical order. Finally, list the members of the IAC.

Detailed Budget for Initial Budget Period (PHS398 Form Page 4). In addition to the standard Detailed Initial Budget for the entire application, use separate PHS 398 Form Page 4 sheets to provide detailed initial budget individually for I. Separately break out the budget into sections using different Form Page 4 for each stage, as follows: (i) Planning Stage; (ii) Priority-Setting Stage; and (iii) Implementation Stage Budget.

It is expected that total requested costs in the first year will be less than costs in the second or third years, given that planning and priority-setting are not as expensive as the implementation of a project or a program.

Budget for Entire Proposed Period of Support (PHS398 Form Page 5). In addition to the standard Budget for Entire Proposed Period of Support for the entire application, use separate PHS 398 Form Page 5 sheets to provide individual budgets for each stage of partnership development during entire proposed period of support (i.e., separate budgets for the entire period of support for (i) planning stage, (ii) priority-setting stage, and (iii) implementation stage).

Use PHS398 Form Page 5 for the entire application (and continuation sheets, if needed) to provide budget justification. Provide specific justifications for costs for each year requested appropriate to the stage of development. Costs for each year would include administrative costs and developmental costs as needed within the $275,000 direct cost cap (for both linked applications together). A three percent cost-of-living escalation may be included in future years.

Budgets Pertaining to Consortium/Contractual Arrangements. Follow the PHS398 instructions to complete this information if your application (either the MSI application or Cancer Center application) involves a consortium of more than one institution of its type. One of these institutions will serve as the primary applicant institution (the one formally submitting the application) and the other one will be involved under a subcontract.

Biographical Sketches. Follow the PHS398 instructions and use the PHS 398 Biographical Sketch Format Page to provide biosketches (not to exceed four pages each) for all the individuals listed on Form Page 2 (collated in the same order).

GUIDELINES FOR THE RESEARCH PLAN SECTION

To match the unique needs of the MI/CCP application, the standard Sections A-D of the PHS 398 Research Plan are replaced by new Sections 1-6. The standard page limit of 25 pages for Sections A-D is replaced by a new limit of 25 pages for these new Sections 1-6.

Other sections of the PHS 398 Research Plan (Sections E-L) in the main body of the application are not modified and should be completed as per the standard PHS 398 instructions.

On the top of this limit for the main body of the application, additional page allocation is allowed for the specific sub-elements (pilot projects/programs and career development plans, if needed) covered in Section 6 whose numbers may vary from application to application. These additional limits are specified below in the guidelines to new Section 6.

Applicants are encouraged to use the minimum number of pages necessary to clearly and succinctly describe each element the Research Plan following the organization as described below.

Introduction to Revised/Resubmission Application (if applicable, not to exceed 3 pages; this section should be identical for both the MSI and Cancer Center applications). 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 important changes must be clearly marked in the text.

New Section 1. Background and Objectives: This section should be identical for both the MSI and the Cancer Center linked applications (2-5 pages suggested).

Describe the characteristics of the MSI and the Cancer Center that will contribute to the planning effort. The description should clearly denote the nature of the interactions and deliberations that occurred between the MSI and the Cancer Center during the preparation of these applications (and identify the individuals involved). State the objectives of the collaboration.

When Cancer Centers are not NCI-designated Cancer Centers, there should be a clear summary of the qualities of the institution that demonstrate that it has a highly organized and integrated cancer research program comparable to an NCI-designated Cancer Center.

New Section 2. Letters-of-Commitment: This section should be different for the MSI and Cancer Center applications in the linked pair (2-3 pages suggested).

The section must contain Letters-of-Commitment from the MSI leadership and the Cancer Center leadership that document: (i) full support of the proposed activities; and (ii) any commitment of resources necessary to ensure that these partnerships will have the maximum chance of success. A complete and specific description of such resources would include the following:

New Section 3. Chronological Estimate of Planning, Priority-Setting, and Implementation Stages: This section should be identical for both the MSI and the Cancer Center application (up to 5 pages suggested).

Include a chronological narrative or table listing the specific first year, second year, third year, and fourth year objectives that are expected to be achieved. For each objective, a brief statement should be made about the separate contributions of the MSI and the Cancer Center in order to achieve success. The final objective of the P20 must be the submission of a specific grant application (R03, R01, T32, K12, R25T, R25E, project on Program Project Research Grant [P01], or Spore Grant [P50]) to the NCI or other funding agencies.

New Section 4. Initial Planning Stage: This section should be identical for both the MSI and the Cancer Center application (up to 5 pages suggested).

The applicants should clearly describe the kinds of planning activities that the MSI and the Cancer Center will conduct to ensure a highly interactive and integrated effort between their faculty and scientists. These applicants should also relate each planning activity (e.g., workshop, retreat, executive meeting) to specific objectives above and name the specific faculty and interests (e.g., training, clinical oncology researchers, research in prostate cancer, establishing new curriculum in cancer health disparities, nutrition, etc.) involved in each activity.

New Section 5. Priority-Setting Stage: This section should be identical for both the MSI and the Cancer Center application (up to 5 pages suggested).

Clearly describe how the specific projects/programs will be prioritized and selected for implementation based on their merit and greatest potential for success.

New Section 6. Implementation Stage: This section should be identical for both the MSI and the Cancer Center application (not counting towards the overall page limit). For each project/program (and Career Development Plan, if needed), page limits specified below apply.

In this section, application must describe at least one (required) or more joint pilot Projects/Programs in any of the four targeted areas. Pilot Projects/Programs proposed for funding cannot exceed $120,000 per project/program in direct costs per year for up to 3 years. The description of these projects/programs should be provided in the following format.

**NOTE: (1) All NIH-supported biomedical or behavioral research projects involving human subjects must consider appropriate inclusion of Gender and Minorities and Children as noted on pages 17-27 of the PHS 398 application instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described on page 27 of the PHS 398 application instructions; and (3) Research components involving clinical trials must include provisions for rigorous data management, quality assurance, and auditing procedures. Funds should be budgeted for these activities and should be justified. The proposed provisions should not duplicate review and monitoring systems already in place at the institution.

For any cancer treatment protocol supported directly or indirectly by the P20 MI/CCP, informed consent forms, early stopping rules, and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application, or in the case of protocols subsequent to funding of a P20 MI/CCP, to the NCI program director.

Plan for Sharing Research Data

Not Applicable.

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/archive/archive/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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.

Appendix Materials

IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

For details on what items are generally allowed as Appendix materials see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

At the end of the entire application, include a List of Appendix Materials. However, do not attach Appendix materials to the application. These materials must be submitted in pdf format, see Section III. 3.B. Sending an Application to the NIH)

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

The linked applications submitted in response to this FOA will be reviewed together and will receive one (i.e., the same) priority score.

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

This FOA is broad in scope with emphasis on objectives raging from cancer research, training and career development, to education and outreach objectives. Therefore, in addition to the standard criteria of Significance, Approach, Environment, Investigators, and Innovation typically used for NIH research grants, additional review criteria for the evaluation of the specific components/aspects of the partnership are listed below.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

MSI-Cancer Center Partnership-specific aspects:

Initial Planning Stage --

Priority-Setting Stage

Pilot Research Project(s) (if applicable) --

Pilot Program(s) (i.e., training and education, if applicable)

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Is the leadership plan for multiple PIs appropriate?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

MSI-Cancer Center Partnership-specific:

Collaboration in Partnership --

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:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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
.
Not Applicable.

2.D. 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/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://ott.od.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/archive/grants/policy/nihgps_2003/index.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).

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

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 (PHS 2590) each year.

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 Locke, M.S.
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:
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:

Amy Knight
Office of Grants Administration
National Cancer Institute
1003 West 7th Street, Suite 300
Frederick, MD 21701
Telephone: (301) 846-6701
Fax: (301) 846-5720
Email: knighta@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 institutional review board (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.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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/archive/archive/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 (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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 PA 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% 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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