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.cancer.gov)

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

Announcement Type
This is a reissue of PAR-07-230

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-09-201

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

Key Dates
Release/Posted Date: June 11, 2009
Letters of Intent Receipt Date(s): March 19, 2010; March 19, 2011; March 19, 2012
Application Due Date(s): April 19, 2010; April 19, 2011; April 19, 2012
Peer Review Date(s): July 2010; July 2011; July 2012
Council Review Date(s): October 2010; October 2011; October 2012
Earliest Anticipated Start Date(s): December 2010; December 2011; December 2012
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: April 20, 2012

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 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. Resource Sharing Plan(s)
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 research 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

Cancer Disparities. 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).

Cancer Disparity Research in Minority-Serving Institutions (MSIs). 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 exists.

Cancer Disparity Research in Cancer Centers. 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 underserved 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.

Specific Research Objectives

The Minority Institution/Cancer Center Partnership (MICCP) program is aimed at building excellence. It is strongly encouraged that the P20 application should include some of the following components:

1. Career Developmental Plan. 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.

2. Mentorship Plan. 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 mentor and mentee. 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 may provide compensation for mentors, co-mentors, and/or consultants.

The feasibility studies program sponsored by this 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.

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. On the other hand, Master 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), individual postdoctoral fellowships (F32 and F33), career development awards (K01, K08, K23, K22), and research supplements for trainees. The cancer training activities must include proper tracking of trainees and evaluation of the program.

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 teaching 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. The cancer outreach activities must be hypothesis-driven and include proper research questions, tracking, and evaluation.

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 of Support

This funding opportunity announcement (FOA) will use the NIH P20 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

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

2. Funds Available

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 NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Note 1: Applicants may request a project period of up to four 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. 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. Third party facilities and administrative costs are excluded from direct cost caps and may be requested in addition to the $275,000 direct cost limit (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html). Future years may include cost of living adjustments of 3 percent over the maximum direct cost budget limit for each institution in the partnership.

Note 2: The P20 award will provide support for the following:

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).

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

NIH grants policies as described in the http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

Applicants who choose to designate more than one PI per component must designate one PI from each partnering institution as a contact PI.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct, with different PIs for each application.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Renewal applications will not be accepted.

In addition, there are a number of Special Requirements and Provisions with which each MI/CCP grant application must comply, such as the following:

1) Number of concurrent applications/awards. In addition to this FOA using the P20 mechanism, the MI/CCP programs use the U54 mechanism (see respective links for the latest MI/CCP FOAs using these mechanisms: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-09-501.html). Each MSI and Cancer Center may not have more than one P20 award and one U54 award simultaneously within the same partnering institutions. However, the institutions can establish and apply for P20 partnerships with different partner institutions.

2) Partnership Structure and Leadership. Each P20 MI/CCP application must be submitted as a clearly documented partnership between the MSI and the 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.

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

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:

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:

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 applications for specific projects/programs, ad hoc reviewers from either 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.

National Evaluation. The evaluation being performed by the IAC is a local evaluation of their specific MI/CCP partnership. All MI/CCP partnerships will be required to participate in a national program evaluation. The national evaluation will be contracted out by NCI to assess the effectiveness / success of the overall MI/CCP program in achieving the goals and objectives enumerated in this FOA. For example, the national evaluation will assess the extent to which the MI/CCP is fostering better collaboration between MSI and Cancer Centers; the extent to which the MI/CCP helps new investigators to become more competitive in securing NIH grant awards; increase in access of underserved populations to beneficial cancer diagnosis and treatment, etc.

Participation in Program Evaluation. All PIs of the MI/CCP partnerships are expected to participate and facilitate a national program evaluation that will be conducted by an independent evaluation organization contracted by the NCI. Conducting the national evaluation under contract ensures objectivity and credibility of the evaluation findings and recommendations. The contractor shall seek the input and cooperation of the PIs and NCI program officials in developing the program logic models and in specifying the core data elements. However, the contractor shall still conduct an objective / independent evaluation of the overall program. Each MI/CCP partnership shall submit / transmit a set of core data sets to the national program evaluator (at least semi-annually or periodically as deemed feasible by the NCI and the PIs). The data sets will include both quantitative and qualitative data necessary to adequately conduct a comprehensive cross-site evaluation of the national multi-site MI/CCP program. Data from local evaluations shall be provided to the national evaluation contractor to supplement data submitted for the national evaluation.

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

9) 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 (modified as defined in Section IV.6. Other Submission requirements). 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 in item (box) 2 of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs.

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide Items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et al. The contact PD/PI must be from the applicant organization if the PDs/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Letters of Intent Receipt Date(s): March 19, 2010; March 19, 2011; March 19, 2012
Application Due Date(s): April 19, 2010; April 19, 2011; April 19, 2012
Peer Review Date(s): June/July 2010; June/July 2011; June/July 2012
Council Review Date(s): October 2010; October 2011; October 2012
Earliest Anticipated Start Date(s): December 2010; December 2011; December 2012

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 NCI staff members to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

H. Nelson Aguila, D.V.M.
Diversity Training Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Boulevard, Suite 602, MSC 8341
Bethesda, MD 20892-8341 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7344
Fax: 301-435-9225
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 (for U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for non-USPS delivery)

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 materials must be sent to:

Referral Officer
Program Coordination and Referral Branch
Office of Referral, Review, and Program Coordination
Division of Extramural Activities
National Cancer Institute (NCI)
6116 Executive Boulevard, Room 8040, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-3428
Fax: 301-402-0275
Email: ncirefof@dea.nci.nih.gov

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 CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Information on the status of an application should be checked by the PD/PI in the eRA Commons at https://commons.era.nih.gov/commons/.

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.

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 award if such costs: 1) are necessary to conduct the project; and 2) 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 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

Partnership Structure. Each P20 MI/CCP application must be submitted as a clearly documented partnership between the MSI and the Cancer Center. For each partnership, two separate applications must be submitted: one from the MSI and one from the Cancer Center. Each application may have multiple PIs but one PI from each partnering institution is expected to be designated contact PI.

The P20 MI/CCP application should follow the structure detailed below. 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.

A. Face Page. The title of the partnership (Item 1) should be identical for both the MSI and the Cancer Center linked applications. The title should be unique to the 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.

B. Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells. List the contact PI first followed by the other PIs (the contact PI on the partnership 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.

C. Detailed Budget for Initial Budget Period. In addition to the standard Detailed Initial Budget for the entire application, use separate PHS 398 Form Page 4 sheets to provide individual detailed initial budget for each core. Separately, split the budget into sections using different Form Page 4 sheets 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 subsequent second and/or third years, since planning and priority-setting are not as expensive as the implementation of a project or a program.

D. Budget for Entire Proposed Period of Support. 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 the 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, and what is appropriate to the stage of development. The costs for each year would include administrative costs and developmental costs as needed within the $275,000 direct cost cap (together for both linked applications).

E. Budgets Pertaining to Consortium/Contractual Arrangements. Follow the PHS398 instructions to complete this information if the 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) whereas the other will be involved under a subcontract.

F. 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).

G. Research Plan.

In order to match the unique needs of the MI/CCP application, the Research Strategy section should include the Sections below.

The other sections of the PHS 398 Research Plan should be completed as per standard PHS 398 instructions.

Introduction to Revised/Resubmission (if applicable; not to exceed 1 page): 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. In addition, 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.

Section 1 in Overall Research Strategy. Background and Objectives: This section should be identical for both the MSI and the Cancer Center linked applications (not to exceed 6 pages). 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.

Section 2 in Overall Research Strategy. Letters-of-Commitment: This section should be different for the MSI and Cancer Center applications in the linked pair. 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:

Section 3 of Overall Research Strategy. Chronological Estimate of Planning, Priority-Setting, and Implementation Stages: This section should be identical for both the MSI and the Cancer Center application. 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.

Section 4 of Overall Research Strategy. Initial Planning Stage: This section should be identical for both the MSI and the Cancer Center application. 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.

Section 5 of Overall Research Strategy. Priority-Setting Stage: This section should be identical for both the MSI and the Cancer Center applications. Clearly describe how the specific projects/programs will be prioritized and selected for implementation based on their merit and greatest potential for success.

In addition to the Overall Research Strategy, an additional section is allowed for the Research Plan for each project covered in the Implementation Stage as described below.

Research Strategy for Implementation Stage of each Project: In this section, the application must describe at least one (required) or more joint pilot Projects/Programs in any of the four targeted areas (cancer research; cancer training and career development; cancer education; and cancer outreach). The Pilot Projects/Programs proposed for funding cannot exceed $120,000 per project/program in direct costs per year for up to 3 years.

This section should be identical for both the MSI and the Cancer Center applications, and does not count toward the overall page limits for the Overall Research Strategy.  Each project should have a separate Research Plan.

The description of each joint pilot 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 in the PHS 398 application instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described in 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.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application.See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

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

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group convened by the National Cancer Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Are the strengths, academic qualifications and biomedical expertise of the project investigators appropriate and sufficient for research productivity?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) Protections for Human Subjects, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, specific to this FOA, the additional review criteria will be considered for Approach:

1. Approach. MSI-Cancer Center Partnership-specific aspects:

a) Initial Planning Stage

b) Priority-Setting Stage

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

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

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, specific to this FOA, the additional review criteria will be considered for Environment(MSI-Cancer Center Partnership-specific):

Collaboration in Partnership

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

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.


Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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.

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.

A formal notification in the form of a Notice ofAward (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.

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

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.
Diversity Training Branch
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
6116 Executive Boulevard, Suite 602, MSC 8341
Bethesda, MD 20892-8341 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7344
Fax: 301-435-9225
Email: Aguilah@mail.nih.gov

Peter Ogunbiyi, D.V.M., Ph.D.
Diversity Training Branch
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
6116 Executive Boulevard, Suite 602, MSC 8341
Bethesda, MD 20892-8341 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7344
Fax: 301-435-9225
Email: ogunbiyp@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
Program Coordination and Referral Branch
Office of Referral, Review, and Program Coordination
Division of Extramural Activities
National Cancer Institute (NCI)
6116 Executive Boulevard, Room 8040, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-3428
Fax: 301-402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Ms. Penny Williams
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8791
Fax: (301) 496-8601
Email: plwilliams@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Vertebrate Animals:
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); 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 impact/priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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 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.

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.

Inclusion of Women, Minorities, and Children:
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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigators NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 FOA 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. 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 two 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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