Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov/)
Agency for Health Care Research Quality (AHRQ), (http://www.ahrq.gov)
U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) (http://www.omhrc.gov/)
U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA ) (http://www.hrsa.gov/)
U.S. Department of Health and Human Services (HHS), Centers for Disease Control (CDC) (http://www.cdc.gov/)
U.S. Department of Defense (D.O.D.) Army Medical Research and Materiel Command – (http://cdmrp.army.mil/)

Components of Participating Organizations
National Cancer Institute (NCI) http://www.cancer.gov/
National Center for Research and Resources (NCRR) (http://www.ncrr.nih.gov/)NIH
Office of Research on Women Health (ORWH)(http://orwh.od.nih.gov/)
National Institute for Allergy and Infectious Diseases (NIAID ) (http://www.niaid.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
Agency for Health Care Research Quality (AHRQ), (http://www.ahrq.gov)
U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) (http://www.omhrc.gov/)
U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA ) (http://www.hrsa.gov/)
U.S. Department of Health and Human Services (HHS) Centers for Disease Control (CDC), The National Center for Health Statistics (http://www.cdc.gov/)
U.S. Department of Health and Human Services (HHS), Centers for Disease Control (CDC), Division of Cancer Prevention and Control (http://www.cdc.gov/)
U.S. Department of Defense (D.O.D.) Army Medical Research and Materiel Command – (http://cdmrp.army.mil/)

Title: Community Networks Program (CNP) – Centers for Reducing Cancer Disparities through Outreach, Research and Training (U54)

Announcement Type
This is a reissue of RFA-CA-05-012.

Request For Applications (RFA) Number: RFA-CA-09-032

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.399, 93.226, 93.389, 93.856

Key Dates
Release Date: October 2, 2009
Letters of Intent Receipt Date: November 15, 2009
Application Receipt Date: December 15, 2009
Peer Review Date: February-March, 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: December 16, 2009

Due Dates for E.O. 12372

Not Applicable

PRE-APPLICATION MEETING

The NCI anticipates holding a pre-application meeting to which all interested prospective applicants are invited. The meeting will include: (1) a presentation by the NCI program staff members to explain the objectives of the Community Networks Program and goals and requirements for Centers for Reducing Disparities through Outreach, Research and Training; (2) discussion (by the NCI review staff members) of the application peer review process; and (3) questions and answers session. An NCI Grants Management Specialist will be available to answer financial questions. The meeting will take place on October 22, 2009 at the NIH Main campus in the Natcher Building (Bldg. 45), Room E1/E2 from 1:30 pm to 3:30 pm (EST). The meeting also will be videocast (http://videocast.nih.gov/) with an opportunity for internet viewers to submit questions by e-mail (cantom@mail.nih.gov) before and during the pre-application meeting. Updates and further details about the meeting will be available at http://crchd.cancer.gov/.

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, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The Community Networks Program (CNP) is an initiative designed to address the cancer burden in racial/ethnic minorities and other underserved populations by engaging community members through Community-Based Participatory Research (CBPR).

To address the CNP goals, this Funding Opportunity Announcement (FOA) solicits applications for comprehensive Centers for Reducing Cancer Disparities (CNP Center). The programs of the proposed CNP Centers must be based on the CBPR approach and must include the three required components: (1) Outreach; (2) Research; and (3) Training.

Applicant teams responding to this FOA must be based on established partnerships between academic institution(s) and targeted community entities/community-serving healthcare organizations. The partnering community components are expected to contribute substantially to the design of the Center programs, following the principles of CBPR.

The overall purpose of CNP Centers is to increase knowledge of, access to, and utilization of beneficial biomedical and behavioral procedures related to reducing cancer disparities ranging from prevention through early detection, diagnosis, treatment and survivorship in racial/ethnic minorities and other underserved populations. In this CNP issuance, particular emphasis is on high quality research involving properly controlled and rigorous intervention studies aimed at reducing cancer health disparities.

With the emphasis on the CBPR approach, the main goals for the CNP Centers, include the following:

Note: In the context of this FOA, the term “beneficial biomedical and behavioral procedures” refers to primary prevention measures (for example, smoking prevention and cessation, increasing Hepatitis B vaccination and Human papillomavirus vaccination, reducing obesity, increasing physical activity), secondary prevention measures (for example, mammography, Pap smear, colorectal cancer screening), evidence-based cancer treatments (i.e., treatments based on positive results of appropriate clinical trials), and survivorship supportive measures.

This FOA is open to all qualified applicants regardless of whether or not they participated in the previous CNP issuance.

Background

Critical factors in health disparities. Identifying and understanding the social determinants of health are critical factors that must be considered in efforts addressing health disparities. These determinants include (but are not limited to): socioeconomic status, culture, transportation options, housing quality, access to services, and social or environmental stressors. Addressing these factors or barriers will have an impact on communities. Although many beneficial biomedical and behavioral procedures/services are available for prevention, early detection, diagnosis, treatment and survivorship, many health disparities continue because these benefits are not shared by all. Health disparities affect various racial/ethnic minorities (e.g., African Americans, Asians, Pacific Islanders, American Indians, Alaska Natives, Hispanics or Latinos) and other underserved populations (e.g., Appalachians, rural and low socioeconomic status groups). Further efforts are needed to address these disparities. Important roles in such efforts should be played by community-driven outreach, research, and training programs.

Another, often overlooked aspect of health disparities problems are the limited number of well-trained competitive researchers in biomedical and behavioral sciences from diverse populations and/or have appropriate cultural sensitivities and insights into sources of health disparities needed for effective strategies to reduce those disparities. In addition, few investigators are trained in research approaches that engage community members, notably CBPR. Again, this deficiency is particularly pronounced for researchers from racial/ethnic minorities and other underserved populations.

Thus, there is the need to increase the number of well-trained health disparities researchers, specifically including individuals from diverse backgrounds. In this context, particular efforts are needed to foster career development of competitive researchers trained in the CBPR approach.

Community–Based Participatory Research (CBPR). CBPR is a research approach that mandates a partnership between academic investigators/trained experts and members of a community, with all parties interested in addressing a common research problem. In this approach, the community representatives serve as full research partners, who participate in the research planning, development and implementation, as well as in the evaluation and dissemination of research results. Thus, CBPR is characterized by substantial community input in the development of research proposals, implementation of the resulting research projects, and dissemination of the findings of the conducted research.

The nine principles of CBPR include the following elements:

1. Acknowledge the community;

2. Foster co-learning and capacity building for all;

3. Build on strengths and resources within the community;

4. Integrate and achieve a balance of all partners;

5. Facilitate collaborative, equitable partnership in all phases of the research;

6. Focus on the local relevance and determinants of health;

7. Involve systems development in a cyclical and iterative process;

8. Disseminate findings and knowledge gained to all partners and to involve all partners in the dissemination process; and

9. Plan for a long term process and commitment.

The need for consistent use of the CBPR principles reflects the notion that the problems of the community can be solved more readily by and with the community members.

Cancer and Co-Morbidities in the Context of this FOA. Studies indicate that racial/ethnic minorities and underserved populations carry a greater burden of co-morbidity than other population groups when diagnosed with cancer. These co-morbidities may have a negative impact on individuals’ access to services (screening and diagnostic) and in their cancer treatment. In the cancer context, co-morbidities may be divided into two groups: (1) those that are cancer-unrelated (e.g., pre-existing conditions at the time of cancer diagnosis); and (2) those that are either a cause of cancer or a side effect of cancer or the cancer treatment.

Origins of the Community Networks Program (CNP). To address cancer-related health disparities, CNP was launched in 2005 by the National Cancer Institute (NCI) Center to Reduce Cancer Health Disparities (CRCHD). Initially, 25 institutions were funded under this initiative. The initial CNP issuance focused on: (1) increasing access to and use of beneficial biomedical and behavioral procedures in primary and secondary cancer prevention, and (2) developing a cadre of well-trained competitive health disparity researchers. Since the CNP inception, CBPR was used as the underlying scientific approach to ensure that various stakeholders (community members, key organizational representatives, health care delivery team members, decision makers, and researchers) actively participate in achieving the goals of the CNP.

The initial CNP was implemented in three phases. CNP Phase I was focused on capacity building and education, and included such activities as establishing and maintaining an infrastructure to support community-based participatory education, research, and training. During the first 3 years of CNP, more than 1,250 partnerships were established with community-based organizations that served a broad range of diverse racial/ethnic minorities and other underserved populations. Also, more than 300 partnerships were established with organizations providing clinical services including primary and secondary prevention. The 25 awardees conducted more than 7,500 diverse educational activities (i.e., workshops, health fairs, home health parties) in response to the needs expressed by their communities.

CNP Phase II focused on CBPR research and training. In the CNP Phase II, awardees conducted more than 140 needs assessments to identify barriers, resources and health priorities. They developed more than 120 new educational interventions to increase primary prevention and early detection. Examples of these educational interventions included programs for: smoking cessation, encouraging proper nutrition, encouraging physical activity, Hepatitis B screening/vaccination, mammography and colorectal cancer screening. Through the work of the CNP, over 330 new investigators have been trained in cancer health disparities research. CNPs’ new investigators conducted 53 small pilot research projects as part of the training activities.

Finally in the CNP Phase III, awardees implemented strategies to establish sustainability of some of their activities beyond the initial CNP project period (April 2010) through efforts to obtain additional research and community funds. The goals for post-CNP efforts are: (1) to continue the dissemination of CNP findings and (2) to further inform health policies through education and collaborations with decision makers. To date, the CNP awardees have obtained more than $226 million in new funds. Overall CNP productivity and success are reflected by a large number of peer reviewed scientific publications (nearly 500) that have resulted from the work of the CNP awardees. In addition, CNP awardees have used lay publications, public service announcements, electronic media, national, regional and local meetings as well as other means of disseminating their findings to scientific and lay audiences.

Specific Research Objectives and Main Requirements for this FOA

CNP Centers proposed in response to this FOA must have a clear potential for a meaningful reduction in cancer disparities and other co-morbid conditions affecting defined racial/ethnic minorities and other underserved populations.

Applicants must directly address the main goals of the CNP Centers that involve using the CBPR approach to:

  1. Facilitate an increase in knowledge, access and use of beneficial biomedical and behavioral procedures in cancer disparities, which may include other co-morbid conditions (i.e. heart disease, diabetes, stroke, neuropathies, HIV/AIDS, depression, stress, trauma, cognitive function disorders and dementia);
  2. Develop and perform evidence-based intervention research to increase use of beneficial biomedical and behavioral procedures for cancer prevention, detection and treatment, which may include related co-morbid conditions; and
  3. Train and promote the development of a critical mass of competitive new researchers using CBPR to reduce health disparities.

Applicant Teams: Academic-Community Institutions Partnerships. All CNP Center applications must be based on established (and documented) partnerships among an academic institution, community organization, and community-serving healthcare providers.

Either the academic research institution or community-based organization may serve as the application submitting institution (provided such organization can provide leadership and a proper infrastructure to efficiently manage CNP Center awards).

If appropriate, applicants are encouraged to consider the option to designate in the application more than one Project Director/Principal Investigator (PD/PI). All of the designated multiple PDs/PIs must have defined and meaningful contribution to the leadership of CNP Centers.

Applicants must have prior CBPR training and experience in designing and implementing culturally appropriate interventions.

Academic partners of the applicant teams must document their experience in working effectively with racial/ethnic and underserved populations.

The partnering community members/organizations are expected to contribute substantially to the design, implementation and evaluation of the programs proposed in applications.

Target Community (ies) – National and Regional CNP Centers. Applicants must define the relevant community (or communities) for their program using a set of tangible and explicit criteria.

The community to target must be definable, for example, based on:

Applicants are expected to designate a “Headquarters” site (at the application submitting institution) and sites in additional defined locations/areas in which partnering community institutions/organizations and/or targeted populations are situated.

Headquarters site. Typically, the Headquarters site will be expected to provide scientific and/or organizational leadership to the proposed CNP Center.

Defined geographical areas. Geographical areas may be defined at the level of a city, county, and/or state.

Depending on the breadth of the proposed efforts (and the total number of sites involved), applicants may propose “National” or “Regional” CNP Centers.

All specific activities of CNP Centers proposed must be based on a thorough and properly documented assessment of the needs of the target community.

Required Components of the proposed CNP Centers:

To address properly the stated CNP goals and research objectives, all CNP Center applicants must propose the following components (described in more detail below):

  1. Administrative Core to provide the leadership structure and organizational infrastructure for the proposed CNP Center (expected to be localized at the headquarters institution);
  2. Community Outreach Program to support health promotion and educational activities;
  3. Research Program to develop and conduct evidence-based intervention research using the CBPR approach; and
  4. Training Program to develop and support training in using the CPBR approach in cancer health disparities research and other co-morbid conditions.

1) Administrative Core. Applicants must define the leadership structure and outline organizational infrastructure for the proposed CNP Center. Specific plans must be described in detail to address the following roles of the Administrative Core:

    • Leadership for the Center’s overall strategic planning;
    • Scientific leadership and oversight on using the CBPR approach and its nine core principles;
    • Scientific oversight and program evaluation to ensure quality and productivity of all three component programs;
    • Logistic/administrative support to the three required Center programs/components;
    • The creation, maintenance, and expansion (if needed) of a network of partnerships under the umbrella of the CNP Center;
    • Logistic support for trans-CNP Centers interactions (i.e., among/across the CNP Center awardees);
    • Logistic support for interactions with the NCI;
    • Logistic support for securing additional funds for outreach, research, and training (beyond the CNP funding, see Note: Planning Beyond the CNP below).

In typical settings, it is expected that the Headquarters will provide logistics and infrastructure for the Administrative Core.

2) Community Outreach Program. CNP Center applicants must design an outreach program to benefit their targeted community and critical community partners. The proposed program must be based on the documented assessment of needs in the targeted community.

In the description of this program, the following aspects must be addressed:

In planning their outreach programs, applicants should take into consideration the availability of assistance from the NCI in such areas as:

It is expected that certain activities conducted under the Outreach Program will be guided and coordinated by the NCI (for details see Section IV.6. Other Submission Requirements of this FOA). In addition, Outreach Program at each CNP will have to create and support a position for a Community Health Educator (CHE). The CHEs will be engaged in various activities directed by their “parent” Center but also in specific required activities coordinated by NCI (for details see Section IV.6. Other Submission Requirements of this FOA).

3) Research Program. CNP Center applicants must propose well-developed plans for innovative and evidence-based clinical research (including population-based studies) following the principles of CBPR.

It is expected that the proposed research will have a potential for significant impact in terms of a reduction in specific cancer disparities, which may include co-morbid conditions.

Each applicant team must design and propose two research projects:

  1. One full research project for a controlled intervention; and
  2. One pilot educational research project.

A. The full research project must be well developed and based on preliminary data obtained from the needs assessment and/or pilot studies. The overall goal must be to increase use of beneficial biomedical and/or behavioral procedures related to cancer prevention, detection, and/or treatment. The study design must include a proper comparison or control group. Applicants should designate a qualified individual (preferably an established investigator) to serve as a director of this research project.

B. The pilot educational research project proposed should be relevant to the assessed needs of the targeted community but do not require other preliminary data. The pilot educational research project is meant to serve primarily as research education experience for new or early stage investigators (as defined by NIH, see http://grants.nih.gov/grants/new_investigators/). Therefore, pilot project proposed must identify a new or early stage investigator to serve as Pilot Project Director as well as an experienced established investigator, who would serve as a mentor. The role of the mentor is to foster the research development of the mentee and increase his/her potential to compete for independent funding in the future. The mentoring plan for the Pilot Project Director must be included in the description of the Training Program (see below).

Both projects must be developed in collaboration with the established community partners and their expected outcomes should be directly relevant and useful to the community.

4) Training Infrastructure Program. Plans must describe how the proposed CNP Center applicants will build a critical mass of scientists and health professionals, particularly researchers from racial/ethnic minorities and other underserved populations, with in-depth scientific expertise and complementary skills in conducting health disparities research using CBPR. Training efforts proposed should be primarily focused on postdoctoral, new- and early-stage investigators.

Governance of the CNP Centers and Trans-CNP Activities

The activities of each CNP Center will be coordinated by the individual Center Steering Committee (CSC) acting as an executive body. In addition, applicants must plan to form a Community Advisory Group (CAG) comprised of lay, clinical, and academic members. CNP Center applicants (including all collaborating institutions) must accept that the decisions of their individual CSCs and the recommendations of the CAG will be binding for that CNP Center (as indicated in Section VI.2. Terms and Conditions of the Cooperative Agreements of this FOA).

CNP Center awardees will also be expected to share experiences and participate in trans-CNP activities.

To coordinate the trans-CNP activities, the PDs/PIs of the awarded CNP Centers will form the CNP Strategic Committee. The CNP Strategic Committee will establish a subcommittee(s) composed of invited external multidisciplinary experts to advise the CNP Strategic Committee on aspects pertinent to all CNP Centers and the entire program.

CNP awardees will be expected to follow the strategic recommendations of the CNP Strategic Committee to the extent consistent with grant regulations.

Details on the composition and functions of the CSC, CNP Strategic Committee, and External Advisory Panel are provided in Section VI.2.A.3, Terms and Conditions of Cooperative Agreement “Collaborative Responsibilities”.

The annual CNP meetings will serve as another forum to share information and exchange ideas across the awarded CNP Centers.

Note 1: Planning Beyond the CNP

The intent of the CNP is to achieve the sustainability of the sponsored activities to reduce cancer health disparities. Therefore, CNP Center awardees will be expected to vigorously seek additional funding for outreach, research and training. For example, external funding may be sought to conduct additional pilot projects beyond the scope of CNP research program. The community should be involved in all these activities.

CNP Center applicants should list in the application relevant funding from other sources and should outline their plans for the path to sustainability.

Note 2: CNP applicants are encouraged to explore possible collaborations/interactions with members of the NIH Clinical and Translational Science Awards (CTSA, www.ctsaweb.org), Science Education Partnership Awards (SEPA, www.ncrrsepa.org, or Research Centers in Minority Institutions (RCMI, http://www.ncrr.nih.gov/research_infrastructure/research_centers_in_minority_institutions/), programs sponsored by the National Center for Research Resources (NCRR, http://www.ncrr.nih.gov/). The CTSA consortium currently includes 46 medical research institutions located throughout the nation that may provide additional important expertise and resources pertinent to the translational aspects of CNP. As an institution that participate in this FOA, NCRR will facilitate such interactions. For further information contact; CTSA: Dr. Donna Jo McCloskey, mccloskd@mail.nih.gov; SEPA, Dr. L. Tony Beck, beckl@mail.nih.gov; RCMI: Dr. Sheila A. McClure, mcclursh@mail.nih.gov.

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 will use the NIH Specialized Center Cooperative Agreement (54) award mechanism(s).

The Project Director/Principal Investigator (PD/PI) 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).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The NCI intends to commit up to $23.57 million in total costs in FY 2010 and up to $117.85 million over a 5-year period to support up to 23 awards for Regional and National CNP Centers (up to five National Center awards are anticipated and the reminder for Regional Center awards).

Regional Centers. Total cost requested in application for a Regional CNP Center (a Headquarters and 2-3 additional “sites” in defined geographical areas) may not exceed $900,000 in the first year. Funding may be requested for a 5-year period with a standard 3% cost of living increase allowed for years 2-5.

National Centers. Total cost requested in application for a National CNP Center (a Headquarters and at least four additional “sites” in defined geographical areas) may not exceed $1.5 million per year in the first year. Funding may be requested for a 5-year period with a standard 3% cost of living increase allowed for years 2-5.

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 and the receipt of a sufficient number of meritorious applications.

Facilities and administrative 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 NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

In addition to the NCI, other institutions will participate in this FOA with no specific set-aside funds (mainly to provide their resources to the CNP program and CNP awardees). the Agency for Healthcare Research and Quality (AHRQ) will consider co-sponsorship of applications that propose research relevant to AHRQ’s mission and research priorities (for details on these priorities see http://www.ahrq.gov/fund/ragendix.htm).”

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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.

If appropriate, applicants are encouraged to consider the option to designate in the application more than one Project Director/Principal Investigator (PD/PI). However, the use of the multiple PDs/PIs option must be justified. In addition, to ensure meaningful contribution to the leadership of CNP Centers, individuals designated as PD/PIs will be expected to commit a substantial effort to the program (not less than 2 person months).

Typically, the single PD/PI (or at least one of multiple PD/PIs) is expected to be affiliated with the institution submitting CNP Center application. However, other arrangements in specific situations are also possible.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/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 decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/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 required reports. For further information on multiple PDs/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.

3. Other-Special Eligibility Criteria

Number of Applications. Applicant institutions may submit only one application per institution in response to this FOA. Multiple applications from the same institution will be considered non-responsive and will not be reviewed.

Resubmissions. Applicants may NOT submit a resubmission application.

Renewals. Renewal applications are NOT permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed in item (box) 2 only 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 PD/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 such as Signing Official [SO] or Peer Reviewer in Internet Assisted Review [IAR] 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 (NoA).

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: November 15, 2009
Application Receipt Date: December 15, 2009
Peer Review Date(s): February-March, 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010

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 IC staff 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:

María Teresa Canto, DDS, MS, MPH
Disparities Research Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Boulevard, Room 602
Bethesda, MD 20892–8341 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8589
FAX: 301-435-9213
Email:cantom@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the 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 service; non-USPS service)

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

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express 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) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or 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.

Information on the status of an application should be checked by the Principal Investigator 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. The Grants Policy Statement can be found at 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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

Research Plan Page Limitations

CNP Centers U54 applicants must demonstrate in the application their ability to meet:

Terms and Condition of Award.

Modification to PHS 398 Instructions for Application Preparation

Table of Contents (PHS 398 Form Page 3): Modify Page 3 of the PHS 398 to replace standard Items 2-5 of the PHS 398 Research Plan with the following new sections:

Budget (PHS 398 Form Pages 4 and 5): Follow the current PHS 398 instructions to provide a detailed budget (direct costs) for the entire application for the first 12-month period (Form Page 4) and the entire proposed project period (Form Page 5). Include appropriate budget pages for any subcontractual arrangements proposed.

Use additional Form Pages 4 and 5 to provide detailed budget information (itemized costs for first year and cumulative budgets for the entire project period) for the following individual application components:

  1. Administrative Core (include costs for personnel, travel, the Center Steering Committee meetings etc.);
  2. Community Outreach Program (include costs for any new/additional needs assessments required to developed and expand educational activities and CHE support);
  3. Research Program – full research project (include costs for personnel, supplies, etc.);
  4. Research Program – pilot educational research project (include costs for personnel, supplies, etc.);
  5. Training Program – (include costs of planned seminars, courses, mentoring activities, and travel of new or early stage investigators to national meetings and workshops related to training and career development plan).

RESEARH PLAN: The standard PHS398 Research Plan (Items 2-5) is altered as follow:

Note: Within the stated overall page limit, numbers of pages “suggested” in the text below for an individual section are provided solely as nonbinding guidance for applicants. Applicants are encouraged to use the minimum number of pages necessary to describe the research plan clearly and succinctly.

Other items of the PHS398 Research Plan remain unmodified.

Section N1: Center Overview and Targeted Community(ies) (suggested 2-3 pages)

Present the overall vision for the proposed CNP Center including the following segments:

Section N2: Team and Leadership (Administrative Core) (suggested 8-10 pages)

In this section, describe the following aspects of the proposed CNP Center:

Note that the Administrative Core budget should not exceed 20% of direct costs requested for the entire Center.

Community Involvement

Section N3: Community Outreach Program (suggested 10 pages)

Describe the specific aims to attain the community outreach program goal of increasing knowledge of, access, and use of beneficial biomedical and behavioral procedures to reduce cancer burden.

CNP Center Directed Activities

Note: The CNP Center funds cannot be used to pay for the biomedical procedures or clinical services (the awardees will have to use existing resources from established partnerships that provide these services).

NCI-coordinated activities (National Outreach Network)

These NCI-coordinated activities will be conducted mainly by specific, trained individuals designated as Community Health Educators (CHEs). These individuals must have knowledge of the NCI programs and experience in communications, comprehensive cancer control, training, program planning, and evaluation. The CHE will work with the community and NCI’s National Outreach Network (http://cis.nci.nih.gov/ncioutreach.html) to identify, develop, and disseminate health promotion/cancer education materials, important NCI messages, etc. In their plans, CNP Center applicants should anticipate that approximately 50% of the workload of Community Health Educators will be devoted to NCI-coordinated activities and the remainder 50% to Center-directed activities. In this context, the plans should also include description of procedures for evaluating the impact of the NCI-coordinated activities.

Given the needs, it is expected that approximately 20% of direct costs requested for the entire Center should be allocated to the Community Outreach Program to be sufficient. This budget allocation should include support (up to $125,000 per year) for one CHE position.

Section N4: Research Program (limit 28 pages)

Describe the overall strategy to develop and perform evidence-based intervention research addressing CNP goals (outlined in Section I of this FOA).

Provide detailed description of two pertinent research projects:

  1. Full research project (intervention study); and
  2. Pilot research project.

Both projects must use the CBPR approach. Expected characteristics of projects are:

  1. Full research project (intervention study) (up to 20 pages):
  1. Pilot Educational Research Project (up to 8 pages) must be directed by a junior faculty member, who meets the NIH requirements for new or early stage investigator (http://grants.nih.gov/grants/new_investigators/). This pilot project should be designed as part of the training experience of that individual, who should have an identified established investigator as a mentor. This research project should include one of the following options:
    • An assessment of and changes in knowledge, attitudes, and/or behaviors of racial/ethnic and underserved populations regarding participating in NCI sponsored clinical trials. In designing the pilot study, consider collaborations with other NCI-sponsored resources/programs [e.g., the NCI Cancer Centers (http://cancercenters.cancer.gov/), the Community Clinical Oncology Program (CCOP) and the Minority-Based Community Clinical Oncology Program (MB-CCOP) (http://dcp.cancer.gov/programs-resources/programs/ccop), Clinical Trials Cooperative Groups (http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group), and/or the NCI Community Cancer Center Program (NCCCP) (http://ncccp.cancer.gov/)].
    • An assessment of and changes in the knowledge, attitudes, and/or behaviors related to the collection of bio-specimens from racial/ethnic minorities and other underserved populations. A few NCI programs/resources for potential collaborations in this area include the Cancer Genome Atlas (TCGA) (http://cancergenome.nih.gov/) and the Office of Biorepositories and Biospecimen Research (OBBR) (http://biospecimens.cancer.gov/default.asp).
    • An evaluation of the effectiveness of trained patient navigators in the recruitment to clinical trials and/or bio-banking, or
    • Other projects that promote the role of racial/ethnic and other underserved populations in the research enterprise.
    • Budget for pilot research project should not exceed $80,000 (direct costs) per year (same limit for National and Regional Centers).

For both projects, applicant should outline their plans to disseminate information gained and proposed approaches to increase the use of beneficial biomedical and behavioral procedures to reduce the cancer burden. Dissemination may be directed to communities, researchers, healthcare providers and health policy decision makers. Posting the description of an intervention in Cancer Control P.L.A.N.E.T. (http://cancercontrolplanet.cancer.gov/) is one of the actions that should be generally considered.

Note: Submission of data pertaining to specific communities/populations to the NIH and the use of such data in scientific publications may require approval or clearance from appropriate entities (e.g., community organizations, tribal Councils, etc.). For applications selected for funding, all such approvals must be obtained (and properly documented) prior to the award as part of Just-in-Time requirements.

It is expected that all the combined activities of the Research Program will correspond to at least 50 % of the direct costs requested for the entire Center.

Format for the description of Research Projects:

The CNP center applicant needs to describe each research project in sufficient detail to enable reviewers to judge its scientific merit. The description must contain the following elements:

Section N5: Training Program (suggested 8 pages)

The proposed CNP Centers must have a training program with the overall goal to increase the number of qualified health disparity researchers experienced in using CBPR approach. The major focus is expected to be on junior faculty members and postdoctoral fellows.

In this section, describe the following elements:

OTHER REQUIREMENTS

CNP Center applicants must have prior CBPR training and experience in designing and implementing culturally appropriate intervention.

Awardees must agree to the award administration information detailed in Section VI.2.A, “Cooperative Agreement Terms and Conditions of Award.

Site Visits and Annual Meetings. Because of the complexity of the CNP Centers, NIH/NCI program staff members will conduct annual administrative site visits. CNP Center applicants must agree to participate in this process and should plan for annual visits (with appropriate budget, including travel for collaborators and other necessary costs). Applicants must plan appropriate travel funds for the PD/PI and team leaders (up to three persons) to participate in the annual meeting of CNP awardees.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CDs only, and 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 of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Include documentation of previous collaborations such as a Memorandum of Agreement(s) (MOA) or Memorandum of Understanding(s) (MOU) that clearly delineates the roles and responsibilities of the collaborating individuals and organizations/institutions.

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: Investigators seeking $500,000 or more in direct costs in any year 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/.

Note on Data Sharing: It is the responsibility of applicants to identify any approval or clearance from appropriate entities (e.g., community organizations, tribal Councils, etc.) that might be needed for submission of data from the proposed studies to the NIH and use of these data in scientific publications. Applicants whose applications are selected for funding will be required to submit (as part of Just-in-Time requirements) documentation that they secured such approvals or clearances.

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 and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer 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:

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?

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) protection of human subjects from research risks, 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?

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?

NIH considers the following in evaluating Center grant applications:

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

(A) Criteria for Overall Evaluation of the Proposed Centers: Will the proposed CNP Center have a significant impact on the broader field of health disparities? What is the potential of the proposed Center to impact on the relevant cancer disparities within the targeted community(-ies)? Is the choice of the targeted community(-ies) appropriately based on the established partnerships and well justified in terms of the goals of CNP? What is the potential contribution of the proposed CNP Center on changes in the state of knowledge, opinions, and practices in the targeted community (-ies)? Do the applicants have appropriate prior CBPR training and experience in designing and implementing culturally appropriate interventions?

(B) Review Criteria for Center Structure and Administrative Core: How appropriate is the Center structure in the context of the goals of the CNP? How well do all the proposed efforts take advantage of the infrastructure of the proposed CNP Center and existing resources of the participating institutions? Will the proposed Administrative Core effectively coordinate the efforts of the participating institutions and outside interactions at the CNP Center level? Do the applicants provide credible evidence of institutional and community support through letter or memorandum of Agreement (MOA) or Memorandum of Understanding (MOU) and description of previous collaborations?

(C) Review Criteria for Community Outreach: Is there evidence of ongoing productive interactions among participating investigators/institutions and the community? Is the scope and nature of the past collaborations between the academic and community partners adequate to meet the stated requirements for the proposed CNP Center? Do the applicants describe clearly the way in which community partners will be included in all the activities of the proposed CNP center? What is the likelihood that the proposed outreach, training, and education activities will accomplish the anticipated effects on the targeted community(-ies)?

(D) Review Criteria for Research Program: How appropriate are the full research project and pilot educational project proposed for the CNP goals? How creative is the research program for the proposed Center? Is the intervention proposed for the full research project entirely original or is it a new application (to a different racial/ethnic or underserved population)of a known intervention type? Does the research program adequately reflect the recommendations from the community needs assessment(s)? How well is the proposed full research project (intervention study) culturally tailored for the community of interest? How strong are the preliminary results and study design in terms of the best possible balance of scientific rigor, implementation constraints, and ethical treatment of community partners? Are the potential limitations of the study design and CBPR approach adequately addressed? Is there an adequate plan for facilitating dissemination and translation of study findings through the CBPR process? How well will the proposed pilot project serve the purpose of fostering career development of junior investigators?

(E) Review Criteria for Training Program: How experienced are the applicant team members in training and fostering career development of new and early stage investigators? How adequate is the training program, including the mentoring plan, in the context of the overall Center profile and the goals of CNP? Is the environment of the proposed Center conducive to research training of new and early stage investigators?

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.

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/priority 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 Agent 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).

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.

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.

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

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

These Terms and Conditions of Award apply to all individual CNP Center U54 awardees. All the awardee institutions (including collaborating community entities), principal investigators (PDs/PIs) and other key personnel must agree to collaborate on the goals of the CNP Center.

2. A.1. Awardees and Principal Investigators Rights and Responsibilities

The Principal Investigators(s) will have the primary responsibility for:

Note on CHE: The PD/PI(s) will ensure that the activities of CHE are properly divided between the CNP Center directed activities (50%) and the NCI-coordinated activities (50%). For the NCI-coordinated activities, the CHE will interact closely with the NCI staff members and will interface with researchers, partners, and members of the targeted community. A CHE must have experience in and knowledge of research (an M.S., M.P.H. or equivalent degree is desirable). The CHE will be obliged to participate in NCI-sponsored training and other communication activities to ensure consistency and access to the latest cancer information.

General Awardees Rights and Responsibilities

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

2. A.2. NIH Responsibilities

NCI program staff member(s), acting as Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below: Responsibilities of the NCI Project Scientist(s) will include the following aspects:

The NCI reserves the right to award reduction or suspension of funds for a CNP Center that is unable to realize its research projects and/or other programs.

The NCI Project Scientists will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, these individuals will seek an NCI waiver according to the NCI procedures for management of conflict of interest.

Additionally, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. A Program Official may also have substantial programmatic involvement (as a Project Scientist). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications, or will seek an NCI waiver.

2. A.3. Collaborative Responsibilities

Individual CNP Center Steering Committee (CSC)

Awardees will collaborate with the NCI Project Scientist(s) to establish and maintain a Steering Committee for their CNP Center (CSC), which will function as an executive body for that Center.

As needed for a given Center, the CSCs will be composed of scientists, community leaders, and/or community facilitators.

Membership of the individual CSCs will include:

The chair of the CSC will be one of the CNP Center’s PDs/PI. Decisions and recommendations of the CSC will be binding for that CNP.

Responsibilities of the CSC will include:

CSC meetings need to be organized so to accommodate the schedule of the assigned NCI Project Scientist.

Community Advisory Groups (CAGs)

The CAG to each CNP Center will facilitate involvement of the community and their guidance. Members of the CAG will include the director of CNP Center’s Outreach Program and community partners.

CNP Strategic Committee

The CNP Strategic Committee will serve as trans-CNP body to support the discussion, exchange of ideas and strategic evaluation of the program and progress across CNP Centers. The CNP Strategic Committee will consist of the following voting members:

Other NCI staff members may be invited to participate in the meetings of the CNP Strategic Committee as needed.

If the decisions of CNP Strategic Committee require voting, each represented CNP Center will have one vote. Regardless of the number of representatives, the NCI will have collectively one vote.

Responsibilities of the CNP Strategic Committee will include the following aspects:

The chair and co-chair of the CNP Strategic Committee as well as the NCI Project Scientists may be members of any subcommittee as they deem appropriate. Additional NIH staff members may also participate as appropriate.

CNP Strategic Committee will conduct one face-to-face meeting per year (during the CNP Annual Meeting, see below) and monthly teleconference calls. The Expert Advisory Subcommittee will meet twice a year, once by teleconference call and once face-to-face during the CNP Annual Meeting.

Other Joint Activities. CNP awardees and the NCI Project Scientist(s) will jointly plan and organize an annual CNP conference. The goal for these conferences is to:

2.A.4. Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Strategic Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's rights in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Should problems arise in the conduct of the study, the NCI may require that the Center awardee submit quarterly reports on progress and fiscal matters.

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:

Kenneth C. Chu, PhD
Disparities Research Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Boulevard, Room 602
Bethesda, MD 20892-8586 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8589
FAX: 301-435-9213
Email: kc10d@nih.gov

Leslie C. Cooper, PhD, MPH, BSN
Disparities Research Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Boulevard, Room 602
Bethesda, MD 20892–8341 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8586
FAX: 301-435-9213
Email: lc58q@nih.gov

María Teresa Canto, DDS, MS, MPH
Disparities Research Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Boulevard, Room 602
Bethesda, MD 20892–8341 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8589
FAX: 301-435-9213
Email:cantom@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 regular or express 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. Crystal Wolfrey
Office of Grants Administration
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: 301-496-8634
E-mail: crystal.wolfrey@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); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

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

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/.

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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (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 investigator’s 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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