NCI Community Oncology Research Program (NCORP) - Minority/Underserved Community Sites (UM1)

NCI Community Oncology Research Program (NCORP) - Minority/Underserved Community Sites (UM1) is sponsored by National Cancer Institute (NCI). This program aims to bring cancer clinical trials and cancer care delivery research to individuals in their own communities, especially minority and underserved populations. The goal is to generate evidence to improve patient outcomes and reduce cancer disparities.

Expired RFA-CA-13-014: NCI Community Oncology Research Program (NCORP) - Minority/Underserved Community Sites (UM1) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating National Cancer Institute ( NCI ) Funding Opportunity Title NCI Community Oncology Research Program (NCORP) Minority/Underserved Community Sites (UM1) UM1 Multi-Component Research Project Cooperative Agreements June 13, 2018 - This RFA has been reissued as RFA-CA-18-017 . November 15, 2013 - See Notice NOT-CA-14-011.

Public Pre-application Webinar for this FOA. Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-CA-13-012 , RFA-CA-13-013 Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.

393, 93. 394, 93. 395, 93.

399 Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) solicits applications from institutions/organizations to participate in NCI's Community Oncology Research Program (NCORP) as NCORP Minority/Underserved Community Sites.

The goal of NCORP is to build upon the scope and activities of NCI's previously supported community networks, the Community Clinical Oncology Program (CCOP) which includes CCOP community sites (CCOPs), Minority-Based CCOP sites (MB-CCOPs), and CCOP Research Bases, and NCI's Community Cancer Centers' Program (NCCCP) by establishing a single community-based research program.

NCORP will be an integrated national network to: 1) design and conduct cancer prevention, control and screening/post-treatment surveillance clinical trials; 2) design and conduct cancer care delivery research; 3) enhance patient and provider access to treatment and imaging clinical trials conducted under the reorganized National Clinical Trials Network (NCTN); and 4) integrate disparity research questions into clinical trials and cancer care delivery research.

NCORP consists of three components each with its own FOA, which are: NCORP Research Bases; NCORP Community Sites; and NCORP Minority/Underserved Community Sites (covered by this FOA). The NCORP Minority/Underserved Community Sites will accrue patients/participants to NCI-approved cancer clinical trials and cancer care delivery research designed by NCORP Research Bases and NCTN Groups.

The Minority/Underserved Community Sites provide access for practicing oncologists who serve large numbers of racial/ethnic minority and underserved patients to the NCI clinical trials network, as well as provide a unique opportunity to identify and address clinical trial and cancer care delivery research questions related to the more serious, prevalent cancers and cancer-related problems which persist in racial/ethnic minorities and other Letter of Intent Due Date(s) AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Looking ahead : NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and NIH’s Applying Electronically website for more information.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description This Funding Opportunity Announcement (FOA) is one of three FOAs that implement the NCI Community Oncology Research Program (NCORP).

The overall goal of NCORP is to bring cancer clinical trials, as well as cancer care delivery research, to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes and a reduction in cancer disparities.

NCORP is expected to interact with the main NCI-supported clinical trial program NCI National Clinical Trials Note: The NCTN structures are evolving from the current main clinical trials program, the NCI Clinical Trials Cooperative Groups .

Because not all awards for the NCTN components may be in place at the time of NCORP application submission, the further text related to FOA requirements provides dual references, e.g., "Clinical Trials Cooperative Groups or NCTN Operations Centers".

NCORP will support the following components that will be individually awarded through the respective FOAs indicated below: NCORP Research Bases (see RFA-CA-13-012 ); NCORP Community Sites (see RFA-CA-13-013 ); Minority/Underserved Community Sites (this FOA ) NCORP Research Base is defined as a research hub for NCORP program.

Research Bases must be located at leading institutions with comprehensive expertise in cancer clinical trials, such as institutions that are cancer foundations, healthcare research organizations (including sites of Clinical Trials Cooperative Groups or NCTN Group Operations Centers), NCI-designated Cancer Centers, or integrated healthcare systems.

These institutions must have an established organizational structure for the design and conduct of multi-center cancer prevention, control and screening/post-treatment surveillance clinical trials and cancer care delivery research.

The Research Base provides scientific and statistical leadership for developing, implementing, and analyzing multi-institutional cancer prevention, control, and screening/post-treatment surveillance clinical trials, quality-of-life studies embedded within treatment and imaging clinical trials and studies on cancer care delivery.

The Research Bases will be responsible for study operations and data management, including timely protocol development, compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements, audits, training, quality assurance, and site support.

NCORP Community Site is defined as a consortium of community hospitals and/or oncology practices or a community-based integrated healthcare system that accrues participants to: 1) cancer prevention, control, and screening/post-treatment surveillance clinical trials designed and conducted by the NCORP Research Bases; 2) NCTN-sponsored cancer treatment and imaging clinical trials, as well as quality-of-life studies embedded within them; and 3) cancer care delivery research where participants can be defined as patients, practitioners, and/or healthcare organizations.

NCORP Minority/Underserved Community Site is defined as a consortium of community hospitals and/or oncology practices, a public hospital, or academic medical center that has a patient population comprising at least 30% racial/ethnic minorities or rural residents and accrues participants to: 1) cancer prevention, control, and screening/post-treatment surveillance clinical trials designed and conducted by the NCORP Research Bases; 2) NCTN-sponsored cancer treatment and imaging clinical trials, as well as quality-of-life studies embedded within them; and 3) cancer care delivery research where participants can be defined as patients, practitioners, and/or healthcare organizations.

This FOA solicits applications specifically for NCORP Minority/Underserved Community Site awards. Applicants interested in other NCORP components must use an appropriate companion FOA. Although cancer clinical research has traditionally been conducted at academic medical centers, the bulk of cancer care takes place in the community setting.

Expanding clinical research beyond the academic environment allows access to a larger and more diverse patient population treated in a variety of real-world healthcare delivery settings, which can accelerate accrual to clinical trials, allow for feasibility testing of promising new interventions in variable care environments, and increase the generalizability and relevance of study findings.

Engaging community oncologists in collaborative research can also facilitate the uptake of effective, evidence-based practices into routine care.

In recognition of the importance of community-based clinical research, three decades ago, the NCI launched the Community Clinical Oncology Program (CCOPs, MB-CCOPs, and CCOP Research Bases) to form a clinical trials network to expand patient and physician access to cutting-edge cancer treatment clinical trials outside of traditional academic medical settings, as well as develop multi-institutional cancer prevention, control and screening clinical trials.

In the years since, the CCOP network has become a key component of the national cancer clinical trials enterprise, contributing a substantial proportion of accrual to phase 2 and 3 treatment and imaging clinical trials with significant representation of minority patients, and implementing a series of pivotal and influential multi-institutional clinical trials in cancer prevention, control, and screening.

In 2007, the NCI’s Community Cancer Centers Program ( NCCCP ) was initiated to explore ways in which community hospitals could enhance access to care, improve the quality of care, and expand research across the entire cancer continuum with a focus on diverse racial, ethnic, and underserved populations.

Strong clinical trial programs remain essential to address the many unmet needs in cancer prevention, control, screening, and treatment. Yet findings from health services research and the promising role of quality improvement initiatives underscore the critical, complementary role of care delivery structures, processes, and organizational policies as determinants of patient care experiences and outcomes.

Systematic studies and improvement of these factors are important in assuring that all patients, specifically those from minority/underserved populations, benefit from the best available knowledge about cancer prevention, control, screening, and treatment.

The importance and influence of cancer care delivery on patient care have led to the emergence of cancer care delivery research as a multidisciplinary field of scientific investigation that studies how complex, multi-level forces including social factors, financing systems, organizational structures and processes, health technologies, provider and individual behaviors affect cancer outcomes, access to cancer care, the quality and cost of cancer care and ultimately the health and well-being of cancer patients and survivors.

Its focus includes individuals, families, organizations, institutions, providers, communities, populations, and their interactions. As the bulk of cancer care occurs in a community setting, community-based care organizations must be a key focus of cancer care delivery research that seeks to understand and improve patient outcomes based on these factors.

Goal, Scope, and Strategy of the NCORP NCORP, while maintaining a vigorous program for the design and conduct of cancer prevention, control, and screening clinical trials and participation in NCTN treatment and imaging clinical trials, will expand the scope of activity to include cancer care delivery research.

An important component of NCORP will be research on the diverse and multi-level factors that affect access to and quality of care in the community and also increase the focus on minority/underserved populations that are underrepresented in clinical trials and for which cancer care delivery issues are of great importance.

During the start-up and initial phase of NCORP, the expected relative balance in the level of effort between clinical trials and cancer care delivery research will be approximately 90% and 10%, respectively for a given Research Base and this is reflected in the FOA funding estimates.

However, funding from other sources can be used to augment the cancer care delivery To address these goals, it is anticipated that NCORP awardees will focus on the following activities: Implementing an integrated national network of community organizations and Research Bases that will: 1) design and conduct cancer prevention, control, and screening/post-treatment surveillance clinical trials; 2) design and conduct multi-level cancer care delivery research; and 3) enhance patient and provider access to treatment and imaging clinical trials conducted under the reorganized NCTN.

Facilitating the participation of minorities and other underserved populations across all study types and settings. Increasing the integration of health disparities questions across all study types and settings. Integrating the expertise of primary health care providers, other specialists, and health services and behavioral researchers with oncologists, especially as they relate to transition in care.

Accelerating the translation of knowledge gained from cancer clinical trials into clinical practice. Accelerating the transfer of knowledge from cancer care delivery research into healthcare systems and organizations. The current CCOP agenda for clinical trials is expected to be continued under NCORP as its predominant activity.

Specifically, the NCORP agenda is expected to include the following aspects: Cancer prevention research aimed at identifying and evaluating interventions to reduce cancer risk and incidence. Cancer control research aimed at reducing the incidence and co-morbidity of cancer and its treatment and enhancing the quality of life of those affected by cancer.

Cancer screening research aimed at evaluating early diagnosis and Secondary endpoints of health-related quality of life or patient-reported outcomes in NCTN treatment trials.

New areas of special emphasis will include studies addressing mechanisms of cancer symptoms and treatment-related toxicities, observational or longitudinal studies to understand the natural history of cancer symptoms and treatment-related toxicities, molecularly targeted agents to understand toxicities, post-treatment surveillance, underdiagnosis and overdiagnosis, and management of precancerous lesions.

Post-treatment surveillance studies will evaluate the use of optimal screening modalities or tumor markers designed to detect recurrences of cancers following curative intent. Methods of diagnosis for cancers will be collected within NCORP trials to facilitate the collection of data required to evaluate over and under diagnosis of cancers (e.g., interval breast cancer between screenings).

NCORP will also build an infrastructure and research agenda for cancer care delivery research that includes the following: Developing the necessary data infrastructure and site training for the conduct of studies. Analyzing new or existing data to better understand current patterns of cancer care in the community setting.

Observational studies of the effect of alternative care models on patient outcomes (e.g., patterns of care or service utilization; health behavioral improvement programs; organizational structures such as integrated healthcare systems versus freestanding hospitals; organizational policies such as reimbursement arrangements).

Interventional studies of approaches (single and multi-level) to improve care delivery practices across the cancer care continuum (e.g., decision-making tools to support genomically-informed diagnostic testing or therapies; new approaches for team-based care such as multi-modality therapy planning and delivery, patient navigation or other care processes to evaluate care transitions and incorporation of patient reported information into clinical decision-making).

The NCORP cancer disparities research agenda will integrate into clinical trials and cancer care delivery research, as appropriate, the Studies to enhance participation of racial/ethnic and other underserved populations underrepresented in research.

Studies that address determinants of disparities (e.g., social factors, health care system factors, co-morbidities, genomics) that disproportionately affect outcomes for racial/ethnic and underserved NCORP’s operating approach will share the principles underlying the transformation of the national cancer clinical trials enterprise and the creation of the NCTN.

Essential features include: A coordinated and collaborative process involving broad representation from the oncology community, including academic and community clinical investigators, translational science investigators, statisticians, medical informatics, patient advocates, health services, behavioral, and disparities researchers, and healthcare administrators, for generating concepts for clinical trials and care delivery research studies.

Evaluation of concepts for clinical trials and cancer care delivery research for scientific merit by NCI-managed steering committees composed of leading experts from the extramural community in cancer prevention, control, screening/post-treatment surveillance, care delivery and disparities, community oncologists and patient advocates, consistent with national priorities for cancer prevention, control, and screening/post-treatment surveillance clinical trials and cancer care delivery research.

Efficient and timely activation, conduct, and completion of studies, through the effective integration of scientific expertise with operational management capabilities.

Incorporation of innovative science into clinical trials and cancer care delivery research through collaboration with institutions and investigators conducting basic or early phase clinical trial research relevant to cancer prevention, control and screening as well as those conducting exploratory research on new care delivery approaches and methodologies. NCI-supported Programs.

In addition to the three key components of NCORP which will be directly funded by the NCORP, other NCI-supported research programs and their awardees will have important supporting roles in achieving the research objectives of the NCORP.

The NCORP awardees will be expected to interact with such entities/programs as the NCTN, the NCI Clinical Trials Tumor Banks, the NCI Cancer Trials Support Unit , the pediatric and adult NCI Central Institutional Review Boards (CIRBs), research programs of NCI’s Center to Reduce Cancer Health Disparities, and NCI Advisory and Scientific Committees including the NCI Scientific Steering Committees.

Program Evaluation : NCORP will be subject to external evaluation (to be coordinated by NCI Program Staff) near the end of the project period. Such evaluation is part of NIH efforts to optimize the efficiency of funded research. Section II.

Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed Glossary and the PHS 398 Application Guide provide details on these application Funds Available and Anticipated Number of Awards The National Cancer Institute intends to commit an estimated total of $9. 3 million ($7. 3 million for cancer clinical trials and $2 million for cancer care delivery research ) for up to 14 awards in FY 2014.

Future year amounts will depend on annual appropriations. Application budgets are not limited, but need to reflect the actual needs of the proposed project. Because the nature and scope of the proposed research will vary from application to application, the size of each described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Additional eligibility provisions: Applicant institutions must be healthcare providing entities (such as hospitals, integrated care systems, academic medical centers, etc.).

An applicant must have a catchment area comprising at least 30% racial/ethnic minorities or rural population; An applicant may be an NCI-Designated Cancer Center if: 30 percent or greater of its patients are a racial/ethnic minority or rural population; the Center focuses on research and methodologies to analyze outcomes in cancer disparities; and the Center can demonstrate experience in community outreach and accrual of minority or rural populations.

Additional information on eligibility: Definition of racial/ethnic minorities or rural population Office and Management Budget (OMB) guidelines will define race/ethnicity (see OMB Statistical Policy Directive No. 15: from sites that serve rural areas and wish to be considered for the NCORP Minority/Underserved component should meet the 30 percent requirements for this underserved population using criteria for describing rural populations from sources such as the OMB, U.S. Census Bureau Rural and Urban Taxonomy or the Rural/Urban Commuting-Area Taxonomy.

Applicants should address the following to demonstrate that the proposed catchment area has cancer-related provider shortages or cancer service barriers due to lack of proximity to cancer centers or practices (see Health Resources and Services Administration: Defining Rural Populations: http://www. hrsa. gov/ruralhealth/policy/definition_of_rural.

html , http://www. ncbi. nlm.

nih. gov/pmc/articles/PMC1449333/ ).

Please note demographic information can be county-based but must include information about physician-to-population ratios, access to advanced technologies, the environment in which rural physicians practice oncology (e.g., higher overhead, travel from urban or more densely populated towns, high unemployment and poverty among patients, cultural barriers) and other features that influence health outcomes among rural populations.

Institutions not eligible to apply include: A Lead Academic Program (LAP) funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI. Department of Veterans Affairs hospitals, or military treatment facilities are not eligible to apply, but may be included in an application as a member of a consortium led by a qualified applicant, although they may not be the applicant organization or the major contributor to patient accrual.

Institutions funded as clinical trials cooperative group affiliate programs are not eligible to apply unless they state in the application that support through this award will be relinquished if a NCORP Minority/Underserved Community Site cooperative agreement is awarded.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3. Additional Information on Eligibility Each applicant organization may submit only one application in response to this FOA.

.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

Section IV. Application and Submission Information Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 2. Content and Form of Application Submission It is critical that applicants follow the instructions in Application Guide , except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Worta McCaskill-Stevens, M. D. , M.

S. National Cancer Institute (NCI) 9609 Medical Center Drive, Room 5E502, MSC 9785 Bethesda, MD 20892-9785 (for U.S. Postal Service regular or express mail) Rockville, MD 20852 (for non-USPS delivery) Telephone: (240) 276-7050 Applications must be prepared using the PHS 398 research grant application forms and 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) At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to: National Cancer Institute (NCI) 9609 Medical Center Drive Bethesda, MD 20892-9750 (for U.S. Postal Service regular or express mail) Telephone: (240) 276-6390 All page limitations described in the PHS 398 Application Page Limits must be followed, with the following exceptions or additional Research Strategy must consist of the following sub-sections with the indicated page limits: A.

Organization and Structure - 12 pages C. Clinical Trials Research Program - 12 pages D. Cancer Care Delivery Research Program - 12 pages E.

Operations/Data Management Core - 12 pages Instructions for the Submission of UM1 Applications The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a UM1 All instructions in the PHS 398 Application Guide Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic All instructions in the PHS 398 Application Guide All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Modify the Table of Contents to include the required sub-sections of Research Strategy: A.

Organization and Structure C. Clinical Trials Research Program D. Cancer Care Delivery Research Program E.

Operations/Data Management Core Detailed Budget for Initial Budget All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: should provide an itemization showing for each expense category how the initial period budget is divided between Clinical Trials expenses and expenses for Cancer Care Delivery Research. Applicants may visit the NCORP website at http://prevention. cancer.

gov/ncorp for a worksheet that may help them complete the application budget section.

Budget for Entire Proposed Period of All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Applicants should provide within the budget justification an itemization showing for each expense category how the entire period budget is divided between Clinical Trials expenses and expenses for Cancer Care Delivery Research.

NOTE: Budget requests may include the following allowable items: partial support for the PD(s)/PI(s) salaries but ONLY for time spent on NCORP organizational/administrative tasks; salary support for full or part-time research nurses, pathologists, administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); handling of investigational drugs related to NCI-approved protocols; travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel); and special personnel resources needed to support the recruitment and retention of eligible minority participants on clinical trials/studies.

The following items are NOT allowed in the budget requests: costs of clinical care provided to patients (e.g., for patient care reimbursement, transportation costs); salary support for clinical support personnel (e.g., physicist, clinical psychologist, and dosimetrist); and physician compensation (other than specified above for PD(s)/PI(s) for their NCORP Community Site related administrative activities).

All instructions in the PHS 398 Application Guide All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: In addition to standard information, provide in this section documentation of important capabilities and available resources as indicated for specific functional components of the NCORP Minority/Underserved Community Site below.

Relevant information may be provided in tabular form as listed below. Applicants are strongly encouraged to use, as appropriate, table templates provided at http://prevention. cancer.

gov/ncorp .

Table 1 NCORP Components/Sub-components Table 2 NCORP Site Accrual Record Table 3a Currently Active NCI Clinical Trials Table 3b NCI Clinical Trials Expected to be Table 4 Current and/or Planned Research Base Table 5 NCORP Site Capabilities Table 6 Past Experience in Cancer Care Delivery Table 7 Audit Summary Report Table 8 - Number of Newly Diagnosed Cancer Patients Facilities: List and provide specific details on the available facilities, including laboratories, inpatient and outpatient resources, cancer registries, affiliated providers, delivery systems, etc. Clearly describe space available for administrative activities and personnel to serve as primary locus for data management, quality control, and communication.

The description of this administrative space may be included in the Resources Section. Commitments: Provide factual details documenting other resources committed to the program by the participating institutions.

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Aims: Outline the Specific Aims of the proposed Minority/Underserved Community Site, indicating how they fit into the overall goals of the NCORP Program and the key requirements of the FOA. This section must consist of the sub-sections A-E A. Organization and Structure Structure for NCORP Research Activities.

Organizational Structure for NCORP Research Activities. Describe the current and/or planned organizational structure under which the applicant proposes to conduct clinical trials and cancer care delivery research. Include an organizational chart.

NCORP Minority/Underserved Community Sites are expected to function as consortia of the Minority/Underserved Community Site awardee institution and several partners. Depending on the relationship to the proposed Minority/Underserved Community Site institution, specific partners are Community Site "components" or "sub-components" .

of Community Site Component: In the context of NCORP Minority/Underserved Community Site structure, a "component" refers to a