Expired RFA-CA-09-502: Cancer Disparities Research Partnership (CDRP) Program: Limited Competition (U54)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services

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

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

Title: Cancer Disparities Research Partnership (CDRP) Program: Limited Competition (U54)

Announcement Type
This funding opportunity announcement (FOA) is a reissue of RFA-CA-03-018.

Request For Applications (RFA) Number: RFA-CA-09-502

Catalog of Federal Domestic Assistance Number(s)
93.394, 93.395, 93.399

Key Dates
Release Date: October 24, 2008
Letters of Intent Receipt Date: November 22, 2008
Application Receipt Dates: December 22, 2008
Peer Review Date: April/May 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: December 23, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. This funding opportunity announcement (FOA) issued by the National Cancer Institute (NCI) is designed to extend the Cancer Disparities Research Partnership (CDRP) program into its second (and final) implementation stage. This limited competition FOA solicits applications for NIH U54 cooperative agreement awards from the five current recipients of the CDRP Cooperative Agreement Planning Grants (U56). The CDRP U56 awardees represent community-based institutions serving a larger fraction of generally medically underserved, low-income, ethnic and minority populations than most other healthcare institutions. Still, community-based institutions have not been proportionately involved in NCI-sponsored research initiatives pertinent to these underserved populations. The U56-based CDRP program had built the necessary clinical research infrastructure to support the development of partnerships between the awardees and their associated mentor cancer centers, which are actively involved in accrual of patient populations into NCI-supported cancer clinical trials. The transition to the U54 status under this FOA is expected to enable the CDRP sites to maximize the access, accrual, and participation of their targeted minority/underserved populations into NCI-sponsored clinical trials in cancer control, prevention, and treatment.
Mechanism of Support. This FOA will utilize the National Institutes of Health (NIH) cooperative agreement specialized center (U54) award mechanism.
Funds Available and Anticipated Number of Awards. The NCI intends to commit up to approximately $2.55 million in total costs in FY2009 and up to a total of $9.3 million over a 5-year period to support up to 3-5 awards.
Budget and Project Period. 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. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received and the availability of funds.
Eligible Institutions/Organizations. The only eligible organizations are the current recipients of the CDRP U56 cooperative agreement planning award.
Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
Number of PDs/PIs. Only one PD/PI may be designated on the application.
Number of Applications. Each current CDRP U56 awardee may submit one application.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Since this FOA involves a change in the mechanism, all applications submitted in response to this FOA will be considered new applications.
Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
Application Materials. See Section IV.1 for application materials.
Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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 and Information

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

This funding opportunity announcement (FOA) issued by the National Cancer Institute (NCI) is designed to extend the Cancer Disparities Research Partnership (CDRP) program into its second (and final) implementation stage. This limited competition FOA solicits applications for U54 cooperative agreement awards from the five current recipients of the CDRP Cooperative Agreement Planning Grants (U56). The CDRP U56 awardees represent community-based institutions serving a larger fraction of generally medically underserved, low-income, ethnic and minority populations than most other healthcare institutions. Still, community-based institutions have not been proportionately involved in NCI-sponsored research initiatives pertinent to these underserved populations. The U56-based CDRP program had built the necessary clinical research infrastructure to support the development of partnerships between the awardees and their associated mentor cancer centers, which are actively involved in accrual of patient populations into NCI-supported cancer clinical trials. The transition to the U54 status under this FOA is expected to enable the CDRP sites to maximize the access, accrual, and participation of their targeted minority/underserved populations into NCI-sponsored clinical trials in cancer control, prevention, and treatment.

This FOA is intended to: (a) support transition of some of these pilot CDRP programs from a U56 planning phase into a U54 implementation phase; (b) enable the pilot CDRP sites at community-based institutions to maximize the access and participation of their targeted minority/underserved populations into NCI-sponsored clinical trials in cancer control, prevention, and treatment. The overall goal of this new U54 CDRP program is to: (a) provide and expand the necessary clinical research infrastructure, training outreach and patient navigation and research collaborative capabilities; and (b) to increase minority/underserved patient accrual into NCI-supported cancer prevention, symptom management, and medical/surgical/radiation treatment trials. It is anticipated that, by the end of this second funding period, the impacts made by the CDRP program participants would insure their sustainability by securing additional non-NIH funding for addressing cancer health disparities in targeted communities.

Background

Since the enactment of the National Cancer Act in 1971, advances in cancer detection, prevention, and treatment have led to a steady decline in the cancer-related deaths. However, disparities in cancer incidence and mortality still exist as functions of gender, ethnicity, and socioeconomic statuses. Men are about 50% more likely than women to die from cancer. The incidences of colon and rectum cancers and of lung and bronchus cancers in Alaska Natives and African American men and women are significantly higher compared with the incidences in other ethnic groups. The death rate from prostate cancer among African-American men is almost twice that in white males. The incidence of cervical cancer in the Hispanic population has been consistently higher at all ages, and African-American women have the highest rate of deaths from cervical cancer. Five-year survival rates by selected sites among populations experiencing the negative consequences of health disparities in the United States (U.S.) (e.g., African Americans, Asians, Pacific Islanders, Hispanics, Latinos, American Indians, Native Alaskans, and/or those of low socioeconomic status) are lower than the 5-year survival rates of the rest of the population.

Socioeconomic status and cancer. Communities that are characterized by lower socioeconomic statuses for their populations generally exhibit higher cancer death rates. The cancer mortality rates for lung, trachea, bronchus, and pleura for minority males and females differ widely when measured by state economic area. Examples of geographical differences are seen in a pattern of excessive prostate cancer among African American males in the Southeastern U.S., particularly in rural areas. High rates of esophageal cancer in the District of Columbia and in the Coastal area of South Carolina appear to be related to alcohol consumption, tobacco use, and dietary deficiencies.

Risk behaviors and cancer. The significant negative consequences of cancer-related health disparities are also reflected in risk behaviors and health service utilization. These include higher rates of smoking among some populations (e.g., American Indians), strikingly higher rates of obesity among African Americans and Hispanics, and related dietary practices. Similarly, differentials have been documented by age, income, education, and race/ethnicity in these health practices as well as in cancer screening and treatment. Data confirm lower rates of cancer screening and early detection, differential treatment patterns, and greater frequency of a number of chronic diseases with similar risk profiles to cancer. These and many other factors contribute to more advanced disease at diagnosis, lower survival, and higher cancer death rates among certain population groups.

Inadequate access to healthcare and cancer. Due to a lack of screening and delays in accessing adequate healthcare, underserved populations suffer disproportionately from locally advanced cancers such as cancers of the cervix, breast, lung, and head and neck, for which radiation therapy is the primary treatment. Therefore, new pilot programs at community-based hospitals/institutions are needed to develop new strategies/approaches to address these existing cancer health disparities seen through the U.S.

Establishment of the U56 CDRP program. The first stage of the CDRP program (which was initiated in 2002) involved funding of Cooperative Agreement Planning Grants (using the U56 funding mechanism). The goal of that initiative was to get community-based hospitals/institutions to plan and develop strategies for patient accrual to radiation oncology trials, and to reduce the negative consequences of cancer disparities in underserved U.S. populations. The populations targeted by this first funding period for the CDRP (RFA-CA-03-018) were those whose members accessed the health care system primarily when in the advanced stages of their diseases. Because of these delays in obtaining adequate healthcare, radiation oncology usually represents a major component of the cancer treatment.

During the first funding period, the six CDRP awardees used the U56 funding mechanism to establish:

The clinical trial research infrastructure necessary at the community-based institution so that members of their targeted ethnic/minority, medically underserved or low income populations could participate in the latest NCI-sponsored radiation oncology or combined modality treatment trials;
Mentoring partnerships with cancer centers/institutions with clinical trial expertise, and, particularly, experience in clinical trials utilizing the TELESYNERGY® telemedicine system (http://telesynergy.nih.gov/index.html); and
The necessary community education/outreach activities and patient navigation program required before patient recruitment and accrual into clinical trials could begin.

Main goals of the initial U56 funding period. Since 2003, the CDRP U56 awards have allowed the awardees to plan, develop, and implement their cancer disparity programs. Since the initial objective/goal was to increase access and accrual of their targeted populations into primarily radiation oncology focused clinical trials, it became evident that due to the late stage of disease, co-morbidities, etc., the eligibility criteria for accrual were often too restrictive for participation in existing cooperative group clinical trials. In an effort to overcome this accrual barrier at all of the CDRP sites, supplemental funds were earmarked from the NCI’s Clinical Trial Working Group initiative to increase participation of minority/underserved patients in NCI cancer clinical trials. This allowed an expansion into surgical and medical oncology clinical trials for at least three CDRP sites, thus boosting the trial availability for many more patients and higher accrual rates.

Specific Research Objectives

Applications submitted in response to this FOA must address all of the following objectives/goals of the U54 implementation phase of the CDRP programs:

Establish and implement tracking mechanisms to determine screening, eligibility and accrual rates for all cancer and disparity patients receiving services at the CDRP sites;
Acquire specific information to identify causes of clinical trial ineligibility and non-accrual to trials;
Develop strategies and approaches to address ineligibility and accrual barriers for their targeted populations;
Increase accrual of the targeted populations to the NCI-sponsored cancer clinical trials including, but not limited to: (a) prevention trials sponsored by the NCI Division of Cancer Prevention (DCP); (b) symptom management and treatment trials sponsored by the NCI’s Cancer Therapy Evaluation Program (CTEP); (c) CDRP investigator-initiated clinical trials appropriate for disparities populations; and (d) research collaborators’ institutional clinical trials;
Refine/modify the current clinical research infrastructure as necessary to certify that the CDRP awardee institution will qualify to submit a competitive application for funding as a Community Clinical Oncology Program (CCOP) or a Minority-Based CCOP (MB-CCOP; http://prevention.cancer.gov/programs-resources/programs/ccop) at the end of the next funding period;
Disseminate the experience gained and approaches used to build the CDRP infrastructure and program to the public, targeting particularly other disparities investigators. To maximize gains to others, this dissemination goal should include sharing both successful and unsuccessful efforts. Plans for information dissemination should include publication and presentation of findings and results from ongoing U56 CDRP planning grant activities on various aspects, e.g., community outreach, patient navigation, barriers to recruitment and enrollment, etc. In addition to individual institutional reports, collaborative publications among CDRP awardees are encouraged to contrast and compare how different strategies were applied. Plans for information dissemination should include publication and presentation of findings and results from ongoing U56 CDRP planning grant activities on various aspects, e.g., community outreach, patient navigation, barriers to recruitment and enrollment, etc.;
Participate in the ongoing formal program evaluation process conducted by a current contract awarded to NOVA Research Company; and
Assume advocacy and leadership roles to assist disparities populations in the U.S. become involved in NCI-supported cancer prevention, screening, treatment, and other trials.

Main Requirements

All the CDRP U54 applicants must meet the main requirements defined below.

1. The applicant institution must have the necessary facilities to provide radiation oncology services according to current standards, such as three-dimensional treatment planning and computerized tomography (CT) simulation.

2. The applicant institution must have a level of professional expertise that, at the minimum, includes:

one board certified radiation oncologist (to be designated as the PI)
another investigator who is either a radiation, surgical, or medical oncologist who will serve as a “back-up” to the PI and be capable of assuming the role of PI in the event a change of PI is required
Physics support at one or more full-time (40 hours) physicist at the Ph.D. or M.S. level.

The PI and the ”back-up” PI are each expected to contribute at least 10% of his/her time to the CDRP grant effort. A strong rationale must be provided (in the budget justification) for commitment of less than 10%.

3. The percentage of one or more of the target populations (e.g., African Americans, Asians, Hispanics, Latinos, Native Americans, Alaskan Natives, Native Hawaiians, Pacific Islanders and/or those with low socioeconomic status) which is to be served by the applicant institution must be greater than the state average of that population according to the 2000 U.S. Census Bureau statistics (http://www.census.gov/main/www/cen2000.html). These populations must have a greater cancer incidence and/or mortality than the national average according to NCI data (http://seer.cancer.gov). The applicant institution must be a primary provider of care for the population group(s) identified above according to the respective State Department of Health statistics (http://apps.nccd.cdc.gov/uscs).

4. If the applicant institution decides to continue the research collaborations with the previously established research investigator institutions, he/she must identify a mentor or consultant from each of the current and future research collaborating institutions involved in their program.

NOTE: The existing relationships that applicants have with their mentor institutions and collaborators under the initial CDRP planning phase must now be converted into research collaborations during the U54 implementation phase. Any changes or additional new partnerships proposed for the U54 partnership should be justified. These collaborating institutions can be either an NCI-designated cancer center or a university-affiliated medical center, health care institutions or freestanding cancer centers that are accredited by:

The Joint Commission on Accreditation of Health Organizations (http://www.jointcommission.org/); or
A nationally recognized accrediting body such as the American College of Radiology (http://www.acr.org/), either in the U.S. or in territories under U.S. jurisdiction.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity announcement (FOA) will use the NIH Specialized Center (U54) Cooperative Agreements award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

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

This is 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."

This FOA is a one-time solicitation and will not be reissued.

2. Funds Available

The NCI intends to commit approximately $2.55 million in total costs in FY 09, and a total of $9.3 million over a 5-year period to support three to five awards. Future year amounts will depend on annual appropriations.

The total project period for an application submitted in response to this FOA may not exceed 5 years. An applicant may request a project period of up to 5 years with the annual budget requests gradually scaling down as follows. For the first year of the project, the applicants may request a budget up to the level of the final full year of their current CDRP U56 award. Because each CDRP site is expected to work towards complete sustainability after the next funding period, the applicants’ requested budgets for years 2 and 3 must be reduced by 20% and then finally capped at $350,000 (total costs) for years 4 and 5, reflecting the basic funding required for maintenance of the clinical trials research staff only.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Public/State Controlled Institutions of Higher Education;
Private Institutions of Higher Education;
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education);
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education);
For-Profit Organizations (Other than Small Businesses);
Regional Organizations; and
Eligible Agencies of the Federal Government.

The only eligible organizations are the current recipients of the Cancer Disparities Research Partnership (CDRP) U56 cooperative agreement planning awards.

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.

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

Resubmission applications will not be accepted through this program.

Applicants may submit only one application.

Since this FOA involves a change in the mechanism from U56 to U54, all applications submitted in response to this FOA will be considered new applications.

Applications will only be accepted from health care institutions, treatment centers, or free-standing cancer centers that are accredited by:

The Joint Commission on Accreditation of Health Organizations (http://www.jointcommission.org/); or
A nationally recognized accrediting body such as the American College of Radiology (http://www.acr.org/), either in the U.S. or in territories under U.S. jurisdiction.

Each applicant CDRP institution may decide to continue their research collaborations with their prior mentor institution/organization established during the U56 planning phase and/or establish new collaborations. Letters of Commitment from all proposed U54 collaborators must be included in the application.

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) 710-0267; Email: [email protected].

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Specific Guidelines and Modifications for Content of Application. For the application submitted in response to this FOA, follow the standard instructions for the PHS 398 Research Plan (Items 2-5 as per Revision 11/07 of the PHS 398 Table of Contents, previously known as “Sections A-D”), with the following specifications and amendments:

Additional instructions for Items 4 and 5 of the PHS 398 Research Plan are given below.
Other items of the PHS398 Research Plan remain unmodified.

Additional Instructions for Items 4 and 5 of the PHS 398 Research Plan

Item 4: Preliminary Studies/Progress Report (up to 10 pages recommended). The application must include a progress report, which must address progress made in achieving the goals and objectives of the original CDRP application during the current funding period. This section should include the following:

major accomplishments under the U56 support;
description of academic, clinical or research collaborations initiated as a result of NCI CDRP funding, including mentor/partnerships activities;
description of recruitment and retention of physicians, clinical research staff and other key personnel in the program;
description of Telesynergyâ telemedicine resource capabilities;
description of established community and outreach activities;
patient navigation program;
list of abstracts or presentations at national meetings, such as those for RTOG, ASCO, ASTRO, etc.; and
list of all publications and completed manuscripts resulting from the U56 grant, providing URLs or PubMed Central submission identification numbers where applicable.
provide patient accrual numbers by minority status/ethnicity for each year of U56 support; indicate also the yearly number and percentage of patients/participants who are: a) children; b) elderly; and c) underinsured/uninsured, if known.

In addition, Item 4 must include the following elements:

Summary of the social science/behavioral activities undertaken each fiscal year or ongoing during the U56 support, including the rationale for the studies, the number of participants involved and the results of these activities.
Summary Table showing the number of active clinical protocols opened each fiscal year since receipt of the CDRP award in each of the following categories: 1) investigator-initiated (II); 2) radiation only (R); 3) surgical only (S), medical only (M), or with radiation (RS/M); 4) cancer prevention (CP); 5) cancer control/symptom management (CC); and 6) industry/pharmaceutical (P). Indicate the new yearly accrual of patients to the different types of clinical protocols.
Summary of the clinical research infrastructure standard operating procedures the applicant institution has established during the U56 grant period to recruit its targeted minority/underserved population into NCI cancer clinical trials. A critical requirement in the next funding period is the detailed tracking of screening, eligibility, and accrual of patient population into clinical trials at each CDRP awardee site. An example could be a diagrammatic flow chart of activities/tasks involved along with designated personnel responsible for them to justify requested personnel for next funding period.

Item 5: Research Design and Methods (up to 10 pages recommended). This section will include research plans for the U54 grant period in the following areas:

A. Clinical Research Infrastructure – following an analysis of current CDRP program for strengths and weaknesses, propose modifications to achieve the overall goal of increasing accessibility and eligibility of targeted populations into NCI cancer clinical trials, including but not limited to:

1) Division of Cancer Prevention (DCP) prevention trials;

2) NCI’s Cancer Therapy Evaluation Program (CTEP) sponsored cooperative group cancer control, symptom management and treatment trials;

3) CDRP investigator-initiated disparities appropriate clinical trials; and

4) Research with collaborating institution clinical trials, etc. The ultimate goal at the end of next funding period is to acquire the capability to submit a competitive application for funding as a Community Clinical Oncology Program (CCOP) or Minority-based CCOP (http://prevention.cancer.gov/programs-resources/programs/ccop).

B. Investigator-Initiated Clinical Protocols – Applicants considering the design of any investigator-initiated clinical trial to be implemented during the U54 phase must provide a plan for scientific evaluation of the validity and appropriateness of the proposed trial before IRB submission.

C. Community Outreach Activities and Patient Navigation Program – detailed description of modifications, if any, to one or both components of the current CDRP program to increase recruitment of targeted populations into NCI-supported cancer clinical trials.

Letters of Commitment from all proposed collaborating institutions/organizations must be included in the application.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: November 22, 2008
Application Receipt Date: December 22, 2008
Peer Review Date: April/May 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July/August 2009

3.A.1. Letter of Intent

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

Descriptive title of proposed research;
Name, address, and telephone number of the Principal Investigator;
Names of other key personnel;
Participating institutions; and
Number and title of this funding opportunity.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff 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:

Rosemary S. L. Wong, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 6016, MSC 7440
Bethesda, MD 20892-7440 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-9362
Fax: (301) 380-5785
Email: [email protected]

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 non-USPS delivery)

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

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 (for U.S. Postal Service Express or regular mail)
Telephone: (301) 496-3428
Fax: 301-402-0275
Email: [email protected]

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 or renewal 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 or renewal 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 and Information

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

Representatives of all recipients of CDRP U54 Cooperative Agreement Grant Awards will be expected to participate in two Radiation Therapy Oncology Group (RTOG) meetings and the annual American Society for Therapeutic Radiology and Oncology (ASTRO) meeting, where the CDRP Program Steering Committee and Program Expert Committee meetings, respectively, are held. Travel funds for this purpose should be budgeted for in the grant application from the applicant institution.

The PI of each CDRP site and research group will serve as a member of the CDRP Steering Committee, and will participate in monthly conference calls. In addition, each CDRP awardee will present its research findings at annual meetings of the steering committee and at no more than three meetings per year. Funds for travel of the PIs and relevant staff to these meetings should be included in the proposed budget.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

Appendix Materials

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

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

Resource Sharing Plan(s)

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

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

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

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

Section V. Application Review Information

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

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

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:

Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned a priority score;
Receive a written critique; and
Receive a second level of review by the National Cancer Advisory Board.

The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as determined by peer review;
Availability of funds; and
Relevance of the proposed project to program priorities.

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

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

In addition, specific to this FOA. Does this application address important cancer-related health disparities problem(s) in their targeted population? In particular, what has been and will be the effect of the proposed studies on addressing cancer-related health disparities in their targeted population? If the aims of the application are achieved, how will the proposed collaborative undertaking advance scientific knowledge?

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

In addition, specific to this FOA:

A. Progress Report:

Is the feasibility of the proposed plans for the U54 application adequately supported by the accomplishments made during the U56 planning phase?
Do the activities and studies proposed appropriately address the strengths and weaknesses identified during the U56 planning period?
Do the mentor/partnership collaborations, community outreach and patient navigator programs established during the U56 funding period reflect this program’s potential for being successful in accruing their targeted population into NCI-supported cancer clinical trials?
Does the application adequately describe and provide the rationale for any studies of attitudes, behavior, and beliefs undertaken in the targeted population with regard to clinical trial participation?
Has the applicant shown adequate progress in developing the clinical research infrastructure at their hospital/institution/community to accrue patients to radiation oncology or multimodality NCI-sponsored CTEP cancer clinical trials?
For the applicants who designed and implemented their own investigator-initiated radiation oncology clinical trials which address some specific barriers to accrual, has accrual to these specific trials been completed, data analysis done and results published? What is the progress to date for ongoing trials?
For those applicants successful in receiving the NCI’s Clinical Trial Working Group’s supplements for expanding minority/underserved patient accrual into surgical and medical oncology clinical trials, has progress been demonstrated to justify effective use of these funds?
Has the applicant been successful during the current funding period in establishing the mentor partnerships necessary to help develop and design their current CDRP program to address cancer disparities in their targeted populations?
Has the applicant been successful in developing the community outreach activities and collaborations along with their patient navigator program in order to establish the process necessary for recruitment of their targeted population into NCI-supported cancer clinical trials?
Has the applicant participated in programs to bring the CDRP program to the attention of their local community and to the oncology community in general, including presentations, publications, and targeted meetings?

B. Future Research Plans. Has the applicant analyzed the current CDRP program to determine areas of strengths and weaknesses? Does their research plan adequately address/propose implementation of new strategies or modification of current procedures for overall improvement of program efficiency, effectiveness, and its likelihood for sustainability and eventual application to become a CCOP or MB-CCOP at the end of the U54 phase?

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

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

In addition, specific to this FOA. Are the qualifications and experience of the collaborating investigators adequate to provide strong programmatic (e.g., scientific) and administrative leadership? Are the qualifications and experience of other key personnel of the applicant and the mentor partners adequate to successfully implement and achieve the objectives of the U54 activities proposed? Do letters of commitment from their research collaborators support the priorities and objectives of the plan for the collaborative partnership?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed work take advantage of the unique features of the scientific environment or employ useful collaborative arrangements? How would resource/infrastructure provide long-term stability to the activities of the partnership? Is there evidence of institutional support?

Does the application adequately describe the infrastructure for clinical research that was established under the previous U56 award for patient participation in radiation oncology, surgical and medical oncology clinical trials?
Does the application adequately describe the resources available and necessary for the success of the program (e.g., discretionary resources, space, faculty positions, and protected time for research)?

In addition, specific to this FOA. Core Resources. Does the Telesynergy® telemedicine resource provided in the U56 planning phase been effectively and efficiently used to support their proposed research activities to achieve the goals of its application? Is each specialized resource justified as essential for the conduct of proposed research? Are the qualifications of the IT manager adequate?

2.A. Additional Review Criteria

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

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

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

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

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

2.B. Additional Review Considerations

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

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the NCI will be responsible for monitoring the resource sharing.

Data Sharing Plan. [http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm]
Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

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

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.

Throughout these Terms and Conditions of Award, the Cancer Disparities Research Partnership (CDRP) refers to all individual CDRP awardees. All the awardee institutions, principal investigators (PDs/PIs) and other key personnel (including collaborating investigators and institutions) must agree to collaborate on the goals of the CDRP Program and adhere to these Terms and Conditions of Award.

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

The PD/PI(s) will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. The PD/PI(s) assume(s) responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the NCI-CDRP program supported by the U54 in accordance with these terms and conditions of the award. The PI and Co-investigators are expected to contribute at least 10% of his/her time to the CDRP grant effort. A strong rationale must be provided (in budget justification) for commitment of less than 10%.

Specific rights and responsibilities will include the following:

Awardees have primary authorities and responsibilities for the project as a whole, including defining objectives and approaches, planning, implementing, clinical trials development, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, analysis and interpretation, preparation of publications, as well as collaboration with their partner and other awardees, and with assistance from NCI Radiation Research Program (RRP) staff;
Each U54 research project awardee must designate one representative to serve as a voting member on the NCI-CDRP Program Steering Committee (PSC). The representative could be the PD/PI or another designated co-investigator. This representative will have one vote;
All awardees must agree to abide by the decisions of the PSC. The PD/PI(s) of the U54 awards will be responsible for accepting and implementing the goals, priorities, procedures, and policies agreed upon by the PSC;
Awardees are responsible for establishing an external advisory committee composed of experts not otherwise associated with the activity;
Each CDRP awardee should conduct monthly meetings to discuss the progress and directions of its activities to insure that the necessary interactions are taking place;
The Principal Investigator, Co-Investigators, and other designated investigators will attend an annual Program Expert Committee meeting to be organized by NCI staff and held at the annual American Society for Therapeutic Radiation Oncology (ASTRO) meeting;
The CDRP awardee institutions shall work collaboratively with an evaluation organization designated by the NIH/NCI (e.g., NOVA Research Company) to facilitate evaluation of the program on an ongoing basis;
Each CDRP awardee will submit annual progress reports to the NCI that describe the activities and accomplishments during the previous funding period as part of the Non-Competing Continuation Renewal; and
CDRP 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

A designated NCI Program Director acting as a Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. The NCI Project Scientist will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

A Program Official may also have substantial programmatic involvement (e.g., as a Project Scientist or Coordinator). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications, or will seek NCI waiver.

The main NCI responsibilities pertinent to CDRP program include the following activities:

The NCI Project Scientist will be a voting member of the CDRP Program Steering Committee (PSC);
The NCI Project Scientist will work closely with individual investigators and partners to facilitate successful collaborations;
The NCI Project Scientist will facilitate access to fiscal and intellectual resources provided by RRP, NCI, NIH, other Federal funding agencies, industry, and private foundations;
The NCI Project Scientist will provide assistance in reviewing and commenting on all major transitional changes of the awardee or partner institution’s activities prior to implementation to assure consistency with the goals of this FOA;
The NCI Project Scientist will serve as liaison between the PSC, the CDRP, and the NCI;
The NCI Project Scientist will provide technical assistance and advice to the CDRP awardees and will facilitate and coordinate their interactions with other NCI staff members and other NCI and NIH programs, as needed;
The NCI Project Scientist will assist the PSC in developing and drafting operating policies;
The NCI Project Scientist will notify the Steering Committee of the NCI decisions regarding the funding of the CDRP program;
The NCI Project Scientist will review the scientific progress of individual CDRP U54 awardees, and the compliance of the awardees with the operating policies developed by the PSC;
The NCI Project Scientist will monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success;
The NCI Project Scientist will help reprogram efforts, including options to modify clinical research projects/programs when certain objectives of this FOA are not met -- Specifically, the NCI Project Scientist may recommend withholding of support, suspension, or termination of a U54 award for lack of adherence to policies established by the PSC;
Working together with PSC, the NCI Project Scientist will organize and make final decisions on the agenda for an annual workshop that engages all of the partnerships and other participants as needed. This meeting will be held for all funded investigators to share progress and research insights that may benefit all of the projects;
The NCI Project Scientist will call additional meetings/workshops of the participants to address emerging areas of high priority to the NCI and/or the problems of high cancer incidence and mortality in populations experiencing cancer disparities; and
The NCI Project Scientist will facilitate formal program evaluation, currently conducted by NOVA Research Company.

2.A.3. Collaborative Responsibilities

A. The Program Steering Committee (PSC). The NCI Project Scientist and the PD/PIs of the CDRP awards will be responsible for forming a Program Steering Committee (PSC), the main governing board of the CDRP program. The PSC will make strategic decisions with regard to goals and research implementation, including the establishment of shared resources and the development of collaborations within the CDRP.

The PSC will be composed of the following voting members: The designated PD/PI of each CDRP program U54 awardee; a senior co-investigator from the collaborating institutions; and, the NCI/RRP Project Scientist;
The PSC chairperson(s) may not be an NCI representative;
The PSC’s recommendations, in the form of a written annual report, are to be submitted to the PD/PI and co-investigators at the collaborating institutions, the Board of Scientific Advisors, sub-committees, and to the NCI;
One or more NCI-CDRP patient advocates will be included as non-voting members of the PSC;
The PSC may establish sub-committees, as it deems appropriate, such as a Program Expert Committee (PEC), which will provide advice and make recommendations to the PSC, such as changing priorities and directions or identifying areas of new opportunity. The PEC will be composed of three members from the extramural community knowledgeable in cancer disparities, and the RRP Program Director as an Ad Hoc member;
The NCI Project Scientist will serve on sub-committees, as deemed appropriate;
The PSC may, when it deems it to be necessary, invite additional, non-voting science advisors to the meetings -- The NCI reserves the right to propose such additional candidates to augment the research or patient advocate expertise of the CDRP program, when necessary; and
The PSC will meet twice every year at the summer and winter RTOG meetings. Generally, an annual meeting of the PSC, the PEC, the NCI/RRP Program Scientist, and other experts (as necessary), will be held at the annual ASTRO meeting to review and discuss individual progress and that of the overall CDRP Program.

2.A.4. Arbitration Process

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

3. Reporting

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

Reporting by U54 research awardees

In addition to the standard information about research accomplishments (as required by the PHS 2590 instructions, http://grants.nih.gov/grants/funding/2590/phs2590.doc#_Toc186430767, Section 2.2.6 “Progress Report Summary”), U54 research project awardees will be required to include in their PHS 2590 Reports information on:

Collaborative activities within the CDRP program;
Participation in the Program Steering Committee and other meetings; and
Cooperative activities with the NCI.

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:

Rosemary S. L. Wong, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 6016, MSC 7440
Bethesda, MD 20892-7440 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-9362
Fax: (301) 380-5785
Email: [email protected]

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: [email protected]

3. Financial or Grants Management Contacts:

Alice Wong
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, Room 243P, MSC 7150
Bethesda, MD 20892-7150
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-9312
Fax: (301) 496-8601
Email: [email protected]

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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy 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.