RFA-CA-07-501: NCI Limited Competition Supplements for Pilot Projects for Community Networks Program to Reduce Cancer Health Disparities (U01)

Part I Overview Information

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

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

Title: NCI Limited Competition Supplements for Pilot Projects for Community Networks Program to Reduce Cancer Health Disparities (U01)

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
This is a reissue of RFA-CA-06-504, which was released on March 2, 2006, and is affiliated with grants funded in connection with RFA-CA-05-012, which was released on April 26, 2004.

Request For Applications (RFA) Number: RFA-CA-07-501

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

Key Dates
Release Date: October 17, 2006
Letters of Intent Receipt Date(s): November 20, 2006; May 29, 2007
Application Receipt Date(s): December 18, 2006; June 27, 2007
Peer Review Date(s): March 2007; September 2007
Council Review Date(s): May 2007; January 2008
Earliest Anticipated Start Date(s): August 2007; February 2008
Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: June 28, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The purpose of this limited competition Request For Applications (RFA) is to enable the NCI Community Networks Program (CNP) awardees to apply for competitive supplements for pilot projects as part of the Community Networks Program RFA-CA-05-012 requirements.
The NCI intends to commit approximately $2,000,000 in each of FY 2007 and FY 2008 to fund up to 27 competitive supplements in response to each submission date for this announcement.
This funding opportunity will use the NIH Competitive Supplement award mechanism to supplement currently funded (U01) CNP awards (see https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-05-012.html).
Eligible institutions or organizations are the current CNP awardees (institutions/organizations) that have transitioned to Phase II (as defined in RFA-CA-05-012).
Eligible principal investigators (PIs) are the current CNP awardees (i.e., PIs of CNP awards) who have transitioned to Phase II. Project Leaders, who will conduct the pilot projects, must be new investigators (see https://grants.nih.gov/grants/guide/notice-files/not97-231.html for the definition of new investigator), and include any individual with the skills, knowledge, and resources necessary to carry out the proposed research, are invited to collaborate with the PI to develop an application for support.
Each CNP awardee (PI) may submit up to four separate applications per submission date. Each CNP can have up to four applications funded per fiscal year.
The application should be within scope of the parent CNP grant.
See Section IV for application and submission information.
Telecommunications for the hearing impaired is 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 and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    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

The purpose of this limited competition RFA is to solicit competitive supplements from the NCI Community Networks Program (CNP) awardees for pilot projects in community-based participatory research to reduce health disparities as part of the Community Networks Program RFA-CA-05-012 requirement.

GOAL AND OBJECTIVES OF THE CNP PILOT PROJECTS

Phase II of the CNP is the development and implementation of community-based participatory research/training programs to reduce cancer health disparities. The development of pilot projects is a part of the training program. The previous RFA, CA-05-012, entitled “Community Networks To Reduce Cancer Health Disparities,” included the following statements:

“II.2. Develop pilot research projects. As part of the CNP research efforts, the Community Networks Program will develop and implement collaborative developmental pilot research projects involving community-based participatory research in cancer health disparities. Pilot research projects should address the spectrum of research on cancer health disparities from needs assessments to intervention research to policy assessments. A principal objective of this research is the development of efficacious community-based participatory interventions to reduce cancer health disparities that can be used nationwide.”

The pilot projects are new activities. They should be within the scope of the parent CNP grant and will require additional personnel, equipment, and/or other resources. The competitive supplement application must be submitted, peer reviewed, and obtain a scientifically meritorious score to be considered for award.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH competitive supplement award mechanism to an existing CNP cooperative agreement grant.

The Project Leader is expected to closely collaborate with the CNP PI and/or the mentor in planning, directing and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for 1 year of support is submitted with the application.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator (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 PI, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award." However, these competing supplements are to be performed by the Project Leaders and their staff with no assistance from NCI, unless stated in the application.

2. Funds Available

The NCI intends to commit approximately $2,000,000 in each of FY 2007 and FY 2008 to fund up to 27 competitive supplements in response to this RFA for each submission date. An applicant may request a project period of 1 year and a budget for direct costs of no more than $50,000 per award.

The number of competitive supplements recommended for award will depend on the overall scientific merit and program priorities of the applications reviewed.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Eligible institutions or organizations are the current CNP awardees (institutions/organizations) that have transitioned to Phase II.

In addition, the parent CNP grant must have a minimum of 2 years remaining on the parent CNP grant period.

1.B. Eligible Individuals

Eligible PIs are the current CNP awardees (i.e., PIs) that have transitioned to Phase II. Project Leaders, who will conduct the pilot projects, must be new investigators (see https://grants.nih.gov/grants/guide/notice-files/not97-231.html for the definition of new investigator), and include any individual with the skills, knowledge, and resources necessary to carry out the proposed research, are invited to collaborate with the CNP PI to develop an application for support.

2. Cost Sharing or Matching

Not applicable.

3. Other-Special Eligibility Criteria

Competitive supplements are available to these NCI grantees to conduct 1-year pilot projects, which was and is a Phase II.2 Objective of the Community Networks Program RFA-CA-05-012.

The pilot project is to be conducted and performed by the Project Leader of the pilot project who is a new investigator (see https://grants.nih.gov/grants/guide/notice-files/not97-231.html for the definition of new investigator) and who is not the PI of the CNP award. The Project Leader does not have to be a member of the CNP Institution. The Project Leader can conduct the pilot project as a subcontract from the CNP Institution. The Project Leader may be any individual with the skills, knowledge, and resources necessary to carry out the proposed research.

The pilot projects are a mechanism for new investigators to begin a career in community-based participatory research in reducing cancer health disparities. The Project Leaders of the pilot projects are expected to seek other grants, such as career development grants (e.g., K01, K07, K08, K23) and research grants (e.g., R03, R21, R25, R01) that can develop their careers in this area (see http://minorityopportunities.nci.nih.gov/).

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at https://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 Grants Info -- Telephone: (301) 710-0267; Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

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

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Date(s): November 20, 2006; May 29, 2007.
Application Receipt Date (s): December 18, 2006; June 27, 2007.
Peer Review Date(s): March 2007; September 2007.
Council Review Date(s): May 2007; January 2008.
Earliest Anticipated Start Date(s): August 2007; February 2008.

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/training;
Name, address, and telephone number of the PI;
Names of other key personnel, including most importantly those of the Project Leader and Mentor(s);
Participating institutions; and
Number and title of this funding opportunity announcement.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH institute and/or center (IC) staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Kenneth Chu, Ph.D.
Disparities Research Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Boulevard, Room 602, MSC 8341
Bethesda, MD 20892-8341 (for U.S. Postal Service express and regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8589
Fax: (301) 435-9225
Email: KC10D@NIH.GOV

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; non-USPS service)

Personal deliveries of applications are no longer permitted (see https://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
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8042, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NCI. Incomplete and non-responsive applications will not be reviewed and will be returned to the applicants.

The NIH will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. This does not preclude the submission of a substantial revision of an unfunded version of the application already reviewed, but such an application must include an Introduction addressing the previous critique. Applications that are not funded in the competition described in this RFA may be resubmitted as amended applications for receipt dates listed in the RFA.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

6. Other Submission Requirements

APPLICATION DETAILS

The pilot project application will follow the standard format of the R01 (PHS 398) application except the Research Plan will be limited to 15 pages instead of the usual 25 pages.

Special Instructions for Recommended Format:

Key Personnel
CNP PI should be listed first and identified as the PI, last name first. The Project Leader of the pilot project should be listed next, followed by the mentor(s). Other key personnel and consultants for the competitive supplement should then be listed. Provide biosketches of the key personnel involved in performing the pilot project, including that (those) of the mentor(s).

Budget Instructions
A maximum of $50,000 direct costs may be requested. Follow the instructions for non-modular budget research grant applications. A detailed categorical budget is to be submitted and the budget requested should reflect the total direct costs only of items for which additional funds are requested. Provide a detailed justification for the proposed budget. Note that Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).

Amended Application
An amended application (i.e., a substantial revision of an unfunded version of an application already reviewed) must include an Introduction addressing the previous critique. The Introduction is limited to one page.

RESEARCH PLAN (15 pages maximum)

Introduction – Discuss how the pilot project is within the scope of the CNP grant (one page recommended).

A. Specific Aims - Specific aims should include the goals and objectives of the pilot project (1-page recommended).

B. Background and Significance - Provide a description of the cancer health disparities of the communities to be addressed and its significance (one page recommended).

C. Feasibility/Preliminary Studies/Progress Report - Describe techniques/approaches that may be used. Preliminary data are not required, but can be provided (one page recommended).

D. Research Design and Methods - Describe your proposed pilot project in detail (eight pages recommended). Discuss how the aims have the potential to be achieved, such as a discussion of how the disparities in the community are to be reduced, the interventions to be used, the metrics that will be used to measure reductions in disparities, the partnerships and collaborations proposed, etc. The pilot projects should be community-based participatory research (CBPR) projects that can reduce disparities and not basic science/laboratory projects. The approach should be scientifically sound and have an active community-based participatory component. It is recognized that due to the short duration of the project and the limited funds available for it, a pilot project may not be able to satisfy all the elements/criteria of CBPR; however, participation of the community at some level must be demonstrated in the overall execution of the project.

D1. Career development plan for the Project Leader – The plan should provide a description of the research and training experiences that will occur during the proposed period of support. The candidate must present a convincing case that there is a high probability of developing the research skills and abilities needed to conduct the project (one page recommended).

D2. Role and Qualifications of the Mentor - Describe how the mentor will help the Project Leader on the pilot project and describe the mentor’s qualifications as they relate to the project. A letter of commitment signed by the mentor should be included (one page recommended).

D3. Role of PI of CNP and CNP resources for pilot – Describe the role of the PI of CNP on this pilot project and the CNP resources that may be used on the pilot project. How does this pilot project fit into the scope of parent CNP grant? (one page recommended).

E. Human Subjects Research - see instructions in PHS 398 (no page limit)

The Project Leader, who is to perform the pilot project, must be a new investigator (see https://grants.nih.gov/grants/guide/notice-files/not97-231.html for the definition of new investigator) and not the PI of the CNP. The Project Leader of the pilot project may be a Co-investigator of the CNP parent grant. The Project Leader of the pilot project does not have to be from the Institution that has been awarded the CNP grant. The Project Leader can be subcontracted to the awardee Institution. A letter of commitment signed by the mentor should be included in the appendix. There should be a letter of support from the institution of the Project Leader, where the work will be conducted.

Each CNP awardee (PI) may submit up to four separate project applications per submission date. Each CNP can have up to four project applications funded per year. Each application must be submitted on a separate PHS 398 form and in a separate package. Each application should have a different Project Leader. An individual may only be a Project Leader on one funded project per year.

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and at https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, https://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

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

2. Review and Selection Process

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

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

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

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, peer reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.

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

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

Are the pilot projects community-based participatory research (CBPR) projects that could lead to the reduction of disparities? (They should not be basic science/laboratory-based projects.)
Is the approach scientifically sound?
Does the approach have an active community-based participatory component?

(It is recognized that due to the short duration of the project and the limited funds available for it, a pilot project may not be able to satisfy all the elements/criteria of CBPR; however, participation of the community at some level must be demonstrated in the overall execution of the project.)

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or community/clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop and/or employ novel concepts, approaches, methodologies, tools, and/or technologies for this area? (For this program, an investigator may propose to carry out an important work that by its nature is not innovative but is essential in reducing disparities.)

Investigators: Are the Project Leader, mentor(s), and project team appropriately trained and experienced to carry out this work? Is the work proposed appropriate to the experience level of the Project Leader and the project team? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Is the proposed career development plan for the Project Leader appropriate and adequate?
Is the research team of the Project Leader and mentor(s) appropriate and adequate for the project?

(For this program, emphasis will be placed on the Project Leaders’ training and their research potential as well as their mentor’s (mentors’) appropriateness rather than on their professional track record and number of publications.)

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

(For this program, there should be some evidence of institutional commitment in terms of space and time to perform research. There also should be evidence of community support for the project.) There should be a letter of support from the institution of the Project Leader, where the work will be conducted.

2.A. Additional Review Criteria

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

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

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

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of 1 year of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the 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 (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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

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

2. Administrative and National Policy Requirements

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

The following Terms and Conditions will be incorporated into the award statement and will be provided to the PI 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, DHHS 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 DHHS, U.S. Public Health Service (PHS), and NIH grant administration policies.

The administrative and funding instrument used for this program will be competitive supplements to cooperative agreements from RFA-CA-05-012. The projected funded by these supplements are to be performed by the Project Leaders and their staff with no assistance from NCI, unless stated in the application.

2.A.1. Principal Investigator Rights and Responsibilities

The PI of the competitive supplement will have the primary responsibilities as follows:

a. Awardees have primary authority and responsibility to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their projects. Awardees must establish and maintain a Project Steering Committee. The role and responsibilities of the Steering Committee are described below under Collaborative Responsibilities.

b. Awardees must manage the performance of the pilot project.

c. Awardees will retain custody of and have primary rights to data and software developed under these awards, subject to Government rights of access consistent with current U.S. Department of Health and Human Services (DHHS) policies, such as Health Insurance Portability and Accountability Act (HIPAA) regulations, Public Health Service (PHS) policies, and National Institutes of Health (NIH) policies.

The CNP Steering Committee and the Community Advisory Group may provide advice on pilot projects. Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to arbitration. (See Arbitration, below.)

d. Awardees must provide annual progress reports of the pilot projects and additional information, as requested by the NCI Program Coordinator. Upon completion of the pilot project, awardee will submit a paper describing the study with abstract, introduction, methods, results, discussion, and references to be completed by the Project Leader of the pilot project. This paper is due with the progress report for the parent grant.

2.A.2. NIH Responsibilities

NCI Staff Responsibilities

The NCI Program Coordinator (and other NCI staff) will have substantial scientific/programmatic involvement during the conduct of the CNP through technical assistance, advice, and coordination above and beyond normal program stewardship for grants, as described below. The NCI Program Coordinator shall:

a. Serve as a member of the Steering Committee;

b. Assist awardees with planning and establishing priorities and approve awardees’ plans prior to implementation of activities;

c. Determine whether an awardee-planned community activity or pilot project is consistent with NCI guidelines;

d. Coordinate activities with other Federal agencies (e.g., Centers for Disease Control and Prevention [CDC], Centers for Medicare & Medicaid Services [CMS], and DHHS Office of Minority Health [OMH]) and broker interactions between NCI and awardees, as necessary, to provide technical assistance and guidance in specialty areas, as well as arrange short-term training assignments for minority researchers;

e. Convene special meetings and ad hoc groups to address NCI priority issues; and

f. The NCI staff will not be involved in the performance of the pilot projects of the competitive supplements, unless indicated by the application.

An NCI Program Director will be responsible for normal program stewardship of this award, including monitoring of progress and other required reports. The NCI Program Director may identify other NCI staff to provide technical assistance in specific areas as needed. The NCI Program Director may also serve as the Program Coordinator.

NCI reserves the right to terminate or curtail the program (or an individual award) in the event of substantial shortfall in the performance of requirements for any single Phase or key activity of the program.

2.A.3. Collaborative Responsibilities

Awardees will collaborate with the NCI Program Coordinator to establish and maintain for their projects a Steering Committee whose role is to function as a governing body. The Steering Committee will appropriately comprise scientists and community leaders and/or facilitators and will set policy, provide overall guidance and direction, and provide support for project-sponsored activities. Membership will include the Project PI, NCI Program Coordinator, Regional PIs, and others with expertise in relevant scientific or other cancer-related or disparity-related disciplines. Responsibilities of the Steering Committee include: reviewing and ensuring scientific soundness of project plans; guiding development and implementation of population-specific cancer control and prevention activities; approving joint and pilot research project plans and applications; prioritizing project needs; promoting collaborations; and facilitating interactions among the NCI, partners, and community populations. The PI will serve as chairperson of the Steering Committee and be responsible for selecting other members. Decisions and recommendations of the Steering Committee will be binding and take precedence over those of regional advisory committees.

The pilot projects are to be performed by the Project Leader and staff identified in the pilot project applications. NCI will not become involved in the pilot project, unless indicated by the application.

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 PHS Non-Competing Grant Progress Report, Form 2590, annually (https://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Kenneth Chu, Ph.D.
Disparities Research Branch
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Boulevard, Room 602, MSC 8341
Bethesda, MD 20892-8341 (for U.S. Postal Service express and regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8589
Fax: 301-435-9225
Email: KC10D@NIH.GOV

2. Peer Review Contacts:

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 (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (https://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); and efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://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 (https://grants.nih.gov/grants/policy/data_sharing).

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

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public 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 https://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 https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement at https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://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 (https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects; or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://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 funding opportunity is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov.

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NIH Funding Opportunities and Notices

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