It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This U24 funding opportunity announcement (FOA) is a part of the National Cancer Institute (NCI) initiative to establish the "NCI Awardee Skills Development Consortium (NASDC)". The overarching goal of this initiative is to provide opportunities for current NCI grantees, especially those who are junior faculty (e.g., assistant professors, instructors, research scientists, or equivalent), to enhance their skills in areas that are critical for establishing and maintaining successful independent academic cancer research careers.

This U24 FOA solicits applications for a Coordinating Center to address the NASDC logistics and evaluation needs in serving the NASDC Research Education Short Courses that will be supported by a companion UE5 FOA (RFA-CA-19-010).

The anticipated roles of the U24 NASDC Coordinating Center include, but are not limited to, working together with the UE5 Research Education Short Course awardees on:

• Advertising the NASDC Short Courses and recruiting participants;
• Providing logistic support during course implementation;
• Arranging periodic NASDC Steering Committee in-person meetings and teleconferences and preparing summary minutes; and
• Assuming a primary role in the evaluation of the NASDC Courses and overall program.

The pool of junior faculty investigators supported by NCI "K" career development mechanisms, R00, R21, and first R01-equivalent awards comprises approximately 1,500 recipients. These NCI grantees are at a critical juncture in their research careers, at which they are expected to continue to compete successfully for NIH funding to support their research groups and also become academic leaders proficient at teaching, mentoring, and managing a research program.

In recent years, it has become increasingly difficult for these investigators to succeed on an academic career trajectory, primarily because of the hypercompetitive funding climate. In recognition of this situation, Congress established the Next Generation Researchers Initiative (NGRI) as part of the 21st Century Cures Act (Title II, Sub-Title C--Supporting Young Emerging Scientists). The NGRI tasked the NIH "to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to: receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity."

NASDC will support programs that further develop NCI grantees' essential skills, such as writing competitive grant applications, managing the personnel and finances of a research program, building networks of collaborators, providing mentorship to the next generation of researchers, and staying abreast of relevant technological advances in the field, all to help them navigate through critical career junctures. The development of these skills is especially urgent, given that typical graduate/medical student academic programs and postdoctoral/fellowship training do not provide adequate educational content experiences in these arenas. Although there are existing courses and workshops on some of these topics, none are specifically tailored to meet the needs of junior faculty NCI grantees who are striving to establish successful academic careers.

Targeted (priority) Participants for NASDC Short Courses:

The courses to be supported through the NASDC initiative will primarily focus on meeting the academic career development needs of junior faculty NCI grantees with various "K", R00, R21, and first R01-equivalent awards. It is anticipated that NASDC courses will help participants maintain long-term productivity in their cancer research careers, thereby maximizing the outcomes from NCI's investment in these individuals.

Important Note: The priority participant audience for NASDC Short Courses (as defined above), which is based on current career development needs, should not be confused with the NIH-defined category of Early Stage Investigators (ESI), which is determined by the number of years since the completion of a terminal research degree or end of post-graduate clinical training. Although there is considerable overlap among the individuals in these two groups, the groups are distinct entities.

The Roles and Expectations for the NASDC U24 Coordinating Center:

The NASDC Coordinating Center awardee will be expected to interact closely with the NASDC UE5 awardees as well as with NASDC Steering Committee. The Coordinating Center will participate in advertising the NASDC Short Courses. The Coordinating Center will be involved in facilitating the implementation of the NASDC Short Courses and coordinating and supporting their organization by the UE5 awardees. The Coordinating Center will participate in organizing annual NASDC Steering Committee meeting and monthly teleconferences and other NASDC meetings as needed. The Coordinating Center will also play a primary role in conducting ongoing evaluation of the NASDC courses and overall program evaluation.

Specific activities and roles of the NASDC Coordinating Center may include, but are not limited to, working together with the UE5 Research Education Short Course awardees on:

Advertising the NASDC Short Courses and recruiting participants

• Coordinating advertising efforts for the NASDC Courses
• Receiving and prescreening applications from prospective Course participants

Providing logistic support during course implementation

• Establishing a calendar of NASDC Short Courses offerings and identifying appropriate venues for the Courses
• Providing staff support during the Courses to assist with meeting logistics.

Arranging periodic NASDC Steering Committee in-person meetings and teleconferences and preparing summary minutes

• Co-organizing with the NASDC Steering Committee an annual in-person meeting and periodic teleconferences
• Providing summaries of NASDC meeting and teleconferences to attendees

Assuming a primary role in the evaluation of the NASDC Courses and overall program

• Assisting UE5 awardees with evaluation of their Courses
• Leading the evaluation of the overall NASDC program

Important Note: Because the NASDC Coordinating Center will have to interact closely with, and provide infrastructure to, the NASDC UE5 Short Course awardees, it is imperative that all applicants responding to this FOA familiarize themselves with the companion UE5 FOA (RFA-CA-19-010).

NASDC Governance

The NASDC Program will be governed by a Steering Committee. The Steering Committee will include representatives from each NASDC UE5 award funded through RFA-CA-19-010 and Coordinating Center funded through this FOA as well as NCI staff members. For details on the composition and responsibilities of the NASDC Steering Committee, see Section VI.2 under Cooperative Agreement Terms and Conditions of the Award.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than 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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Note: Institutions applying for the UE5 NASDC award under the companion FOA RFA-CA-19-010 are welcome to also apply for the U24 award under this FOA.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• o   NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Individual(s) designated as PD(s)/PI(s) on applications submitted to this FOA are expected to be senior faculty with successful track records of providing collaborative leadership in the organization, management, and evaluation of large educational programs involving multiple institutions and drawing participants from a national audience.

While an institution may submit applications in response to this U24 FOA and its companion UE5 FOA, RFA-CA-19-010, an individual designated as a PD/PI (or one of multiple PD(s)/PI(s)) on a U24 application submitted in response to this FOA must not be also designated as a PD/PI (or one of multiple PDs/PIs) on an application submitted in response to RFA-CA-19-010.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, submission of such a letter is strongly encouraged. The information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Jeannette Korczak, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5630
Fax: 240-276-5659
Email: korczakj@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities & Other Resources. Describe the institutional environment in which the Coordinating Center will operate, including the institutional support, equipment and other physical resources available to the Coordinating Center investigators that can contribute to the success of the NASDC consortium. Include the following information:

• Highlight any relevant unique features of the institutional environment, infrastructure, or human potential that may be leveraged to the advantage of the NASDC consortium.
• Discuss any available resources within the scientific environment that will support electronic information handling and NASDC evaluation activities.
• If multiple sites are participating in the Coordinating Center, describe how this will enhance the quality of the NASDC program, as well as how activities will be coordinated and effective communication maintained among the multiple sites.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. Also include the following additional modifications:

• A minimal effort of 1.2 person-months is required for all designated PD(s)/PI(s) and cannot be reduced below that level during the project period.
• U24 applicants should include in their budget the hotel/facility and audiovisual costs required to conduct the annual, 2- to 3-day NASDC Steering Committee meeting in the Washington, DC metro area.
• U24 applicants should include travel funds in their budget for PD(s)/PI(s) and other senior/key persons on the U24 Coordinating Center award to attend the annual NASDC Steering Committee meeting, including the cost of transportation, housing, and per diem expenses.
• U24 applicants should include travel funds (transportation, housing, and per diem expenses) in their budget for U24 personnel to provide logistic support to the NASDC Short Courses offered by the UE5 awardees.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims:

Outline Specific Aims for the proposed Coordinating Center along with the main benchmarks for their realization.

Research Strategy

Research Strategy must consist of the Subsections A-C, as defined below.

Subsection A: Coordinating Center Overview

• Describe the overall organization of the proposed Coordinating Center.
• Without repeating information in biosketches, summarize the collective team expertise and organizational strengths, especially those that are relevant to multi-institutional endeavors.
• Outline the main activities of the Coordinating Center and explain how they will address the needs of the NASDC research education consortium identified in Section I.
• Outline general strategies that will be used to identify potential participants for the NASDC courses and to facilitate their recruitment to these courses in consideration of the priority on NCI-funded junior faculty.
• Highlight any generally innovative aspects, e.g., innovative management strategies, novel approaches to course advertising to reach prospective participants of the targeted profile, course evaluation strategies, etc.

Subsection B. General Approaches to the Coordination of NASDC Activities

• Describe the overall operational plan for the Coordinating Center. Explain strategies to coordinate efforts with respective UE5 Short Course awardees to accomplish the goals of the NASDC consortium.
• Describe how the Coordinating Center will optimize communications across the consortium with UE5 awardees and NCI-involved staff members, with prospective participants, venue offerors, etc.
• Discuss potential problems that may be encountered and describe alternative strategies to optimize the NASDC consortium activities.

Subsection C. Plans for Basic Coordinating Center Functions

As applicable describe concrete plans (including work-flow, timelines, benchmarks for success, etc.) for the following specific Coordinating Center functions:

• Advertising the NASDC Short Courses and recruiting participants. At a minimum, address all the listed aspects:
•     Coordinating advertising efforts for the NASDC Short Courses with the UE5 awardees
•     Receiving and prescreening applications from prospective Course participants to select appropriate candidates for Courses to ensure that an adequate, highly qualified and diverse pool of potential participants are recruited to each of the NASDC courses;
•     Planning/strategizing ways to optimize/maximize the reach and use of the Courses at the level of the entire Consortium.
• Providing logistic support during course implementation. Examples of aspects to address include, but are not limited to:
•     Proposing ways to optimize efforts to coordinate with the UE5 awardees;
•     Developing a consolidated calendar of all NASDC Short Course offerings and considering factors for the optimization of their scheduling;
•     Describing criteria to be used in identifying appropriate venues for the Courses;
•     Specifying plans for operational staff support during the Courses to assist the organizers and participants with meeting logistics.
• Providing logistic support for the NASDC Steering Committee. Examples of aspects to address include, but are not limited to:
•     Co-organizing with the NASDC Steering Committee an annual in-person meeting;
•     Scheduling/coordinating monthly teleconferences; and
•     Preparing and providing summaries/minutes of NASDC meetings and teleconferences for attendees.
• Leading evaluation efforts for the NASDC Courses and overall NASDC program. Examples of aspects to address include, but are not limited to:
•     Assisting UE5 awardees with evaluation of their individual Courses;
•     Using feedback from evaluations effectively to improve/enhance courses; and
•     Integrating core evaluation data across the Courses to facilitate the evaluation of the overall NASDC program.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: The NASDC Coordinating Center must have all the requisite skills and technical/operational capabilities to efficiently support the NASDC UE5 Short Course awardees by facilitating/coordinating the efforts to advertise the courses, recruit participants with priority on junior faculty-level investigators with current NCI grants, provide logistical support to implement and organize the Courses, as well as lead the evaluation of the individual Courses and the overall NASDC program.

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

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

Does the proposed Coordinating Center (CC) address the needs of the NASDC research education consortium that it will serve? Is the scope of activities proposed for the CC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the NASDC research education consortium?

Specific to this FOA: How strong are the overall strategies of the proposed CC in terms of adequate focus on the intended target population for participation in the NASDC courses? What is the likelihood that the proposed CC will significantly advance the goals of the NASDC research education consortium?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the CC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research education programs? Do the investigators demonstrate significant experience with coordinating collaborative research education activities? If the CC is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the CC? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA: How strong are the team's expertise, skills, and past accomplishments in coordinating and administering specialized courses and other educational activities that extend beyond a single institution? Does the CC team have appropriate information technology skills and capabilities required for planning the Coordinating Center functions?

Does the application propose novel organizational concepts or management strategies in coordinating the NASDC research education consortium that the CC will serve? Are the concepts or strategies novel to one type of research education program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the NASDC research education consortium the CC will serve? Will the investigators promote strategies to ensure a robust approach across the NASDC consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed?

Specific to this FOA: Is the proposed approach for overall management of the NASDC consortium as well as for coordination with the UE5 course activities feasible and appropriate to achieve the CC’s program goals? Are the advertising and recruitment activities likely to ensure a highly qualified and diverse participant pool? Is the proposed plan for promoting collaboration across the UE5 sites adequate? Is the plan for taking a lead role in the development of an evaluation protocol and common evaluation measures adequate? Does the proposed CC demonstrate adequate capacity and ability to manage data and communications and the ability to coordinate the NASDC educational objectives?

Will the institutional environment in which the CC will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the CC proposed? Will the CC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this FOA: How sufficient is institutional support to the proposed CC in terms of attainment of the goals of the NASDC program for the participants? How conducive is the institutional environment to enhancing the educational value of the NASDC program?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Cancer Institute (NCI), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May 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 an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will 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 scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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.

The PD(s)/PI(s) will have the primary responsibility for:

• Defining the overall objectives and directions for the NASDC Coordinating Center;
• Ensuring that Center interactions with the NASDC UE5 awardees and the Steering Committee are consistent with the NASDC goals and objectives;
• Serving as a voting member on the NASDC Steering Committee;
• Adhering to the decisions and recommendations of the Steering Committee to the extent compatible with applicable grant regulations;
• Taking the lead role in developing strategies to promote the NASDC Consortium and advertise the NASDC courses to potential participants [in collaboration with the UE5 PD(s)/PI(s)].
• Assisting the UE5 NASDC awardees in the recruitment of course participants in such aspects as:
•     Receiving and pre-screening all applications to NASDC courses to determine applicant's eligibility to participate based on academic position and current NCI funding;
•     Recording pre-screening results and core data elements on all applicants in a tracking database and providing access to the database and the applications to the NASDC UE5 PD(s)/PI(s) and their staff;
•     Taking the lead role in establishing the master schedule of NASDC course offerings, in collaboration with the UE5 PD(s)/PI(s) and the NCI Program Scientist;
•     Taking the lead role to identify available hotel/facility space in the Washington, DC area to host the courses in accordance with the NASDC master course schedule and provide housing for course faculty, staff, and participants. This will be done in collaboration with the UE5 PD(s)/PI(s) who will be responsible for executing and fulfilling the contracts;
• Designating U24-supported staff to provide on-site logistic support during the NASDC courses;
• Taking the lead role in organizing monthly NASDC Steering Committee teleconference meetings and providing minutes of the meetings and teleconferences to the attendees;
• Co-organizing and arranging logistics for the annual Steering Committee meetings (that are expected to take place in the Washington, DC area) and attending these meetings;
• Creating web-based resources for NASDC including a program-wide website addressing NIH policies, procedures, and application information and materials; web-based course content; and email and other web-based systems for group communication;
• Developing surveys to collect core NASDC-specific evaluation data from all participants and faculty in NASDC courses, in collaboration with the UE5 PD(s)/PI(s) and NCI Project Scientist;
• Analyzing core NASDC-specific evaluation data and presenting the results at annual NASDC Steering Committee meetings, professional conferences and/or in publications, in collaboration with the UE5 PD(s)/PI(s) and NCI Project Scientist; and
• Sharing knowledge, data, research education materials, and any other resources necessary and relevant to the NASDC consortium.

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 DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

One or more designated NCI Program staff members will have substantial involvement as Project Scientist(s) for the NASDC initiative.

Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The role of the Project Scientist(s) will be to facilitate, but not to direct, the NASDC project activities.

The specific roles of the substantially involved NCI staff members include the following activities:

• Serving as a member of the NASDC Steering Committee, as described below in "Areas of Joint Responsibility";
• Serving as a liaison to the NASDC awardees identifying relevant NIH expertise and/or resources related to NIH and NCI funding mechanisms and initiatives, various NIH programs designed to help junior investigators, and other resources, expertise, or skills that may be relevant to optimizing the content of NASDC courses, designing the strategies to reach targeted audiences, etc.;
• Providing technical assistance to NASDC awardees and/or access to NIH technical resources that may be needed for the NASDC program (e.g., for the efficient identification of early career stage, NCI-funded investigators, including their general research profiles, geographical distribution, etc.);
• Assisting the NASDC awardees with the promotion of the courses and reaching the targeted investigators; and
• Working closely with the NASDC U24 Coordinating Center on planning and supporting the logistics of NASDC meetings and courses.

While NASDC awardees will retain custody of the data and resources developed under these awards, the NCI will have access to all recruitment data, course materials, evaluation data etc., and may periodically review these data.

The NCI reserves the right to reduce the budget or withhold an award in the event of substantial awardee underperformance or other substantial failure to comply with the terms of award.

Areas of Joint Responsibility include:

A Steering Committee will be convened to serve as the NASDC main governing board. The Steering Committee will be composed of the following voting members:

• One representative from each UE5 award (a PD/PI or a designee) who will each have one vote;
• One representative from the U24 Coordinating Center award (a PD/PI or a designee) who will have one vote;
• NCI Project Scientist(s) who will have collectively one vote;

The Chair and co-Chair of the Steering Committee will be selected from the representatives of all NASDC awardees.

Additional NCI staff members may participate in Steering Committee meetings as non-voting members.

The Steering Committee may decide to establish sub-committees for specific purposes. The NCI Project Scientist(s) may serve on such sub-committees as they deem appropriate.

The Steering Committee will meet monthly by teleconference and annually in-person. The annual Steering Committee meetings will take place in the Washington, DC area and will be logistically arranged by the U24 NASDC Coordinating Center. In addition to Steering Committee members, the annual meeting is expected to include additional investigators from each NASDC UE5 and U24 awardee team, as determined by the respective PDs/PIs.

Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

• Serving as NASDC main body overseeing the realization of the Program goals;
• Ensuring that the content of all NASDC Short Courses, their participants, locations, and other salient characteristics are optimal for the goals of the NASDC Program;
• Monitoring the overall NASDC performance, identifying impediments to success, and developing appropriate strategies to overcome the problems;
• Developing/approving NASDC policies and procedures for such aspects as:
•     Trans-network rules regarding participant recruitment, course conduct, and course evaluation;
•     Developing shared tools for disseminating information about the NASDC consortium and its courses; and
•     Establishing/approving the master schedule of NASDC course offerings.
• Developing agendas and content for the annual Steering Committee meetings;
• Facilitating communication and fostering productive interactions across the NASDC consortium;
• Promoting collaborations on research education and, as appropriate, joint publications by consortium members; and
• Ensuring that the NASDC consortium leverages optimally existing NIH and NCI resources and programs.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Jeannette F. Korczak, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: korczakj@mail.nih.gov

Referral Officer

National Cancer Institute (NCI)

Telephone: 240-276-6390

Email: ncirefof@dea.nci.nih.gov

Jason Gill
Office of Grants Administration (NCI)
Telephone: 240-276-6885
Email: gilljas@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Part 75.