Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This Notice of Funding Opportunity Announcement (NOFO) is one of six NOFOs that support the comprehensive effort by the National Cancer Institute (NCI) to provide the infrastructure for the conduct of national clinical trials through the National Clinical Trials Network (NCTN). The primary goal of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and advanced imaging trials across a broad range of cancers, modalities, and diverse patient populations as part of the NCI's overall clinical research program for adults, adolescents and young adults, and children with cancer. The NCTN also conducts, as necessary, preliminary studies needed for development of definitive trials, especially umbrella/basket trials and rare tumor trials, when an extensive, national patient catchment area is required.

The NCTN Program supports the following clinical trials infrastructure components through individual awards made under the respective NOFOs indicated below:

• NCTN - Network Group Operations Centers under RFA-CA-24-030 (U10)
• NCTN - Network Group Statistics and Data Management Centers under RFA-CA-24-031 (U10)
• NCTN - Canadian Collaborating Clinical Trials Network under RFA-CA-24-032 (U10)
• NCTN - Network Lead Academic Participating Sites under RFA-CA-24-033 (UG1) - this NOFO
• NCTN - Network Radiotherapy & Imaging Core Services Center under RFA-CA-24-034 (U24)
• NCTN - Network Group Integrated Translational Science Centers under RFA-CA-24-035 (UG1)

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications from institutions/organizations that propose to maintain or establish Network Lead Academic Participating Sites (LAPS) for the NCI National Clinical Trials Network (NCTN). The NCTN Network LAPS will provide scientific leadership by helping to develop and conduct clinical trials in association with one or more adult U.S. Network Groups and will contribute substantial accrual to clinical trials conducted across the entire NCTN.

Background

The NCI National Clinical Trials Network (NCTN) was established for the conduct of large-scale, national, oncology treatment and advanced imaging clinical trials in an era of precision medicine.

Recent advances in deciphering the cancer genome, along with the emergence of successful targeted agents, immunotherapies, and cellular therapies, have fundamentally changed our approach to cancer treatment and have introduced new challenges to performing clinical trials. Due to the low incidence of certain molecular abnormalities, the development of targeted therapies often requires an infrastructure for the conduct of clinical trials that can screen large numbers of patients with the same or different cancer type to identify those patients whose tumors contain the distinct molecular targets of the therapies being tested. Immunotherapeutic approaches also present a similar challenge in that not all tumor types respond to this approach, and selecting the cancer types most likely to respond is critical for success.

The NCTN's integrated and collaborative network infrastructure has allowed the Program to meet the challenges of evaluating emerging therapies within its broad investigator base drawn from NCI-designated Cancer Centers, the NCI Community Oncology Research Program (NCORP), Minority/Underserved NCORPs, and other academic and community hospitals and private practitioners across the U.S. and internationally. The primary focus of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and investigation of new advanced imaging techniques; however, appropriate preliminary studies needed for development of potential definitive trials, especially umbrella/basket trials and rare tumor trials oriented to discovery, are also conducted when an extensive, national patient catchment area is required. With its state-of-the-art clinical trials infrastructure, the NCTN can implement and completes trials rapidly. The NCTN has streamlined trial registration, data management, and tumor banking processes. It has a Cancer Trials Support Unit (CTSU) to provide online access to all necessary study materials and a Central Institutional Review Board (CIRB) to make ethics review easier and less redundant across the country. The NCTN also has appeal for industry partners such as biotechnology and pharmaceutical companies that collaborate on NCTN trials, including precision medicine trials harnessing next generation DNA and RNA sequencing methods to inform treatment choices. NCTN's resources are ideal for screening large numbers of patients to identify patients whose tumors exhibit the molecular features that may be responsive to new, targeted treatments and/or immunotherapy approaches. In addition, biospecimens collected from patients on NCTN trials are available to help determine the underlying biological reasons for response and resistance to therapy.

The NCTN also promotes the evaluation of multi-modality treatments, including surgery and radiotherapy in combination with novel agents, and has a commitment to the conduct of trials in special populations (e.g., children, adolescents, young adults, and underserved populations) as well as in rare tumor types. This focus allows the NCTN Program to complement, rather than duplicate, research conducted by the private sector. Annual accrual to NCTN trials has remained in the 17,500 to 22,000 patient range in mostly large phase 2 and phase 3 trials, but with a larger number of patients screened on study to determine whether they might benefit from the therapy under evaluation.

Each of the key components of the NCTN Program is described briefly below.

• Network Group Operations Centers: The Operations Centers provide scientific leadership for developing and implementing multi-disciplinary, multi-institutional trials in a range of diseases and special populations with specific scientific strategy and goals. The Operations Centers' scientific goals may include strategic innovation in advanced technology for specific research areas (e.g., advanced imaging methods/agents, radiotherapy) and the testing of innovative concepts and tools in prospective, multi-institutional clinical trials. Operations Centers are responsible for trial operations including timely protocol development and management, compliance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) regulatory and patient protection requirements, audits, training, quality assurance, and site support. The Operations Centers are expected to be closely integrated with their corresponding Statistics and Data Management Center in all aspects of trial operations through jointly developed policies and procedures for clinical trial development and conduct. The Operations Centers are also responsible for Network Group administration, including financial management, monitoring of member institution/site performance, coordination of biospecimen collection from patients on clinical trials, and adherence to all applicable NIH/NCI policies and regulations. Network Group Operations Centers may also provide trial operations for NCI Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (NCI/DCTD, approved, multi-center phase 2 and phase 3 trials originating outside the Network Groups in special situations.
• Network Group Statistics and Data Management Centers: These Centers are responsible for providing the statistical expertise required to ensure effective scientific design and conduct of clinical trials as well as leadership in innovation in statistical methodology. These Centers are also responsible for data management, data analysis, and statistical analysis for NCTN trials led by their affiliated Network Group Operations Center as well as for translational and other ancillary studies associated with the trials.
• Network Group Integrated Translational Science Centers - These awards provide support for leadership and expertise to facilitate incorporating translational science into Network Group clinical trials.
• Network Lead Academic Participating Sites: These academic institutions/sites provide scientific leadership in development and conduct of clinical trials in association with one or more adult U.S. Network Groups as well as substantial accrual to clinical trials conducted across the entire NCTN.
• Network Radiotherapy and Imaging Core Services Center: This institution/organization provides scientific and technical expertise for incorporation of appropriate, integrated quality assurance/control and image data management for applicable clinical trials conducted by the NCTN that require specialized quality assurance/control or imaging data management and/or assessment for radiotherapy and imaging interventions. In addition, the Center may also provide similar services for other approved NCI-supported clinical trials network programs (e.g., NCI/DCTD/CTEP early phase clinical trial network program and the NCI Division of Cancer Prevention (NCI/DCP) NCI Community Oncology Research Program (NCORP).
• Canadian Collaborating Clinical Trials Network: This Canadian organization is a non-profit clinical trials organization capable of being a full partner with the U.S. Network in the conduct of large-scale, multi-site clinical trials that have relevance for U.S. cancer patient populations. Incorporation of a Canadian Clinical Trials Network as a collaborating partner brings an additional advantage as U.S. Network Groups are anticipated to have Canadian member sites. A Canadian network can help reduce duplicative regulatory staff at U.S. NCTN Group Operations Centers.

Interactions with Other NCI-supported Programs. In addition to the six key components of the NCTN that are described above that are directly funded by the NCTN Program, other NCI grant and contract-supported Programs and their awardees as well as NCI Advisory Committees have important supporting roles in carrying out the research objectives of the NCTN Program. Thus, the NCTN awardees are expected to interact as appropriate with such entities/programs as the NCI Clinical Trials Tumor Banks, the NCI Community Oncology Research Program (NCORP) and Minority/Underserved NCORPs, the NCI Cancer Trials Support Unit, the pediatric and adult NCI Central Institutional Review Boards, and NCI Advisory and Scientific Committees, including the NCI Scientific Steering Committees.

Main Research Objectives and Requirements of this NOFO

The Network Lead Academic Participating Site application must address the following 2 required functional components related to clinical treatment trials and advanced imaging trials for adult cancer patients only:

Clinical Trial Program - This functional component encompasses the LAPS scientific leadership in helping to develop and conduct clinical trials in association with one or more Network Groups, including the LAPS support of NCTN initiatives and mentorship of junior investigators.

Site Accrual Program This functional component provides robust accrual to NCTN trials across the Network, including accrual to rare cancers and accrual from special populations (e.g., minority and underserved communities, adolescents and young adults), as well as timely activation of trials and good clinical trial stewardship.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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)

Local 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)

Eligible institution/organization for the purposes of this application is defined as an academic hospital and/or academic clinic program providing direct medical care to patients that is considered one integral organizational entity under a single financial management system and governance structure. Academic centers for this application are distinguished from large medical centers whose primary mission is patient care. In addition to patient care, academic centers have comprehensive medical training programs and have preclinical laboratories that perform basic research.

Hospitals, clinics, military or Veterans Administration (VA) hospitals or treatment facilities, and health care organizations that may provide services in collaboration with the applicant institution in a network, but which are not an integral component of the academic organization under a single financial management system and governance structure that comprises the applicant institution (i.e., Network Lead Academic Participating Site consisting of an academic center and its essential components) may not be considered part of the academic institution. These other organizations may be considered "affiliates" of the Network Lead Academic Participating Site and be included in the application under the "affiliate" designation only if the Network Lead Academic Participating Site will provide complete management services for the affiliate site related to enrollment of patients on NCTN trials.

An academic institution/organization for the purposes of this award cannot be an NCI Community Oncology Research Program (NCORP) Community Site funded by the NCI Division of Cancer Prevention (DCP).

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 not allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• 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.
  • 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019, and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 How to Apply - Application Guide.

The named PDs/PIs for applications for NCTN Network Lead Academic Participating Sites cannot be named as PDs/PIs on applications for:

• NCTN - Network Group Operations Centers (RFA-CA-24-030)
• NCTN - Network Group Statistical and Data Management Centers (RFA-CA-24-031)
• NCTN - Canadian Collaborating Clinical Trials Network (RFA-CA-24-032)
• NCTN - Network Radiotherapy and Imaging Core Services Center (RFA-CA-24-034)

However, an individual who is designated as a PD/PI on the application for the NCTN Network Lead Academic Participating Site can, if appropriate, be listed as key personnel on applications for any of the RFAs listed above.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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:

Margaret Mooney, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-6006
Email: [email protected]
 

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

For this specific NOFO, the Research Strategy is limited to 30 pages.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments: Applicants must provide the following additional material specified below in support of their application. The attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).

Attachment 1. Summary of Lead Academic Participating Site Roster (use filename LAPSRoster). In this attachment, provide a list of the clinical sites that will be participating in patient accrual under the application. A table can be used to show this information with column headings for the major site/institution category (i.e., main academic site, integral component site, or affiliate), name of site/institution, Cancer Therapy Evaluation Program (CTEP) Site ID, city for site, and state for site, sorted by major site/institution category.

The following definitions should be used for the major site/institution category: the main academic site is the major hospital/clinical care center for the applicant, an integral component of an academic center is one that is under the single financial management system and governance structure of the main academic center but may be at a different geographic location (e.g., a clinic center in the suburbs of a city distinct from a downtown location for the academic center). These integral components usually have separate CTEP site codes. Other organizations that are associated with an academic center (e.g., VA Hospitals), but that are not under the same financial management and governance structure, may be considered "affiliates" of the Lead Academic Participating Site and may be included in the application under that designation (i.e., "affiliate"), if the Lead Academic Participating Site will be providing complete management services for the affiliate site related to enrollment of patients on NCTN trials (although the complete management services do not have to include IRB services since the NCI CIRB is used for NCTN trials as the IRB of record for U.S. sites).

Please Note: Affiliate(s) that meet the description provided above are allowed to be included in the application of the academic center for ease of administration for the academic center (i.e., so that the NCI funding for data management of NCTN enrollments at the affiliate(s) go to the academic center directly from the NCI), but affiliate(s) do not have to be included in the application. The accrual and other activities of the affiliate(s) are not part of the review criteria for the academic center application affiliate accrual is only included in the budget request of the academic center as the goal of the academic center award is to provide funding for academic centers and their integral components that have the potential to provide significant scientific leadership and accrual to the NCTN (it is not a goal of the award to build affiliate or regional networks). Thus, an academic center can have all its affiliates or some of its affiliates funded outside of the application. In the circumstance that an affiliate of an academic center with a Lead Academic Participating Site (LAPS) grant is not included in its application, the affiliate would receive its "per-case management" funding via the Network Group it credits with the accrual. If an affiliate is included in a Lead Academic Participating Site application, then that affiliate will receive all NCI funding for data management associated with patient enrollment to any NCTN trial via the LAPS grant (i.e., the affiliate cannot be an affiliate of another institution for purposes of its NCTN program participation in treatment and advanced imaging clinical trials).

Attachment 2. Summary of Key Leadership Staffing for NCTN Network Groups, NCI Steering Committees, and NCTN Initiatives (use filename KeyLeadershipStaff). In this attachment, provide information on NCTN-related positions held by investigators that were at the main academic site for the applicant or integral component of the applicant between March 1, 2019 and August 31, 2024. Only key senior leadership positions (i.e., Chair or Vice-Chair) on Network Group scientific or administrative committees and standing subcommittees under those main committees should be listed, not general membership on those committees. However, general membership on important Network Group Oversight or Executive committees (e.g., Data Monitoring Committee, Executive Committee) can be included, not just the senior positions on those committees. General membership on NCI disease-specific Steering Committees (e.g., NCI Breast Cancer Steering Committee) or standing Task Forces of NCI disease-specific Steering Committees (e.g., Colorectal Task Force of NCI GI Steering Committee) and other NCTN Initiatives (e.g., NCI Central Institutional Review Boards, NCTN Core Correlative Science Committee) should also be included in this attachment. A table can be used to show this information with column headings for the general category of Network Group/NCI Steering Committee/NCI Initiative, specific category or activity, institution's investigator's position on the committee category, investigator's name, investigator's title and discipline, and length of service on the committee/initiative. The timeframe for the table should be provided as a sub-heading (e.g., March 1, 2019 through August 31, 2024). This attachment should not include information on whether an institutional investigator is a PI on a study as that type of information can be provided in Attachment #5 described below (filename CurrentNCTNTrialPIs).

Attachment 3. Summary of Important Primary Scientific Achievements on NCTN Clinical Trials by major cancer category, trial phase, and trial number (use filename PrimaryScienceAchievements). In this attachment, provide information on important primary scientific achievements that were reported out between March 1, 2019 and August 31, 2024 with contributions by the academic site member/investigator while at the main academic site for the applicant or integral component of the applicant. The primary scientific achievement refers to the Primary Endpoint(s) for the NCTN clinical trial specified in the protocol document. Applicants should briefly explain the importance of the achievement regardless of whether results were positive or negative as it is the importance of the achievement itself that is the focus for review (and not the number of publications). A table can be used to show this information with column headings for the general cancer site category (e.g., breast, hematology - leukemia, gastrointestinal - colorectal cancer), trial phase, year of publication of study primary outcome or FDA indication or other significant impact, Network Group Trial # and brief title, manuscript or abstract reference, brief description of the importance of the primary scientific achievement, and brief description of the contribution made by the institution member/investigator). The timeframe for the table should be provided as a sub-heading (e.g., March 1, 2019 through August 31, 2024).

Attachment 4. Summary of Other Important Achievements for NCTN Clinical Trials by major cancer category, trial phase, and trial number (use filename OtherScienceAchievements). In this attachment, provide information on other important achievements associated with NCTN trials that were reported out between March 1, 2019 and August 31, 2024 with contributions by the academic site member/investigator while he/she at the main academic site for the applicant or integral component of the applicant. Other important achievements refer to important information from secondary endpoints or sub-studies of NCTN clinical trials specified in the protocol such as validation of an integrated biomarker or other important analyses (e.g., meta-analyses; special population analyses). Applicants should briefly explain the importance of the achievement as it is the importance of the achievement itself that is the focus for review, not number of publications.). A table can be used to show this information with column headings for the general cancer site category (e.g., breast, hematology - leukemia, gastrointestinal - colorectal cancer), trial phase, year of publication of study primary outcome or FDA indication or other significant impact, Network Group Trial # and brief title, manuscript or abstract reference, brief description of the importance of the important other achievement, and brief description of the contribution made by the institution member/investigator). The timeframe for the table should be provided as a sub-heading (e.g., March 1, 2019 through August 31, 2024). Please Note: Quality of Life (QOL) sub-studies in NCTN trials funded by DCP NCORP Research Base grants should not be included in this table as those activities are funded and reviewed under the DCP NCORP Research Base grants.

Attachment 5. Summary of Leadership on NCTN Clinical Trials by Major Cancer Category, Trial Phase, and Trial Number (use filename CurrentNCTNTrialPIs). In this attachment, provide information on NCTN clinical trials leadership (i.e., PI and/or co-PI status for the main NCTN trial and/or co-PI or Champion (i.e., study liaison for accrual and trial monitoring and conduct for a NCTN Group not leading the main trial) for any NCTN trial that was open to accrual in the Network between March 1, 2019 and August 31, 2024. Please note that this information refers only to those individuals at the main academic site for the applicant or integral component of the applicant involved in the main trial (primary scientific endpoint), not in sub-studies embedded in the trials (e.g., ancillary studies) or oversight of other components of the trial (e.g., pathology, laboratory/correlative studies). A table can be used to show this information with column headings for the general cancer site category (e.g., breast cancer, gastrointestinal cancers, genitourinary cancers, leukemia, lymphoma, myeloma), trial phase, date of trial activation, date of trial closure to accrual (or list trial accrual as still on-going), institution's investigator's position on the trial (i.e., main trial PI/co-PI or co-PI/Champion status for other Network Groups participating in the main NCTN trial, investigator's name, and investigator's title and discipline. The timeframe for the table should be provided as a sub-heading (e.g., March 1, 2019 through August 31, 2024).

Attachment 6. Summary of Accrual for All NCTN Clinical Trials - All Diseases and All Trial Phases (use filename SummaryAllAccrual). In this attachment, provide documentation of patient accrual on NCTN clinical trials between March 1, 2019 and August 31, 2024 from the main academic site for the applicant and any integral components of the applicant (not affiliate sites). Accrual figures should include the unique number of patients enrolled on each NCTN trial regardless of whether the accrual was a screening or an intervention accrual (biospecimen submissions should not be counted as accrual). However, because of the large number of screening accruals on the following 3 NCTN Precision Medicine Trials: LUNGMAP Screening protocol, Adult MATCH (trial # EAY131), and ALCHEMIST (trial # A151216), patient accrual to these trials should be presented separately from all other accrual. Therefore, the accrual information can be provided in two tables - one table for the number of unique patients enrolled on the 3 NCTN Precision Medicine Trials with large screening components (i.e., LUNGMAP Screening protocol, EAY131, A151216) and one table for accrual to all other NCTN trials. The column headings for each table should include all trial phases (pilot/other, phase 1, phase 2 (including phase 1/2 trials), phase 3 (including phase 2/3 trials) and total column summing accrual across all trial phases. The timeframe for the period of accrual should be provided as a sub-heading for each table (e.g., March 1, 2019 through August 31, 2024).

Attachment 7. Summary of Accrual for Major Disease Categories - All Trial Phases (use filename SummaryAccrualMajorCancerSite). In this attachment, provide documentation of patient accrual by major disease category on NCTN clinical trials between March 1, 2019 and August 31, 2024 from the main academic site for the applicant and any integral components of the applicant (not affiliate sites). Accrual figures should include the unique number of patients enrolled on each NCTN trial regardless of whether the accrual was a screening or an intervention accrual (biospecimen submissions should not be counted as accrual). However, because of the large number of screening accruals on the following three NCTN Precision Medicine Trials of LUNGMAP Screening protocol, Adult MATCH (trial # EAY131), and ALCHEMIST (trial # A151216), patient accrual to these trials should be presented separately from all other accrual. Therefore, the accrual information can be provided in two tables - one table for the number of unique patients enrolled on the 3 NCTN Precision Medicine Trials with large screening components (i.e., LUNGMAP Screening protocol, EAY131, A151216) and one table for accrual to all other NCTN trials. The column headings for each table should include major disease category (e.g., breast cancer, gastrointestinal cancers, genitourinary cancers, leukemia, lymphoma, myeloma), all trial phases (pilot/other, phase 1, phase 2 (including phase 1/2 trials), phase 3 (including phase 2/3 trials), and total column summing accrual across all trial phases by major disease category. The timeframe for the period of accrual should be provided as a sub-heading for each table (e.g., March 1, 2019 through August 31, 2024).

Attachment 8. Summary of Timelines for Local Activation of NCTN Clinical Trials at Main Academic Site and Integral Component Sites (use filename SummaryActivationTimelines). In this attachment, provide information on the timeline for the initial activation/opening of NCTN trials at the main academic site and integral component sites if those sites open studies via a different process and different timeline from the main academic site (Do not provide this information for affiliates). This information should be provided only for NCTN trials that activated on or after March 1, 2019, through August 31, 2024. This information may be provided in a table with column headings for the site name, site category (main academic site or integral component), major disease category, trial phase, trial number and brief title, date the study was activated/opened for patient accrual by the Lead Group, date the trial was submitted for evaluation by at the site, date the trial opened at the site for patient enrollment, # days from evaluation to opening at the site, and an optional comments field. The data in the table should be sorted by major disease/cancer category, Lead Group trial activation date, and trial #. Please note that the date the site began the process for evaluation of opening the trial is the date the site starts with formal resource or other review of the trial by any review committee/process at the site.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

The following additional instructions apply to this NOFO.

a) General determination of level of overall funding. The NCTN provides general total cost support for different types of accrual for LAPS depending on the accrual type category and site category where patient enrollment occurred.

For intervention accrual at the Main Academic Site & all Integral Component Sites

Total cost funding for "per case management" for treatment intervention trials is expected to be provided in following estimated amounts by accrual category per enrolled patient listed below:

• IND-Exempt Intervention Treatment Trial: $5,300
• Non-CTEP IND Intervention Treatment Trial: $5,800
• CTEP IND Intervention Treatment Trial: $6,500
• Primary Imaging Base Intervention Trial: $1,350
• Screening Only on Treatment/Primary Imaging Trials: $700 (patient does not go onto intervention of trial)
• One Biospecimen Collection “Package” per Patient: $600 (for Intervention Treatment/Primary Imaging Trial enrollments only)

For affiliate sites of the Main Academic Site (non-integral component sites)

Total cost funding for "per case management" for treatment intervention trials is expected to be provided in following estimated amounts by accrual category per enrolled patient listed below:

• IND-Exempt Intervention Treatment Trial: $3.700
• Non-CTEP IND Intervention Treatment Trial: $4,200
• CTEP IND Intervention Treatment Trial: $5,000
• Primary Imaging Base Intervention Trial: $1,350
• Screening Only on Treatment/Primary Imaging Trials: $700 (patient does not go onto intervention of trial)
• One Biospecimen Collection “Package” per Patient: $600 (for Intervention Treatment/Primary Imaging Trial enrollments only)

The applicant should sum the estimated total cost funding for all categories (as noted above) for the “anticipated” number of patient accruals and collections that the applicant envisions on an annual basis. The applicant should then add an additional 20% to annual total sum for scientific coordination of patient enrollments across all its component sites to NCTN Group trials. This annual Grand Total Amount represents the estimated “ballpark” total cost figure for the entire grant application each year of the project period. The applicant should then create a standard grant "level-of-effort" budget using the cost categories for the standard R&R budget application.

The applicant can allocate the total cost amount across all allowable cost categories in any amount or distribution pattern that the applicant believes is appropriate. The applicant can request more (or less) than the estimated amounts with appropriate budget justification; however, the estimates amounts should be presented using the categories above.

To justify the budget, the applicant needs to describe using an "Accrual Input Table or Narrative" in the budget narrative detailing the number of patients expected to be accrued in the various accrual categories listed above: (1) intervention category for treatment trials by various IND status; (2) intervention category for primary imaging trials; (3) "screen only" category for treatment and/or imaging trials; and (4) 1 biospecimen collection “package” for each enrollment on a treatment or primary imaging trial presented by site type (Main Academic Site & Integral Components versus Affiliate Sites).

Please Note: Scientific leadership positions in the Network Groups will be funded by the Network Groups Operations Centers or associated Network Group Statistical and Data Management Centers (i.e., support for the activities of academic center investigators on Network Group oversight committees such as the Data Safety Monitoring Committees or Executive Committee and support for study chairs as well as Chair and Vice or Co-Chairs of scientific committees and administrative committees). Applicants can include these scientific leadership positions as accomplishments for the review to demonstrate how the LAPS application has the potential to provide leadership for the NCTN Program, but budget support for these positions if provided is included in the Network Group Operations Centers and SDMCs application budget, not in the LAPS application budget.

b) Travel Expenses: Applicants must budget travel funds for two persons (two PDs/PIs or one PD/PI and an additional senior investigator) to attend up to 3 NCTN Network Lead Academic Participating Site in-person meetings or other NCTN meeting over the grant's entire project period in addition to other travel expenses.

c) Routine Patient Care: NCI does not support costs associated with routine patient care as a budget expense under this NOFO.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: Outline succinctly the overall goal and research strategy for applicant to provide scientific leadership in development and conduct of clinical trials in association with 1 or more adult NCTN Network Group(s) as well as substantial accrual to clinical trials conducted across the entire NCTN.

Research Strategy: Organize the overall Research Strategy section with sub-sections in the specified order and using the instructions provided below. Start each sub-section with the appropriate sub-section heading: Sub-section A. Lead Academic Participating Site Overview; Sub-section B. Lead Academic Participating Site Clinical Trial Program; and Sub-section C. Lead Academic Participating Site Accrual Program.

Sub-Section A. Lead Academic Participating Site Overview - Address the following:

• Describe the governance and organizational capabilities and commitment relevant to the award as well as the general expertise of the senior leadership team as a whole for the Lead Academic Participating Site (LAPS) application.

Sub-Section B. Lead Academic Participating Site Clinical Trial Program - Address the following areas:

• Describe the LAPS' scientific leadership in development of NCTN clinical trials and in the scientific activities of the NCTN, including activities with all the Network Groups to which the LAPS belongs as well as activities related to NCI initiatives for the NCTN Program such as participating in the NCI Central Institutional Review Board (NCI CIRB), NCI Scientific Steering Committees and Task Forces, and NCI NCTN Core Correlative Science Committee.
• Describe how institutional activities related to the NCTN across various disciplines and departments at the LAPS are coordinated and how activities and responsibilities will be carried out among the PD(s)/PI(s). Describe how the LAPS selects NCTN clinical trials to activate and how funding associated with patient enrollment and clinical data collection and management is distributed to the various disciplines and clinical departments involved in the conduct of NCTN trials.
• Describe the most important achievements related to NCTN trials that show potential for achievement in the NCTN Program as well as the potential for mentorship of junior investigators clinical trial research within the NCTN.

Sub-Section C. Lead Academic Participating Site Accrual Program - Address the following areas:

• Describe the LAPS plan for robust accrual to NCTN trials across the Network, including accrual to rare cancers and accrual from special populations (e.g., minority and underserved communities, adolescents and young adults) as well as community outreach programs to achieve robust accrual. LAPS applicants should provide information on past minority and underserved community accrual to NCTN trials.
• Describe the operational efficiency of trial activation and conduct by the LAPS (including the timeliness of data submission and auditing results as well as how quickly the LAPS activates NCTN trials).
• Describe the ability of the LAPS to conduct trials with good clinical trial stewardship as demonstrated by audit results from accrual to NCTN trials and data submission timelines/quality on NCTN trials.

Letters of Support: If the application includes affiliates for which the lead academic center provides complete management services, the application section on Letters of Support should include Letters of Support from the affiliate organizations acknowledging that the affiliate site supports its inclusion in the application and agrees to receive NCI funding for patient data management on all NCTN trials they participate in via the LAPS grant should it be funded (i.e., an affiliate cannot be an affiliate of another institution for purposes of its NCTN Program participation; it would only participate and receive funding for patient data management in NCTN trials through the applicant's LAPS grant).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. 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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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.

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.

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.

Specific to this NOFO:

• Does the LAPS applicant demonstrate capacity to provide scientific leadership in the NCTN Network Groups as well as for other NCTN initiatives and programs such as participation in the NCI Central Institutional Review Board (NCI CIRB)?
• Does the LAPS applicant demonstrate the potential to overcome critical barriers for robust accrual for NCTN trials, across disease areas, including trials in rare cancers, and for special populations, including minority and/or underserved populations as well as adolescence and young adults? 
• Does the LAPS applicant have active programs to recruit minorities and underserved patient populations to NCTN trials?
• Does the LAPS applicant demonstrate the potential for robust accrual (e.g., 55 to 70 patients per year or more) to multi-institutional NCTN trials?
• Does the LAPS applicant have processes in place for timely activation of NCTN trials?
• Do NCTN clinical trials conducted at the LAPS applicant's sites appear to be conducted in accordance with good clinical practice as evidenced by audit results and data quality/submission timelines?

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policies and practices, 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 will receive a written critique.

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.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Development of an overall research strategy for the supporting the adult U.S. NCTN Group(s) in the development of clinical trials for the NCTN Program and providing senior leadership on NCTN Group Committees and for NCTN Program Initiatives.
• Oversight and accrual at the LAPS sites on NCTN clinical trials including use of the NCI Central Institutional Review Board (NCI CIRB) as the IRB of Record on all NCTN trials.
• Compliance with Part 1 of the NCI National Clinical Trials Network (NCTN) Program Guidelines/Handbook dated December 15, 2012 (https://ctep.cancer.gov/initiativesPrograms/docs/NCTN_Program_Guidelines.pdf) and any subsequent updated versions of the Guidelines/Handbook.
• Recipients will comply with the Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI at (https://ctep.cancer.gov/investigatorResources/investigators_handbook.htm), the NCI Guidelines for Auditing Clinical Trials for the National Clinical Trials Network (NCTN) Program including NCI Community Oncology Research Program (NCORP) and Research Bases at (https://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm), and the NCI/DCTD CRADA agreements, and the Intellectual Property Option to Collaborators at (https://ctep.cancer.gov/branches/rab/intellectual_property_option_to_collaborators.htm) for NCTN trials and other clinical trials conducted under a NCI/DCTD Investigational New Drug (IND) Application and/or Investigational Device Exemption (IDE).
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies and within the limits of any accepted binding NCI/NIH collaborative agreements with biotechnology and as governed by NCI-approved Data Management and Sharing Plans and NCI-approved review for use of biospecimens collected in association with NCTN trials.

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

• Working with Lead Academic Participating Sites to collaboratively manage major issues associated with their participating in the conduct of trials across the Network, including major initiatives for the Network such as streaming clinical trial conduct and broadening eligibility for patient enrollment to trials.
• Informing the PD(s)/PI(s) of the Lead Academic Participating Sites of scientific opportunities resulting from NCI-supported clinical research programs and facilitating collaborations between the Network Groups and other NCI-sponsored programs.
• Facilitating the LAPS scientific involvement in oncology treatment research, including advanced imaging research and radiation oncology research, associated with NCTN trials.
• Involvement in auditing of Network LAPS institutions via their membership in the Network Groups with oversight of compliance with applicable DHHS, FDA, OHRP, NIH, and NCI regulations for clinical research involving human research subjects.
• Review of accrual and overall performance of NCTN trials by the LAPS institutions.
• Advising recipients concerning mechanisms established for quality control of therapeutic and diagnostic modalities used in NCTN clinical trials.
• The NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data. The NCI may also review all records related to recipients' performance under the award for appropriate collection, review, and distribution of biospecimens collected in association with NCTN pilot studies.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• General aspects of collaboration on study development and conduct especially with respect to compliance with federal regulations for clinical trial research and participating in activities related to the collective management of the NCTN Program and its initiatives, as appropriate.
• Review of recommendations from the NCI Clinical Trials and Translational Research Advisory Committee (CTAC) on strategic directions for the NCTN Program related to LAPS support of and participation in NCTN clinical trials that might impact the awards.

Dispute Resolution:

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

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Margaret Mooney, M.D.
National Cancer Institute (NCI)
Telephone: 240-276-6006
Email: [email protected] 

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Section VIII. Other Information

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 2 CFR Part 200.