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 Funding Opportunity Announcement.

It is critical that applicants follow the instructions in 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 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for a Data Management and Coordinating Unit (DMCU), one of the two components of the Precompetitive Collaboration on Liquid Biopsy for Early-Cancer Assessment Consortium (LBC). LBC is an Academic-Industrial Partnership program to develop and validate liquid biopsy technologies, methods, or assays (collectively termed “technologies”), for early-cancer detection and risk assessment. The proposed DMCU will be responsible for the following activities: (1) Consortium Coordination; (2) Statistical and Computational Analysis Support; and (3) Data Management and Protocol Development.

In addition to the DMCU (this FOA), LBC will include up to six Liquid Biopsy Research Laboratories (LBRLs). LBRLs will conduct research on the development of liquid biopsy technologies for the capture and multi-dimensional quantitative analysis of tumor associated cells, DNA, RNA, exosomes and/or other cancer-associated analytes in body fluids of individuals with early-stage cancer or at high risk of developing the disease; and/or for distinguishing cancer from benign disease or aggressive from indolent cancers. A required component of LBRLs are well-integrated precompetitive alliances between academic and industry research and development teams that ensure the successful analytical and/or diagnostic validation of the developed liquid biopsy technologies.

Key Definitions for the context of this FOA

Liquid Biopsy: denotes a clinical test performed on a sample of blood or another type of body fluid aimed at the detection of characteristics that may reveal the presence of a cancer or risk for cancer in an individual. For the purpose of this FOA, the definition encompasses detection/monitoring of all tumor-associated circulating cells, nucleic acids, and extracellular vesicles in blood and/or other biofluids.

Technologies for early-cancer assessment refers collectively to tools, methods, assays, and other technical aspects relevant to the early detection and characterization of human pre-cancers and early-stage cancers.

Pre-competitive collaboration refers to the situation when entities (that might ultimately become commercial competitors) share information and collaborate on early stages of research and development and/or specific, defined aspects/domains (e.g., establishing standards, best practices), where joint efforts may be beneficial to all stakeholders. It is a means of efficient utilization and sharing of resources that allows effective movement to market competition.

Partnership team: each application must involve a team with complementary expertise representing investigators from academia and biomedical industry; thus, for the purpose of this FOA, such teams are referred to as "Partnership Teams" and the entire endeavor proposed for the U01 cooperative agreement award - as "Partnerships".

Background

Cancer is the second leading cause of death both globally and in the United States. Recent studies suggest that the detection of cancer at early, pre-clinical stages has the potential to reduce cancer-specific morbidity and mortality. Yet, at present, more than 70% of cancer deaths occur in organ sites without approved early detection modalities, mainly due to cost-ineffectiveness caused by low disease prevalence in most organ sites, combined with the low sensitivity of detection at early stages, and the relatively high false positive rates that can lead to significant morbidities or mortality from unwarranted invasive diagnostic procedures, or to unnecessary financial toxicity. Currently, screening programs for early-cancer detection in the general population in the United States are recommended only for a few organ sites with relatively high incidence, including colon, breast, and cervix, as well as for lung cancer in individuals with increased, smoking history-based risk, or for prostate cancer at an individualized basis. Existing screening programs, such as colonoscopy for colorectal cancers, mammography for breast cancer or low-dose computed tomography for lung cancer, require expensive infrastructure and highly trained technical and medical personnel. Hence, compliance with recommended screenings has remained poor, especially among socioeconomically vulnerable populations, such as ethnic/racial minorities, under-insured or uninsured individuals or those residing in rural areas with limited access to health care services.

In the era of personalized medicine, it is desirable to have noninvasive or minimally invasive methods to determine the presence of a cancer at its earliest possible stage of progression when curative treatment is most effective and likely to have an impact on mortality. One such approach is through liquid biopsy that could enable clinicians to screen for disease in asymptomatic individuals at normal or high-risk for cancer. Liquid biopsies can be used to detect components of a growing cancer, such as circulating tumor cells (CTC), circulating cell-free DNA (cfDNA) derived from tumor cells (ctDNA), circulating tumor-derived exosomes and other analytes in body fluids, including blood (serum or plasma), urine, saliva, sputum, etc. Liquid biopsies have the potential of changing the way early cancer diagnosis is made in routine medical care. They can help characterize the tumor molecularly, monitor genetic changes over time using repeat sampling of biofluids and by gaining a better understanding of the disease dynamics to identify patients that would require immediate treatment intervention versus those that would benefit from active surveillance. Liquid biopsy can also offer an opportunity to detect early lesions in cases where biopsy is difficult, such as brain cancer, as it has been shown that tumor DNA can be found in the cerebrospinal fluid (CSF). These assays can aid in the differential early diagnosis of brain cancers in combination with imaging. Due to both analytical and biological challenges, the implementation of liquid biopsy approaches for early-cancer detection has been lagging behind relative to their implementation for use in cancer diagnosis, predicting response to therapy and monitoring relapse. This is related to the relatively low levels of CTCs, ctDNA or other cancer-related analytes released into the bloodstream by early-stage cancers and the lack of technologies with appropriately high levels of analytical and diagnostic sensitivity and specificity.

Despite recent advances in the liquid biopsy research and development space, many challenges remain in adapting and utilizing new technologies in routine cancer screening either for a single cancer type or in the context of multi-cancer early detection (MCED) tests. MCED tests are liquid biopsy assays designed to screen for multiple types of cancers simultaneously by interrogating multiple circulating analytes and signatures in a single sample and offer an opportunity for streamlining the cancer screening process with the potential of improving both adherence to and cost-effectiveness of screening. The Precompetitive Collaboration on Liquid Biopsy for Early-Cancer Assessment (LBC) initiative is an Academic-Industrial Partnership program whose goal is to address some of the existing challenges and to accelerate progress in the implementation of liquid biopsy technologies in the early-cancer detection space. Some of the remaining challenges that could be addressed by the LBC program are:

• Lack of standardization in technical aspects for circulating biomarker detection resulting in false positivity/negativity and difficulties in obtaining reproducible results;
• Difficulty with the multiplicity of potential biomarkers to be evaluated in one sample;
• Insufficient data identifying the clinical impact of genomic variants of uncertain significance;
• Challenges with the Limit of Detection (LOD) - i.e., what is the lowest level of the biomarkers that must be present in the biofluid to be detected in early-stage disease or in asymptomatic individuals.

Main areas of research to be supported by the LBC program may include, but are not limited to:

• Validation of assays that can detect/screen for multiple types of cancer from a single blood sample (e.g., colon, lung, pancreas, breast, prostate). The assays would need to distinguish the cancer type or have viable imaging or biopsies for a definitive diagnosis.
• Validation of existing technologies, methods, assays for the detection and quantification of tumor associated circulating DNA, RNA, or exosomes in blood or body fluids of patients with early-stage disease or those at high risk.
• Detection of low allelic variance (<0.5%) suitable for the detection of early-stage disease.
• Sharing of data through collaboration with BloodPAC and other organizations. The LBC program has developed a letter of interest with BloodPAC, a non-profit institution, and actively participates in their committees on data standardization, harmonization and uptake using Common Data platforms.
• Development and/or characterization of computational tools to integrate data arising from a variety of circulating molecular signatures in the blood or body fluids of patients with early-stage disease or those at high risk and developing algorithms for tissue-of-origin prediction.

LBC Administrative and Governance Structure (For Information Only)

LBC will be structured around the two main units - the LBRs and the DMCU. Although individual teams of LBC recipients (LBRs and the DMCU) will operate independently, they will be required to interact closely with other LBC recipients and engage in collaborative activities with them.

Steering Committee: The LBC administrative structure and all activities will be governed by its Steering Committee, which will include representatives of the LBC recipients and the NCI. The Steering Committee will be the governing body of LBC that will integrate the efforts of all recipients and will provide oversight of collaborative activities. The Chair and co-Chair of the Steering Committee will be PDs/PIs of LBC cooperative agreement awards and will be elected by the Steering Committee. Any member of the Steering Committee can offer nominations for the Chair and co-Chair.

Further details of the Steering Committee composition and responsibilities are provided in Section VI.2. Administrative and National Policy Requirements: Cooperative Agreement Terms and Conditions.

Specific Research Objectives and Requirements

Scope. This FOA encourages the submission of applications to establish and enhance the LBC DMCU. The DMCU must have expertise and capabilities in biostatistics, computational analysis, imaging, machine learning modeling and Artificial Intelligence, information technology, bioinformatics, data management, protocol development, and in coordinating and providing logistical support for meetings and conferences. DMCU is expected to evolve, adapt and improve in response to the needs of the LBC community. It is essential that the DMCU applicants familiarize themselves with the other LBC component with which the DMCU must work, the LBRS by reviewing the previously published FOA (RFA-CA-23-018).

DMCU responsibilities include but are not limited to:

• Provide statistical analysis for LBC collaborative studies.
• Support the development, coordination, implementation, and conduct of LBC-collaborative research protocols.
• Support NIH Single-IRB policy to enhance and streamline the IRB process for multi-site post-award collaborative research studies supported by set-aside funds, as needed.
• Deploy state-of-the-art management of data and protocol development, Laboratory Information Management System (LIMS), which provides a comprehensive array of support services including study development, documentation of Common Data Elements (CDEs), data entry checks and specimen tracking for biospecimens used in collaborative studies, data harmonization and study-specific reports.
• Work closely with LBC investigators to support data analysis, Machine Learning modeling and Artificial Intelligence, and utilize any visualization tools as needed. Additional consultations and support on statistics and modeling will be made available through the NCI Division of Cancer Prevention's Biometry Research Group as directed by the Steering Committee and NCI staff.
• Enhance, improve and maintain LBC network integration and coordination.
• Provide logistical and administrative assistance in arranging LBC-wide meetings and workshops and employ various electronic channels of communication to promote and disseminate information among LBC investigators and the broader scientific community.
• Collect, store, curate, and disseminate all data, metadata, analysis and visualization tools, and computational models and lead the development of common data elements, data and metadata standards, clinical and epidemiological data requirements, and data processing pipelines. Assist in the identification and adoption of existing liquid biopsy-related standard data elements and resources for analytical and clinical validation of liquid biopsy assays, such as those developed through the efforts of BloodPAC and the FNIH.

Note: NCI will hold a pre-application informational webinar for this FOA. When published, the related Notice will be linked with the FOA.

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 FOA.

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)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

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 not 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.

• 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 registration; 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.

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.

An investigator designated as a Contact PD/PI of an application under this FOA must not be the designated Contact PD/PI or a Multi-Principal Investigator (MPI) or co-I on another application under the companion FOA (RFA-CA-23-018).

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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, per 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 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 FOA. 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 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.

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:

Lynn Sorbara, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7135
Email: [email protected]

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

• For this specific FOA, the Research Strategy must not exceed 30 pages.

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.

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

Specifically, describe the knowledge and experience of the PD(s)/PI(s) and other Senior/Key Persons in cancer research, technologies for cancer detection, imaging, informatics, and computational data science.

R&R Budget

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

The following additional instructions apply:

a) Leadership Effort Commitment: The contact PD/PI must commit a minimum of 1.8 person months of his/her time per year and all other PDs/PIs (if multiple) must commit a minimum of 1.2 person months of their time per year to the U24 award. This commitment cannot be reduced in later years of the award.

b) Restricted Travel Funds: Applicants must budget for travel and per diem expenses for Steering Committee meetings. Applicants should plan for the PD(s)/PI(s) and an additional senior investigator to attend one annual Steering Committee meeting per year.

c) Other: It is expected that funds will be allocated to open-access publishing.

Other Budget-Related Information: Budget for personnel services directly involved in the activities of the DMCU should be clearly identified. Applicants should budget to cover the types of services listed below. The workload in each category will vary as the needs and priorities of the DMCU may change during the funding period. The applicant’s staffing plan must allow for the flexibility needed to adapt to these changes.

1) Administrative Services:

• Team Leader's and other PD(s)/PI(s)' time to administer the DMCU and coordinate LBC collaborative projects;
• Logistical arrangements and support for one Steering Committee meeting every year. The place and dates for each Steering Committee meeting will be decided by the NCI Project Coordinator in consultation with the Steering Committee;
• Monthly conference calls for the Steering Committee, working groups and subcommittes (prepare agendas in consultation with the corresponding leads and the NCI staff liaison, arrange teleconferences, and keep minutes);
• Serve as the Single-IRB of record for multi-site, post-award collaborative research studies supported by set-aside funds, as needed.

2) Informatics Services:

• Develop and maintain secure website to allow for communication among DMCU members and posting of study results;
• Support data analysis, computational models and visualization tools.

3) Statistical Analysis and Study Protocol Development Services:

• Assist in the design of LBC collaborative studies (data collection and entry, sample tracking, calculation of populations and power analysis) and perform statistical analysis on data;
• Assist in the design of LBC specimen reference set collections (data collection and entry, sample tracking, calculation of populations and power analysis);
• Assist in data science projects, i.e., computational tools for data mining, machine learning, big data, and modeling.

R&R Subaward Budget

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:

The standard PHS398 Research Plan (Item 3 as per Revision 08/12 of the PHS 398 Table of Contents) is altered as follows: Standard Items 2-5 of the PHS 398 Research Plan are replaced by the following three sections: 1) Investigators' Leadership and Experience; 2) Plans for The Required Areas of Responsibility; and 3) Compliance with Consortium Cooperative Agreement Terms.

Specific Aims: The DMCU will serve as the scientific and organizational hub for the entire LBC program. In light of this significance, the applicants should describe the scope and innovation of the proposed strategies for coordinating the LBC program, as well as available expertise, resources, and capabilities for supporting the program's research on the precompetitive collaborative development of liquid biopsy technologies and assays for the early detection of cancer.

Research Strategy: Specific Sections to be included in Research Strategy are described below:

The responsibilities of the LBC DMCU are diverse. Each of the responsibilities described in the section "Section I. Funding Opportunity Description: 1. Research Objectives” is relevant to the overall performance of the Consortium.

Section 1. Investigators' Leadership and Experience

• Describe the applicant organization's facilities and resources, and how the strengths of the PD(s)/PI(s) and other key personnel in biostatistics, data management, data analysis, and project management have been used in previous, successful collaborative research projects;
• Describe the knowledge and experience of the PD(s)/PI(s) and other key personnel in research on cancer and technologies used in cancer detection, diagnosis, and prognosis;
• Describe the experience of the key personnel in protocol design, data entry procedures, and manual preparation, and in data collection and data quality control for previous technology/assay development and validation related research projects;
• Present the applicant's record in generating reports on data collection and performance in previous collaborative projects, including preparation of manuscripts;
• Describe how logistical services and organizational support have been utilized in managing resources and monitoring performance in previous collaborative research; and
• Describe the applicants’ experience and accomplishments in the development of statistical and computational tools, statistical modeling, innovative sampling and study designs, and present a plan to develop a research project that is relevant to early-cancer detection and diagnosis.

Section 2. Plans for the Required Areas of Responsibility

Applicants must describe in detail the development, implementation, and maintenance plans for each required area of responsibility . These main areas of responsibility include:

(a) Consortium Coordination:

• Provide logistical and administrative assistance in arranging meetings of the Steering Committee (e.g. preparing, distributing, and maintaining minutes of meetings), including the selection and contract development with appropriate venues as decided by the Steering committee. There will be one face-to-face Steering Committee Meeting per year, as well as monthly teleconferences;
• Provide other operational support for LBC (e.g., communications, working groups and subcommittee meetings and teleconferences);
• Employ various electronic channels of communication to promote and disseminate information among LBC investigators, other NCI-supported programs, and the broader scientific community;
• Develop and maintain all documents, including a Manual of Operations and other procedure manuals as needed with oversight and guidance by the LBC Steering Committee and input from NCI staff;
• Contribute to the development and maintenance of an interactive LBC website to disseminate information on important accomplishments of the Consortium, and to publicize the availability of LBC-supported resources;
• Develop and maintain a "listserv" interactive email system for communication within the Consortium;
• Work with the NCI Project Scientists/Coordinators on the review of collaborative study proposals submitted by the LBRLs to the LBC Steering Committee for the use of set-aside funds;
• Work with the NCI Project Scientists/Coordinators on the review of Associate Membership applications submitted to the LBC Steering Committee.

(b) Statistical and Computational Analysis Support:

• Provide statistical support for LBC collaborative studies;
• Conduct data analysis and assist in the publication of results of LBC collaborative studies;
• Demonstrate expertise in data integration and statistical modeling approaches for using data generated from complex liquid biopsy target analytes such as those derived from ‘-omics’ technologies;
• Demonstrate expertise and flexibility to accommodate increasing data volume/types from LBC studies (bioinformatics, imaging, data science, modeling, visualization tools, etc.);
• Demonstrate expertise in data mining using ML, AI and bioinformatic tools;
• Utilize data analytics (statistics, AI, ML, Deep Learning, bioinformatics tools, etc.) to improve the analytical and diagnostic performance of liquid biopsy technologies and assays for the early detection of cancer.

(c) Data Management and Security plans, and Protocol Development:

• Support the development, coordination, and implementation of LBC collaborative research protocols and their registration on the interactive LBC website;
• Develop uniform investigative protocols for data and specimen collection as appropriate, including development of new CDEs or adopting existing standard data elements, reference standards and other resources, such as those developed through the efforts of BloodPAC and the FNIH;
• Support the collection, assembly, and distribution of biospecimen sets for LBC collaborative studies and analyze data that result from the use of these specimens;
• Provide a mechanism for rapid and routine (to be decided by the Steering Committee) transmittal of materials (e.g. computer output, reports, etc.) among the Consortium participants and the NCI Project Coordinators and other NCI staff;
• Provide advice and consultation to LBC investigators in study design and protocol development of LBC collaborative studies, after the study has been reviewed and approved by the LBC Steering Committee;
• Develop data capture, management, security and sharing plans.

These plans should include description of design, personnel requirements, and infrastructure (hardware, software, other). Applicants are encouraged to describe in their application the cost-efficient use of existing technologies.

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. 

In addition to the standard NIH rules, the following LBC-specific expectations apply:

• Collaboration among LBC investigators, as well as between Consortium investigators and third-party is a core mission of the LBC program, which entails the sharing of Intellectual Property (IP) arising out of research resources developed in Consortium-related activities.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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.

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

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

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 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.

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

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.

5. Intergovernmental Review (E.O. 12372)

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 fieldof 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 FOA 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 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 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

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.

Overall Impact

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).

Scored Review Criteria

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.

Significance

Does the proposed DMCU address the needs of the research consortium that it will coordinate? Is the scope of activities proposed for the DMCU appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Specific to this FOA: 

How adequate are the proposed theoretical and applied research management and program coordination plans, methods, and approaches for addressing the overall LBC program needs, including study design, and the analysis, harmonization, and stewardship of generated data? 

Over the project period, how likely is that the applicant will develop statistical and analytical approaches other than those specified in the application? 

How adequate are the structure and activities planned for the DMCU for the needs and coordination of the proposed studies and the anticipated trans-LBC activities? 

How likely is the proposed DMCU to contribute unique expertise, capabilities, and/or resources to the entire Consortium?

Investigator(s)

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

Specific to this FOA: 

Are the PD(s)/PI(s) and their collaborators appropriately trained and have demonstrated experiences in the areas of program management, statistical, mathematical, and computational biology? 

Will this team of investigators contribute unique skills to the overall objectives of the LBC program? 

Is the commitment of the PD(s)/PI(s) and other senior investigators adequate? 

To what degree, does the applicant team take advantage of a collaborative and interactive model of research management and coordination? 

How likely are the applicants to engage in collaborations, sharing information, and work towards the priorities and goals agreed upon by the Steering Committee for trans-Consortium collaborative studies? 

Are the PD(s)/PI(s) and support personnel adequately trained and qualified for participating and managing multi-institutional collaboration?

Innovation

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

Specific to this FOA: 

Is a refinement, improvement, or new application of organizational concepts, management strategies or statistical/computational tools proposed? 

Does the proposed approach/methodology challenge existing paradigms or develop new computational/statistical approaches?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the DMCU will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the 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? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) 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), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: 

Does the application adequately address how each of the goals set for the required areas of responsibility will be accomplished? 

Are relevant technical problems and their timely and effective solutions adequately addressed? 

Are the conceptual framework, design, methods, and analyses adequately developed and appropriate for providing data and resource management and program coordination? 

Are there adequate plans for effective interaction and coordination with the other Consortium components (LBRLs), the Steering Committee, and the NCI? 

Will the proposed approaches be generally applicable to the systematic analysis of data relevant to the analytical and diagnostic validation of liquid biopsy technologies/assays for early-cancer detection and diagnosis?

Environment

Will the institutional environment in which the DMCU 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 DMCU proposed? Will the DMCU 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: 

Are facilities and equipment for data management, data security, and data analysis appropriate to support the objectives of the FOA? 

Has the applicant demonstrated adequacy of proposed infrastructure and commitment and documented evidence of institutional support for the proposed endeavor and institutional support for computer services? 

Additional Review Criteria

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.

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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 Animals Section.

Biohazards

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.

Resubmissions

Not Applicable 

Renewals

Not Applicable 

Revisions

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.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, NIH 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 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 FOA.

Applications will be assigned to NCI. 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.

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 VI. Award Administration Information

1. Award Notices

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 recipient's business official.

Recipients 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.

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

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, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 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.”

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (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 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 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 for the project as a whole resides with the recipients, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

• Defining objectives and approaches, overseeing planning and conducting experiments, analyzing and interpreting results, and publishing reports of studies conducted under this award.
• Assuming responsibility and accountability to the applicant organization and to the NCI for the performance and proper conduct of the research in accordance with the terms and conditions of the award.
• Serving as voting members of the Liquid Biopsy Consortium Steering Committee (the PD/PI and another senior investigator from each Consortium award (U01) will be required to attend Steering Committee meetings once a year).
• Accepting and implementing the goals, priorities, procedures, and policies agreed upon by the Steering Committee to the extent consistent with applicable grant regulations.
• Coordinating efforts and cooperating with the other components of the Liquid Biopsy Consortium and with NCI staff members.
• Overseeing the implementation of the approved Data Management and Sharing Plan.
• Ensuring that experimental data and their format, analytical algorithms, computational modeling and visualizations, and other bioinformatics tools resulting from this FOA are compatible with the NIH-approved bioinformatics platforms, such as those designed and implemented by the NCI Center for Biomedical Informatics and Information Technology (http://cbiit.nci.nih.gov).
• The PDs/PIs and their recipient institutions will be accountable for implementing the approved research resource sharing plan.
• All institutions/organizations participating in the Liquid Biopsy Consortium will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to the Liquid Biopsy Consortium.
• Each Consortium award recipient and the entire Liquid Biopsy Consortium programmatic initiative will be subject to external evaluation (coordinated by the NIH). Consortium Awardees will be expected to participate in such evaluations.
• Recipients of awards 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.
• Award recipients will be required to collaborate with other Consortium recipients on such aspects as developing and conducting trans-Consortium collaborative projects, sharing resources (as applicable: biospecimens, standards, and/or procedures), and other activities of pre-competitive nature that may benefit all participants, as appropriate and consistent with achieving the goals of this program.

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

Designated NCI Program Directors serving as a Project Scientist(s) and a Project Coordinator(s) will be involved in assisting and coordinating interactions and collaborations among the various investigators and industrial partners and will ensure access to other NIH relevant programs.

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.

Specific activities of substantially involved NCI staff members will include:

• Advising the award recipients on specific scientific and/or analytic issues as well as programmatic priorities.
• Facilitating access to NCI resources, biospecimens, epidemiological expertise, etc.
• Facilitating various activities of the Liquid Biopsy Consortium programs.
• Participating in the activities of the Liquid Biopsy Consortium Steering Committee.
• Serving as a liaison between the Steering Committee, the Liquid Biopsy Consortium recipientss, and the NIH.
• Ensure common access to Consortium-generated resources and reagents for the broader cancer research community and facilitating access to NCI resources, biospecimens, epidemiological expertise, etc.
• Ensuring, in cooperation with the NCI CBIIT, that there are effective mechanisms to enable electronic communication among the Liquid Biopsy Consortium recipientss, and between the Liquid Biopsy Consortium and the NCI.
• Assisting the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action.
• Assisting the investigators in avoiding unwarranted duplications of effort across the Liquid Biopsy Consortium.
• Co-organizing and participating in the Liquid Biopsy Consortium Steering Committee meetings.
• Monitoring the scientific progress of individual Consortium awards and the entire program.
• Reviewing the compliance of Consortium recipientss with the recommendations developed by the Steering Committee; and coordinating external evaluation of the Liquid Biopsy Consortium.

Areas of Joint Responsibility

Steering Committee: The Steering Committee will be the main governing body for the Liquid Biopsy Consortium, as defined below.  The LBC Steering Committee will convene after all Consortium components have been funded and will be composed of the following voting members:

• Two representatives from each Consortium award (the PD(s)/PI(s) or a PD/PI and a designated senior investigator) who will have one vote each; and
• The NCI Project Coordinator will have one vote for the NCI. 

The chair of the Steering Committee (who cannot be an NIH staff) will be selected from the representatives of all recipientss.

Additional NIH staff may participate in Steering Committee meetings as non-voting members as needed (for example to provide additional expertise). The non-voting members may include representatives from NCI extramural divisions and a representative from the NCI CBIIT.

Additional non-voting members may participate on the Steering Committee in an advisory capacity on an as needed basis and decided by the existing voting committee members.

The Steering Committee may decide to establish sub-committees for specific purposes. The NCI Project Scientists/Coordinators will serve on such sub-committees, as they deem appropriate.

The Steering Committee will meet once every year, at locations selected by the Steering Committee in consultation with the NCI. The first meeting will focus on defining the process and procedures for the coordination of the Liquid Biopsy Consortium activities.

Primary responsibilities of the Steering Committee will include the following aspects:

• Recommendation for proceeding through the three stages of progress (development, harmonization, and application);
• Identifying areas of opportunity that can best be exploited with a group effort via the Liquid Biopsy Consortium; coordinate the acquisition and distribution of biospecimens;
• Encouraging the development of new methodologies and approaches to be shared among the Liquid Biopsy Consortium members;
• Optimizing the information flow between the teams and the NCI;
• Establishing procedures guiding how collaborative activities (to be supported by the restricted set-aside funds of each LBRL U01 award) will be initiated, formulated, and presented to the Steering Committee for recommendation regarding execution of collaborations.
• Reviewing (with the help of external reviewers if needed), prioritizing, and recommending for activation trans-Consortium collaborative activities to be supported by these restricted set-aside funds.

Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to 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 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 regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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.

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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]

Christos Patriotis, PhD
National Cancer Institute
Telephone: 240-276-7134
Email: [email protected]

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

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6885
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 45 CFR Part 75 and 2 CFR Part 200.