National Institutes of Health (NIH)
National Cancer Institute (NCI)
The Early Detection Research Network: Biomarker Developmental Laboratories (U01)
U01 Research Project – Cooperative Agreements
Reissue of RFA-CA-14-014
The purpose of this Funding Opportunity Announcement (FOA) is to solicit organ-specific applications for Biomarker Developmental Laboratories (BDLs), one of the four scientific units of the recently funded Early Detection Research Network (EDRN). The EDRN is a national infrastructure funded to discover, develop, and validate biomarkers for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. BDLs are responsible for the discovery, development, characterization, and testing of new, or the refinement of existing, biomarkers and biomarker assays for risk assessment, detection, and molecular diagnosis and prognosis of cancers. The existing BDLs are primarily focused on ovary and gastrointestinal cancers. The proposed BDLs (to be supported under this FOA) must be focused on cancers of the breast, prostate and other genitourinary organs, and lung. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be responsive.
The other three scientific units of the continuing EDRN program are: the Biomarker Reference Laboratories (BRLs), which serve as Network resources for clinical and laboratory validation of biomarkers; the Clinical Validation Centers (CVCs), which conduct clinical research on the validation of biomarkers and serve as resource centers for the EDRN by participating in collaborative biomarker validation studies with EDRN BDLs and BRLs; and the Data Management and Coordinating Center (DMCC), which support statistical and computational analyses, informatics infrastructure, study design, coordination and support of EDRN-sponsored biomarker validation studies, and the coordination of Network-wide meetings and conferences.
March 17, 2016
April 23, 2016
30 days prior to the application due date
May 23, 2016, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on this date.
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.
May 24, 2016
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This Funding Opportunity Announcement (FOA) is a reissuance of RFA-CA-14-014, which is part of the Early Detection Research Network (EDRN) initiative. EDRN (http://edrn.nci.nih.gov/) is a national, integrated infrastructure for the development of biomarkers and the assembly of necessary resources. The goal of EDRN is the development, evaluation, and validation of biomarkers for risk assessment, detection, and the molecular diagnosis and prognosis of early cancer.
The FOA solicits applications for organ-specific EDRN Biomarker Developmental Laboratories (BDLs) for cancers of the breast, prostate and other genitourinary organs, and lung. These cancer types are not adequately represented in the recently funded applications and are of programmatic priority. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be responsive.
The proposed BDLs will be responsible for the development and characterization of new or the refinement of existing biomarkers and biomarker assays for early cancer detection, risk assessment, and molecular diagnosis and prognosis of early cancer. Prior affiliation with the EDRN is not required and all qualified investigators are invited to apply.
EDRN has three major scientific units besides BDLs:
The Clinical Validation Centers (CVCs) conduct clinical research to validate biomarkers for risk assessment, detection, and the molecular diagnosis and prognosis of early cancer. CVCs also serve as resource centers for collaborative research within the EDRN by participating in collaborative biomarker validation studies and collaborating with EDRN BDLs and Biomarker Reference Laboratories (BRLs);
The BRLs serve as a Network resource for clinical and laboratory validation of biomarkers, including assay development and refinement; and
The Data Management and Coordinating Center (DMCC) conducts statistical and computational analyses and data management, study protocol development, study design, and coordination of EDRN-sponsored biomarker validation studies, participate in the development and maintenance of informatics infrastructure, and coordinate Network-wide meetings and conferences.
Biomarker Definition. In the context of this FOA, biomarkers are defined as cellular, biochemical, and/or molecular (including genetic and epigenetic) characteristics by which normal and/or abnormal biological processes can be recognized and/or monitored. Biomarkers are measurable in biological materials, such as in tissues, cells, and/or bodily fluids.
EDRN Scientific Premise
Since its inception in 2000, the EDRN has followed a "vertical" approach to biomarker research that facilitates collaborations and hand-offs among technology developers, basic scientists, clinicians, epidemiologists, biostatisticians, and other health professionals. It also expedites efficacious clinical applications of the molecular knowledge that has burgeoned in recent years. The NCI anticipates that EDRN investigators will collaborate with industry both to develop biomarkers and/or reagents and to provide a clinical environment for the evaluation of new technologies. Early interactions with industry leading to research collaborations are likely to benefit both EDRN grantees and industry partners. Many EDRN investigators have or have had active collaborations with the industry. It is hoped that validated biomarkers may ultimately be commercialized into diagnostic products for early detection of cancer and cancer risk assessment. Structured around four main scientific units, the EDRN currently includes 20 BDLs, three BRLs, eight CVCs, and one DMCC.
The EDRN program is established to: (a) promote translational research to identify biomarkers for cancer risk, early detection, and molecular diagnosis and prognosis of early cancer; and (b) coordinate biomarker research within the extramural community and with other NCI programs in cancer prevention, screening, and treatment to reduce cancer morbidity and mortality (see EDRN Strategic Plan, http://edrn.nci.nih.gov/docs). In the future, candidate biomarkers are likely to be discovered by integromic approaches where genomics data will increasingly be integrated with other 'omic' data, such as proteomic, epigenomic, metabolomic, etc., to take advantage of the exponentially growing genomic knowledge of the cancer landscape.
EDRN's specific interests include but are not limited to the following:
Discover, develop, evaluate, and validate promising 'omic' biomarkers (e.g., genomic, proteomic epigenomic, metabolomic) for effective cancer risk assessment, early detection, and early diagnosis and prognosis of cancer.
Integrate biomarkers with imaging to reduce the false positive rate of imaging and to improve the detection of clinically significant cancers.
Develop and validate biomarkers to improve the detection of cancer progression for patients on active surveillance.
Develop assays for accelerating biomarker discovery and translation into the clinical area. This would include measures of diagnostic or predictive accuracy, sensitivity, specificity, and, whenever possible, clinical impact/benefits.
Develop and implement diagnostic assays in support of the EDRN objectives by using multiple biomarkers, gene expression patterns, post-translational changes, epigenetic changes, and changes in metabolic profiles.
Facilitate the development of high-throughput, sensitive assay methods to identify and implement biomarkers that are useful in assessing cancer risk, detecting early stage cancers, cancer diagnosis and prognosis.
Support collaboration among academic and industrial leaders, whose areas of interest are in molecular biology/molecular genetics, clinical oncology, computer science, public health and/or other related areas, leading to the development of cancer diagnostics.
Conduct clinical/epidemiological studies (e.g., cross-sectional, prospective, retrospective, etc.) in order to evaluate the predictive value of biomarkers.
Continue to expand the informatics infrastructure to facilitate pre-competitive data sharing on biomarker discovery, development, and validation.
Serve as a core resource so that NCI and the cancer community at large can leverage the well-developed EDRN infrastructure and expertise in order to facilitate translational cancer research and cancer therapeutic trials.
These goals are achieved through a systematic, evidence-based discovery, development, and validation of biomarkers, based upon Standard Operating Procedures (SOPs) and Common Data Elements (CDEs) developed by the EDRN investigators and described in the EDRN Manual of Operations (http://edrn.nci.nih.gov/docs). The EDRN has established a five-phase approach as a standard and a roadmap for successfully translating research on biomarker applications from the laboratory to the bedside. The five phases for biomarker discovery and validation are:
Phase 1: The pre-clinical exploratory phase;
Phase 2: The validation phase (case/control);
Phase 3: The retrospective longitudinal phase;
Phase 4: The prospective screening study phase; and
Phase 5: The cancer control phase.
The EDRN has also proposed a coherent and comprehensive set of guidelines for biomarker discovery and validation studies for early cancer detection, diagnosis and prognosis, known as the prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) study design. The PRoBE study design includes four key units, which relate to: 1) the clinical context and outcomes; 2) criteria for measuring biomarker performance; 3) the biomarker itself; and 4) the sample size included in the study. The PRoBE design involves prospectively collected biological specimens from a cohort that represents the target population envisioned for clinical application of the biomarker. Nested case-control studies, as described in the PRoBE design, can improve the quality of discovery research and increase the chances of truly valuable markers to undergo definitive evaluation. The biomarker is assayed in a blinded fashion on the specimens collected prior to and near the time of diagnosis among the case subjects and at similar times in the control subjects in the cohort. Studies using such banked specimens and data collected prior to symptoms or diagnosis are increasingly recognized as precious resources for making comparisons that have strong internal validity. Clinical studies seldom have prediagnostic specimens on most subjects because obtaining them requires following large cohorts of asymptomatic people, ideally at periodic intervals, to ascertain if they develop cancer. One biological explanation as to why prediagnostic and clinical early stage specimens may differ is that acute phase plasma proteins may be increased by inflammatory and other conditions present near the time of symptomatic diagnosis.
The articles on five-phase approach and PRoBE design are provided on the EDRN website (http://edrn.nci.nih.gov/docs).
EDRN Administrative Structure (For Information Only)
The current EDRN scientific units are composed of: 7 BDLs, 8 CVCs, 2 BRLs, and one DMCC. Although the newly funded individual teams of investigators (BDLs, CVCs, BRLs, and DMCC) will operate independently, they are required to interact closely with other EDRN awardees and engage in collaborative activities with them. At present, the BDLs lack core strengths and expertise in cancers of the breast, prostate and other genitourinary organs, and lung; cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers; and/or cancers with unique etiology, e.g., mesothelioma.
The EDRN administrative structure is composed of the following:
Steering Committee: The Steering Committee, which includes representatives of the EDRN awardees and the NCI, is the governing body of EDRN that integrates the efforts of all EDRN awardees and provides oversight of collaborative activities. The Chair and co-Chair of the Steering Committee are PDs/PIs of EDRN cooperative agreement awards and are elected by the Steering Committee. Any member of the Steering Committee can offer nominations for the Chair and co-Chair. The co-Chair serves as the Chair of a small subgroup of the Steering Committee, the Executive Committee. Other members of the Executive Committee include the leading PD/PI of the DMCC, a representative PD/PI of BRLs, the NCI Project Coordinator, and the Chairs of the EDRN Collaborative Groups. The latter are based on organ site and EDRN PDs/PIs can be members of one or more Collaborative Groups.
Assisted by the Executive Committee and NCI Program staff, duties of the Chair of the Steering Committee include:
Preside at all meetings of the Steering Committee;
Appoint and re-appoint members of Subcommittees, Review Groups, and designate special assignments;
Appoint ad hoc committees as needed;
Invite consultants as needed to Subcommittees, etc.;
Appoint EDRN liaison members to other organizations;
Serve as an ex-officio member of all Subcommittees, ad hoc Committees, and Task Forces;
Submit annual EDRN Progress Reports to NCI and the Network Consulting Team.
Further details of Steering Committee composition and responsibilities are provided in Section VI.2. Administrative and National Policy Requirements: Cooperative Agreement Terms and Conditions.
Headquarters: The institution of the Chair of the Steering Committee serves as the Headquarters of the EDRN. The Headquarters serve as a center for dissemination of information to investigators and institutions in EDRN, as well as to those outside the Network. The Chair serves as the PD/PI of the Headquarters and oversees the implementation of the scientific, operational, and organizational policies of the Network.
Core Fund: The EDRN will have a restricted Core Fund that will be made available to support post-award collaborative research projects, validation of new biomarkers, expansion of the EDRN portfolio, and making the Network inclusive by supporting non-EDRN investigators. Since the Core Fund is restricted and reserved for post-award activities, no requests for Core Fund support can be made in the application in response to this FOA.
The management of the EDRN Core Fund will be a responsibility of the DMCC and will be restricted via a term of award pending review of proposed projects by the EDRN Steering Committee and NCI approval of the projects. The solicitation of requests for use of Core Fund and the organization of their review will be the responsibility of the Steering Committee. The procedure for selecting activities and releasing the funds will involve the following steps: EDRN-affiliated investigators as well as non-EDRN investigators will be able to request Core Fund support for specific collaborative activities relevant to the EDRN goals. The Steering Committee will assign these requests for review to PDs/PIs from appropriate EDRN Collaborative Groups with the assistance of external reviewers as needed. Final review and selection of requests to be recommended for funding will be conducted by the Executive Committee. Following these recommendations and the NCI approval of funds release, the DMCC will distribute the approved funds under appropriate sub-award agreements.
Network Consulting Team: The Network Consulting Team is composed of a Chair and non-EDRN members appointed by NCI. The Network Consulting Team reviews the progress of the EDRN, recommends new research initiatives, and ensures that the Network is responsive to promising opportunities in early detection research and risk assessment. The Network Consulting Team can recommend new research projects to the Steering Committee or to NCI. Members of the Network Consulting Team can serve on ad hoc Committees of the EDRN, internal Review Groups, and as consultants to subcommittees.
Scope: This FOA encourages the submission of applications in broad categories of biomarker discovery for cancers of the breast, prostate and other genitourinary organs, and lung. These cancer types are not adequately represented in the recently funded applications and are of programmatic priority. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be considered.
Biomarkers may be derived from the expanded knowledge of complex cellular pathways, processes, and networks that could identify the molecular and cellular signatures of cells, which can be used for risk assessment, detection, and molecular diagnosis and prognosis of early cancer. Use of integromic approaches, systems biology approaches, and/or signaling pathway analyses to identify biomarkers that not only predict onset of a certain cancer but also delineate the specific biochemical, cellular, and physiological characteristics associated with a particular neoplasia is desirable and encouraged. Use of information from The Cancer Genome Atlas (TCGA), high throughput sequencing technologies and other molecular approaches to understand what types of molecular properties confer aggressiveness to some pre-neoplastic lesions, define and characterize pre-neoplastic lesions in order to improve current standards in histology and cytology, and more accurately predict tumor behavior at the tissue, cellular or molecular level is encouraged. Applicants can propose to utilize bodily fluids, readily available biopsy or tissue specimens procurable through minimally invasive technologies, circulating nucleic acids or cells, and other media as appropriate to the proposed study.
Examples of specific research areas include but are not limited to:
Types of Cancer: This FOA is limited to applications for research on cancers of the breast, prostate and other genitourinary organs, and lung. In addition, cancers with rapidly rising incidence rates, e.g., endometrial, hepatocellular, kidney, thyroid, oropharyngeal cancers, and/or cancers with unique etiology, e.g., mesothelioma, will be responsive.
Examples that illustrate the types of appropriate translational biomarker studies include but are not limited to the following:
Partnerships/Collaborations with Industry:
Applicants are encouraged to consider partnerships and/or collaborations with the for-profit private sector, if applicable. For EDRN-related public-private partnerships, please visit the EDRN website at http://edrn.nci.nih.gov. Industrial scientists or collaborators can provide valuable expertise, reagents and technology for biomarker discovery. EDRN encourages pharmaceutical and biotechnology companies to participate in Network-sponsored studies for moving biomarkers through qualification for an FDA-approved clinical use. Applicants are encouraged to develop collaboration with industry or diagnostic companies to share precompetitive data on their proposed research to avoid competition and foster complementation. In structuring such partnerships or collaborations, take into account pre-existing intellectual property rights associated with the use of existing models/reagents and make appropriate licensing arrangements.
The present EDRN has an adequate representation of cancers of the gastrointestinal sites, ovary, and pancreas. Applications focused on these cancer types will be considered non-responsive to this FOA. The FOA will also not support mechanistic studies, such as studies on growth regulation, cell cycle control, or other basic studies, which are not explicitly focused on risk assessment, on early cancer detection, and on molecular diagnosis and prognosis of early cancer in humans. Applications using “convenience samples” (i.e., samples to be used were not collected based on SOPs and/or the intended clinical use of the biomarkers to be developed and not in compliance with the PRoBE or a similar study design for minimizing bias) will also be considered non-responsive. Non-responsive applications will not proceed to review.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
NCI intends to fund an estimate of 8-10 awards, corresponding to a total of $5,500,000 for fiscal year 2016. Future year amounts will depend on annual appropriations.
A budget of up to $400,000 per year in direct costs may be requested. The indicated budget limit may be appropriate for larger projects involving multiple laboratories (and possibly multiple PDs/PIs). Smaller projects (e.g., involving one PD/PI and a single laboratory) are expected not to exceed $250,000 per year in direct costs.
Application budgets need to reflect the actual needs of the proposed project.
An applicant may request a project period of up to 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
A PD/PI may not serve as a contact PD/PI on more than one application submitted in response to this FOA. In addition, contact PDs/PIs of currently funded EDRN awards may not serve as a contact PD/PI on an application submitted to this FOA.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
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:
The letter of intent should be sent to:
Sudhir Srivastava, Ph.D., M.P.H.
Chief, Cancer Biomarkers Research Group
Division of Cancer Prevention
National Cancer Institute
9609 Medical Center Drive, Room 5E136, MSC 9790
Bethesda, MD 20892-9790 (for USPS Regular or Express delivery)
Rockville, MD 20850 (for non-USPS delivery)
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
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. Additional instructions are defined below.
Facilities & Other Resources: Applicants must list/document the following:
Other Attachments: Applicants should provide additional supporting materials relevant to the research proposed in the categories defined below. Upload these materials as individual pdf files using the indicated file names (these file names will become bookmarks in the application).
All instructions in the SF424 (R&R) Application Guide must be followed. All Key Personnel must provide a detailed description of their expertise that is relevant to the proposed studies.
In addition, the following specific requirements must be addressed:
All instructions in the SF424 (R&R) Application Guide must be followed. The following additional instructions apply:
a) The contact PD/PI must commit a minimum of 1.8 person-months effort per year to the U01 award. This commitment cannot be reduced in later years of the award. For multiple PD/PI applications, the other PD(s)/PI(s) must devote a minimum of 1.2 person months effort per year to their respective projects.
b) Applicants must set aside 30 percent of their annual budget for Network collaborative studies from the first year onward.
The use of the set-aside funds will be restricted for collaborative studies whose specific details (i.e., biomarkers prioritized/selected) will be determined based on initial studies and will be subject to review by the Steering Committee, including external consultants as needed (see Section VI.2 Cooperative Agreement Terms and Conditions of Award.) The release of these funds from individual U01 awards will be contingent upon the advice of the EDRN Executive Committee and authorization by the NCI. The amount should be presented in the Other Expenses category under the heading “Network Collaborative Funds.”
c) Applicants must budget for travel and per diem expenses for Steering Committee meetings. In the first year, applicants should plan for at least two senior investigators (all PDs/PIs, if desirable, or the PD/PI and a senior investigator if multi-PDs/PIs option is not used), to attend a Planning Meeting and two Steering Committee meetings. In the second and subsequent years, applicants should plan for at least two senior investigators (all PDs/PIs, if desirable, or the PD/PI and a senior investigator if multi-PDs/PIs option is not used) to attend two Steering Committee meetings per year and an EDRN Scientific Workshop every 18 months (this usually coincides with one of the Steering Committee meetings.)
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: In addition to a brief description of the specific aims and approach(es) to be employed, applicants must outline the scope of the proposed research and its relevance to a specific unmet clinical need in the management of human malignancies.
Research Strategy: Instead of the standard SF424 sub-section of Research Strategy, applicants must use subsections A-D defined below.
Sub-section A: Overview
Outline the overall research theme of the proposed BDL, as well as the Significance and Innovation of the proposed study in the context of a specific unmet clinical need. Define clearly the clinical endpoint (outcome or condition the biomarker is to classify). Describe the overall translational potential and relevance of the proposed studies to the early detection of cancer. Explain how the proposed research will enhance existing biomarker detection systems or methodologies.
To address how the BDL will ensure the complementary multidisciplinary scientific expertise required for integrated and comprehensive approaches to the key research problems proposed, address the following aspects.
Sub-section B: Previous Accomplishments
Provide a brief description of relevant previous research accomplishments/preliminary studies on which the team builds the proposed biomarker development activities. Indicate the status of developed markers according to the EDRN-defined biomarker phases.
Without repeating information in biosketches, explain the roles of the team investigators in relevant collaborative activities, including those with academic and industry partners, as appropriate. Include in the description any sharing of data and resources. If the team investigators have participated in any networks- or consortia-supported biomarker development studies or other biomarker-relevant projects supported (irrespective of funding source), elaborate on the role(s) played and the contribution(s) made to the outcome of these studies.
Note: Supplementary data for this sub-section are requested under "Other Attachments".
Sub-section C: Research Project
Define the major clinical question(s) to be addressed by the proposed project. Outline its rationale and significance as they relate to the objectives of the EDRN and on the basis of existing scientific evidence derived from epidemiologic, model systems or clinical studies. The focus of the proposed translational studies is expected to be on the discovery, development, characterization, and testing of biomarkers of cancer risk and/or early cancer. The development of diagnostic and/or prognostic markers may also be proposed, provided that: (a) the selection is sufficiently justified and reflects urgent clinical needs. Include a detailed description of the target population and clinical setting in accordance with the intended clinical endpoint of the biomarkers proposed to be developed; and (b) the effort proposed is part of the overall strategy to improve early detection and risk assessment. In the context of this FOA, development will encompass further studies to evaluate and validate promising candidate biomarkers identified by applicants themselves or by other investigators in accordance with EDRN-defined Phases 2 and 3 of the biomarker development approach. Applicants must describe the study design and approaches to be followed for the proposed studies.
Applicants should propose their discovery studies based on the EDRN-established Phase 1 and Phase 2 biomarker development guidelines and PRoBE (http://edrn.nci.nih.gov/docs) or similar study design criteria to avoid bias and make best use of available resources. This will strengthen “discovery” research and increase the likelihood of reproducibility of results.
In addition, a clear statement is required on how statistical power is defined in multiple tests and what sample size is required to achieve this power. Examples of power definition: (a) the probability to detect at least one of possible true non-zero effects; (b) the probability to detect all non-zero effects; and (c) true discovery rate, etc. Also, in case-control designs, clear descriptions are required of whether matching is involved and what cofounders are adjusted for and why.
The applicant is required, if applicable to their proposed research, to address the following in the proposed study:
Sub-section D: Project Management Plan
The following three major requirements must be addressed:
a) A tentative timeline for conducting the proposed studies, with brief descriptions of how the goals of each of the proposed specific aims will be achieved on a year-by-year basis by providing tentative, interim milestones. In addition, the applicants should clearly delineate the time-line for transition of biomarkers from Phase 1 to Phase 2, and to Phase 3 validation.
b) Overall Project Milestones, which must be well described, quantitative, and scientifically justified. Discuss the milestones as a means of judging the success of the proposed studies during the initial 3 years of support by the U01 award. Specific aims may not be regarded as milestones (unless they include quantitative end points). The specific aims describe the goals and intended path of the proposed research. Quantitative milestones are a way of determining whether an applicant has successfully reached the specified goals. Generally, applicants are expected to provide milestones for each specific aim. Milestones should be clearly stated and presented in a quantitative manner, such as numerical specifications of sensitivity and specificity or a count of some newly discovered molecules or molecular pattern(s) that can be used as biomarkers for early cancer detection, risk assessment, diagnosis or prognosis of cancer.
Examples of quantitative milestones are listed below:
Any application lacking milestones will be considered incomplete.
c) Applicants should also elaborate on a decision-tree scheme to be used during biomarker developmental studies for triaging biomarker candidates, as well as the criteria based on which specific biomarkers should continue to be pursued [‘go’ or ‘no go’ decision]. Should certain promising biomarkers be dropped at any stage during development, alternative steps or strategies to be followed must also be described. In this context, outline the approaches for transitioning selected biomarkers to the next phase of development (to be done through the reserved set-aside funds).
Shortly before completion of the third year of award, the progress made towards these milestones will be reviewed by a site visit of the laboratory by Program staff members and external expert consultants. A decision by NCI will be made at that time based on the comments from the site visit review team as to whether or not funding for this BDL should continue for the remaining period of the 5-year term.
Multiple PD/PI Leadership Plan: In addition to following standard instructions, applicants should explain how the multiple PDs/PIs will divide their scientific responsibilities in terms of focus on different platforms for biomarker discovery and development. In this context, it is expected that each PD/PI will be responsible for a different platform (although overlap in types of tumors of focus across PDs/PIs is acceptable).
Letters of Support: In addition to standard items, provide letters of commitment for resources and/or technology made available by industry partners involved in the proposed research.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
In addition to the standard NIH expectations, the following EDRN-specific expectations apply:
(a) Specimen Sharing: The success of EDRN is dependent on collaborative interactions of all its laboratories. Clinical specimen collections funded through EDRN cooperative agreements must become available to all investigators in the Network and must be made available for Network validation studies. Applicants seeking to use funding via this U01 mechanism to collect clinical specimens must state their willingness to share these samples with others in the Network.
(b) Intellectual Property: Collaboration among EDRN investigators, as well as between Network investigators and third-party industry partners is a core mission of the EDRN, which entails the sharing of intellectual property arising out of research resources developed in Network-related activities.
Applicants are expected to submit an Intellectual Property Management Plan (IPMP) in line with the accepted IP Rights and Responsibilities (http://edrn.nci.nih.gov/docs). The proposed plan should address the strategy to be followed for both solely or jointly owned inventions (including patents and licensing issues) and how these resources will be made available to the broader scientific community, consistent with the EDRN initiative. Any approved IPMP will become a condition of the award.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, 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 NOT-OD-13-030.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, specific to this FOA: Is the clinical endpoint (outcome or condition the biomarker is to classify) clearly defined? How significant would be the proposed research in terms of complementing or augmenting existing biomarker detection systems or methodologies? What is the likelihood that this research during the next five years will succeed in moving biomarkers to Phase 2 or Phase 3 in light of the EDRN-established phases of biomarker development for early detection of cancer? What is the likelihood that the proposed study will lead to a potentially routine use of a new biomarker in clinical practice?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, specific to this FOA: Has the applicant team demonstrated sufficient training and expertise in the biology of biomarker discovery and the use of proposed technology platforms?
Does this team of investigators show a significant measure of success in experimental approaches to biomarker discovery and development in collaborative, multi-investigator consortia or network? Does this team of investigators contribute unique capabilities to the trans-Network activities? Is the commitment of the PD(s)/PI(s) and other key investigators in line with the scope of the proposed project? Is there evidence that different PDs/PIs and co-investigators have effectively worked together in the past? Are the investigators likely to participate in EDRN collaborative projects?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
In addition, specific to this FOA: Can the proposed approaches be used to derive biomarkers/reagents for a variety of malignant tumors? Are the target population and clinical setting for the intended use of the biomarker clearly defined? Has the applicant provided documentation as to the source of high quality, clinically-annotated preclinical and clinical specimens for the proposed discovery research? Are the samples to be used in the proposed study appropriate for the requirements of the PRoBE study design or a similar design? Has the applicant provided adequate scientific evidence from epidemiologic, model systems (cell culture, animal models) or clinical studies warranting success of the proposed study? Are parameters, such as sensitivity, specificity, and predictive value, chosen to characterize the biomarkers/reagents sufficient and appropriate? Are the study designs supported by adequate sample size and statistical reasoning? Is it clear how statistical power is determined in the context of multiple tests and the sample size that would be required to achieve this power? Are considerations given to minimize bias, chance, overfitting, and reproducibility issues in the proposed study design? Is it clear how the marker performance will be evaluated? How well does the applicant understand the nuances of biomarker discovery and address the problems/challenges in data reproducibility and quality of discovery in selecting appropriate specimens and for data analysis? How appropriate are the strategies and approaches for transitioning biomarkers from initial evaluation to validation phase?
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 children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, specific to this FOA: Are the primary resources for the proposed study within the laboratory under the direct oversight of the PD(s)/PI(s)?
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.
Are the proposed collaborations scientifically justified? Are the roles of collaborating units clearly defined and appropriate for the proposed goals? If applicable, how meaningful is the industry participation? Are there adequate plans and commitments for effective interactions and effort coordination with other Network units, the Steering Committee, the DMCC, and the NCI?
Project Management Plan
Are the proposed project management plan and study time-line acceptable? Are the proposed milestones quantitative and in line with the proposed research? Is there a decision-tree scheme for the biomarker developmental study to determine the stages at which specific biomarkers should continue to be pursued or whether to triage any biomarkers? Are the criteria used to make these decisions specified or the alternative steps that will be taken should certain biomarkers be dropped at any stage defined?
For research that involves human subjects but does not involve one of the six 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS)
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
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 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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
This award will include restricted funds that will be used to support biomarker validation studies based on biomarker selection as recommended by the Steering Committee and approved by the NCI.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
PD(s)/PI(s) Responsibilities for Network Collaborative Studies:
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
A designated NCI Program staff member serving as Project Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may also become substantially involved as needed.
Main NCI Project Coordinator responsibilities include the following:
The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those Network awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.
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. Program Officials may also have substantial programmatic involvement (as Project Scientists).
of Joint Responsibility Include:
Steering Committee: The EDRN Steering Committee will convene after all the Network units have been funded and will be composed of the following voting members:
Each voting member will have one vote.
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 Chair of the Steering Committee (who cannot be NIH staff member) will be selected by the Steering Committee. The awardee institution represented by the Chair of the Steering Committee will serve as the Headquarters (for definition, see Section I. Funding Opportunity Description. EDRN Administrative Structure).
The Steering Committee will meet twice every year, at locations selected by the Steering Committee in consultation with the NCI.
The Steering Committee may establish subcommittees for specific purposes. The NCI Project Coordinator/Scientists will serve on such subcommittees, as appropriate.
Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
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
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
(Questions regarding application instructions and process, finding NIH grant
Email: GrantsInfo@nih.gov (preferred method of contact)
Sudhir Srivastava, Ph.D., M.P.H.
National Cancer Institute (NCI)
National Cancer Institute (NCI)
National Cancer Institute (NCI)
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.
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