National Institutes of Health (NIH)
U24 Resource-Related Research Projects – Cooperative Agreements
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
The purpose of this limited competition Funding Opportunity Announcement (FOA) is to continue support for the Center for International Blood and Marrow Transplant Research (CIBMTR) as a data resource enabling broad studies on Hematopoietic Stem Cell transplantation (HCT) and Adoptive Cellular Therapy (ACT) research. The CIBMTR represents a network comprised of more than 350 US and international transplant centers that submit outcome data for patients receiving cellular therapies. The CIBMTR Statistical Center provides data acquisition and management and information technology services to maintain a unique contemporary clinical outcomes' database and facilitates observational and interventional research through scientific and statistical expertise necessary to support analyses of these data. NIH is supporting the CIBMTR to ensure the database remains available to the public and to improve the treatment, survival, and quality of life for patients diagnosed with cancer and non-malignant blood disorders.
August 15, 2022
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| Not Applicable | September 15, 2022 | Not Applicable | October 2022 | January 2023 | March 2023 |
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.
Not Applicable
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.
PURPOSE AND SCOPE
The purpose of this limited competition Funding Opportunity Announcement (FOA) is to continue support for the Center for International Blood and Marrow Transplant Research (CIBMTR) as a data resource enabling broad studies on Hematopoietic Stem Cell transplantation (HCT) and Adoptive Cellular Therapy (ACT) research. The CIBMTR represents a network comprised of more than 350 US and international transplant centers that submit outcome data for patients receiving cellular therapies. The CIBMTR Statistical Center provides data acquisition and management and information technology services to maintain a unique contemporary clinical outcomes' database and facilitates observational and interventional research through scientific and statistical expertise necessary to support analyses of these data. NIH is supporting the CIBMTR to ensure the database remains available to the public and to improve the treatment, survival, and quality of life for patients diagnosed with cancer and non-malignant blood disorders.
This FOA seeks to renew the CIBMTR with the expectation of enhancing HCT and ACT data collection and to address research and objectives of relevance to researchers, clinicians, HHS policymakers, pharmaceutical companies, and patient organizations. The applicant responding to this FOA is required to provide an overall program that continues to facilitate hypothesis-testing research, assess safety and efficacy of cellular therapies, conduct studies for evidence-based clinical decisions, inform clinical practices and guidelines, and strategies to achieve the highest quality of care. The data resource should continue to serve the needs of ongoing HHS special initiatives such as the Food and Drug Administration (FDA) 15-year follow-up data to assess potential late effects from genetically modified cells, such as chimeric antigen receptors (CAR) T cell therapy, the Centers for Medicare & Medicaid Services (CMS) evidence development clinical trials for coverage, and the stem cell transplant outcomes data collection for the C.W. Bill Young Transplantation Program managed by the Health Resources and Services Administration (HRSA).
The CIBMTR is also expected to propose a scientific research plan of relevance to the mission and goals of NCI, NHLBI, and NIAID. Among this includes collecting HCT and ACT data for researchers to study, predict, and potentially intervene in the late effects of treatments, and modify current treatment approaches to treat blood cancers, solid tumors (as appropriate), and non-malignant blood disorders. NCI will continue to support data collection for standard of care and investigational treatments from HCT. In addition, NCI is interested in ACT data collection from promising and emerging clinical indications. This enhancement of the database may include different forms of adoptive cell therapies such as CAR T cell therapy, T cell Receptor gene therapy, and other available cellular products (e.g., tumor infiltrating lymphocytes, cytotoxic T lymphocytes) for treating heme malignancies and solid tumors. This area of interest can include ACT administered in the context of HCT, either as a bridge to HCT or post-HCT as well as cell therapies administered as the primary therapy (non-HCT) pursued to treat cancer. NHLBI priorities include evaluation of these therapies for non-malignant blood diseases, complications from these therapies, and long-term outcomes and late-effects, including cardio-pulmonary toxicities, subsequent malignancies, and poor quality of life. The NIAID will support clinical studies in primary immune deficiency and autoimmune disease, including use of NIAID funds to reimburse sites for completion of supplemental data forms. In addition, the CIBMTR team of investigators are encouraged to propose additional priorities to enhance the resource such as novel therapies (e.g., non-commercial products) that should be in the queue.
BACKGROUND
The CIBMTR has been funded by NIH for more than 30 years and has established itself as a national resource of information in blood stem cell transplantation, and a network of world leaders that bring expertise to the medical and scientific community. The CIBMTR collects real-world outcomes data on every allogeneic transplantation performed in the U.S. as required by law. U.S. transplant centers also voluntarily submit autologous transplantation and cellular therapy data to the registry. Transplant centers worldwide also voluntarily submit both autologous and allogeneic transplantation data. As of December 2020, the clinical database contained information from more than 575,000 patients with the following distribution: 51% allogenic transplants, 48% autologous transplants, and 1% non-transplant cellular therapy. CAR-T cell therapies represent 70% of the non-transplant research. Most of the CAR-T data entry is due to the FDA long-term follow-up requirement. New additions to the registry include the collection of COVID-19 infections and corresponding treatment data from ~1,132 patients. Now with data from more than 600,000 patients, more than 1,650 publications, and more than 225 ongoing studies and clinical trials, the CIBMTR is at the forefront of research to increase access to cellular therapies and to improve outcomes for this patient population.
Continuing to support the CIBMTR database will provide essential information or improvements relevant to: developing approaches to evaluate transplant and ACT outcomes; comparing transplant regimens and donor sources; planning new clinical trials and amending ongoing trials, assessing variabilities in transplant diagnosis, outcomes and procedures; evaluating discoveries associated with solid tumors and specimens collected from transplant patients; evaluating transplant costs and cost-effectiveness; and identifying prognostic factors for transplant and ACT recipients. In addition, the database will be able to inform newer treatment protocols, advance the field of immunotherapies, determine outcomes of cellular therapy for rare diseases and new indications, and define trends in cellular therapy activity, such as increased use and success in older patients.
GOALS AND REQUIREMENTS OF THIS FOA
The applicant is expected to address the following goals and objectives specified in this FOA while achieving the priorities defined by the NCI, NHLBI, and NIAID in the above purpose and scope.
Goals for the CIBMTR Data Resource: The main goal of the next U24-funded resource is to maintain and broaden, as appropriate, the clinical outcomes database for the HCT and ACT communities and support critical observational and interventional research through scientific and statistical expertise to improve clinical outcomes. The applicant must ensure that the CIBMTR database continues to serve as a robust and efficient research resource for the collection and utilization of data on transplant and cellular therapy patient outcomes. The proposed continuation of the Data Resource must also provide wide and sustaining value to the scientific and lay communities and be properly optimized to meet new challenges and emerging opportunities in transplant and cellular immunotherapy research to treat malignancies and non-malignant blood disorders. To achieve these goals, the proposed program must adhere to the following organizational elements.
Organizational Requirements: To address the stated goals and priorities, the data resource is required to have appropriate capabilities, leadership, and governance to ensure a smooth integration of the next phase of the network’s function. The applicant should include a description of the organizational structure as defined herein, including the two current leading sites, and plans to fulfill the objectives of the following programs:
(1) Resource Development Program is expected to focus on optimizing and enhancing the quality and scope of the database in HCT and ACT associated with the treatment of malignancies and non-malignant blood disorders, relevant to the mission of all participating institutes. Particularly important are issues of improving all areas of data collection, data verification management, and returning data back to centers, as well as further development and optimization of information technology. This program must provide the strategies and ensure/provide/improve upon the capabilities (but additional relevant aspects should also be considered) that:
- Optimize the collection and scope of research-level data from patients undergoing HCT, receiving autologous cells modified by gene therapy or gene editing, or receiving novel ACTs for hematologic malignancies, solid tumors, and nonmalignant blood diseases;
- Enhance data collection for vaccinations and infections (such as COVID) to determine the impact on clinical trajectory and late effects in malignant and non-malignant blood diseases;
- Expand data on quality of life and late effects of treatment;
- Enhance longitudinal data collection on HCT and ACT survivors to capture the occurrence and progression of cardiac, pulmonary, and/or hematologic complications, as well as second malignancies;
- Optimize the overall quality of the database (e.g., improve quality control procedures, data validation, and audits);
- Enhance data retrieval and back-to-centers processes
- Support the Data Transformation Initiative in streamlining data transfer to the CIBMTR resource;
- Continue development of the Integrated Data Warehouse for aggregation and management of metadata associated with data from various sources; and
- Collaborate with the Foundation for the Accreditation of Cellular Therapy to streamline reporting requirements.
The applicant is also encouraged to consider new data collection strategies and public-private partnerships in their plans for the Resource Development Program and to support the HHS federal initiatives as those described in the Purpose and Scope section of this FOA. For instance, providing data to Centers for Medicare & Medicaid Services to be used for coverage decisions for patients receiving HCT and ACT and are not currently covered when appropriate. The CIBMTR is also expected to further international collaborations as related to the global influence of the CIBMTR.
NOTE: For further instructions on the proposed plans for the Resource Development Program, see sub-section C specified in Section IV of this FOA under Research Strategy.
(2) Resource Utilization Program is expected to focus on providing novel observational studies in hematologic malignancies, solid tumors, and non-malignant blood disorders. Plans for this program must define strategies and ensure/provide the necessary capabilities to achieve the objectives below (but additional relevant aspects should also be considered) including a Research Plan with scientific agendas demonstrating the use of the database:
Objectives
- Enhance knowledge of outcomes of HCT and ACT for malignancies and non-malignant blood disorders and indications, particularly rare indications;
- Facilitate health services research related to HCT and ACT;
- Link CIBMTR outcomes data to cellular/immunological data obtained from analyses of biospecimens to help understand outcomes, toxicities, survivorship issues, and promote the development of clinical risk prediction tools (e.g., assess the impact of bone marrow microenvironment, proteomic, immunologic, genetic or secondary lymphoid tissue on transplant outcomes);
- Encourage collaboration with societies (e.g., the European Society for Blood and Marrow Transplantation, and Society for Immunotherapy of Cancer) particularly for studies in rare disorders, to achieve a meaningful number of cases and datasets for secondary research;
- Develop studies to understand the efficacy and toxicity of transplant therapy (e.g., autologous cells modified by gene therapy or gene editing, or receiving novel ACTs), including the study of immune reconstitution and quality of life post-therapy, as well as the long-term outcomes, late effects, and rare unanticipated events with attention to cardiac, pulmonary, hematological and sleep complications;
- Enhance interactions with investigators at relevant clinical entities supported by the NIH for use of CIBMTR data in the design and conduct (e.g., through amendments) of clinical trials and provide a mechanism to support multi-center clinical trials;
- Optimize the data analysis process through enhanced biostatistical methodologies, with increased emphasis on meta-analyses when appropriate, and in collaboration with the bioinformatics program for studies utilizing genomics data; and
- Improve the timeline from research ideas to review of proposals for studies using resource data, to final activation of studies, and publication of results.
Research Plan Overview and Scientific Agendas:
The application should provide an overview of a Research Plan consistent with the above objectives and comprise of two distinct scientific agendas; one for HCT and one for ACT outcomes research. The CIBMTR investigators are responsible for defining the type of data, clinical indications to study, and approaches to capture disease-specific outcomes from standard of care transplants and investigational therapies (including non-commercial products as appropriate) that should be in the queue. The plan should state the goals and strategies for data collection and curation (audits) and implement novel research studies that will advance their respective fields. Included in these plans should be a description of the type of therapy and treatment protocol (cellular therapies administered in the context of HCT, either as a bridge to HCT or post-HCT) as well as cellular therapies administered as the primary therapy (non-HCT) to treat blood cancers, solid tumors, and nonmalignant blood disorders. Observational studies of interest include:
- Efficacy of HCT compared to ACT, as data become available;
- Efficacy of various ACT as a bridge to transplant, or for prevention of relapse after transplant for hematologic malignancies;
- Efficacy and toxicity of T cell and natural killer cell therapies as a bridge to transplant as data become available;
- Role of donor selection based on natural killer cell genes especially when an alternative donor is selected;
- Long-term outcomes of transplant to each organ, including immune reconstitution and subsequent malignancies, with or without chronic graft-vs.-host disease;
- Effect of patient age, gender, and ethnic/racial background on the outcome of transplant in various disease settings, including assessment for underserved and minority populations;
- Impact of patient oncogenic mutation status on transplant outcomes;
- Prognostic markers of relapse and non-relapse mortality (e.g., GVHD); and
- Transplant outcomes for patients with extremely rare disorders, including but not limited to, non-malignant blood diseases.
NOTE: For additional instructions on plans proposed for the Resource Utilization Program, see sub-section D in Section IV of this FOA under Research Strategy.
Leadership and Governance Requirements: The applicant should also establish the following leadership and governance structures in response to this FOA reissuance. The criteria specified below are to address the broader scope (e.g., all types of cancers) and scientific priorities defined herein, as well as the significant increase of HCT and ACT transplants and regulatory approvals of cell-based products forecasted for the next 5-year project period.
(1) Modification to the Leadership Structure. This FOA requires the use of the Multi-Principal Investigators/Program Directors (MPI) model to lead and manage the NIH-funded program via a team science approach. The application should identify at least two Principal Investigators with the appropriate scientific disciplines to achieve the HCT and ACT research goals and who are knowledgeable of the CIBMTR systems and operations. Each PI should have distinct roles and responsibilities that must be described in an MPI Leadership Plan. For example, one PI may assume full responsibility for the HCT of the overall program (e.g., plans to meet Resource Development & Utilization goals) and the second PI for the ACT component. Alternatively, the activities of the overall program could be partitioned using other strategies subdivided by disease, clinical indications, etc. However, the MPI leadership plan should align with the requirement of having two separate scientific agendas in the overall Research Plan, meaning, one PI that leads the proposed research studies for HCT and one to oversee the ACT-specific studies. Each PI would not only be responsible for the implementation of these programs but also, for reporting progress updates in accordance with the following governance structure.
In addition, NCI intends to restrict funds within its contributions to the U24 award to enhance data collection from adoptive cell therapies used to treat cancer. The dollar amount will be commensurate with the proposed work and staffing requirements to achieve this goal but not exceed $2 million per year in total cost. For details on the ACT budget allocation specific to cancer, see the Funding Restriction Section of this FOA.
(2) Modification to the Overall Governance Structure. The CIBMTR is expected to resume the current governing structure that utilizes an Executive Committee, Steering Committee, and an Advisory Board to support the data resource and update charters as appropriate. The governance should also include a Stakeholders Council to provide guidance and recommendation on policies, practices, decisions, and challenges raised by the Principal Investigators/Scientific Leads of the ACT component of the program. Alternatively, the CIBMTR may choose to establish an integrated governance structure inclusive of both HCT and ACT functions. NIH Program Directors will review the nominations for the Council to mitigate bias, and conflicts of interests, and ensure the database remains an open resource to the public.
Administrative and Statistical Functions: The CIBMTR is required to provide a brief overview of the administrative and statistical group functions in the application. Statistics services must be able to ensure accuracy in the collection and management of the data and support data-analysis projects. CIBMTR statisticians should be involved in reviewing requests for access to the data to ensure sound statistical design and analysis consistent with the overall design. The statisticians are also expected to review manuscripts of scientific publications generated using CIBMTR data for appropriateness of method descriptions and data interpretation. Statisticians and ancillary personnel will be expected to interact regularly with the senior leadership to discuss emerging issues associated with the data collection/management as well as study design and analytic issues relevant to ongoing data-analysis projects.
NOTE: For additional instructions reporting on the administrative and statistical group functions, see sub-section E in Section IV of this FOA under Research Strategy.
See Section VIII. Other Information for award authorities and regulations.
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. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
The following NIH components intend to commit the following amounts in FY 2023 to jointly fund one award:
NCI, $4,790,000
NHLBI, $1,675,000
NIAID, $250,000
The budget request must not exceed $5,500,000 per year in direct costs.
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
This is a limited competition FOA. Only the awardee institution for the Center for International Blood and Marrow Transplant Research (CIBMTR) is eligible to apply.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- 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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.
This FOA proposes the use of the Multiple Program Director/Principal Investigator (MPI) model for overall program leadership and thus requires an MPI Leadership Plan. The applicant must specify at least two PDs/PIs to address the HCT and ACT expertise required to implement integrated and comprehensive approaches to the research proposed.
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
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
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)
This is a limited competition resulting in one award. Therefore, only one application may be submitted.
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:
Lori A. Henderson, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5930
Email: hendersonlori@mail.nih.gov
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:
For this specific FOA, the Research Strategy section is limited to 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.
Facilities and Other Resources: The applicant must provide evidence that the appropriate resources will continue to be available and will continue to function for the design and implementation of research studies in the CIBMTR. Include a complete description of the infrastructure at the two CIBMTR sites.
Other Attachments: Provide the following materials listed below as Other Attachments as a PDF file. Upload these items as indicated attachments using file names provided (these file names will become bookmarks in the application).
Attachment 1 (filename - Organizational Data):
- A table of contents;
- An organizational chart of the CIBMTR;
- An outline of the form submission processes;
- A list of U.S. and international-based transplant centers that contribute data to the CIBMTR with their basic capabilities to provide transplant-essential data or research-level data for autologous, related and/or matched unrelated donor transplants listed. Also indicate which centers on this list are likely to contribute data to meet the ACT goals;
- A separate list of other institutions (not affiliated with institutions forming the CIBMTR), pharmaceutical companies, and potential or established partnerships capable of contributing ACT data to the data resource; and
- A high-level summary of the CIBMTR Research Programs including a list of the Scientific Working Committees and their leaders.
Attachment 2 (filename –CIBMTR Research Highlights):
- A table of contents;
- Summary tables for completed studies from each of the working committees in the current funding period;
- A summary of the research impact of CIBMTR, (e.g., a table(s) showing selective examples of innovative, high impact research using CIBMTR) and impact on clinical practice (a table listing examples of publications informing clinical guidelines);
- A table listing the datasets distributed in the past 3 years to investigators;
- A summary of the number of data requests, acceptances, and rejections; and
- A list of characteristics of CIBMTR biospecimens resource (in tabular format).
Attachment 3: (filename – Resource Development for Outreach)
- An outline of approaches to communicate and educate study participants and patients; and
- A summary table of approaches to increase the scientific and public visibility of the CIBMTR findings. Include new proposals to efficiently disseminate the resulting findings to broad communities.
Attachment 4 (filename – Resource Utilization Agendas):
- Include the CIBMTR proposed observational studies for HCT and ACT research as a single pdf file. Refer to the two scientific plans using the following headings in a table format:
- Scientific Agenda for HCT Research
- Scientific Agenda for ACT Research
- List project title and define the lead investigator(s), type of data collection, and specific objectives/goals for each study planned or under development;
- A table listing the datasets requested if proposed or known at time of submission; and
- An outline of the process to potentially collect and characterize tissues from subsequent neoplasms to create an archive for future studies (as appropriate).
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R 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.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Outline succinctly the overall strategic goals for the CIBMTR and the plans to achieve these goals.
Research Strategy: The Research Strategy must consist of the new sub-sections A-E below.
Sub-section A: CIBMTR Overview
In this sub-section, address the following aspects:
(1) Significance and Overall Goals:
- Outline the rationale underpinning the need for the continuation of the database and proposed expansion cohorts. Include the significance of CIBMTR in terms of risk identification for transplants survivorship and impact on transplant and adoptive cell therapy research;
- Summarize the main scientific and public health-related benefits anticipated from the continuation of the CIBMTR resource and address how the CIBMTR Center meets the needs of transplant researchers, physicians, their patients, and HHS federal initiatives;
- Summarize the CIBMTR's role and potential relative to mortality, morbidity, and quality of life of long-term survivors of cancers and nonmalignant blood disorders with illustrative examples; and
- Summarize the overall HCT and ACT goals of the Center and describe how the goals will lead to new clinical research studies, and/or potentially inform clinical practices and guidelines.
(2) Proposed CIBMTR Structure and Operations
Describe in general, the:
- Experience of the team in designing and implementing the CIBMTR;
- Roles and function of the governing entities of the CIBMTR, such as the Executive Committee, Advisory Committee, and Stakeholders Council (if applicable), particularly related to how the proposed organizational structure will serve the goals;
- Planned procedures for concept reviews and approvals;
- Current data archive. Summarize the main characteristics of the data resource cohorts, including a breakdown by gender and racial/ethnic subpopulations. Include an update on the HCT and ACT recruitments, attributes collected, and partnerships established to achieve study subjects; and
- Proposed improvements in data collection and management strategies.
Note: Supplemental data including membership and organizational charts to support this sub-section is requested above under Other Attachments as Attachment 1 and can be cross-referenced in this sub-section to avoid duplicating information.
Sub-section B. CIBMTR Progress Report
In this sub-section, summarize the main accomplishments of the CIBMTR during the current funding period; include information on maintenance, and enhancement of the resource; salient contributions to peer-reviewed literature; and CIBMTR functioning as a resource for investigators, physicians, industry, and policymakers. Report key contributions from implementing benchmarks identified in the Resource Development and Resource Utilization Programs of the current RFA-CA-17-031.
Note: Supplemental data including research highlights and publications to support this sub-section is requested above under Other Attachments as Attachment 2 and can be cross-referenced in this sub-section to avoid duplicating information.
Sub-section C. Resource Development Program
In this sub-section, describe plans proposed to achieve the required goals and objectives of the Resource Development Program as outlined in Section II. FOA Description. Include strategies, methodologies, and procedures optimal for the collection and scope of research-level data from patients undergoing HCT, receiving autologous cells modified by gene therapy or gene editing, or receiving novel ACTs for cancer, nonmalignant blood diseases, and primary immune deficiency/autoimmune diseases. This sub-section should also entail plans to recruit a new cohort of patients diagnosed between 2023-2028 and receiving HCT and ACT (e.g., solid tumors) and any planned enhancements to bioinformatics. In addition, include the following aspects:
- Define the overall goals for data collection, integration, and basic resource needs for new clinical indications;
- Describe plans for surveillance and maintenance of the HCT and ACT resource including validation and quality control;
- Describe plans to enhance data collection, where needed, to meet the objectives of the FOA and to address the evolving needs of HCT and ACT; and
- Indicate any concepts, methodologies, and/or intervention options proposed that are novel to the field (although innovation is not essential for CIBMTR research).
Note: Supplemental data regarding approaches for continuous outreach to support this sub-section is requested above under Other Attachments as Attachment 3 and can be cross-referenced in this sub-section to avoid duplicating information.
Sub-section D. Research Utilization Program
In this sub-section, describe plans proposed to achieve the required goals and objectives of the Resource Utilization Program as outlined in Section II. FOA Description. Also include plans for observational studies proposed beyond the scope of studies presented in this FOA. This section should also describe the measures in place or planned to ensure access to CIBMTR data and findings. In addition, briefly summarize the following aspects of research proposed/under-development, if applicable, by the CIBMTR members (internal) and other partnerships (external):
- Strategies to answer the study objectives and questions in HCT and ACT research fields, including any required modifications to working groups or new working groups;
- Focus areas and scientific rationale for each HCT and ACT study proposed;
- Groups and collaborationsthat will provide access to the needed patient populations to support the research study;
- Research aimed at developing, testing, and validating new methods and approaches to analyze data; and
- Existing and planned international collaborations with other transplant and cell therapy groups.
Note: Supplemental data on the two scientific agendas to support this sub-section is requested above under Other Attachments as Attachment 4 and can be cross-referenced in this sub-section to avoid duplicating information.
Sub-section E. Leadership and Functional Group Support
In this sub-section, summarize the specialized groups needed to support the basic functions of the CIBMTR. For each of these groups, identify the group leader(s) (if applicable) and outline how the group (or its prior equivalent) has contributed to past performances. Outline planned activities of these groups using the guidelines provided below.
- Program Leadership. Outline the proposed leadership structure here. Without repeating information in respective biosketches, explain how the qualifications and experience of the multi-PIs/PDs would be advantageous for organizing and managing the CIBMTR as a collaborative multi-facet effort. List specific topical areas expected to be covered by each person. Address the requirements of the MPI plan in Section IV under the R&R Senior/Key Person Profile outlined in the current NIH Application Guide.
- Administrative Functions. Explain the roles and responsibilities of this unit, which will be providing administrative services to CIBMTR and logistic support for the interactions among the CIBMTR investigators, the Steering Committee, and the NIH. Identify an individual who will be primarily responsible for the administrative support. The administrative support must have appropriate capabilities to manage communications as well as other administrative staff, as needed.
- Statistical Support Activities. Outline the priorities for this unit and explain the rules and general procedures for curating datasets for release to the CIBMTR members and external investigators. Develop timelines with milestones and projected time frames for approval, development, analysis, and publication for projects utilizing CIBMTR datasets.
Note: Supplemental data on the functional groups to support this sub-section is requested above under Other Attachments as Attachment 1 and can be cross-referenced in this sub-section to avoid duplicating information.
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.
The following modifications also apply:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
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.
In addition, NCI intends to restrict funds within its contributions to the U24 award to enhance data collection from adoptive cell therapies used to treat cancer. The dollar amount will be commensurate of the proposed work and staffing requirements to achieve this goal but not exceed $2 million per year in total cost.
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 (UEI) provided 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 and/or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
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.
For this particular announcement, note the following:
The overall goal and priorities of this FOA are on ensuring that the CIBMTR continues to serve as a robust and efficient research resource for collection and utilization of data on patients who received HCT and ACT. The CIBMTR is expected to function as a resource that is responsive to changes in collection and use of data and thus meet the needs of a variety of potential users of the resource.
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 Center address the needs of the research consortium that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the Center?
Specific to this FOA: How well is the proposed Resource Development Program addressing the needs of transplant researchers, physicians, their patients, and HHS initiatives? How well does the proposed Resource Utilization Program anticipate the needs in stem cell transplant and adoptive cell therapy used to treat malignant and non-malignant blood disorders? As proposed, will the continuation of the CIBMTR provide the anticipated public health-related benefits in terms of meaningful scientific and clinical insight that would be able to inspire strategies for alleviating the late effects of treatment, improving patient outcomes or quality of life? What is the likelihood that the proposed overall ACT goals and activities of the Center will generate new knowledge, new clinical research studies, and/or inform clinical practice and guidelines?
Investigator(s)
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing such research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills? Are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Specific to this FOA: How appropriate is the CIBMTR overall leadership and staff operations and management in terms of ensuring optimal functioning of the CIBMTR? To what degree does the organization and make-up of the leadership of the working committees and biostatistical program ensure optimal scientific productivity in the CIBMTR?
Innovation
Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research network the Center 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 organizational concepts, management strategies or instrumentation proposed?
Specific to this FOA: Does the CIBMTR design/overall Research Plan include novel elements, as appropriate, that enhances its potential for information or the potential to advance scientific knowledge or inform clinical practice (e.g., compared to recently published research)?
Approach
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Center 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?
Specific to this FOA:
A. Basic Resource Function & Cohort Integration: How well do the proposed plans cover and track outcome variables that are critical for the goals of this FOA? How optimal are the strategies, methodologies, and procedures for the collection and scope of research-level data from patients undergoing HCT, receiving autologous cells modified by gene therapy or gene editing, or receiving novel ACTs for cancer, nonmalignant blood diseases, and primary immune deficiency/autoimmune diseases? How feasible and appropriate are the plans to capture ACT data (e.g., safety and efficacy) from patients with solid tumors or approaches to evaluate transplant and ACT outcomes from novel therapies (e.g., non-commercial products) proposed that should be in the queue? Are the proposed cohorts for the next phase of the CIBMTR award adequate for the overall goals of the program? If the cohorts are not sufficiently representative, does the applicant address this issue and are the proposed approaches appropriate?
B. Functional Support: How well optimized and appropriate are the organization, personnel, and procedures proposed for the specific Functional Support groups?
C. Scientific Agendas (network members): How appropriate are the two scientific agendas for the CIBMTR developed and suited to the needs and expectations of the scientific community? How specific and well thought out are the observational research studies (e.g., in terms of study participants, outcomes dataset, clinical indication, therapeutic regimen, treatment protocol, and scientific rationale)?
D. Outreach: How appropriate are the measures proposed to ensure that investigators will have access to the CIBMTR-based research findings and data? How valuable are the international and external collaborations (e.g., FACT, etc.,) to the data resource?
Environment
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center 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: To what degree is the environment of the CIBMTR applicant institutions conducive to the goals of the Resource Development Program, including enhancing the information technology required for the observational research? How optimal are the environments of those campuses to the goals of the Resource Utilization program with respect to integration and interaction with other relevant programs and activities in the general field of HCT science and practice? To what extent will these environments address the needs of the communities to be served by the Data Resource?
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 Animal 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
For Renewals, the committee will consider the progress made in the last funding period.
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 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).
Authentication of Key Biological and/or Chemical Resources:
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.
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 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 will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
The limited competition application will be assigned to the National Cancer Institute. Following initial peer review, if recommended the application 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.
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:
- Federalwide 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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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.htmlandhttps://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/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 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 75.205and 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 award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipientsis 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 recipientsfor 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 following primary responsibilities for:
- Defining the overall goals for CIBMTR and overseeing the execution of the program as a whole;
- Ensuring optimal operation of the resource related to data management and statistical analyses;
- Coordinating the activities of CIBMTR organizational components, including the Advisory Committee, the Executive Committee and topical Scientific Working Committees;
- Seeking opportunities for collaborations with other investigators and investigator teams (consortia or collaborative groups) outside of the CIBMTR to enhance and extend the utility of the CIBMTR database;
- Assuring that the CIBMTR establishes and implements mechanisms to ensure that data collection and management procedures are adequate for quality control and analysis and patient and donor privacy;
- Ensuring compliance of the Resource with the mandatory regulations, including compliance with the assurance program of the Federal Office of Human Research Protections;
- Interacting with NIH staff members involved and ensuring their access to Resource data if needed;
- Cooperating with the NIH staff members in the periodic evaluation of the Program and its specific goals and priorities;
- Providing NIH with information relevant to such evaluations or other purposes as needed when such information is requested by the participating ICs; and
- Administratively managing the award.
General responsibilities of the CIBMTR as the awardee will include:
- Maintaining a resource of data and statistical expertise available to the broad community for clinical research in blood and marrow transplantation in the areas identified in this FOA;
- Optimizing and enhancing the quality and scope of the database in aspects relevant to the mission of the participating institutes;
- Participation in new research and analyses using the CIBMTR data in areas relevant to the priorities of the participating ICs as stated in this FOA, including efforts to ensure timely publication of such studies in peer-reviewed biomedical journals. Although initiating new research and analyses is not the main role of the CIBMTR, investigators involved in CIBMTR are expected and encouraged to actively engage in such efforts, e.g., through collaborations within the CIBMTR Working Committees
Expected Activities and Responsibilities of the Executive Committee include:
- Providing advice to the overall PD/PI for scientific activities and policy decisions;
- Periodically assessing and revising relevant sections of the CIBMTR data collections forms;
- Establishing priorities for scientific studies after obtaining input from Working Committees;
- Reviewing results of audits and recommending measures to correct deficiencies;
- Reviewing and assisting in preparation of the agenda for annual Advisory Committee meetings.
Expected Activities of the Scientific Working Committees include:
- Prioritization of proposals submitted to the Working Committees for review;
- In the context of submitted proposals, designing and conducting studies relevant to their subject area using CIBMTR data and CIBMTR statistical and other resources;
- Planning and conducting work sessions for proposal review and other workshops as needed at the annual CIBMTR meetings; and
- Periodically assessing and revising relevant sections of the CIBMTR data collections forms.
The activities of the Working Committees are expected to be based on the voluntary service and expertise by hundreds of physicians, basic scientists, and clinical research associates. The CIBMTR plays a central role in these activities as well as in coordinating data collection and management and providing statistical and administrative support for studies involving use of data in the CIBMTR database.
Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
- A designated NCI Program Director, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. Other NCI staff members, as well as staff members from the participating ICs, may also become substantially involved. The activities of all NIH representatives involved in this cooperative agreement will be internally (within NIH) coordinated by the NCI Program Director.
- In addition, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
The specific responsibilities of substantially involved NIH staff members representing the NCI and other participating ICs will include, but will not be limited to, the following activities:
- Monitoring CIBMTR progress and coordinating periodic external reviews;
- Serving as ex officio member(s) of the CIBMTR Advisory Committee;
- Serving as a resource with respect to other ongoing NCI, NHLBI, and NIAID activities that may be relevant to the CIBMTR research efforts;
- Reviewing mechanisms for data analysis and review, when appropriate;
- Participating in appropriate CIBMTR committee meetings and conference calls;
- Reviewing Progress of the CIBMTR at least annually. Progress in areas of interest to the participating ICs include, but are not limited to, publications and CIBMTR special reports. In case of insufficient progress, or noncompliance with the terms of the award, the NCI and other participating ICs reserve the right to reduce the award budget, withhold support, suspend, or terminate the award.
- NIH staff members will coordinate with Health Resources and Services Administration/HHS on activities in stem cell transplant outcomes data collection for the C. W. Bill Young Cell Transplantation Program to avoid duplication in data collection and harmonizing computer systems.
Access to Data: The NCI and other participating ICs will have access to all data collected under this cooperative agreement and may periodically review the data. The awardee will retain custody and primary rights to the data consistent with current HHS, PHS, and NIH policies.
Areas of Joint Responsibility include the following:
- Advisory Committee consisting of CIBMTR representatives and NIH staff members is expected to provide oversight for all CIBMTR policies, agendas and long-term mission. Representatives of the NIH (NCI and other participating ICs) serve on the Advisory Committee as non-voting ex officio members.
- Collective responsibilities of the members of the Advisory Committee include:
- Reviewing policies for use of CIBMTR data;
- Assisting in grant application preparation and other fund-raising activities;
- Reviewing all research reports and manuscripts that describe results of CIBMTR-linked studies.
Dispute Resolution
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
3. 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Lori A. Henderson, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5930
Email: hendersonlori@mail.nih.gov
Linda M. Griffith, M.D., M.H.S., Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
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Email: LGriffith@niaid.nih.gov
Nancy L Difronzo
National Heart, Lung, and Blood Institute (NHLBI)
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Referral Officer
National Cancer Institute
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Shane Woodward
National Cancer Institute
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Tamia Powell
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2982
Email: tamia.powell@nih.gov
Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-827-8014
E-mail: agrestia@nhlbi.nih.gov
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