Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Limited Competition: A Data Resource for Analyzing Blood and Marrow Transplants (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-CA-12-503

Related Notices
  • August 23, 2017 - Notice of Participation of National Institute of Allergy and Infectious Diseases (NIAID) on RFA-CA-17-031. See Notice NOT-AI-17-038.
Funding Opportunity Announcement (FOA) Number

RFA-CA-17-031

Companion Funding Opportunity

None

Number of Applications

Applicant institution may submit only one application Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.395, 93.839, 93.855

Funding Opportunity Purpose

 The purpose of this limited competition Funding Opportunity Announcement (FOA) is to solicit the Center for International Blood and Marrow Transplant Research (CIBMTR) a limited competition application for the continued support of the Data Resource for Analyzing Blood and Marrow Transplants program. The support for this FOA is to ensure the continued availability of the CIBMTR database as a resource to investigators, transplant physicians, and healthcare policy-makers.

Key Dates
Posted Date

August 15, 2017

Open Date (Earliest Submission Date)

September 26, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

October 26, 2017), by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late application will be accepted for this FOA.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

January-February, 2018

Advisory Council Review

May, 2018

Earliest Start Date

July, 2018

Expiration Date

October 27, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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

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

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

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

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

The purpose of this limited competition Funding Opportunity Announcement (FOA) is to solicit a renewal application from the Center for International Blood and Marrow Transplant Research (CIBMTR) for the continued support of the Data Resource for Analyzing Blood and Marrow Transplants program, currently funded by a cooperative agreement resource (U24) award. The support for this FOA is to ensure the continued availability of the CIBMTR database as a resource to investigators, transplant physicians, and healthcare policy-makers.

Background

The CIBMTR collects outcomes data from consecutive patients transplanted from centers throughout the world. These data cover virtually all the allogeneic hematopoietic stem cell (HSC) transplants and approximately 80% of the autologous transplants in the United States. Data are collected for about 23,000 patients per year, and the database now contains information on more than 470,000 HSC transplant recipients. More than 500 transplant centers in 48 countries are currently submitting data to the CIBMTR. Approximately 80% of allogeneic and greater than 99% of autologous HSC transplants are for treatment of patients with hematologic and other malignancies.

The CIBMTR has a proven system for facilitating the use of its database for research, with a strong record of collaborations with investigators, government agencies, international partners, corporate partners, and patient organizations. Currently, the CIBMTR has 15 Scientific Working Committees that function to facilitate the use of CIBMTR data by transplant researchers to undertake observational research studies to answer questions that can only be addressed by using an updated, contemporary database of outcomes of transplants. Studies that utilize the CIBMTR database provide information relevant to: developing approaches to evaluate transplant 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 specimens collected from HSC transplant patients; evaluating transplant costs and cost-effectiveness; and identifying prognostic factors for transplant recipients.

Goals and Requirements of this FOA

Overall Goals for the Data Resource for the CIBMTR: The applicant responding to this FOA must ensure that the CIBMTR continues to serve as a robust and efficient research resource for collection and utilization of data on transplant patient outcomes. The proposed continuation of the Data Resource must provide wide and sustaining value to the scientific and lay communities, and be properly optimized to meet new challenges and emerging opportunities in transplant research.

Organizational Requirements for the Data Resource: The proposed Data Resource must be structured to include the two current sites and cover the following two programs:

Resource Development Program is expected to focus on optimization and enhancing the quality and scope of the database in aspects of transplantation associated with 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 ensure/provide all of the following capabilities and functions (but additional relevant aspects should also be considered):

  • Optimization of data collection across a wide variety of transplant centers, including not only cancer centers, but also smaller institutions and hospitals, with expanded use of AGNIS (A Growable Network Information System, http://www.agnis.net/).
  • Optimization of quality control procedures via increased refinement of data validation and data auditing;
  • Continued global expansion of the CIBMTR Research Database, through AGNIS to optimize data harmonization, with increased global influence of CIBMTR expertise;
  • Continued development of the Integrated Data Warehouse for aggregation and management of metadata associated with data from various sources, such as patient clinical data and HLA and other data from biospecimens;
  • Collection of data on patients receiving cellular (e.g., gene-modified T cells) therapies related to treatment of patients with hematologic malignancies or non-malignant blood diseases in conjunction with HSC transplant;
  • Collection of data on long-term HSC transplant survivors for malignant and non-malignant hematologic diseases to capture information about potential cardiac, pulmonary, and/or hematologic complications, as well as second malignancies;
  • Collection of data on patients on clinical trials that compare HSC transplant with non-transplant therapies;
  • Optimization and expansion of information retrieval from the CIBMTR database for use by investigators through refinements of the electronic data-back-to-centers and related tools (e.g., optimal use of the Qlikview (https://www.visualintelligence.co.nz/qlikview/);
  • Continued communications with the Foundation for the Accreditation of Cellular Therapy (FACT) to diminish duplications in reporting requirements to both entities;
  • Optimization of interactions between the CIBMTR and patients and patient advocates to develop patient-reported-outcomes (PROs) and quality-of-life (QOL) studies, especially for long-term post-survivors of HSC transplant;
  • Strategies to enhance the collection of comprehensive data for therapeutic applications other than those for hematopoietic malignancies, specifically for rare blood diseases, such as sickle cell disease and thalassemias; aplastic anemia and other bone marrow failure diseases; and primary immune deficiency disease, metabolic disorders and autoimmune diseases.

Resource Utilization Program is expected to focus on providing novel observational studies in hematologic malignancies and non-malignant blood disorders. This program must ensure/provide all of the following capabilities and functions (but additional relevant aspects should also be considered):

  • The organization of membership, function, and leadership of the scientific Working Committees and the procedures for their review;
  • The process of final review, prioritization and implementation of the proposed studies that are received and evaluated by the Working Committees;
  • The movement and timeline of research ideas from CIBMTR investigators to review of proposals for studies using resource data, to final activation of studies, and publication of results;
  • The process by which observational studies emanating from the scientific agenda in the CIBMTR are linked to decisions for prospective clinical trials design or amendment of trials (for example in the Blood and Marrow Transplant Clinical Trials Network, BMT CTN);
  • Linkage of clinical outcomes data for defined patient subsets with genomic information to help understand outcomes, toxicities and survivorship issues;
  • When research goals are complementary, outreach to other societies (e.g., the European Society for Blood and Marrow Transplantation) to facilitate collaborations to achieve a meaningful number of cases, particularly in rare disorders.
  • A scientific agenda that should include use of CIBMTR outcomes data for:
  • Linkage of donor and recipient genomic variants and correlating HLA and KIR genotyping via next generation sequencing with outcomes, such as survival, graft-vs.-host disease, minimal residual disease, infections, and relapse) using biospecimens, for example, obtained from the National Marrow Donor Program (NMDP) repository; such immunobiological and immunogenetic studies using biospecimens are welcomed but remain beyond the scope of this FOA;
  •  Assessment of the effect of patient age, gender, and ethnic/racial background on outcome of transplant in various disease settings;
  • The role of donor selection based on alternative sources of HSC (haploidentical or cord blood) when a matched sibling or well-matched unrelated donor is not available for transplant;
  •  The role of donor selection based on natural killer cell genes especially when an alternative donor is selected;
  • Studies comparing HSC transplant to therapies for malignancies other than transplant;
  • Understanding the role of cellular products (e.g., genetically-modified T cells) for enhancing HSC transplant outcomes;
  • Assessment of long-term outcomes of transplant to each organ, including immune reconstitution, with or without chronic graft-vs.-host disease (GVHD);   
  • Long-term follow up of patients in studies enrolled in clinical trials in transplant conducted by the BMT CTN;
  • Support the linkage and transfer of CIBMTR data to the NHLBI-supported Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) for patients participating on BMT CTN trials (https://biolincc.nhlbi.nih.gov/home/);
  • Studies to evaluate survival and outcomes of patients transplanted for non-malignant blood diseases, including but not limited to transplant for hemoglobinopathies, certain anemias (e.g., severe aplastic anemia), primary immune deficiency (PID) diseases and autoimmune diseases;
  • Identify the most successful transplant approaches to reduce toxicity and optimize transplant regimens in patients with non-malignant diseases;
  • Support research on heart, lung, blood and sleep complications, as well as subsequent malignancies, including PRO and QOL studies, in long-term survivors post-transplant for malignant and non-malignant diseases;
  • Provide data to Centers for Medicare & Medicaid Services to be used for coverage decisions for transplant for patients with non-malignant blood diseases who are not currently covered.
  • Selected Research Examples for the agenda include:
  • Assess the efficacy of autologous transplant compared to non-transplant therapy for treatment of lymphoma;
  • Assess the efficacy of various adoptive T cell therapies for prevention of relapse after transplant for hematologic malignancies;
  • Assess the efficacy and toxicity of T cell and natural killer (NK) cell therapies as a bridge to transplant;
  • Studies of non-human leukocyte antigen/killer inhibitory receptor (HLA/KIR) genetic allelic determinants associated with non-relapse [e.g., graft-versus-host disease (GVHD)] and relapse mortality outcomes in patients undergoing allogeneic transplant for hematologic malignancies;
  • Assess the role of non-HLA germline genetic variation in survival and treatment-related mortality after HSC transplant;
  • Estimate the efficacy and toxicity of haplo-identical donors vs. cord blood to transplant for adults and children with severe sickle cell disease (SCD), such as effects on strokes and frequent pain crises;
  • Assess the efficacy, toxicity and immune reconstitution in patients with aplastic anemia using cord blood or haplo-identical transplantation and an optimized conditioning regimen;
  • Evaluate the donor cell chimerism levels needed to achieve therapeutic benefit in allogeneic HCT for non-malignant indications, e.g., to avoid sickling symptoms following allogeneic HCT for SCD and restore immune functions in patients with PID;
  • Compare short-term and long-term rates of infections in recipients of different sources of stem cells (related matched donors, unrelated matched donors, mismatched unrelated donors, haplo-identical cord blood);
  • Evaluate long-term outcomes of contemporary cases of autologous HSC transplant for autoimmune diseases including multiple sclerosis and systemic sclerosis (schleroderma).
  • Governing and Administrative Structure: The CIBMTR should have appropriate organizational and managerial structures for the programmatic goals defined above. It is expected that the CIBMTR will have an Executive Committee for providing scientific and policy advice to the Chief Scientific Director (the contact PD/PI) and Statistical Center, and a larger Advisory Committee, to provide oversight for all CIBMTR policies, agendas and long-term mission. In addition, it is anticipated that the current topical Scientific Working Committees will continue to function for the design and implementation of research studies in the CIBMTR but their structure may be optimized as needed.

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

Section II. Award Information
Funding Instrument

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.

Application Types Allowed


Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts (total costs) in FY2018 to fund jointly one award:

NCI, $2,500,000;

NHLBI, $1,495,000; and
NIAID, $250,000.

NIAID intends to commit $250,000 in FY2018; $250,000 in FY2019; $250,000 in FY2020, $250,000 in FY2021, and $250,000 in FY2022.

Award Budget

The budget request must not exceed $ 2,875,000 per year in direct costs.

Award Project Period

 Project period of five years should be requested

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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Only the current CIBMTR awardee (under RFA-CA-12-503) is eligible to apply.

Foreign Institutions

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.

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – 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. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit only one application.

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

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

Buttons to access the online ASSIST system or to download application forms 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 Research (R) 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.

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:

William D. Merritt, Ph.D.
Telephone: 240-276-6137
Email: merrittw@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following specific requirements:

  • Research Strategy section is limited to 30 pages
Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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: The applicant must provide the following additional materials specified below in support of their application:

Attachment 1: Organizational Data. Provide the following information as a PDF file (use the filename "Organizational Data"):

  • Table of contents
  • Overall organizational charts of the CIBMTR, including both sites
  • Forms submission processes
  • Scientific Working committees listing
  • U.S.-based participating transplant centers
  • International participating transplant centers

Attachment 2: CIBMTR Accomplishments. Provide the following information as a PDF file (use the filename "Accomplishments"):

  • Table of contents
  • Summary tables for completed and under-development studies from each of the working committees in the current funding period

Attachment 3: Transplant Centers. Provide the following information as a PDF file (use the filename "Transplant Centers"):

  • Full list of transplant centers, domestic and international, which will be contributing 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
SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.  If only one PD/PI is designated, the applicant should identify a senior investigator who is qualified to take over the responsibility as PD/PI for the CIBMTR if the need arises.

The contact PD/PI is expected to be designated as the CIBMTR Chief Scientific Director.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. The effort of the PD/PI should be a minimum of 1.2 person-months and this commitment cannot be reduced during the project period.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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:

Standard sub-sections of Research Strategy are replaced by the new sub-sections A-C.

Sub-section A: CIBMTR Overview

In this sub-section, provide an overview of:

  • The formation and evolution of the CIBMTR and general makeup of the participating sites;
  • The composition and function of the significant administrative and scientific bodies of the CIBMTR, such as the Executive Committee and Advisory Committee, particularly related to how the proposed organizational structure will serve the goals of the CIBMTR;
  • Data collection and management and accrual;
  • Current transplant data archive (basic and comprehensive).
  • Progress in the current funding period in the areas of:
  • Data collection technology related to simplification of data reporting from centers as well as enhancement of data quality;
  • Data retrieval by centers for enhanced speed of data utilization;
  • Community outreach such as development of web-based applications;
  • Information technology advances to enhance speed and throughput of the CIBMTR;
  • Efforts to enlist additional institutions (U.S. and global) to submit data to CIBMTR;
  • Plans for interactions with other relevant data collection initiatives, e.g., Stem Cell Therapeutic Outcomes Database.
  • Progress in the current funding period regarding use of the CIBMTR data by the statistical center and the scientific working committees to:
  • Enhance knowledge of outcomes of hematopoietic cell transplant for various malignancies and non-malignant blood disorders and indications, particularly rare indications;
  • Further develop and enhance the role of CIBMTR studies in the field of hematopoietic cell transplantation;
  • Support prospective multi-site clinical trials;
  • Provide novel biostatistical approaches to transplant research;
  • Expand health services research on hematopoietic stem cell transplantation;
  • Expand data on quality of life and late effects of HSC treatment;
  • Facilitate collaborations of working committees with other organizations; and
  • Utilize the NMDP tissue bank using paired donor-recipient specimens for studies in  immunology and genetics of transplant linked to clinical outcomes.

Note: Supporting information relevant to this sub-section is requested above under Other Attachments.

Subsection B: Resource Development Program

In this sub-section, describe plans proposed to:

  • Optimize the overall quality and scope of the database;
  • Optimize collaborative ventures with U.S. medical centers to enhance database connectivity and improve data transmission rates/throughput and reliability as needed;
  • Further international collaborations as related to the global influence of the CIBMTR;
  • Enhance data retrieval functionality for transplant centers as well as community-based physicians including web-based access;
  • Optimize data collection procedures from multiple, novel, or genetically-modified cellular products associated with cellular therapies associated with HSC transplant;
  • Optimize collection of research data from patients undergoing hematopoietic cell transplants for non-malignant blood diseases; and
  • Collect research data on patients with certain hematopoietic malignancies (e.g., lymphoma) who do not undergo transplant from trials comparing transplant versus non-transplant.

Subsection C: Resource Utilization Program

In this sub-section, describe plans proposed to:

  • Optimize the process of the review and prioritization of proposals emanating from the working committees, the communication of these committees with senior leadership, and the timeline for publication of studies;
  • Improve scientific basis for selection of alternative donors when a matched sibling or well-matched unrelated donor is not available (e.g., use of KIR ligand mismatch);
  • Use CIBMTR data in novel ways to obtain further information on relation of conditioning regimen, engraftment and GVHD on outcomes;
  • Assess impact of patient oncogenic mutation status on transplant outcomes;
  • Develop studies to define prognostic markers of relapse and non-relapse mortality (e.g., GVHD);
  • Develop studies to understand the value of use of cellular therapies, e.g., genetically engineered T cells, on transplant outcomes;
  • Enhance interactions with investigators at relevant clinical entities supported by the NIH (e.g., BMT CTN) for use of CIBMTR data in design and conduct (e.g., through amendments) of clinical trials;
  • Develop studies comparing transplant with non-transplant alternatives (e.g., for lymphoma);
  • Link CIBMTR outcomes data and deep sequencing genomics data from biospecimens, to further  studies to understand the role of non-major HLA types or non-KIR ligand with non-relapse (e.g., GVHD) and relapse-associated mortality;
  • Link CIBMTR outcomes data to cellular/immunological data obtained from analyses of biospecimens, (e.g., assess impact of patient microenvironment in bone marrow and secondary lymphoid tissue on transplant outcomes);
  • Assess transplant outcomes for patients with extremely rare disorders, particularly including, but not limited to, non-malignant blood diseases;
  • Assess effects of transplant on organs other than GVHD-related and appearance of second malignancies in long-term survivors after transplant for hematologic malignancies or non-malignant blood disorders;
  • Assess the impact of patient age on transplant outcomes in various disease settings;
  • Optimize the data analysis process through enhanced biostatistical methodologies, with increased emphases on meta-analyses when appropriate, and in collaboration with the bioinformatics program for studies utilizing genomics data;
  • Provide further collaboration with the Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI-BMT) program and the Health Services Research Program;
  • Encourage collaboration with other societies, when research goals are complementary, and particularly for studies in rare disorders, to achieve a meaningful number of cases.

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

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

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.  

PHS Assignment Request Form

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

4. Submission Dates and Times

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.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

For NCI-relevant CDEs, please visit CDE (Common Data Element) Browser.

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

For this particular announcement, note the following:

The overall goal and priority 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 a HSC transplant. The CIBMTR is expected to function as a resource that is responsive to changes in collection and use of data from HSC transplant and thus 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 CIBMTR renewal address the needs of the investigator community that it will serve? Is the scope of activities proposed for the CIBMTR appropriate to meet those needs? Will successful completion of the aims bring unique        advantages or capabilities to the research program?

Specific to this FOA: How well is this Resource Development Program in particular addressing the future needs of transplant researchers, physicians and their patients? How significant for the overall goals of the program are the proposed improvements in the overall infrastructure and information technology? How well does the Resource Utilization Program anticipate the future needs in the field of hematologic stem cell transplant in areas of both malignant and non-malignant blood disorders?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the CIBMTR? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing data collection and outcomes research? Do the investigators demonstrate significant experience with coordinating collaborative clinical 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, appropriate for the CIBMTR? Does the applicant have experience overseeing selection and management of sub-awards?

Specific to this FOA: How appropriate are the overall leadership of the CIBMTR and staff of CIBMTR operations and management in terms of ensuring optimal functioning of the CIBMTR? Do the members of the team bring complementary and integrated expertise to the Resource? To what degree do 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 management strategies and/or organizational concepts in coordinating the research program the CIBMTR 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 and/or management strategies proposed?

Specific to this FOA: How innovative are approaches, methodologies and directions proposed for the collection of and use of transplant data from malignant and non-malignant hematologic diseases, non-transplant data from transplant trials, and data from cell therapies associated with transplant?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program, as a resource, that the CIBMTR will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage           the risks associated with the activities of the program? 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: Are the methods for data collection and information technology adequately developed, well-integrated, feasible, and appropriate to the various scientific goals of the Resource? How appropriate and how well integrated are the data retrieval and the data-back-to-centers processes, proposed? Is the next phase of expansion of the Resource globally appropriate and well-integrated for future development?

Are the Scientific Working Committees with associated biostatistical input structured for optimal and efficient consolidation of data and formulation of study proposals? How well is the CIBMTR, as proposed, structured for the optimal prioritization of research problems in HCT that can be addressed by observational studies; and are mechanisms in place to address late effects such as organ toxicities on transplant patients?  How strong is the approach to transfer long-term outcome data from patients enrolled on BMT CTN trials to BioLINC in a timely manner? Will CIBMTR contributions in that regard drive further research in the field of HCT for a wide variety of disease settings, including non-malignant blood disorders? How robust is their approach to include new data in cellular therapies in conjunction with transplant to assess their impact on outcomes?  Are there plans to study outcomes comparing non-transplant vs. transplant in one or more hematologic malignancies? Are plans to connect CIBMTR outcomes data with corresponding genetic and immunological data to take advantage of available biospecimens well described and feasible? How well-defined, appropriate and efficient are the proposed processes for proposal approval, study completion, and timely publication of the results?

Environment

Will the institutional environment in which the CIBMTR will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the CIBMTR proposed? Will the CIBMTR 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, e.g., with respect to integration and interaction with other relevant programs and activities in the general field of HSC transplant science and practice? To what extent will these environments address the needs of the communities to be served by the 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 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.

Inclusion of Women, Minorities, and Children 

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.

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

Additional Review Considerations

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, the application:

  • Will receive a written critique.

Appeals of initial peer review will not be accepted for application 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. . Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information
1. Award Notices

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

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

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, 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.

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

Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the 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;
  • 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.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current 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 Project Scientist.

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 same individual may serve as both Project Scientist and Program Official.

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 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;
  • Review of Progress: Performance of the CIBMTR will be reviewed as requested, and at least annually. For example, the NCI Project Scientist, in consultation with NIH staff members from NHLBI and NIAID, will review mechanisms established by CIBMTR for data management and analysis, when appropriate. Also evaluated will be progress in areas specific to the interests of participating ICs, including resulting publications and IC-specific reports from the CIBMTR. In case of insufficient progress, or noncompliance with the terms of 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 especially to eliminate and 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, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

 Scientific/Research Contact(s):

William D. Merritt, Ph.D.
National Cancer Institute
Telephone: 240-276-6137
Email: merrittw@mail.nih.gov

Nahed El Kassar, M.D., Ph.D.
National Heart, Lung and Blood Institute
Telephone: 301-827-8268
Email: nahed.elkassar@nih.gov

Linda M. Griffith, M.D., M.H.S, Ph.D.
National Institute of Allergy and Infectious Diseases
Telephone: 240-627-3525
Email: LGriffith@niaid.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Shane Woodward
National Cancer Institute
Telephone: 240-276-6303
Email: woodwars@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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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