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	A Data Resource for Analyzing Blood and Marrow Transplants (Limited Competition U24)
Activity Code	U24 Resource-Related Research Projects Cooperative Agreements
Announcement Type	Reissue of RFA-CA-07-506
Related Notices	August 15, 2017 - This RFA has been reissued as RFA-CA-17-031.
Funding Opportunity Announcement (FOA) Number	RFA-CA-12-503
Companion FOA	Not Applicable
Number of Applications	Eligible applicant organization may submit only one application in response to this FOA. Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.395, 93.839, 93.855
FOA Purpose	The purpose of this Funding Opportunity Announcment (FOA) is to continue the support for the Center for International Blood and Marrow Transplant Research (CIBMTR). This database resource collects consecutive outcomes data from transplant centers worldwide and makes them accessible to transplant investigators, patients, and healthcare policy makers. In addition, the CIBMTR provides quality data to transplant researchers for observational research studies on patients who had blood and marrow transplants.

Posted Date	March 30, 2012
Letter of Intent Due Date	May 11, 2012
Application Due Date(s)	June 11, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October-November 2012
Advisory Council Review	January 2013
Earliest Start Date(s)	March 1, 2013
Expiration Date	June 12, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of 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

The National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute of Allergy and Infectious Diseases (NIAID) solicit a renewal application from the Center for International Blood and Marrow Transplant Research (CIBMTR) for the continued support of the established Data Resource for Analyzing Blood and Marrow Transplants, currently funded by a cooperative agreement resource (U24) award. The purpose of this Limited Competition Funding Opportunity Announcement (FOA) is to ensure the continued availability of the CIBMTR database as a resource to investigators and healthcare policy makers.

The CIBMTR collects consecutive data for transplant outcomes from transplant centers throughout the world. These data cover essentially all of the allogeneic hematopoietic stem cell (HSC) transplants and approximately 60% of the autologous transplants in the United States (U.S.). Data are collected for about 18,000 HSC transplant recipients per year, and the database now contains information on over 400,000 HSC transplant recepients. More than 450 transplant centers in 48 countries are currently submitting data to the CIBMTR. Approximately 85% of allogeneic transplants and greater than 99% of autologous transplants performed in the U.S. are for treatment of patients with hematologic malignancies.

The CIBMTR has a proven system for facilitating the use of its database for research, and a record of collaborations with investigators, government agencies, professional groups, international partners, and patient organizations. Currently, the CIBMTR has 19 working committees that function to facilitate the use of CIBMTR data by transplant researchers. These committees assist investigators in answering key observational research questions that can only be addressed by using an updated and 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; planning new transplant clinical trials and amending ongoing trials; assessing variabilities in transplant diagnosis, outcomes and procedures; evaluating transplant costs and cost-effectiveness; and identifying prognostic factors for transplant recipients.

The overall goal that the applicants responding to this FOA must address is to ensure that 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 CIBMTR 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.

Applicants must propose the following two Programs in their applications:

• Resource Development Program; and
• Resource Utilization Program.

The applicant team is expected to address at a minium the topics provided below in two respective lists. However, these lists of required topics are by no means inclusive. Applicant team is encouraged to include other relevant aspects consistent with the overall objectives of the FOA.

Resource Development Program is expected to focus on optimization and enhancing the quality and scope of the database in aspects relevant to malignancies as well as in other aspects relevant to the mission of NIAID and NHLBI. Particularly important are issues of data collection and management as well as on further development and optimization of information technology. Required topics to address include:

• Optimization of data submission across a wide variety of U.S. transplant centers, including those at cancer centers and smaller hospitals using "A Growable Network Information System" (AGNIS, http://www.agnis.net/);
• Global expansion of database communications via AGNIS, and global influence of CIBMTR expertise;
• Data retrieval from the CIBMTR database for use by CIBMTR investigators and other interested parties ("data back to centers" functionality);
• Optimization of interactions between the CIMBTR and patients and patient advocates to facilitate the design of quality-of-life studies as well as overall information access for involved parties;
• Strategies to enhance the collection of data for alternative therapeutic applications other than for hematopoietic malignancies, and specifically for rare diseases including but not limited to transplant for hemoglobinopathies, primary immune deficiencies, metabolic diseases, and autoimmune diseases

Resource Utilization Program should address optimization of the following aspects, at a minimun:

• The formation, 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 received and evaluated by the Working Committees;
• Timeline of movement of research ideas from CIBMTR investigators to review of proposals for studies using resource data, final activation of such studies, and to 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 and/or amendment of such trials;
• Use of data from immunobiological and immunogenetic studies, such as for studies of graft-versus- host disease and minimal residual disease, from biospecimens obtained from the The National Marrow Donor Program (NMDP) repository (such experimental studies are welcomed but remain beyond the scope of this FOA);
• The selection of an alternative donor when a matched sibling or well-matched unrelated donor is not available for allogeneic transplant, for example, use of data on haploidentical and cord blood transplants as well as donor selection based on natural killer cell receptor genes;
• Use of data to assess the effect of patient age on outcome of transplant in various disease settings;
• New statistical methodologies for studies on HSC transplant patients;
• Alternative therapeutic applications other than for hematopoietic malignancies, and specifically for rare diseases including but not limited to transplant for hemoglobinopathies, primary immune deficiencies, metabolic diseases, and autoimmune diseases
• Assistance (e.g., data collection) in long-term follow-up studies for patients participating in prospective clinical trials conducted beyond the scope of this FOA.

Governing and Administrative Structure. The CIBMTR must 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 Officer and Statistical Center, and a larger Advisory Committee, to provide oversight for all CIMBTR 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.

Funding Instrument	The Cooperative Agreement (U24) mechanism will be used to support this research. For this mechanism, there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities, but will not direct activities proposed by the grantee.
Application Types Allowed	Renewal for the award made under RFA-CA-07-506. The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The NIH intends to fund one award, contingent upon NIH appropriations, and the submission of a meritorious application. The following NIH components intend to commit the following amounts (in total costs) in FY 2013: NCI intends to commit $2.35 million; NHLBI plans to contribute $970,000; NIAID will contribute $300,000. The amount of funding over the 5 year project period is expected to be up to $18.1 million (total cost).
Award Budget	The budget requested for the initial project period must not exceed $3.62 million (total costs).
Award Project Period	A project period of 5 years may 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.

This is a limited competition FOA. Only the current CIBMTR awardee institution is eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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.

Any individual 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 the CIBMTR awardee institution 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.

If proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy (http://grants.nih.gov/grants/multi_pi) and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide. Underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

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

Eligible applicant organization may submit only one application.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 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.

By the date listed in Part 1. Overview Information, the prospective applicant is asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research;
• Name, address, and telephone number of the PD(s)/PI(s);
• Names of other key personnel;
• Participating institutions; and
• Number and title of this funding opportunity.

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 NCI staff members to estimate the potential review workload and plan the review. The letter of intent should be sent to:

Dr. William D. Merritt
Clinical Grants and Contracts Branch
Cancer Therapy and Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Blvd, EPN Rm 7009, MSC 7432
Bethesda, MD 20892-7432 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8866
Email: [email protected]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: [email protected]

In addition, applicants are encouraged to include in the submission to this address an electronic version of the application (in pdf format with text attributes on a CD).

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirements:

• Specific Aims is limited to 1 page.
• Research Strategy section is limited to 12 pages for Resource Overview, 12 pages for Resource Development Program, and 12 pages for Resource Utilization Program.

Include the full list of transplant centers which contribute data for their patients to the CIBMTR.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Table of Contents. Modify Form Page 3 of the PHS 398 (Table of Conents) to include under Section 3 Research Strategy the following subsections:

A. Overview of the Resource;

B. Resource Development Program; and

C. Scientific Resource Utilization Program

Research Strategy. Section 3. Research Strategy of the PHS 398 Research Plan must consist of the following Subsections A-C (corresponding to individual application components, see details below).

Subsection A. Overview of the Resource (12 pages)

In this section, describe the following aspects:

• Overview of the formation and evolution of the CIBMTR and general makeup of the participation sites;
• Organizational and leadership structure of the CIBMTR, including the composition and function of the significant administrative and scientific bodies such as the Executive Committee and Advisory Committee,.
• Overview of 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; and
  • Plans for interactions with other relevant data collection initiatives, e.g., Stem Cell Therapeutic Outcomes Database.
• Progress in the current funding period in regard to 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, solid tumor transplants, non-malignant indications and 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.

Subsection B. Resource Development Program (12 pages)

In this section, the 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 collection of research data from patients undergoing hematopoietic cell transplants for non-malignant indications and with multiple, novel, or genetically-modified cellular products; and
• Initiate collection of research data on patients with myelodysplastic syndromes who do not undergo transplant.

Subsection C. Resource Utilization Program (12 pages)

In this section, describe the plans proposed to:

• Provide novel observational studies in hematologic malignant and non-malignant blood disorders, including use of genetically engineered cellular products;
• Optimize the process of the review and prioritization of proposals emanating from the scientific working committees, the communication of these committees with senior leadership, and the timeline for publication of studies;
• Improve the scientific basis for selection of an alternative donor when a matched sibling or well-matched unrelated donor is not available;and use CIBMTR data in novel ways to obtain further information on engraftment, GVHD and outcomes, for example outcomes as related to aspects of natural killer (NK) cell-KIR ligand mismatch;
• Enhance interactions with investigators at relevant clinical entities supported by the NIH for use of CIBMTR data in the design of prospective clinical trials;
• Link outcomes data to immunological data obtained from biospecimens;
• Optimize the data analysis process through enhanced biostatistical analyses;
• Assess transplant outcomes for patients with extremely rare disorders, including non-malignant diseases;
• Assess the effect of patient age on transplant outcomes in various disease settings;
• Use the data from patients with myelodysplastic syndromes who do not undergo hematopoietic cell transplant in a prospective study to adhere to Coverage with Evidence Determination guidance (https://www.cms.gov/CoverageGenInfo/03_CED.asp) issued by the Centers for Medicare & Medicaid Services (CMS); and
• Provide health services research on hematopoietic stem cell transplantation.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modifications:

• This application should address a Data Sharing Plan (specific data sharing aspects may be appropriate to mention in other sections of the application as well).

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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.

Application must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, the application will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Application that is incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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 transplant patient outcomes. The CIBMTR is expected to function as a living resource that is responsive to the needs of the communities served and a variety of potential users.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Resource 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 Resource proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Resourcet that by its nature is not innovative may be essential to advance a field.

Significance

Does the Resource address an important problem or a critical barrier to progress in the field? If the aims of the Resource are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: How well is the Resource Development Program 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 infrastucture and information technology? How well does the Resource Utilization Program anticipate future research needs in the field of hematopoietic stem cell transplant?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Resource? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: How appropriate are the overall leadership of the CIBMTR and staff of CIBMTR operations and management appropriate for 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 makeup of the leadership of the working committees and the statistical center ensure optimal scientific productivity in the CIBMTR?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Resource? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the Resource involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Are the methods of data collection and information technology adequately developed, well integrated, feasible, and appropriate to the scientific goals of the Resource? Specifically, how suitable and well reasoned are the proposed data submission goals? How appropriate and how well integrated are data retrieval processes proposed? Is expansion of the data resource globally appropriate and well integrated for future development?

Are the Scientific Working Committees with associated biostatistical input structured for optimal and efficient critical consolidation of data and formulation of study proposals? How well is the CIBMTR (as proposed) structured for the optimal prioritization of research problems that can be addressed by observational studies? Will the CIBMTR contributions in that regard sufficiently help drive further research in the field of hematopoietic stem cell transplant for a wide variety of disease settings, including non-malignant disorders? Is there evidence for meaningful collaborative initiatives to enhance linkage to relevant clinical entities supported by the NIH for purposes of running prospective clinical trials in transplant research? Are the plans to connect CIBMTR data with corresponding immunological data taking sufficient advantage of the available biospecimens? How well-defined, appropriate and efficient are the proposed processes for proposal approval, study completion, and timely publication of the results?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA: To what degree is the environment of the CIBMTR applicant institutions conductive to the goals for 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 Resource Utilization Program, e.g., with respect to integration and interaction with other relevant programs and activities in the general field of hematopoietic stem cell transplant science and practice? To what degree will these environments help respond to the needs of communities to be served by the Resource?

As applicable for the Resource proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed Resource involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 Resource 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/priority 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) Genome Wide Association Studies (GWAS).

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.

Application will be evaluated for scientific and technical merit by a Scientific Review Panel convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, application submitted in response to this FOA will receive a written critique.

Appeals of initial peer review will not be accepted for the application submitted in response to this FOA.

Applicationwill be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended 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.

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other DHHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U24), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• 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 outside of the CIBMTR in order 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 Protection;
• 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 aspects;
• 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.

The main 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 particpating 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.

To perform its functions, the CIBMTR must maintain an appropriate organizational and administrative structure. This structure is expected to include the Advisory Committee, the Executive Committee, and several Scientific Working Committees.

Expected activities of the Executive Committee include:

1) providing advice to the overall PD(s)/PI(s) for scientific activities and policy decisions;

2) establishing priorities for scientific studies after obtaining input from the Working Committees;

3) reviewing results of audits and recommending measures to correct deficiencies; and

4) reviewing and assisting in preparation of the agenda for annual Advisory Committee meetings.

Expected Activities and Responsibilities of the Scientific Working Committees include:

1) designing and conducting studies relevant to their subject area and involving CIBMTR data, statistical resources, networks, and/or centers;

2) considering proposals to use CIBMTR data for studies pertinent to their subject area;

3) periodically assessing and revising relevant sections of the CIBMTR data collections forms; and

4) planning and conducting workshops at CIBMTR meetings.

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. NCI Project Scientist will not attend peer review meetings of renewal and/or supplemental applications. If such participation is essential, this individual will seek NCI waiver according to the NCI procedures for management of conflict of interest. Other NCI staff members as well as staff members from the participating ICs may also become substantially involved. Those individuals will not attend peer review meetings of renewal and/or supplemental applications (or will seek waiver). 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. If the same individual serves as both Project Scientist and Program Official, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NCI waiver if such participation is essential.

The responsibilities of substantially involved NIH staff members representing the NCI and other participating ICs will include, but will not not limited to, the following activities:

1) Monitoring CIBMTR progress and coordinating periodic external reviews.

2) Serving as ex officio member(s) of the of the CIBMTR Advisory Committee.

3) Serving as a resource with respect to other ongoing NCI, NHLBI, and NIAID activities that may be relevant to the CIBMTR research efforts.

4) Reviewing mechanisms for data analysis and review, when appropriate.

5) Participating in appropriate CIBMTR committee meetings and conference calls.

6) 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 (based on IC-specific reports from 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.

7) NIH staff members will coordinate with Health Resources and Services Administration/DHHS 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. Respresentatives 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:

1) reviewing policies for use of CIBMTR data;

3) assisting in grant application preparation and other fund-raising activities; and

4) reviewing all research reports and manuscripts that describe results of CIBMTR-linked studies.

The Advisory Committeee is expected to meet annually, with additional teleconferences, as needed.

The CIBMTR and NIH staff members will jointly develop methods to make this resource accessible to other investigators. This joint development may occur through strategy meetings, development of datasets for publication on the Internet, and other mechanisms, as deemed appropriate.

The CIBMTR and NIH staff will jointly coordinate activities to eliminate and avoid duplication in data collection and harmonizing computer systems.

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between the award recipient and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardees right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. In addition to the standard annual PHS 2590 report, the participating ICs may request, as needed, interim reports on progress in areas specific to their interests.

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

For NCI:

William D. Merritt, Ph.D.
Clinical Grants and Contracts Branch
Cancer Therapy and Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Blvd, EPN Room 7009, MSC 7432
Bethesda, MD 20892-7432 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8866
Email: [email protected]

For NHLBI:

Nancy L. DiFronzo, Ph.D.
Transfusion Medicine and Cellular Therapeutics Branch
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7950
Bethesda, Maryland 20892-7950
Telephone: 301-435-0065
Fax: 301-480-1046
E-mail: [email protected]

For NIAID:

Linda M. Griffith, M.D., Ph.D.
Autoimmune and Primary Immunodeficiency Diseases Section
Autoimmunity and Mucosal Immunology Branch
Division of Allergy, Immunology and Transplantation
National Institute of of Allergy and Infectious Diseases
6610 Rockledge Drive, Room 6716, MSC 6601
Bethesda, MD 20892-6601 (for U.S. Postal Service regular or express mail)
Bethesda, MD 20817 (for non-USPS delivery)
Telephone: 301-496-7104
Fax: 301-480-1450
Email: [email protected]

Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
6116 Executive Blvd, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for US Postal Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]

Romy M. Reis
National Cancer Institute
Office of Grants Administration
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150 (for US Postal Express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-2834
FAX: 301-496-8601
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.