Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This Notice of Funding Opportunity (NOFO) requests applications to support the Data Coordinating Center (DCC) for the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The recipient of this NOFO will provide the relevant medical, scientific and regulatory expertise, as well as support for coordination, data management, budgetary management, statistical design and analysis, and operational support for the program.

There is a separate NOFO for BMT Core Clinical Centers (CCCs) (RFA-HL-24-010).

Background and Objectives

Each year in the US, approximately 20,000 patients receive hematopoietic stem cell transplantation (HCT) for rare and various hematological indications. Most HCT centers treat small numbers of patients with this rapidly evolving therapy, despite transplant being the only curative option for larger numbers of patients with acquired and congenital non-malignant blood diseases and for significantly larger numbers of patients with hematological malignancies. Optimizing HCT strategies for patients seeking these potentially curative therapies is critical to enable patients to live longer and with a better quality of life. However, a number of factors make HCT trials challenging, including rare hematologic diseases, small patient populations in need of HCT, the imperative to improve HCT and cell therapy approaches, and the need to engage many centers to obtain sufficient patient numbers. A clinical trials network provides a critical mass of investigators and participating sites, increases patient availability and opportunity, and provides centralized and efficient approaches to conduct rigorous and well-designed, well-coordinated trials.

The objective of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) is to provide the infrastructure for multi-site collaborative clinical trials evaluating HCT and adoptive cell therapy approaches to cure blood diseases. Sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI) since 2001, BMT CTN has conducted more than 50 Phase II and Phase III trials to address key issues for the field including donor availability, treating or preventing graft versus host disease (GVHD) or infections, disease control, treatment-related toxicity, cost-effectiveness, and quality of life. While many trials were developed from concepts provided by BMT CTN investigators, a large number were guided by the scientific community during State of the Science Symposia conducted in 2007, 2014, and 2021, or in collaboration with other networks and groups, including NCI’s National Clinical Trials Network (NCTN), NCI's AIDS Malignancy Consortium, or implemented with funds provided by other NIH-funded investigator teams or pharmaceutical companies. Six to eight clinical studies are always active. The BMT CTN's past and ongoing activities can be found on the public website for the BMT CTN.

In this next funding cycle, BMT CTN will continue to address the most pressing issues for individuals with non-malignant and malignant blood diseases seeking curative therapies. This Notice of Funding Opportunity (NOFO) and the companion NOFO for the Core Clinical Centers (CCCs) (RFA-HL-24-010) will support the BMT CTN infrastructure for seven years. Funds for trials and other studies will be included in the DCC budget, but BMT CTN investigators will also be encouraged to seek funding for additional trials and studies through investigator-initiated grants, industry participation, and foundation grants. Clinical studies that advance HCT approaches for non-malignant blood diseases, where toxicity must be minimized, will be prioritized for BMT CTN funds. Trials evaluating ex vivo manipulated or genetically-modified cells in non-malignant and malignant blood diseases will be encouraged, as will trials evaluating new approaches for stem cell mobilization, less toxic conditioning, reducing regimen-related toxicity and GVHD, and enhanced immune function. As in the past, collaborations with the NCTN will be encouraged, often with the NCTN leading the trial. Protocol topic areas will be decided cooperatively by the BMT CTN Steering and Executive Committees.

CCCs selected to join the BMT CTN through RFA-HL-24-010 should be prepared to contribute to the development of BMT CTN protocols, to enroll patients on multiple BMT CTN trials simultaneously, to provide complete data for analysis, and to disseminate findings. Funds available through the DCC will support up to six clinical trials to address the most important HCT problems for non-malignant blood diseases and hematological malignancies. CCCs should have the infrastructure to evaluate ex vivo manipulated and genetically modified cells and have a catchment area or collaborations in place to enroll participants from minority health and health disparity populations, including patient populations diverse in age, ethnicity, gender, and geographic area. In addition, CCCs should have the ability to contribute to a biorepository for patients with non-malignant blood diseases who receive HCT or cell therapy as part of an observational protocol collecting clinical information and late effects. CCCs must be willing and capable of enrolling patients to BMT CTN protocols with the goal of providing answers through these studies more rapidly than individual centers, and to support the various activities of the BMT CTN.

The objectives of the DCC are to address a comprehensive plan to provide overall project coordination, administration, data management, biostatistical support, and regulatory support while emphasizing patient engagement, equity, and collaboration with multiple sites and other research groups. In particular, this NOFO seeks applications to successfully support the next phase of the BMT CTN. One award will be made for the application that provides the medical, scientific, and operational leadership and plans necessary to meet the following goals:

1. Comprehensive management of administrative, operational, and scientific activities related to study development, trial launch and coordination, medical oversight, quality assurance, data analysis, manuscript preparation, and results dissemination.
2. Provision of plans and expertise to identify scientific gaps, launch trials for patients with non-malignant blood diseases and hematologic malignancies evaluating HCT, adoptive cell therapy or genetically-modified cells to improve transplant outcomes.
3. Biostatistical support for study design, sample size calculations, safety monitoring, and data analysis.
4. Development and implementation of a plan to identify and qualify clinical sites that are not CCCs (Affiliate Centers) and that serve children, adults, individuals from under-represented racial and ethnic groups, and geographically diverse areas.
5. Development and implementation of a plan for engagement of patients, caregivers, and patient advocates for BMT CTN trials.
6. Provision of all regulatory and administration activities, including a single Institutional Review Board (sIRB); support for NHLBI-appointed committees that review protocols scientifically and oversee the safety of participants enrolled on trials.
7. Regulatory and data management support for all studies, including trial master files for studies conducted under an Investigational New Drug (IND) application and registration trials, as well as patient reported outcomes.
8. Provision of expertise needed for interactions with the Food and Drug Administration and to serve as the Authorized Representative for trials conducted under INDs.
9. Coordination of logistical and other support services, including convening an External Advisory Group, in collaboration with NHLBI and NCI, and all committees required for the governance of the BMT CTN.
10. Management and distribution of funds to support the patient care costs associated with the protocols on a per-patient basis and subcontracts with central laboratories and pharmacies, according to the approved protocol budgets.
11. Integration of relevant data from the Center for International Blood and Marrow Research into BMT CTN data sets.
12. Provision of expertise and an approach to build a biorepository from patients with non-malignant blood diseases who receive HCT or an adoptive cell therapy.
13. Plans to support investigator and site staff mentorship and training to ensure the conduct of high quality clinical trials.
14. Development and implementation of project-based opportunities to benefit early- and mid-career investigators to help advance the next generation of clinical trialists.

Organization and Governance. The BMT CTN is funded using cooperative agreements. The BMT CTN consists of Core Clinical Centers and Consortia (CCCs), the Data Coordinating Center (DCC), and NHLBI and NCI staff. The organization and governance involve the following components:

1. Data Coordinating Center (DCC)

The DCC is responsible for the overall coordination and administration of the BMT CTN program; maintaining the Manual of Operating Procedures; supporting protocol development, finalization and prioritization; providing sample size calculations, sophisticated statistical advice, and data analyses; developing accrual plans and patient-facing materials; facilitating safety monitoring of BMT CTN trials; providing regulatory support, secure data management systems and systems for quality control; preparing minutes and reports for BMT CTN committees/subcommittees, and the NHLBI; identifying, qualifying and subcontracting with Affiliate transplant centers (Affiliate Centers) and other collaborators for BMT CTN clinical trials; reimbursing (per-patient) participating centers; subcontracting central laboratories needed for network studies including long-term storage, retrieval, and shipment of biospecimens, and pharmaceutical companies for specific drugs and reagents; preparing data and safety reports for the Data Safety and Monitoring Boards (DSMBs); coordinating the development of manuscripts and presentations; and coordinating meetings and activities of the DSMBs, the BMT CTN Steering Committee, the External Advisory Committee, and other BMT CTN committees and subcommittees.

Funds to support the patient care costs associated with the protocols will be part of the DCC grant award. The DCC will distribute funds on a per-patient basis to the CCCs and other sites (Affiliate Centers) according to the approved protocol budgets.

Awards for the DCC and a CCC will not be made to the same principal investigator to ensure that data analyses are conducted independently of data acquisition. However, the same institution may apply for both awards.

2. Core Clinical Centers/Consortia (CCCs)

The CCCs will be supported by separate awards, described in RFA-HL-24-010. The CCCs are responsible for conducting HCT clinical trial protocols consistent with the mission of the BMT CTN, as described on the public website for BMT CTN. CCCs are responsible for proposing, developing, and refining protocols; identifying, recruiting, and retaining study participants such that the trial will provide information about differences by sex/gender and race and/or ethnicity; entering data promptly and accurately into the electronic data capture system; interpreting the results; contributing to manuscripts and disseminating research findings; and contributing to BMT CTN’s governance through committee participation. The CCCs are expected to participate in a cooperative and interactive manner with staff from the NHLBI and the NCI, the DCC, as well as other collaborators. In addition, the CCCs are expected to enroll participants to multiple BMT CTN trials simultaneously and to contribute high-quality biospecimens to a biorepository from participants with non-malignant blood diseases. These biospecimens will be stored at a central biorepository at the DCC or at a subcontractor to the DCC. Ultimately, this collection will be transferred to the NHLBI biorepository and made available to the wider scientific community for cellular and molecular analyses of disease pathogenesis and recovery, disease stratification and mechanistic studies.

3. NHLBI & NCI

NHLBI and NCI staff are responsible for the strategic direction and support for the BMT CTN. NHLBI staff and Office of Grants Management staff are responsible for the overall management of the grants for the BMT CTN. In addition to regular grant stewardship, NHLBI and NCI staff will be involved with the recipients as partners, consistent with the Cooperative Agreement mechanism.

4. Steering Committee (SC)

The SC will provide overall scientific governance for the BMT CTN and consist of the PD/PI(s) from each CCC, PD/PI(s) of the DCC, and NHLBI and NCI staff. A subcommittee from the SC nominates the Chair, but NHLBI and NCI reserve the right to approve the nomination and may otherwise appoint a Chair for the SC. The Chair rotates every two years. The SC formulates and implements all policy decisions related to the work of the BMT CTN and establishes its scientific agenda. The SC meets in-person up to three times annually and by videoconference on a monthly basis to monitor the progress of the BMT CTN and consider special issues, as needed. Affiliate Centers that meet the metrics established by the Steering Committee are invited to serve as voting SC members.

The NIH's decision to fund a particular CCC will not commit the BMT CTN to develop a proposed concept into a full protocol. The SC will prioritize and select the protocol(s) to be conducted during the funding period from among those submitted in response to this NOFO. The SC will appoint Protocol Teams, set timelines for protocol development and trial implementation, and ratify changes to the overall BMT CTN Manual of Procedures including updates to include procedures and guidelines for collaborative trials. The Steering Committee has final responsibility for approving the protocols before review by the PRC or DSMB.

5. Executive Committee (EC)

The EC and the DCC provide the day-to-day scientific management of the BMT CTN. The EC is a subset of the SC and will be comprised of the SC Chair, the immediate past Chair, the rising Chair, PD/PI(s) of the DCC, and the NHLBI and NCI Program Directors and Project Scientists. The EC sets the agenda for the SC meetings and makes the necessary day-to-day decisions between SC meetings.

6. External Advisory Committee (EAC)

NHLBI will appoint an independent EAC to review the BMT CTN portfolio and to make recommendations to the Institute regarding the progress and scope of the BMT CTN program. The EAC will convene at least once during the 7-year project period and upon NHLBI request. The BMT CTN will have an opportunity to provide input on the expertise and responsibilities of the potential EAC members, and the DCC will support the activities of the EAC.

7. Protocol Review Committee (PRC)

An independent NHLBI-appointed PRC, comprised of experts in HCT, hematology, cell therapy, statistics, and ethics, is charged with the scientific review of BMT CTN protocols. The PRC may require protocol modification, or may recommend or not recommend to NHLBI that the protocol be implemented.

8. Data and Safety Monitoring Board (DSMB)

An NHLBI-appointed DSMB(s) will review and recommend BMT CTN protocols for implementation and monitor patient safety and the study performance for the implemented trials. As a part of their monitoring responsibility, the DSMB(s) will submit recommendations to the NHLBI regarding the conduct and continuation of each clinical study.

9. Single Institutional Review Board of Record (sIRB)

The BMT CTN will utilize a single Institutional Review Board of Record (sIRB), per NIH policy for multi-site research (NOT-OD-16-094). The DCC will select and administer an sIRB to streamline IRB approvals, provide ethical review, and maintain patient safety. The sIRB will reduce the inefficiencies and burden of each clinical site conducting a duplicative IRB review. All CCCs must provide institutional letters and agree to utilize the sIRB engaged and implemented on the BMT CTN's behalf by the DCC.

10. Administrative & Technical Committees

The BMT CTN's scientific and administrative work is assisted by staff drawn from the CCCs, the DCC, the NHLBI, the NCI, Affiliate Centers, and additional experts as needed. Committees may include protocol development, publications, finance, patient advocacy, biospecimen and core lab, clinical research associate, pharmacy, ancillary studies, implementation, and training. Other committees will be constituted as needed. The PI/PDs of each CCC will nominate members to serve on various committees; selected investigators are expected to participate actively in committee activities.

11. Identification and Selection of new BMT CTN Trials

Once convened in the new funding cycle, the BMT CTN Executive and Steering Committees will review and prioritize the concepts proposed for new studies. Four to six new trials will be funded by the NHLBI and the NCI, depending on the nature and extent of the investigations proposed, as well as a protocol for a biospecimen collection for patients with non-malignant blood diseases. Clinical protocols need to be reviewed by the NHLBI PRC and DSMB, approved by the Director of NHLBI (or his/her designee), and approved by the sIRB prior to initiation of trials. It is expected that clinical trial protocols will be launched and completed within the timeframe of the program. The program funded by this NOFO is of seven-year duration.

The DCC will have a major role in identifying feasibility for studies proposed as concepts by the CCCs and other investigators. Concepts for clinical trials that address a significant gap in the clinical practice of HCT will be considered in an ongoing manner, with the DCC managing resources for the protocols selected for implementation by the Steering Committee and approved by NHLBI and NCI.

For studies conducted in collaboration with and led by the NCTN, NCI processes will be used for the scientific review of the protocol and conduct of the trial. Collaborations with other clinical trial groups, networks, R01-funded investigators, or pharmaceutical companies, will be considered on a case-by-case basis. For these trials, the DCC will negotiate support and per-patient reimbursement, and most will be reviewed and monitored per NHLBI processes.

12. Participation in BMT CTN Trials

Protocol budgets and the per-patient reimbursement will be set by the DCC at the time the trial is launched. Each CCC must be willing to pursue this funding arrangement with the DCC. NHLBI and NCI expect that each CCC will participate in multiple BMT CTN-led protocols each year, and that each CCC will participate in most protocols selected during the project period by the SC.

In addition, several BMT CTN clinical trials from the existing BMT CTN may still be enrolling participants when awards are made for this NOFO. Recipients of the new BMT CTN program will be encouraged to enroll study participants on these ongoing trials. Recruitment status and details on each trial can be found on the BMT CTN website.

Plan for Enhancing Diverse Perspectives (PEDP)

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as an attachment in the SF424 (R&R) Other Project Information section (see Section IV.2). Applications lacking the PEDP will not proceed to peer review. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Notice of NIH's Interest in Diversity

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in NIH programs to enhance diversity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm).

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.

C. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:

1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);
2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care);
3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);
4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);
5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);
6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).
7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (qualifying zipcodes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/; https://nces.ed.gov/programs/coe/indicator_tva.asp; https://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/ ).

See NOT-OD-20-031 and NOT-OD-22-019 for details.

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

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Early Stage Investigator (ESI) applicants can be the PI/PD of an application, providing they can show support of investigators with appropriate clinical trials experience (as part of a multiple PI team). ESIs are encouraged to be part of the?study?team?and?they should be?budgeted for?support?at a level appropriate for the role on the project.?

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Page Limitations

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

Descriptive Title of the Applicant’s Project: Applicants must use the naming convention Blood and Marrow Transplant Clinical Trials Network DCC - [insert name of Site] replacing the words in italics with the name of the applicant site.

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: Describe the facilities and resources available for the coordination of the BMT CTN, including project management tools that will be used. Describe how the infrastructure at the DCC and performance sites will facilitate the efficient operation of up to 6 multi-site clinical trials simultaneously (assume that some trials will be up to 60 sites, while other trials may be limited to fewer sites). If applicable, discuss any community participatory agreements, patient advocacy groups and/or stakeholder agreements to support the BMT CTN.

Other Attachments: Attachments marked as Required must be provided or the application will not be peer reviewed. The Attachments will be assessed during the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions. Upload each attachment as a separate pdf file with the names specified below.

1. DCC Management Plan Required

A management plan describing staffing and roles and responsibilities must be provided as an attachment and cannot exceed 10 pages. This attachment must be named "DCC Management Plan.pdf" and be reflected in the final image bookmarking for easy access for reviewers.

Describe the strategy to ensure that management activities of the BMT CTN trials are performed, including directly supporting the needs of scientific study leadership to identify barriers, making timely responses, and optimizing the allocation of limited resources to meet pre-defined study objectives. This strategy must describe:

• The DCC governance, the project management teams and functional groups, and levels of effort.
• Assigned DCC responsibilities, using a Responsibility Assignment Matrix.
• Communication plans for the DCC and for BMT CTN.
• Plans for risk assessment and risk management that address contingencies in the event that there is inadequate progress toward achieving trial milestones. The approach must identify a range of contingencies that could threaten study progress or feasibility, and propose solutions using study resources.
• Key methodology and standard operating procedures governing study deployment, operations/execution, and study closure.
• Approaches to resolving fiscal and logistical issues in a timely manner, including plans to proactively evaluate and prioritize study risks and issue corrective responses.
• Processes required for orderly study closure, including how each trial will comply with the NIH Data Management and Sharing Policy, and biorepository plans if specimens will be stored after planned study testing and analyses are complete.
• Plans for supervision, training, certification, data handling, quality assurance, and budget management.
• Any applicant who designates multiple PD/PIs (on the G.240 - R&R Senior/Key Person Profile (Expanded) Form) must include a Multiple PD/PI Leadership Plan. For applications designating multiple PD/PIs, all such individuals must be assigned the PD/PI role on the G.240 - R&R Senior/Key Profile (Expanded) Form, even those at organizations other than the applicant organization.
• Whether the application is single-PD/PI or multi-PD/PI, provide a Leadership Succession Strategy that describes the procedure for selecting a proposed replacement for the PD/PI, should the need arise. The NHLBI must approve any request to replace the PD/PI.

2. Clinical Research Capabilities Required

An attachment that illustrates the capabilities of the DCC for multi-site trials must be provided and cannot exceed 10 pages. Provide a detailed table of all multi-site HCT clinical trials coordinated by the applicant that demonstrates the applicant's experience in trial coordination and management. This must be provided as an attachment named "Clinical Research Capabilities.pdf", and be reflected in the final image bookmarking for easy access for reviewers. For this attachment, provide an introduction that highlights the significance of the DCC contributions (for example, innovative trial design, monitoring approaches, or analysis, as appropriate) to key studies listed in the requested Table, below.

For this Table, include trials that utilized at least 5 recruitment sites, and that were developed, launched, conducted, analyzed, or published during the 5-year period spanning 2018-2022.

The table must include the following information:

A: Title of study/trial; clinical trial.gov number
B: Applicant’s role in the study (DCC PI, DCC member, site PI, etc)
C: Brief description of study design
D: IND or IDE (yes or no); if yes, was the trial for registration (yes or no)
E: Mean Planned Quarterly Enrollment at Steady-state
F: Mean Actual Quarterly Enrollment at Steady-state
G: Number of Enrolling Sites
H: Days from sIRB approval to first patient enrolled
I: Trial completed on schedule or not (yes or no) - if not, number of months delayed
J: Publication reference(s)
K: Impact (or potential future impact) to the field

3. Project Management Plan Required

A Project Management Plan must be provided as an attachment and cannot exceed 6 pages. This attachment must be titled "Project Management Plan.pdf" and be reflected in the final image bookmarking for easy access for reviewers. The Project Management Plan must describe the evidence-based strategy that will be used throughout the project by the DCC to ensure that the unique goals of the BMT CTN are met within the constraints of time and funding permitted under this NOFO.

Project management planning must directly support the goals of the NOFO, identify barriers, make timely responses, and optimize the allocation of limited resources. Describe the key processes to evaluate scientific and fiscal performance. Include a description of the standards and processes governing resource management, study deployment, operations/execution, and study closure that will be used. Describe plans for how the DCC, in collaboration with the SC, the NHLBI and the NCI, will proactively evaluate and prioritize issues that jeopardize study goals and development of corrective responses to resolve fiscal and logistical issues (risk planning) in a timely manner. Clearly describe the processes that will be required for orderly project closure.

4. Plan for Enhancing Diverse Perspectives (PEPD) Required

A summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity must be provided as an attachment using the file name PEDP.pdf . The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP may be cannot exceed 3 pages. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Plans to establish an interdisciplinary team necessary to support the activities of the DCC for the BMT CTN.
• Plan to support career-enhancing research opportunities for early- and mid-career researchers and women and individuals from groups traditionally under-represented in the biomedical research workforce through the BMT CTN activities.
• Participation of investigators from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans for partnerships with Affiliate Centers to enhance geographic and regional diversity to enhance investigator and patient access to trials.
• Plans for monitoring activities to measure PEDP progress benchmarks.
• Plans for outreach or engagement activities to enhance recruitment of individuals as research participants from underserved racial and ethnic groups.

5. Plan to Support the Next Generation Required

A plan to support early- and mid-career investigators in the BMT CTN must be provided as an attachment named Next Generation.pdf and cannot exceed 1 page. Describe the proposed BMT CTN-wide strategy to engage early- and mid-career investigators in BMT CTN activities. Provide a plan outlining eligibility, activities and projects that would leverage BMT CTN resources and expertise to help train the next generation to be leaders in HCT and cell therapy trials that address issues for non-malignant and malignant blood diseases. This attachment must be reflected in the final image bookmarking for easy access for reviewers.

SF424(R&R) Senior/Key Person Profile

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

The PD(s)/PI(s) must be experienced in the conduct of multi-site HCT trials for either adult or pediatric patients. In addition, the application should propose at least one team member with expertise in either clinical non-malignant hematology or cell therapy, and engage another expert, when appropriate; other team members are individuals required to facilitate the implementation of all aspects of BMT CTN trials.

All Key Personnel should demonstrate strong administrative, technical, and management expertise in the areas that are critical to the success of the application, including experience with working productively in collaborative environments; and experience with administrative management of resource-based operations important for HCT. Key Personnel who are major contributors to the DCC must provide an NIH Biosketch whether or not they are budgeted.

Applications with Multiple PDs/PIs:

When multiple PD/PIs are proposed, one PD/PI must be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system. Follow all instructions in the SF424 (R&R) Application Guide.

Multiple PD/PI Leadership Plan: For applications designating multiple PD/PIs, all such individuals must be assigned the PD/PI role on the G.240 - R&R Senior/Key Profile (Expanded) Form, even those at organizations other than the applicant organization.

For applications designating multiple PDs/PIs, provide a Multiple PD/PI Leadership Plan in Attachment 1: DCC Management Plan. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Whether the application is single-PD/PI or multi-PD/PI, a Leadership Succession Strategy should be provided in the application in Other Attachment 1: DCC Management Plan. The Leadership Succession Strategy should describe the procedure for selecting a proposed replacement for the PD/PI, should the need arise. The NHLBI must approve any request to replace the PD/PI.

R&R Budget

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

Application Direct Costs must plan for the following:

Staff, infrastructure, and costs necessary to support all activities of the BMT CTN.

Also include the cost related to:

• Activities of two DSMBs. This includes up to four virtual all-day meetings annually, and up to 8 monthly virtual meetings per DSMB. The DCC should assess the need for liability insurance for DSMB members and provide a plan commensurate with the risk of the trial. The budget should include provision for executing the plan proposed. The DCC should also include a plan for assessing DSMB member conflicts of interest.
• Three in-person SC meetings annually, and other meetings as needed.
• Activities of an sIRB. Assume initial and annual reviews for up to six BMT CTN-led trials plus the observational study to create a biospecimen collection from non-malignant blood diseases.
• Activities of an NHLBI-appointed External Advisory Committee. Assume an honorarium and travel for 5 members to attend 2 all-day meetings in the Washington, D.C. area in the 7-year period.
• Support for publication, data sharing, and dissemination of results.
• Support for all teleconferences/webcasts for the SC, protocol teams, and all technical and other committees supporting the BMT CTN.
• Implementation of the Data Management and Sharing Plan.
• BMT CTN s Next Generation Program, at $75,000 each fiscal year.
• Protocol development and patient-related costs (e.g., clinical costs that are not part of routine clinical care such as laboratory tests, sample and data collection, supplies, drugs) and related activities to support up to 6 BMT CTN-led clinical trials. Also include protocol development, specimen-collection and storage for a study to build a collection of specimens from patients with non-malignant blood diseases who receive HCT or cell therapy or genetically modified autologous cells, and costs to link these with clinical information from these patients. Allocate an estimated $28,404,000 for these studies to be distributed across the 7-year period.
• For PEDP implementation, applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

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:

Research Strategy: The Research Strategy must discuss the overall approach to coordinate and administer all aspects of multi-site HCT trials conducted by the BMT CTN.

The following criteria must be addressed in the research strategy:

Significance: Describe the significance of a network for clinical trials aimed at treating blood diseases (non-malignant and malignant); trials aimed at addressing HCT-related issues (i.e., donor source, regimen-related toxicity and complications, quality of life); and trials incorporating novel adoptive cell/gene therapies. Discuss how the DCC team of HCT and medical experts, biostatisticians, operations, administrative and regulatory experts will contribute to the completion of current BMT CTN trials and the development, implementation, and completion of new trials expected to include rare patient populations and use adoptive cell therapy or genetically-modified cells, or biomarker-driven HCT approaches.

Innovation: Applicants must describe:

• Plans to employ unique or novel methodologies to enhance the clinical trial design, management, or methods for monitoring or data analysis.
• Innovation of planned approaches to project coordination and logistical support.
• Plans to utilize the best practices to improve and implement BMT CTN clinical trials.
• Plans to integrate activities of the CCCs and Affiliate transplant centers, and to leverage existing resources and minimize the duplication of effort.
• The approach to advance trials in non-malignant blood diseases, hematologic malignancies, and to identify new opportunities for HCT trials that incorporate adoptive cell therapy or genetically-modified cells.
• Any novel methodologies or approaches to overcome potential challenges of developing and implementing multiple studies simultaneously.
• Approaches to identifying and nurturing areas of mutual interest with other funded clinical trial groups, pharmaceutical companies, or other clinical researchers.

Approach: Applicants must describe the DCC's plans for:

• Rigorous trial design, study coordination, data management (including data security procedures), data monitoring and reporting, as well as statistical support, noting any novel aspects. Discuss how these approaches will contribute to the overall success of the BMT CTN.
• Coordination and management of the project, overall timeline for the program, communication strategies, study design, milestone plan development and monitoring for each trial, trial implementation and accrual, data collection and case report forms, management and quality control, use of specimens from trials for ancillary studies, and dissemination of results.
• Provision of medical expertise to monitor adverse events from patients with diverse blood diseases, both non-malignant and malignant.
• Dissemination and implementation of trial results to help inform and change clinical practice.

Specifically address:

• Project Coordination: Describe plans for selecting the best concepts; developing and vetting protocols; selecting sites; and launching, conducting and completing up to six new clinical trials led by BMT CTN within the 7-year project period, as well as several trials led by non-BMT CTN investigators. Anticipating the potential of BMT CTN to leverage other funding sources, provide an anticipated capacity to support clinical trials within the BMT CTN 7-year time frame, including how many multi-site clinical trials could be conducted simultaneously. Include plans for providing administrative and operational support. Describe staffing support during the development, execution, and completion of studies. Describe an approach to supporting timely data entry into government websites such as clinical trials.gov and eConnects (NHLBI's clinical trial data management system, which contains enrollment data and other key trial information). Describe how the DCC will interact and collaborate with the CCCs and Affiliate Centers, including evaluating the transmission of data in an accurate and timely fashion, and monitoring of activities. Describe how the DCC plans to facilitate implementation of trials conducted in collaboration with other clinical trial groups including the NCTN, NIH grant-funded investigators, and pharmaceutical companies.
• Study Design: Given the 7-year project period, resource limitations, and the large number of concepts associated with the CCC awards, propose an approach for guiding the BMT CTN in prioritizing, developing and implementing BMT CTN-led studies, and for partnering with the NCTN on NCTN-led trials. Describe the approach for simultaneously developing, launching and monitoring up to 6 BMT CTN protocols, including protocol maintenance and twice annual reporting of study data to the DSMBs, as well as completing trials on time and on budget. Discuss approaches to overcome the unique challenges of enrolling children, older adults, minorities, and participants with very rare blood indications on BMT CTN trials.
• Data Management, Data Systems and Quality Control: Describe the approach to data management, including data management systems, data entry, case report forms, methods for monitoring the safety, quality and consistency of the intervention(s); policies and methods for ensuring blinding of study results; data confidentiality and subject privacy. Describe the system for quality control for data entry, queries and audits. Discuss the approach to site monitoring and quality assurance activities, including site visits as needed, and remote monitoring consistent with FDA guidance. Describe plans for data cleaning and preparation of datasets to ensure that analyses of the data can be completed in a timely manner.
• Acquisitions and Storage of Biospecimens: Describe plans to collect, process, label, track, store, retrieve, and distribute high-quality biospecimens. Describe plans to ensure that biospecimen information can be reliably linked to the corresponding participant's clinical and other data. Describe the approach to build a biospecimen collection from patients with non-malignant blood diseases and linkage to clinical data; this collection will be transferred to NHLBI’s biospecimen repository at the end of the project.
• Accrual Plans: Describe the process for projecting study timelines and accrual targets, and approaches to increase accrual of minorities. For trials that are accruing slower than expected, describe the approach to identify the barriers and potential solutions.
• Statistical Analysis Plan: Describe the approach and key considerations for statistical analysis of BMT CTN trials. Discuss the evaluation by race/ethnicity and gender, and the plans for separate and adequately powered analyses. Discuss the potential use of adaptive designs.
• Medical and Regulatory Support: Discuss the approach for monitoring patient safety. Discuss the approach to support investigational new drug applications (INDs) and investigational device exemption (IDE) applications and to either serve as the Authorized Representative for BMT CTN-led trials or, upon request, to hold INDs or IDEs for specific trials. Describe the approach for training investigators for BMT CTN protocols and Good Clinical Practice as needed.
• Reports, datasets and study documentation: Describe the approach for preparing reports of data and safety for the DSMB, FDA, and Office of Human Subjects Protection. Discuss the approach to notify stakeholders of patient safety concerns or trial continuation; preparation of data reports for BMT CTN subcommittees, and public-use data files. Describe a plan to evaluate the performance of centers annually, as well as the overall performance of the BMT CTN. Describe the approach to provide an online tool to track the progress of all BMT CTN publications and key metrics for the DCC and writing teams. Describe other reports needed for announcing and tracking BMT CTN scientific contributions.
• sIRB: Indicate how the proposed DCC will engage and manage the sIRB across all sites in the CCC. The sIRB will carry out the functions required for institutional compliance with IRB review set forth in the HHS regulations at 45 CFR 46, and allow research to proceed as expeditiously as possible without sacrificing ethical principles and protections for participants enrolled in BMT CTN studies. Provide a plan to establish and implement a sIRB for BMT CTN-led trials and provide reliance agreements for all US sites participating on BMT CTN trials, as needed. Describe the respective authorities, roles, responsibilities and communication between the sIRB and the sites participating in the BMT CTN.
• DSMB Support: Discuss the plan for assessing and managing DSMB member conflicts of interest relative to BMT CTN trials. Describe a plan to provide liability coverage to DSMB members who request this insurance for their monitoring role of BMT CTN-led trials. Options for providing coverage may include reimbursing individual DSMB members who obtain their own liability insurance, extending the DCC’s liability coverage to DSMB members, or purchasing a liability policy for the DSMB.
• Budgets: Describe the approach to preparing protocol budgets based on per-patient costs, monitoring the ongoing expenditure of protocol funds, and preparing financial reports as requested. Discuss the approach used to negotiate and manage contractual arrangements with transplant centers, laboratories and third-party contributors, and the approach to distribute funds to support BMT CTN trials. Describe the approach to issue Requests for Proposals for study medications, core labs, or the manufacturing of novel cell therapies when required by a study, as well as the approach for selection and execution of subcontracts.
• Core BMT CTN operations: Describe the approach to manage meetings and calls for the SC, EC, DSMBs, Protocol Teams, and other committees essential to the conduct of the BMT CTN; provide the logistical support necessary to run an efficient and productive BMT CTN; maintain and update the BMT CTN website to include information about studies and summaries of study results; include a summary for patients and laypersons.
• Coordination of logistics and other support services: Describe the approach to maintain the infrastructure necessary to support all BMT CTN activities, including conference calling and webinar capabilities, electronic billing and payment capabilities, and maintenance of the public and administrative BMT CTN websites and electronic data capture systems; execute master agreements and protocol rider agreements with all CCCs and NCTN partners, as well as Affiliate Centers which are often needed to meet recruitment sample sizes; handle travel arrangements for EAP and other consultants as needed.
• Collaborations: Describe processes to facilitate collaborations with the NCTN; or to advance HCT trials for non-malignant blood diseases including the use of genetically-modified cells.
• Data Systems To be Used and Data Transfer: Describe data integration with Center for International Blood and Marrow Transplant Research (CIBMTR) data systems and other relevant data systems, such as NHLBI's clinical trial data management system, eConnects, that collects enrollment data and other key trial information on a quarterly basis.

Letters of Support: Letters of institutional and departmental support for participation in the BMT CTN are required.

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.

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

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

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

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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.

• Awards issued under this NOFO will be incrementally funded for up to 7 years. These will not be Multi-Year Funded.
• Awards issued under this NOFO will be excluded from automatic carryover. All carryover actions will require NHLBI prior approval.
• Awards issued under this NOFO will not be provided the authority to automatically extend the final budget period. All extensions, including the first, will require NHLBI prior approval.
• Awards issued under this NOFO will be excluded from SNAP.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

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. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NHLBI Office of Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or 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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75, 2 CFR Part 200 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 recipient is anticipated during the performance of the activities. Under the cooperative agreement, the purpose of the NIH 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 recipient for the project as a whole, although specific tasks and activities may be shared among the recipient and the NIH as defined below.

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

The DCC PDs/PIs play an important role in all aspects of BMT CTN studies, including participating in protocol development, preparing protocol budgets in collaboration with the CCCs, modifying proposals if indicated, monitoring recruitment of study participants, assuring the quality of study participant protocol adherence, assuring the accurate and timely transmission of data, analyzing and interpreting data, preparing publications, and working with the CCCs and the NHLBI and NCI to disseminate research findings in a timely manner. The DCC will also be responsible for working with the CCCs to develop common definitions and standardization across protocols wherever appropriate. Recipients must agree to the governance of the study through a Steering Committee. Investigators will be required to project patient enrollment for a specific protocol during a specified time frame; continuation and level of funding will be based on actual recruitment.

The BMT CTN program includes the CCCs, a DCC, and staff from the NHLBI and the NCI. All CCCs will be required to participate in a cooperative and interactive manner with one another and with the DCC. All awardees also agree to work collaboratively with the current CCCs and the DCC to complete ongoing protocols. Recipients agree to the governance of the BMT CTN through a Steering Committee and agree to work with the DCC, NHLBI, and NCI Staff to achieve the BMT CTN’s objectives.

The DCC is responsible for overall administration and coordination of the BMT CTN. An important part of the cooperative nature of the DCC's processes includes evaluating the feasibility of trials and identifying new priority areas of research. Other areas or responsibility include collaboratively developing and implementing BMT CTN clinical trials; accurately projecting patient enrollment for each protocol during a specified time-frame; collecting protocol-specific data; leading data cleaning, data analysis and interpretation; preparing reports and disseminating results through publications and presentations in a timely manner; establishing and maintaining a Manual of Operations and ensuring compliance of all BMT CTN components with this document and all applicable federally mandated regulatory requirements; timely reporting of all serious and/or unexpected adverse events and all relevant medical information; receiving, processing, and storage or shipping biospecimens per protocol specifications; providing biospecimen-associated clinical data per protocol specifications; serving as a resource for conduct of protocol-specified laboratory assays and ancillary studies, mechanistic, and biomarker studies; other scientific contributions such as developing presentations and publications following the BMT CTN publication procedures; and developing and implementing a program to support the next generation of clinical trial investigators.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, within three years of the end of the period of NHLBI support, provided such release is consistent with the study protocol and governance and according to NHLBI Policy (http://www.nhlbi.nih.gov/research/funding/human-subjects/data-sharing and https://sharing.nih.gov/data-management-and-sharing-policy).

Support or other involvement of industry or any other third party in the study may be advantageous and appropriate. Participation by the third party by involvement of study resources, citing the name of the study or NHLBI support, or special access to study results, data, findings or resources requires notification and concurrence by NHLBI. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NHLBI.

Study PDs/PIs are encouraged to publish and disseminate results and other products of the study in accordance with study protocols and governance. For applicable studies, data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, within three years of the end of the period of NHLBI support, provided such release is consistent with the study protocol and governance.

Study PDs/PIs are required to provide updates at least annually on the implementation of the PEDP.

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

NIH Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards and will monitor patient recruitment and study progress, ensure disclosure of conflicts of interest, and ensure adherence to NHLBI policies. NHLBI will appoint an independent Protocol Review Committee and independent Data and Safety Monitoring Boards (DSMBs).

NHLBI will appoint an NHLBI Program Official who will be responsible for the normal program stewardship of the cooperative agreement, and will be identified in the Notice of Award. However, NHLBI may elect to have a dual-role approach where a single individual may act as the NHLBI Project Scientist and Project Officer. Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the Project Scientist. The responsibility for final decision-making may reside with Senior Institute management, separate organizational components and/or oversight committees. Because it is anticipated that the Project Scientist/Program Official will participate in activities that rise to a level of involvement that results in conflicts of interest, for example, co-publication, other staff members such as direct line supervisors and/or other Senior NHLBI Program management staff will serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award.

The NHLBI reserves the right to phase-out or curtail trials (or an individual award) in the event of (a) failure to develop or implement mutually agreeable collaborative protocols; (b) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (c) major breach of the protocols or substantive changes in the agreed-upon protocols with which NHLBI cannot concur; (d) attaining of a major study endpoint before schedule with persuasive statistical significance; or (e) human subject ethical issues that may dictate a premature termination.

Areas of Joint Responsibility include:

BMT CTN Steering Committee:

Recipient(s) agree to the governance of the study through a Steering Committee. The Steering Committee will have primary responsibility for identification of priority areas for research, the conduct of protocols, data analysis and the preparation of publications and dissemination of products. The Steering Committee will be responsible for ensuring that there are well-documented policies, procedures, and bylaws to guide all aspects of BMT CTN activities and operations.

Steering Committee voting membership shall consist of all Principal Investigators (i.e., cooperative agreement recipient), one NHLBI Project Scientist, and one NCI Project Scientist. Each Award is limited to one vote. The NIH members of the committee will share one vote in support of the project, with the administering/lead IC having the final say. Recipient members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. The Steering Committee chair will be appointed by the Steering Committee members. The Steering Committee Chair will be responsible for ensuring that there are well-documented policies, procedures, and bylaws to guide all aspects of BMT CTN activities and operations. All major scientific decisions will be determined by majority vote of the Steering Committee. The Steering Committee has final responsibility for approving the protocol before review by the DSMB. Technical Committees (i.e., Pharmacy, Publication) and subcommittees of the Steering Committee will be established as necessary. A protocol is the detailed-written plan of a clinical experiment. The following approvals are needed prior to activating a clinical trial: PRC, DSMB, NHLBI (with NCI consultation), FDA of IND or IDE (as appropriate), and sIRB. All study protocols must adhere to current NIH policies for human subjects research. The PD/PIs will establish mutually agreed upon milestones with the steering committee for the development of each clinical research protocol and trial implementation; milestones may include such things as time to DSMB approval, time to a signed institutional contract for per-patient reimbursement, first patient enrolled, etc. Trial performance should be consistent with the NIH and NHLBI policies, including the Milestone Accrual Policy.

In-person meetings of the Steering Committee will ordinarily be held in the metropolitan Washington, D.C. area up to three times a year, and by telephone conference call monthly. Steering Committee members must make every effort to attend Steering Committee meetings and participate in conference calls. Should the PD/PI find it impossible to attend a Steering Committee meeting or conference call, he/she is required to notify the NHLBI Program Officer and/or Steering Committee Chair of the expected absence and ensure attendance by their designated alternate.

The Steering Committee and the DCC will be responsible for ensuring that there are well-documented policies, procedures, and bylaws to guide all aspects of BMT CTN activities and operations.

The NHLBI and NCI Project Scientists will serve on the Steering Committee and other study committees, when appropriate. The Project Scientists may work with recipient on issues coming before the Steering Committee such as recruitment, protocol development, follow-up, quality control, adherence to protocol, possible changes to the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment.

NHLBI-appointed DSMB:

The NHLBI Director appoints an independent DSMB(s) to the NHLBI that provides overall monitoring of interim data and safety issues. Meetings of the DSMB are ordinarily held in the metropolitan Washington, D.C. area. An Executive Secretary to the Board, other than the NHLBI Program Official, will be appointed by NHLBI to support the DSMB. Because the DSMB serves as an independent advisory group, study investigators should not communicate with the DSMB members regarding study issues, except as authorized by the DSMB’s Executive Secretary. The DSMB will consist of a chairperson and scientists with expertise in hematopoietic stem cell transplantation, bioethics, clinical research, clinical trial design, biostatistics, and other areas of expertise as needed. The DSMB will provide a written critique of each protocol and a final recommendation to the NHLBI. All study protocols must be reviewed and recommended by the DSMB and approved by the NHLBI before IRB submissions occur. The DSMB is also responsible for monitoring clinical trials while they are being conducted with particular attention to safety issues.

Single Institutional Review Board of Record (sIRB):

The BMT CTN will utilize a single Institutional Review Board of Record (sIRB) for BMT CTN-led trials, per NIH policy for multi-site research (NOT-OD-16-094). A sIRB is expected to eliminate duplicative IRB review, reduce unnecessary administrative burdens and systemic inefficiencies, and shift workload away from conducting redundant reviews to allow institutional IRBs to concentrate more time and attention on the review of single site protocols. The DCC will engage and implement this board on the BMT CTN's behalf. The sIRB will carry out the functions required for institutional compliance with IRB review set forth in the HHS regulations at 45 CFR 46 and allow research to proceed as expeditiously as possible without sacrificing ethical principles and protections for participants enrolled in BMT CTN studies. Reliance agreements will delineate the respective authorities, roles, responsibilities, and communication between the sIRB and the U.S. sites participating in BMT CTN-led trials. All BMT CTN Core Clinical Centers/Consortia members must agree to participate in the registered sIRB engaged and implemented on the BMT CTN's behalf by the DCC.

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 comprised of a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter therecipient's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Data Management and Sharing

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

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Nancy L. DiFronzo, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0065
Email: nancy.difronzo@nih.gov

Lori A. Henderson, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5930
Email: hendersonlori@mail.nih.gov

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Tanya Smith
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-7072
Email: tanya.smith@nih.gov

Shane Woodward
National Cancer Institute (NCI)
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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.