Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Advancing Translational Sciences (NCATS)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Data Management and Coordinating Center (DMCC) for Rare Diseases Clinical Research Network (RDCRN) (U2C Clinical Trial  Not Allowed)

Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type

Reissue of RFA-TR-13-003

Related Notices
  • June 19, 2018 - Notice of Pre-Submission Webinars for RFA-TR-18-020: Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional) and RFA-TR-18-021: Data Management and Coordinating Center (DMCC). See Notice NOT-TR-18-029.
Funding Opportunity Announcement (FOA) Number

RFA-TR-18-021

Companion Funding Opportunity

RFA-TR-18-020  U54 Specialized Center- Cooperative Agreements

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

93.350; 93.853  

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites new applications for the Data Management and Coordinating Center (DMCC) for the Rare Diseases Clinical Research Network (RDCRN).  Each consortium within the RDCRN is intended to advance the diagnosis, management, and treatment of rare diseases.  The DMCC will facilitate and support the activities of each Rare Diseases Clinical Research Consortium (RDCRC) along with trans-network activities that broadly facilitate the advancement of rare disease research via four Cores: 1) Administrative; 2) Data Management; 3) Clinical Research and; 4) Engagement and Dissemination.

Key Dates

 

Posted Date

June 8, 2018

Open Date (Earliest Submission Date)

September 9, 2018

Letter of Intent Due Date(s)

September 9, 2018

Application Due Date(s)

October 9, 2018), by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February 2019

Advisory Council Review

May 2019

Earliest Start Date

July 2019

Expiration Date

October 10, 2018

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH's new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD(S)/PI(S) data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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


Table of Contents

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

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

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

Purpose

The Office of Rare Diseases Research (ORDR) within the National Center of Advancing Translational Science (NCATS) along with ICOs listed in Part 1 at the National Institutes of Health (NIH) invites applications in response to this Funding Opportunity Announcement (FOA) for new applications for the Data Management and Coordinating Center (DMCC) for the Rare Diseases Clinical Research Network (RDCRN).  Each consortium within the RDCRN is intended to advance the diagnosis, management, and treatment of rare diseases.  The DMCC will facilitate and support the activities of RDCRCs along with trans-network activities that enable the advancement of rare disease research via four Cores: 1) Administrative; 2) Data Management; 3) Clinical Research; and 4) Engagement and Dissemination.

Background

Despite the advances in our understanding of the causes and mechanisms of many diseases, effective treatments are available for fewer than 5% of rare diseases.  Advances in technologies such as gene therapy have recently led to promising and potentially transformative treatments.  However, there are several challenges in bringing effective treatments to more people living with rare diseases.  First, making a diagnosis can be challenging with many patients experiencing a "diagnostic odyssey" of many months or even years because of limited knowledge of the range of disease manifestations and of genotype-phenotype studies.  Second, there are often no high quality natural history datasets documenting how the disease affects patients' functioning, and how it progresses over time.  Third, there are often no adequate clinical or biological markers to support the clinical development of new therapeutics.  Fourth, the relatively small number of patients and clinicians caring for them cause challenges to the design and implementation of clinical trials.  Finally, the resources available for therapeutics development are limited, making it critical to find frameworks for leveraging partnerships between patient groups, industry, academic investigators and Federal funding agencies. In addition, the global burden associated with rare disease necessitates international coordination and collaboration.

To facilitate progress in addressing these challenges the Rare Diseases Act of 2002 (Public Law 107-280) directed ORDR to support regional "Rare Diseases Clinical Research Consortia (RDCRCs) of Excellence" for clinical research into, training in, and demonstration of diagnostic, prevention, control, and treatment methods for rare diseases.  Since the enactment of this legislation numerous NIH institutes (NCATS/NCRR, OD(ODS/ORDR), NICHD, NINDS, NIAMS, NHLBI, NIDDK, NIDCR, NIMH, NCI, NIAID and NEI), led by the ORDR at NCATS, have partnered to support the RDCRC. 

Since its inception the RDCRN research program has successfully supported 31 individual consortia that conducted research on 238 individual disorders, leading to a greater understanding of rare diseases.

Each RDCRC, within the RDCRN, is intended to advance the diagnosis, management, and treatment of rare diseases.  Individual RDCRCs will promote highly collaborative, multi-site, patient-centric, translational and clinical research with the intent of addressing unmet clinical trial readiness needs.  Each RDCRC must target at least three rare diseases/disorders/syndromes/conditions/manifestations (referred to in this document as rare diseases). The RDCRCs will provide an outstanding environment for the training of the next generation of rare diseases researchers. Patient and stakeholder (in this document stakeholder refers to parents, caregivers, support and advocacy groups), experiences, perspectives, needs and priorities should be meaningfully incorporated into decisions and activities of the RDCRC.  Participants of the RDCRN will also be expected to contribute collectively to a knowledge base that broadly facilitates the advancement of rare disease research.  The DMCC will facilitate and support both the activities of RDCRCs along with trans-network activities via four Cores: 1) Administrative; 2) Data Management; 3) Clinical Research: and 4) Engagement and Dissemination.

Prospective applicants are urged to consult with the Scientific/Research Contacts of the NIH early in the preparation of the application (see Section VII. Agency Contacts).

Scope

It is imperative that applicants for the DMCC carefully review the companion FOA [Rare Diseases Clinical Research Consortia (RDCRC) for Rare Diseases Clinical Research Network (U54) (RFA-TR-18-020) to understand the full mission of the RDCRN.

Overall, the DMCC's role within the RDCRN is threefold, with each function of equal importance.  The DMCC:

  • provides clinical research and data management support to the individual RDCRCs. 
  • coordinates activities across the RDCRN and helps establish an identity for the network as a rare diseases resource.
  • serves as a conduit of information related to the rare diseases research being conducted within the network to both the research community and the general public. 

The DMCC will provide services and resources to the network via the following four cores. Cores may be located at different locations as long as there is a strong plan for communication and collaboration. Investigators are encouraged to convene a diverse, multidisciplinary, skilled team that provides synergy to the RDCRN by working together with both individual RDCRCs and across the RDCRN.

Administrative Core:  The administrative core will: 1) provide overall coordination for the RDCRN and management of RDCRN activities including steering committee meetings; 2) provide oversight and ensure coordination of all DMCC Cores; 3) provide support for Coalition of Patient Advocacy Groups (CPAG) meetings, and 4) is responsible for the preparation of the annual report for the External Scientific Panel (ESP).

Data Management Core:  The Data Management Core will support and enhance a collaborative informatics community for the RDCRN.

Deidentified data collected within this Network and housed within cloud services provisioned by NCATS will become a resource for the greater rare disease research community and will be made available to the scientific community, stakeholders and other relevant partners in a timely manner that meets all NIH human subject's protection, data safety and data sharing requirement.  RDCRN participants will be required to share their data within the DMCC.

The Data Management Core, in collaboration with the Engagement and Dissemination Core, will provide:

  • A management system for collection, storage, and quality control of clinical research data, including a web-based platform that allows for real-time tracking of data quality and completeness and that facilitates remote monitoring. 
  • A portal and tools for research scientists and clinicians to access and manage their own data.
  • A portal and tools to share information both within and outside of the RDCRN in a manner that meets all NIH human subject's protection, data safety and data sharing requirements.

Data Management Services

The DMCC Data Management Core will provide Cloud Computing Services and Engineering Support provisioned by the Information Resources Technology Branch (ITRB), NCATS.

NCATS ITRB will provide access to various public cloud services, and high-performance computing services for the needs of the awardees. This enables the awardees to offer their systems, projects and research in a secure environment with simplified implementation, deployment and operational reliability. Through these services, NCATS ITRB will enable the awardees to gain a self-service capability. NCATS ITRB will provide the following:

  • Infrastructure as a Service (IaaS) on any of the major public cloud providers via NCATS' Federated Authorization Service
  • If requested, access to NCATS' Federated Authorization Software as a Service (SaaS) to any of the RDCRC awardees systems and applications, if requested, various Common Cloud Engineering and Support Services.

IaaS Services

NCATS ITRB will provide the awardee with a cloud instance on any of the following public cloud service providers: Amazon Web Services, Microsoft Azure or Google Cloud Platform. This instance would be co-managed by the awardee and NCATS ITRB. Access to the awardees cloud instance would be managed using NCATS' Federated Authorization System and the awardees would have complete rights to all services provided by the Cloud Service Provider.

Federated Authorization Services SaaS

If requested, at no cost to the awardee, NCATS ITRB would provide access to NCATS' Federated Authorization Service. The awardee could use NCATS' Authorization Service to provide for federated access to any of their systems and applications.

Cloud Engineering Support

If requested, NCATS IRTB will provide access to and administrative support for various common cloud services including configuration, patching, backups, and user account management. These services include, but are not limited to: Automated Configuration Management Services; Continuous Integration Services; Automated Deployment Services; Code Analysis Services; Log Aggregation and Analysis; Usage and Performance Monitoring Services; Aggregated Search Services; Cache management services; and Message Queue and Notification services.

Cloud based High Performance Computing

If requested, NCATS ITRB can also provide a cloud based elastic HPC service designed to automate and scale, giving the scientists the ability to model and deploy their HPC applications in a cloud that can provide the scale and performance needed.  The cloud HPC provides resources without undue access restrictions, while addressing the security concerns surrounding cloud deployments. The cloud HPC solution addresses use cases that deal with various storage, hypervisor and network services. The cloud HPC offers higher utilization and operational savings while providing a high speed, secure and federated access.

They will coordinate and support efforts, in collaboration with representatives of the RDCRC, to develop and monitor Good Data Practices (GDP) of clinical and research data and will assist in facilitating the use of Common Data Elements (CDE).  The Data Management Core will coordinate and facilitate data standards across the network.

Clinical Research Core: The Clinical Research Core will serve as a Network resource, providing expertise and consulting to the RDCRCs in areas including, but not limited to, Protocol Development and Management, Biostatistics, Study Designs and support in establishing single IRBs.  This core will also provide cutting edge information and guidance for RDCRN members on trans-RDCRN rare disease research issues such as working with industry or navigating the regulatory process.  In collaboration with the RDCRCs the Clinical Research Core will coordinate training issues that cut across topics relevant to multiple RDCRC sites for RDCRN trainees.

Engagement and Dissemination Core:  Working collaboratively with the RDCRCs and the Coalition of Patient Advocacy Groups (CPAG), the Engagement and Dissemination Core will develop a broad RDCRN outreach plan for the consortium. The outreach will extend to basic and clinical researchers, academic and practicing physicians, patients, and the general public. The core will provide an internet-based web-portal to serve as a central access point to information generated by the RDCRCs.

DMCC Governance

The PD(s)/PI(s) of the DMCC will serve as the Core Lead(s) for the Administrative Core.  The DMCC PD(s)/PI(s) should develop and maintain an environment that fosters collaboration that will provide support to the RDCRCs' patient-oriented, multi-site, multi-disciplinary research collaborations and training. The DMCC PD(s)/PI(s) cannot serve as the Program Director/Principal Investigator of a project in another active RDCRN award.

The DMCC will establish an External Advisory Committee (EAC) consisting of scientific, clinical and patient group representation that will be composed of at least five members.  The EAC serves in an advisory capacity to the DMCC by providing an annual review and critique of progress of the DMCC. The EAC should meet in-person or electronically at least once a year, beginning in the first or second year of the award. 

RDCRN Formation and Governance (Network specific)

The award funded under this FOA will be a cooperative agreement (see Section VI.2. Cooperative Agreement Terms and Conditions of Award).  Close interactions among awardees and NIH will be required to manage this complex network. 

The RDCRN will consist of all the awarded RDCRCs and the DMCC.  The RDCRN governance will rest with the Network Steering Committee, with advice from an External Scientific Panel (ESP).  The Network Steering Committee may establish subcommittees and working groups to facilitate development, implementation, and monitoring of specific Network functions as needed.

The Network Steering Committee is composed of:

  • The RDCRC PD(s)/PI(s) and patient advocate group representative(s) from each RDCRC
  • The PD(s)/PI(s) of the DMCC
  • NIH Program Director(s)/Scientist(s) from participating institutes

The Network Steering Committee will identify scientific and policy issues that need to be addressed at the Network level, as well as broad issues in the field of rare diseases research that can be addressed by the Network.  It will also ensure dissemination of program data, training schedules and other materials to the wider scientific community.  

The ESP will be named by NIH program officials and will serve in advisory capacity by reviewing RDCRN activities and making recommendations to the Network Steering Committee and the NIH regarding process and substantive issues that arise during Network operations.

Rare Diseases Clinical Research Network (RDCRN)

All awardees of an RDCRC are members of the RDCRN and as such are part of a National Rare Diseases Resource.  The DMCC will coordinate and facilitate RDCRN wide activities. Each RDCRC will be expected to share data, actively participate in network activities, including meetings of the Steering committee and biennial RDCRCs meetings, and various relevant workgroups (e.g., bioinformatics, engagement and dissemination of information). 

Each RDCRC, in collaboration with the DMCC, must be willing to work towards being a member of a network that supports Good Data Practices across sites, encourages the use of common data elements, has a commitment to community engagement and sharing of data and other resources to both the scientific communities and the general public.

Coalition of Patient Advocacy Groups (CPAG)

The Coalition for Patient Advocacy Groups (CPAG), was established to promote collaboration between rare disease patient and stakeholder organizations and the RDCRN in order to facilitate better access to, and earlier benefit from, research conducted on rare diseases.  As the patient advocacy arm of the RDCRN, CPAG members will use their position to advance the cause of rare disease research and improved patient outcomes through the network.  Each RDCRC must be actively engaged with the CPAG.

Regulatory Requirements

Data and Safety Monitoring Board (DSMB)

If DSMB services are required, they may be requested from the DMCC, only if no alternate source exists. To be eligible for the DMCC services clinical trials or pilot studies must be of greater than minimal risk, and include one or more of the following:

  • Have protocol designs that allow for modifications to the trial or statistical procedures of the trial after its initiation, such as an adaptive design;
  • Evaluate novel technology or an intervention for which prior data (e.g., pre-clinical toxicology or from a related compound) suggest the intervention under study has the potential to induce a potentially severe or unacceptable toxicity;
  • The study is intended to provide definitive information about the effectiveness or safety of the intervention (e.g., a Phase 3 or efficacy trial, such as a trial intended to support product registration);
  • It would be ethically important to stop the study early if the primary question is addressed, for futility, or for other pre-specified reasons.

Single IRB (sIRB) for Multisite Projects

Investigators are strongly encouraged to use SMARTIRB and its reliance agreements. https://smartirb.org/.

Genomic Sequencing

Due to regulatory requirements for using research results in clinical care, some sequencing data will be expected to be in compliance with the Clinical Laboratory Improvement Amendments (CLIA). In addition, a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) may be needed for new sequencing methods used in clinical care, separate from the requirement for the test to have been conducted within a CLIA-certified environment. Investigators must be prepared to discuss the possible need for an IDE with their IRBs and document the outcome of those discussions, and to subsequently engage in pre-submission discussions with the FDA if the IRB determines they are needed. These typically involve submission of actual study protocols, including the entire sequencing pipeline from sample preparation to return of results. Applicants may wish to consult the following "Points to Consider in Assessing When an Investigational Device Exemption (IDE) Might be Needed" (http://www.genome.gov/27561291).

Pre-application Information Session

All applicants are strongly encouraged to contact NIH Staff to discuss the alignment of their proposed work with the goals of this FOA and the RDCRN. A technical assistance teleconference will be held for potential applicants. NIH staff will be available to answer questions related to this and the companion FOA.  Time, date, and dial-in information for the call will be announced in an NIH Guide Notice.

Note: For more information please refer to the Questions and Answers web site for this FOA.

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

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.  

Application Types Allowed

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials  

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCATS intends to commit an estimated $3.5 million in direct costs in FY 2019 to fund one cooperative agreement application in response to this FOA. 

Award Budget

Applicants may request up to $3.5 million in direct costs in FY 2019.  

Award Project Period

The maximum project period is 5 years.      

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   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)

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)
  • 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
Foreign Institutions

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

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

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD(S)/PI(S)) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

The DMCC PD(s)/PI(s) cannot serve as the Program Director/Principal Investigator of a project in another active RDCRN award.

The cumulative effort of the Principal investigator(s) should be at minimum 2.1 person months per year.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

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

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

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH's ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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

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

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

The letter of intent should be sent to:

B. Duane Price, Ph.D.
Telephone: 301-435-0829
Email: b.duane.price@nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Admin Core (use for Administrative Core)

12

Data Mngmnt Core (use for Data Management Core)

12

Clinical Rsrch Core (use for Clinical Research Core)

12

Engmnt Dsmntion Core (use for Engagement and Dissemination Core)

12

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required
  • Administrative Core: required; maximum of 1
  • Data Management Core: required; maximum of 1
  • Clinical Research Core: required; maximum of 1
  • Engagement and Dissemination Core: required; maximum of 1
Overall Component

When preparing your application in ASSIST, use Component Type 'Overall'.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

Project Summary/abstract:

Briefly describe the theme, goals, and objectives of the RDCRN DMCC and the cores.

Include:

  • ·    Synergy among cores
  • ·    Organizational structure  

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD(S)/PI(S)) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Describe the overall goals of the DMCC for the proposed performance period of the application.  Describe the objectives of the center for facilitating clinical trial readiness.  Also describe the center's objectives for providing clinical research and data management for the RDCRCs, coordinating RDCRN-wide activities and establishing an identity for the network as a rare disease research resource and serving as a conduit of RDCRN-related information to both the research community and the general public. 

Research Strategy: The Overall Research Strategy should describe the DMCC, its goals and objectives, background information, the overall importance of the program in establishing the RDCRN as a data management and coordinating center and as a resource for rare disease researchers, patients, stakeholders, clinicians and the general public. Describe the rationale for the overall proposed program. Explain the strategy for achieving the goals defined for the overall program and how each core relates to that strategy.  A successful grant application will include a well-integrated strategy that clearly shows how the cores will foster clinical trial readiness and how the DMCC will serve as a resource for the greater rare disease research community.  It will also describe how data will be made available to the scientific community, patients, stakeholders and other relevant partners in a manner that meets all NIH human subject's protection, data safety and data sharing requirements, as appropriate and consistent with achieving the goals of the program. A description of how the NCATS ITRB Cloud Computing Services and Engineering support will be used to achieve the mission of the DMCC must be included.

The DMCC should be viewed as interrelated Cores that provide support to individual RDCRCs, to the network as a whole, and to the greater rare diseases research community.  Because each core should be strong individually and complementary to the other cores and the RDCRN, it is important to describe the synergy across cores.  Provide justification in the application that key personnel will collaborate effectively. Describe the organizational structure of the DMCC including the Cores.  Explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goals of the RDCRN, and how combined resources create capabilities that are more than the sum of the parts. Describe how patients and stakeholders are meaningfully incorporated into DMCC activities. Describe work-flow plans and timelines. 

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.

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

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions. 

PHS Human Subjects and Clinical Trials Information (Overall)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application in ASSIST, use Component Type 'Admin Core.'

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • ·    Applicant Information
  • ·    Type of Applicant (optional)
  • ·    Descriptive Title of Applicant's Project
  • ·    Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)
  • ·    In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
  • ·    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • ·    Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • ·    If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
  • ·     The PD(s)/PI(s) of the DMCC must serve as the Core Lead(s) for the Administrative Core.
Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims:  Describe the goals of the Administrative Core and how these goals will contribute to substantial and sustained support of the DMCC and, as a result, the RDCRN.  The specific aims should address plans for communication and coordination across Cores, the RDCRN and the CPAG.   

Research Strategy: The Administrative Core will be responsible for the management and administration of the DMCC.  This section of the application should describe the strategies and processes that will be used to manage the DMCC and achieve the goals of both the DMCC and the overall RDCRN.  A narrative should be provided that describes how the Administrative Core will:

  • ·    Provide oversight for the cores.
  • ·    Promote coordination and collaboration within the DMCC and with investigators and organizations within the RDCRN. 
  • ·    Support the Steering Committee, CPAGs and special workgroups via meeting planning, support for calls and preparation of materials.
  • ·    Coordinate with the RDCRCs to develop an annual report for the ESP. 
  • ·    Provide information describing the oversight of fiscal and resource management; Indicate who will be responsible for each of these activities. 

External Advisory Committee (EAC)

Describe how an External Advisory Committee (EAC) consisting of scientific, clinical and patient group representation that will be composed of at least five members will be established and will function.  Applicants without an existing EAC should describe their plans for constituting an EAC but should not specify names and should not contact potential EAC members in advance of review of the application.  Those applicants with established EAC members should include their continued commitment in Letters of Support.

When multiple performance sites are planned, the Administrative Core should include leadership (including a succession plan) and communication plans adequate to manage the multiple sites, referencing but without repeating information on the Multiple PD(S)/PI(S) Leadership plan, if applicable.

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.

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

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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

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

Data Management Core

When preparing your application in ASSIST, use Component Type 'Data Mngmnt Core.'

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

SF424 (R&R) Cover (Data Management Core)

Complete only the following fields:

  • ·    Applicant Information
  • ·    Type of Applicant (optional)
  • ·    Descriptive Title of Applicant's Project
  • ·    Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data Management Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Management Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Data Management Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data Management Core)

  • ·    In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
  • ·    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • ·    Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • ·    If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Data Management Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Data Management Core)

Specific Aims:  Describe the specific aims of the Data Management Core and how these goals will facilitate the development of a management system for the collection, storage and quality control of data; promote the use of data standards; and provide a portal for data use and sharing, as appropriate and consistent with achieving the goals of the program.  The aims should address not only the delivery of services or materials, but also the processes for ensuring the consistent quality of the services or materials, fair access by users and efficient use of the resources.

Research Strategy: Describe the function of the core as a resource for the program. This section must clearly present the facilities, techniques, and professional skills that the core will provide.  Describe the role of the core as a resource to the RDCRN. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the program.  Describe how the NCATS ITRB Cloud Computing Services and Engineering support will be used to achieve the goals of the Data Management Core.

Describe how the Data Management Core, in collaboration with the Engagement and Dissemination core, will provide:

  • ·    A management system for the collection and storage of data
  • ·    A plan for maintaining confidentiality and addressing privacy issues
  • ·    An easily accessible portal and tools for RDCRN members to independently access and download data sets for analysis
  • ·    Remote data auditing

Describe how the Data Management Core will support and enhance a collaborative informatics community for the RDCRN Program by:

  • ·    Establishing a Good Data Practices work group with representatives from each RDCRC
  • ·    Facilitating the use of Common Data Elements
  • ·    Establishing processes and methods for common IT architecture for the RDCRN Program Consortium including defining technical standards, identifying security requirements, and identifying and integrating existing resources
  • ·    Leveraging innovative new resources including those developed by other NIH supported initiatives (e.g. CTSA Program Data to Health [CD2H])
  • ·    Promoting the use of clinical and research data that are machine readable and that adhere to the FAIR (findable, accessible, interoperable, and re-useable) Principals
  • ·    Developing and implementing standard uniform protocols for data collection (e.g., Common Data Elements, CDE), as well as specimen tracking in individual and multi-center Consortium studies;

Data Sharing under this FOA is expected to be handled to increase the value of the significant public investment in the creation and operation of the Network. Consistent with achieving the goals of the program, NIH expects that datasets from the RDCRN will be widely shared with the scientific community for research, while carefully observing standards of patient privacy, confidentiality, and management of health information.  Information such as study protocols, descriptions, bioinformatics tools, and publications are expected to be made available through an open access section of a database such as the RDCRN and other public web sites, and publication in the scientific literature. 

Describe how the afore-mentioned issues will be addressed while providing optimal data sharing.

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.

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

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.  

PHS Human Subjects and Clinical Trials Information (Data Management Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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. 

Section 3 - Protection and Monitoring Plans

3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

If yes, describe the single IRB plan

Single IRB (sIRB) for Multisite Projects

Investigators are strongly encouraged to use SMARTIRB and its reliance agreements. https://smartirb.org/

Delayed Onset Study

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

Clinical Research Core

When preparing your application in ASSIST, use Component Type 'Clinical Rsrch Core.'

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

SF424 (R&R) Coordination (Clinical Research Core)

Complete only the following fields:

  • ·    Applicant Information
  • ·    Type of Applicant (optional)
  • ·    Descriptive Title of Applicant's Project
  • ·    Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Clinical Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Research Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

The applicant is expected to submit a plan describing the use of a Single IRB (sIRB) that will be selected to serve as the IRB of record for all study sites.  The plan should include a statement confirming that participating sites will adhere to the sIRB Policy and describe how communications between sites and sIRB will be handled.  If, in delayed-onset research, an sIRB has not yet been identified, applications should include a statement that awardees will follow this Policy and communicate plans to use a registered IRB of record to the funding NIH Institute/Center prior to initiating a multi-site study.  The applicant may request direct cost funding for the additional costs associated with the establishment and review of the multi-site study by the sIRB, with appropriate justification; all such costs must be reasonable and consistent with cost Principals, as described in the NIH Grants Policy Statement and the Federal Acquisition Regulation (FAR) 31.302 (Direct Costs) and FAR 31.203 (Indirect Costs).

Project /Performance Site Location(s) (Clinical Research Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Clinical Research Core)

  • ·    In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
  • ·    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • ·    Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • ·    If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Clinical Research Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Clinical Research Core)

Specific Aims: 

Describe the specific aims of the Clinical Research Core and how these goals will facilitate the development of clinical trial readiness within the RDCRN. The aims should address not only the delivery of services or materials, but also the processes for ensuring the consistent quality of the services or materials, fair access by users and efficient use of the resources.

Research Strategy: Describe the role of the core as a resource for the program as a whole.  Describe the function of the Clinical Research core as a resource to the program. This section must clearly present the facilities, techniques, and professional skills that the core will provide. Describe the function of the core as a resource to the program. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the program.  Describe the Clinical Research Core's ability to provide expert consulting and support for:

One of the challenges of clinical trial readiness is transitioning from one phase of the drug development pipeline to the next.  Often there are unfamiliar requirements during these translational periods.  Describe the  synergy and expertise of the team as a whole to provide information, guidance and training for issues including, but not limited to, navigating the regulatory process, working with industry or leveraging other NIH sponsored programs (e.g., Therapeutics for Rare and Neglected Diseases [TRND] or Trial Innovation Network) that will foster appropriate communication among RDCRCs and other relevant participants in the drug development pipeline. Applicants should not duplicate individual expertise that belongs in the biographical sketches.

While each RDCRC will have its own rare disease specific career enhancement program describe how the Clinical Research Core will provide trans-RDCRN career enhancement opportunities to RDCRC student(s)/post-doc(s) that is disease agnostic and promotes best practices in clinical trial readiness. 

The DMCC will provide consulting services to the RDCRCs to assist in establishing a single IRB for Multisite projects.

DSMB services may be requested for RDCRC clinical trials or pilot studies that meet program requirements.  Describe the process for requesting and receiving DSMB services.

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

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

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

PHS Human Subjects and Clinical Trials Information (Clinical Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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. 

Section 3 - Protection and Monitoring Plans

3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

Single IRB for Multisite Projects

Investigators are strongly encouraged to use SMARTIRB and its reliance agreements. https://smartirb.org/.

Delayed Onset Study

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

Engagement and Dissemination Core

When preparing your application in ASSIST, use Component Type 'Engmnt Dsmntion Core.'

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

SF424 (R&R) Cover (Engagement and Dissemination Core)

Complete only the following fields:

  • ·    Applicant Information
  • ·    Type of Applicant (optional)
  • ·    Descriptive Title of Applicant's Project
  • ·    Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Engagement and Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Engagement and Dissemination Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Engagement and Dissemination Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Engagement and Dissemination Core)

  • ·    In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
  • ·    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • ·    Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • ·    If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Engagement and Dissemination Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: 

Describe the specific aims of the Engagement and Dissemination Core and how these goals will facilitate a broad outreach plan for the RDCRN. The aims should describe outreach to basic and clinical researchers, academic and practicing physicians, patients, stakeholders and the general public.   The aims should address not only the delivery of services or materials, but also the processes for ensuring the consistent quality of the services or materials, fair access by users and efficient use of the resources.

Research Strategy: Describe the role of the core as a resource.  Describe the function of the Engagement and Dissemination Core as a resource for the RDCRN as well as the Rare Diseases Research Community as a whole. This section must clearly present the facilities, techniques, and professional skills that the core will provide. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the program.

Describe how the Engagement and Dissemination Core will develop a robust Promotion and Outreach plan for the RDCRN that details interactions with key partners, beyond patients and stakeholders, that include other rare diseases experts, related NIH programs, the greater biomedical research community, NIH staff, journal editors, professional societies, and industry, to meet the goals of the Program, including data sharing.

Describe how the Engagement and Dissemination Core will facilitate collaborations among key stakeholders to further the application of research findings from the RDCRN. Describe how the DMCC will utilize the NCATS ITRB Cloud Computing Services and Engineering support to achieve the Center's goals.

Describe how the Engagement and Dissemination Core, in collaboration with the data management core, will provide a secure internet-based infrastructure (web-portal or other method) to support communications, and document and resource sharing with sources both internal and external to the RDCRN.  Innovative synchronous and asynchronous communication and messaging are encouraged for the various activities.  

Describe how the accomplishments, resources, policies and best practices of the RDCRN will be shared with the CPAGs as well as the general public.  Also describe how scientific information will be shared in plain language to provide greater access to the information. 

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

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

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

PHS Human Subjects and Clinical Trials Information (Engagement and Dissemination Core)

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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. 

Section 3 - Protection and Monitoring Plans

3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

Single IRB for Multisite Projects

Investigators are strongly encouraged to use SMARTIRB and its reliance agreements. https://smartirb.org/

Delayed Onset Study

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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(S)/PI(S) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation.   As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.  Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits. 

If selected, appropriate funding will be provided by the NIH Intramural Program.  NIH intramural scientists may participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA.  Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights. 

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application.  The intramural scientist may submit a separate request for intramural funding as described above.

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

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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

Scored Review Criteria - Overall

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 DMCC that by its nature is not innovative may be essential to advance a field.

Significance

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

Specific to this FOA:  As it related to the relationship to the Network, does the proposed DMCC address the needs of the research network that it will serve? Is the scope of activities proposed for the DMCC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?    

Investigator(s)

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

Specific to this FOA:  Are the PD(s)/PI(s) and other personnel well suited to their roles in the DMCC? Have they demonstrated experience and an ongoing record of accomplishments in managing broad ranging research projects? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Center is multi-PD(S)/PI(S), are their plans for conflict resolution appropriate for the RDCRN? Have they provided a feasible succession plan with their Leadership plan? 

Innovation

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

Specific to this FOA: As it relates to coordinating with the research network, does the application propose novel organizational concepts, management strategies, or instrumentation the DMCC will serve?  Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?       

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the DMCC? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the DMCC involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the RDCRN? Is an appropriate plan for work-flow and a well-established timeline proposed?  Are patients and stakeholders involved in DMCC activities in a meaningful manner? 

Is there strong justification that this will be a successful DMCC, with each of the cores not only individually meritorious but also complementary to the other components, and related to the overall RDCRN?  Are there appropriate plans for the Center to collaborate and otherwise contribute to the broad Rare Disease Research Community?  Does the DMCC have a clear vision for establishing an identity for the RDCRN as a Rare Diseases Research Resource. Do the centralized services produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the program? 

Environment

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

Specific to this FOA: Will the institutional environment in which the DMCC will operate contribute to the probability of success in facilitating the research network it serves? Will the DMCC benefit from unique features of the institutional environment, infrastructure, or personnel?  Are adequate resources available within the scientific environment to support electronic information handling?  

Overall Impact - Cores

Reviewers will provide an overall impact score for each Core to reflect their assessment of the likelihood for the core to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria.

Review Criteria for the Administrative Core
  • Is the purposed Administrative Core well matched to the needs of the DMCC?
  • Are the proposed strategies and processes that will be used to manage the DMCC appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting etc.? 
  • Is the DMCC structure sufficient, including its internal and external procedures for managing the activities of the DMCC and the RDCRN?
  • Are there appropriate plans for establishing the EAC, and are there appropriate plans for the EAC to serve in an advisory capacity for the whole DMCC?
  • Does the Director have the leadership and research qualifications to lead the Administrative Core?
  • Is there an appropriate plan for establishing and maintaining effective communication and cooperation among the DMCC cores? With RDCRC sites? As a network as a whole?
  • Is there meaningful engagement with patient or stakeholder groups?
  • Is the environment for the Administrative Core adequate and appropriate to support the overall DMCC?  Is there evidence of institutional support for the management of the DMCC?
Review Criteria for the Data Management Core
  • Are the core activities capable of effectively and efficiently supporting research productivity?
  • Is the plan for oversight and prioritization of user requests for core services adequate and fair?
  • Does the core provide adequate leadership and technical expertise to ensure that it meets its stated goals?
  • Are the staffing, allocated space, equipment and other resources that are available to the core sufficient to meet the anticipated demand for its services?
  • Will the services provided facilitate clinical trial readiness?
  • Does the plan provide provisions for diverse programmatic needs and capabilities of the RDCRCs?
  • Is the plan for data to be made available for RDCRN participants, the broad research community and patients and/or stakeholders appropriate?
  • Is there meaningful inclusion of patients or stakeholders?
 
Review Criteria for the Clinical Research Core
  • Are the core activities capable of effectively and efficiently supporting research productivity?
  • Is the plan for oversight and prioritization of user requests for core service adequate and fair?
  • Does the core provide adequate leadership and technical expertise to ensure that it meets its stated goals?
  • Are the staffing, allocated space, equipment and other resources that are available to the core sufficient to meet the anticipated demand on its services?
  • Will the services provided facilitate clinical trial readiness?
  • Does the plan provide provisions for diverse programmatic needs of the various RDCRCs?
  • Is there a plan to provide career enhancement on issues that are relevant to all RDCRC sites at levels appropriate for both senior researchers as well as students/post-docs?
  • Is there meaningful engagement of patients or stakeholders in core activities?
Review Criteria for the Engagement and Dissemination Core
  • Are the core activities capable of effectively and efficiently supporting research productivity?
  • Is the plan for oversight and prioritization of user requests for core service adequate and fair?
  • Does the core provide adequate leadership and technical expertise to ensure that it meets its stated goals?
  • Is the plan for interacting with RDCRCs feasible?
  • Are the staffing, allocated space, equipment and other resources that are available to the core sufficient to meet the anticipated demand on its services?
  • Is the outreach plan feasible and meaningful?  Does it include relevant parties, including patients, stakeholders and key partners?
  • Is the plan for sharing information/materials/data described in a manner that makes it available for both the scientific community and the general public?
  • Will information be shared in a timely manner?
Additional Review Criteria - Overall, Administrative Core, Data Management Core, Clinical Research Core, Engagement and Dissemination Core

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall, Administrative Core, Data Management Core, Clinical Research Core, Engagement and Dissemination Core

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .


Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NCATS 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:

  • 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.
  • Will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NCATS Advisory Council. 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(S)/PI(S) will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the Principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

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

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

Terms for the RDCRN (RDCRC & DMCC)

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

  • defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. 
  • Serving as Core Director(s) responsible for the integration and management of activities within the RDCRN.
  • organizing a local Executive Committee for day-to-day management of the DMCC, and an External Advisory Committee, with scientific, clinical and patient or stakeholder representation. The role of these Committees will include the oversight, review, and evaluation of the DMCC, and the selection and prioritization of projects that will use resources and services that are provided through the RDCRN.
  • serving as a member of the RDCRN Steering Committee and participating in required activities, including regular conference calls and 1-2 annual RDCRN face-to-face meetings.
  • participating in the overall coordination of NIH research efforts in Rare Diseases; this participation may include collaboration and consultation with other NIH awardees, the appropriate sharing of information, data, and research materials, and participation in NIH efforts to standardize and harmonize pre-clinical and clinical data collection.

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

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

  • The NIH Project Scientist(s) will work closely with the PD(S)/PI(S), the Steering Committee, and the PIs of all RDCRCs in order to ensure proper conduct of the DMCC.
  • The assigned Project Scientist will be responsible for: (1) overseeing the activities of the DMCC, along with the other entities delineated above, to ensure that activities and services are properly conducted and completed in a timely fashion; (2) providing advice and guidance to ensure that the DMCC runs in accordance with NIH policies and procedures, and is consistent with the mission of the NIH to improve public health; (3) serving as a point of contact for investigators with the NIH; and (4) disseminating information from the Center and communicating with Center leadership to ensure that the DMCC operates smoothly.

An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

None; all responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

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

Multi-site clinical studies

  • Any third-party collaboration should be governed by a research collaboration agreement (e.g. CTA, RCA, MOU, etc.) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH policies and procedures.
  • Any third party in the study, including access to any study data; study results; using the name of the study; or the name/logo of the RDCRN, NIH or any NIH institute, is permitted only after concurrence by the PO who may consult with others at NIH, including the Technology Advancement Office.
3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Telephone: 301-945-7573

Scientific/Research Contact(s)

Tiina K. Urv, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-2846
Email: urvtiin@mail.nih.gov

Jill A. Morris, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5745
Email: jill.morris@nih.gov

Peer Review Contact(s)

B. Duane Price, Ph.D.
National Center for Translational Sciences (NCATS)
Telephone: 301-435-0829
Email: b.duane.price@nih.gov

Financial/Grants Management Contact(s)

Laura Gray
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-4238
Email: laura.gray@nih.gov

Tijuanna Decoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.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 Principals, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.