Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Strategic Coordination (Common Fund)

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the NHLBI on behalf of the NIH.

Funding Opportunity Title
Somatic Cell Genome Editing Program Translational Coordination and Dissemination Center (TCDC) (U24 - Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices
  • April 26, 2022 - Request for Information (RFI): Inviting Comments and Suggestions on the Potential Development of a Challenge Prize for Transformative Genome Editor Delivery Technologies.See Notice NOT-RM-22-013
Funding Opportunity Announcement (FOA) Number
RFA-RM-22-017
Companion Funding Opportunity
RFA-RM-22-014 , U01 Research Project (Cooperative Agreements)
RFA-RM-22-015 , U19 Research Program (Cooperative Agreement)
RFA-RM-22-016 , UG3/ UH3 Phase 1 Exploratory/Developmental Cooperative Agreement/Exploratory/Developmental Cooperative Agreement Phase II
Assistance Listing Number(s)
93.310
Funding Opportunity Purpose

The purpose of this FOA is to support the establishment of a Translational Coordination and Dissemination Center (TCDC) for the NIH Somatic Cell Genome Editing (SCGE) Consortium. In its second phase (FY2023-2027), the SCGE program will accelerate the development of genome-editing therapeutic agents by: facilitating IND-enabling studies; establishing pathways to regulatory approval; and disseminating successful strategies for initiating first in human clinical trials. In addition to this TCDC, the Consortium will include three components (development of technology/assays that support IND-submissions, optimize genome editing-based therapeutic leads for safety and efficacy and conduct platform clinical trials using genome editing technologies in >1 disease) which together will accelerate the optimization of promising clinical candidates toward IND filings and future first in human clinical trials. The TCDC is expected to lead consortium-wide activities that facilitate intra-consortium collaborations and that support broad dissemination strategies for regulatory submission. The TCDC will develop a publicly available online platform for data collection and dissemination of consortium-wide activities including stewardship and preservation of data generated by SCGE in Phase I.

Key Dates

Posted Date
April 11, 2022
Open Date (Earliest Submission Date)
June 17, 2022
Letter of Intent Due Date(s)

June 17, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 19, 2022 Not Applicable Not Applicable November 2022 January 2023 April 2023

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

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

Expiration Date
July 20, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background   

The NIH Somatic Cell Genome Editing (SCGE) program is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold and innovative approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for transformation of research processes.

The simplicity and broad applicability of targeted and programmable genome editing approaches, including but not limited to those based on CRISPR-Cas9, raise the possibility of a fundamentally new way to treat a variety of genetic diseases. However, many challenges need to be overcome before such techniques could be widely used in the clinic. To maximize the potential of genome editing technology, the SGCE program was developed to accelerate the translation of genome editing technology into clinical applications.

Based on input received from stakeholders from academia, industry, and regulatory agencies, as well as the substantial progress in the field of genome editing since the launch of the first five-year phase of the SCGE program, the second five-year phase of SCGE will focus on translating and accelerating safe and effective genome editing therapeutics into the clinic. Specifically, SCGE Phase 2 will support the following initiatives: 1) Technologies and Assays for Therapeutic Genome Editing INDs; 2) IND-enabling Studies of Somatic Genome Editing Therapeutic Leads; 3) Platform Clinical Trials of Somatic Genome Editing for Multiple Diseases and 4) Somatic Cell Genome Editing Translational Coordination and Dissemination Center.

The SCGE program will involve collaborative research by a consortium of grantees with differing expertise to develop, optimize and demonstrate improved candidate genome editing therapeutic as treatments for human disease. Recipients from all four SCGE program components will form a consortium, governed by a steering committee of investigators and NIH staff that will develop consensus policies and procedures for Consortium-wide activities such as data and resource sharing. Collectively, these initiatives are intended to substantially expand the number of genetic diseases treated by in vivo genome editing, ultimately allowing this technology to achieve its potential as a therapeutic platform to treat genetic disease.

Program Formation and Governance

The awards funded under this FOA will be cooperative agreements (see Section VI.2. Cooperative Agreement Terms and Conditions of Award). Close interactions among the recipients and NIH will be required to maintain this complex program. The whole SCGE program governance will rest with the SCGE Program Steering Committee in collaboration with NIH program officials, with advice from Program Consultants (PCs) providing critical scientific and managerial insights, and subject to oversight by the NIH SCGE Working Group. The NIH SCGE Working Group consists of NIH programmatic staff from multiple Institutes and Centers of the NIH as well as the Office of the Director. This group will be primarily responsible for the stewardship of the SCGE program. The SCGE Working Group is co-chaired by the Director of the National Center for Advancing Translational Sciences (NCATS) and the Director of the National Institute for Neurological Disorders and Stroke (NINDS). It reports to the Directors of the Office of Strategic Coordination/Common Fund and the Division of Program Coordination, Planning, and Strategic Initiatives for final funding decisions.

Research Objectives

This Funding Opportunity Announcement (FOA) supports applications for a Translational Coordination and Dissemination Center (TCDC) to support the goals of the second phase (FY2023-2027) of the SCGE program. This phase will stimulate research toward the development of safe and effective in vivo genome editing therapeutics. This FOA will utilize a cooperative agreement mechanism of award and runs in parallel with all companion FOAs for the SCGE program. The overall goal of the SCGE TCDC is to provide Consortium-wide support and leadership to strengthen the national capacity for translating genome editing therapeutics into the clinic by supporting infrastructure and programming that engages healthcare and research partners with this common goal. The aim of the SCGE TCDC is provide a framework for dissemination strategies that will lead to the implementation of best practices and incorporation of new technologies for translating genome editing therapeutics into clinical care. Research partnerships are essential to translation of these technologies-successful approaches and best practices established through the Consortium should have a major impact on genome editing research and clinical care in the U.S.

In partnership with the SCGE Consortium, the Translational Coordination and Dissemination Center will:

  1. Provide national leadership and technical expertise in all aspects of therapeutic genome editing.
  2. Lead the design, development and execution of a high impact online platform that will facilitate data sharing and best practices for translation of genome editing therapeutics.
  3. Make available data, tools, technologies, and protocols from projects across the Consortium to facilitate expansion of research, clinical and industry partnerships that accelerate the use of genome editing therapeutics in the clinic.
  4. Manage consortium-wide education and outreach activities.

The TCDC will be responsible for data sharing across the Consortium, with the goal of disseminating the most efficient gene editing and trial approaches to the broader research community. Close interaction and efficient lines of communication between the TCDC and the research teams of other Consortium components will be essential due to the TCDC's role in scientific and logistic coordination of intra-Consortium interactions and collection of complex data from multiple research teams for storage, sharing and dissemination.

The TCDC will lead development and dissemination of a publicly available online platform that sustains data collected in SCGE Phase I. The Phase II platform is intended to support data sharing and consortium-wide activities including, but not limited to: SOPs for data sharing, presentation of novel IND-enabling technologies, and technical and regulatory support protocols for therapeutic development. The purpose of the SCGE Phase II Platform is to provide online tools to help researchers find the most appropriate resources to facilitate therapeutic genome editing development programs and support their regulatory submissions. The SCGE Phase II platform should present resources generated from the Consortium in an intuitive and readily accessible online interface. Resources should be organized and presented at a high level, while also allowing researchers to access more detailed information associated with each tool, approach or protocol. The SCGE Phase II Platform will be a major and primary deliverable from the overall NIH SCGE Consortium effort. The TCDC will also coordinate efforts across and between SCGE components in order to support educational activities both within the SCGE Consortium and with external stakeholder communities.

Specific roles and activities of the TCDC include, but are not limited to:

1. Consortium Coordination

  • Provide oversight and coordination of the SCGE Program Steering Committee, including providing leadership, logistical support and hosting regular Committee meetings and up to two annual in-person meetings to ensure Consortium members have opportunities to provide meaningful and broad input on the goals of the SCGE Phase II program
  • Coordinate Consortium-wide or component-specific subcommittees or working groups that arise to support synergistic activities (e.g., publication, data sharing, outreach) or address the emerging education and training needs of the Consortium, including hosting a “Meet the Expert” series covering topics such as regulatory, IND development, clinical trials, etc.
  • Provide communication support to facilitate Consortium-wide information exchange and discussion. Information to be maintained within the communication platform may include (but is not limited to): Consortium presentations, meeting agendas and summaries, subcommittee documents, and additional collaborative Consortium activities
  • Support the Steering Committee in the development and dissemination of Consortium-wide Manual of Operations (MOO) covering policies and procedures for best practices for activities across the Program
  • Serving as a resource within the Consortium for potential ethical, legal and social implications (ELSI) issues related to somatic cell genome editing. The TCDC will produce a systematic review of ethical and regulatory challenges related to somatic cell genome editing therapies, including important gaps for which more research is needed. The TCDC will contain the requisite expertise to anticipate possible emerging ELSI and regulatory issues, including but not limited to genome editing utilizing in utero approaches, throughout the course of the program and convene expert workshops or tutorials on such issues, as needed.

2. Assembly and dissemination of the SCGE Phase II Platform, including stewardship of the Phase I data. Considerations for development of the SCGE Phase II Platform include (but are not limited to):

  • Developing and maintaining common data elements across the SCGE Consortium projects
  • Working with NIH SCGE Program staff and Consortium investigators to facilitate collecting and curating critical data resources for the assembly of the SCGE Phase II Platform
  • Create a process to evaluate the quality of submitted data prior to Consortium use and public release
  • Interacting closely with informatics and data science experts to develop user-friendly tools and interfaces for Consortium and public users
  • Developing a web portal that provides clear and easy management and retrieval of data, tools and protocols from the SCGE Program in order to disseminate findings generated from the Consortium to broader audiences in a manner that is accessible to the general scientific community across a variety of platforms
  • Creating and implementing a sustainability plan for stewardship and preservation of data generated by SCGE Phases I and II, and ensuring the data, tools and technologies produced by the SCGE Program remain available beyond the SCGE Program funding period
  • Serving as the main resource for data acquisition, presentation and preservation expertise for the SCGE Program
  • Serving as the primary point of contact for engagement with the Common Fund Data Ecosystem (CFDE) to ensure that SCGE data will be interoperable with other Common Fund datasets, as appropriate
  • Creating methods and best practice protocols associated with the above-mentioned resources

3. Collaboration support

  • Coordinating efforts across and between SCGE components in order to support educational activities, developing novel data dissemination tools and identifying areas of synergy and opportunity both within the SCGE Consortium and with external stakeholder communities
  • Designing and implementing effective procedures to ensure evaluation and sharing of newly developed assays, technologies and protocols occurs frequently across the three other components of the Consortium to facilitate shared learning and acceleration of Consortium regulatory submissions
  • Facilitating multi-directional interactions between the Consortium and appropriate national and international biomedical research communities with the goal of identifying and developing strategies to address outstanding barriers to accelerating and improving IND submissions for genome editing
  • Disseminating protocols, products and information generated by the SCGE Consortium including facilitating the request and distribution of Consortium-generated resources within and outside of the Consortium

Research Scope

The SCGE TCDC will be a key element of the Somatic Cell Genome Editing Consortium, which is composed of four FOAs, of which this FOA is one:

RFA-RM-22-014: Technologies and Assays for Therapeutic Genome Editing INDs (U01, Clinical Trial Not Allowed)

RFA-RM-22-015: IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, Clinical Trial Not allowed)

RFA-RM-22-016: Platform Clinical Trials of Somatic Genome Editing for Multiple Diseases (UG3/UH3, Clinical Trial Required)

RFA-RM-22-017: Somatic Cell Genome Editing Translational Coordination and Dissemination Center (U24, Clinical Trial Not Allowed)

The SCGE TCDC tasks fall into three general categories:

  • Managing data collection and release
  • Managing program education and outreach
  • Coordinating logistics

In all these areas, the SCGE TCDC will need to work closely with other researchers in the Consortium, external stakeholders and NIH staff.

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 SCGE program.

Pre-application Information Session

A technical assistance teleconference will be held for potential applicants. NIH staff will be available to answer questions related to this and companion FOAs. Time, date, and dial in information for the call will be announced in an NIH Guide Notice and will be posted on the SCGE program website: https://commonfund.nih.gov/editing.

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. Only those application types listed here are allowed for this FOA.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

The NIH Common Fund (Office of Strategic Communication) intends to commit total costs of up to $2.0M per year in FY2023 through FY2027 for one award, contingent upon NIH appropriations and submission of a sufficient number of meritorious applications.

Award Budget

For all years, budget must reflect the actual needs of the proposed projects.

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:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

  • 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 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.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Marrah Lachowicz-Scroggins, PhD
Telephone: 301-827-8229
Email: marrah.lachowicz-scroggins@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

The TCDC budget should include funds to host and support the two annual SCGE Program Steering Committee meetings and include travel funds for the External Scientific Panel members to attend one of those meetings annually.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

The Research Strategy section must consist of subsections A-E and FOA-specific review criteria as defined below.

Subsection A: Overview of the Translational Coordination and Dissemination Center (TCDC)

  • Provide a brief overview of the proposed TCDC and its role in the NIH SCGE Consortium, addressing the primary responsibilities identified in Section I, indicating how the TCDC will meet the needs, facilitate, and enhance the work of the entire NIH SCGE Consortium.
  • Describe the operational plan, workflow, and organizational structure of the TCDC, including but not limited to:
    • Strategies to promote a robust and unbiased scientific approach across the SCGE Consortium
    • Plans to identify potential problems, alternate strategies, and risk management
  • Describe how the TCDC activities will challenge and seek to shift current paradigms, policies, and practices to advance genome editing research and technologies, and to impact data management and research implementation strategies.
  • Highlight unique approaches of the proposed TCDC that reflect effective and innovative ways of coordinating multi-institutional, trans-disciplinary research, including novel collaboration and communication strategies..
  • Without repeating information in individual biosketches and Facilities and Other Resources, summarize the collective capabilities of the team and previous accomplishments, in areas vital to the role of TCDC, including (but not limited to):
    • Coordination of multi-faceted and complex Consortia, including activities such as administering multiple subcommittees and planning large in-person meetings.
    • Support of collaborative research efforts/programs having with a variety of stakeholders with emphasis on the aspects of focus relevant to this FOA.
    • Synthesis and harmonization of disparate data types;
    • Development and harmonization of standard operating procedures (SOPs) and Consortium policies;
    • Development and usability testing of data sharing and dissemination platforms;
    • Infrastructure and/or expertise to support the Consortia's research strategies as part of the regulatory decision making process and regulatory review including but not limited to lead candidate selection, IND development and submissions and conduct of clinical trials;
    • Conducting research on the ethical, legal and social implications of gene therapy or genome editing.

Subsection B. Plans and Approaches to Basic Coordinating Center Functions

  • Describe detailed plans for the creation and maintenance of the TCDC that address the coordination aspects identified in Section I;
  • Describe approaches to Consortium coordination, support for the SCGE Program Steering Committee and potentially relevant subcommittees;
  • Describe administrative coordination of Consortium activities and providing logistical/operational support;
  • Describe plans for supplementing the Consortia's expertise in technical and regulatory support protocols for therapeutic development in genome editing technologies;
  • Describe plans for engaging external experts in regulatory development, IND submissions, clinical trials and tools/technologies for genome editing therapeutics to promote shared learning and Consortium educational opportunities.

Subsection C. Plans and Approaches for Assembly and Dissemination of the SCGE Phase II Platform

  • Describe detailed plans and workflows for the development and dissemination of the aspects of the SCGE Phase II Platform described in Section I;
  • Detail experience with creating solutions for data deposition and dissemination with a focus on relevant informatics, data science and Cloud infrastructure/expertise;
  • Describe details for implementation of a sustainability plan for preservation of SCGE Phase I and II Consortium-wide data beyond the SCGE Program funding period;
  • Describe the strategy for usability testing of the SCGE Phase II Platform by Consortium members and public research community. Such testing should include assessing usability for scientists and clinicians with varied expertise in bioinformatics;
  • Describe the proposed prototype of the SCGE Phase II Platform which will contain the various data sets and resources generated by the SCGE Consortium. Applicants should describe how the resources developed by the SCGE will be organized into an intuitive and accessible online platform to enable researchers to determine the best approach for their intended therapeutic development program(s);
  • Applicants should describe whether the proposed SCGE Phase II Platform would be one single online tool that integrates the deliverables of each Consortium component or a collection of several online tools that each integrate the deliverables from a subset of components within the Consortium. If the latter approach is taken, applicants should describe how the collection of tools will be carefully integrated to enable researchers to readily access all the potential resources available from the SCGE Consortium.
  • Without repeating information in individual biosketches, summarize the capabilities of the TCDC and previous accomplishments in supporting complex data presentation in meaningful ways and experience in web-interface design.
  • Describe the proposed capabilities of the SCGE Phase II Platform, which could include but are not limited to:
    • virtual decision engines that would use researcher-specified parameters to provide recommendations for the best choice of IND-enabling tools or technologies which would facilitate translation of a genome editing technology into clinical practice;
    • search functions to enable researchers to readily identify technologies and assays appropriate for safety studies (potency, pharm/tox, CMC, immune responses, cell tracking studies, etc.) for therapeutic development programs and inclusion in regulatory packages;
    • support data collection and repository of data elements, including clinical protocols and manuals for the SCGE Clinical Trials of >1 Disease Programs;
    • an index or links to publicly accessible resources where Consortium-generated data are stored to facilitate access to Consortium-derived primary data;
    • other novel strategies and innovating approaches to integrating, curating, and disseminated resources developed by the SCGE Consortium.

Subsection D. Plans and Approaches for Collaboration Support Functions

  • Describe detailed plans for the intra-Consortium collaboration support functions identified in Section I.
  • Describe the outreach and dissemination plan for the Consortium that details interactions with key stakeholders (international genome editing experts, other related NIH programs, greater biomedical research community, NIH staff, relevant federal agencies, journal editors, professional societies, industry, and others) to meet the goals of the Program to address barriers for improving IND submissions and accelerating for genome editing therapeutics into the clinic.
  • In addition to disseminating the SCGE Phase II Platform generated by the Consortium, the plan should also include engagement with the genome editing and biomedical research communities at large and should describe metrics to assess program success. This plan should be reviewed by the Consortium at each Annual Program Meeting to assess progress and make updates as necessary.

Subsection E. Project Timeline

Project timeline: A timeline (Gantt chart) that includes milestones is required for all projects. Milestones are goals with clear and quantifiable criteria/benchmarks for success. The milestones are required in order to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project funding of non-competing award years. The application should also include milestones for all critical steps with appropriate benchmarks and timelines towards achieving the stated goals of the TCDC.

Example milestones include:

  • By end of year 1, have created intra-consortium working groups to support collaboration and sharing between initiatives;
  • By the end of each budget year, have held two consortium-wide steering committee meetings and intra-consortium working group meetings as needed;
  • By the end of each budget year, have held at least four “Meet the Expert,” meetings;
  • By the end of year 1, deliver to the NIH Program Official and the SCGE Consortium through a Manual of Operations: the finalized policy and procedures for consortium-wide data, metadata and resource sharing; SOPs for sharing and protocols, and a publication policy (including policies, workflows, and logistics);
  • By the end of year 1, deliver to the NIH Program Official a finalized sustainability plan for Phase I SCGE data and plans for providing a publicly available data sharing platform for Phase II;
  • By the end of year 2, a prototype of the Phase II data dissemination platform for Somatic Genome Editing Technologies is developed;
  • By the end of year 3, have implemented the process for quality control and deposition of metadata and protocols across Initiatives, as appropriate, to facilitate design and build of Phase II platform;
  • By the end of year 4, have completed usability testing and launch of the Phase II data and resource dissemination platform for Somatic Genome Editing Technologies;
  • By the end of award year 5, have completed the quality control for the final deposition of metadata and protocols across Initiatives, as appropriate, to capture post-launch results and resources across the initiatives.

The NIH expects a sustainability plan for the data elements collected in SCGE Phase I to be proposed in the first year and that a prototype of the SCGE Phase II Platform could be built within two years for data population and testing by the SCGE Consortium. A public-facing version, presenting SCGE Consortium protocols and data, would be expected by the end of the fourth budget period. The SCGE Phase II Platform would continue to be expanded and improved upon over the course of the project.

Letters of Support: Applications should include letters necessary to demonstrate the support of participating institutions, equipment, and other physical resources required for the TCDC to perform the functions described in Section I.

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

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the SCGE Program Steering Committee and approved by NIH staff. A primary goal of the SCGE program is to facilitate discoveries by the broad scientific community, thereby accelerating the translation of genome editing technologies into treatments for human disease. Restrictive licensing terms and sharing practices for SCGE-generated data, tools, and resources could substantially diminish their value and public benefit. Accordingly, recipients should manage data, resources, protocols, tools, and software in a way that achieves this goal. Sharing practices that would hinder, prevent or block access to or use of SCGE program data, tools, and resources for research purposes will be considered to be hindering the goals of the SCGE program. The development of policies, methods, and standards for such sharing is critically important. The NIH expects that the recipients, through the SCGE Program Steering Committee, will develop such policies, methods, and standards in concert with the NIH. These policies, methods, and standards will remain consistent with NIH-wide policies on data and resource sharing.
  • Specific Plan for Data Sharing: Consistent with achieving the goals of this program, the NIH expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be deposited as appropriate into existing, publicly available data repositories that are easily accessible, and in machine readable format. Where appropriate, applicants should identify such repositories and plans for deposition. For datatypes that lack suitable public repositories, applicants should indicate their willingness to identify an appropriate alternative solution that is consistent with achieving the goals of the program. Data should also be made available as appropriate via the SCGE Phase II Platform that will serve as the central access point for information regarding data, critical tools, protocols and reagents being developed by the SCGE program. If applicable, applicants must abide by the NIH Genomic Data Sharing Policy (https://gds.nih.gov/) and should indicate their agreement to it in the data sharing plan.
  • Specific Plan for Protocol, Tool, and Reagent Sharing: As one of the primary goals of this program is to advance research through development, establishment, broad dissemination and use of community resources across the research community, NIH intends that protocols, tools, and reagents generated by the SCGE program be broadly available and distributed at no to minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible for research purposes by the larger scientific community, while encouraging rapid adoption and commercialization of the technologies for the development of genome editing therapies. For all applications and where otherwise applicable, the applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including animal strains, protocols, biomaterials, and reagents. The SCGE TCDC will work with all SCGE program investigators to collect, curate, and disseminate information regarding tools and reagents being developed by the program and to disseminate this information through the SCGE Phase II Platform and other sources as appropriate and consistent with achieving the goals of the program.
  • Specific Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected in applications that are developing software. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact:
    • The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
    • The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
    • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
    • The terms of software availability should include the ability of researchers outside the project and its collaborating projects to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent “official” versions of a piece of software.
    • Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.
    • Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan.
  • Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (http://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov).

Prior to funding, NIH Program Staff may negotiate modifications to the Sharing Plan with the applicant.

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, 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.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Center address the needs of the research consortium that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Specific to this FOA:

How strong are the plans for the TCDC proposed activities to meet those needs? What is the likelihood that successful the completion of the proposed aims will help the SCGE Consortium advance genome editing technologies into clinical practice?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing collaborative research? Do the investigators demonstrate significant experience with coordinating collaborative basic and/or clinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Is it likely that the applicant has the necessary experience overseeing selection and management of subawards, if needed?

Specific to this FOA:

Will the team be able to contribute unique expertise and perspectives to the overall SCGE Program goals? Is the expertise well described for successful coordination, data management and facilitation of Program collaborations? Do study personnel have experience with complex data presentation in meaningful ways, experience in web-interface design and experience in collaborative research with a variety of stakeholders?

Innovation

Does the application propose novel organizational concepts, management strategies, and/or instrumentation in coordinating the research Consortium the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies and/or instrumentation proposed?

Specific to this FOA:

Does the application demonstrate that the proposed activities will challenge and seek to shift current research or clinical practice paradigms, national policies and practices to advance genome editing technologies by utilizing novel theoretical concepts, approaches, methodologies, interventions, or tools? Will the proposed activities advance and seek to impact current data management and research implementation strategies by utilizing novel theoretical concepts, approaches or methodologies, or tools? Are the plans adequate for leveraging novel collaboration and communication strategies? Does the proposed application indicate creativity and flexibility to innovate on an ongoing basis?

Will the proposed design of the SCGE Phase II Platform contain innovative and novel strategies for integrating and curating critical resources developed by the SCGE Consortium? Are novel dissemination strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research SCGE Consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the SCGE Consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the SCGE Consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the SCGE Consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

If the project 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Are the plans well described for the proposed design of the SCGE Phase II Platform? Are the plans feasible for sustaining the SCGE Phase I and Phase II data beyond the SCGE Program funding period? How effective are the dissemination strategies proposed? Is the proposed timeline feasible for launch and completion of the SCGE Phase II Platform?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research of the SCGE Consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

      Not Applicable

Additional Review Considerations

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

Milestones

To what extent are the proposed Milestones well-defined with quantifiable measures that will enable clear decisions about their attainment?

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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.

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

Applications will be assigned 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of the 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, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's 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 reside with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

  • Determining research approaches, designing protocols, setting project milestones, and conducting research.
  • Participating in group activities, including a Consortium-wide SCGE Program Steering Committee and subcommittees as needed.
  • The SCGE Consortium will meet in person at least twice a year and the SCGE Program Steering Committee will recommend the frequency of other in-person and teleconference meetings.
  • Providing reports and data in a timely fashion as agreed upon by the SCGE Program Steering Committee.
  • Submitting all required data, SOPs, protocols, and resources as soon as they are scheduled for submission to the SCGE TCDC for quality control and compilation in the SCGE Phase II Platform.
  • Preparing abstracts, presentations, and publications and collaborating Consortium-wide in making the public and professionals aware of the program.
  • Assessing and disseminating data, protocols, and methods developed for or derived from the SCGE program within and outside the Consortium.
  • Adhering to policies regarding data sharing, and publication established by the NIH and the SCGE Program Steering Committee.
  • Abiding by common definitions, protocols, and procedures, as chosen by a majority vote of the SCGE Program Steering Committee.
  • Submitting periodic progress reports in a standard format, as agreed upon by the SCGE Program Steering Committee and NIH SCGE Working Group.
  • Attending and participating in SCGE Program Steering Committee meetings and accepting and implementing decisions by the NIH SCGE Working Group, as appropriate.
  • Overseeing all aspects of the organization and execution of the studies outlined in the application and approved by NIH Working Group program staff after peer review.
  • Putting all study materials and procedure manuals into the public domain. Recipients are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by NIH.

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

  • The NIH SCGE Working Group consists of NIH programmatic staff from multiple Institutes and Centers of the NIH as well as the Office of the Director.
  • The NIH Project Scientist(s) will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of NIH staff will be to facilitate and not to direct the activities. The Project Scientist(s) will participate as members of the SCGE Program Steering Committee. The Project Scientist(s) will have the following substantial involvement:
  • Participating with the other SCGE Program Steering Committee members in addressing issues that arise with SCGE planning, operation, assessment, and data analysis. The Project Scientist(s) will assist and facilitate the group process and not direct it.
  • Serving as a liaison, helping to coordinate activities, including acting as a liaison to other NIH Institutes/Centers, and as an information resource for the recipients. The Project Scientist(s) will also help coordinate the efforts of the SCGE Consortium with other groups conducting similar efforts.
  • Attending all SCGE Program Steering Committee meetings, assisting in developing standard operating procedures, and consistent policies for dealing with situations that require coordinated action. The Project Scientist(s) will be responsible for working with the recipient as needed to manage the logistic aspects of the SCGE program.
  • Reporting periodically on SCGE progress to the Common Fund SCGE Working Group and through it to the NIH Common Fund.
  • Serving on subcommittees of the SCGE Program Steering Committee as appropriate.
  • Assisting recipients in the development, if needed, of policies for dealing with situations that require coordinated action.
  • Providing advice in the management and technical performance of the award.
  • Assisting in promoting the availability of the data and related resources developed in the course of this program to the scientific community at large.
  • Participating in data analyses, interpretations, and, where warranted, co-authorship of the publication of results of studies conducted through the program.
  • The NIH reserves the right to phase-out or curtails an individual award in the event of (a) failure to develop or implement core milestones mutually agreed upon by the recipient organization and PD/PI and the NIH, (b) insufficient consortium participation and collaboration with other recipients, (c) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (d) ethical issues that may dictate a premature termination, or (e) results that substantially diminish the scientific value of study continuation.
  • Other NIH SCGE Working Group staff may assist the recipient as designated by the Program Official.
  • Additionally, 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. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed milestones and any changes suggested by NIH staff. The Program Official will negotiate with the applicant and agree on a final set of approved milestones which will be specified in the Notice of Award.

NIH reserves the right to withhold funding or curtail an award in the event of:

  • Substantive changes in the project, or failure to make sufficient progress toward the work scope with which NIH concurred, or
  • Ethical or conflict of interest issues.

Areas of Joint Responsibility include:

The SCGE Program Steering Committee will serve as the main scientific body of the program. The SCGE Program Steering Committee will be responsible for coordinating the activities being conducted by the program and is the committee through which the NIH SCGE Working Group formally interacts with the SCGE investigators. The SCGE Program Steering Committee membership will include PD(s)/PI(s) of each SCGE award (limited to one person for a Project with multiple PIs), other staff as needed (ex-officio), and the NIH Project Scientist(s). The SCGE Program Steering Committee may add additional members, and other government staff may attend the SCGE Program Steering Committee meetings as desired. Each award recipient Steering Committee member will have one vote, and the NIH Program Scientist(s) together will have one vote.

The SCGE Program Steering Committee may establish subcommittees as needed to address particular issues, which will include representatives from the program and the NIH, and possibly other experts. The SCGE Program Steering Committee will have the overall responsibility of assessing and prioritizing the progress of the various subcommittees.

The SCGE recipient agrees to work collaboratively to:

  • Provide secure, accurate, and timely data, SOP, protocol, and resource submission.
  • Participate in presenting and publishing new processes and substantive findings.
  • Assess and disseminate the SCGE Phase II Platform.
  • Participate in the governance of the SCGE program as a member of the SCGE Program Steering Committee.
  • Interact with other relevant NIH activities, as needed, to promote synergy and consistency among similar projects.

Program Consultants (PCs):

  • PCs will be responsible for reviewing and evaluating the progress of the entire SCGE program. PCs will also, as appropriate and at the request of the NIH SCGE Working Group, provide input to the NIH about the progress of the individual SCGE projects in meeting their individual and Consortium goals and milestones. The PCs will include 4-6 senior, non-federal scientific experts who are not directly involved in the activities of the SCGE program. NIH will appoint PCs and may adjust the roster of PCs in response to program needs. The SCGE POs, PSs, NIH SCGE Working Group, and other NIH staff may attend the PC meetings.
  • The PCs will meet at least once a year, in conjunction with a meeting of the SCGE Program Steering Committee in the DC Metro area, to allow the PCs to interact directly with the PD/PI(s), and by phone or email, at other times as needed.
  • Annually, the PC members will provide their individual assessments to the NIH of the progress of the SCGE Consortium, and, as necessary, will present recommendations regarding any changes to the SCGE program. The assessments and recommendations will be provided, through the NIH SCGE Working Group, to the Director of the Office of Strategic Coordination, NIH.

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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

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

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

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

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

Scientific/Research Contact(s)

Marrah Lachowicz-Scroggins, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8229
Email: marrah.lachowicz-scroggins@nih.gov

Peer Review Contact(s)

Elena Smirnova, Ph.D.
Center for Scientific Review
Telephone: 301-357-9112
Email: smirnove@csr.nih.gov

Financial/Grants Management Contact(s)

John Hrivnak
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-301-7717
Email: john.hrivnak@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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