Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title

Somatic Cell Genome Editing Dissemination and Coordinating Center (U24 Clinical Trial Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-RM-18-018

Companion Funding Opportunity

RFA-RM-18-012 U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements

RFA-RM-18-013 U24 Resource-Related Research Projects – Cooperative Agreements

RFA-RM-18-015 U01 Research Project – Cooperative Agreements

RFA-RM-18-016 UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

RFA-RM-18-017 U01 Research Project – Cooperative Agreements

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

93.310

Funding Opportunity Purpose

The purpose of this FOA is to support the establishment of a Dissemination and Coordinating Center (DCC) for the NIH Somatic Cell Genome Editing (SCGE) Consortium. In addition to this DCC, the Consortium will include four components (genome editing tools, delivery systems, animal models and biological assays) to produce validated techniques and knowledge through exchange of expertise, information and research tools. The DCC is expected to interact with other components of the SCGE Consortium to facilitate collaborative activities within the entire Consortium. The DCC will develop an online platform to facilitate information sharing within the Consortium, assemble resources (tools, methods, data and best practices) generated from all Consortium components into a SCGE Toolkit for Therapeutic Genome Editing, and disseminate the SCGE Toolkit and other appropriate resources to researchers across the biomedical research community.

Key Dates

 

Posted Date

January 24, 2018

Open Date (Earliest Submission Date)

March 3, 2018

Letter of Intent Due Date(s)

March 3, 2018

Application Due Date(s)

April 3, 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.

No late applications will be accepted for this Funding Opportunity Announcement.

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

June/July 2018

Advisory Council Review

October 2018

Earliest Start Date

December 1, 2019

Expiration Date

April 4, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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



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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

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, innovative, and often risky 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 rare genetic diseases, as well as numerous therapeutic strategies for common diseases.  However, many challenges need to be overcome before such techniques could be widely used in the clinic. Participants in a 2017 NIH workshop identified several research areas in need of investment, including optimized genome editors, specifically targeted delivery systems, and more predictive animal models and studies. Contingent on availability of funds, the NIH plans a future funding opportunity for Large Animal Testing Centers that will use either pigs or non-human primates, including wild-type animals as well as reporter animals developed by RFA-RM-18-013, to assess efficacy and safety of in vivo genome editing and delivery technologies. Although research in each of these fields has been very active, efforts have focused on the needs of individual studies and not on overall procedures for improving and testing the safety and efficacy of genome editing approaches.

To maximize the potential of genome editing technology to treat as many diseases as possible, the SGCE program has been developed to accelerate the translation of genome editing technology into clinical applications.  The key components of the SCGE program include: (1) better animal models for assessing genome editing in vivo (SCGE Animal Models, RFA-RM-18-012 and RFA-RM-18-013); (2) tools and assays to detect adverse consequences of genome editing in human cells (SCGE Biological Systems, RFA-RM-18-015); (3) new technologies to deliver genome editing machinery into disease-relevant cells and tissues in vivo (SCGE Delivery Technologies, RFA-RM-18-016); (4) novel genome editing and engineering systems (SCGE Editing Systems, RFA-RM-18-017); and (5) the SCGE Dissemination and Coordinating Center (SCGE DCC, RFA-RM-18-018). The SCGE DCC will make the results, tools and technologies developed under this program widely available to facilitate adoption for translation into clinical applications.

The deliverables of the SCGE program will be a collection of tools, methods, data, and best practices that will accelerate development and testing of new treatments for many diseases, i.e. the SCGE Toolkit for Therapeutic Genome Editing or SCGE Toolkit. The SCGE program will involve collaborative research by a partnership of genome editing experts, delivery systems experts, animal model creators and assay developers to produce validated techniques and knowledge through exchange of expertise, information and research tools. Awardees from all five 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. Contingent on availability of funds, the NIH plans a future funding opportunity for Large Animal Testing Centers that will use either pigs or non-human primates, including wild-type animals as well as reporter animals developed by RFA-RM-18-013, to assess efficacy and safety of in vivo genome editing and delivery technologies. It is expected that all awardees will collaborate to accelerate the translation of genome editing technologies into treatments for human disease.

Research Objectives

This FOA calls for the establishment of a DCC for the SCGE Consortium. Close interaction and efficient lines of communication between the DCC and the research teams of other Consortium components will be essential due to the DCC's role in scientific and logistic coordination of intra-Consortium collaborations and collection of complex data from multiple research teams for storage, sharing and dissemination.

The DCC is also expected to develop and disseminate a SCGE Toolkit for Therapeutic Genome Editing (SCGE Toolkit), which will be the major and primary deliverable from the overall NIH SCGE Consortium effort. The purpose of the SCGE Toolkit is to provide online tools to help researchers find the most appropriate resources to facilitate therapeutic genome editing development programs and regulatory submissions. The SCGE Toolkit 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 or approach.

The DCC is also expected to implement collaborative opportunities for investigators within the Consortium to meet program goals. A single Collaboration Opportunity Fund (COF) of up to $3,000,000 total costs per year in fiscal years 2020-2022 will be established under this FOA to support new and pilot research projects led by investigators within the SCGE program. The COF is meant to promote the exchange, cross-testing and evaluation of the improved technologies within the Consortium. For example, it is anticipated that Delivery Systems projects may benefit from collaborations with Biological Systems investigators to adapt assays to specific needs of the improved delivery systems, e.g., by incorporating additional cell types or readouts. Likewise, novel Editors may inspire the development of different reporter animals in which they could be tested. Additionally, cross-species comparison of delivery systems in, for example, a rodent vs. large animal may reveal properties best assessed in each animal type. The DCC will have the responsibility of administering the SCGE COF, thus the institution must agree to take responsibility for managing the COF, including fund disbursement, administration, and reports. Management of the COF will involve:

  • Establishing an administrative structure to manage the COF
  • Disbursing and tracking COF funds under the direction of the NIH SCGE Working Group
  • Implementing plans for interacting with the institutions that will receive COF funds, including establishing Consortium agreements, when applicable
  • Establishing procedures, formats, and timelines for reporting on the status of COF projects and expenditures to the NIH and the SCGE Program Steering Committee

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

1. Consortium Coordination

  • Providing oversight and coordination of the SCGE Consortium and the SCGE Program Steering Committee, including logistical and administrative assistance, such as organizing the SCGE Program Steering Committee, arranging two in-person SCGE Program Steering Committee meetings per year, and arranging conference calls for the Consortium;
  • Developing and implementing a comprehensive Consortium-wide Manual of Operations (MOO) to be shared within the Consortium. The MOO will contain Consortium operating policies and procedures developed under the guidance of the NIH SCGE Program Steering Committee. Policies may cover the areas of publication, Consortium collaboration, data sharing and dissemination, and outreach, as well as other activities deemed necessary by the SCGE Program Steering Committee.
  • Developing consensus standards and guidelines for sharing program resources among Consortium members to test the safety and effectiveness of genome editors, delivery systems and reporter animals;
  • Developing an internal Consortium communication platform 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 summaries, subcommittee documents, and additional collaborative Consortium activities.
  • Coordinating the establishment and operation of dynamic, Consortium-wide or component-specific subcommittees to address the emerging needs of the Consortium, including scheduling meetings/calls, preparing summaries, and tracking progress towards desired outcomes;
  • Serving as a resource within the Consortium for potential ethical, legal and social implications (ELSI) issues related to somatic cell genome editing. The DCC 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 DCC will contain the requisite expertise to anticipate possible emerging ELSI and regulatory issues throughout the course of the program and convene expert workshops or tutorials on such issues, as needed.

2. Assembly and Dissemination of the SCGE Toolkit

  • Working with all Consortium investigators to facilitate collecting and curating critical resources for the assembly of the SCGE Toolkit. Resources to be included in the SCGE Toolkit may include (but are not limited to):
  •     a collection of genome editing delivery systems developed by the Consortium, along with detailed characteristics and associated validation data
  • a collection of genome editors developed by the Consortium, along with detailed characteristics and validation data
  • a collection of biological assays to monitor and measure the adverse effects of genome editing in human cells
  • a collection of small and large animal models for assessing the efficacy of various genome editing approaches
  • methods and best practice protocols associated with the above-mentioned resources
  • Developing, maintaining and enhancing an appropriate web portal to present the SCGE Toolkit for public access, and to facilitate the request and distribution of Consortium-generated resources within and outside of the Consortium.

3. Collaboration support

  • Designing and implementing effective procedures to ensure cross-testing and validation of newly developed tools and technologies between the four other components of the Consortium, distributing collaboration funds based on budget analysis and justifications. Funding for collaborative opportunities as approved by the NIH SCGE Working Group will be available on a competitive basis through the COF.
  • 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 concerns in the application of genome editing technologies.

Program Formation and Governance

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 the awardees 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 an External Scientific Panel (ESP) 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 NIH SCGE Working Group is chaired by the Director of the National Center for Advancing Translational Science (NCATS). 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.

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 SCGE program. 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 Common Fund 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.

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

The NIH Common Fund (Office of Strategic Coordination) intends to commit up to $2.0M for FY 2019, $5M for FY 2020 - 2022, and $1.5M for FY 2023 for one award, contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets should not exceed $1.25M in direct costs in FY 2019, $3.25M in direct costs in FY 2020 - 2022 and $1.0M in direct costs in FY 2023 and need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period for this FOA is 5 years (FY2019 - 2023).

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/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit 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

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Colin Fletcher, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2270
Email: fletcherc2@mail.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 or Modular Budget
  • All instructions in the SF424 (R&R) Application Guide must be followed.  The DCC budget should include funds to 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. The proposed budget for COF management should only include funds for an administrator with a maximum effort of .5 person months per year.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

The Research Strategy section must consist of subsections A-E as defined below.

Subsection A: Overview of the Dissemination and Coordinating Center (DCC) 

  • Provide a brief overview of the proposed DCC and its role in the NIH SCGE Consortium, addressing the primary responsibilities identified in Section I, indicating how the DCC can facilitate and enhance the work of the entire NIH SCGE Consortium;
  • Highlight unique approaches of the proposed DCC that reflect effective and innovative ways of coordinating multi-institutional, trans-disciplinary research;
  • 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 DCC, 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 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;
  • 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 DCC 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.

Subsection C. Plans and Approaches for Assembly and Dissemination of the SCGE Toolkit

  • Describe detailed plans for the development and dissemination of the aspects of the SCGE Toolkit described in Section I;
  • Describe the proposed prototype of the SCGE Toolkit 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. Applicants should describe whether the proposed SCGE Toolkit 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.
  • Describe the proposed capabilities of the SCGE Toolkit, 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 delivery system, along with associated in vivo validation data and/or adverse biological events data;
  • search functions to enable researchers to readily identify editors based on multiple parameters (type of editing, off-target editing rates, size of editor, delivery limitations, etc.) to find the optimal editor to meet the researcher's therapeutic development needs;
  • search functions to enable researchers to readily identify biological assays appropriate for safety studies for therapeutic development programs and inclusion in regulatory packages;
  • an index or links to publicly accessible resources where Consortium-generated data are stored to facilitate access to Consortium-derived primary data.
  • Describe the strategy for usability testing of the SCGE Toolkit by Consortium members and public research community. Such testing should include assessing usability for scientists with varied expertise in bioinformatics.

Subsection D. Plans and Approaches for Collaboration Support Functions

  • Describe detailed plans for the intra-Consortium collaboration support functions identified in Section I.
  • Describe a management plan for the collaboration opportunity fund (COF) that includes an administrative structure, proposed methods/procedures to support funds disbursement, reporting, and monitoring (e.g. time interval for establishment and renewal of subcontracts, invoices to be paid, and plans for handling subcontract administration delays), and plans for interacting with the institutions that will receive COF funds.
  • 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. In addition to disseminating the SCGE Toolkit 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 studies.  Milestones are goals with clear and quantifiable criteria 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 DCC. The NIH expects that a prototype of the SCGE Toolkit could be built within two years for data population and testing by the SCGE Consortium.  A public-facing version, presenting some SCGE Consortium protocols and data, would be expected by the end of the fourth budget period. The SCGE Toolkit would continue to be expanded and improved upon over the course of the project.

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

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • 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, awardees 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 awardees, 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 Toolkit 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 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 DCC 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 Toolkit 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 NIH-defined human subjects research, clinical research, and/or 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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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).

Significance

Does the proposed DCC address the needs of the SCGE Consortium that it will service? Is the scope of activities proposed for the DCC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the genome editing research?  

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the DCC? 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 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 DCC? Does the applicant have experience overseeing selection and management of subawards?  

Specific to this FOA:

Do the personnel have the appropriate breadth of expertise and experience, including but not limited to, experience with data harmonization, synthesis, and dissemination, and expertise in ethical, legal and social implications (ELSI) related to somatic genome editing?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the SCGE Consortium the DCC 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 or instrumentation proposed?   

Specific to this FOA:

Does the proposed design of the SCGE Toolkit 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 SCGE Consortium the DCC 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 NIH SCGE Consortium is in the early stage of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the NIH 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?

Specific to this FOA:

Is the proposed design of the SCGE Toolkit robust and rigorous? Are effective dissemination strategies proposed?

Environment

Will the institutional environment in which the DCC 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 DCC proposed? Will the DCC 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 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

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

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:

  • 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 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 grantee's business official.

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

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

2. Administrative and National Policy Requirements

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for the SCGE 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. Awardee will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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 validation data as soon as they are collected to the SCGE DCC for quality control and compilation in the SCGE Toolkit.
  • 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 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.

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 and will have one vote.  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 awardees. 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 as a voting member, 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 grantee 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 awardees 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. 
  • Other NIH SCGE Working Group staff may assist the awardee 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. The assigned Program Official may also serve as an NIH Working Group Project Scientist(s) to assist the awardee. 

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:

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to manage, assess, and disseminate the SCGE program. The awardees and the Project Scientist(s) will meet in person with the SCGE Program Steering Committee twice a year and on conference calls as needed to share information on methodologies, analytical tools, and preliminary results. PDs/PIs, key co-investigators and pre- and post-doctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings.

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 project 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 awardee agrees to work collaboratively to:

  • Provide for secure, accurate and timely data submission.
  • Participate in presenting and publishing new processes and substantive findings.
  • Assess and disseminate the SCGE Toolkit.
  • 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.

External Scientific Panel (ESP):

  • An ESP will be responsible for reviewing and evaluating the progress of the entire SCGE program. The ESP 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 ESP will be composed of 4-6 senior, non-federal scientific experts who are not directly involved in the activities of the SCGE program.  NIH will appoint members to the ESP and select one member as chair. The SCGE POs, PSs, NIH SCGE Working Group, and other NIH staff may attend the ESP meetings.
  • The ESP 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 ESP members to interact directly with the awardees, and by phone or email, at other times as needed.
  • Annually, the ESP 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 SCGE Program Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

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

Scientific/Research Contact(s)

Colin Fletcher, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2270
Email: fletcherc2@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: Deanna.Ingersoll@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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