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 Center for Advancing Translational Sciences (NCATS) on behalf of the NIH.
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.
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.
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. 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, RFA-RM-18-013, and RFA-RM-18-014); (2) tools and assays to detect adverse consequences of genome editing in human cells (SCGE Biological Systems, RFA-RM-18-015, RFA-RM-18-022, and RFA-RM-18-025); (3) new technologies to deliver genome editing machinery into disease-relevant cells and tissues in vivo (SCGE Delivery Technologies, RFA-RM-18-016 and RFA-RM-18-023); (4) novel genome editing and engineering systems (SCGE Editing Systems, RFA-RM-18-017 and RFA-RM-18-024); 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. It is expected that all awardees will collaborate to accelerate the translation of genome editing technologies into treatments for human disease.
The objective of this FOA is to support the development and evaluation of innovative approaches to deliver genome editing machinery into targeted somatic cells, with the ultimate goal of enabling genome editing therapeutics to treat human disease. Building upon recent successful gene therapy trials, many current and announced genome editing clinical trials in the US are focusing on a small number of rare diseases affecting tissues that have been shown to be amenable to gene delivery, such as the liver and retina. However, maximizing the therapeutic impact of somatic genome editing requires the development of safe and effective technologies to deliver genome editing machinery into all disease-relevant somatic cells and tissues.
This FOA will use the UG3/UH3 Cooperative Agreement mechanism. This funding mechanism involves two Phases. During the UG3 Phase (3 years), support will be provided for proof of concept studies of technologies to deliver genome editing machinery into disease relevant cells and tissues in vivo. As used here, the term genome editing machinery includes the editor, guide RNA, and DNA, if applicable. By the end of the second year of funding, it is expected that delivery systems will be ready to send to the Rodent Testing Centers (RFA-RM-18-012) for independent validation of genome editing in target cells in a small animal. The 1-year UH3 Phase will support the scale up and testing of the genome editing delivery technology, in collaboration with SCGE Large Animal Testing Centers (LATC; RFA-RM-18-014). Successful delivery systems and associated protocols are expected to be shared with the broader community via a "Toolkit for Therapeutic Genome Editing Approaches" developed under RFA-RM-18-018 that will be the primary output of this collective Common Fund-sponsored program.
The objective of this FOA is to support the development and evaluation of innovative approaches to deliver genome editing machinery into somatic cells in humans, with the ultimate goal of accelerating the development of genome editing therapeutics to treat human diseases. Like all Common Fund initiatives, this FOA invites 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 UG3/UH3 mechanism is intended to support feasibility studies of such approaches in the UG3 Phase.
Projects can focus on a single cell type, or multiple cell types. Emphasis will be placed on organs and cell types that are clinically relevant for disorders amenable to genome editing in humans, but have no effective in vivo delivery technologies currently available.
Cell types of interest include but are not limited to endogenous stem cells and cell types of origin for cancer in any organ, as well as disease relevant cells in the:
Cardiovascular system, including hematopoietic and immune cells in vivo
For applications proposing delivery technologies for organs and cell types that are currently accessible to in vivo genome editing by available methods, emphasis will be placed on technologies that produce substantial qualitative improvements in clinical application.
Examples of qualitative improvements that would substantially enhance clinical application include but are not limited to:
Projects focusing on either viral or non-viral delivery systems can be supported under this FOA. However, given the interest and rapid progress using adeno-associated virus (AAV) vectors for gene therapy and genome editing, applications proposing to simply incorporate different genome editors into currently known AAV serotypes would not be responsive.
Non-viral vector technologies could include but are not limited to:
Applications to develop delivery technologies for nucleic acids or nucleic acid analogs that can trigger targeted genome editing by endogenous enzymatic mechanisms, independent of exogenous editing enzymes, are responsive to this RFA.
Projects proposing the use of high-throughput, combinatorial, or barcoding-based screening approaches to develop cell-type specific delivery vehicles are encouraged.
For proof of concept studies for delivery of enzymatic editors, investigators can choose from any programmable editors, including but not limited to Class 2 CRISPR-Cas systems, other nucleases, and related DNA- or RNA-targeted base editors. It is not the purpose of this FOA to support the development or testing of new genome editors. Investigators seeking funding for the development of new genome editing systems can apply for support under companion funding announcement? RFA-RM-18-024.
Activities considered nonresponsive to this announcement include:
The UG3 Phase will support feasibility and proof of principle studies of technologies to deliver genome editors to one or more cell types in vivo, and to demonstrate that these technologies are effective in vivo in animals. Additional supported activities could include, but are not limited to:
Transition to the UH3 Phase:
UG3 projects that have met the scientific milestones and other requirements will be eligible for transition to the second UH3 Phase after NIH administrative review. The criteria to determine whether a UG3 project will be continued into the UH3 Phase will be negotiated between the NIH and applicant prior to funding, and include the following:
Consistent with recent NIH guidance on rigor and reproducibility in research (https://grants.nih.gov/reproducibility/index.htm), the most important milestone for the transition will be independent validation of the delivery technology. To achieve this milestone, NIH expects that investigators funded under this FOA will incorporate a genome editor targeted to a mutation in a reporter gene in SCGE reporter animals created under RFA-RM-18-012. This material will then be sent to the testing center for validation of genome editing in target cells in the reporter animals.
The UH3 Phase is intended to support the scale up of genome editing delivery technologies, and testing in non-rodent species (pigs, marmosets, or Rhesus macaques) in collaboration with the LATCs (RFA-RM-18-014). For validation, investigators will incorporate a genome editor into the delivery vehicle, and this material will then be sent to one of the LATCs for testing genome editing in target cells of the chosen animal species.
Additional activities supported during the UH3 Phase may include:
Experiments involving the development and testing of genome editing delivery technologies in animal models of disease will be considered out of scope for the UH3 phase.
The data from validation and collaborative studies, as well as information about the delivery technologies developed under this FOA, will be communicated to the SCGE Dissemination and Collaboration Center (RFA-RM-18-018) for incorporation into the SCGE Toolkit.
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 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 SessionAll 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.
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.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The NIH Common Fund (Office of Strategic Coordination) intends to commit $7.5M in FY 2019-2021 and $12.0M in FY2022 to fund 8-10 awards, contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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.
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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
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:
The letter of intent should be sent to:
P.J. Brooks, Ph.D.
All instructions in the SF424 (R&R) Application Guide must be followed.
The one Specific Aims attachment should include Aims delineated for the UG3 (Phase 1) and UH3 (Phase 2) components:
1. UG3 (Phase 1)
Define the aims of the proof of concept studies, focusing on the proposed delivery technology. The aims should include the target cell types, as well as the animal species to be used for testing in vivo editing.
2. UH3 (Phase 2)
Define the aims of the demonstration phase studies.
The aims should include plans for scale up, and choice of animal species for testing.
All within the single Research Strategy attachment, separate the information for each Phase. Provide the following information for each of the UG3 and UH3 Phases: Background and Significance, Approach, and Milestones and Timeline. The combined page limit for UG3 and UH3 Phases is 12 pages total. Applications will be assigned a single impact score.
UG3 Development Phase:
1. Background and Significance:
Provide a rationale for the choice of delivery technology, its mechanism of action, and route of administration. Identify the target cell type(s), and provide a brief description of the therapeutic rationale for genome editing in this cell population.
If proposing a project involving a currently available vehicle, provide an explanation of how the approach would substantially enhance clinical utility.
Provide an overall plan to develop and test the delivery technology in animals, including:
The choice of animal species, including genetic modifications, if any.
Choice of genome editor to be delivered, along with guide RNA and DNA, if applicable.
The approach(es) used to demonstrate and quantify genome editing in target cell types in vivo.
The route of administration.
If available, preliminary data that support the feasibility of conducting studies to address the specific aims, including the proposed technology to deliver genome editing machinery to target cell types.
If a screening approach is proposed, a description of how the screening will be carried out, including plans for replication and validation of "hits".
Experiments to test the proposed delivery technologies in relevant human cell types in vitro, if available.
Proposed quantitative criteria for successful editing in animals (i.e., % of target cell types showing evidence of genome editing).
3. Milestones and Timeline:
A timeline (Gantt chart) including milestones is required for all studies. Milestones are goals that create go/no-go decision points in the project and must include clear and quantitative criteria for success. Yearly quantitative 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 for funding of non-competing award years. The application must include clearly -specified, well-defined milestones, quantitative go/no-go decision points, and timelines for assessing progress within both the UG3 and UH3 Phases. The application should also include? a timeline for progressing from the UG3 Phase to the UH3 Phase, as well as quantitative criteria (i.e., % of target cell types showing evidence of genome editing) for independent validation by the SATC.
UH3 Demonstration Phase:
1. Background and Significance:
Identify and justify the choice of animal species (pigs, marmosets, or Rhesus macaques) to be used for testing in collaboration with one of the LATCs.
Provide an overall plan to scale up the delivery technology, editor, and guide RNA and DNA, if applicable, including calculations of the magnitude of scale up required for different doses.
Identify potential problems that may be encountered during scale up and propose alternative plans and strategies.
Describe the design of studies to assess delivery of the editor to target cells in a large animal species. Discuss plans and protocol for assessing additional safety/toxicity endpoints (e.g. immune response, inflammation).
3. Milestones and Timeline:
A timeline (Gantt chart) including milestones is required for the UH3 Phase.
The following modifications also apply:
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
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
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.
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.
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.
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.
The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: Has the PD/PI provided a convincing therapeutic rationale for genome editing in the chosen target cell population?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA:
If the investigators are proposing a project involving modifications of currently available vector(s), have they provided a convincing explanation of how the approach would substantially enhance clinical utility?
Have they included adequate plans to assess whether the proposed technologies will deliver genome editing machinery to human cells in vitro, if appropriate human cell systems areavailable?
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 children, justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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.
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.
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.
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.
Are the proposed Milestones well-defined and reasonable, with quantifiable measures that will enable clear decisions about their attainment?
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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).
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).
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Information regarding the disposition of applications is available 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.
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.
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.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for 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:
NIH staff will 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:
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. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed UG3 and UH3 milestones and any changes suggested by NIH staff or the NIH review panel. The Program Official and Project Scientist will negotiate with the applicant and agree on a final set of approved UG3 milestones which will be specified in the Notice of Award. The NIH Program Official, in consultation with the Project Scientist and NIH SCGE Working Group, will determine if the awardee has met the milestones for transition of the project from the UG3 to the UH3 stage.
NIH reserves the right to withhold funding or curtail an award in the event of:
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:
External Scientific Panel (ESP):
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.
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.
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