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U01 Research Project Cooperative Agreements
New
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169.
August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109
August 26, 2020 - Notice of Correction to Eligibility in NIH Funding Opportunity Announcements. See Notice NOT-OD-20-171.
None
93.279, 93.242, 93.867, 93.866, 93.273, 93.286, 93.865, 93.173, 93.121, 93.853, 93.113, 93.213
The purpose of this FOA is to develop tools and technologies to conduct scientifically rigorous, ethical, efficient, and cost-effective research, as well as develop necessary infrastructure, that supports germline and somatic transgenic and gene editing studies in the common marmoset (Callithrix jacchus). These studies should answer crucial scientific questions that require genetic perturbation in a non-human primate model organism, as well as support the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) goals of understanding the brain in health and disease.
30 days prior to application due date
October 15, 2020 and October 14, 2021
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not applicable
March 2021; March 2022
May 2021; May 2022
July 2021; July 2022
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose:
The purpose of this FOA is to develop tools and technologies to conduct scientifically rigorous, ethical, efficient, and cost-effective research, as well as develop necessary infrastructure, that supports germline and somatic transgenic and gene editing studies in the common marmoset (Callithrix jacchus). These studies should answer crucial scientific questions that require genetic perturbation in a non-human primate model organism, as well as support the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) goals of understanding the brain in health and disease.
BRAIN Initiative
The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat and prevent brain disorders.
NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, BRAIN 2025: A Scientific Vision, which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This and other Funding Opportunity Announcements (FOAs) issued as part of the BRAIN initiative are based on careful consideration by the NIH of the recommendations of the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group. Videocasts of the NIH BRAIN Multi-Council Working Group are available at http://www.braininitiative.nih.gov/about/mcwg.htm.
To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from disciplines such as statistics, physics, mathematics, engineering, and computer and information sciences. NIH welcomes applications from investigators in all of these disciplines.
NIH encourages BRAIN Initiative applications from investigators that are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds.
NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business FOAs (http://braininitiative.nih.gov/funding/index.htm).
In addition to the BRAIN Initiative, the NIH continues to have a substantial annual investment in neuroscience research. The Institutes and Centers contributing to the NIH BRAIN Initiative (http://braininitiative.nih.gov) support those research efforts through investigator-initiated applications as well as through specific FOAs. Potential applicants to this FOA are strongly encouraged to contact Scientific/Review staff if they have any questions about the best FOA for their research.
The BRAIN Initiative will require a high level of coordination and sharing between investigators. It is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities.
The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.
This FOA is related to the recommendations in Section III.5 of the BRAIN 2025 Report. Specifically, this FOA solicits applications that will address the recommendations on Identifying Fundamental Principles .
Background:
The common marmoset (Callithrix jacchus) is an emerging non-human primate (NHP) model organism with the potential to leverage the power of gene editing technologies (e.g. germline and somatic cell genetic manipulations, including gene targeting and transgenic manipulations in the brain and other tissues) in a model organism that exhibits primate neural circuitry and social behaviors. These small new world monkeys share a core primate brain architecture and exhibit similar social behaviors to humans. Their average lifespan is 14 years and they live in small social groups. Marmosets have a highly developed frontal lobe, facilitating studies of cognition, communication and social behaviors. Females reach sexual maturity between 12 and 18 months and typically give birth to two litters a year, with twins being common. Their short gestation period and ability to produce multiple litters per year provides a distinct genetic advantage to marmosets over other common non-human primate species for development of strong gene editing and transgenic technologies. In addition, a few published studies indicate that gene editing and transgenic approaches are feasible and could be optimized to contribute to the development of more personalized therapeutics for appropriate neurodevelopmental, neurodegenerative, and neuropsychiatric disorders.
Recent meetings and reports (http://nas-sites.org/ilar-roundtable/roundtable-activities/care-use-and-welfare-of-marmosets-as-animal-models-for-gene-editing-based-biomedical-research/abstracts-and-speakers/, http://nationalacademies.org/hmd/Reports/2019/transgenic-neuroscience-research-exploring-the-scientific-opportunities-afforded-by-new-nonhuman-primate-models-proceedings.aspx, https://orip.nih.gov/about-orip/research-highlights/nonhuman-primate-evaluation-and-analysis-part-1-analysis-future, https://orip.nih.gov/about-orip/research-highlights/nonhuman-primate-evaluation-and-analysis-part-2-report-expert-panel) indicate that tool and technology development for gene editing and transgenic studies are in the nascent stages. Examples of tools that need to be built and/or optimized include, but are not limited to, technologies to enhance: 1. assisted reproductive technologies; 2. germline and somatic cell gene editing tools and methods; and 3. gene editing tools (e.g. CRE driver lines and CRISPR/Cas constructs).
Due to its small size, short gestational period, twin births, and a genome that has been sequenced and annotated, the common marmoset is strongly positioned for genetic studies of diseases and processes affecting neurological function. Although there have been a few gene editing studies in marmoset, gene editing tools need to be further developed, refined, and optimized for the marmoset to reach its full potential as a genetically tractable, model organism to uncover the functions of circuits and cell types underlying neurodevelopmental, neurodegenerative, and neuropsychiatric disorders. With the optimization of gene editing tools, the marmoset can help translate findings from animal models to humans and validate human studies.
Research Objectives
Although germline and brain-specific gene editing and transgenic studies in rodents have been widely successful, there are distinct differences in anatomy, physiology, and cognition between rodents and non-human primates that necessitate studies in organisms that more closely model human brain anatomy and circuitry. The marmoset, with its large prefrontal cortex and primate neuroanatomy is strongly positioned for translational studies involving many aspects of neurological function, including cognition, executive function, emotion, social behaviors, neurodevelopmental processes, neurodegenerative diseases, and behaviors associated with substance use disorders.
This Funding Opportunity Announcement (FOA) solicits applications to develop tools and technologies to routinely conduct germline and somatic transgenic studies and gene editing in the common marmoset with the aim of supporting the BRAIN goals of understanding the brain in health and disease. This includes optimization of strategies, tools, and methods to build a scientifically rigorous, ethical, efficient, and cost-effective brain-specific research infrastructure that can support all aspects of gene editing in marmosets, including optimizing assisted reproductive technologies, embryonic stem cell culture, ovarian stimulation protocols, development of pre-implantation protocols, standardization of semen collection and freezing, developing molecular genetic tools for gene editing and inducible/tissue-specific studies, creation of CRE driver lines, etc. Awardees are expected to participate in and provide information to an NIH-Funded Marmoset Coordination Center to disseminate the tools to the broader marmoset community. Studies proposing to conduct gene editing must contain at least one germline gene editing component.
In order to be considered responsive to this FOA, applications must address at least one of the following needed tools and technologies. Studies proposing to conduct gene editing must contain at least one germline gene editing component. Applications that are not responsive to this FOA will be withdrawn without review.
Tools and technologies are needed to:
Some potential research topics applications may address include, but are not limited to:
See Section VIII. Other Information for award authorities and regulations.
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. Only those application types listed here are allowed for this FOA.
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Issuing IC and partner components intend to commit an estimated total of $4 M to fund 2-6 awards in both FY2021 and FY2022.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
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
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov
Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:
NATIONAL INSTITUTES OF HEALTH
NIDA/DER/OEPR
3WFN 9th floor MSC 6021
301 NORTH STONESTREET AVE
BETHESDA MD 20892
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Facilities and Other Resources: Describe the infrastructure the team has to conduct the proposed research, include an account of the space allocated to this marmoset project. If additional infrastructure (e.g. cages, space, equipment) is needed to successfully complete the project, include this plan in the application.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy:
The research strategy must contain the following information. It would be helpful if applicants use appropriate sub-headings for each section.
A. Rationale for marmoset research. Describe the rationale for choosing to conduct this study in marmosets. Include descriptions of why this study needs to be conducted in marmosets instead of other animal or cellular models and why marmosets are the best model organism for the project. Provide details regarding the long-term and short-term goals of the research team with a description of how this project addresses these goals. Provide data from pilot studies and/or preliminary data in marmosets or non-human primates (NHP) that support this project, when applicable. Pilot data may include failed work in other organisms that suggest conducting studies in an NHP model is necessary. Pilot studies may also include data from other non-NHP model organisms suggesting that validation in NHP is essential for translation to humans. Describe the research questions for this project and illustrate how the proposed experimental design addresses these questions. Provide details on the health and wellbeing benefits of addressing the proposed research in marmosets.
B. Description of the research strategy and design. Describe in detail the planned research project. Delineate the research questions and the supporting scientific data for conducting the research. Document any preliminary data that supports the research project, including, but not limited to pilot studies, published research, and/or supporting data from the literature. Provide sufficient details to allow assessment of the capabilities of the team to conduct the project. Describe the predicted outcomes from the study, the benefit to public health and basic research, and document the limitations, potential pitfalls and alternative strategies. Provide a description of plans to distribute resources created in this project to the neuroscience research community. Describe how requests will be vetted and how the team will work with existing marmoset colonies and the BRAIN Initiative: Marmoset Coordinating Center.
C. Ethical considerations. The Public Health Services Policy on Humane Care and Use of Laboratory Animals (PHS Policy) applies to the use of live, vertebrate animals in any activity supported by the NIH or other PHS agency. This is true for NIH-funded research with NHPs, whether genetically modified or not. However, genetic modification may result in novel phenotypes, which may necessitate, for instance, changes to animal husbandry such as special housing or social arrangements. Personnel involved with genetically modified NHPs may need to develop new methods to ascertain these and other potential consequences of genetic manipulation, such as changes in animal welfare. Provide details on how the research team will address these considerations. Also, as with all animal research, studies supported by this FOA must be adequately designed and powered, which may require increased use of NHPs. Describe how the study design balances potential benefits to human health and/or science with the Three R’s (replace, reduce, and refine) goals of minimizing the numbers of animals used and the refinement of experimental methodology.
D. Milestones and timeline. Provide a timeline and delineate annual SMART milestones for the project. Milestones should be Specific, Measurable, Attainable, Relevant, and Timely. Applicants must describe the total number of animals and total number of phenotypic, cellular, and/or molecular assays that will be completed for each year of the project period and by the end of the project period.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
A primary goal of this program is to facilitate discoveries by the broad scientific community. Restrictive sharing practices and licensing terms for program-generated data and resources could substantially diminish their value and public benefit. Accordingly, awardees are expected to manage data, resources, protocols, and software in a way that achieves this goal.
Data will be made available through appropriate portals and applicants will designate a central data repository for information regarding data, critical tools, protocols, and reagents developed by this program.
Effort should be taken to work with the BRAIN Initiative: Data Coordination Center(s) for all data submissions.
Data will also be deposited into appropriate public or controlled-access data repositories. Applicants should identify such repositories and describe plans for deposition. For data types that lack suitable public repositories, applicants should indicate their willingness to identify an appropriate alternative solution consistent with achieving the goals of the program.
Applicants are expected to register resources supported by this FOA in the Neuroscience Information Framework (https:/neuinfo.org) and use Research Resource Identifiers (RRID) assigned by https://scicrunch.org in any publications supported by this FOA.
Genomic Data Sharing Plan: If applicants propose to generate genomic data, they must indicate their willingness to abide by the NIH Genomic Data Sharing Policy (https://gds.nih.gov/) and should indicate their agreement to it in the data sharing plan.
Only limited Appendix materials are allowed.
Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign Institutions
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.
This initiative is not subject to intergovernmental review.
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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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.
Applications Involving the NIH Intramural Research Program
The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists 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.
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.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following: This Funding Opportunity Announcement (FOA) solicits applications to develop tools and technologies to routinely conduct germline and somatic transgenic studies and gene editing in the common marmoset with the aim of supporting BRAIN goals of understanding the brain in health and disease. This includes optimization of strategies, tools, and methods to build a scientifically rigorous, ethical, efficient, and cost-effective research infrastructure that can support all aspects of gene editing in marmosets, including assisted reproductive technologies, focused on the brain.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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 for this FOA: Does the research topic or question address an important gap in establishing germline and/or somatic cell gene editing in marmosets? Does the project provide a strong scientific rationale for conducting the study in marmosets? Has the research team carefully documented the value of conducting this research in marmosets instead of other animal, cellular, or in silico approaches? Will the proposed tool(s) significantly facilitate the creation of NHP models of brain disorders in a timely fashion?
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?
Specific for this FOA: Does the team have the necessary expertise in marmoset or other non-human primate research to complete the study? Does the PI/MPI have appropriate experience, training, and/or a record of accomplishment in managing non-human primate reproduction studies?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific for this FOA: Has the applicant(s) provided innovative approaches to develop toolkits that will push the boundaries of gene editing in marmosets, including but not limited to studies aimed at optimizing assisted reproductive technologies, embryonic stem cell culture, ovarian stimulation protocols, development of pre-implantation protocols, standardization of semen collection and freezing, developing molecular genetic tools for gene editing and inducible/tissue-specific studies, creation of CRE driver lines, etc.?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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 for this FOA: Do the applicants provide preliminary data in marmosets or NHP that support the project, or data from failed studies in other organisms that suggest studies in NHP are necessary to address the research question or translate to humans? Have the applicants demonstrated adequate feasibility? Have the applicants documented the limitations, and discussed pitfalls and alternate strategies? Please assess the study design for its strategy to balance potential benefits to human health and/or science with the goals of the Three R’s (replace, reduce, and refine) goals to minimize the numbers of animals used and the refinement of experimental methodology?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific for this FOA: Does the team have the necessary infrastructure to support this project? Have they considered the number of animals they need to achieve their expected results?
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.
Have the applicants provided sufficient justification for how the team will address potential changes to animal husbandry such as special housing or social arrangements, and other potential consequences of genetic manipulation, such as changes in animal welfare?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Not Applicable.
Not Applicable.
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.
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The NIH Project Scientist(s) will have substantial scientific 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 NIDA Animal Genetics Consortium. 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. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed milestones and any changes suggested by NIH staff or the NIH review panel. The Program Official will negotiate with the applicant and agree on a final set of approved milestones which will be specified in the Notice of Award. The NIH Program Official will determine if the awardee has met the milestones required for each year of funding.
NIH reserves the right to withhold funding or curtail an award in the event of:
Areas of Joint Responsibility include:
Areas of Joint Responsibility include close interaction among the participating investigators, as well as significant involvement from the NIH, to manage and assess the project. The awardees and the Project Scientist(s)will meet annually in person andmonthly via conference calls 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.
In addition, investigators will participate in the Marmosets for Neuroscience Steering Committee and comply with all policies established by the steering committee. They will schedule quarterly calls with the awardees ofRFA-MH-20-150 (Marmoset Coordinating Center) andRFA-MH-20-145 (Marmoset Colonies for Neuroscience Research). Awardees are encouraged to acquire animals from the Marmoset Breeding Colonies funded under RFA-MH-20-145 and must deposit relevant data into the Marmoset Coordinating Center.
The awardee agrees to work collaboratively to:
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 Marmosets for Neuroscience 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.
Annual Milestones, along with progress made toward each milestone, must be stated in the annual RPPR.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Amy C. Lossie, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6092
Email: lossieac@mail.nih.gov
Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: dharmendar.rathore@nih.gov
Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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