Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Cancer Institute (NCI) on behalf of the NIH.
Reissue of RFA-RM-14-010
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
RFA-RM-20-008, U01 Research Project – Cooperative Agreements
93.310
This Funding Opportunity Announcement (FOA) invites an application from the currently funded NIH Common Fund-supported 4D Nucleome Network (4DN) Organizational Hub (4DN-OH) to support Phase 2 efforts of this program. The overall programmatic goal of the OH is to provide administrative infrastructure for the 4DN Network and facilitate and coordinate all common activities of the 4DN Network.
December 20, 2019
February 17, 2020
March 17, 2020
No late applications will be accepted for this Funding Opportunity Announcement
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
June/July 2020
August 2020
September 2020
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.
Background
The 4D Nucleome (4DN) NIH Common Fund Program was launched in 2015 with the goal of developing the tools and resources that would enable the characterization of the three-dimensional structure and dynamics of human and mouse genomes and provide deeper mechanistic insights into how the nucleus is functionally organized. The impetus for its selection as a Common Fund program was the growing awareness that understanding the architecture of the cell nucleus may have widespread and profound implications for human health and disease, but our ability to study nuclear organization was hindered by technological and conceptual challenges.
Key deliverables from the initial 5 years of support include: 1) next-generation genome analysis, imaging and computational tools to explore nuclear organization and its relationship with the regulation of gene expression programs, including in single cells; 2) pilot reference maps of the 3D architecture of the interphase nucleus for a select set of eukaryotic cells; 3) validated predictive models of genome conformation/function relationships; 4) first-generation tools to explore nuclear dynamics through controlled disruption of nuclear architecture and imaging of reporter loci in live cells and tissues;,and 5) first-generation community data and metadata standards for the most commonly used 4DN technologies and protocols (https://www.4dnucleome.org/).
A number of outstanding questions and technological challenges remain. These include: 1) better means of studying chromatin dynamics in live cells and in complex tissues, which will likely imply a heavier reliance on high-content imaging-based approaches and methods to distill massive amounts of imaging data; 2) better tools for the controlled disruption of nuclear features to better understand structure/function relationships in dynamic experimental systems; 3) tools to explore molecular components of the functional nuclear architecture that are still undefined, including protein complexes, non-coding RNAs, and the composition and organization of nuclear bodies, compartments and microenvironments; and 4) development of next-generation analytical, visualization and modeling tools that would be accessible and usable by the broader scientific community and could lead to reliable 4D models of genome organization.
These outstanding scientific and technology challenges can be met through the creation of a research environment that promotes multidisciplinary approaches, team science and data integration. The ultimate goal for this endeavor is to deliver data and tools to be used by the broader community to address the role of nuclear organization in health and disease and in lifespan.
The proposed second phase of this program is designed to achieve these goals through the following six initiatives, of which this funding opportunity announcement (FOA) is one:
RFA-RM-20-003 Real-Time Chromatin Dynamics and Function (U01 Clinical Trial Not Allowed)
RFA-RM-20-004 4DN Centers for Data Integration, Modeling and Visualization (UM1 Clinical Trial Not Allowed)
RFA-RM-20-005 4DN Organization and Function in Human Health and Disease (U01 Clinical Trial Not Allowed)
RFA-RM-20-006 New Investigator Projects on 4DN Organization and Function in Human Health and Disease (U01 Clinical Trial Not Allowed)
RFA-RM-20-007 Limited Competition: 4DN Organizational Hub (U01 Clinical Trial Not Allowed)
RFA-RM-20-008 Limited Competition 4DN Data Coordination & Integration Center (U01 Clinical Trial Not Allowed)
Awards funded under these FOAs are anticipated to pursue research activities conducted by multidisciplinary teams of investigators. Awardees from all 6 initiatives will form the 4DN Network, with the overarching goal of understanding the role of nuclear organization in health and disease and in lifespan. Validation and comparisons across studies will be essential to achieve this goal so investigators must be willing to work collaboratively as part of the Network.
Objective and Scope
This Limited Competition FOA invites an application from the currently funded NIH Common Fund-supported 4D Nucleome Network Organizational Hub (4DN-OH) to support Phase 2 efforts of this program.
The 4DN-OH will continue to consist of a single U01 award led by a Program Director/Principal Investigator (PD/PI) with expertise in the administrative management of resource-based operations that serve the biomedical research community, such as reagent-generating consortia or research networks.
The overall programmatic goal of the 4DN-OH is to integrate the efforts of all the funded initiatives of the 4DN Network, and to promote collaboration and communication among network participants. Through the continued development and administration of the 4DN Web Portal, the 4DN-OH will serve as the community-wide resource and point of access for all data, protocols, reagents, resources, and methods developed by 4DN Network investigators, and for publicizing information related to the NIH 4DN Program.
The 4DN-OH will work closely with the 4DN Network Data Coordination and Integration Center (4DN-DCIC), the 4DN Steering Committee (4DN-SC), the Chromatin Dynamics and Function investigative teams, the Centers for Data Integration, Modeling and Visualization investigative teams, 4DN Organization and Function in Human Health and Disease investigative teams, all 4DN Network investigators, and NIH staff in order to accomplish its mission in ways that benefit all units of the 4DN Network.
Specifically, 4DN-OH will be tasked to:
Consortium Responsibilities
This FOA uses the U01 Cooperative Agreement mechanism. Successful applicants will become members of the larger 4D Nucleome Consortium composed of investigators who have been funded in response to at least one of the six related 4DN Network FOAs. In addition to completing the research goals outlined in their applications, successful applicants will be expected to work collaboratively with all members of the 4D Nucleome Network, including the 4DN Network Organizational Hub (RFA-RM-20-007) and the 4DN Network Data Coordination & Integration Center (RFA-RM-20-008), to help develop common standards, metrics for data generation and storage, and data analysis and visualization tools that can be used by the broader scientific community. The 4DN Network will encourage the initiation of new collaborative research projects across the entire network.
A key aspect of this program is the formation of a consortium-type partnership amongst all 4DN Network awardees. Shared responsibilities derived from the use of the cooperative agreement mechanism are described later in this FOA and will be further articulated during the kickoff meeting of the 4DN Network that will take place a few months after awards are made. All 4DN Network investigators will be required to attend this initial 4DN Kickoff meeting, as well as annual 4DN investigator meetings and regular teleconferences with Network members and NIH Staff for the duration of the funding cycle.
All applicants are strongly encouraged to contact NIH Staff to discuss the alignment of their proposed work with the goals of this FOA, and the 4DN Program. A Technical Assistance teleconference will be held for potential applicants. NIH staff will be available to answer questions related to this FOA. Time, date, and dial in information for the call will be announced in an NIH Guide Notice and will be posted on the 4DN website: http://commonfund.nih.gov/4Dnucleome/index.
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.
Need help determining whether you are doing a clinical trial?
The Office of Strategic Coordination (Common Fund) intends to commit $1.5M total costs in FY2020 to fund a single award.
The project period cannot exceed 5 years.
Eligibility is limited to the awardee of RFA-RM-14-010.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not 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.
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.
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.
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:
Ian Fingerman, Ph.D.
National Cancer Institute (NCI)
Division of Cancer Biology
9609 Medical Center Drive Room 6W430
Telephone: 240-276-6250
Fax: 240-276-7861
Email: [email protected]
Key personnel should demonstrate strong scientific, administrative, technical, and management expertise in the areas that are critical to the success of the application, including experience with working productively in collaborative environments; experience with administrative management of resource-based operations that serve the biomedical research community, such as reagent-generating or service-providing consortia or centers; and experience and capabilities in website design and management. Applicants should also describe their plans addressing some of the anticipated challenges of the 4DN-OH.
All instructions in the SF424 (R&R) Application Guide must be followed.
Specific Aims: Outline the specific goals of the project, including major milestones.
Research Strategy: The application sought in this Limited Competition FOA will propose to provide the administrative infrastructure for a research network. In order to fully assess the potential of the applicant to fulfill this important responsibility, the following information is required:
Applicant should provide a list of the ultimate goals/deliverables that will be generated by the U01. Deliverables should be quantitative whenever possible and should include items such as: 1) Organizing the first annual 4DN Network grantees meeting (kick-off meeting) and subsequent annual meetings thereafter; 2) Maintain and continue to improve a 4DN Network community web portal and the 4DN virtual repository; 3) reaching consortium-wide consensus on protocols and data format; 4) making available an E-Manual of protocols; 5) providing 4DN Network-specific and community access to 4DN Network-generated data; 6) development of user-friendly tools for the novice user; 7) continued development of outreach strategy to advertise resources and training programs; and 8) expand social media presence with associated metrics. Before knowing the specifics of the projects that will be supported by the 4DN Program, it may be difficult for the 4DN-OH applicant to predict the exact volume and types of data and resources that will be generated by 4DN Network investigators over the lifetime of the 4DN Program. As the data/resource storage, analysis, and dissemination needs of the 4DN Network change with time, and administrative needs evolve (creation of new working group and committees, organization of small meetings and hands-on workshops, etc.), the 4DN-OH may be asked to implement modifications to their workflow as agreed upon by the 4DN-SC. 4DN-OH applicants should indicate their willingness and aptitude to be flexible in their implementation of 4DN Network coordination.
Management Plan - Describe the plans for management and integration of the 4DN-OH activities, who will oversee the day-to-day activities (e.g., a project manager if not the PD/PI) and how the management structure will support achievement of the proposed goals and milestones. Useful elements of this description include: the organization of the proposed project; its management structure; personnel and leadership structure; and oversight mechanisms for evaluating progress towards milestones. The plan should also describe how the various units will be integrated, and how collaborations or subcontracts, if proposed, will be managed.
Outreach and Training - Applicants should describe a plan and allocate sufficient resources to provide outreach to the user communities to educate investigators within and outside of the 4DN Network about the data, resources, and tools being developed by 4DN investigators. Examples include: presentations, short courses, and symposia offered independently or in conjunction with scientific meetings attended by the user community; web-based tutorials; and user manuals and training guides that describe the features of the 4DN Web Portal and the 4DN virtual repository.
Milestones and Progress - Applicants should define a clear set of goals for the proposed project and annual milestones with metrics that will document progress towards the achievement of the ultimate goals. Applicants should include plans for critically evaluating and revising these milestones on a regular basis. The number and duration of milestones will depend on the project being proposed, so applicants should include these items for every year, as appropriate. Applicants should describe how they will prioritize their activities to ensure that the main goals of the 4DN-OH will be achieved. Milestones may be revised at the time of the award. Applicants should also describe plans to solicit user feedback, monitor 4DN website usage, and otherwise evaluate all aspects of the usability of the website. The 4DN OH should commit to meeting the following milestones:
Data Export and Dissemination – To ensure continuity of operations after the conclusion of the program, applicants should describe plans for developing an export process to permit transfer of 4DN resources from the public-facing web portal to appropriate public repositories and community databases. These repositories may include the Common Fund Data Ecosystem (CFDE) or other resource deemed suitable by 4DN consortium members and NIH staff. Ideally, this would include the web portal mirrored in its entirety with all associated data, metadata, protocols, publications, tools and other consortium generated resources.
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.
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.
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.
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.
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 to this FOA: If the proposed 4DN-OH is fully successful in carrying out its plan and mission, will it have a synergistic effect on the overall performance of the 4DN Network, collaborations between 4DN investigators, and the dissemination of data and reagents to the broader scientific community?
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 to this FOA: Do the project team members have appropriate experience with fulfilling the mission of the 4DN-OH, including the proper scientific background, experience with the administrative management of large research projects or consortium activities, experience with database and professional web portal design and curation, and dissemination of research information to the broader scientific community?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: How innovative are the proposed team structure/interactions, strategies and tools compared to standard team science management and data/reagent/technology sharing approaches?
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?
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 to this FOA: Is the applicant organization concentrating on its core competencies in order to maximize its chances of success? Has the applicant established alliances/collaborative partnerships where they are appropriate or needed to facilitate achievement of the research goals? Does the project take advantage of the best available tools and resources available to the scientific community?
For research that involves human subjects but does not involve one of thecategories 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.
Not Applicable
For Renewals, the committee will consider the progress made in the last funding period.
Not Applicable
Not Applicable
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 the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
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 all 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.
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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://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 https://www.hhs.gov/civil-rights/for-individuals/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.htmlor 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 OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 75, and other HHS PHS, and NIH grant administration policies.
The administrative and funding instrument used for all awards in the 4DN program will be the cooperative agreement (U01 or UM1 grants), 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. A Memorandum of Understanding (MOU) developed by the NIH Common Fund should serve as a guidance document to provide a framework under which relationships between investigators and NIH Program Staff are established. Templates for Confidential Disclosure Agreements (CDAs) and Collaborative Research Agreements (CRAs) have been developed by the NIH Office of Technology Transfer. 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.
Responsibilities of PD(s)/PI(s):
Sharing:
Involvement of NIH Program Staff
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of joint responsibilities:
4DN Consortium Steering Committee
The awardee agrees to the role and authority of the 4DN-SC that is responsible for joint governance of 4DN Consortium activities. The main characteristics and functions of the 4DN-SC are as follows:
4DN Data Release and Use, Software Sharing and Publication Policies
The PD/PI agrees to follow the 4DN Data Release and Use, Software Sharing and Publication Policies as currently stated (see https://www.4dnucleome.org/policies.html), and to follow any updates to these policies that may be approved by the 4DN-SC in the future.
4DN External Program Consultants (4DN-EPCs)
An independent panel of 4-8 External Experts will be appointed on an ad hoc basis by NIH and meet by teleconference or in person with the 4DN Program Staff at least once a year. The 4DN-EPCs will be updated on progress and provide feedback to NIH on adjustments and future directions for the 4DN Network activities. NIH staff will appoint a 4DN-EPC Chair who will attend the annual 4DN Network Investigator Annual Meeting and be invited to participate ex officio in 4DN-SC meetings. All 4DN-EPCs will be given the opportunity to listen to 4DN-SC meetings and to attend the annual 4DN Network Investigator Annual Meeting. The 4DN-OH will support costs for 4DN-EPCs who wish to participate in the 4DN Network Investigator Annual Meeting.
Dispute Resolution
Disagreements that may arise in scientific/technical matters, publication/authorship matters or programmatic matters (within the scope of the award) between award recipients, or between award recipients and the NIH, may be brought to arbitration after first attempting to resolve the issue through the 4DN-SC or its subcommittees, as appropriate. An Arbitration Panel composed of three members will be convened. The Panel will be composed of: a designee of the 4DN-SC 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 members; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure in no way affects the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 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 agreementsare 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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Contact Center Telephone: 800-518-4726
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Ian Fingerman, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6250
Email: [email protected]
David Balasundaram, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1022
Email: [email protected]
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]