Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

Funding Opportunity Title
HEAL Initiative: Human Pain-associated Genes & Cells Data Coordination and Integration Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices
  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
  • May 26, 2022 - Notice of Change to Key Dates for HEAL Initiative: RFA-NS-22-021 Human Pain-associated Genes & Cells Data Coordination and Integration Center (U24 Clinical Trial Not Allowed). See Notice NOT-NS-22-099
  • February 28, 2022 - Notice of Change to Award Budget for RFA-NS-22-021. See Notice NOT-NS-22-085.

Funding Opportunity Announcement (FOA) Number
RFA-NS-22-021
Companion Funding Opportunity
RFA-NS-22-018 , HEAL Initiative: Discovery and Functional Evaluation of Human Pain-associated Genes & Cells (U19 Clinical Trial Not Allowed). U19 Research Program (Cooperative Agreement)
Assistance Listing Number(s)
93.853, 93.866, 93.273, 93.846, 93.393, 93.865, 93.213, 93.121
Funding Opportunity Purpose

The goal of this funding opportunity announcement is to support a Human Pain-associated Genes & Cells Data Coordination and Integration Center as part of the NIH HEAL Initiative’s Program to Reveal and Evaluate Cells-to-gene Information that Specify Intricacies, Origins, and the Nature of Human Pain (PRECISION Human Pain).The Data Coordination and Integration Center will curate, harmonize, and integrate comprehensive -omics and cellular function datasets generated by companion U19 Centers for Discovery and Functional Evaluation of Human Pain-associated Genes & Cells, which include the characterization of functional genetic elements, epigenetic signatures, and molecular/cellular pathways that underlie human pain signal transduction, transmission and processing.

The Human Pain-associated Genes & Cells Data Coordination and Integration Center will lead efforts to establish spatial and semantic standards for managing heterogeneous human pain-associated data types and information, collect and register multimodal human pain-associated data to common neural tissue coordinate systems, and establish a web-accessible information system that can be widely used throughout the research community. A central goal of the PRECISION Human Pain network is to generate comprehensive, integrated datasets, maps, and other resources on human genes and cellular function phenotypes underlying the heterogeneity, pathogenesis and susceptibility to specific pain conditions.

Key Dates

Posted Date
February 01, 2022
Open Date (Earliest Submission Date)
February 17, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 17, 2022 March 17, 2022 Not Applicable July 2022 October 2022 December 2022
October 11, 2022 October 11, 2022 Not Applicable March 2023 May 2023 July 2023

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

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

Expiration Date
October 12, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance on the prescription of opioids for chronic pain despite their poor ability to improve function and high addiction liability. This contributed to a significant and alarming epidemic of opioid addictions and overdose deaths. Innovative scientific solutions to develop alternative pain treatments are critically needed.

Through targeted research efforts, the NIH HEAL Initiative aims to accelerate the discovery and successful translation of pain therapeutics by supporting collaborative efforts to gain a better, more direct understanding of human pain-associated genes, cells, and tissues that underly specific human pain types, conditions and/or diseases. Towards that end, this funding opportunity announcement (FOA) is designed to support a Human Pain-associated Genes & Cells Data Coordination and Integration Center that will work closely with companion U19 Centers for Discovery and Functional Evaluation of Human Pain-associated Genes & Cells to curate and harmonize generated datasets characterizing the functional genetic elements, epigenetic signatures, and molecular/cellular pathways that contribute to human pain signal transduction, transmission, and processing. The Center will also lead efforts to integrate these datasets and generate digital resources, such as interactive maps, machine-readable protocols, data dictionaries, and other materials, that can be used widely by the research community.

Background

This funding announcement is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at: https://heal.nih.gov/.

The advent of single cell -omics and high throughput electrophysiologic technologies provide an immense opportunity to significantly expand currently available datasets concerning gene expression and cellular function of human pain processing cells and/or tissues. For example, several recent transcriptomic and single-cell functional studies utilizing primary neurons from human pain processing tissues; namely dorsal root ganglia (DRG), spinal cord (SC), trigeminal ganglia (TG), and tibial nerves, have identified a number of potential genetic and cellular differences in human sensory neuron electrophysiologic signatures with translational implications. In addition, recent comparative transcriptomic studies of [whole] DRGs obtained from human subjects with or without pain conditions suggest several common genes associated with a small subset of neuropathic and cancer pain conditions. While promising, these data only begin to uncover the breadth of knowledge to be gained in this space and highlight the need to expand datasets to include heterogeneities across specific pain type/conditions comparing variables such as chronic analgesic or other drug use and co-morbid and/or overlapping pain conditions. It also highlights the need for standardization of methods, as approaches for tissue collection, processing, and analysis often vary across individual laboratories, thus posing a tremendous challenge for harmonized data collection, analysis, and reporting that would enable cross-comparison and rigorous validation.

To capitalize on recent technological advances in high throughput analyses of molecular, anatomic, and physiological measurements for single cell and tissue-level characterizations and address the increasing need to enhance data interoperability and harmonization among data producers, the NIH Heal Initiative has created the Program to Reveal and Evaluate Cells-to-gene Information that Specify Intricacies, Origins and the Nature of Human Pain (PRECISION Human Pain). The PRECISION Human Pain network will be composed of a group of Centers supported via two FOAs; the companion FOA, RFA-NS-22-018, will support a group of U19 Centers for Discovery and Functional Evaluation of Human Pain-associated Genes & Cells. The subject of this FOA is the U24 Human Pain-associated Genes & Cells Data Coordination and Integration Center that will curate and harmonize core datasets generated by the U19 Centers and integrate these datasets into digital resources.

Rapid progress in the discovery and understanding of the role of functional genetic elements, epigenetic signatures, and molecular/cellular pathways that underlie human pain processing, as well as integrated data analysis and development of digital assets will require collaborations across disciplines. To effectively achieve the goals of the PRECISION Human Pain network and facilitate advances in pain research, the NIH HEAL Initiative encourages the formation of multidisciplinary research teams including neurobiologists, pain biologists, human pain scientists and/or physicians, and scientists from statistics, physics, mathematics, engineering, and computer and information sciences. NIH and the NIH HEAL Initiative also strongly encourage input from patients and caregivers on the scientific and research goals of PRECISION Human Pain network.

In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. Please refer to Notice of NIH's Interest in Diversity?NOT-OD-20-031?for more details.

The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities. In addition, it is expected that PRECISION Human Pain Centers will work together, operating as a cooperative network to achieve its overall goals. This will include regular meetings and other coordinated activities within the PRECISION Human Pain network as well as the NIH HEAL Initiative. In particular, network Centers will work closely with the HEAL Data Ecosystem, which coordinates data sharing across the NIH HEAL Initiative.

Research Objectives
The NIH HEAL Initiative - PRECISION Human Pain network

In alignment with the goals of the NIH HEAL Initiative’s PRECISION Human Pain network, this FOA intends to support a Human Pain-associated Genes & Cells Data Coordination and Integration Center (DCIC) that will work closely with the PRECISION Human Pain network U19 Centers on the Discovery and Functional Evaluation of Human Pain-associated Genes & Cells to adopt and promote standard terminology, data acquisition protocols, quality control metrics, and metadata requirements to enhance data interoperability and harmonization.

The U19 Centers will consist of multidisciplinary groups of researchers who will conduct collaborative, team-based science utilizing cutting-edge technologies and approaches to generate comprehensive datasets from primary human tissues involved in pain signal transduction, transmission, and processing, including but not limited to DRG, SC, TG, sympathetic ganglia (SG), brainstem, brain, peripheral nerve bundles/fibers, and skin. U19 Center research projects will focus on large-scale, high-throughput analyses of human genes, epigenetic elements, proteome, metabolome, and phenotyping of neuronal and non-neuronal cells at the single-cell and tissue levels, as well as their functional crosstalk that leads to the hyper/hypo-activation of sensory neurons within the context of individual pain types, pain conditions and/or diseases. The DCIC will then collaboratively generate comprehensive, integrated datasets by curating and harmonizing U19 Center-generated data and metadata elements.

Key objectives of the PRECISION Human Pain network are to:

  • Elucidate and validate functional roles of human genes and cellular phenotypes underpinning the heterogeneity, pathogenesis, and susceptibility to specific pain conditions, and
  • Enable and accelerate the discovery and validation of condition/disease-specific human pain therapeutic targets with enhanced translational potential.

In order to maximize the utility of the data, any human biological samples collected and studied or that are derived from existing biospecimens or sources are expected to have been obtained using a documented informed consent process that explicitly allows for future research use and broad data sharing (NOT-HG-20-011; see ENCODE project for informed consent examples). Sources with participant consent for unrestricted access is strongly encouraged. The DCIC will work with the U19 Centers to coordinate standardized consent language for broad sharing across the network and the broader research community, as appropriate. Applicants are also expected to consider Ethical, Legal and Social Issues (ELSI) of tissue collection and to consider return of results to donors or their families.

A central goal of the PRECISION Human Pain network is to build a human pain-associated genes, cellular function and tissue microenvironment resource that can be widely used throughout the research community. The expected outcomes of the network include:

  • Elucidation of comprehensive, high-resolution maps of functional genetic elements (including non-coding RNAs and mircoRNAs), epigenetic signatures, proteome and metabolome signatures, molecular/cellular phenotypes and pathways that underlie human pain transduction, transmission and processing under diverse pain types, conditions and/or diseases.
  • Identification of cellular bases underlying individual susceptibility to diverse human pain conditions, including in conditions of chronic analgesic use, other drug use, SUDs and other co-morbidities and/or overlapping pain conditions.
  • Epigenetic and cellular/molecular profiling of human pain transmission and processing (including cells and molecules of the immune system, myofascial, and musculoskeletal structures), which could significantly contribute to cross-validation of animal pain models, genes, and cells.
  • Identification and validation of potential therapeutic targets for specific pain conditions in human cells and tissues, including in conditions of chronic drug use, SUDs and specific co-morbid and/or overlapping pain conditions.
  • Development of optimized, machine-readable experimental protocols and functional assays utilizing primary human cells and tissues (including neuronal cultures and co-cultures with ganglionic non-neuronal cell types as well as SC and brainstem slices).
  • Datasets and standards that complement and cross-inform other NIH-supported research programs and networks for optimization of induced-pluripotent stem cell (iPSC)-derived cells and organoids for pain therapeutic target validation and screening.

The comprehensive -omics and cellular function datasets generated from this initiative will significantly accelerate validation of therapeutic targets in human pain-relevant cells and tissue as well as facilitate the identification and development of potential markers that reflect target engagement, thus providing valuable assets for translational research and therapeutic development. These studies would be highly informative for multiple ongoing and future pre-clinical and translational programs in the NIH HEAL initiative and the NIH more broadly.

The PRECISION Human Pain network DCIC will be a member of a larger HEAL Initiative Data Ecosystem that will work across HEAL initiative activities to promote integration of a variety of data types. The HEAL Data Ecosystem coordinates data sharing across the NIH HEAL Initiative, including such efforts as generating a metadata model and curation guidance supporting discovery, access to, and reuse of digital assets produced by HEAL-funded projects. In addition, the HEAL Data Ecosystem is generating materials to guide investigators in storing their data in appropriate long-term repositories, leveraging this forementioned metadata to make data easily findable, accessed, and reused within the HEAL Platform, which is a cloud-based and multifunctional web interface that provides a secure environment for discovery and analysis of NIH HEAL results and data. These materials, both developed and upcoming, can be found at HEALdatafair.org.

Research Scope of the Human Pain-associated Genes & Cells Data Coordination and Integration Center

The Data Coordination and Integration Center (DCIC) will establish a web-accessible information system for network-generated data and metadata derived from primary human tissues involved in pain processing by adopting and promoting common coordinate systems and semantic standards. Tissue and cell atlases and common coordinate systems play a fundamental role in gathering, analyzing, communicating, and standardizing data. This FOA embraces existing efforts of the research community (e.g., the International Neuroinformatics Coordination Facility) to collaboratively build up human neural tissue atlases with broadly accessible common coordinate systems for datasets on human pain-associated genes, cellular function and tissue analysis. The DCIC is expected to:

  • lead efforts to establish spatial and semantic standards for managing heterogeneous human pain-associated genes, cellular function, and tissue analysis data types and information;
  • lead efforts to collect and register multimodal human pain-associated genes, cellular function, and tissue analysis datasets to common neural coordinate systems;
  • establish a web-accessible information system to capture, store, analyze, curate, and harmonize data and metadata generated by the PRECISION Human Pain network;
  • generate interactive digital maps of neural tissue with human pain genes, cellular function and tissue analysis datasets; and
  • generate comprehensive, integrated datasets and digital assets on human genes, cellular function, and tissue microenvironment data that may underlie heterogeneity, pathogenesis and susceptibility to specific pain conditions, including in conditions of chronic analgesic or other drug use, SUDs, and other co-morbid and/or overlapping pain conditions.

While the information system and associated digital assets will initially be developed specifically for U19-generated datasets, applicants should consider flexibilities to incorporate other potentially relevant datasets in the future, as well as the overall sustainability and scalability of the digital resources developed through this initiative

There will be two parts to the DCIC: a data coordination component and a data integration and visualization component.

Data Coordination Component

The data coordination component will interface directly with the PRECISION Human Pain network U19 Centers on the Discovery and Functional Evaluation of Human Pain-associated Genes & Cells. Throughout the funding period, it will be essential for this component to work with the U19 Center investigators and Data Cores to define data and metadata types to be collected in support of the overall network goals. Although contributing projects will not yet be known at the time of application submission, expected data elements include: (1) molecular signatures (e.g., transcriptome, epigenome, proteome, metabolome), (2) anatomy (e.g., cell and nerve/neurite location, size, orientation, morphology, and connectivity), and (3) functions (e.g., electrophysiology, functional connectivity). The following data types are likely to be collected: fluorescence in situ hybridization (FISH), single cell RNAseq, immunohistochemistry, cell morphology, neuronal connectivity, electrophysiology, calcium imaging, mass spectrometry-based proteome and metabolome, etc. Due to the heterogeneous nature of the tissue, pain, drug use and co-morbid conditions, as well as the heterogeneous data being collected, a key functionality of the DCIC will be to link and display datasets in space and time and give users the ability to easily browse and navigate datasets on the basis of key metadata fields including (but not limited to):

  • specific human pain conditions, including in conditions of chronic drug use, SUDs and specific co-morbid and/or overlapping pain conditions;
  • specific human tissue type in the pain neuraxis; and
  • sex, age, brain region, cell type, and molecule type.

The data coordination component will develop a secured database that can receive data from the U19 Centers and allows for private collaboration among researchers prior to public release, leveraging the HEAL Platform infrastructure as appropriate. This component will also develop a quality control and quality assurance pipeline for (meta)data ensuring appropriate quality control standards for laboratories within the network. HEAL Initiative-wide metadata models developed by the HEAL Data Ecosystem should also be included. The DCIC may take the strategy of reviewing all data submissions and giving them grades with respect to the adherence of that dataset to the standards set up by the network. The DCIC will also help to establish domain specific quality control metrics, metadata requirements, and controlled vocabularies beyond those required by the HEAL Data Ecosystem to ensure that the data are interoperable and maximally useful to the community.

The data coordination component will work closely with awardees funded under the PRECISION Human Pain network to collect and archive datasets in HEAL-recommended existing repositories, where appropriate, along with experimental and analytical protocols. The DCIC is also encouraged to work closely with the NIH HEAL Initiative’s Data Ecosystem to ensure that data generated by the network is findable and accessible through the HEAL Platform. The DCIC may also help network awardees deposit data into other sustainable databases, such as those supported by the NCBI.

The data coordination component will work with the research community, biomedical journals, and with other interested parties, such as the NIH BRAIN Initiative Cell Census Network (BICCN) to adopt and promote a standard terminology to describe experiments and datasets by leveraging existing resources (e.g., Neuroscience Information Framework, BAMSAllen Brain Atlas). This will include a nomenclature for the cells and neural circuits themselves. It is also highly encouraged that data coordinating centers across the research community and HEAL programs collaborate in implementing and aligning with HEAL Data Ecosystem recommendations, guidance, and infrastructure.

Data Integration and Visual Component

The data integration and visualization component will play a pivotal role in data management and integration and will be expected to be staffed mostly by specialists in informatics. It will process and register data to common neural tissue coordinate systems, generate digital neural tissue atlases, link multiple data elements (e.g., molecular, anatomical, and functional) in space and time for cell type taxonomy, and provide analyses and reports for presentation to awardees, advisors, NIH staff, and the HEAL Initiative Multi-Disciplinary Workgroup. The data integration and visualization component is expected to implement user-friendly data registration tools for the PRECISION Human Pain network to interact with the digital neural tissue atlases to share and cross validate the data. It will also lead the effort to establish spatial and semantic standards that will incorporate multiple ways to define a location in the pain neuraxis, including spatial coordinates, anatomic names, and spatial organizational rules of neural tissue.

The data integration and visualization component will develop tools that provide analytical and visualization capabilities to its end users. It will also develop a database that is broadly accessible to anyone with a web browser to view and access data or tools, protocols, and other relevant information generated by the network. The web site is expected to have a broad user base that will include both naïve users and experienced bioinformaticians and should provide an interface that will accommodate both types of users. Some datasets may require controlled access although it is expected that most datasets will not. The DCIC may, but is not required to, leverage the NIH STRIDES Initiative to support its activities as appropriate. To the extent allowable in alignment with open-access licensure and protection of sensitive data, digital assets crucial to the reproducibility of the research data lifecycle and data reuse, including analytic software and code, should be made shareable and accessible in alignment with the HEAL Platform protocols and infrastructure. To promote broad discovery and reuse, these data and tools can be version controlled, assigned persistent identifiers and appropriate metadata to support their accessibility through the HEAL Platform and other HEAL Data Ecosystem websites.

The data integration and visualization component will be responsible for coordination with other relevant informatics efforts (such as the NIH BRAIN Initiative, SPARC, and the work of the International Neuroinformatics Coordination Facility) and will be expected to identify, use, and support standard practices and pipelines to align the DCIC with community standards, and other data repositories and knowledgebases as appropriate to create a unified spatial and semantic framework and neural tissue and cell information system. The DCIC will have the responsibility for operating an infrastructure that is useful to the community but should use and/or leverage existing infrastructures and standards. These would include persistent identifiers such as digital object identifiers and/or Resource Identifiers. While there will be some parts of the application that propose to do research for optimal solutions, the focus should be on delivering the infrastructure – not on research.

Other Coordination and Communication Functions

The DCIC will also provide the administrative infrastructure and functions necessary to facilitate and coordinate both internal PRECISION Human Pain network communication and activities to maximize the impact of the program as well as external partnerships and outreach. Specifically, the DCIC will be tasked with:

Meeting organization: In cooperation with other Centers and the NIH, the DCIC will take primary responsibility for the planning and logistics associated with organizing the PRECISION Human Pain network meetings that include monthly on-line and annual in-person Steering Committee meetings, and subcommittee meetings involving informatics efforts such as developing and implementing spatial and semantic standards, data/metadata submission and deposition.

PRECISION Human Pain network communication: To facilitate communication across the network and with the HEAL Data Ecosystem, the DCIC will provide resources such as mailing lists, forums, or wikis to enable discussion. When needed, the DCIC will provide computational and data analysis support to the PRECISION Human Pain network members and the NIH to identify knowledge gaps, prioritize research, and prepare reports.

Education and outreach: To facilitate the data use by the broad scientific community, the DCIC will be responsible for coordinating education and outreach efforts. This could include, for example, the development of tutorials, conducting user workshops, use of social media outlets, or other activities not specifically named here.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIH HEAL Initiative intends to fund an estimated total cost of $1M per year, for to fund 1 award, starting with fiscal year 2022 or 2023.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

  • Eligible Agencies of the Federal Government, including the NIH Intramural Program
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Julia L. Bachman, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-7383
Email: julia.bachman@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Required Other Attachments:

Milestones and Timeline (maximum 2 pages): A detailed set of milestones and timeline covering all aspects of the Human Pain-associated Genes & Cells Data Coordination and Integration Center must be presented, which include annual milestones with metrics that will document progress towards the achievement of the ultimate goals. Milestones should be clear, quantitative and actionable, and establish feasibility for all aspects of the proposed research. Milestones are required to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application, not only in peer review, but also in consideration of the awarded project for funding of non-competing award years. Examples include, but are not limited to, milestones that track time to develop data and metadata standards and formats, turn-around time to release submitted data, or analysis and visualization software implementation activities. Applicants should include plans for critically evaluating and revising these milestones on a regular basis. Applicants should describe how they will prioritize their activities to ensure that the main goals of the Center will be achieved. Milestones may be revised at the time of the award, however, applications lacking this information, as determined by the NIH staff, will be considered incomplete and will not be reviewed. Proposed timelines for achieving milestones should be realistic and include necessary steps, while being efficient, without adding unnecessary steps.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

The Center PD/PI funded under this FOA should devote at least 25% effort (3 person months) to the Center project for the duration of the award.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: All applications must include the following sections:

Data Coordination: This section of the research strategy should describe how the Human Pain-associated Genes & Cells Data Coordination and Integration Center (DCIC) will:

  • Work with the PRECISION Human Pain network U19 Center awardees and other interested researchers to define and refine: all data and metadata types, experimental protocols, using and promoting common spatial and semantic standards for neural tissue region, cell types and neural circuits associated with human pain
  • Develop a quality control and quality assurance pipeline for data and metadata ensuring appropriate quality control standards for collaborating U19 Center awardees
  • Develop a streamlined workflow for upload, validation, and dissemination of all relevant types of experimental data as well as associated experimental and analytical protocols in coordination with guidance produced within the HEAL Data Ecosystem
  • Work with U19 Center awardees to collect and archive appropriate datasets in HEAL-recommended existing repositories along with experimental and analytical protocols for long-term storage and ensure data and other digital assets developed are discoverable through the HEAL Data Ecosystem
  • List and define the data to be shared with justification of the data quality and utility. For shared data, propose when it will be made available, where it will be stored, how it will be maintained, and how others will be able to find, access, and reuse it
  • Develop a secured database that can receive and store data that allows for private collaboration among researchers prior to public release, leveraging the HEAL Platform infrastructure as appropriate
  • Plan for sustainability and/or future accessibility of the digital assets and resources developed beyond the initial length of the program, including potential to augment and scale these resources to incorporate datasets generated by investigators outside the network

Data Integration and Visualization: This section of the research strategy should describe how the DCIC will:

  • Lead the effort to coordinate with multiple interested parties to adopt and refine spatial and semantic standards for linking heterogeneous data sets
  • Develop a process for data registration to common neural tissue coordinate systems.
  • Develop interactive digital neural tissue and cell atlases to link and visualize human pain-associated genes, cellular function and tissue analysis datasets
  • Identify, use, and support standard practices and pipelines to align the DCIC with other data repositories and knowledgebases, as appropriate, to create a unified and comprehensive open-access human pain-associated genes and cells information system
  • Leverage existing infrastructures aligned with the HEAL Data Ecosystem
  • Develop innovative strategies to collect and integrate datasets generated by the PRECISION Human Pain network
  • Develop and disseminate user-friendly data registration, data analysis, and data visualization tools that are aligned with the HEAL Data Platform protocols and infrastructure
  • Create a web site that allows anyone to explore the spatially linked data and knowledge

Other Coordination and Communication Functions: This section of the research strategy should describe how the DCIC will:

  • Organize meetings that include the PRECISION Human Pain network Steering Committee meetings, and subcommittee meetings involving informatics efforts
  • Facilitate communication across the network and with the HEAL Data Ecosystem
  • Provide computational and data analysis support to identify knowledge gaps, prioritize research, and prepare reports
  • Coordinate with the HEAL Data Ecosystem to maximize sharing and dissemination of data and digital assets to the pain research and therapeutics development communities.
  • Facilitate the use of human pain-associated genes, cellular function and tissue analysis datasets by the broad research community through education and outreach

Management Plan: This section should describe how:

  • the PD(s)/PI(s) will manage the proposed DCIC, who will oversee the day-to-day activities (e.g., a project manager if not a PD/PI);
  • the management will support achievement of the proposed goals and milestones. Describe the organizational structure of the proposed U24 Center and individual responsibilities; its management structure regarding the data coordination and data integration and visualization components, and other coordination and communication functions; key personnel; section leaders and reporting relationships; a management plan for fiscal accountability and communication. Highlight the relevant expertise of key personnel regarding bioinformatics and data science as it relates to the goals of the Center and the overall network; Recruitment and training of personnel may also be discussed;
  • various components and multiple efforts of the DCIC will be integrated;
  • collaborations or subcontracts, if proposed, will be managed;
  • the U24 Center plans to enhance the collaborative effort among the PRECISION Human Pain network U19 Centers to ensure efficient cooperation, communication and coordination, and resource sharing.

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. Letters of support should indicate the specific activities the individual or organization will perform in pursuit of the DCIC goals; letters of support from individuals or organizations without a specific role in the DCIC should not be included.

Applications are expected to include written statements from the officials responsible for intellectual property issues at all of the applicant institutions (including subcontractors) to the effect that the institution supports and agrees to abide by the resource sharing plans put forth in the application if applicable. Such letters would be clear expressions of commitment. A separate letter should be sent by each participating organization including each subcontractor. Please note that institutional sign-off on the grant application signifies that all relevant components of the institution, including the relevant office handling intellectual property matters have reviewed and approved the document.

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:

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing.Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), , all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It is expected that data generated by HEAL Initiative-funded projects will be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via the HEAL Initiative Data Ecosystem. Additional guidance on data related activities can be found at https://www.healdatafair.org/.

To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:

  • Applicants are encouraged to ensure that data collected by the study conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
  • Applicants are specifically encouraged to incorporate into their planning, an alignment with the guidelines, principles and recommendations developed by the HEAL Data Ecosystem, including but not limited to preparing data to store in selected specified repositories, applying minimal metadata standards, use of core HEAL Clinical Data Elements (CDEs, https://heal.nih.gov/data/common-data-elements), and other necessary requirements to prepare data to connect to the HEAL Data Ecosystem.
  • All new HEAL clinical pain studies are required to submit their case-report forms/questionnaires to the HEAL Clinical Data Elements (CDE) Program. The program will create the CDE files containing standardized variable names, responses, coding, and other information. The program will also format the case-report forms in a standardized way that is compliant with accessibility standards under Section 508 of the Rehabilitation Act of 1973 (29 U.S.C § 794 (d)), which “require[s] Federal agencies to make their electronic and information technology accessible to people with disabilities.” HEAL Initiative clinical studies that are using copyrighted questionaries are required to obtain licenses for use prior to initiating data collection. Licenses must be shared with the HEAL CDE team and the program officer prior to use of copyrighted materials. For additional information, visit the HEAL CDE Program.

The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.

  • Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
  • NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories (NOT-OD-21-016).
  • NIH encourages the use of data standards including the PhenX Toolkit (www.phenxtoolkit.org) (for example, see NOT-DA-12-008, NOT-MH-15-009)
  • NIH encourages researchers to explore the use of the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data (NOT-OD-19-122). The FHIR® standard may be particularly useful in facilitating the flow of data with EHR-based datasets, tools, and applications.
  • NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards, as they are applicable (NOT-OD-20-146). Use of the USCDI can complement the FHIR® standard and enable researchers to leverage structured EHR data for research and enable discovery.

Recipients conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

 

Applications Involving 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 to the NIH Intramural Program, not through the extramural awardee's institution. 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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:
Overall Impact

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

Scored Review Criteria

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

Significance

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

Do the proposed aims and scientific questions align well with the overarching goals and the expected outcomes of the NIH HEAL Initiative PRECISION Human Pain network?

Are the expected results likely to provide a significant scientific resource for the comprehensive discovery and characterization of functional genetic elements, epigenetic signatures, molecular/cellular functions and pathways, and neural circuits that underlie human pain transduction, transmission and processing?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well-suited to their roles in the proposed DCIC? 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 investigators demonstrate significant experience with coordinating collaborative basic research? Does the applicant have experience overseeing selection and management of subawards, if needed?

Has adequate leadership for day-to-day project management activities been described?

Innovation

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: Does the application propose novel organizational concepts for coordinating the research and network that the DCIC will serve?

Does the application propose innovative strategies to integrate and visualize heterogeneous data?

Are there innovative strategies to involve the broad research community?

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Data Coordination

Does the application provide a clear strategy for working with the PRECISION Human Pain network U19 Center awardees and other interested researchers to define and refine all data and metadata types and experimental protocols using and promoting common spatial and semantic standards?

Does the application provide a clear strategy for developing a quality control and quality assurance pipeline for data and metadata submission processes and standards?

Does the application adequately describe how to develop a streamlined workflow for upload, validation, and dissemination of all relevant types of experimental data as well as associated experimental and analytical protocols in coordination with guidance produced within the HEAL Data Ecosystem?

Are there appropriate plans to work with U19 Center awardees to collect and archive appropriate datasets in HEAL-recommended existing repositories for long-term storage?

Does the application include an adequate strategy to develop a secured database that can receive and store data that allows for private collaboration among researchers prior to public release?

Has the applicant provided adequate plans for sustainability and/or future accessibility of the digital assets and resources developed from this program? Are the approaches scalable to potentially allow for incorporation of datasets generated by investigators outside the network?

Data Integration and Visualization

Does the application provide a clear and effective strategy for how the U24 Center will lead the effort to coordinate with multiple interested parties to adopt and refine spatial and semantic standards for linking heterogeneous data sets?

Are plans to develop a process for data registration to common neural tissue coordinate systems included and appropriate?

Does the application provide an adequate strategy to develop interactive neural tissue and cell atlases to link and visualize the human pain-associated genes, cellular function and tissue analysis datasets?

Does the application provide a clear strategy to identify, use, and support standard practices and pipelines that align the U24 Center with other data repositories and knowledge bases as appropriate to establish a unified and comprehensive open-access human pain-associated genes and cells information system?

Does the application adequately describe efforts to develop and disseminate user-friendly data registration, data analysis, and data visualization tools?

Does the application provide an adequate strategy for creating a website that allows anyone to explore the spatially linked data and knowledge?

Other Coordination and Communication Functions

Does the application provide adequate and effective strategies for how the proposed DCIC will:

  • organize meetings that include the PRECISION Human Pain network Steering Committee meetings and subcommittee meetings involving informatics efforts;
  • facilitate communication across the Network members;
  • provide computational and data analysis support to identify knowledge gaps, prioritize research, and prepare reports; and
  • facilitate the use of human pain-associated genes, cellular function and tissue analysis datasets data by the broad research and education community?

Does the application provide an adequate strategy for how the U24 Center will coordinate with the NIH HEAL Data Ecosystem to maximize sharing and dissemination of data and digital assets to the pain research and therapeutics development communities?

Does the Management Plan adequately describe:

  • how the PD(s)/PI(s)will manage the proposed project;
  • the DCIC's organizational structure and individual responsibilities;
  • how management will support the U24 Center to achieve the proposed goals and milestones;
  • how multiple efforts will be integrated;
  • how collaborations or subcontracts (if proposed) will be managed; and
  • how to enhance the collaborative effort among the PRECISION Human Pain network U19 centers to ensure efficient cooperation, communication and coordination, and resource sharing as appropriate?

Environment

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?

Additional Review Criteria

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

Specific to this FOA:

Overall Coordination
Is there a clear and sound plan for communication and coordination within the proposed DCIC and across the PRECISION Human Pain network demonstrating an integrated Center project capable of performing the functions specified in the FOA? Is there a clear description on how the DCIC will coordinate with the NIH HEAL Initiative’s Public Access and Data Ecosystem (https://heal.nih.gov/about/public-access-data), to maximize sharing and dissemination of datasets and digital assets to the pain research and therapeutics development communities?

Milestones and Timeline
Are clear, quantitative, and actionable, milestones and timelines proposed? Do the milestones establish feasibility for all aspects of the proposed research? Does the application include plans for critically evaluating and revising milestones on a regular basis? Are there additional key experiments that need to have milestones? Will the overall milestones provide adequate information to evaluate yearly progress of the DCIC as a whole? Are the timelines proposed for achieving the milestones realistic and inclusive of necessary steps, but also efficient without adding unnecessary steps?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NINDS, 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.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the 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 responsibilities as described below:

  • Define the details for the project within the guidelines of this FOA.
  • Oversee and perform the scientific activities.
  • Administratively manage the Center grant.
  • Accept close coordination, cooperation, and participation of NIH HEAL Initiative program staff in the scientific, technical, and administrative management of the PRECISION Human Pain network. Inform the NIH program official of all major interactions with other members of the Steering Group.
  • Provide milestones and cost for the Center operation to the NIH HEAL Initiative program staff as requested (usually at the outset of the award and annually thereafter, but also at other times as requested by the program staff).
  • Use human pain-associated tissue samples, common neural tissue coordinate systems, and standard nomenclature to generate and integrate the data, metadata, and knowledge.
  • Demonstrate capability and flexibility for modifying human neural tissue regions of study, data formats and metadata.
  • Ensure that the products of the production effort meet the quality standards.
  • Share data and resources according to the data release and resource sharing policies developed for and by this project as appropriate and consistent with achieving the goals of the PRECISION Human Pain network.
  • Fully disclose algorithms, software source code to the other members of the Network for the purpose of scientific evaluation.
  • Not disclose confidential information obtained from other members of the Network.
  • Submit data for quality assessment and/or validation in any manner specified by the Steering Group, the External Scientific Panel, and/or the NIH HEAL Initiative program to ensure scientific rigor;
  • Adhere to NIH policies regarding intellectual property and other policies that might be established during the course of this activity. Awardees will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
  • Participate in PRECISION Human Pain network activities, including periodic meetings to report the Center’s progress, and coordinate publication of research results.
  • Coordinate and collaborate with other U.S. and international groups that may be generating relevant human pain-associated genes, cellular function and tissue analysis datasets;
  • Serve as a member of the PRECISION Human Pain network Steering Committee.
  • Submit periodic progress reports as agreed upon by the Steering Committee.
  • Accept and implement the common guidelines and procedures approved by the Steering Committee, External Scientific Panel, and NIH.

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

  • A Program Officer will be assigned to this award. The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance for the overall project within the NIH HEAL Initiative and will ensure that the generation of human pain-associated genes, cellular function and tissue analysis datasets and resources that are relevant to the diverse research community served by the NIH Institutes and Centers. The Program Officer will be responsible for milestone negotiations to ensure that the milestones are achieved and goals are being met. In addition, the NIH Program Officer is responsible for monitoring and implementing the NIH Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/index.htm), as well as the NIH HEAL Initiative Public Access and Data Sharing requirement - https://heal.nih.gov/about/public-access-data. The NIH Program Officer may attend Steering Group meetings as a non-voting participant. The NIH Program Officer will be named in the award notice.
  • One or more extramural NIH program staff member may be assigned as the Project Scientist(s) for this award. The same person may serve as the Project Scientist for multiple HEAL Initiative awards. The Project Scientist(s) may interact scientifically with the PDs/PIs and other named personnel of that award, as a partner in the research, including providing technical assistance, advice, and coordination for the PRECISION Human Pain network and its component parts. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the PRECISION Human Pain network Steering Committee and that NIH staff will be given the opportunity to offer input to this process. One NIH Project Scientist will participate as a member of the Steering Committee and will have one vote.
  • An NIH HEAL Initiative PRECISION Human Pain network Project Team will be composed of Program Officials and other relevant extramural staff from NIH Institutes and Centers and the Project Scientist(s). Its primary role is to ensure that the datasets and resources generated represent the diverse interests of the participating NIH Institutes and Centers, advise on human pain-associated genes, cellular function and tissue analysis datasets, resources, and activities relevant to their individual Institute/Center mission, monitor overall progress, attend Steering Group meetings as required, and report back to the NIH HEAL Initiative, as well as their Institute/Center.
  • The NIH HEAL Initiative PRECISION Human Pain network Project Team will establish an External Scientific Panel (ESP) to help evaluate the progress of the PRECISION Human Pain network.
  • NIH intramural scientists involved in the PRECISION Human Pain network will have the same rights and responsibilities as the comparable extramural scientists involved in the PRECISION Human Pain network. An intramural scientist may not receive salary, equipment supplies, or other remuneration from awards resulting from this FOA. The intramural scientist must obtain written approval of his/her NIH Institute Scientific Director for the amount of resources that may be allocated to the project. The approval must also specify that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research. The participation of an intramural scientist is independent of and unrelated to the role of the NIH Project Scientist(s). The involvement of intramural scientists needs to be consistent with NIH Policy. http://sourcebook.od.nih.gov/ethic-conduct/ethical-conduct-toc.htm

Areas of Joint Responsibility include:

PRECISION Human Pain network Steering Committee:

The Steering Committee will be composed of the PD(s)/PI(s), Project Scientist(s) and External Scientific Panel members (experts to be named after award). The Steering Committee may also include designated representatives from the HEAL Data Sharing Ecosystem, as appropriate. The Steering Committee will be established to help monitor progress, encourage improvements, and coordinate the production of human pain-associated genes, cellular function and tissue analysis datasets and resources through the PRECISION Human Pain network. It is anticipated that additional coordination mechanisms might be set up with other U.S. and international groups that may join this effort. The PRECISION Human Pain network Steering Committee members will meet periodically to plan and design activities, review and discuss progress, and establish priorities and policies. A chair will be designated on a rotating basis as needed. Each PD(s)/PI(s), and external scientific advisor will have one vote each and the NIH will have one vote through the participation of the Project Scientist(s). The frequency of meetings will be determined by the Project Scientist(s) who will be responsible for scheduling the time and place and for preparing concise proceedings or minutes which will be delivered to the Steering Committee members within 30 days after the meeting. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

The PRECISION Human Pain network Steering Committee will:

  • Discuss progress in meeting the research community's need for human pain-associated genes, cellular function and tissue analysis datasets and resources.
  • Facilitate the development of uniform procedures and policies, for example for data standards, quality measures and assessment, nomenclature and annotation conventions for data depositions, and so forth.
  • Awardee members of the Steering Group will be required to accept and implement the common guidelines and procedures approved by the Steering Group.
  • Coordinate and improve human pain-associated genes, cellular function and tissue analysis datasets data production, for example by reporting progress, disseminating best practices and collectively evaluating new procedures, resources, and technologies.
  • Establish subcommittees as needed to address particular issues. Subcommittees will include representatives from the PRECISION Human Pain network, the NIH HEAL Initiative PRECISION Human Pain network Project Team, and possibly other experts. Subcommittees may be formed to: 1) develop and implement data production and analysis standards including spatial and semantic standards for integrating heterogeneous data sets and information; 2) address data submission, management, and analysis issues; 3) develop quality standards and methods for quality control and assurance; and 4) develop common reagents and informatics tools. In these cases, common policies, uniform practices (as needed), and data exchange will be critical to the success of the effort and will enable harmonization and eliminate duplication/overlap.

External Scientific Panel (ESP):

The ESP will provide recommendations to the NIH HEAL Initiative PRECISION Human Pain network Project Team and the PRECISION Human Pain network about the progress and scientific direction of all components of the program. The ESP will be composed of four to six senior scientists who represent broad research community and have relevant expertise, although the membership may be enlarged permanently or on an ad hoc basis as needed. The ESP will meet at least twice a year; some meetings may be conducted by telephone conference. At least once a year, there will be a joint meeting with the Steering Committee for the members of both ESP and Steering Committees to interact directly. Twice a year the ESP will make recommendations regarding progress of the PRECISION Human Pain network and present advice to the NIH HEAL Initiative PRECISION Human Pain network Project Team about changes, if any, that may be necessary in the HEAL Initiative PRECISION Human Pain program.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

Scientific/Research Contact(s)

Julia L. Bachman, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-7383
Email: julia.bachman@nih.gov

D.P. Mohapatra, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Fax: 301-402-2060
Email: dp.mohapatra@nih.gov

Michael L. Oshinsky, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: michael.oshinsky@nih.gov

Inna Belfer, MD, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-435-1573
Email: inna.belfer@nih.gov

Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: 301-827-5899
Email: devon.oskvig@nih.gov

Melissa Ghim, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone:
301-529-6570
Email: melissa.ghim@nih.gov

Rachel Altshuler, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5873
Email: rachel.altshuler@nih.gov

Joe Bonner, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-8303
Email: joe.bonner@nih.gov

Mark Egli
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-594-6382
E-mail: megli@mail.nih.gov

Aron Marquitz, Ph.D.
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-435-1240
E-mail: marquitzar@mail.nih.gov

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Email: nindsreview@nih.gov

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Jeni Smits
National Institute on Aging (NIA)
Phone: 301-827-4020
Email: jeni.smits@nih.gov 

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@mail.nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Erik Edgerton
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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