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 Biomedical Imaging and Bioengineering (NIBIB)

Funding Opportunity Title

Pediatric Research using Integrated Sensor Monitoring Systems (PRISMS): Data and Software Coordination and Integration Center (DSCIC) (U24)

Activity Code

U24 Resource-Related Research Projects Cooperative Agreements

Announcement Type

New

Related Notices

  • May 7, 2015 - Notice of Applicant Information Webinar for the NIBIB Program on Pediatric Research using Integrated Sensor Monitoring Systems (PRISMS): U01, U54, U24. See Notice NOT-EB-15-007.
  • February 19, 2015 - Notice of Intent to Publish a Funding Opportunity Announcement for Pediatric Research using Integrated Sensor Monitoring Systems (PRISMS): Data and Software Coordination and Integration Center for Asthma (DSCIC) (U24). See Notice NOT-EB-15-006 .

Funding Opportunity Announcement (FOA) Number

RFA-EB-15-004

Companion Funding Opportunity

RFA-EB-15-002, U01 Research Project Cooperative Agreements
RFA-EB-15-003, U54 Specialized Center- Cooperative Agreements

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

93.286

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage U24 applications for the development of a data and software coordination and integration center (DSCIC) that will coordinate and integrate outputs from the Informatics Technology Platform Centers (supported under RFA-EB-15-003) of the Pediatric Research using Integrated Sensor Monitoring Systems (PRISMS) Program, which also includes an initiative to fund development of sensors for pediatric asthma populations (supported under RFA-EB-15-002). The three FOAs together (RFA-EB-15-002, RFA-EB-15-003, RFA-EB-15-004) will make up the PRISMS Program. The central mission of the PRISMS Program is to develop sensor-based integrated health monitoring systems to serve as research tools to measure pediatric environmental, physiological, and behavioral factors in epidemiological studies of asthma, and eventually other chronic diseases, in the pediatric population. The three arms to the PRISMS Program will work very closely together to ensure functionality of the overall systems.

It is expected that this DSCIC will focus on coordinating and integrating data acquired on environmental and behavioral pediatric exposure factors and physiological parameters in natural environments, as well as developing tools to process the data. A successful DSCIC will ensure consistent annotation of data and tools generated within the PRISMS program, incorporate (without replicating databases) relevant non-PRISMS data into the PRISMS resource; support integration of relevant data and tools to allow for seamless exploration of the PRISMS program’s output by a broad range of biomedical researchers; support linkages to outside knowledge bases, data portals, and resources; support training in integrated sensor monitoring data science skills; build innovative access and query tools to disparate databases hosting multiple data types; and disseminate the resulting tools and resources to the broad range of biomedical researchers.

Key Dates
Posted Date

March 25, 2015

Open Date (Earliest Submission Date)

May 1, 2015

Letter of Intent Due Date(s)

May 1, 2015

Application Due Date(s)

June 1, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. No late applications will be accepted for this Funding Opportunity Announcement.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2015

Advisory Council Review

August 2015

Earliest Start Date

September 30, 2015

Expiration Date

June 2, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Purpose

The purpose of this funding opportunity announcement is to develop a data and software coordination and integration center (DSCIC) that will coordinate and integrate outputs from the Informatics Technology Platform Centers component (supported under RFA-EB-15-003) of the Pediatric Research using Integrated Sensor Monitoring Systems (PRISMS) Initiative, which also includes an initiative to fund the development of sensors technology for pediatric populations (supported under RFA-EB-15-002).

The goals of the DSCIC are to:

  • Enable pediatric research by providing unified community access for analysis of diverse environmental and behavioral pediatric exposure.
  • Undertake research to enable unified community access and analysis of the diverse environmental and behavioral pediatric exposure data, pediatric sensors data, and analytical tools that are generated by the PRISMS program, to enable access to the data science research undertaken by the DSCIC which includes integrating PRISMS data and data available from other related research efforts.
  • Support the overall aims of the PRISMS program by undertaking the role of a coordinating center for the PRISMS programmatic activities e.g., by establishing relevant common metadata standards for the all data types and analytical tools that are a part of the PRISMS program as well as interactions with various relevant NIH initiatives (such as BD2K and CHEAR) and other relevant community projects.
  • Support dissemination of PRISMS resources to enable the study of a broad range of pediatric environmental exposure concerns, including access to the data science research undertaken.
Background

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), on behalf of National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Environmental Health Sciences (NIEHS), National Library of Medicine (NLM), and Office of Behavioral and Social Sciences Research (OBSSR) , intends to create a new Program by publishing three Funding Opportunity Announcements (FOA) to solicit applications for research on the development of pediatric sensor-based health monitoring systems with an initial focus on pediatric asthma.

Accumulating evidence is pointing toward exposures in the modern environment as contributors to the etiology and severity of many pediatric health care problems such as asthma, cancer, and childhood obesity coupled with Type 2 diabetes. Despite recent gains in knowledge of environmental contributions to the causation of chronic disease in children, major questions about the impact of the environment on children's health remain unanswered due to the lack of exposure metrics.

Asthma is a common condition of childhood currently affecting approximately 7 million children in the United States or 9.3% of the pediatric population. It is a chronic condition characterized by inflammation of the lower respiratory track airways prone to acute exacerbations secondary to a variety of triggers including, but not limited to, infections, pollens, smoke, mold, chemicals, etc. Encouragingly, mortality rates secondary to asthma appear to be decreasing, however its morbidity in children remains substantial. Data suggest that asthma is the third most common cause for hospitalization in children less than 15 years old. It is a leading cause of school absenteeism with more than 14 million lost school days in children who had an asthma exacerbation in the previous year.

Significant disparities exist among children with asthma. For example, racial and ethnic disparities exist with African American and Puerto Rican children incurring a disproportionate part of the burden. Moreover, children from lower socioeconomic conditions tend to be disproportionately affected. In a recent report, the prevalence rate of asthma among children whose health status was described as fair or poor was 37% compared to only 15% among those defined as being in good health and 7.5% in those with a very good or excellent health status.

Recent technological advances in wearable and non-wearable sensors, microelectronics integration and miniaturization, low-power electronics, wireless networking, mobile computing, and cloud computing offer new ways to collect and interpret data on environments, behaviors, physiology, and health.

The development and use of an array of sensors to collect real life environmental and physiological data among pediatric patients could enable the rigorous testing of many hypotheses about environmentally-related chronic pediatric illnesses such as asthma. Sensors can be coupled with wireless communication systems, data treatment algorithms, and visualization tools, for a robust integrated health monitoring system.

The work required to develop health monitoring systems to study pediatric asthma will be accomplished using three related FOAs to create the Pediatric Research using Integrated Sensor Monitoring Systems (PRISMS) Program. One FOA (RFA-EB-15-003) will fund U54 Centers to create new informatics platforms that will support smart mobile devices that collect data from multiple sensors, analyze the data, present data to the user in age appropriate ways, compile personalized health status information, and securely upload data over the internet to a data center. This FOA (RFA-EB-15-004) will support a Data and Software Coordination and Integration Center (U24) that will coordinate and integrate outputs from the PRISMS Program. A third FOA (RFA-EB-15-002) will fund the development of arrays of wearable and non-wearable wireless sensors, for monitoring users environmental conditions, physiological signals, and activity and behavior and that will "plug and play", physically or wirelessly, into the informatics platform

All three arms of the PRISMS Program will be expected to work very closely together to ensure functionality of the systems as a unit, as well as the individual projects.

Research Objectives and Requirements

The PRISMS DSCIC will be expected to address significant data science and tool development challenges associated with integrated monitoring systems datasets to enable important advances in our understanding of environmental determinants of pediatric asthma. NIH expects that the datasets generated within the PRISMS program will act as a core for the DSCIC projects since these will be consistently generated, and there is a programmatic commitment to deep metadata annotations. In addition to undertaking computational and algorithmic work, the DSCIC will also address data science challenges specifically related to providing a uniform and coordinated access to the scientific community distributed databases (primary focus here being the databases created in the PRISMS program by the informatics platform technology centers established under RFA-EB-15-003 (which are, in turn, working with the sensor development teams funded through RFA-EB-15-002) that hold a large diversity of data types, electronic signatures, and tools to access them.

The companion PRISMS Informatics Platform Technology Centers FOA (RFA-EB-15-003) will support new PRISMS Informatics Platform Technology Centers (PTCs) that will integrate data from multiple sensors, analyze the data, present data to the user in age appropriate ways, compile personalized health status information, and securely upload data over the internet to the DSCIC. Each PTC will be responsible for generating one or a few data types, analyzing the data to build signatures, and providing access to the data, metadata, signatures, and SOPs via integration with the DSCIC. Each PTC will also be responsible for building software and analytical tools to provide access to its own data and signatures. The PTCs are then expected to work closely with each other, with the DSCIC, and with NIH staff to provide an integrated user experience for all of the PRISMS data. The primary responsibility of building the knowledge environment leading to such an integrated user experience is with the DSCIC.

Integrated Knowledge Environment

To meet the goals of this FOA, and the PRISMS program, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) on behalf of other NIH Institutes and Centers (ICs) anticipate that innovative data science approaches to integrated access, querying, visualization, and analysis of PRISMS and PRISMS-like data acquired on environmental and behavioral pediatric exposure factors and physiological parameters in natural environments would be essential. Unified access would support an integrated knowledge environment that can be used to obtain access and use to facilitate the research aims of many groups across the broad biomedical research community.

The activities of the DSCIC will be focused on data and software integration, providing infrastructure and analytical capability to support the ability of the community to run queries on its own data, and providing the capability to seamlessly query across diverse data and signature sources from the PTCs and other related data sources outside the PRISMS consortium. Such seamless queries should accommodate different database and software interfaces.

While innovative new solutions are encouraged, so is building upon existing open-source community tools or projects. It is also critical, however, to maintain flexibility and innovation both in the types of data science research undertaken during the course of this project as well as software engineering approaches that will be adopted. Such flexibility is essential given the potential uncertainty regarding the data types that will be the core part of PRISMS PTCs and rapidly evolving pace of science in the field. However, given the constraints of scale and data quality for the PTCs, the range of data types will be constrained. While many of these data types can be scientifically anticipated in the DSCIC application, it is also anticipated that the PTCs and the DSCIC will work together to coordinate the transfer of data from the various platforms to the data coordination center. A suitably robust and flexible approach should be able to adapt to incorporate new, diverse data types.

Innovative solutions in enabling a knowledge environment including the associated software, technical, infrastructural solutions, are clearly necessary for a DSCIC. Other essential features of the knowledge environment would include scientifically meaningful metadata annotations, and visualization and analytical tools to support multiple types of data integration activities. The data sources supporting the knowledge environment should include datasets and signatures from funded PTCs, and other data and tools relevant to PRISMS programmatic goals. The data should be presented through a user-friendly web-interface, and the DSCIC should address the needs of both the typical biomedical researcher and the expert computational researcher in accessing and using PRISMS resources. Flexibility in the implementation plan including for the single-user interface is crucial, as the DSCIC implementation plan may be adjusted after award to accommodate the approaches and data from the PTCs that will be funded after the DSCIC application is due. The web-interface built and maintained by the DSCIC will also be the public face of the entire PRISMS program, so professional design and software elements should be incorporated. In addition, it would be helpful to provide the community with useful summaries of the content of the PRISMS and related resources available for querying and browsing. The DSCIC will build an integrative knowledge environment that will be used to advance the understanding of the interconnections between environmental and behavioral pediatric exposure factors and physiological parameters. To that end, the DSCIC is expected to conduct research and development of approaches, methods, software, tools, and other resources relevant to PRISMS-type data to enable management (e.g., approaches for developing efficient querying of distributed databases storing diverse data types, suitable data and metadata formats, provenance, standards, ontologies, and as relevant, interoperability, etc.), processing, and annotation. Development of novel methods of visualization, statistical and computational analysis, simulation, and modeling as applicable for generating an integrative understanding and classification or predictions of perturbation datasets would be core data science research areas for the DSCIC. The main aim of the data science research should be to enhance the value of the PRISMS resource and other environmental and behavioral pediatric exposure factors public domain data for a broad segment of the biomedical research community.

Data Integration

Data integration is a substantial data science challenge. In the particular case of the PRISMS program, data integration critically involves relating data acquired on environmental and behavioral pediatric exposure factors to physiological parameters, including additional knowledge from non-PRISMS sources to make the PRISMS resources more valuable and useful. In integrating non-PRISMS data to other types of data it might be useful to consider other relevant data science challenges, such as those associated with multiplatform data (desktop, cloud-based storage, etc.), multisensor data (accelerometers, gyroscopes, thermistors, chemical sensors, etc.), or data with special considerations (e.g., sparse data, heterogeneous data, or very large or very small datasets), or efficient access of distributed databases serving different data types. The utility of other, non-PRISMS community resources could be key in undertaking a number of data integration tasks, e.g., knowledge of disease interconnections may be extracted and synthesized from information sources such as existing public databases and published literature. NIH recognizes that the DSCIC application will be written in the absence of information about the PTCs and the sensor development projects that will form the new PRISMS consortium. This can be challenging. Scientifically, one way to address it is by utilizing public domain datasets as exemplars to describe the types of data integration algorithms that would be built along with detailed description of the general guiding principles on collaborations with PTCs that could have newer data types.

Collaborative Environments and Technologies

It is anticipated that novel data science challenges will have to be addressed in providing an integrated access to PRISMS and other data resources to the broader scientific community. One aspect of this challenge is how to engage and provide access to PRISMS data and tools to a diverse user community that includes biomedical researchers, computational experts, and big data scientists. Potential solutions may include (but are not limited to) proposing knowledge environments or research commons; scalable, extensible, and maintainable methods of data and metadata curation; novel and robust approaches of data attribution and provenance; and support PRISMS analysis using external data sets.

Support Unified Access to PRISMS PTC Resources

The success of the project requires the DSCIC to work with the PTCs to provide unified access to the PRISMS-related data, signature, and tool resources to the user community through a web portal or by other methods. The user community is expected to encompass typical biomedical researchers, epidemiologists, and computational scientists, amongst others; each of whom has different needs and requirements for data and signature access. A core scientific requirement for the DSCIC would be to enable a PRISMS user to execute scientifically feasible queries on the entire PRISMS matrix. To enable this, the PRISMS program will be set up such that each instance of a platform (PTC) will upload data to the DSCIC at least once a day, and more often if needed. The NIBIB and other interested NIH Institutes and Centers understand that this is another challenging part of the application since the PTC implementations are not available to the DSCIC applicant at the current time. The scientific challenge can be met by describing the best software design to achieve these goals along with a description of suitable backup plans as well as principles of collaboration with the PTC and the PRISMS consortium to achieve this overall aim.

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.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIBIB intends to commit approximately $1.5M in FY15 to fund 1-2 awards.

Award Budget

Application budgets are not limited but should reflect the actual needs of the proposed project. Typical direct costs for Centers range between $600,000 and $1,000,000 per year.

Award Project Period

The project period is limited to 4 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Vinay M. Pai
Telephone: 301-451-4781
Fax: 301-480-1614
Email: paiv@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

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:

Specific Aims: The FOA seeks to create a central data and software resource for integrating and facilitating access, analysis, and dissemination of data and software generated within the PRISMS program. Applicants should outline specific aims to address these goals.

Research Strategy: Applications should describe the following:

  • The overall vision of the DSCIC and how this meets the PRISMS objectives.
  • The proposed process for creating a data repository with the capability to store/aggregate all primary and processed data and associated metadata generated by the PRISM Informatics Platform Technology Center(s) (see RFA-EB-15-003 for more information).
  • Plans to collaborate with the PRISMS Informatics Platform Technology Center(s) to establish a data submission pipeline, quality control metrics, provenance checking, and minimal metadata elements required to deposit PRISMS data into the repository.
  • Plans to combine and analyze various formats of data made available from the PRISMS Informatics Technology Center(s) including environmental and behavioral pediatric exposure data, pediatric sensors data, etc.
  • Overall approach and methods to establish a data portal for user-friendly community access to PRISMS data (both raw and processed datasets), metadata, and visualization tools. This web-based interface should provide controlled access to both PRISMS participants and the broader scientific community, enable federation to relevant external databases and data resources and facilitate the direct submission to the repository of limited types of additional data generated within and outside of PRISMS for specific collaborative analyses (e.g., genomic data in a specified format, or electronic health records)
  • Plans to establish a software clearinghouse which will collect software developed within the PRISMS program and make them available to the broader community.
  • Plans to collaborate with PRISMS Informatics Platform Technology Center(s) to develop and implement the policies and procedures for data sharing as well as create systems to facilitate such sharing, consistent with the goals of the program;
  • Demonstrated expertise to enable data security and maintain confidentiality of personally identifiable information
  • Specific methods for integration of data generated by outside (i.e. non-PRISMS) sources
  • Technical capabilities to provide interoperability of the PRISMS data with other databases through federation (e.g. linkage to the Comparative Toxicogenomics Database, dbGAP, ENCODE, GEO, CF Metabolomics, CIDR, RoadMap Epigenomics, CHEAR, BD2K);
  • Public dissemination of software and data capabilities available within the PRISMS program, consistent with the goals of the program;
  • Technical capabilities and strategies for designing the data repository and management systems in such a way to maximize sustainable functioning in the future, even under limited or no funding; and
  • Description of server maintenance, software maintenance and upgrades, and security and backup processes.

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

Specific Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected to be included in the application. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. A dissemination plan guided by the following principles is thought to promote the largest impact:

  • The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
  • The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
  • The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.
  • Given the long-term goals of this initiative to create software and tools for pediatric data science research that will serve as a resource to biomedical researchers across the nation, applicants are expected to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This application may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

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? 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? Does the overall vision of the DSCIC meet the PRISMS Program objectives?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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? Do the investigators have technical capabilities to provide interoperability of the PRISMS data with other databases through federation (e.g. linkage to the Comparative Toxicogenomics Database, dbGAP, ENCODE, GEO, CF Metabolomics, CIDR, RoadMap Epigenomics, CHEAR, BD2K) ? Is there demonstrated expertise in the team to enable data security and maintain confidentiality of personally identifiable information?

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is the process for setting up the data repository with the capability to store/aggregate all primary and processed data and associated metadata generated by the PRISM Informatics Platform Technology Center(s) well-reasoned? Are the plans to collaborate with the PRISMS Informatics Platform Technology Center(s) to establish a data submission pipeline, quality control metrics, provenance checking, and minimal metadata elements required to deposit PRISMS data into the repository well-reasoned and appropriate? Are the plans to combine and analyze various formats of data made available from the PRISMS Informatics Technology Center(s) including environmental and behavioral pediatric exposure data, pediatric sensors data, etc., reasonable?

Are the overall approach and methods for establishing a data portal for user-friendly community access to PRISMS data (both raw and processed), metadata, and visualization tools, well-reasoned and appropriate? Does the web-based interface provide controlled access to both PRISMS participants and the broader scientific community, enable federation to relevant external databases and data resources, and facilitate the direct submission to the repository of limited types of additional data generated within and outside of PRISMS for specific collaborative analyses (e.g., genomic data in a specified format, or electronic health records), consistent with achieving the goals of the program? Are the plans to establish a software clearinghouse that will collect software developed within the PRISMS program and make them available to the broader community reasonable and feasible? Are the plans for collaborating with PRISMS Informatics Platform Technology Center(s) to develop and implement the policies and procedures of data sharing as well as to create systems to facilitate such sharing well-reasoned and practical, consistent with achieving the goals of the program? Are the plans for public dissemination of software and data capabilities available within the PRISMS program appropriate? Are the specific methods for integration of data generated by outside (i.e. non-PRISMS) sources well-reasoned? Are the technical capabilities and strategies for designing the data repository and management systems in such a way to maximize sustainable functioning in the future adequate?

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

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? Are the described server maintenance, software maintenance and upgrades, and security and backup processes adequate?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan; and 4) Software Sharing Plan.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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.

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75 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 responsibility for:

  • Conducting the scientific research in the Center, reporting progress and milestones or objectives to NIH staff, coordinating research plans with other members of the network to ensure the maximum utility of the work to the network, reporting results to the scientific community, and disseminating approaches, methods, software, and tools broadly.
  • Abiding by the governance of the PRISMS program through the Steering Committee and recommendations from the Independent Experts Committee.
  • Agreeing to be active participants in the PRISMS program, including attending meetings and teleconferences of the Consortium, and participating in collaborative activities. The Steering Committee will recommend the frequency with which the meetings and teleconferences will be held.
  • Providing goals and milestones or objectives at the time of award and summaries of progress toward those goals at regular intervals as requested by the Steering Committee. The milestones or objectives will be reviewed annually (and at other times, if necessary), and new milestones or objectives will be negotiated with the NIH Program Officers as needed.
  • Working with the Program Directors and other PD(s)/PI(s) on Consortium goals and milestones or objectives after the award has been made.
  • Agreeing to abide by any policies -- including those regarding intellectual property, data and software release, publication of Consortium papers, and others that arise -- that are
  • recommended by the Steering Committee and approved by the NIH Program Staff, as well as applicable NIH policies, laws, and regulations.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

  • One or more NIH Program Officers will serve as the Project Coordinator(s) for the PRISMS award; if there is more than one Project Coordinator, one of them will be designated as the Lead Project Coordinator. The Project Coordinator(s) will provide the day to day substantial NIH scientific programmatic involvement with the awardee that is anticipated during the performance of the activities supported by the Cooperative Agreement.
  • The NIH Lead Project Coordinator for this award will serve on the PRISMS Network Steering Committee and will have one vote.
  • NIH Project Coordinator will assist the Steering Committee in developing operating guidelines and consistent policies for dealing with situations that require coordinated action.
  • The NIH Project Coordinator will help the other Steering Committee members to coordinate the group process of exchanging information about research approaches and protocol designs and of developing Consortium policies.
  • An NIBIB Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Program Officer will perform the initial analysis of Center milestones or objectives, and will work with the Center PD(s)/PI(s) on any milestone or objective renegotiations.

Support or other involvement of industry or any other third party in the study, e.g., research participation by the third party, provision of study resources, or special access to study results, data, findings, or resources, may be appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will be allowed only following notification of and concurrence by the NIH Program Officer.

The Steering Committee

This is the primary executive management for the PRISMS Program. The PI(s)/PD(s) of the awards and the NIH Lead Project Coordinator will serve on the Steering Committee. The Steering Committee will:

  • Identify scientific and policy issues that need to be, or can benefit by being, addressed at the PRISMS Program level.
  • Develop recommendations to the Project Team for addressing such issues.
  • Steer common data structures, software and hardware to ensure interoperability.
  • Coordinate the dissemination of the activities and products of the PRISMS Centers to the wider scientific community.
  • Develop operational guidelines, including frequency of meetings, items requiring voting, number or proportion of votes required to pass any initiatives, etc.
  • Coordinate any issues of joint relevance to the PRISMS Program relating to individual Center or U01 milestones or objectives between the Centers PD(s)/PI(s).

The Independent Experts Committee:

  • This committee will be composed of senior scientists with relevant expertise who are not PI(s)/PD(s) or supported by an award under the PRISMS Program. NIH will appoint the members of the IEC. This group will participate in the annual grantees meetings, review of progress reports, and other activities as needed to provide an independent review of the Program progress. The IEC will: Be responsible for reviewing and evaluating the progress of the PRISMS Program.
  • Be expected to have a pediatric medicine subgroup, a sensor subgroup, and a computer science subgroup that will independently monitor the effectiveness of the approaches being taken by the Program.
  • Report to the NIBIB Program Officers.
  • Appoint members to the IEC and select one member as chair.
  • Allow NIBIB and other NIH Program Staff to attend IEC meetings as non-voting participants.

The Independent Experts Committee (IEC) will be responsible for reviewing and evaluating the progress of the PRISMS Network. In particular the committee is expected to have a pediatric medicine subgroup and a computer science sub group that will independently monitor the effectiveness of the approach being taken by the Network. The IEC will report to the NIH Program Officers. NIH will appoint members to the IEC and select one member as chair. NIH Program Staff may attend the IEC meetings as non-voting participants.

The Pediatric Research Using Integrated Sensor Monitoring Systems (PRISMS) Program is the set of interconnected projects that will be funded in response to RFA-EB-15-002, RFA-EB-15-003 and RFA-EB-15-004 to develop sensor-based integrated health monitoring systems to study asthma within the pediatric population. The success of this overall program will partially be dependent upon cooperation across the different projects in the Program. To facilitate this cooperation a combination of regular reporting across the network, annual face to face meetings, establishment and reporting of milestones, and governance by a steering committee will be used. The PRISMS Program will rely on collegial and cooperative interactions among its members, and with other initiatives that may emerge.

Each year there will be a PRISMS grantees meeting, where annual progress will be critically discussed. Each funded Center and U01 within the PRISMS program will present its research findings at this meeting. There will also be two Steering Committee meetings per year. The annual grantees meetings will be held in the Washington, DC locale and the applicants must budget for these meetings accordingly.

Areas of Joint Responsibility include:

Not Applicable

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 arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the award recipient(s) 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for a multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instruction on how to submit the report are posted at http://grants.nih.gov/grants/policy/myf.htm.

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

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

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Vinay M. Pai
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4781
Email: paiv@mail.nih.gov

Peer Review Contact(s)

J. Thomas Peterson, Ph.D.
Center for Scientific Review
Telephone 301-408-9694
Email: petersonjt@csr.nih.gov

Financial/Grants Management Contact(s)

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: huffj@mail.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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