NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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

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. This FOA (RFA-EB-15-003) will fund U54 Centers to create new informatics platforms that will support mobile devices that collect data from multiple sensors, analyze the data, present the data to the user in age appropriate ways, compile personalized health status information, and securely upload the data over the internet to a data center. A second 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 wearable and non-wearable sensors for asthma that can monitor the users' environmental conditions, physiological signals, and activity and behavior and that will "plug and play", physically or wirelessly, into the mobile platform.

All three arms of the PRISMS Program will be expected to work very closely together to ensure functionality of the overall system, as well as the individual projects. Details of this coordination are laid out in section VI.2.

There are multiple challenges to the realization of broad acceptance and sophisticated adoption of sensors and information technology in everyday research. A major challenge involves the design of effective tools. Issues include lack of common standards for data collection and data exchange, lack of common data elements for data harmonization and dissemination, a lack of modularity in the interface systems so that a system only is useful for a single project, inadequate tools for visualizing and creating knowledge from data, and a lack of secure communication modalities for the wireless transmission of data and information flowing back and forth from the user.

Besides the technical challenges, there are major challenges relating to usability of devices. Issues like need for user input when taking measurements, need for recharging batteries, or need for calibration can doom studies to failure. There is a need for user-friendly software tools and information technology support for key stakeholders, especially in association with data generated by emerging sensor technologies.

There are also significant opportunities associated with the use of an integrated system to collect environmental, physiological and behavioral data. A key advantage is the scalability of integrated sensors and mobile devices such as smart phones. The technology scales in two ways. First, smart phones are becoming ubiquitous so that a major component of a monitoring system (an informatics, data processing, and data presentation platform) is already in place without any requirement of deploying it. Second, the sensors that will generate the data often lend themselves to the same fabrication technologies that have been used in the making of computers enabling low-cost, reliable devices for many sensing applications. Finally, a major part of this system (the platform) can be designed once and then used for multiple studies and applications.

This FOA, for creating an information technology platform to support new pediatric exposure sensor development, addresses these multiple considerations in conjunction with announcements RFA-EB-15-002 and RFA-EB-15-004.

This FOA encourages applications for the development of an innovative pediatric information technology platform. This platform is part of a larger system and this initial discussion will describe the exact role and boundaries of the platform in the system.

In broad terms, the platform will be the part of the monitoring system that can be invariant across applications. Wherever practical, existing software and systems should be utilized in developing this platform. It is expected to consist of the following elements:

• Software interface that resides on a user’s smart phone, mobile device, or wearable device (e.g., smart watch)
• Software and standards for securely moving data from the phone to the data center
• Software and standards for acquiring data from sensors to the phone (e.g. WBAN, Android app service)
• Software for presenting information to the participant (e.g. Android app activity, Processing)
• Software to configure and control the system for a variety of experimental designs (e.g. lab view, Android app)
• A wearable participant identity module (hardware and/or software) that, at a minimum identifies, the participant to all sensors and permits user transparent identification of identity, time, and location for all sensor data

Wherever practical the software and standards should be open or at least readily shared. This research and development effort will devise and validate a system that has common elements that can be readily programmed for a variety of investigations and investigation specific sensors. A hypothetical use for the platform follows: To study environmental risks for asthma an investigator wants to use this system to collect data on pollen, secondary smoke, medication use, and simple pulmonary function tests. Assuming that the necessary sensors have been developed, the investigator will use the platform to collect all data from sensors, to provide feedback and instructions to the user, and to transmit data to the data center. Utilizing the open software of the platform the investigator will be able to program all aspects of the experimental design including how and when different samples are taken, how data is processed, and how information and instructions are presented to the user. The platform will also have responsibility for providing identity, time, and location information for all data records. The complete system will function as much as possible with no or minimal user intervention.

The platform should demonstrate utility and usability by targeted stakeholders; i.e., researchers, healthcare providers, and participants and families, that could benefit from its development. The emphasis will be on creation of a modular platform that can control and accept data from multiple sensors (starting with the sensors developed within RFA-EB-15-002 of the PRISMS Program). Once data are accepted, then the platform should integrate the information into the system for short-term storage and processing with algorithms developed by the investigator. Data will be uploaded at least daily into the data and software coordination and integration Center funded under this initiative RFA-EB-15-004. The interface should be modular and developed in a way that promotes usability among the stakeholders. This usability includes standardization of data entering the system into frameworks that are consistent amongst devices, visualization of data that supports knowledge and methods for interacting with the participants collecting data that includes communicating not only about problems, but also age-appropriate feedback (e.g., age-appropriate contacts with participants for data problems, feedback for use or for reporting a change in status, etc.).

The platform will require a flexible modular interface for participants that can be used in both a mobile and wearable format that supports low-burden participation with the device (i.e., not requiring manual uploads, and simple and engaging formats for displaying of their data and data collection status, feedback and other communications). In addition, the platform should include an interface for other key stakeholders that brings together all the sensor data from the initiative and provides a usable format for visualizing and organizing information. The platform should also facilitate wireless data collection and store forward capabilities that happen without any participant action. The platform should be designed for a pediatric population. The platform is not required to cover the full pediatric age range but investigators need to clearly identify the target population they are designing for.

Potential applicants are advised to consult with the Scientific/Research Contact listed for Section VII for appropriateness of submission to this FOA.

The scope of this FOA is limited to mobile and informatics technology development. Some examples of the utility of the information technology platform that should be addressed in response to this FOA include, but are not limited to:

• Developing a usable interface for the key stakeholders. Including:
  • A research and healthcare interface that is able to process and display data from all sensors that conform to the platform data protocols.
  • A flexible interface for participants that can be used in both a mobile and wearable format that supports participant use of the device (i.e., displaying of their data, feedback and other communications). The interface should have the ability to collect and store forward time and ID stamped data from all the initiative’s sensors.
• Employing existing standards, if applicable, or developing new standards, if necessary, so that all sensors in the initiative are using common data standards and data elements to foster data harmonization and dissemination
• Developing stakeholder specific tools within the platform for data presentation and visualization, for data collection, for data analysis, for sensor programming and control, and for secure data transmission
• Developing software interoperability and compatibility with other devices, such that data from the platform can be efficiently uploaded into the electronic health record (EHR) and the personal health record (PHR)
• Establishing secure communication modalities to transmit and receive data, including developmentally-appropriate communications with participants
• Developing technology for sensor performance evaluation of software tools, algorithms, and data collection methods

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.

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

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.

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.
  • 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.
• 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.

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

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

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

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

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

• 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).

Applicants can access 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

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:

William Heetderks, MD, PhD
Telephone: 301-496-9388
Email: heetderw@mail.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	6
Project	6

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Projects: Three to six projects may be included. The scope of the projects in total must cover all aspects of the platform. Examples of projects might include user interface, sensor standards protocol, data processing and acquisition control, etc.

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Project Summary/Abstract: The application should include a succinct project summary of the proposed work. State the proposed Center's broad, long-term objective, specific aims, and the significance to the field of Biomedical Imaging and/or Bioengineering. Define the relevance of each proposed project to the overall theme and goals of the program.

Project Narrative: Provide the Project Narrative of the entire U54 application.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: State concisely the overall vision of the proposed Center. This should not be specific aims of the projects, but should be overarching and at a high level.

Research Strategy: Describe how the projects of the U54 will interact to provide a functional, scalable platform and how this platform center will collaborate and interact with other members of the PRISMS Program.

Describe how the components of the Center, including key personnel, will interact within the Center, why each is essential for accomplishing the overall Center goals, and how the organization of the components into a Center will create an entity that is greater than the sum of its parts in terms of generating results that will be important for the greater biomedical research community.

Describe the strategy for dividing the platform development among the proposed projects. Identify the weakest points in the overall platform and propose alternative approaches for these points.

Letters of Support: Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as senior/key personnel and Other Significant Contributors included in the application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services.

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:

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

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.

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.

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package. The Admin Core should include funds for two participants to the yearly meetings of the full PRISMS Program as well as funds for regular teleconferences.

Personnel: The budget should include a detailed justification for key personnel. The PD/PI or each of the PD(s)/PI(s) is expected to devote at least 3 calendar months of his/her efforts to the U54 Center. Salaries for support positions in the U54 Center are permitted. No overlap of time and effort between the U54 Center and other funded projects is permitted.

Supplies: Consumable supplies related to the operation of the U54 Center such as office materials are permitted.

Service Contracts: Service Contracts for major equipment items are allowed.

Travel: Domestic and foreign travel for U54 Center personnel is permitted, if the travel is directly related to the activities of the U54 Center.

Consultants: Consultants and any associated costs are permitted.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Describe general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives.

Research Strategy: Describe the overall administrative and organizational oversight and management of the Center.

Describe the roles and contributions of other staff who will be involved in the Administrative Core. Do not repeat information that is included in the biosketches.

Describe the U54 Center operating procedures. Specifically, the applicant should address the following:

Overall leadership and personnel capacity, including but not limited to the following:

• Administrative, operations, and meeting support staff;
• Business and/or legal expert staff;
• Other staff required to support the U54 PRISMS Center as a whole;
• Working with diverse communities;
• Developing software;
• Technical development of mobile data standards; and
• Managing a community-driven standards development process

Leadership Plan

• Plan for coordination of the individual projects.
• Coordination with the rest of the PRISMS Program will be managed.
• How disagreements within the center be managed.

Plans for internal evaluation and self-assessment, including:

• Progress reports;
• Modification of plans of an individual project for the greater good of the Center
• Assessment and anticipation of researcher needs; and
• Prioritization and incorporation of improvements into operations and software that enhance its utility for research.

Letters of Support: Do not include any letter of support here.

Resource Sharing Plan: Not Applicable

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.

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

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

When preparing your application in ASSIST, use Component Type Project.

Applications for the U54 center should be organized with up to six project components that address specific elements of the platform. These projects should be chosen so that the projects, taken as a whole, produce a complete platform with all the required elements. A project, for example, could be 'software and standards for moving data from sensors to the smart phone', or 'user interface for the pediatric population'.

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

SF424 (R&R) Cover (Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package.

Personnel: The budget should include a detailed justification for key personnel under this project component. If the level of effort for a project will vary significantly over the duration of the project this should be reflected in the budget.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project Name)

Specific Aims: State concisely the rationale and specific aims of this project and explain how it fits into the function and organizing framework of the Platform.

Research Strategy: The research project must contribute to a complete platform that will interact seamlessly with the sensors, the data center, and the user. The platform must provide research investigators with a high level of programmability for developing studies.

Discuss how this project fits with the other projects and explain in detail how the Specific Aims of the project will be achieved.

Identify key milestones for the project and alternative approaches for all high risk components. Provide a timeline for the milestones.

Discuss the role and contributions of the leader(s) of the Project. Do not repeat information that is included in the biosketches.

Describe:

• Contribution of this project to the overall Platform;
• Background;
• Significance;
• Innovation and/or utilization of existing tools and standards;
• Preliminary Studies;
• Approach and alternatives

Letters of Support: Do not include.

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:

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 (Project Name)

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 (Project)

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

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) using ASSIST or other electronic submission systems. 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.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). 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.

In order to expedite review, applicants are requested to notify the NIBIB Referral Office by email at {Zullost@mail.nih.gov} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 center proposed).

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

Does the U54 Center address an important problem or a critical barrier to progress in the field? If the aims of the U54 Center 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? How will the U54 Center significantly contribute to the overall success of the PRISMS program?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the overall center and the individual projects? 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? Is appropriate expertise available to cover all elements of the platform? Do the investigators have a track record of collaborating with other teams? Do they have a track record of modifying aims to accomplish an overall goal that extends beyond their project? Does the staff have relevant expertise (e.g., working with diverse communities, developing software, technical development of mobile data standards; managing a community-driven standards development process) needed to achieve goals of PRISMS? Is the percent effort of the PD/PI adequate?

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? The overall goal of this center is the development of an innovative platform; that is a platform that can be widely used to study environmental and behavioral exposure in the pediatric population. Will this platform scale, be easily configured, be easily used, ensure privacy, and make use of existing technology wherever practical? Is it likely to be widely adopted by the research community?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the U54 Center? 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?

If the Center 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? Are the approaches for the projects making up the center well-reasoned and appropriate? Have the investigators identified all potential weak points in the system and provided back up strategies? Will the individual projects integrate well into the overall platform? Is the allocation of resources across the projects appropriate through the duration of the project? Are the proposed interfaces/tools to be developed likely to facilitate access to information on mobile standards? Are plans for identifying and implementing standards adequate? Are they designed to allow input from other PRISMS components as well as other appropriate members of the broader scientific community? Does the application describe a plan to provide the coordination and structure with the U01 Sensors and the U24 Data Centers to enhance the functioning of the PRISMS program as a whole?

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 agreements in place for the use of any standards, software, or devices that are not open source?

As applicable for the Center 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.

Integration of the U54 Center

Will the center function as a true integrated Center rather than as a collection of unrelated research projects and support services? Will the whole Center be greater than the sum of its individual components? Do coordination and integration among the proposed components reflect a cohesive research program? Does the center have a plan to integrate with the other components of the PRISIMS Program including the data coordination center and the sensor projects? Does the center have a plan to ensure input and output interoperability between its platform and a platform developed by another center within the PRISMS Program?

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

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

Not Applicable

Not Applicable

Not Applicable

As applicable for the Center 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.

Not Applicable

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

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

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

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

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.

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.

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 or U01, reporting progress on milestones to NIH staff, coordinating research plans with other members of the Program to ensure the maximum utility of the work to the overall Program, 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) within the PRISMS Program on 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 Project Coordinator(s) for each PRISMS award; if there is more than one Project Coordinator, one of them will be designated as the Lead Project Coordinator. The Project Coordinators(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 Program Steering Committee and will have one vote.
• The 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 NIBIB 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 NIBIB 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 will:

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 that 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.

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.

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

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 Center Telephone: 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

William Heetderks, MD, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-9388
Email: heetderw@mail.nih.gov

Melinda Jenkins, PH.D
Center for Scientific Review
Telephone: 301-437-7872
Email: jenkinsml2@csr.nih.gov

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

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

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