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.

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-15-002, 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 informatics platforms that will be developed (RFA-EB-15-003. 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 data to the user in age appropriate ways, compile personalized health status information, and securely upload data over the internet to a data center. A third 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.

All three arms of the PRISMS Program will 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.

Research conducted under this FOA will include the development of new sensors, or the integration or re-design of existing sensors, to monitor multiple environmental stressors and physiological parameters correlated with pediatric asthma. The sensors will plug and play , physically or wirelessly, into the overall health monitoring system that will be developed as part of the PRISMS Program. The goal of the PRISMS Program is to create a tool that can be used for epidemiologic research in the pediatric asthmatic population to better understand environmental factors contributing to asthma as well as the physiological responses. All sensor developments should be wearable or non-wearable and non-or minimally invasive and have the ability to transmit data from the sensors to an informatics platform being developed under a companion FOA, RFA-EB-15-003.

The sensors can be developed to detect exposures and response bio-signatures together or alone. The sensors focused on exposure should be capable of detection and speciation of multiple components such as gaseous, particulate, biological (for example, pollen, flagella, etc.) and chemical entities (pesticides, insecticides, plasticizers, constituents of diesel exhaust, tobacco smoke, endocrine disruptors, additive substances such as flavoring agents used in e-cigarettes). The sensors focused at detecting biological response should be non-, to minimally-invasive. The sensors for non-invasive sampling such as exhaled breath samples should detect volatile organic compounds, reactive oxygen species and integrated with metabolomics analysis. Sensors for samples such as blood prick, nasal lavage or induced sputum, that can be performed in toddlers to young adults, could detect mediators of inflammation (cytokines, chemokines, lipid mediators such as lipoxins, resolvins, etc.). Also, sensor devices that can integrate biomarkers with physiological measurements such as spirometry will be strongly encouraged.

This FOA is not intended to support large scale clinical studies involving the recruitment of large numbers of humans study subjects, although it is desirable that sensor systems be tested using pilot studies. It is expected that projects funded through this FOA will be scalable and lead to the development of sensor technologies that can be utilized for large-scale epidemiological studies; however, such expectations are tempered during this funding period.

Research Topics: Illustrative examples of research that would be relevant for the development of U01 applications under this FOA include, but are not limited to:

• Development of clothing-based sensors that can capture particulates from the atmosphere over the course of the day and at the end of the day send the particulate data, as well as location and time of capture, to a mobile platform. Sensors providing chemical speciation information are encouraged.
• Novel unobtrusive wearable sensors such transdermal patches, contact lenses, clothing, armband, watch, etc. for pediatric populations
• Development of energy harvesting sensors, which recharge during physical activity by the child and also provide information on range of physical activity that could be tracked. The sensor system could be a combination of a wearable sensor and a stand-alone, static sensor system.
• Development of age and gender specific wearable sensor systems that are modular and expandable with the child’s physical development.
• Development of a wearable sensor to track exposure to second-hand smoke, and monitor its concentration and duration. The detection of gaseous and polycyclic aromatic hydrocarbons, formaldehyde and acrolein are targets that are strongly encouraged.
• Non Wearable Sensors (static, fixed location, smart in household and community)
• Power-miser sensor versions capable of harvesting energy
• Sensors capable of storing and transferring data at different frequencies and quantities

Collaboration with the PRISMS Informatics Technology Platform Centers and Data Coordination Center

The sensors system should be designed with the capability of data transmittal into wireless communication technologies developed through the PRISMS Platform Technology Centers (supported under RFA-EB-15-003). It is expected that the sensors and platform technologies that emerge from the PRISMS initiative will produce a rich enviro-bio-database that can be mined across a large number of target parameters (location, age, exposure history, social patterns, genomic profiles, as well as electronic health records). Such data may lead to a better understanding of the information pathways regarding disparities in health outcomes, including but not limited to environmental exposures, genetic variations and/or other underlying biological, race/ethnic, social, and familial factors.

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 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.

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.

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:

Tiffani Bailey Lash, Ph.D.
Telephone: 301-451-4778
Fax: 301-480-4973
Email: baileyti@mail.nih.gov

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

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

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed. PD(s)/PI(s) should provide evidence of demonstrated expertise in sensor development (most likely through prior sensor development) and experience working in a collaborative environment. The research team should also demonstrate expertise in various aspects of sensor developent.

All instructions in the SF424 (R&R) Application Guide must be followed in addition to the following: Investigators will be expected to attend Steering Committee meetings two times per year and participate in monthly conference calls to discuss their research progress. It is expected that the PDs/PIs and one other senior member on the cooperative agreement will attend the Steering Committee meetings. Funds to support travel to this meeting should be requested in the budget.

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

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

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

Specific Aims:Describe specific aims that will address the FOA's focus of newly developed, existing, or redesigned wearable and non-wearable sensors that can monitor pediatric environmental exposures, physiological signals, activity and/or behavior in a natural environment to gain new insights into environmental determinants of asthma.

Research Strategy: Applications should describe and include the following informations:

Describe how the sensor technology meets the PRISMS objectives and will significantly impact epidemiological research on environmental determinants of asthma in the pediatric population.

It is imperative to emphasize how the sensor technology proposed is likely to be integrated within a sensor-based health monitoring system. All applications must include a specific section labeled Milestones for each year. Milestones should be well described, quantitative, and scientifically justified and not simply a restatement of the specific aims. The milestones should offer a timeline and a pathway for the development and testing of the proposed sensors within the PRISMS Program. These milestones will be used to judge the success of the proposed research on an individual-project basis. It is expected that the milestones will be adjusted at the beginning of the PRISMS Program and at least annually thereafter to incorporate the progress and direction of the PRISMS Program and to reflect any recommendations of the Steering and Advisory Committees.

Preliminary data should be provided in the application that establishes the feasibility of the sensor system.

Evidence that important barriers, both technical and non-technical, have been identified and convincing strategies (such as preliminary data) to overcome or address them should be included.

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.

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.

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.

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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.

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 project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Does the project address an important problem or a critical barrier to progress in the field? 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?

Is the sensor technology proposed likely to result in a tool that could be integrated within a sensor-based health monitoring system that could be used for epidemiological research of pediatric asthma?

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?

Has the PD(s)/PI(s) demonstrated expertise in sensor development (most likely through prior sensor development)? Does the team have expertise in various aspects of sensor development?

Is there evidence that the PD(s)/PI(s) will collaborate with the PRISMS Program as a whole?

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?

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?

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?

Are project milestones and a timeline clearly articulated and appropriate?

Are all the important technical and non-technical barriers identified, and are the proposed strategies suitable for overcoming them?

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?

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.

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 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.

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 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.

Not Applicable

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

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

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 has 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 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 Program 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 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 will be the primary executive management for the PRISMS Program. The PD(s)/PI(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.

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.

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

A final 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.

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GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
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Telephone: 301-710-0267

Tiffani Bailey Lash, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: baileyti@mail.nih.gov

J. Thomas Peterson, Ph.D.
Center for Scientific Review
Telephone 301-408-9694
e-mail: petersonjt@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.