Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Advancing Translational Sciences (NCATS)

Funding Opportunity Title
Screening for Conditions by Electronic Nose Technology (SCENT) (U01 Clinical Trial Optional)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-TR-21-009
Companion Funding Opportunity
None
Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.350
Funding Opportunity Purpose

This FOA is seeking applications for a portable sensing device to detect volatile organic compounds (VOCs, i.e. scents or odors) emanating from skin and to develop a catalog of VOCs as distinct signatures for at least 20 human diseases and conditions. These sensing devices must be able to associate VOC patterns using artificial intelligence to patients with various conditions for diagnostic purposes along with capabilities to incorporate and integrate vital signs. For VOC monitoring, these sensing devices can be Electronic-nose (E-nose) technology, Gas Chromatography (GC) or any sensing technology able to detect VOC patterns associated with disease. This new program is called SCENT, which stands for Screening for Conditions by E-Nose Technology.

To ensure project success, this FOA requires multidisciplinary collaborations and a team science approach. Groups may include a combination of the following: Biomedical engineers, material scientists, biosensing experts, software engineers, chemists, clinicians, clinical trialists, biostatisticians, data analysts and/or other relevant experts in academia and industry.

Key Dates

Posted Date
February 03, 2021
Open Date (Earliest Submission Date)
May 10, 2021
Letter of Intent Due Date(s)

May 10, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 10, 2021 Not Applicable Not Applicable October 2021 January 2022 April 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

Expiration Date
June 11, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of the SCENT FOA is to enable the development of a disease-agnostic platform for the diagnosis and monitoring of a wide range of disease conditions thereby catalyzing the use of the technology for the clinic and beyond. Detection of Volatile Organic Compounds (VOCs) emanating from skin should be the primary focus in the conceptualization and application of this SCENT platform to differentiate and quantify disease-specific VOC signatures. SCENT should employ an array of chemical gas sensors, a sample handling system and a pattern recognition system. Pattern recognition using artificial intelligence and machine learning integrated into the VOC detection should provide a higher degree of selectivity and specificity into the system and are expected to enable the diagnosis, prediction, and monitoring of at least, twenty (20) human diseases and conditions by the end of the five (5) year project. The breakdown of required disease conditions is described in Specific Research Objectives below. The incorporation of vital sign measurements such as temperature, pulse rate, respiration rate, blood pressure etc. is an additional requirement as these can expand and discriminate the data learning sets along with VOC pattern recognition for sensitive and specific disease diagnoses and monitoring.

Background

It is well known that dogs can be trained to detect the scent of various medical conditions including cancer, Parkinson’s disease, hypoglycemia, epileptic seizures and narcolepsy. This is possible because the dog’s olfactory system contains 300 million receptors whereas the human nose has only 5 million receptors. This FOA seeks to mimic or emulate the biological sense of smell for disease diagnosis but in a more robust, standardized and mechanized platform. For example, unique VOC skin signatures are already identified in symptomatic and asymptomatic malarial infections vs. uninfected cases. The SCENT platforms must be readily adaptable to the detection of a variety of human diseases and conditions limited only by the development, availability and quality of the training and validation data sets for VOC signatures and vital signs for the machine learning competency. Consequently, a catalog of VOC patterns that are specific to a number of human diseases and conditions will be established.

The recent advances in biosensing, micro-electromechanical systems (MEMS) and nanotechnology combined with artificial neural networks, artificial intelligence/machine learning (AI/ML) and smart phone technologies could make a multifunction portable or wearable SCENT device a reality. The innovation/challenge is to combine these technologies into devices that measure VOCs and vital signs on skin, then correlate those patterns to disease signatures through AI/ML.

The SCENT device is envisioned to be used in a hospital or clinical setting, at the Point of Care, in the home or workplace. The key substrates for SCENT will be small molecules with low boiling points (VOCs), i.e., scents or odors emanating through skin, which can be standardized to account for person-to-person differences in skin permeability by, at least, two ways, namely Total Evaporative Water Loss (TEWL) or skin impedance. Intermittent testing may be done with a handheld device held over the skin, while continuous monitoring (of chronic diseases) may be done with a wearable device. The researchers can decide on intermittent diagnostic devices or wearable devices based on their disease(s) expertise and the diseases addressed. However, investigators must plan to develop at least one wearable device for a chronic disease by the end of the 5-year project.

Leveraging Existing Research Resources: Applicants are strongly encouraged to leverage existing research resources for their studies whenever possible including improvements to existing prototypes. Additionally, NIH has developed innovative solutions that will improve the efficiency, quality, and impact of the process for turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public through programs such as: NCATS Clinical and Translational Science Awards (CTSA) Program, patient data resources and repositories. Applicants are encouraged to leverage all available internal (e.g. home institutional) and external (e.g. external institutional, NIH, and NCATS) resources to identify clinically relevant patient populations.

Specific Research Objectives

This initiative seeks to advance the development of novel, safe and effective biosensing and detection technologies for volatile organic compound (VOC) signatures of various human diseases and conditions from human skin and associated vital signs. To this end, leveraging dedicated engineering and artificial intelligence systems are required. This initiative anticipates the implementation of such technologies into everyday settings and routines for detection, diagnosis, prediction, and monitoring of disease conditions in clinical, community or applied settings. It is envisioned that these technologies will complement traditional blood analysis or invasive, painful, inconvenient, expensive, and highly technical procedures to monitor the onset, progression, and resolution of disease. Wearable devices and internet-of-things are highly encouraged.

1. Assembly and integration of the prototype SCENT platform: The SCENT platform must be comprised of a VOC sampler; a sensing technology for VOCs such as an electronic nose, or a gas chromatographic system (GC); sensors for vitals such as temperature, heart rate, respiration rate, etc.; AI/ML capabilities to distinguish the totality of vital signs and VOC skin signatures across many human diseases and conditions for accurate diagnosis; and an intuitive, user-friendly interface.

Design of experiment (DoE) techniques are encouraged for minimizing unnecessary steps in device design and validation. These preclinical development strategies will increase the likelihood of success in meeting eventual clinical performance requirements. Additionally, a systems engineering approach must be applied to product development and preclinical performance testing of the proposed device to establish a robust proof-of-concept feasibility. The sampling system/s will have to be validated against standard mixtures of VOCs (see below) with and without in vitro skin models. Novel skin sampling designs are encouraged.

The E-Nose is generally an array of a number of materials including conducting polymers, quartz crystal microbalances, fluorescence sensors, semi-conducting metal oxides, etc. The collective signals are processed in an artificial neural network and pattern recognition software. For GC, the detector can be a mass spectrometer (MS), flame ionization detector (FID) or other novel detection methods. Identification of the VOC components by comparison to an MS data base is desirable, however, the pattern recognition is more important. It should be noted that this FOA does not seek to discover new biomarkers. Additionally, basic studies on the functionality of VOCs will be considered nonresponsive.

For off-the-shelf components, compatibility of software must be considered even before assembly of the SCENT platform. The prototype must be validated and tested for sensitivity and accuracy against Certified Reference mixtures of VOCs (e.g., EPA 524 Update Ketones Mix available from multiple vendors).

Quality by Design (QbD) is required and must be prominently described in the application. QbD will allow for ease and precision of future manufacturability (Good Manufacturing Practices) and ensure that device to device differences are at a minimum (e.g., synthesis of sensor arrays must be repeatable), while adverse events that are of device origin are limited.

Adoption of human-factors-engineering and usability-engineering principles must also be considered as part of QbD during the development process. This includes criteria such as comfort and ease of use to ensure user acceptance and compliance.

Additionally, VOC sensing approaches must incorporate design specifications and performance criteria for risk mitigation of potential measurement interferents including, but not limited to: compounds introduced during patient treatment such as drugs, plasma expanders, and anticoagulants; and substances ingested by the patient such as alcohol or nutritional supplements. Lastly, the proposed approaches must address other potential causes of examination (analytical) interferences, such as: chemical, physical and detection artifacts; non-selectivity and non-specificity of detection; and other sources of error that might affect disease diagnostics. Risk mitigation and alternative methods are expected.

Process analytical technologies (PATs) are required and must be prominently described in the application. PATs must be considered in the SCENT platform for accuracy and precision of measurements between devices and between patients. PATs for devices are needed to verify the working condition of each device within an acceptable range and may include standard VOC mixtures, pressure meters, temperature sensors, etc. PATs for patient-to-patient standardization are required to normalize for individual differences between patients that can affect the quantity (and perhaps quality) of VOCs sensed by the detectors and may include skin temperature sensors, skin permeability sensors (e.g. Transepidermal Water Loss [TEWL], skin impedance, etc.) or skin stiffness among others.

Most of the technological components required to build the SCENT sensing platforms are already developed and used for other purposes (e.g., environmental monitoring). The innovation in this initiative will be to bring together expertise in these technologies and couple them with clinical and disease expertise to develop an integrative, noninvasive device that will be used for the diagnosis of a range of human diseases and conditions. The metrics/requirements for a successful SCENT platform are accuracy, sensitivity and selectivity comparable to or exceeding current standard, FDA-approved diagnostics. Portability, accessibility, and affordability are also key considerations for SCENT.

Since SCENT can potentially have global applicability and use, it must follow the principles of ASSURED (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free and deliverable to end users) criteria, outlined by the World Health Organization (WHO), which provides a good framework for evaluating point of care devices specially for resource-limited environments.

2. Software Development. Use of commercially available pattern-recognition and machine learning software is allowed. The sensitivity and accuracy of the software must be tested on surrogate samples as above. In addition, reference/training and validation sets from actual clinical samples must be used to show proof of principle of the machine learning algorithm.

3. Testing SCENT on Patients. Data training sets must be collected on known positive, symptomatic patients, and negative/healthy subjects as benchmarked against the current standard FDA approved method.

This FOA requires plans for the diagnosis of, at least, two (2) disease conditions by the end of the project’s second year; five (5) by the end of the third year; ten (10) by the end of the fourth year and twenty (20) by the end of the project and, at least one wearable for a chronic disease. These numbers are based on the expectation that a SCENT prototype already exists in the applicants’ portfolio of work at the start of the project. Thus, the first two years may require some minimal assembly, incorporation of vital signs sensors and validation of the prototype and the machine learning capabilities. This is to be demonstrated by the diagnosis of at least two (2) disease conditions. By the third year, collection of data for these two conditions may continue to further improve the training sets. Note again that negative control subjects are required. At the same time, the collection of data for another three (3) or more conditions must commence for a total of at least five (5) disease conditions diagnosed by the end of the third year. By the fourth year, the applicants’ SCENT platform is required to be functioning as expected based on QbD principles and another five (5) or more disease conditions diagnosed for a total of at least ten (10) disease conditions by the end of the fourth year. By the fifth year, all the ASSURED principles must be fully established by the diagnosis of a minimum of ten (10) additional disease conditions. A total of at least twenty (20) diseases should be available in the SCENT platform’s repertoire of diagnostics by the end of the fifth year. At least, one wearable for a chronic disease (included in the 20) must be planned.

An additional goal is the ability to discriminate closely related diseases such as hereditary breast and ovarian cancer, the seasonal flu and other respiratory diseases, or autism and disorders with similar symptoms (e.g., Williams Syndrome). The choice of diseases will be based on the capability of the applicants’ multidisciplinary group or their access to specific patient group resources.

If possible, the test conditions should include a combination of metabolic, neurological, chronic, infectious, inflammatory diseases, respiratory, cardiovascular, mental and psychiatric conditions etc. NCATS Clinical and Translational Science Awards (CTSA) hubs can be harnessed in the clinical validation for recruitment and trial implementation.

4. Regulatory (FDA) Approval Plan. A short plan for the regulatory approval of technologies, tests and approaches must be developed based on the data generated from the research objectives upon completion of the proposed project. The plan must describe the expected regulatory pathway for the technology and describe foreseeable regulatory risks that could impact the technology development. It must also describe how the technology would fit with current standard of care.

5. U01 Milestones: All projects must be milestone-driven with clear go/no-go criteria that are quantifiable. Prior to funding an application, the Program Official will contact the applicant to discuss the proposed U01 milestones and any changes suggested by NIH staff or the NIH review panel. The Program Official and the applicant will negotiate and agree on a final set of approved U01 milestones, which will be specified in the Notice of Award.

Applications proposing the following topics will be deemed non-responsive and will not be reviewed.

  • Basic studies on VOCs as biomarkers for disease.
  • Basic studies on VOC sensors (e.g., the physics of graphite-based VOC sensors) unless relevant to optimization and validation.
  • Development of the sensors or the detectors or the machine learning software solely without being part of a whole VOC-based diagnostic platform.
  • VOC-based diagnostic platforms not feasible for point of care, such as platforms that are not portable and require large, heavy components and a large footprint.

Investigators planning to submit an application in response to this FOA are strongly encouraged to contact the relevant program officer listed below early in the process to discuss the relevance of the proposed project.

 Additional Requirements

  • Grantees are required to obtain and retain personal identifiers on all research participants where it is not prohibited (i.e., Tribal data sovereignty) for future longitudinal follow-up and to be leveraged for intervention research. Data collected from this program will be protected by a Certificate of Confidentiality.
  • Grantees are required to use guidance for data acquisition, collection, and curation, including appropriate consent for data sharing and implementation of the schemas proposed under the ABOUT ML effort (“Annotation and benchmarking on understanding and transparency for machine learning lifecycles”; available at https://www.partnershiponai.org/about-ml/).

Projects must include an evaluation plan demonstrating how the proposed diagnostic strategies/activities will be assessed for effectiveness and impact.

  • As with all NIH supported research, details regarding human subjects research are required, including data safety and monitoring plans and, if needed, plans for a Data Safety and Monitoring Board (DSMB).
  • Grantees are required to disaggregate study results by sex/gender; race and ethnicity; age and other relevant demographic factors, and to consider intersectionality as appropriate.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIH intends to commit $18 million in total costs over a five-year period, i.e. up to $3M for Years 1 and 2 and up to $4M for Years 3 - 5. NIH anticipates funding 2 - 3 awards.

Award Budget

Application budgets are limited to $650,000 direct cost per year for Years 1 and 2, and $800,000 direct cost per year for Years 3 - 5.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

  • U.S. Territory or Possession

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Carol Lambert, Ph.D.
Telephone: 301-435-0814
Email: lambert@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Requested budgets must include funds for travel by the PD/PI and key personnel to an annual meeting in Bethesda, Maryland (USA).

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: Milestones

Applications must include milestones towards progress and a timeline for completion as described in Specific Research Objectives. The timeline depicted through a Gantt chart must include plans for regular reports of progress to be submitted to the Program Officials. Reporting of milestones is described in more detail below. Milestone plan must:

  • Provide detailed quantitative criteria by which milestone achievement will be assessed. Quantitative milestones are required in order to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years.
  • Provide detailed timelines for the anticipated attainment of each milestone and the overall project goals.
  • Identify any impediments that could require an addendum to the research plan, milestones, or timeline with a discussion of alternative approaches.
  • Include clearly identified Go/No-Go criteria for each milestones.
  • A timeline (Gantt chart) including milestones is required for all studies.
  • See https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/Devices-Milestones for an example of NIH Cooperative Agreement milestones. NOTE: These are suggested formats only and should be adapted as appropriate.

Letter(s) of Support from Collaborator(s)

Given that this FOA requires multidisciplinary collaborations and a team science approach, applications should include Letters of Support from collaborators. 

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

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Upon completion or termination of the project, all study materials, tools, databases and procedures developed from the project should be broadly available (e.g., into the public domain) or made accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research. The data sharing plan should include a strategy to accomplish this within 90 days of the end of the study.
  • Data management should adhere to the FAIR guiding principles of Findability, Accessibility, Interoperability, and Reusability.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

To what extent will successful completion of the aims contribute to public health efforts for the monitoring and diagnosis of various disease conditions? To what extent are the disease categories selected amenable to the approach(es) as indicated in the application? To what extent will the proposed technologies result in a noninvasive, reliable, and reproducible test? To what extent is there a clear characterization of the benefit (e.g., exponential or incremental, faster, smaller, cheaper, easier, safer, more effective, more accurate)?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

To what extent have the research team members demonstrated an ongoing record of accomplishment in the development of analytical technologies and specifically VOC analytical technologies? Does the team include experts in AI/ML, neural networks and pattern recognition, specific disease conditions and diagnostics, and skin physiology? Is the Multi-PI leadership plan, if applicable, well-described, including plans for dispute resolution?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

To what extent is the SCENT platform readily adaptable to the detection of a variety of human diseases and conditions?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

Specific to this FOA:

To what extent will the expected results lead to advances in technologies used in the diagnosis and treatment of human diseases? To what extent does the applicant describe how the technology would fit with current physician practice/standard of care? Does the application include an evaluation plan demonstrating how the proposed diagnostic technology will be assessed for effectiveness? Are confounding factors such as alcohol, drugs, nutritional supplements, etc., addressed? To what extent is the proposed platform (the sampler, the sensing technology, the AI/ML capabilities, and the interface) appropriate for the goals of the project? To what extent is the proposed platform amenable for validation and testing for sensitivity and accuracy using clinical samples? To what extent does the application address sources of error that might affect disease diagnostics and incorporate Process Analytical Technologies, systems engineering approaches, Quality by Design principles, human-factors-engineering principles, usability-engineering principles, and ASSURED principles? To what extent does the proposed FDA Approval Plan describe the expected regulatory pathway for the technology, foreseeable regulatory risks that could impact the technology development, and how the technology would fit with current standard of care? To what extent is the proposed evaluation plan appropriate for the goals of the project?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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

Milestones

To what extent are the listed milestones and Gantt chart appropriate for the goals of the project (a platform to detect a total of at least twenty diseases including at least one wearable for a chronic disease by the end of the fifth year)? To what extent are the milestones relevant, measurable, achievable, result-focused and time-bound?

Study Timeline

Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Compliance with resource sharing policies.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR 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 recipients 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:

  • Determining experimental approaches, designing protocols, setting project milestones and conducting experiments;
  • Providing information to the NIH Program Officer(s) and Project Scientist(s) concerning progress;
  • Adhere to the NIH policies regarding intellectual property, data release and other policies that might be established during the course of this activity;
  • Participating in group activities, including program-wide Work Group(s) and Steering Committee meetings at the consortium level or the NIH level, as needed;
  • Submit biannual progress reports during the five-year U01. This will include the annual Research Performance Progress Report (RPPR) and a midyear progress report submitted to the Program Officer and Grants Management Specialist;
  • Accept and participate in the cooperative nature of the consortium;
  • Attend Steering Committee meetings and an annual face to face meeting, conditions permitting, in Bethesda, MD organized by the NCATS;
  • Accept and implement any other common guidelines and procedures developed by the NCATS Executive Committee, and approved by the SCENT Steering Committee.
  • Upon completion or termination of the project, ensuring all study materials, tools, databases and procedures developed from the project are broadly available (e.g., putting into the public domain) or made accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research. The data sharing plan should include a plan to accomplish this within 90 days of the end of the study.

Publications

The Program Director/Principal Investigator (PD/PI) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The PD/PI and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIH support. Timely publication of major findings is encouraged.

Intellectual Property

  • The recipient is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the applicant to perform the project.
  • Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the recipient any proprietary rights, including intellectual property rights, or any materials needed by the recipient to perform the project.
  • The recipient is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).
  • Recipients will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.

NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. NIH Project Scientists(s) will:

  • Participate in the group process of setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols, project milestones or approaches as warranted. The Project Scientists will assist and facilitate the group process but not direct it;
  • Serve as a liaison between the recipients and Executive committee for administering Institutes and the larger scientific community;
  • Coordinate the efforts of the recipient with others in this SCENT program, including other awardees under this FOA and those awardees involved in related NIH programs;
  • Attend Steering Committee meetings and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action;
  • Maintain an up-to-date summary of program accomplishments.
  • Periodically report progress to the Directors, NIH Institutes involved in this initiative;
  • Serve on subcommittees/working groups of the Steering Committee as appropriate;
  • Provide advice in the management and technical performance of the investigation;
  • Assist in promoting the availability of data and resources developed in the course of this project to the scientific community at large;
  • Assist recipients in the development, if needed, of policies for dealing with situations that require coordinated action.

An NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The program official(s) will:

  • Assist in enforcing general statutory, regulatory or administrative assistance policy requirements;
  • Evaluate progress by reviews of technical or fiscal reports or by site visits to determine that performance is consistent with objectives, terms and conditions of the award;
  • Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer reviewed funding mechanisms;
  • Review and approve all major transitional changes prior to implementation to ensure consistency with the goals of this FOA;
  • Retain the option to recommend the withholding or reduction of support from any cooperative agreement that either substantially fails to achieve its goals according to the milestones agreed to at the time of award, fails to maintain state-of-the-art capabilities, or fails to comply with the Terms and Conditions of the award.

Areas of Joint Responsibility include:

Recipients agree to governance, through voting and decision making, of the SCENT Initiative through a Steering Committee (SC). The Steering Committee membership will include the PD/PI of each awarded cooperative agreement and a NIH Program Official. The PD/PI of each award (or designee) will have one vote on the SC. The NIH Project Scientist will have one vote. The Steering Committee Chairs will not be NIH staff members. Recipient members of the SC will be required to accept and implement policies approved by the SC. Other government staff may attend the Steering Committee meetings if their expertise is required for specific discussions. The Steering Committee will:

  • Discuss progress in meeting the goals of various SCENT projects;
  • Develop recommendations for uniform procedures and policies necessary to meet the goals of the SCENT initiative, for example for data quality measures and assessment or measuring costs and throughput.

Communication Plan

  • Participate in regular (monthly) conference calls with NIH Project Scientists and Program Officials.
  • Coordinate efforts with other recipients , especially in circumstances where synergy of efforts and resources is beneficial to the overall goals of the SCENT program.
  • Participate and present findings at meetings convened by NCATS. One meeting per year must be an in-person meeting, travel conditions permitting, in Bethesda, MD.
  • Coordinate or jointly publish findings in a timely manner as to have the broadest impact.
  • Make new information and materials known to the research community in a timely manner through publications, web announcements, reports and other mechanisms.

Data

  • Recipients will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Performance Requirements

  • Meeting yearly milestones as defined by investigators and NIH program at the time of award.
  • Working with, cooperatively interacting with, and actively seeking input from NIH.
  • Sharing broadly data and biological specimens within the broader scientific community.
  • The NIH will enlist additional scientific experts as necessary from within the NIH, other government agencies, such as the FDA to assist the recipients in carrying out the goals and aims of the approved studies.

Dispute Resolution:

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

T&C Inclusions and Modifications:

The Terms and Conditions of Award will include references to the currently approved versions of the Sharing Plans for Resources and Data. Before the initial award is made, NIH and the recipients may negotiate changes or additions to the versions of these plans in the application. Future changes or additions to these plans may be developed by the NIH and the PD(s)/PI(s) and negotiated with the recipient . Changes will be documented by an exchange of correspondence and the updated plans will become part of the Terms and Conditions of a revised Notice of Award.

3. Reporting

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

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.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

Danilo Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: danilo.tagle@nih.gov

Leah Tolosa Croucher, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 240-701-2580
Email: leah.croucher@nih.gov

Peer Review Contact(s)

Carol Lambert, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0814
Email: lambert@mail.nih.gov

Financial/Grants Management Contact(s)

Shannon Oden
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-3028
Email: shannon.oden@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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