Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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

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

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

Funding Opportunity Title
HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)
Activity Code

R18 Research Demonstration and Disseminations Projects

Announcement Type
New
Related Notices

September 22, 2022 - Notice of NIDDK Participation in RFA-EB-22-002 "HEAL Initiative: Translational Development of Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)". See Notice NOT-DK-22-030

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-EB-22-002
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.286, 93.213, 93.846, 93.395, 93.393, 93.867, 93.273, 93.853, 93.121, 93.866, 93.865, 93.847
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to develop clinical-grade prototype devices intended for use as safe, effective, and non-addictive diagnostics and treatments for pain or opioid use disorder (OUD). The goal of the program is to demonstrate treatment using credible neural targets for device-based interventions and/or diagnostics for pain or OUD, building upon the latest mechanistic knowledge about the anatomy and physiology of central, spinal, and peripheral pathways involved in pain or OUD. Awarded activities will facilitate the translation of new devices up to the stage of readiness for first in human (FIH) clinical trials by overcoming key challenges identified during preliminary proof-of-concept studies. The scope of the program includes technology development and optimization, and studies to prepare for approvals for human use.

Key Dates

Posted Date
August 23, 2022
Open Date (Earliest Submission Date)
October 14, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 14, 2022 Not Applicable Not Applicable March 2023 May 2023 July 2023
June 19, 2023 June 19, 2023 Not Applicable November 2023 January 2024 March 2024
February 20, 2024 February 20, 2024 Not Applicable June 2024 October 2024 December 2024
October 15, 2024 October 15, 2024 Not Applicable March 2025 May 2025 July 2025
June 17, 2025 June 17, 2025 Not Applicable November 2025 January 2026 March 2026

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

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

Expiration Date
June 18, 2025
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

Background

The NIH HEAL Initiative:

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

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

This Funding Opportunity Announcement (FOA) is part of a coordinated set of initiatives within HEAL to support the development of safe and effective devices to diagnose or treat pain and opioid use disorder (OUD) with little or no addiction liability. It is intended that technologies developed under this FOA may graduate to other funding opportunities that facilitate device translation to clinical use (see HEAL's Notice of Special Interest to the Blueprint MedTech Program NOT-NS-23-002).

Although there are many devices available on the market to treat pain, their efficacy is limited by imprecise targeting resulting from insufficient mechanistic data about the "device-able" targets, and from lack of closed-loop feedback to modulate the therapy. There is untapped potential to improve patient outcomes through new technologies with enhanced targeting and control. Other FOAs, referenced on the HEAL Initiative website https://heal.nih.gov/funding/open, solicit grant applications to mechanistically research new targets, to demonstrate the viability of these "device-able" targets, to demonstrate new preclinical models for pain and to discover and validate new biomarkers of pain.

In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details.

The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative recipients will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

Scope

As part of the mission of the HEAL Initiative, the participating NIH Institutes and Centers are encouraging the translation of early- and mid-stage technologies and approaches into new non-addictive treatments for pain and OUD. This program announcement is intended to develop new clinical-grade medical devices that are built upon a mechanistic understanding of the underlying biology. A secondary goal of this program announcement is to catalyze the development of partnerships between the academic and industrial sectors so that translational research can flourish as a cooperative, iterative process leading to safe, effective, and non-addictive treatments for pain and OUD. This funding announcement is specifically focused on the preclinical translational development necessary to advance existing and emerging technologies and approaches to the point of clinical testing. The program supports bench and preclinical development of technologies and approaches leading to assembly of market approval applications for the FDA. The scope of this program excludes basic research, or studies of disease mechanism or mechanism-of-action studies. Clinical evaluation of the safety and efficacy of the intended device is beyond the scope of this FOA. Applications to this FOA should not be hypothesis-driven, but should propose design-directed development of a new technology or approach.

The intended use of candidate devices may be to diagnose, treat, or rehabilitate, and there are no restrictions on invasiveness—the devices may be non-invasive, minimally invasive, or invasive. The devices may be combination products involving use of drugs and biologic agents, however the drugs or biologics must already be approved by the FDA for use in pain or OUD treatment. Devices may utilize any viable modality to focally interact with the nervous system, in order to overcome challenges that often lead to medical devices being considered a treatment of last resort. Examples of focal interaction include, but are not limited to: optical, electrical, magnetic, acoustic, chemical/pharmaceutical, microfluidic, or combinations thereof.

This FOA is not specific for any one or a group of pain conditions. Projects to treat novel targets for acute pain, chronic pain, migraine, other headache disorders, osteoarthritis, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, pain conditions across the lifespan (including in the context of aging), etc. will be responsive. Projects to treat a combination of chronic overlapping pain conditions or for specific pathological conditions will be responsive. Projects that seek to treat novel targets in specific patient populations such as under-represented populations, women, older adults, and children will also be responsive to this FOA and are strongly encouraged.

Preclinical activities supported by this FOA are expected to generate preliminary safety and effectiveness evidence. Applicants are encouraged to plan for a pre-submission meeting with the FDA to discuss this safety and effectiveness evidence during the course of a supported project.

General Entry Criteria

Projects must have a rigorous mechanistic biological rationale and scientifically sound assays to test the device. Supporting data must be provided that the mechanism of therapy, rehabilitation, or diagnosis has been demonstrated in humans or bench top, ex vivo, in silico, in vitro, and/or in vivo models representative of the intended patient population and indication. Early-stage technologies are responsive, and applicants at an early stage are encouraged to provide a sufficiently credible research plan and supporting data that clinical testing is likely to commence within five years.

Successful applications are expected to:

  • Develop a technology or approach that is on a credible path towards clinical use within five years and commercialization within ten years, and perform a preliminary hazard analysis.
  • Address the factors that might have otherwise led to the proposed medical device to be considered a treatment of last resort, such as poor identification of responders, invasiveness, surgical revisions or complications, side effects, and unpredictable outcomes.
  • Have a plan to continue developing the device after successful completion of the project. One example of such a pathway would be submission of an application to the companion HEAL Initiative FOAs to perform a clinical trial. Applicants are encouraged to discuss with program staff and to consider the entry criteria and goals of these companion FOAs https://heal.nih.gov/funding/open.
  • "Begin with the end in mind," using design-driven development principles, such as gathering input from stakeholders and manufacturing partners, and safe, consistent, and reliable operation. If the candidate device is at a very early stage, then applicants are expected to perform a needs assessment early in the project. Otherwise, the needs assessment is expected to be performed prior to grant application and be included in attachment, as described in Section IV.2.
  • Leverage existing technologies and capabilities as much as practicable. Letters of support from all industrial partners are required, and signed agreements will be required prior to award.
  • Consider, where appropriate, Multiple-PD/PI applications that integrate various domains of expertise, including engineering (biomedical, electrical, mechanical, industrial), computational (modeling, control theory, and statistical analysis), and scientific.

Required Project Activities: Applications that do not include the following will be considered non-responsive, will be withdrawn, and will not be reviewed:

  • Applications must propose to develop a prototype intended for use in a future clinical study.
  • Applications must include a plan to evaluate the progression and ultimate success of the project. Specifically, applications must have a defined timeline and the associated Gantt chart attachment.

Non-Responsive Activities: Applications that include the following activities will be considered non-responsive, will be withdrawn, and will not be reviewed:

  • Projects that seek to develop or validate animal models, diagnostic procedures, biomarkers, rehabilitation strategies, small molecules, or biologics. Applicants seeking to pursue these scopes of work are encouraged to consider other HEAL FOAs, available at https://heal.nih.gov/funding/open.
  • Projects that include the use of drugs and/or biologics that are not already FDA-approved for the treatment of pain or OUD.
  • The project's primary objective is to study scientific or clinical hypotheses, efficacy, or effectiveness.
  • Projects that will not conclude with a path to human use.
  • The basis for the device’s functionality is rooted in phenomenology or purely empirically determined measurements, and no justification for the mechanism of action is provided.

Intellectual Property

Since the ultimate goal of this program is to bring new pain and OUD technologies and approaches to the market, the creation and protection of appropriate intellectual property are significant considerations in designing research strategies and prioritizing projects for funding. Each applicant is encouraged to address intellectual property issues related to the proposed device, with input from the institution's technology transfer officials, if applicable. Peer reviewers will be instructed to comment on the intellectual property landscape for each application. If none is provided in the application, recipients will be encouraged to include commercialization plans to protect intellectual property within the first year. Recipients of awards are encouraged to identify potential licensing and commercialization partners early in the development process. The PD(s)/PI(s) is encouraged to work closely with technology transfer officials at their institution, if applicable, to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner. (See Section IV.2.Other Project Information for details.)

Prior Consultation with HEAL Program Staff

HEAL intends to fund a limited number of applications. Therefore, consultation with the Scientific/Research Contacts listed at the end of this FOA at least 6 weeks prior to the application due date is strongly encouraged. Once applicants have identified overall program objectives, HEAL staff may be able to advise applicants whether the proposed research strategy meets the goals of HEAL and mission of the ICs, whether it addresses one or more high priority research areas, and whether it is appropriate for this program. HEAL staff will not evaluate the technical and scientific merit of the proposed program in advance; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. During the consultation phase, if the proposed research strategy does not meet HEAL's programmatic needs, or is not appropriate for this program, applicants will be encouraged to consider other funding opportunities.

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

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

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NIH intends to commit an estimate of $6,000,000 to fund approximately 8-12 awards in fiscal year 2023. Future year amounts will depend on annual appropriations. Awards issued under this FOA are part of funds set aside to support the HEAL (Helping to End Addiction Long-term) Initiative.

Award Budget

Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Budgets should rarely exceed $750,000 direct cost per year.

Award Project Period

Applications may request up to three years of support. However, the scope of the proposed project should determine the project period.

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

  • 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)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Required Registrations

Applicant Organizations

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

  • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Moria F. Bittmann
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-7699
Email: moria.bittmann@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) Project/Performance Site Locations

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

SF424(R&R) Cover

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.

Other Attachments:

Gantt Chart (Required – 1 page maximum):

Applications that lack this required attachment will be considered incomplete, and will be withdrawn. Applications that exceed this page limit will be withdrawn. This attachment should be entitled “Gantt.pdf”. Applicants should include a project timeline in the form of a Gantt chart (or similar) that includes all major tasks to be performed during the project. The chart should also include estimated start and completion dates for those tasks, and should identify the contributions expected from each PD/PI toward accomplishing each task. For a truly integrated collaborative project, it is expected that most or all of the scientific aims will require substantial contributions from more than one PD/PI. This chart will aid reviewers in assessing the feasibility and likelihood that the work plan is adequate for achieving project objectives within the funding period. It will also aid in assessing the degree of integration and collaboration, and the availability of appropriate intellectual and technical expertise for each aim.

IACUC Feedback (Optional – 3 pages maximum):

Applications that exceed this page limit will be withdrawn. This attachment should be entitled "IACUC Feedback.pdf". Applications may include IACUC feedback that contains communications between the PD/PI and the IACUC regarding use of the anticipated animal model. Ideally, these communications will describe the likelihood that the anticipated animal use protocol will be approved. Applications are expected to use existing animal models, and will be required to submit IACUC approval prior to award.

Needs Assessment (Optional – 3 pages maximum):

Applications that exceed this page limit will be withdrawn. This attachment should be entitled "Needs Assessment.pdf". Applications may include a needs assessment that establishes performance requirements with clear, quantifiable metrics and identify significant issues faced by stakeholders (patients, clinicians, caregivers, customers), which is a key step in the design control process and will be evaluated for adequacy.

The Needs Assessment should:

  • provide strong, systematic evidence for the most efficient and effective route to addressing an unmet need;
  • critically evaluate primary or secondary data that have been used to identify deficiencies in current capabilities and the origins of the problem or critical barrier;
  • describe the beneficiaries of the proposed work and how their needs have been identified;
  • distinguish "wants" from "needs" and outline the input gathered to-date from those who will benefit in the development of a solution; and
  • identify critical human factors to incorporate into the proposed research that will optimize usability.

Intellectual Property (IP) Strategy (Optional – 2 pages maximum):

Applications that exceed this page limit will be withdrawn. This attachment should be entitled "IP Strategy.pdf". Applicants are encouraged to prepare an intellectual property strategy in consultation with their institution's technology transfer officials, if applicable.

  • Applicants should describe the IP landscape surrounding their device. Applicants should describe any known constraints that could impede their technology development (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar technologies that are under patent protection and/or on the market, etc.) and how these issues could be addressed.
  • If the applicant proposes using a component or method whose IP is not owned by the applicant's institution, the applicant should address any limitations imposed on the studies or the project (including IP generation) which would impede achieving the goals of the funding program, such as impeding robust licensing opportunities at project completion. Applicants should include a letter (see Letters of Support) from the entity that owns the IP indicating whether the entity will provide the technology, if there are any limits on the studies that can be performed with that technology, and agreement about public disclosure of results (including negative results), and whether there is an agreement already in place.
  • If patents pertinent to the device being developed under this application have been filed, the applicant should indicate the details of filing dates, what type of patents are filed, application status, and associated USPTO links, if applicable.
  • Applicants should discuss future IP filing plans. For a multiple-PD-PI and/or multiple-institution application, applicants should describe how IP will be shared or otherwise managed, and the infrastructure of each institution for bringing the technologies to practical application and for coordinating these efforts (e.g., licensing, managing IP) among the institutions.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

The research strategy must focus on technology development rather than mechanistic, hypothesis-driven research or biological aims. Applicants must describe the engineering design principles to be used to manage their projects. These principles should specify how design requirements will be developed, refined, and validated; how risks and timelines will be managed; how the team will be managed; and how resource allocations will be modified if obstacles are encountered during execution of the project.

While it is expected that the early- to mid-stage research supported by this FOA may not have reached a design freeze prior to submitting the application, applicants are nonetheless expected to provide initial target specifications that describe the intended capabilities of the device to be developed. Applicants are expected to describe the anticipated maturity, if all Aims are successful.

Applicants must include a description of and justification for the specific pain or OUD condition(s) and population(s) being treated. Applicants should compare their candidate device’s expected capabilities against the standard-of-care treatment for these condition(s) and population(s). Applicants must describe the metrics to evaluate the effectiveness of the non-addictive treatment. If not using the standard-of-care metric for the specified condition(s), justify the metric to be used within the project.

Applicants must justify the intended biological target/pathway (e.g., nerve fiber or spinal circuit) and the technique to modulate neural activity. Applicants should provide evidence that this is a compelling target for the condition(s). Supporting data may be preliminary (i.e., unpublished). Supporting data should adequately describe the rigor of those studies, and applicants could include details such as animal model, control groups, numbers in each group, steps used to eliminate potential bias, specific statistical analysis methods, the methodology used to validate the preliminary treatment, and the preliminary device used to perform preliminary studies. In addition, justification must be provided that the device will focally interact with the anatomical target.

Applicants must use an existing animal model for OUD or the specific pain indication to be addressed by the device. If no such animal model exists, include a justification for the animal model to be used. Applicants are not required to have tested a prototype device with this animal model, but IACUC approval for use of this animal model will be required prior to award. If IACUC approval cannot be provided in the application, applicants may provide preliminary discussions with their IACUC as an attachment, as described in Section IV.2.

Target specifications are encouraged to be quantitative as possible (e.g. “prototype survives 32 days under accelerated aging at 80 degrees C with less than 5% degradation in any one operational parameter”). Quantifiable (e.g. “we will measure how long it survives in accelerated aging”) or subjective (e.g. “our device will survive aging tests”) specifications are significantly less desirable. If a quantitative target specification is a “best guess estimate”, then applicants are encouraged to describe their assumptions and degree of confidence in the planned value. Applicants should furthermore provide a rationale for each criterion, such as a comparison against the state of the art.

Details on methods, assumptions, experimental designs, and data analysis plans should be included. Ultimately, the approach should be designed to provide confidence that the device will meet its target specifications, achieve a specific level of maturity at exit, and perform preclinical safety and effectiveness testing to inform at least one pre-submission meeting with the FDA.

Experiments should be formulated to validate the technique or approach, and to demonstrate its capabilities on the bench or preclinically, rather than advancing the state of biological knowledge. Applicants must justify the specific techniques to be utilized for validation, and should relate them to the target condition(s) and population(s). Ensure the experimental design is rigorous. This includes, but is not limited to justification for model systems, endpoints, adequacy of controls and sample sizes, description of statistical analyses, inclusions of measures to reduce bias, and plans for replication, if applicable.

A thorough risk analysis must be included. It is expected that among the analyses, applicants will describe the maturity and limitations of existing components to be integrated into the device, the maturity and limitations of scientific knowledge about the biological mechanistic basis for the treatment, factors that may adversely affect the timeline, and factors that may limit translation into clinical use. Applicants are encouraged to use a hazard analysis to inform the risk analysis.

Although this FOA supports early- and mid-stage medical devices, applicants are nonetheless expected to consider barriers to translation, such as regulatory, reimbursement, IP, and commercialization factors. Applicants must describe the preliminary capabilities and maturity of any device or component to be integrated into the project and describe other resources, technologies, or capabilities to be incorporated into the system design. For each component to be developed within the project, applicants must justify why off-the-shelf components are inadequate. Applicants should also describe the anticipated plan after conclusion of the grant period, if successful.

If any other NIH-provided resources will be utilized, these should be described.

Any collaborators, consultants, or subcontractors should be identified, no matter when during the conduct of the research activity the proposed interaction occurs. Describe how the team, including consultants, has already been engaged and a plan as to how they will continue working together over the course of the project (e.g., recurring team meetings, review and report of data across disciplines, decision-making, participate in meetings with NIH, communication, etc.).

If the applicant has any material from a preliminary needs assessment, it must be included in the separate Needs Assessment attachment as a part of your application package, and not in the Research Plan.

Letters of Support

Letters should be included from all organizations critical to the success of the project. These letters should not be generic, but instead indicate what has been contributed so far and what they expect to provide during the project to allow an evaluation of team engagement.

  • If applying from an academic institution, include a letter of support from the technology transfer official who will be managing intellectual property associated with this project.
  • If research will be performed at more than one institution, include a letter of support from each institution clarifying how intellectual property will be shared or otherwise managed across the institutions.
  • If collaborating with a private entity, include a letter of support that addresses any agreement to provide a device or technology, any limits on the studies that can be performed with said device or technology, any limitations on sharing of data (including negative results), and whether a licensing agreement(s) will be needed and in place once the project is funded. This letter should come from a high official within the private entity who has authority to speak on these issues.
  • If an application plans to utilize the infrastructure or resources of existing projects, whether funded by the NIH, other governmental or non-governmental entities, letters of support detailing the terms of collaboration, data sharing, and intellectual property must 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.

The following modifications also apply:

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

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

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

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

  • Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
  • NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories (NOT-OD-21-016).
  • NIH encourages the use of data standards including the PhenX Toolkit (www.phenxtoolkit.org) (for example, see NOT-DA-12-008, NOT-MH-15-009)
  • Data should be organized according to a standard model that is widely accepted within the field. An example for the clinical research studies would be the OMOP Common Data Model, which has also been successfully adapted for use with observational (including survey) studies more generally. In addition, the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard (NOT-OD-19-122) may facilitate the flow of data with EHR-based datasets, tools, and applications.
  • NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards, as they are applicable (NOT-OD-20-146). Use of the USCDI can complement the FHIR® standard and enable researchers to leverage structured EHR data for research and enable discovery. In addition to USCDI, OMOP, and FHIR standards for enhanced interoperability, investigators and data centers should align their data collection and management practices with recommended guidance emerging from the HEAL CDE and Data Ecosystem programs.
  • Recipients conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).

If patent protection is being sought, investigators should explain how data will be shared after filing for patent protection to allow for both further research and the development of commercial products to advance forward, consistent with achieving the goals of the program.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

As proof-of-concept is required prior to entry, innovation will in part be evaluated by having a clear, comprehensive, and credible path towards transitioning an emerging technology to broad and routine clinical practice.

The market size for the devices solicited in this FOA may be considered small compared to other markets. Provided these smaller markets are sustainable, applications should not be penalized for their comparatively smaller market. NIH is supportive of research for both rare and high incidence disorders that fall under the mission of NIH.

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.

 

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?

Further criteria specific to this opportunity: 1) How significant of an advantage will the candidate device offer over clinically available diagnostic, rehabilitative, or therapeutic approaches for the specified pain or OUD condition and population? 2) What is the strength of the rationale for the biological target? 3) How well havethe investigators considered the phenotype, physiology, and feasibility of treating the targeted clinical population in the design of their technology?

 

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?

Further criteria specific to this opportunity: 1) Do the investigators have sufficient expertise in the target biology, pain condition, OUD, clinical phenotype, pre-clinical technology development, regulatory matters, technology translation, etc. in order to design, develop, and validate a diagnostic, rehabilitative, or therapeutic system? 2) How well are the roles of each collaborator carefully defined in the research plan?

 

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?

Further criteria specific to this opportunity: 1) To what extent does the the applicants making effective use of existing resources, technologies, and capabilities to speed translation?

 

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?

Further criteria specific to this opportunity: 1) Is the overall plan for device development reasonable, including the plan after conclusion of the grant period? 2) How well are the the applicants considered the critical factors that might limit clinical adoption?

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?

How well does the Data Management and Sharing Plan describe information such as a summary of the data to be shared, a description of the data reporting standards, a plan for the data archiving, a timeline for data submission to an archive and sharing data with the research community, and other elements outlined in the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/data/public-access-data)?

 

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?

Further criteria specific to this opportunity: 1) How sufficient is translational experience (e.g. regulatory, manufacturing, commercialization) represented to guide development of the device towards human use within five years?

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.

 

Does the Gantt chart provide sufficient detail on the timing and duration of key project tasks? Are the timelines proposed for achieving project goals realistic and inclusive of necessary steps, but also efficient without adding unnecessary steps?

 

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.

 

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.

 

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.

 

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.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

Not Applicable

 

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.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

 

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 Data Sharing Plan (GDS).

 

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.

 

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications 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 National Advisory Council for Biomedical Imaging and Bioengineering (NACBIB). The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Moria F. Bittmann
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-7699
Email: moria.bittmann@nih.gov

Dana K. Andersen, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 410-868-0638
Email: dana.andersen@nih.gov

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

Jenica Dawn Patterson, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-827-6166
E-mail: jenica.patterson@nih.gov

Helena H. Ahn, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-3207
Email: helena.ahn@nih.gov

Eric Hudak, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: NINDS-Devices@nih.gov

Melissa M Ghim, PhD
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: none
E-mail: ghimm@mail.nih.gov

Emrin Horgusluoglu, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Phone: 240-383-5302
Email: emrin.horgusluoglu-moloch@nih.gov

Xibin Wang, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-451-3884
E-mail: wangx1@mail.nih.gov

Devon Oskvig, Ph.D.
National Institute on Aging (NIA)
Phone: (301) 496-9350
E-mail: devon.oskvig@nih.gov

Houmam H Araj
National Eye Institute (NEI)
Phone: (301) 435-8166
E-mail: ha50c@nih.gov

Will M. Aklin, Ph.D.
National Institute on Drug Abuse (NIDA) 
Telephone: 301-827-5909-5909
Email: aklinwm@mail.nih.gov

Peer Review Contact(s)

Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4791
Email: kellis@mail.nih.gov

Elizabeth Gutierrez
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8844
Email: gutierrezel@niddk.nih.gov

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

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

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

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

Diana Rutberg, MBA
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: dr258t@nih.gov

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

Ms. Victoria Matthews
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-3968
Email: victoria.matthews@nih.gov

Jeni Smits
National Institute on Aging (NIA)
E-mail: jeni.smits@nih.gov

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: kyr@nei.nih.gov

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6698
Email: pfleming@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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