Translational Devices Program (PAR-25-053)

Translational Devices Program (PAR-25-053) is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), NIH. This program provides support for the development, optimization, translation, and first-in-human testing of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. It includes funding opportunities for investigator-initiated projects.

PAR-25-053: Translational Neural Devices (R61/R33 - Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 Neurological Disorders and Funding Opportunity Title Translational Neural Devices (R61/R33 - Clinical Trial Optional) R61 / R33 Exploratory/Developmental Phased Award March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of low risk therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems.

Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study (R61 phase), as well as a subsequent small clinical study (R33 phase).

The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.

This NOFO utilizes an Exploratory/Developmental Phased Award and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Transition from the R61 to the R33 phase is contingent upon the successful completion of proposed milestones.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description This NOFO supports non-clinical testing to enable IRB approval needed to conduct a small NSR clinical study.

Studies addressing neurological diseases and care across the lifespan are highly encouraged. All projects must have two phases: R61 and R33. The R61 phase will support non-clinical testing to obtain IRB approval for an NSR clinical study.

All projects will start at the R61 phase. The duration of the R61 phase will depend on the maturity of the project at entry and can range from one to two years. Only those R61 phase projects that have met specific criteria (see below) will transition to the R33 phase after NIH administrative review.

The R33 phase will support a small clinical study and can last one to three years, however, the total project period (including both the R61 and R33 phases) must not exceed five years. Projects for which only a clinical phase is proposed are outside of the scope of this funding opportunity. This NOFO utilizes a R61/R33 Exploratory/Developmental Phased Award mechanism.

As such, this NOFO supports milestone-driven projects and involves NIH program staff’s participation in negotiating project and milestone plan before award, monitoring the research progress, and making go/no-go decisions. The expectations of the program are in line with those of industry regarding the advancement of devices through the developmental and translational pipelines.

As such, an inherent rate of attrition is possible within this program. Applicants are strongly advised to contact the Scientific/Research contact listed below prior to submission. Projects must focus on a condition that falls within the mission of NINDS.

It is expected that devices within the scope of this program either: are very close to the 'final system' and manufactured using very close to the same manufacturing process as the device to be marketed or studied in a larger clinical trial following the completion of this project; or have received Pre-Submission feedback from the FDA (see https://www. fda.

gov/medical-devices/products-and-medical-procedures/neurological-devices and https://www. youtube. com/watch?

v=u0zPKPLW2mU for helpful resources); require clinical data to inform the final device design or manufacturing processes; are already approved, but are being used for a novel indication, target, or patient population. For entry to the program, projects should have: Comprehensive supporting data based on bench, in vitro, and/or in vivo models representative of the intended patient population and indication.

Identified one or more clinically meaningful device outcome measures based on input from key stakeholders (e.g., clinicians, patients, and caregivers) as well as supporting literature. A compelling case for successful IRB approval for an NSR study. All regulatory approvals must be in place prior to the start of the R33 phase.

Applicants are encouraged, but not required, to consult with FDA via a Pre-Submission meeting, study risk designation request, and/or 513(g) submission prior to applying for funding through this grant mechanism.

Applicants who do not have sufficiently relevant feedback from the FDA regarding all planned activities prior to application for funding may be expected to do so as the first milestone during the first year of the R61 phase of the award.

In the event that FDA feedback is not consistent with the plans in the grant, program staff will evaluate the concerns and change of scope that would be needed and work with the investigators to determine the most appropriate course of action.

Examples of studies that may be proposed during the R61 phase include, but are not limited to Non-Good Laboratory Practice (GLP) animal studies to develop surgical techniques relevant to the device, optimize relevant therapeutic or diagnostic parameters, and refine device design as necessary for subsequent GLP testing or additional clinical studies for regulatory approval.

Bench-top and animal testing to demonstrate compliance with FDA Recognized Standards. Activities to become current Good Manufacturing Practice (GMP) compliant. Activities to bring the development process under Design and Quality Systems Control.

Device, software, and firmware design verification and validation activities. Development of packaging, connectors, and other accessories necessary for the translation of this technology. Regulatory activities, including pre-submission meetings with FDA or other FDA regulatory submissions (e.g., Humanitarian Device Exemption (HDE), Request for Risk Designation, 513(g) submission).

A limited Non-Significant Risk (NSR) clinical experience that does not meet the NIH definition of a clinical trial is also allowable during the R61 phase if it is necessary to support the IRB NSR designation for the small clinical study conducted in the R33 phase.

The R33 phase will support a small Non-Significant Risk (NSR) clinical study that will lead to either: A marketing application if only a small clinical study or experience is needed to demonstrate the device is safe and effective; or A larger clinical study that will lead to a marketing application; or Use of the clinical experience to inform device design decisions.

Examples of studies that can be proposed during the clinical phase include, but are not limited to: Optimization of the device design with respect to the human functional anatomy; Identification of the most simple, reliable, and cost-effective device configuration for more advanced clinical studies and eventual market approval; Basic proof-of-concept testing in human patients; Studies of the key physiological variables that may impact the function of the device in humans; and Initial assessments of device safety are expected, but only in conjunction with obtaining enabling data about device design or function E.

Non-Responsive Activities Applications that include the following activities will be considered non-responsive and will be withdrawn and not reviewed: Basic research and studies of disease mechanisms. Animal model development: all in vivo models must be well established and characterized, and available to the applicant. Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses.

Significant Risk (SR) clinical studies/studies requiring an Investigational Device Exemption (IDE) from the FDA. Delayed-onset clinical studies. Applications lacking a clinical study protocol synopsis included with the submission.

Projects focused on technologies for augmentation of healthy individuals. Applications that are missing parts are deemed to be incomplete and will be withdrawn and not reviewed: Include a Gantt chart as an attachment, as described in Section IV. 2.

Include an Intellectual Property (IP) Strategy as an attachment, as described in Section IV. 2. Include a Needs Assessment as an attachment, as described in Section IV.

2. Include a Long-term Care Plan for Patients as an attachment, as described in Section IV. 2.

Include a Team Management Plan as described in Section IV. 2. Attachments that exceed the maximum page limits listed for each attachment in Section IV.

2 will be considered non-responsive and will be withdrawn. Because device development is inherently risky, it is anticipated that there may be attrition as projects move through the process. Applications must propose one or more milestones associated the transition from the R61 phase to the R33 phase of the project.

Milestones are goals that measure success and efficacy that will be used for go/no-go decision-making for the project and should have quantitative success criteria associated with them (see below for details). For each milestone, provide details on methods, assumptions, experimental designs, and data analysis plans (if the results are quantitatively measured).

Specify the quantitative criteria for measuring success and the rationale used to develop and justify the quantitative criteria identified. Quantitative criteria should be robust and consistent with the state-of-the-art in the field. Applicants are encouraged to read examples of milestones ( https://www.

ninds. nih. gov/Funding/Apply-Funding/Application-Support-Library/Devices-Milestones ).

NIH program staff will contact the applicant to discuss, negotiate the proposed milestones and any changes suggested prior to funding the application. The final agreed upon and approved milestones will be specified in the Notice of Award (NoA). Progress towards achievement of the milestones in the R61 phase will be evaluated by NIH program staff to recommend a transition to R33 phase.

Program staff may involve independent consultants or subject matter experts with relevant expertise. If, based on the progress report, a funded project does not meet the milestones, funding for the project may be discontinued.

In addition to milestones, the decision regarding continued funding will also be based on the overall robustness of the entire data package that adequately allows an interpretation of the results (regardless if they have been captured in the milestones), overall progress, portfolio balance and program priorities, competitive landscape, and availability of funds.

NIH encourages increasing the rigor and reproducibility of observed results. In some cases, conducting additional critical experiments will be important for NIH to have confidence in making a funding decision.

R61 phase to R33 phase transition: An administrative review will be conducted by program staff, with potential input by independent consultants, to decide whether a R61 phase project will be transitioned into the R33 phase based on the following: Successful achievement of the defined milestones for the R61 phase of the project; Likelihood of success in clinical testing; IRB approval(s) and non-significant risk (NSR) designation; Submission of the final clinical protocol and supporting documents to NIH for administrative review, and notification of approval by NIH; Feedback on activities involving humans subjects obtained from the NINDS Safety and Risk Assessment Committee (SARAC); and Agreement on updated timeline, milestones, and budget for the clinical study G.

Quality and Compliance Requirement The use of the Design Control and Quality Systems processes (https://www. fda. gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers) to the degree specified by the FDA is required.

Intermediate steps in the Design Control process (e.g., design reviews, design verification, design validation, and design transfer activities) where appropriate. NIH recognizes that the degree to which Design Controls and Quality Systems processes are required by the FDA may vary substantially depending on the specific device.

Investigators are encouraged to discuss these issues with the FDA and regulatory consultants prior to submitting an application so the extent to which these processes are required is clearly defined and verifiable in the application. Applicants should consider the Quality System requirements when preparing their device development activities.

Applicants should consider Guidelines and Policies for Monitoring Clinical Research in the formation of a plan for data and safety monitoring as required by the appropriate IC. H.

Intellectual Property (IP) Since the ultimate goal of this program is to bring new therapeutic and diagnostic devices to the market, the program strongly encourages the recipients and/or their collaborators to obtain and retain any IP developed around the device during the project period (see instructions on attachment or letters to address IP issues in Section IV).

Recipients of awards are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the device development process.

The PD/PI(s) are expected to work closely with technology transfer officials at their institution to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project.

For rare or ultra- rare diseases where commercialization may be challenging, applicants are encouraged to discuss alternative strategies with Scientific/Research staff to get further guidance. Health for all is the principle underlying the continual process of assuring that all individuals or populations have optimal opportunities to attain the best health possible.

Applying the principle of health for all requires that barriers to promoting good health are removed and resources are allocated among populations and/or communities proportional to their need(s). The National Institute of Neurological Disorders and Stroke (NINDS) is dedicated to addressing neurological health disparities as we work to improve the neurological health for all people.

The NINDS mission is in alignment with the NIH’s overall commitment to ensure that health disparities and minority health research is prioritized across clinical trials and human subject research. Despite research advances and improvement of health outcomes overall, health disparities within the US as a whole and within neurological disorders and stroke in particular, persist.

Disparities in neurological diseases can not be explained by biological risk factors alone and social determinants of health (SDOH) are increasingly recognized as important drivers of disparities in neurologic disease and outcomes ( NINDS SDOH framework ). Health disparities in neurological disorders exist across the lifespan.

In pediatric populations, neurological health disparities in acute care settings such as the emergency room impact the diagnosis, treatment and long-term health and longevity from childhood through adulthood. J. Pre-application Consultation As a milestone-driven R61/R33 Exploratory/Developmental Phased Award mechanism, NIH program staff will be involved in the negotiation and execution of the projects.

Applicants are strongly encouraged to consult with NIH program staff when planning an application. Early contact provides an opportunity for staff to provide further guidance on program scope, goals, and developing appropriate milestones. When possible, applicants should contact program staff at least 12 weeks before a receipt date.

See Section VIII. Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. 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 The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but need to reflect the actual needs of the proposed project. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.

The proposed project period for the R61 phase must not exceed 2 years. The proposed project period for the R33 phase must not exceed 4 years. The total duration of the R61 and R33 may not exceed 5 years.

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

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations). Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. Applicant organizations must complete and maintain the following registrations as described in the How to Apply-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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

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 Grants. gov registration; 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 their organization to develop an application for 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 How to Apply- Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility 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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply-Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply-Application Guide must be followed.

Gantt Chart (Required – 1 page max): Applications that exceed this limit or do not include this attachment 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. Intellectual Property (IP) Strategy (Required – 3 pages max): Applications that exceed this limit or do not include this attachment will be withdrawn.

This attachment should be entitled "IP Strategy. pdf". Applicants are encouraged to prepare this section of the application in consultation with their institution's technology transfer officials, if applicable.

A goal of this program initiative is to advance research towards the development of products that will benefit the public. Accordingly, applicants should describe the IP landscape surrounding their therapeutic device.

This should include any known constraints that could impede the development of their therapeutic device or diagnostic (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar technologies that are under patent and/or on the market, etc.) and how these issues could be addressed as appropriate and consistent with achieving the goals of the program.

If the applicant proposes using a device or technology whose IP is not owned by the applicant's institution, either an investigational therapeutic, FDA-approved therapeutic, or other licensed product, the applicant should address any questions that may constrain or impede its ability to operate and move the technology forward consistent with achieving the goals of the program.

Applicants should include a letter (see Letters of Support) from the entity that owns the IP indicating whether the entity will provide the device or technology, if there are any limits on the studies that can be performed with that device or technology, and if there is agreement about public disclosure of results (including negative results), and whether there is an agreement already in place.

If patents pertinent to the therapeutic device being developed under this application have been filed, the applicants should indicate the details of filing dates, what types of patents are filed, application status, and associated United States Patent Office (USPTO) links, if applicable. Applicants should also discuss future IP filing plans.

For a multiple-PD/PI, 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 in the Team Management Plan (see below).

Needs Assessment (Required – 3 pages max): Applications that exceed this limit or do not include this attachment will be withdrawn. This attachment should be entitled "Needs Assessment. pdf".

The Needs Assessment should: Establish 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; 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 involvement of those who will benefit in the development of a solution; Describe how finite resources can best be deployed to develop and disseminate a feasible and applicable solution; and Identify any human factors (i.e. ergonomics) incorporated into the proposed research that optimize human interaction, productivity, and understanding while using the technology.

Long-term Care Plan for Patients (Required – 3 pages max): Applications that exceed this limit or do not include this attachment will be withdrawn. This attachment should be entitled "Long-term Care. pdf" which will be reflected in the final image.

First, applicants should describe the anticipated care needs of participants after a trial has ended, which are related to their trial participation (e.g., continued access to the device, device maintenance, and/or device explant).

Where relevant, it is recommended that applicants consider various posttrial scenarios, such as device and trial failure or success, regulatory approval options, and decisions by device manufacturers to commercialize or discontinue a product. Second, applicants must describe a plan for the care of patients at the end of the study and after the study period, if appropriate, related to the potential care needs.

These plans may vary from project to project, depending on, for example, whether patients are likely to have other ways to access this care, the anticipated risks and benefits of receiving this care, the anticipated risks and benefits of lacking this care, and the feasibility of facilitating this care.

Plans might include, for example: Procedure or plans to bring the subjects' condition to pre-intervention baseline levels or minimize unfavorable residual effects.

manufacturer-supported device maintenance for patients responding to therapy, manufacturer support for filing of compassionate use exemptions for device maintenance, etc. All plans should include information regarding post-trial obligations (e.g., explantation, hardware and software maintenance and/or updates, or device-related medical expenses). Schematics (Optional – 1 page max): Applications that exceed this limit will be withdrawn.

This attachment should be entitled “Schematics. pdf”. This attachment may include images, photos, drawings, engineering schematics, design specifics, and associated labeling and captions.

Communications with the IRB (Optional – 5 pages max): Applications that exceed this limit will be withdrawn. This attachment should be entitled “IRB Communications. pdf”.

Applicants should submit relevant approval letters and associated attachments. For projects requiring non-clinical testing to support an IRB NSR designation, preliminary communications (e.g., letter or other documentation) with the IRB indicating what non-clinical testing will be necessary to support the NSR clinical study. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: In the single Specific Aims attachment, include aims delineated for the non-clinical testing and the clinical study. The single Research Strategy attachment must include the following subsections: A. Clinical Impact and Feasibility Please note that each application must focus