It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The NIH Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/).

Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The Blueprint MedTech program is an NIH incubator that aims to address such challenges and support the innovators by accelerating the development of cutting-edge medical devices to diagnose and treat disorders of the nervous system. The mission of the program is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to:

• Planning resources to support concept development, team building, needs assessment, and other early translational activities.
• Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring).
• Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).
• Advice from industry experts (e.g., meetings with an external oversight committee).

The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.

Objectives

In support of the Blueprint MedTech program, awarded centers will have broad expertise in medical technology translation and serve as incubator hubs that support maturation from early-stage development through preclinical validation. Incubator hubs will help innovators build medical devices as close to the 'final system' as possible. The Blueprint MedTech program supports product development of a clinical-grade commercial prototype through this FOA, and the Companion Funding Announcements (see above under Companion Funding Opportunity) support first-in-human research to evaluate safety and effectiveness.

In order to incubate the most promising innovators, awarded centers will issue solicitations calling for proposals to be submitted by innovators and resource providers. The center will evaluate these proposals and the PI(s)/PD(s) will confer with NIH on which proposals to support. If NIH approves an innovator’s proposal, the center will negotiate a subaward with the innovator and use milestones to monitor the subproject s progress towards the negotiated goals. The center will also negotiate subaward(s) for any resource(s) seen as necessary for the success of the innovator’s product.

Each center will have five Cores, which will be responsible for a number of activities and services including:

• Administrative Core
  • A Steering Committee to advise the PI(s)/PD(s), as discussed in Section IV.
• Outreach Core
  • Educational material for innovators in the form of workshops, webinars, and websites providing guidance on how to take the next step out of the lab and onto the path of translation.
  • Outreach to solicit proposals from technology developers, spanning a breadth of unmet needs across the interests of the Blueprint Institutes and Centers, available at https://neuroscienceblueprint.nih.gov/blueprint-medtech.
  • Coordination to build complementary relationships between participants in the Blueprint MedTech program and with outside strategic partners (such as industry and investors), while remaining sensitive to intellectual property considerations.
• Evaluation Core
  • Evaluation of innovator subprojects, where the evaluation process is inspired by NIH peer review and includes a panel of industry experts to appraise the feasibility of the total lifecycle of the proposed technology using intensive interaction with proposers.
• Innovator Subprojects Core
  • Award managers and project managers to support each innovator subproject’s financial, logistic, and programmatic needs.
  • A consultant network, with the expertise to identify and support innovator projects across the spectrum of technologies and disorders supported by this program.
• Resource Subawards Core
  • Resource management to assemble and support a package of resources tailored to the needs of each innovator subproject. Examples of resources include consultants (regulatory, reimbursement, intellectual property, market analysis) and services (design, prototyping, manufacturing, bench testing, large animal testing).

While the awarded centers will provide many of the resources needed to prepare for first-in-human testing, additional resources will be provided by other recipients in the Blueprint MedTech consortium. Applicants are strongly encouraged to review the structure of the Blueprint MedTech program and a list of anticipated resources at our website, and to engage in discussion with program staff: https://neuroscienceblueprint.nih.gov/blueprint-medtech and in Section VII. Agency Contacts.

All awarded centers will collaborate via frequent information exchange and participate in an annual Blueprint MedTech program meeting. It is expected that lessons learned, vendors' performance, and techniques developed within one disease community will be relevant to other efforts within the program.

Applications to this FOA are expected to present a comprehensive plan for the center (i.e., structure, operations, and budget). It is anticipated that each center would manage no more than fifteen innovator subprojects per year, in addition to linked resource subawards. The budget requested by applications to this FOA should reflect this scale of activity.

Recipients from this FOA should plan to issue a solicitation for innovator subprojects soon after receiving a Notice of Award from NIH. After the center evaluates proposals and after NIH case-by-case approval, the center will make subawards for meritorious innovator subprojects. If any resources are needed to support those innovator subprojects, the center will solicit, evaluate, and award resource subprojects. Federal funding for the centers provided at the time of award is expected to support essential operating expenses in the Administrative, Outreach, and Evaluation Cores but not funding for subawards for the innovator subjects and resource providers. Federal funding for the subawards for innovator subprojects and resources providers will be provided to the centers after NIH approval.

Structure

Each center will be led by scientific, engineering, clinical, and translational experts (i.e., Key individuals). Partners and consultants will be necessary to provide broad support for all the center's activities. Each center must have the following Cores:

Administrative Core

This Core is the managing component of the center, charged with supervision of the center's governance, policy, and continuous improvements in the quality and efficiency of the center. The Administrative Core is also responsible for oversight of all decision-making processes, managing the center's budget, for interactions with NIH, and responding to the evolving needs of the Blueprint MedTech program. In addition, this Core is responsible for administration of the consultant network used by all the Cores. Consultants may be dynamically added and removed from each core on an as-needed basis.

Each center must include a Steering Committee, which meets whenever there is a significant decision to discuss. Centers may plan for other committees or subcommittees as needed to support decision-making processes, such as for identification of targets for active outreach or engagement with industrial and investor partners. The Steering Committee within the Administrative Core will be responsible for making recommendation to the PI(s)/PD(s) on all major decisions, such as subproject triage and funding of innovator proposals.

If the Evaluation Core recommends an innovator subproject to the Administrative Core, then the PI(s)/ PD(s) would work with the Steering Committee to develop a proposal package for NIH that includes its detailed analysis, plan of action, milestones, cost for the subproject, cost for specific resource subawards, and cost for the center to manage the effort.

The PI(s)/PD(s) are expected to coordinate activities across the awarded Blueprint MedTech incubator hubs by joining the Incubator Hubs Coordination Committee.

Outreach Core

Taking direction from the Steering Committee, this Core primarily serves to engage with parties outside the Blueprint MedTech program. Activities include, but are not limited to:

• Serve as the public face of the center, generating and hosting Blueprint MedTech web content, running the center's solicitations, managing consortium publicity, and hosting public outreach events such as workshops and webinars.

• Support inquiries about solicitations for innovator subprojects and resource subawards and manage the proposal intake process.

• Perform needs assessments to inform potential solicitations.

• Collect information on the potential proposer pool, based on inquiries, and share this information with the Steering Committee to assist with planning.

• Perform targeted outreach to potential proposers to encourage participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the translational workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.

• For each innovator subproject, actively foster partnerships with relevant stakeholders, such as patient advocacy groups, partnerships with industry, and potential investors.

• In coordination with other Blueprint MedTech centers, serve as a bridge to industry trade associations, professional societies, and other relevant coordinating bodies.

The NIH Blueprint Institutes and Centers recognize that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse 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 populations participate in, and benefit from research, and enhancing public trust. As such, recipients must plan outreach activities to solicit proposals from innovators with diverse backgrounds.

In addition to externally focused activities, this Core will also serve to coordinate between the center and other Blueprint MedTech recipientsby:

• Hosting the annual Blueprint MedTech consortium meeting, on a rotating basis with other Blueprint MedTech centers;

• Fostering and maintaining collaborations within the Blueprint MedTech consortium, across grantees who have received awards from other FOAs (see Companion Funding Opportunities above).

Activities of this Core should be able to scale up or down in size, based on the diversity and number of subprojects supported by the center.

Evaluation Core

This Core is responsible for accomplishing independent evaluation of all proposals submitted to the center. Each proposal will be evaluated by a panel of experts and must be fair, rigorous, and thorough. The Core will be responsible for recruiting, training, and managing a wide range of relevant panelists from diverse backgrounds and having relevant entrepreneurial, technical, clinical, and scientific knowledge.

The evaluation process will be broken into stages, where each successive stage involves more interaction with the proposer and more effort on the part of evaluators. Applicants are expected to use a funnel approach to winnow down proposals, to yield very thorough and detailed evaluations of recommended subprojects and manage costs. The following case study is an example of how a funnel-based process could be used to evaluate 100 pre-proposals :

• A Triage Panel would review all 100 pre-proposals, but might only recommend 30 for further consideration. The Evaluation Core’s recommendation would be independently considered by the Steering Committee, the PI(s)/PD(s), and NIH program staff leading to approval of only 20. These 20 would be asked to submit a full proposal by the Outreach Core.
• A Viability Panel would review all 20 full proposals, but might only recommend eight for further consideration. After independent consideration by the Steering Committee, the PI(s)/PD(s), and NIH, only six of the recommended might be approved and two additional proposals that were not recommended might be approved.
• The Evaluation Core would work with the Administrative Core to assemble a panel of experts customized to the unique needs (clinical, scientific, and technologic) of each of the eight proposals approved to proceed. Each Deep Dive Panel would individually meet with its respective proposing team and continue to ask questions, until the Panel has completed due diligence on each proposer’s plans. Panel membership might include NIH program staff as non-voting members, as well as members of the Steering Committee and the PI(s)/PD(s). During the Deep Dive stage, the Panel may find that two of the proposals are unlikely to yield viable products, three are at an earlier stage than the proposer believed, and three are ready for further development. The Deep Dive Panel would recommend the three early stage proposals receive mentoring and design support, and the three later stage proposals receive support to build a human-grade prototype.

In addition, the Steering Committee may call upon the Evaluation Core to perform an independent evaluation of ongoing innovator subprojects if problems arise.

For new resource subaward proposals, evaluations should consider the vendor's capabilities, past performance (if known), cost, and fit with the innovator subproject's timeline and needs. The Steering Committee may call upon the Evaluation Core to perform an independent evaluation of ongoing resource subawards if problems arise, deadlines are missed, or costs increase.

Activities of this Core should be able to scale up or down in size, based on the number of proposals received by the center and the available budget.

Innovator Subprojects Core

After each innovator subproject is approved by NIH, the Innovator Subprojects Core will be responsible for administrative and programmatic oversight. It is expected that subprojects would range from six months up to four years and from $50,000 to $500,000 direct cost per year, depending on maturity upon entry. Up to 15 innovator subprojects may be supported in any one year. The number, duration, and size of subprojects would depend on meritorious proposals and available funding from the Blueprint for Neuroscience Research Institutes and Centers.

Supporting translational resources will be provided to innovator subprojects through the Resource Subawards Core. In addition, this Core will help innovator subprojects plan out their product's total lifecycle, with the help of the consultant network, in order to ensure the design freeze is as close as possible to an eventual product.

Activities of this Core should be able to scale up or down in size, based on the diversity and number of subprojects supported by the center.

Entry Criteria for Innovator Subprojects

Proposals to the Blueprint MedTech incubator hubs must include novel medical device technologies that will advance upon current neurotechnology (see non-responsive criteria below). Proposers are expected to provide comprehensive supporting data based on bench, in vitro, and/or in vivo models representative of the intended patient population and indication.

Innovator subproject proposers should clearly define the current state of the art and highlight how their proposed technology will advance patient care. Responsive innovator subproject proposals should propose medical devices with first-of-its-kind technologies, unique and novel intended use, new safety questions, and/or new regulatory questions. Responsive innovator subproject proposals may also pivot and refine existing technologies toward new intended use and use in novel settings (e.g., innovating and translating a neuromodulation device approved for healthcare-setting only to home-use).

Proposed medical devices and their indications will likely follow De Novo or Premarket Approval (PMA) regulatory pathways. Medical devices with indications that may fit within an existing 510(k) pathway may also be accepted, as long as the proposal can demonstrate a clear clinical and technological innovation beyond the state of the art of existing FDA-cleared predicates. Such devices should be reasonably expected to provide new clinically meaningful diagnostic or therapeutic options or improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations.

Resource Subawards Core

The Resource Subawards Core manages the administrative and programmatic oversight of each resource subaward. Resource subawards will be linked to innovator subprojects for as long as the resource is needed. Resource subaward duration must not exceed the duration of the linked innovator subproject. The number, duration, and size of subprojects would depend on the needs of the innovator subprojects and available funding from the Blueprint for Neuroscience Research Institutes and Centers.

Activities of this Core should be able to scale up or down in size, based on the diversity and number of subprojects supported by the center.

Anticipated resources provided by the Resource Subawards Core include, but are not limited to:

• Design expertise (e.g., computational modeling, design for testability, design for manufacturing)

• Prototype manufacture

• Low-rate initial production

• Business development, market/user research, commercialization, and entrepreneurship consultants

• Intellectual property consultants

• Bench and ex vivo tests (does not include standards-based tests)

• Non-GLP in vivo validation

• Surveys and interviews of potential users (e.g., user preference study)

Resources that will be supported through other recipients in the Blueprint MedTech consortium should not be included in the Resource Subawards Core. These include, but are not limited to:

• Human subjects research to evaluate effectiveness

• Good laboratory practice animal studies to evaluate effectiveness

• Standards-based tests (e.g., ISO 10993)

• Customized quality management systems

Applications to this FOA must include the following

Applications that omit any of this information will be withdrawn and not undergo peer review:

• all required Cores;
• plan to ramp up each Core within the first year, including a specific timeline describing when each capability is anticipated to be available and when the first innovator subprojects and resource subawards will be presented to NIH for consideration;
• quantitative benchmarks that can be used to evaluate the performance of the center and its impact (examples are provided in Section IV);
• a preliminary needs assessment to identify areas for targeted outreach;
• a draft of the center's first solicitation;
• biosketches for all members of the Steering Committee.

Non-responsive activities

Applications that include the following activities or centers designed to support the following activities will be considered non-responsive and will be withdrawn and not reviewed:

• Device technologies that are not regulated by the FDA;
• Efforts to develop animal models;
• Efforts to develop neurotechnology for fundamental study of the nervous system;
• Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses;
• Projects focused on technologies for augmentation of healthy individuals;
• Clinical evaluation of safety and effectiveness;
• Center and its core activities intended to generate patentable intellectual property for the Center. This is to avoid conflicts of interest with intellectual property generated by subprojects in the Innovator Subprojects Core.

Pre-application Consultation

As an U54 cooperative agreement, NIH program staff will be involved in negotiating benchmarks and execution of the project. Applicants are strongly encouraged to consult with NIH program staff early in the process of planning an application; this provides a critical opportunity for applicants to confirm that planned activities are responsive to this FOA. Applicants should contact program staff well in advance of the application due date by emailing Blueprint-MedTech@nih.gov.

Benchmarks

After peer review, NIH program staff will contact applicants being considered for funding to discuss their proposed benchmarks prior to funding. The final agreed upon and approved benchmarks will be specified in the Notice of Award. Accomplishment of benchmarks will be evaluated yearly by NIH program staff. Program staff may involve independent consultants or subject matter experts with relevant expertise. If justified, future benchmarks may be revised based on data and information obtained during the previous project period. If, based on the progress report, a funded project does not meet the benchmarks, funding for the project may be discontinued. In addition to benchmarks, the decision to continue funding may also be based on overall progress, portfolio balance and program priorities, competitive landscape, and availability of funds.

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

Section II. Award Information

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

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

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

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

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

Applicant organizations

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

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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 or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:

Michael B. Wolfson, Ph.D.
Telephone: 301-451-4778
Email: Blueprint-MedTech@nih.gov

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

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

* Note: A draft solicitation and a needs assessment must be included as Other Attachments under Research & Related Other Project Information (Outreach Core). Applications without these attachments will be considered incomplete and will not be reviewed.

Overall Component

When preparing your application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Provide a succinct project summary of the center. State the proposed center's broad, long-term objective and significance to the field. Identify the kind(s) of technologies the center is capable of supporting.

Project Narrative: Provide a narrative description of the center and its related activities.

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Specific Aims: Describe the goals for the proposed center. Include a succinct summary of the center and its relevant experience to the stated objectives of this solicitation. State the proposed center's broad, long-term objective and significance to the field. Identify the kind(s) of technologies the center intends to support, and relevant experience.

Research Strategy: Centers are expected be national leaders in facilitating the development and translation of technologies. Applicants are encouraged to use this section to demonstrate that the center’s activities are integrated into a cohesive and coherent unit.

Describe how the center will be structured, having well-delineated roles and responsibilities. Clearly indicate the roles of participating institutions and key individuals.

Describe how the center will operate. Provide a narrative description of how the Cores will work together to support innovator subprojects and resource subawards. Describe how administrative support will facilitate the center’s activities.

Describe what makes the center unique in terms of intellectual, technological, and translational capabilities (i.e., a unifying theme). Although applicants may have strength in one or more thematic areas, it is expected that justification will be provided that applicants are able to support a very broad range of innovator subprojects outside this comfort zone.

Applicants should provide examples of past translational successes relevant to the objectives of this FOA.

Applicants must describe the conflict-of-interest policy for center personnel and members of the consultant network. Applicants must describe the confidentiality policy to protect the interests of innovators and resource providers.

Applications must include benchmarks for success that describe anticipated performance of the center, with continual improvements in impact and cost-effectiveness. Example benchmarks might include:

• proposals received (e.g., total number, diversity of proposers' backgrounds, technology approach, disease/disorder, geographical region, ratio of academic to industrial proposals)
• evaluation efficiency (e.g., time between proposal receipt and start of evaluation, cost to evaluate proposals at each stage)
• innovator subproject management (e.g., administrative cost per project, percent of milestones met on time)
• resource subaward management (e.g., administrative cost per subaward, percent of milestones met on time)
• transitions out of the center (e.g., new funding from NIH or outside investment)

Benchmarks proposed in the application are expected to be quantitative (e.g., "more than 50 proposals received and evaluated each year") rather than quantifiable (e.g., "we will report on the number of proposals received") or qualitative (e.g., "we anticipate a large response to our solicitations").

Provide a high-level plan to ramp up each Core within the first year, including a specific timeline describing when each capability is anticipated to be available and when the first innovator subprojects will be presented to NIH for consideration.

Letters of Support: Applicants must provide letters from the appropriate senior institutional officials from the lead institution and partner institutions that:

• Commit the institution(s) to the center goals, indicating that the program will be integral to their broad vision of translating medical devices.
• Define the institutional officials' positions and authority to commit the institutions.
• Provide evidence and/or assurances that adequate cooperative arrangements are in place between participating institutions.

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:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

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 (Overall)

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

Admin Core

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Admin Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Admin Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Admin Core)

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

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

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

Other Attachments: The following optional documents are allowed under Other Attachments:

• Sample agreements for consultants. If included, this attachment should be entitled "Agreement - Consultants.pdf".
• Sample agreements for innovator subprojects. If included, this attachment should be entitled "Agreement - Innovators.pdf".
• Sample agreements for resource subawards. If included, this attachment should be entitled "Agreement - Resources.pdf".
• Sample agreements between innovator subprojects and resource subawards (e.g., material transfer agreement or collaborative research agreement). If included, this attachment should be entitled "Agreement Innovator-Resource.pdf".

Applications that include additional attachments in this component will be withdrawn.

Project /Performance Site Location(s) (Admin Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Admin Core)

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

Budget (Admin Core)

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

Personnel: The PD/PI must devote at least 2.0 person months to the Administrative core. For Multiple PD/PI applications, the PDs/PIs must devote a combined 2.0 person months to the Administrative core. Applications that do not propose to devote these minimums will be considered non-compliant with the application instructions and not go forward to review.

The budget must include a narrative justification for each member of the Steering Committee. Typical Steering Committee meetings should not involve travel. Funds should be requested in the budget for the PD(s)/PI(s) (and other key staff, as appropriate) and a subset of the Steering Committee to attend annual consortium meetings. The consortium meetings will be rotated annually between the awarded centers. Funds should be requested as consultant costs to support necessary travel expenses of Steering Committee members who are not employees of the participating institutions.

Consultant expenses, other than for Steering Committee activities, should not be included in the Administrative core. The budget should, however, include the administrative effort required to manage the entire consultant network. Activities might include vetting potential consultants, negotiating agreements with them, allocating work to them, records management, and offboarding when consultants leave the network.

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

PHS 398 Research Plan (Admin Core)

Specific Aims: Describe the specific aims to address coordination, governance, as well as evaluation and continuous improvement and quality and efficiency.

Research Strategy: The Administrative core serves as the central element of the center. This core is responsible for leadership, management, and oversight of the other cores. Describe the center's governance plan, approach to prioritizing center activities, and approach to creating and managing policies. Describe how the center will manage the consultant network. Describe the center's process to continuously evaluate their performance to improve quality and efficiency.

One unique feature of this center is the ability to scale up to support new subprojects and subawards, and to scale down when these efforts end or are terminated. Describe the administrative approach to managing personnel, budgets, and other center resources necessary to meet this need. Describe the center's approach to managing intellectual property.

The PIs/PDs will work together with the Steering Committee to make all major decisions. As such, the Steering Committee should include as many diverse perspectives as practicable. Applicants are expected to:

• Describe when the PI(s)/PD(s) will seek input from the Steering Committee to support decision-making. For each kind of decision, indicate whether input will be sought via an in-person meeting, virtual meeting, email or other online communication.
• Describe how the Steering Committee operates and makes decisions.
• Describe the process to create subcommittee(s) and provide information on any planned subcommittee(s).
• Describe how the Administrative Core will present new subprojects to NIH for consideration. Describe how these subprojects will be turned into a proposal package, which includes a plan of action and milestones, as well as a comprehensive budget. The proposal package should include the innovator subproject, specific supporting resource subawards, specific consultants, and associated center expenses.
• Describe how the Steering Committee will decide to initiate re-evaluations of ongoing subprojects and subawards.
• Describe how the Steering Committee will work with the Outreach core to craft new solicitations, and to identify targets for outreach to spur proposals from under-represented technologies, patient populations, geographical regions, and proposers from diverse backgrounds. The description should provide a holistic and integrated view of how enhancing diversity will be supported throughout the Blueprint MedTech center.
• Justify the initial roster of Steering Committee members. Include a very short summary on each individual and their relevance to the center. Justify the size of the Committee. Outline any plans for rotation of the membership.
• Describe how and why members will be added or removed from the Steering Committee.
• Explain the Administrative Core's and/or Steering Committee's conflict of interest policy, if either differs from the policy described in the Overall section of the application.

Describe any planned advisory boards (e.g., scientific, industrial), what role they would play in the center, and how they would engage with center leadership and the Steering Committee. Potential advisory board members should not be contacted or appointed prior to submission of the application; however, the domain expertise of anticipated committee members should be described. The application should not list the names of potential advisory board members.

Describe the roles and responsibilities of key technical and administrative members of this core. Multiple PD/PI applications will use the Multiple PD/PI Leadership Plan to describe the management roles of each PI/PD and how conflicts will be resolved.

Letters of Support: Only letters of support specific to Administrative Core should be attached to this section.

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

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Admin Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Outreach Core

When preparing your application, use Component Type Outreach Core.

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

SF424 (R&R) Cover (Outreach Core)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Outreach Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Outreach Core)

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

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

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

Other Attachments: Draft Solicitation (Required, 3 pages maximum) and Needs Assessment (Required, 3 pages maximum). Applications that exceed this limit or do not include this attachment will be withdrawn. This attachment should be entitled "Draft Solicitation.pdf" and contain instructions for innovator subproject proposers, evaluators, and how to get assistance. The needs assessment should be entitled Needs Assessment.pdf and contain an analysis of areas for targeted outreach.

Project /Performance Site Location(s) (Outreach Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Outreach Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Outreach Core)

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

The budget should include a detailed justification for key personnel under this core. The person months for each member of the center staff related to this core should be included here. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100%.

Include costs to host an annual Blueprint MedTech consortium meeting. Travel expenses for any individual who is not Senior/Key for this core will be included in their core's respective budget (e.g., Steering Committee member, innovator subproject lead).

Include costs for any consultant or subcontractor directly supporting this core's activities (e.g., needs assessment, meeting planner, information services).

As this core is expected to scale up and down over the course of the period of performance, based on available funding and approved subprojects, application budgets should assume a modest base level of activity (e.g., support for one solicitation and three subprojects per year). Describe in the justification how the core's budget would increase with each additional solicitation or subproject.

Participant Support Costs will be considered for innovator subprojects that do not involve human subjects research or vertebrate animal research. The scope of such innovator subprojects is purely to receive mentoring and training from the incubator hubs on topics including, but not limited to, commercialization support, business model development, regulatory strategy, and reimbursement strategy. Only those participant costs directly related to these activities may be charged to the grant. Up to $50,000 direct cost per innovator subproject (inclusive of travel) is allowed for expenses that occur during the period of participation. Costs for material, supplies, food or beverages, or equipment are unallowable. Allowable participant costs are limited to:

• Included in this up to $50,000 direct costs, round-trip travel may be requested for no more than two meetings hosted by the incubator hubs for non-local participants.
• Stipends for participants
• Tuition cost, if applicable

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

PHS 398 Research Plan (Outreach Core)

Specific Aims: Describe the specific aims to serve as the public face of the center, and to provide exemplary customer service to the innovator community.

Research Strategy:

This core will support the Steering Committee by providing analyses of unmet needs for patient populations having Blueprint-relevant indications.

• Describe how needs assessments will be approached, as directed by the Steering Committee.
• Identify initial areas for proposer outreach (e.g., technologies, patient populations, geographical regions, proposers from diverse backgrounds). Provide justification.
• Identify initial areas for other forms of outreach (e.g., industrial partners, industry trade groups).

In addition, this core will manage all aspects of public outreach, targeted outreach, educational material, support for the solicitation process, and collaboration within the Blueprint MedTech consortium.

• Describe public outreach plans (e.g., web content, solicitation management, consortium publicity, outreach events).
• Describe targeted outreach plans to encourage participation of individuals from diverse backgrounds (e.g., as members of the Steering Committee, evaluators, or potential proposers).
• Describe plans to generate and disseminate educational material for researchers who wish to pursue translation. The material should be comprehensive and address steps required for successful medical device development, clinical studies, and commercialization. In addition, the material should include best-practices and resources for each stage in the process, serving to prepare innovators for entry into Blueprint MedTech.
• Describe how the core will support inquiries and communication with proposers and other partners.
• Describe how the core plans to reach potential proposers outside the applicants' organization(s) to maintain a robust pipeline of candidate technologies at the appropriate stage of development for entry into the center.
• Describe how this core will support the specific outreach needs of individual innovator subprojects, once approved (e.g., identifying and recruiting resource providers, patient advocacy groups, other stakeholders).
• Describe planned coordination activities among participants in the Blueprint MedTech program.
• Briefly describe the annual consortium meeting plan.

Provide an explanation if the Outreach Core's conflict of interest policy differs from the policy described in the Overall section of the application.

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

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Outreach Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Evaluation Core

When preparing your application, use Component Type Evaluation Core.

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

SF424 (R&R) Cover (Evaluation Core)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Evaluation Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Evaluation Core)

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

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

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

Project /Performance Site Location(s) (Evaluation Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Evaluation Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Evaluation Core)

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

The budget should include a detailed justification for key personnel under this core. The person months for each member of the center staff related to this core should be included here. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100%.

Include costs for any consultant or subcontractor directly supporting this core's activities (e.g., panelists, meeting planner, information services).

As this core is expected to scale up and down over the course of the period of performance, based on available funding and approved subprojects, application budgets should assume a modest base level of activity (e.g., support for 20-30 proposals per year). Describe in the justification how the core's budget would increase with each additional solicitation or subproject.

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

PHS 398 Research Plan (Evaluation Core)

Specific Aims: Describe the specific aims to evaluate innovator and resource subaward proposals using a process that is at least as rigorous, unbiased, and thorough as the NIH-managed peer review process.

Research Strategy:

For innovator subproject proposals:

This core will evaluate innovator subproject proposals submitted to center-managed solicitations and provide feedback to proposers. As innovator subproject proposals advance through each stage of evaluation, the level of detail provided in the feedback should increase. Although innovator subproject proposers will only be supported by the center to prepare for a first-in-human clinical study, evaluators will consider the total lifecycle of the technology from scientific foundations through regulatory, manufacture, reimbursement, marketing, and obsolescence.

• Describe the stages of evaluation (e.g., responsiveness, triage panel, "deep dive panel").
• For each stage, describe the anticipated breadth of expertise needed and how evaluators will be selected, the format (e.g., written, panel discussion, interactive meeting with proposers), the feedback to proposers (e.g., form letter, slides, written document) and level of detail provided, anticipated success rates, and how the stage's outcome will be used by the Steering Committee and PI(s)/PD(s).
• Describe the timeline for proposals to proceed through the stages of evaluation.
• Describe how a diverse panel of evaluators will be recruited, trained, and managed.

For resource subaward proposals:

In parallel with the innovator subproject evaluation process, this core will also be responsible for evaluating resource subaward proposals. Evaluations should consider the vendor's capabilities, past performance (if known), cost, and fit with the innovator subproject's timeline and needs. Even if the center has a long track record with a vendor, the costs and timeline must be competitive.

• Describe the stages of evaluation (e.g., responsiveness, triage, panel).
• For each stage, describe the anticipated breadth of expertise needed and how evaluators will be selected, the format (e.g., written, panel discussion, interactive meeting with proposers), the feedback to proposers (e.g., form letter, slides, written document) and level of detail provided.
• Describe the timeline for proposals to proceed through the stages of evaluation.
• Describe how a diverse panel of evaluators will be recruited, trained, and managed.

Provide an explanation if the Evaluation Core's conflict of interest policy differs from the policy described in the Overall section of the application.

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

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Evaluation Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Innovator Core

When preparing your application, use Component Type Innovator Core.

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

SF424 (R&R) Cover (Innovator Core)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Innovator Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Innovator Core)

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

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

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

Project /Performance Site Location(s) (Innovator Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Innovator Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Innovator Core)

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

The budget should include a detailed justification for key personnel under this core. The person months for each member of the center staff related to this core should be included here. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100%.

Include costs to administratively manage innovator subprojects. Include costs for any consultant or subcontractor directly supporting this core's activities (e.g., subject matter expert, project manager, information services, site visits).

Include costs for innovator subprojects to attend three quarterly meetings with the center and to attend the annual Blueprint MedTech consortium meeting.

As this core is expected to scale up and down over the course of the period of performance, based on available funding and approved subprojects, application budgets should assume a base level of activity needed to support three innovator subprojects per year. Describe in the justification how the core's budget would increase with each additional subproject.

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

PHS 398 Research Plan (Innovator Core)

Specific Aims: Describe the specific aims to manage innovator subprojects in order to provide them with the greatest chance of success.

Research Strategy: This core is responsible for administrative and programmatic oversight of all innovator subprojects.

• Describe how the core will administratively manage innovator subprojects.
• Describe the project management approach to monitor subproject timelines, milestones, and deliverables.
• Describe how recommendations will be made to the Steering Committee if subprojects miss timelines, milestones, or deliverables.
• Describe how subproject-specific consultants will be engaged, managed, and involved in innovator subprojects.
• Describe how innovator subprojects will coordinate with linked resource subawards.
• Describe how recommendations will be made to the Steering Committee if there are developments that require significant changes (e.g., rebudgeting, new resources needed).
• Provide an explanation if the Innovator Subprojects Core's conflict of interest policy differs from the policy described in the Overall section of the application.

Applicants are encouraged to provide a few hypothetical case studies of anticipated innovator subprojects.

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

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Innovator Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Resource Core

When preparing your application, use Component Type Resource Core.

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

SF424 (R&R) Cover (Resource Core)

Complete only the following fields:

• Applicant Information

• Type of Applicant (optional)

• Descriptive Title of Applicant’s Project

• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Resource Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Core)

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

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

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

Project /Performance Site Location(s) (Resource Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Resource Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource Core)

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

The budget should include a detailed justification for key personnel under this core. The person months for each member of the center staff related to this core should be included here. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100%.

Include costs to administratively manage resource subawards. Include costs for any consultant or subcontractor directly supporting this core's activities (e.g., subject matter expert, project manager, information services).

As this core is expected to scale up and down over the course of the period of performance, based on available funding and approved subprojects, application budgets should assume a base level of activity needed to support three innovator subprojects per year. Describe in the justification how the core's budget would increase with each additional subproject.

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

PHS 398 Research Plan (Resource Core)

Specific Aims: Describe the specific aims to manage resource subawards in order to provide the linked innovator subprojects with the greatest chance of success.

Research Strategy: This core is responsible for administrative and programmatic oversight of all resource subawards.

• Describe how the core will administratively manage resource subawards.
• Describe the project management approach to monitor subaward timelines, milestones, and deliverables.
• Describe how recommendations will be made to the Steering Committee if subawards miss timelines, milestones, or deliverables.
• Describe how subaward-specific consultants will be engaged, managed, and involved in resource subawards.
• Describe how resource subawards will coordinate with linked innovator subprojects.
• Provide an overview of the translational resources currently available to the applicant organization(s).
• Provide an explanation if the Resource Subawards Core's conflict of interest policy differs from the policy described in the Overall section of the application.

Applicants are encouraged to provide a few hypothetical case studies of resources that might be needed for innovator subprojects, including their approximate costs.

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

Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Letters of Support:

Only letters of support specific to Resource Core should be attached to this section. Applicants should provide letters of support from potential resource providers that the applicant has a prior relationship with. These letters should describe the resource provider's unique capabilities and typical costs associated with providing a resource capability to the center.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Resource Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. 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.

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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) and component Project Leads must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

Post Submission Materials

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

Section V. Application Review Information

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.

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

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

Significance

Does the proposed Center address the needs of the research consortium that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing neurotechnology research? Do the investigators demonstrate significant experience with coordinating collaborative translational research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research consortium the Center will serve? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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.

Review for the Overall Center

• Will the center be able to adequately support a broad range of innovator subprojects across interventional approaches, geographical regions, indications, and patient populations?
• Is the confidentiality policy adequate to protect the interests of innovator and resource proposers and subawardees? Is the conflict-of-interest policy adequate for an unbiased approach to evaluation and management of innovator and resource proposals and subawards?

Review Criteria for the Administrative Core

• Has the center defined a viable governance plan? Will the center be able to prioritize its activities and adjust its scale to support new solicitations, innovator subprojects, and resource subawards? Has the center provided a pragmatic framework to work with outside parties (e.g., intellectual property approach, sample agreements under Other Attachments)?
• Are the structure, governance, and composition of the Steering Committee appropriate? Is the approach to making critical decisions appropriate (e.g., setting and evaluating subproject milestones)? Is there a reasonable plan to identify unmet needs in order to target outreach and solicitations?
• For the most promising innovator subproject proposals, will the center be able to develop a comprehensive proposal package of everything needed to bring the technology to the brink of a first-in-human study?

Review Criteria for the Outreach Core

• Is the approach to performing needs assessments adequate? Do the initial needs assessment and draft solicitation (under Other Attachments) target significant unmet need(s)? Will the draft solicitation elicit compelling proposals from an inclusive and diverse pool of proposers to address the unmet need(s)?
• Does the center have adequate plans to provide exemplary customer service to potential proposers, partners, program participants, and the public? Will the educational activities effectively prepare researchers to propose to the center's solicitations? Will the plans prime promising proposals from diverse sources at a national or international scale?
• Will the center be able to tap into and build a consultant network with appropriate breadth and depth of expertise? Will the center be able to effectively partner with other relevant parties (e.g., industry, trade groups, patient advocacy groups)? Will the center be able to serve as a central hub of the Blueprint MedTech consortium?

Review Criteria for the Evaluation Core

• For evaluation of innovator subproject proposals, are the stages of evaluation appropriately tuned to identify the most promising proposals, while maintaining a reasonable evaluation timeline and level of effort? Is the evaluation process at least as rigorous, unbiased, and thorough as an NIH peer review, and able to consider the total lifecycle of the intended product? Is the process to recruit, train, and manage evaluators appropriate?
• For evaluation of resource subaward proposals, are the stages of evaluation appropriately tuned to identify resources that fit with the innovator subproject’s needs, while maintaining a reasonable evaluation timeline and level of effort? Is the evaluation process at least as rigorous, unbiased, and thorough as an NIH peer review, and able to factor in a balance of quality against cost and delivery timeline? Is the process to recruit, train, and manage evaluators appropriate?

Review Criteria for the Innovator Core

• If NIH approves of up to fifteen subprojects, will the center be able to effectively manage them? Is the level of oversight acceptable? Will the center appropriately manage use of the consultant network? Will innovator subprojects be adequately coordinated with linked resource subawards?
• Does the application provide a clear path to scale up in support of additional subprojects? Does the application describe clearly how failing subprojects will be terminated?

Review Criteria for the Resource Core

• If NIH approves of resource subawards to support up to fifteen innovator subprojects, will the center be able to effectively manage them? Is the level of oversight acceptable? Will the center appropriately manage use of the consultant network? Will resource subawards be adequately coordinated with linked innovator subprojects?
• Does the application provide a clear path to scale up in support of additional resources? Does the application describe clearly how failing resource subawards will be terminated?
• Are the currently available resources appropriate to support potential applicants to the draft solicitation included in the Outreach Core under Other Attachments?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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: Grantee 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.

Prior Approval of Innovator Subprojects and Resource Subawards

Recipient-selected projects require prior approval by NIH prior to initiation. In addition, delayed onset studies require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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.

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, 2 CFR 200, and other HHS, PHS, and NIH grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Defining objectives and approaches, and for planning, conducting, analyzing, interpreting, drawing conclusions on their studies, publishing and sharing the results.
• Developing and proposing rigorous benchmarks that will be achieved during the project period.
• Developing and proposing rigorous milestones for innovator subprojects and resource subawards that will be achieved during the project period.
• Define and monitor innovator subproject milestones for prototype development and testing projects, with go/no-go decisions made in appropriate timeframes.
• Providing thorough data packages on a regular basis, which includes interim reports on ongoing subprojects and details on whether center benchmarks and subproject milestones have been met or not. In cases when NIH program staff request raw data, recipients agree to provide the data.
• Participate in progress meetings at least twice a year that are organized with NIH staff.
• Communicating regulatory meeting dates and agenda to NIH program staff and invite their participation.
• Communicating preliminary and critical design review dates and agendas for innovator subprojects to NIH program staff and invite their participation.
• Obtain relevant overall Center IRB and IACUC approvals, regardless of whether subcontractors have separate approvals.
• Develop and execute needs assessments.
• Ensure utilization of rigorous methodologies for needs assessments with appropriate representation of users and/or stakeholders.
• Participate in collaborative activities with other Centers as part of the consortium.
• Serve as a voting member on the Incubator Hubs Coordination Committee with other awarded Centers.
• Coordinate annual meetings of the Blueprint MedTech consortium with other members of the Incubator Hubs Coordination Committee.
• Establish a Steering Committee and coordinate regular meetings. The PD(s)/PI(s) may change the membership of Steering Committee members as needed. Most members should be from outside participating institution(s) and represent a balance of expertise covering both the technology and clinical aspects of the Center.
• Develop and/or maintain external partnerships to assist in meeting goals.
• Ensure national representation in technology evaluation efforts and subproject selection.
• Provide information to NIH staff concerning progress, go/no-go decisions, evaluation processes, and the initiation of new subprojects.
• Seek prior approval from NIH staff (NIH Program Director and Grants Management Specialist) prior to initiation of new solicitations, innovator subprojects, or resource subawards.
• Prepare and submit an annual progress report to the NIH in the format requested.
• Prepare for annual administrative site visits by NIH staff, if requested.

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

NIH Staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The Project Coordinator will have substantial programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond the levels required normally for program stewardship of grants, as described below.
• Each project will have the support of one or more Subject Matter Expert(s) from NIH program staff who are consulted based on their expertise in disorders of the nervous system and / or technological approach. The responsibility of the SME is to advise the Program Official on project approvals.
• NIH program staff may have substantial programmatic involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.
• NIH program staff provide input on the benchmarks and make recommendations regarding their finalization.
• NIH program staff will be responsible for assessing the progress of the project towards the specified benchmarks, and for recommending if further funds should be released to the project.
• NIH program staff participate in meetings together with PIs with regulatory agencies related to the funded project.
• NIH program staff may consult as necessary with independent consultants or specialists with relevant expertise, assuming confidentiality agreements are in place to mitigate conflicts and protect intellectual property.
• An NIH Program Director may be assigned to an award with the primary responsibility for the overall coordination of research efforts across different funding mechanisms and research activities.
• In rare, well-justified occasions, future-year benchmarks may be renegotiated based on data and information obtained during the previous year.
• If, based on the progress report, a funded project does not meet the benchmarks, funding for the project may be discontinued.
• In addition to benchmarks, 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 benchmarks), overall progress, NIH portfolio balance and program priorities, competitive landscape, and availability of funds.
• NIH program staff, in consultation with Subject Matter Experts and non-NIH experts in the field, will review and approve new solicitations, innovator subprojects, and resource subawards prior to initiation.
• NIH program staff will interact with the PD(s)/PI(s) on a regular basis to monitor progress.
• The Project Coordinator and Program Official will serve as a voting members on Center committees and subcommittees.
• NIH program staff will serve as a resource for the Center in identifying opportunities and partnerships that benefit Center activities.
• The Project Coordinator will also be responsible for normal programmatic stewardship as the Program Official. However, the Division Director overseeing this program will make final decisions on project continuation based on program staff recommendations, programmatic prioritization, and budget considerations. This second level of approval is designed to mitigate any potential perceived bias in the administration of the cooperative agreement.
• If there is a disagreement between program staff and the Division Director, they will collaborate with the other Division Directors for resolution of the disagreement with program officials. If disagreements remain, concerns may be escalated to the Director of the Institute for final decision.

Areas of Joint Responsibility include:
NIH staff and the PD(s)/PI(s) of each Center funded under this FOA will form the Incubator Hubs Coordination Committee. The Incubator Hubs Coordination Committee will act as the main governing board that will coordinate activities between all centers supported by the Blueprint MedTech program:

• Develop uniform procedures and policies for the governance of the awards under this FOA.
• Coordinate public-facing communications and publications.
• Coordinate annual meetings of the Blueprint MedTech consortium.
• Share best practices.
• Collectively evaluate new procedures, resources, and technologies.
• Identify targets for outreach.

Each Incubator Hubs Coordination Committee member will have one vote and will be required to accept and implement policies approved by the Committee. The Incubator Hubs Coordination Committee may, as it deems necessary, invite additional, non-voting advisors to meetings at which investment priorities and opportunities are discussed. The Incubator Hubs Coordination Committee will meet once a year at a minimum, with additional meetings scheduled as necessary to accomplish the goals of Blueprint Medtech.

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

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.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 75and 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.

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

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

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

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

Michael B. Wolfson, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: Blueprint-MedTech@nih.gov

Merav Sabri, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301- 496-2583
E-mail: merav.sabri@nih.gov

Thomas Greenwell
National Eye Institute (NEI)
Phone: 301-443-5405
E-mail: greenwellt@mail.nih.gov

Yuan Luo, Ph. D.
National Institute on Aging (NIA)
Phone: 301-496-9350
Email: yuan.luo@nih.gov

Elizabeth Powell
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-443-0786
E-mail: elizabeth.powell3@nih.gov

Theresa Hayes Cruz, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9233
Email: cruzth@mail.nih.gov

Leonardo Angelone, Ph.D
National Institute on Drug Abuse (NIDA)
Email: Blueprint-MedTech@nih.gov

Stacie Gutowski, PhD
National Institute on Drug Abuse (NIDA)
Email: Blueprint-MedTech@nih.gov

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

David McMullen, M.D.
National Institute of Mental Health (NIMH)
Telephone: 301-451-0180
Email: david.mcmullen@nih.gov

Nick Langhals, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: NINDS-Devices@nih.gov

Manana Sukhareva, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-3397
Email: sukharem@mail.nih.gov

Ruthann McAndrew
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8521
Email: Ruthann.McAndrew@nih.gov

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: shelley.headley@nih.gov

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

Jill Morris
National Institute on Aging (NIA)
Phone: 301-496-8986
Email: morrisjil@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

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

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

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov

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

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.