Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This FOA relates to one of the initiatives of the SPARC (Stimulating Peripheral Activity to Relieve Conditions) Common Fund program titled: Use of Existing Market-Approved Technology for New Market Indications. By establishing effective public-private partnerships, this SPARC initiative allows supported investigators to have access to existing neuromodulation technology to explore new indications. A number of device manufacturers have entered into partnership agreements with the NIH to make their neuromodulation technology, consisting of implantable devices with recording and/or stimulation capabilities, available to SPARC’s supported clinical investigators (see Device Portal for a list of companies and available technologies). The specific goal of this FOA is to promote the pre-clinical development of these technologies, in support of a new market indication, towards enabling an Investigational Device Exemption (IDE) submission for a future pilot clinical study. Awarded projects of this FOA that fully reach their pre-clinical testing milestones will be eligible for further support, subject to a subsequent FOA, to conduct a pilot clinical study. The expectation is that these pilot clinical studies will provide the initial proof-of-principle demonstrations in humans that will motivate the additional studies needed in pursuing FDA approval as a labeled indication.

The SPARC program (http://commonfund.nih.gov/sparc/index) is supported by the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. The overall goal of the SPARC program is to provide the scientific foundation necessary to pilot new and/or improved closed-loop neuromodulation devices and stimulation protocols to treat diseases and conditions through precise neural control of end-organ system function. Significant advances in neuromodulation therapies to treat disease have led to industry-supported large, randomized and blinded, controlled trials. While the degree of efficacy of the neuromodulation devices has varied depending on the trial and condition under investigation, the data and approach show great promise for scientific and therapeutic development.

The SPARC program is envisioned as four components to be managed in an interactive manner as a consortium in order to achieve the overall SPARC program goals. To maximize progress, the NIH will actively manage needed expertise, technologies and shared information within the SPARC consortium by adding or subtracting research components as necessary. The four components of the SPARC program are: 1) Anatomical and Functional Mapping of the Innervation of Major Organs, 2) Next Generation Tools and Technologies, 3) Use of Existing Market-Approved Technology for New Market Indications, and 4) SPARC Data Coordination. The current announcement serves as the first FOA addressing component 3 of the SPARC program.

Component 1, which consists of two phases, will support studies focusing on anatomical and functional mapping of peripheral innervation of end-organs. The first phase will be addressed by four FOAs (RFA-RM-15-003, RFA-RM-15-018, RFA-RM-15-019 and RFA-RM-15-020) and will focus on anatomical and functional mapping using current state-of-the-art technologies. The second phase is planned to include application of next generation technologies to enhance and refine the functional mapping, and design and pilot new therapies. The studies under this component are expected to develop the scientific foundation for more effective use of existing neuromodulation therapies and for development of additional neuromodulation therapies.

Component 2 started with the issuance of RFA-RM-15-002 on Exploratory Technologies to Understand the Control of Organ Function by the Peripheral Nervous System for SPARC (U18). This FOA was focused on developing exploratory tools and technologies needed to study function and establishing a quantitative scientific foundation for this overall program. The exploratory technologies solicited through this FOA were intended to address the gaps in understanding detailed underlying physiology and targeted mechanisms of action of future neuromodulation therapies. Additional phases of Component 2 (e.g., RFA-RM-16-002 and RFA-RM-16-003) will include further technology developments to assist in mapping and future development of neuromodulation therapies. The next generation technologies developed will be responsive to, and freely shared with, other SPARC projects.

Component 3, which is the target of this announcement, encourages development of partnerships between device manufacturers and NIH-supported investigators to explore the feasibility of utilizing existing neuromodulation devices for a new therapeutic application. The long-term expectation is that proof-of-principle demonstrations in humans will lead to the larger clinical trials required for taking these ideas to market. Future iterations of this component will make extensive use of information generated by components 1 and 2 to determine possible new therapeutic opportunities and methodologies.

This component, through template agreement documents, will provide the legal and administrative framework necessary for implementing partnerships between companies and clinical investigators. These partnerships will allow investigators to have access to the latest investigational and market-approved neuromodulation technology for conducting both pre-clinical development (focus of this FOA) and early clinical feasibility studies. The ability to leverage the existing safety and efficacy data of these devices is expected to reduce time and costs associated with obtaining regulatory approvals for new exploratory clinical studies. NIH will coordinate efforts with the FDA in order to streamline the Investigational Device Exemption (IDE) approval process.

Component 4 will support assembly of data from all projects into a SPARC data coordination center resource, including the detailed, integrated, predictive functional and anatomical neural circuit maps. Standardized methods, standard operating procedures, and other aspects of consortium coordination will be a part of this component.

Although the description above contains information about the entire SPARC program, this announcement applies only to component 3 of SPARC: Use of Existing Market-Approved Technology for New Market Indications.

This FOA uses a cooperative agreement mechanism to support the pre-clinical phase of studies proposing to utilize existing neuromodulation devices(s), from SPARC’s partnering companies, in support of new indications. The proposed pre-clinical studies will involve testing the safety and efficacy of a company’s device(s) using an in vivo model that is representative of the intended patient population for the new indication. Applicants need to develop pre-clinical applications, to be conducted over a one to two year period, that present a credible path towards an IDE submission for a future pilot clinical study. Depending on the availability of funds, awarded pre-clinical studies that satisfy their milestones will subsequently be encouraged to apply for support to conduct a pilot clinical study.

The SPARC website (Device Portal) provides information about the device(s) and other support provided from each participating company. Applicants need to select one of the device manufacturers and justify in their applications why the particular company s technology is considered suitable for the intended new clinical application. The market size for the proposed new application will not be considered in assessing the significance of the project. Investigators that already have an existing partnership with one of the participating companies are still eligible to apply for support and will follow the same application process.

The proposed pre-clinical assessments should include a large animal safety study using Good Laboratory Practices (GLP). In addition, this FOA will support initial non-GLP animal testing needed for developing surgical techniques relevant to the implantable device and defining therapeutic parameters. To be consistent with the goals of SPARC, the proposed neuromodulation approach for the new indication must be based on the modulation of peripheral neural circuits controlling organ function (excluding the brain and sensory organs of the head and the named voluntary muscles). Stimulation sites in the spinal cord would be acceptable if the purpose is the modulation of visceral end-organ function. The following projects are non-responsive under this initiative:

• Research on neuromodulation through central brain stimulation (neuromodulation through spinal stimulation is allowed as stated above)
• Use of a partnering company’s device technologies for their labeled indication
• Focus on functional mapping of peripheral neural circuits to determine the mechanism of action (these projects are supported by component 1 of the SPARC program as described earlier)
• Animal model development (all in vivo models that will be used for the pre-clinical safety and efficacy testing of company devices must have been established prior to application submission)
• Clinical trials (follow-up pilot clinical studies will be addressed in subsequent FOAs)

This SPARC initiative encourages early engagement with the FDA to provide investigators with guidance on implementing pre-clinical studies that will support a future IDE submission. At the end of the first year of the award period, investigators will be required to submit a request for FDA pre-submission feedback that will guide refinement of pre-clinical plans towards a successful IDE submission.

NIH will provide template agreement documents that will streamline the interaction between investigators and companies. Applicants should use the following steps towards establishing a company partnership:

1. From the Device Portal website, identify a potential company partner whose neuromodulation technology is considered suitable for addressing a new indication.

2. Engage with company to receive early feedback about the planned application and sign a Confidential Disclosure Agreement (CDA) to receive additional device(s) information needed for preparing the application.

3. Submit a Collaborative Research Agreement (CRA) that has been agreed upon with the company partner. The CRA will provide the NIH with documentation of company interest in allowing the investigator access to its technology for the proposed project. The CRA does not have to be completed at the time of the U18 application submission; however, it will be required before the issuance of award for meritorious applications.

Templates for the CDA and CRA documents, mentioned above, are available on Device Portal website. Applicants should review these documents early and consider their willingness to agree to the conditions well in advance of submitting an application to this FOA.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

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

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

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

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

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

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent should be sent to:

Danilo A. Tagle, Ph.D.
Telephone: 301-594-8064
Fax: 301-480-3661
Email: [email protected]

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

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

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

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

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

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

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

The budget must include travel costs to SPARC Consortium meetings twice per year in the Bethesda, Maryland region.

The budget should include expertise necessary for data exchange, as described above, and should be commensurate with the work and deliverables proposed.

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

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

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

Research Strategy: Provide the following information.

• Describe the current state of knowledge on the etiology and clinical characteristics of the new indication being studied. Provide information about its current and projected prevalence. Describe existing therapies and their limitations to justify the need for new therapeutic efforts.
• State the scientific reasoning for the proposed therapeutic effect of stimulation at the chosen site. As part of this reasoning, describe how stimulation modulates peripheral control of end-organ(s) function implicated in the specific indication being addressed.
• Provide a detailed plan of the pre-clinical testing strategy. Describe the suitability of the chosen animal model and why associated date will be instructive for human clinical outcomes.
• Describe, if available, any preliminary data that have been collected so far in support of the proposed study (e.g., simulations or animal model testing).
• Describe the project milestones and provide an estimated timeline under which these will be achieved. Each milestone should include the criteria for success and the rationale.

Letters of Support: A letter of support from the applicant institution is required to demonstrate institutional commitment for the project, including for the Resource Sharing Plan.

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

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. This plan should include timely data release to the SPARC data coordination center and other projects within SPARC as determined by the SPARC Program Manager. The sharing plan should include an agreement that investigators will work collaboratively with the SPARC program to maximize research accomplished by the program, and to implement procedures to provide quality controlled data and information.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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

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

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

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

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

As part of the scientific peer review, all applications:

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

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

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 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.

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. 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. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Determining experimental approaches, designing protocols, setting project milestones and conducting experiments;
• Submitting quarterly progress reports during the funding period, in a format as agreed upon by the NIH SPARC Steering Committee, described below under Areas of Joint Responsibility;
• Participating as a voting member of the Steering Committee and join relevant subcommittees;
• Ensure that the data produced meets the quality standards and costs agreed upon at the time of award, or any improved quality standards and costs negotiated during the award period;
• Adhering to the NIH Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program policies regarding intellectual property, data release and other policies that might be established during the course of this activity;
• Accepting and implementing any other common guidelines and procedures developed for the SPARC Program and approved by the NIH SPARC Steering Committee;
• Accepting and participating in the cooperative nature of the coordinated NIH SPARC Program;
• Attending four workshops organized by the NIH during the award period. There will be an initial kick-off meeting and subsequent meetings at 6 month intervals in the Washington DC Metro region.  The PI and up to one other key personnel with complementary expertise are required to attend these meetings.  Funds to attend these workshops should be budgeted in the application. 

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

• A Program Officer will be assigned to each award. The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance.
• An NIH Project Team composed of NIH Program Staff of the ensuing awards as well as other Program staff of the SPARC ICs, will be created to ensure communication and continuity among the interested NIH ICs related to coordination among SPARC awards and with other grant or contract activities by NIH.
• The Project Team will include and be led by the Program Officer(s) assigned to these SPARC awards.
• One extramural NIH program staff member will be assigned as the Project Scientist for an award. The same person may serve as the Project Scientist for multiple SPARC awards, or others may serve as Project Scientist
• The Project Scientist will also be a member of the Project Team.
• The Project Scientist for an award will interact scientifically with the PDs/PIs and other named personnel of that award, as a partner in the research.
• The Program Officer(s), the Project Scientist(s), and one other member of the Project Team will be members of the SPARC Steering Committee, as described below under Areas of Joint Responsibility.
• The Project Scientist interacts scientifically with the SPARC Steering Committee, described below under Areas of Joint Responsibility, and may assist in research planning, may present experimental findings to the Steering group from published sources or from relevant contract projects, may participate in the design of experiments agreed to by the Steering group, may participate in the analysis of results, and may help ensure that duplication is avoided.
• In all cases, the role of NIH staff will be to assist and facilitate, but not to direct activities.

Areas of Joint Responsibility include:

• A SPARC Steering Committee is formed whose purpose is to transfer information between SPARC awardees in order to achieve the goals outlined in the overall SPARC program.
• The SPARC Steering Committee is composed of PD/PIs, Project Scientist(s), the Program Officer(s) and one other member of the Project Team.
• It is expected that most of the decisions on the activities of the SPARC Steering Committee will be reached by consensus. If a vote is needed, each awardee will have one vote, and the Project Scientist(s) will each have a vote. The number of NIH votes will not exceed one-third of the total votes, since the expectation is that one or more Project Scientists will serve that role on more than one award. When a vote is required, at least 60% of the votes will be required for approval. The Program Officer and the other member of the Project Team will be non-voting participants.

Dispute Resolution:

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

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Danilo A. Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: [email protected]

Siavash Vaziri, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8921
Email: [email protected]

Robert Elliott, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-3009
Email: [email protected]

Irene Haas
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0836
Email: [email protected]

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.