Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

NINDS Cooperative Program in Translational Research (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of PAR-11-294

Related Notices

  • February 13, 2014 - See Notice NOT-NS-14-013. Discontinuation of this PAR.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-13-022

Companion Funding Opportunity

PAR-13-023, R21, NINDS Exploratory/Developmental Projects in Translational Research
PAR-11-296, U44, NINDS Cooperative Program in Translational Research Small Business Awards
PAR-12-054, U44 Advanced Neural Prosthetics Research and Development
PAR-12-053, U01 Advanced Neural Prosthetics Research and Development 

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.853 

Funding Opportunity Purpose

The goal of this funding opportunity announcement (FOA) is to support preclinical development and testing of new therapies for neurological disorders. The program will facilitate therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Projects should include therapeutic leads, a strong biological rationale for the intended approach, and where available in vivo proof-of-concept of efficacy. The program supports preclinical optimization and testing of the leads, and projects must be sufficiently advanced that an Investigational New Drug (IND), Investigational Device Exemption (IDE), 510(k), or 510(k) de novo application to the Food and Drug Administration (FDA) can be submitted during the project period. The program can also support Phase 0 clinical trials for small molecule drugs, proof-of-concept for biologics, or proof-of-concept/pilot clinical trials for therapeutic devices.  The program does not support early-stage therapeutic discovery activities such as screening. The program also excludes clinical research, other than those specified above, basic research, and studies of disease mechanism or mechanistic/mechanism of action studies of the intended therapeutic. The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. This is a milestone-driven cooperative agreement program involving participation of NINDS program staff in the development of the project plan and monitoring of research progress.  

Key Dates
Posted Date

November 19, 2012

Open Date (Earliest Submission Date)

January 7, 2013

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

February 7, 2013; August 20, 2013; February 7, 2014; August 20, 2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

April 4, 2013; August 20, 2013; April 4, 2014; August 20, 2014  

Scientific Merit Review

June 2013, November 2013, June 2014, November 2014

Advisory Council Review

October 2013; January 2014, October 2014; January 2015

Earliest Start Date(s)

December 2013; April 2014; December 2014; April 2015

Expiration Date

(Now Expired February 13, 2014 per NOT-NS-14-013), Originally August 21, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

Recent discoveries across a broad range of research areas in the neurosciences offer promising opportunities for treatment of neurological disorders. As part of its mission to reduce the burden of neurological disease, NINDS is committed to encouraging the translation of these discoveries into new treatments. This Funding Opportunity Announcement (FOA) supports milestone-driven projects focused on the optimization, preclinical testing, and early stage clinical testing of candidate therapeutics (Phase 0 or proof-of-concept/pilot studies). The program will facilitate therapy-directed projects and will accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing.

This FOA is one of five coordinated programs released by NINDS to promote translational research, including NINDS Exploratory/Developmental Projects in Translational Research (R21) (PAR-13-023), NINDS Cooperative Program in Translational Research Small Business Awards (SBIR [U44]) (PAR-11-296), Advanced Neural Prosthetics Research and Development (SBIR [U44]) PAR-12-054, and Advanced Neural Prosthetics Research and Development (U01)  PAR-12-053. The extramural research community may use these translational research initiatives in whatever combinations are necessary to achieve the most rapid and effective development of investigational interventions for neurological disorders.

Definition of Translational Research:

Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease.

Background:

Remarkable advances have been made recently in our understanding of the molecular and genetic bases of disease.  In addition, new advances in device technology enable safer and more effective means of interacting with physiological systems to alleviate the symptoms and treat the underlying causes of many diseases and disorders.  The potential therapeutic opportunities offered by these scientific findings create an opportunity for basic, applied, and clinical scientists to combine and coordinate their efforts. The realization of the potential for translating accumulated new knowledge will depend on the cooperation and partnering of public and private funding organizations, universities, academic medical centers, research institutes, contract research organizations, biotechnology companies, and pharmaceutical companies.

The NINDS Cooperative Program in Translational Research is intended to catalyze the development of partnerships between basic and clinical investigators, and to stimulate agreements between the academic and industrial sectors, so that translational research in neuroscience can flourish as a cooperative, iterative process leading to new and effective interventions for neurological disorders.

Scope of the Program:

The NINDS Translational Research Program is specifically focused on the preclinical therapy development necessary to begin clinical testing of therapeutic candidates for neurological disorders. The program supports the preclinical development of drugs, biologics, and devices leading to IND or IDE applications to the FDA. For devices there are alternative viable pathways to IDE (510(k) and 510(k) de novo), and testing in support of those paths is also supported through this announcement. All proposed studies should be directed at the most efficient route to regulatory submission.

General Entry Criteria:

For entry to the program, projects must have one or more identified therapeutic leads, a strong biological rationale for the intended approach, supporting data and proposed studies that exhibit methodological rigor, and where available in vivo proof-of-concept data on efficacy, which is ideally efficacy data in one or more animal models representative of the intended patient population.

Drug/Biologic Therapies Entry Criteria:

Where efficacy models are not readily available, the project must have in vivo models that include the measurement of a pharmacodynamic biomarker of the intended therapeutic using the intended clinical route of administration. Efficacy data could also be obtained through clinical observations.  Preliminary data should demonstrate rigor in the preliminary evaluation of candidate therapeutics entering the program, including, for example, preliminary assessments of drug-like characteristics.

Within scope examples for Drugs/Biologics include, but are not limited to:

For applications proposing Phase 0 clinical trials, an exploratory IND (eIND) may be required before starting the clinical trial; refer to NOT-NS-11-018 regarding NINDS Policy for the Requirement of Authorization from the Food and Drug Administration (FDA) to use an Investigational Drug, Biologic Product or Device in a Clinical Trial Prior to Submission of an Application.

Such Phase 0/proof-of-concept/pilot clinical trials for drugs/biologics:

It is expected that all preclinical safety studies supporting the safety of an eIND application will be performed in a manner consistent with Good Laboratory Practices (GLP).

Device Therapies Entry Criteria:

For entry to the program, projects must have identified one or more clinically meaningful device outcomes based on input from both clinicians and patients.   Ideally, preliminary proof-of-concept data would be available, preferably obtained using an in vivo animal model representative of the intended patient population. When projects do not include a representative animal model for efficacy testing, an acceptable alternative for entry to the program is efficacy data obtained through laboratory work and in vivo proof-of-concept demonstrated in normal animals. As preliminary proof-of-concept data are strongly recommended for entry into this program, innovation will in part be judged on presenting a credible path towards regulatory submission at the end of the project period.

Within scope examples for Devices include, but are not limited to:

Additional Considerations:

There is increasing awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, analysis, and interpretation.  Program Directors/Principal Investigators (PD(s)/PI(s)) should consider including blinding, randomization, power analysis for sample size, and independent replication in their application.  Examples of the critical elements of a well-designed study are summarized on the NINDS website http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf.  NINDS urges applicants to the program to consider these elements when describing supporting data and designing the proposed studies. 

It is the responsibility of applicants proposing Phase 0/proof-of-concept/pilot clinical trials to be aware of and responsive to the regulatory requirements relevant to the drug, biologic or device therapy being proposed.  These requirements differ between the Centers at FDA, based on risk and existing mechanisms for early phase clinical testing.

Please note that IND/IDE, 510(k) or 510(k) de novo remains an expected goal of the U01 program. Hence, all applicants, including those who propose such Phase 0/proof-of-concept/pilot clinical trials need to include the filing of an IND/IDE, 510(k) or 510(k) de novo application to the FDA as an objective of the application. 

Out of scope examples for all therapies include:

Overall Plan for Therapy Development:

Applicants must include an overall plan for therapy development to be within program scope (See Section IV.2. Research Strategy for details.)

Milestones:

Applications must include proposed annual milestones to be within program scope. Milestones toward therapeutic intervention are goals that create go/no-go decision points in the project and include quantitative success criteria.  For example, refer to

http://www.ninds.nih.gov/funding/research/translational/DevelopingMilestones.htm and http://www.ninds.nih.gov/research/npp/example_milestones_advanced_neural-prosthetics_research_dev.htm. Achievement of milestones will be evaluated by NINDS program staff, and funding of non-competing award years will depend on milestone accomplishment. Because therapy development is an inherently high-risk process, it is anticipated that there will be a significant attrition rate as projects move through the pipeline. Go/no-go milestones will be agreed upon at the start of each project and milestone progress should be included by investigators in their progress report.  If a funded project does not make sufficient progress toward the agreed-upon milestones at any stage, funding for the project may be decreased or discontinued.

Intellectual Property:

Since the ultimate goal of the cooperative agreement program is to bring new therapeutics to the market, the creation and protection of appropriate intellectual property are significant considerations in designing research strategies and prioritizing projects for funding. Each U01 applicant is expected to address intellectual property issues related to the proposed therapeutics, with input from the institution's technology transfer officials, if applicable. Peer reviewers will be instructed to comment on the intellectual property landscape for each U01 application. The project milestone plan may include commercialization milestones to protect and leverage intellectual property. Recipients of U01 awards are encouraged to identify potential licensing and commercialization partners early in the therapy development process. The U01 PD(s)/PI(s) is encouraged to work closely with technology transfer officials at his or her institution, if applicable, to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner. (See Section IV.2. Other Project Information for details.) 

Implementation:

The NINDS Cooperative Program in Translational Research Single-Component Research Projects provides funding through the U01 cooperative agreement mechanism. As a cooperative agreement, implementation will involve participation of NINDS program staff in the planning and execution of the therapy-directed projects. The U01 cooperative agreements support translational research projects that are focused on a single approach to therapy development for a neurological disorder or a group of closely related neurological disorders. A U01 project plan leads and supports the submission of one IND, IDE, 510(k) or 510(k) de novo application to the FDA and supports the planning for one clinical trial.

Applicants are strongly encouraged to consult with NINDS program staff as plans for an application are being developed. Consultations will include conference calls with NINDS program staff.  Early contact provides an opportunity for NINDS program staff to discuss the program scope and goals, and to provide information and guidance on how to develop an appropriate milestone plan. Other aspects of an application that are unique to this program are also discussed. Applicants should contact NINDS program staff at least 12 weeks before a receipt date.

Shortly after receipt, applications will be examined to determine if they are within the scope of this FOA. PD(s)/PI(s) who submit applications that are outside the scope will be asked to consider whether their proposed studies fall within the scope of other FOAs.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project. It is strongly recommended that potential applicants consult NINDS staff about their anticipated budget very early in the planning stage and a minimum of 12 weeks before submission of an application is anticipated.

Award Project Period

A project duration of up to five years may be requested. 

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

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

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download 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.

2. Content and Form of Application Submission

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

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

SF424(R&R) Other Project Information Component

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

Other Attachments - Intellectual property management and commercialization:

Use the Other Attachments function to upload this section. This section of the application should address the following intellectual property issues. Applicants are encouraged to prepare this section of the U01 application in consultation with their institutions' technology transfer officials, if applicable.

Intellectual property considerations for therapeutics proposed for development. Applicants should describe the intellectual property landscape surrounding their therapeutic, to the extent that they are aware. Applicants should describe any constraints of which they are aware that could impede the development of their therapeutic (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present intellectual property filings and publications, similar therapeutics that are under patent and/or on the market, etc.) and how these issues could be addressed.

Applicants should describe their institutions’ existing or planned infrastructure for bringing the therapeutics to practical application (e.g., licensing for further therapeutic development, managing intellectual property, commercializing discoveries) consistent with achieving the program goals.  For multiple-PDs/PIs, multiple-institution applications, applicants should describe the infrastructure of each institution for bringing the technologies to practical application and for coordinating these efforts (e.g., licensing, managing intellectual property) among the institutions consistent with achieving the goals of the program. Applicants should clarify how intellectual property will be shared or otherwise managed if there are multiple PDs/PIs and institutions involved in the U01-supported work. 

PHS 398 Research Plan Component

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

Research Strategy

Overall Plan for Therapy Development:

Projects submitted to the NINDS Cooperative Program in Translational Research must include, within the page limit of the Research Strategy, a description of an overall plan for therapy development to be within program scope. The plan must be based on a clearly stated project timeline that includes practical, achievable goals, project milestones, and IND, IDE 510(k) or 510(k) de novo submission. The plan should also include, when appropriate, a Target Product Profile, including intended Phase I/II clinical trial target population (i.e., stage of the disease, ages of the participants, route of administration, etc).  Clinical feasibility and a path forward from the U01 activities are assessed by reviewers, as well as NINDS program staff, prior to supporting a translational U01.

Team building is an essential step in the development of the overall plan for therapy development. Because translational research is intrinsically interdisciplinary, the plan will often involve cooperation among basic researchers, experts in preclinical development, and clinicians, and may include the participation of private-sector companies and voluntary organizations. Any collaborators, consultants, or subcontractors should be identified, no matter when during the conduct of the research activity the proposed interaction occurs.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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.

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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.

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 SF 424(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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed. 

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 12 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

It is strongly recommended that applicants consult with NINDS program staff as plans for an application are being developed. Consultations will include conference calls with NINDS program staff.  Early contact provides an opportunity for NINDS program staff to discuss the program scope and goals, and to provide information and guidance on how to develop an appropriate milestone plan. Other aspects of an application that are unique to this program are also discussed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:

The NIH is encouraging applications for translational research that may involve standard methodologies applied toward novel therapeutic approaches.  Therefore, a project that does not necessarily employ novel methodologies may still be essential to advance the field.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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? Is the translational research objective important to the neurological disorder under study?

Investigator(s)    

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? Has an interdisciplinary team been assembled, and experts in preclinical development and clinical development been included in the conception, design, and proposed implementation of the project? Are there any concerns about the investigative group’s ability to move the agent forward into a safety, and then efficacy, trial in humans?     

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? Is the overall plan for therapy development through IND, IDE, 510(k), or 510(k) de novo submission practical, achievable, and of high quality? Is the therapeutic under consideration being designed for early stage and/or late stage disease participants? Are there adequate plans for optimization of the therapeutics, as appropriate? Is there evidence of clinical feasibility? Were the unpublished and published data used in support of the application from rigorously designed experiments and are they relevant?   Are the proposed experiments designed using rigorous methodological approaches to minimize potential bias?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

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

FOA-Specific

Are the proposed project milestones adequate and feasible?  Are the project milestones quantitative with clear go/no-go criteria?

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

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

Renewals

Not Aplicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

FOA-Specific

Are there any intellectual property constraints that potentially could impede the development of the therapeutic and/or commercialization and achievement of the goals of the program? 

Applications from Foreign Organizations

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

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) Genome Wide Association Studies (GWAS).

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 the NINDS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the NINDS. 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 National Advisory Neurological Disorders and Stroke Council. The following will be considered in making funding decisions:

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

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 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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

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:

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

Areas of Joint Responsibility include:

None; all responsibilities are divided between awardees and NIH staff as described above.

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Linda McGavern, Ph.D
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-1779
Email: mcgavernlm@ninds.nih.gov

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9223
Email: nindsreview.nih.gov@mail.nih.gov

Financial/Grants Management Contact(s)

Tijuanna E. DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone:  (301) 496-9231
Email: decostert@mail.nih.gov    

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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