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

Clinical Coordinating Center for the Network of Excellence in Neuroscience Clinical Trials (NEXT - CCC) (U01)

Activity Code

U01 Research Project Cooperative Agreements

Announcement Type

New

Related Notices
  • September 20, 2022 - This RFA has been reissued as RFA-NS-22-029
  • June 9, 2011 - See RFA-NS-12-004 Spinal Muscular Atrophy (SMA) Biomarker Study (U01).
  • April 8, 2011 - Notice of Intent to Publish a Request for Applications for a Spinal Muscular Atrophy (SMA) Biomarker Study (U01) and Convene a Related Workshop. See NOT-NS-11-012.
  • December 7, 2010 - Pre-application Meeting for the Network of Excellence in Neuroscience Clinical Trials (NEXT). See Notice NOT-NS-11-005.
Funding Opportunity Announcement (FOA) Number

RFA-NS-11-009

Companion FOA

RFA-NS-11-008, U10 Cooperative Clinical Research Cooperative Agreements

RFA-NS-11-010, U01 Research Project Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.853

FOA Purpose

The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite applications to participate as a Clinical Coordinating Center in the Network for Excellence in Neuroscience Clinical Trials. This clinical research network will develop and conduct multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, whether from academic, foundation or industry discoveries. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials.

The network will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations.

While the network will not be specific to one disease, it will have the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities.

This FOA solicits applications for the Clinical Coordinating Center (CCC). Separate FOAs solicit applications for the Clinical Sites and the Data Coordinating Center (RFA-NS-11-008 and RFA-NS-11-010).

Key Dates
Posted Date
Letter of Intent Due Date

February 11, 2011

Application Due Date(s)

March 11, 2011

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

May/June 2011

Advisory Council Review

August 2011

Earliest Start Date(s)

September 2011

Expiration Date

March 12, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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

PURPOSE

The purpose of this funding opportunity announcement (FOA), issued by NINDS, is to invite applications for participation as the Clinical Coordinating Center (CCC) in the Network for Excellence in Neuroscience Clinical Trials. This clinical research network will develop and conduct multiple, scientifically sound, possibly biomarker-informed exploratory clinical trials evaluating the most promising therapies, whether from academia, industry, foundations, the NINDS intramural laboratories or the NINDS translational program. Examples include Phase 2 clinical trials and clinical research studies aimed at validating biomarkers and clinical outcomes in preparation for clinical trials.

The network will provide a robust, standardized, and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. While the network will not be specific to one disease, it will have the capacity to coordinate a cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities.

The network will include multiple Clinical Sites, one Clinical Coordinating Center (CCC), and one Data Coordinating Center (DCC). The network is designed to increase the efficiency of clinical trials, to facilitate patient recruitment and retention, to increase the quality of neuroscience clinical trials, and to enable public-private partnerships.

BACKGROUND

To translate recent, high quality neuroscience discoveries into better treatments for people burdened by neurological disorders, efficient clinical trials are needed. These trials require cooperation and coordination among investigators, patients and industry partners. Clinical trial networks can increase the efficiency of research by providing infrastructure, centralized resources, and access to patients; however, with more than 400 neurological diseases falling under the auspices of NINDS, creating multiple specialized research networks would not be feasible.

In the traditional model, a consortium of clinical sites is created for each new multi-center trial. This causes redundancy and delays because infrastructure is duplicated. Protracted contract negotiations and approvals at multiple Institutional Review Boards (IRBs) often cause further delays. In addition, there may be loss of expertise as experienced research coordinators move to other fields after a trial is completed. The objective of the network is to increase the efficiency of clinical research through shared infrastructure for NINDS clinical trials.

RESEARCH OBJECTIVES

The network aims to share expertise and infrastructure across diseases, to leverage research resources at clinical sites, and to flexibly take advantage of clinical research opportunities as they arise in different disease areas. Finite resources and especially for rare diseases a small pool of potential participants limit the number of large, confirmatory efficacy (Phase 3) trials that can be conducted at any given time. Therefore, NINDS aims through the network to support exploratory trials that can provide more rapid preliminary testing of new treatments.

The objective of the network is to streamline the implementation of clinical research by using standardized master trial agreements and infrastructure that utilizes a central IRB of record. While NINDS has historically funded trials to test drugs already approved for other indications, the network is designed to assure the broadest access to any new therapies for patients by carrying out trials coming from partnerships between NINDS and industry, foundations, or academia. These trials will be utilizing a variety of the NIH agreement mechanisms (e.g., Cooperative Research and Development Agreements [CRADAs]) that maximize industry participation and support.

It is envisioned that the network will not be "idle" at any time. During the start-up period, as well as during periods of time when new network projects will not take up the entire network capacity, the Clinical Site coordinators and principal investigators will improve the quality and facilitate the implementation of clinical trials at their sites, by offering their support to ongoing NINDS-funded trials and enhancing patient recruitment and retention. The CCC will track site performance as it relates to ongoing NINDS-funded trials.

RESEARCH APPROACHES

Shared Network Infrastructure

This FOA solicits applications for funding of infrastructure for trial coordination. The additional project-specific funds to support the implementation of network protocols will be part of future awards. These funds will be distributed to the Clinical Sites via the CCC on a per-patient basis, according to protocol budgets approved by the network Steering Committee (SC) and via master trial agreements with the Clinical Sites.

The network will give preference to clinical sites agreeing to use a central IRB of record, to accelerate IRB approval in multi-center trials. To that effect, the network will use a federated" IRB model. This model gives participating institutions the option to choose one of three tiers of IRB review:

The Clinical Sites are strongly encouraged to work with a central IRB of record. The CCC will have to coordinate a central IRB of record and manage all required IRB communication and documentation including but not limited to tracking approval, maintaining regulatory documents, communicating with the local IRBs, and handling adverse event reporting and notifications.

Network Projects

Over the 7-year project period, the network will conduct approximately 5-7 clinical research projects, and will promote the implementation of ongoing NINDS-funded clinical trials. The exact number of protocols supported in the 7-year program will depend on the nature and extent of the investigations proposed and the availability of funds.

To ensure that the network is efficiently using resources from its inception, a short-term clinical research project will begin soon after the network has been established. It is anticipated that this first project will be a biomarker validation study for spinal muscular atrophy (SMA). A separate future FOA will solicit applications for this SMA protocol. Additional trials will be selected from project proposals from industry and academic investigators submitted in response to a second, future FOA that will solicit applications for network Phase 2 clinical trials to be implemented through the network. It is anticipated that at least one of the total trials conducted will be targeted to children.

Following a second level of review by the NINDS advisory council, NINDS will select protocols to be fully developed by a protocol lead team consisting of the Project Director/Principal Investigator (PD/PI), disease-experts as co-investigators, and network representatives.

The final protocol will be approved after technical review by a Protocol Review Committee. A subset or all of the Clinical Sites will then be invited to participate in a given project and will have the option to accept or decline, depending on their capacity, interest, and patient population relevant to the specific protocol. It is also possible that non-network sites may be added ad-hoc for a specific project, for their expertise and patient population to complement network sites.

RESEARCH TOPICS

The Clinical Coordinating Center's Scope of Work includes, but is not limited to:

During the Conceptual Phase of each potential new network project, the CCC is responsible for:

During the Planning Phase of approved network projects, the CCC is responsible for:

During the Implementation Phase, the CCC is responsible for:

During the Analysis and Publication Phase, the CCC is responsible for:

Network Structure and Management

The NINDS Network of Excellence in Neuroscience Trials will include: one Data Coordinating Center (DCC), one Clinical Coordinating Center (CCC), and up to 25 Clinical Sites. Investigators at the NIH Clinical Center may function as an additional clinical site.

Section II. Award Information
Funding Instrument

This FOA will use the NIH U01 research Project Cooperative Agreement award mechanism (U01). In the cooperative agreement mechanism, the PD(s)/PI(s) retain(s) the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the PD(s)/PI(s), as described under the Section VI.2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The total amount of funding that NINDS expects to award through this announcement is up to $18.5 Million.

The anticipated number of awards is one (1).

Although the financial plans of the IC provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Award Budget

The expected direct cost amount for individual awards is up to $1.75 Million annually for 7 years.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

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.

Award Project Period

This is a one-time solicitation to fund the network for 7 years. Plans beyond the current funding period are undetermined.

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

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

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 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/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project 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 PHS398 Application Guide.

The PD/PI for the network Clinical Coordinating Center will be a clinical trials expert with a track record in successfully coordinating and implementing complex, multi-center clinical trials in the neurosciences.

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

Only one CCC application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. However, applicants may apply for an award for the DCC or Clinical Site (separate FOAs) as well as for an award under this FOA.

Awards for a CCC and a DCC will not be made to the same Principal Investigator, to ensure that data analyses and data acquisition are performed independently.

Awards for a CCC and a Clinical Site may be made to the same institution.

However, it is preferred that the CCC and a Clinical Site at the same institution be led by separate investigators, to ensure that the CCC activities as well as the local Clinical Site activities receive full attention.

This section contains other eligibility criteria, if applicable (e.g., if entities have violated a particular statute).

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications are not permitted in response to this FOA.

Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

A letter of intent is required.

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 research;
Name, address, and telephone number of the PI;
Names of other key personnel;
Participating institutions;
Number and title of this funding opportunity.

The letter of intent should be sent to:

Petra Kaufmann, MD
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Blvd., Room 2116
Bethesda, MD 20892-9520 (Express/Courier: Rockville, MD 20852)
Telephone: (301) 496-9135
Email: NEXT@ninds.nih.gov

Pre-Application Meeting: The NINDS anticipates holding a technical assistance meeting in January 2011 (now December 17, 2010 per NOT-NS-11-005), through a teleconference to which all interested prospective applicants are invited. Program and review staff will make presentations that explain their goals and objectives for the NEXT Initiative and answer questions from the attendees. Prospective applicants are urged to monitor the NIH Guide for Grants and Contracts regarding a Notice for the date and time of the meeting (http://grants.nih.gov/grants/guide/index.html).

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
E-mail: nindsreview.nih.gov@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Applications should include the following information in the relevant subsections:

1) Leadership and Operations Plan

The PD/PI should describe in the Approach section of the Research Strategy, how clinical trials and research will be strategically supported by the network Clinical Coordinating Center. The PD/PI should describe the expertise and track record of the research staff, the CCCs SOPs, how tasks will be delegated and supervised, and how the team will communicate. The PD/PI should describe how all aspects of complex multi-center trials will be supported by the CCC. Note that the CCC will be responsible for registering all trials with http://www.clinicaltrials.gov.

2) Collaboration Plan

In the relevant sections of the Biosketch, Resources/Facilities and the Research Strategy or (where applicable), in the Multiple PD/PI Leadership Plan, applicants should state their general support of collaborative research and their willingness to participate in a collaborative and interactive manner with the Clinical Sites, the Data Coordinating Center, and NINDS and its partners (both academic and industry partners) in all aspects of the network program. Applicants are encouraged to describe any special expertise or unique strengths they can offer to the collaborative effort (e.g., experience in clinical trial collaborations with industry partners or patient groups). The applicant should indicate how potential network project investigators (from academia or industry) will be motivated to work with the network, supported in the conception phase, and integrated into the network in the planning and implementation phases.

3) Recruitment and Outreach Plan

In the Approach section of the Research Strategy, the PD/PI should describe plans for supporting recruitment of patients at the clinical sites, including plans to optimize minority recruitment. Additional details on recruitment plans may be provided in the Human Subjects section of the application, as appropriate. Prospective recruitment plans should be established for each project and the PD/PI should indicate how outreach into the community at the Clinical Sites, to referring physicians and patients will be encouraged, what actions and materials will be used to support recruitment of patients, and how patients will be included in the conception, planning and implementation of trials so that a strong partnership between investigators and patients can serve as a foundation for successful trial recruitment and retention.

4) Leveraging Local Clinical Research Resources Plan

In the Resources/Facilities section of the application, the PD/PI should describe how local clinical research resources such as equipment, space and research staff will relate to the network CCC activities, and, if applicable, how the network will integrate Clinical and Translational Science Award (CTSA) resources.

5) Plan to Increase the Quality and Efficiency of the Clinical Research Enterprise at the Clinical Sites

For new trials, describe CCC plans to reduce start-up time by increasing the efficiency of contracting and IRB review through use of standardized master trial agreements and federated IRB models. If applicable, describe additional measures in the Research Strategy section that would increase the efficiency of ongoing NINDS-funded clinical research, even if outside of the network. Describe other plans to increase the quality and efficiency of clinical trials. Describe how protocol adherence and data quality will be maximized in collaboration with the Clinical Sites.

6) Performance Monitoring and Potential Interventions Plan

For new and potentially also for ongoing NINDS-funded trials, the application should describe in the Approach section of the Research Strategy, how the CCC will monitor performance and collect data on start-up, recruitment and retention, as well as data quality for NINDS-funded clinical trials at the Clinical Sites.

7) Training Plan

The network presents a rich environment for young investigators to be exposed to and develop additional research skills and to assist them in progressing to more senior status. In the Approach section of the Research Strategy, describe the plans to reach out to young investigators.

8) Clinical Coordination and Project Management Plan

Leading the network CCC will be a complex and time-consuming undertaking, and applicants must have the necessary experience and expertise to coordinate multi-center clinical trials in pediatric and adult patients with neurological disorders. Therefore, a listing of current and up to five of the most recently completed trials that the CCC applicant has coordinated must also be provided in the 30 page Research Strategy.

The standard operating procedures (SOPs) used by the CCC in the implementation of multi-center clinical trials, including, but not limited to SOPs describing regulatory document collection, IRB approvals, study drug management, procedures to minimize bias and maintain blinding, recruitment plans, retention plans, data sharing plans, safety monitoring plans, etc., should be included under Research Strategy. Plans directly related to participants such as adverse event monitoring, may be included in the Human Subjects section, as necessary.

In the Research Strategy section, applicants should include a table with a brief description of current and up to five most recently completed trials that the CCC has coordinated, indicating:

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 PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

The following items are recommended for inclusion as the Appendix:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Qualifications and Experience

Collaboration

Links with NIH Resource Centers

Applications from institutions that have a General Clinical research Center (GCRC) or Clinical and Translational Science Award (CTSA) funded by the NIH National Center for Research Resources should identify the resources that could be available to support the proposed network CCC, commenting particularly on those aspects that will enhance their programmatic and scientific efficiency in the Resources/Facilities section of the application. In such a case, a description of the GCRC or CTSA and how the applicant proposes interacting with it should be included, as well as letter of agreement from either the GCRC/CTSA Program Director or PI included in the Letters of Support section of the application Having a GCRC or CTSA at the institution is not a requirement for application.

Budget

A detailed budget for the CCC should be presented. The budget must include all activities delineated in the list of CCC responsibilities included in this FOA.

All activities related to coordinating at least 5-7 clinical research studies, should be budgeted, including:

The total budget should not exceed $1.75 Million direct costs per year in years 1-7 (all of which will be 12-month project years). The release of funds will be milestone-driven, according to milestones pre-specified in the Notice of Grant Award. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).

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.

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?

Investigator(s)

Are the PD/PIs, 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?

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?

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.

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

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) 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 Scientific Review Branch (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke Council.

For this particular announcement, 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 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, CCR 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 CCC PD(s)/PI(s) will have the primary responsibility for:

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

Areas of Joint Responsibility include:

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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)

Dr. Petra Kaufmann
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: NEXT@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 DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

Section VIII. Other Information

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

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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