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

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

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
  • 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-11-010

Companion FOA

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

RFA-NS-11-009, 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 Data 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 Data Coordinating Center (DCC). Separate FOAs solicit applications for the Clinical Sites and the Clinical Coordinating Center (RFA-NS-008 and RFA-NS-009).

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 to participate as a Data 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. 

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 encourages applications for funding of infrastructure for data and statistical coordination. The additional project-specific funds to support the implementation of network protocols will be part of future awards.

Responsibilities of the DCC include the following:

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 for each selected study 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 Data Coordinating Center' Scope of Work includes, but is not limited to:

1)  Data Management

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

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

During the Implementation Phase of approved network projects, the DCC is responsible for:

2)  Data Quality Assurance

3)  Data Sharing

4)  Communication

5)  Monitoring

6)  Statistical Support

7)  Collaborating with Other Network Components

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. 

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 $13.2 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 $1.25 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 Data Coordinating Center will be an experienced statistician and clinical trial data management expert, with a track record in successfully implementing the statistical and data aspects of multicenter clinical trials. Institutions will be required to document commitment to the PD/PI by providing departmental and institutional support letters, and are encouraged to demonstrate support via other means (e.g., additional protected time, departmental research leadership position, facilities, space, or resources for the PD/PI). 

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

However, it is preferred that the DCC and a Clinical Site at the same institution be led by separate investigators, to ensure that the DCC 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 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 Data Coordinating Center PD/PI and staff, and how the data management and statistical team will be directed.

2) Collaboration and Communications 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 Clinical Coordinating Center, and NINDS and its partners in all aspects of the network program. Applicants should describe their communications plan with the CCC and Clinical Sites within the network. Applicants are encouraged to describe any special expertise or unique strengths they can offer to the collaborative effort (e.g., established database tools, hardware, software, quality control tools, monitoring expertise, team leadership and training, communications platforms, website design and management).

3) Data Management, Quality Assurance and Monitoring Plan

Based on the tasks outlined above, the PD/PI should describe in the Approach section of the Research Strategy, how the data management, quality assurance and monitoring programs for network projects will be supported, building on existing strengths.  A data management system should:

4) Statistical Support Plan

Based on the outline above, the PD/PI should describe in the Approach section of the Research Strategy, how all statistical aspects of trials from the pre-application conceptual phase, the planning phase, the implementation phase and the analysis and publication phase will be supported.  It is anticipated that the DCC will provide full statistical support for all network projects. However, the PD/PI should briefly describe how in the alternative scenario of a non-DCC statistician this statistician would be integrated in network DCC operations of their project. Under the alternative scenario, the project statistician leads the statistical design, analysis plans, and the final analysis for publication, remaining blinded during the course of the trial.  The DCC statistician leads the data management and preparation of unblended reports and analyses. In the Conceptual and Planning phases, both statisticians will work together to ensure the design is suitable for implementation through the network. The applicant should outline their expertise in exploratory clinical trials and adaptive designs. 

5) Plan to Increase Data Sharing Opportunities

According to the goals and tasks outlined above, the PD/PI should describe in the Approach section of the Research Strategy or in the Resource Sharing Plan section how standardization of protocols, data collection and data collection instruments will be promoted, including the integration of NINDS common data elements, if applicable. The PD/PI should describe how datasets of completed trials will be submitted for data sharing to an NINDS repository, using data exchange standards.

6) Trial Start-up and Participant Recruitment

Participation in the network will be a complex and time-consuming undertaking.  Therefore, in the Research Strategy under Preliminary Data/Approach section, the applicant should include a description of current and up to five of the most recently completed trials that were coordinated by the DCC, along with a detailed record indicating the following, in a table or bulleted format:

In addition, the application should include the following information:

7) Project Management and Coordination Plan

The application should include, in the Research Strategy section, the SOPs, with key documents (e.g., Conflict of Interest policy) used by the DCC in the implementation of multi-center clinical trials, included, but not limited to SOPs describing database access, data quality control, data queries with audit trails, etc. 

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 in 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.

 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 in the Resources/Facilities section, the resources that could be available to support the proposed network DCC, commenting particularly on those aspects that will enhance their programmatic and scientific efficiency.  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 (included in the Letters of Support section of the application) from either the GCRC/CTSA Program Director or PI.  Having a GCRC or CTSA at the institution is not a requirement for application.

Budget

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

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

The PD/PI must be available to attend all network investigator meetings, which may include conference calls twice a month and in-person meetings at least three times each year.

The budget should also include travel costs for approximately three trips each year for three team members to attend SC meetings in Bethesda, MD, and other travel related to network operations (including at least one visit per site and funding period).

The total should not exceed $1.25 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 DCC 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 301-435-0714
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)

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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