Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Neurological Disorders and Stroke (NINDS)
Funding Opportunity Title	NINDS Institutional Center Core Grants to Support Neuroscience Research (P30)
Activity Code	P30 Center Core Grants
Announcement Type	Reissue of PAR-12-081
Related Notices	October 14, 2014 - This PAR has been reissued as RFA-NS-14-013. June 19, 2014 - Notice of Intent to Publish a Funding Opportunity Announcement for Institutional Center Core Grants to Support Neuroscience Research. See Notice NOT-NS-14-037. February 21, 2013 - See Notice NOT-NS-13-017. Notice of Correction Regarding Application Instructions.
Funding Opportunity Announcement (FOA) Number	PAR-13-116
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.853
Funding Opportunity Purpose	NINDS invites applications for Center Core Grants that provide resources and facilities shared by a minimum of six NINDS-supported investigators, and supporting a wider base of neuroscience research. The proposed Centers will offer services and expertise that would be difficult or impractical to support in individual labs. The Centers are expected to capitalize on economies and synergies associated with shared resources, and to foster a collaborative environment among neuroscientists at host institutions.

Posted Date	February 13, 2013
Letter of Intent Due Date(s)	April 16, 2013
Application Due Date(s)	May 16, 2013
AIDS Application Due Date(s)	Not Applicable)
Scientific Merit Review	July, 2013
Advisory Council Review	August, 2013
Earliest Start Date	September, 2013
Expiration Date	May 17, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

The National Institute of Neurological Disorders and Stroke (NINDS) invites applications for Center Core Grants to support the NINDS mission, which is to reduce the burden of neurological disease. In pursuit of this mission, NINDS supports basic, translational, and clinical research on the normal and diseased nervous system. For an overview of NINDS, with links to more information, see http://www.ninds.nih.gov/about_ninds/ninds_overview.htm.

The Centers will provide cutting edge resources and facilities to investigators who have existing NINDS-funded research projects, and to other investigators pursuing research consistent with the NINDS mission. The Centers should enhance the effectiveness of ongoing research and facilitate new research directions. This support is intended to increase resource accessibility and to capitalize on potential economies and synergies that would not be attained through independent funding of separate research projects.

To receive a Center Core Grant, an institution or consortium must support at least six Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) who hold qualifying NINDS-funded research projects at the time of application submission. Qualifying projects include R01 and other larger scale awards, as specified in Section III.3. Additional Information on Eligibility.

Support provided by the Cores to the qualifying projects must be within scope of the projects' specific aims.

All of the qualifying investigators must be significant users of the Center, and no more than 25% of the effort from a single Core facility can be devoted to projects directed by any single investigator. The qualifying projects are necessary, but must not be the only projects supported by the Cores, because it is expected that the Cores will serve a wide base of neuroscience investigators. Priority for usage shall be determined according to the Project Prioritization Plan described below.

P30 Center awards will not support independent research that is separate from the goal of service to Center users. Center personnel may receive partial funding from other sources for independent research, but their effort towards Center activities shall be documented as described below. In infrequent cases, technology development may be appropriate for a given Core, but only insofar as this development enhances the service to Center users. Applicants considering technology development efforts are encouraged to contact an appropriate NINDS Program Director to discuss alternative grant mechanisms.

In assessing the appropriateness of potential research Cores, applicants should weigh various considerations, including the following.

• Cores should provide services that would be impractical for individual labs, either because of ongoing requirements for specialized expertise, or because of associated economies of scale.
• A Core must provide unique services that are not available to investigators elsewhere either off-site (e.g., commercially) or via other facilities at the host institution. Exceptions to this requirement may be allowable in infrequent cases, but only if the Core adds substantial and demonstrable value both for potential users and for support of the NINDS mission.
• Cores and Core services must be specifically targeted to neuroscience research. Resources that are general to biomedical sciences are not appropriate, unless there is a specific unmet neuroscience research need.
• Core facilities and personnel should be focused on a service mission, with a goal of meeting the data needs of a variety of potential users.
• Core directors must be expert in the associated technologies, and they should have a history of providing services associated with the Core, e.g., via previous collaborative relationships.
• Cores are expected to provide cutting edge technologies that will add value to future research, in addition to currently supported projects.

The following is a non-exclusive list of types of activities that may be appropriate for individual Core facilities: Animal models, Animal surgery, Behavior, Genomics, Histochemistry, Imaging, Informatics, Microscopy, Pathology, Optogenetics, Physiology, and Statistical/Computational Analysis.

The program will not provide funding for Cores that support clinical trials or provide patient services. For services associated with clinical research, investigators should contact the NINDS Office of Clinical Research (http://www.ninds.nih.gov/research/clinical_research/).

The program will not provide funding for chemistry services associated with candidate therapeutic lead optimization. For services associated with translational research, investigators should consider the NINDS Cooperative Program in Translational Research (http://www.ninds.nih.gov/research/translational/index.htm), and can contact the NINDS Office of Translational Research (http://www.ninds.nih.gov/funding/areas/translational_research/index.htm).

It is expected that the Cores will generate revenue via fee-for-service arrangements whenever possible, in order to optimize efficient resource usage and enhance resource sustainability. Fee-for-service arrangements must be explicitly described in the application.

Co-funding by the applicant organization or by outside sources is encouraged, but the host institution’s existing facilities and available services should be clearly delineated from the facilities and services that are proposed for funding via this FOA in the Resources section of the application (see Section IV. Application and Submission Information). There should be no overlap between the requested NINDS-funded core facilities and other pre-existing core facilities at the host institution.

Dissemination and Access Plan

Center applicants should propose, or have in place, a mechanism for thorough dissemination and advertisement of available services and resources to the full community of neuroscience investigators at the host institution. In addition, each application should propose or have in place a concrete plan for facilitating access to the Center resources, such as a website in which users can sign up for services or equipment.

Steering Committee

Each Center will be directed by a Steering Committee chaired by the PD/PI of the Center Core Grant. The committee will include the directors of the individual Cores, at least two of the PD(s)/PI(s) of the qualifying projects, and a Department Chair or Vice President/Provost for Research, or equivalent, from the applicant organization.

The Steering Committee will establish guidelines to determine the most appropriate methods for providing access to the Core facilities and services, as specified in the Project Prioritization Plan described below. The Steering Committee will also advise the Center PD/PI on strategic and operational issues, to maximize the impact of the Center on NINDS-relevant research at the institution. For consortium arrangements between multiple applicant organizations (see Section III.3. Additional Information on Eligibility), the composition of the proposed Steering Committee must include representation from the respective organizations sufficient to fully support the interests of potential users from each organization.

Project Prioritization Plan

For each of the proposed Cores, the application must include a Project Prioritization Plan that details how the capacity of the proposed Core will be evaluated and allocated by the Steering Committee. Prioritization may be established by virtue of a differential fee structure or by a formal project evaluation mechanism, or by other appropriate considerations.

Pilot research that is not within the scope of NIH-funded research projects should be approved by the Steering Committee. Pilot projects proposed for the first year of award funding must be explicitly described in the application with sufficient detail for evaluation by peer reviewers.

NINDS funded projects shall be given priority over pilot research and over research that is funded from other sources. In all cases, the relevance of the research to the NINDS mission of reducing the burden of neurological disease shall be a primary consideration, with recognition that this mission includes support for basic research on fundamental processes of nervous system function. The plan should permit some level of access to NINDS mission-relevant research for PD(s)/PI(s) who do not hold NINDS qualifying grants, even during busy periods of usage. Centers should serve as resources for early stage as well as established investigators.

Activity Reports

Annual Activity Reports for each of the Cores shall be submitted to the Steering Committee and to the assigned NINDS Program Officer. The reports will document that effort is maintained at the reported level for each individual supported by Center funds, and they will contain quantitative information regarding usage by individual projects and PD(s)/PI(s) for each of the Cores. The Steering Committee shall evaluate the Activity Reports to ensure compliance with Center usage requirements, and to assess the ongoing value of Core services. The format for reporting quantitative information depends on the nature of the services and deliverables provided by the various cores. This format for reporting activities must be specified in the application, as indicated in Section IV.2. Content and Form of Application Submission.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Renewal Resubmission The OER Glossary and the PHS 398 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. NINDS anticipates funding 3 awards in response to the current announcement.
Award Budget	Applications may request up to $400,000 per year in direct costs.
Award Project Period	The maximum project period is 4 years.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

Applicant organizations must complete the following registrations as described in the PHS 398 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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• eRA Commons

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.

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

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. Additionally, an institution is eligible for a maximum of one NINDS Center Core Grant.

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:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicant organizations must have a minimum of six qualifying research projects directed by at least six separate Program Director(s)/Principal Investigator(s). All qualifying projects must be substantial users of the Cores, and Core services must be within scope of the funded aims of the awards identified as qualifying projects. No more than 25% of the effort from a single Core facility can be devoted to projects directed by any single investigator.

Qualifying projects are defined for the purpose of this FOA as NINDS-funded research projects using the R01, U01, R37, P01, P50 and U54 activity codes (for general descriptions/definitions, see http://grants.nih.gov/grants/funding/funding_program.htm) . Multicomponent awards such as Program Projects (P01) and Centers (P50 or U54) each count as only one qualifying project toward the minimum requirement.

Investigators holding smaller research projects (R21 and R03), fellowships, and career (K) awards are eligible for Center services, but these investigators/awards do not count toward the minimum required number of qualifying projects.

Consortium arrangements between applicant organizations are allowed, and qualifying research projects may be included from each organization. Applications with participation by more than one organization must demonstrate that facilities and services will be local and accessible for users from each organization, and that users from each organization have a compelling need for the services of the proposed Center. The composition of the proposed Steering Committee must include representation from the respective organizations sufficient to fully support the interests of potential users from each organization.

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

It is critical that applicants follow the instructions in the PHS 398 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.

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

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

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

The letter of intent should be sent to:

Edmund Talley, Ph.D.
Neuroscience Center, Room 2132
6001 Executive Boulevard, MSC 9521
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-1917
Email (strongly preferred): TalleyE@mail.nih.gov

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 9521
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-9223
Email: nindsreview.nih.gov@mail.nih.gov

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

• Center Overview: 6 pages
• Cores: 6 pages each

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The budget section of the application must include an overall summary budget for the Center that includes the cost of the individual cores, and a separate detailed budget for each proposed core.

The Resources section must include the following components:

• Facilities and Equipment. For each Core, describe the available and planned resources.
• Related Resources. Provide comprehensive information on related facilities and services available at the host institution. These alternative resources must be clearly delineated from those proposed for the Center.
• Qualifying Projects. Provide concise but complete information on the qualifying projects and their associated Investigators, with detail sufficient for verification that proposed core activities are within the scope of the funded aims of the projects. For qualifying project requirements, see Section III.3. Additional Information on Eligibility.

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Research Strategy

The Research Strategy should include the following items. For specific Center requirements and criteria, see Section I. Funding Opportunity Description.

Overview of the Center:

• Goals for the Center. Include unique features of services and/or administration, and how the Cores fulfill the requirements of NINDS-supported research.
• Qualifying investigators research interests. Describe how their long-term research goals align with the NINDS mission, and how the proposed Center will meet current and future needs for their research. It is expected that the qualifying investigators be at the top of their respective fields.
• Institutional support. Describe commitment and support by the host institution, including provision of space, faculty position commitments, salary for Core staff, purchases of equipment, and/or financing for new construction/renovation.
• Center administration. Include a description of the roles and responsibilities of the Steering Committee, the Center PD/PI and Core Directors.
• Project Prioritization Plan. Detail how projects will be evaluated and/or allocated to maximize the capacity of each Core. Describe how pilot research will be evaluated and approved by the Steering Committee. Note that pilot projects proposed for the first year of award funding must be explicitly described in the application with sufficient detail for evaluation by peer reviewers.
• Dissemination and Access Plan. Explain how Core functions will be advertised and accessed by users.

Cores:

• Facilities and Services. Describe essential Core functions and their research value.
• Research Core suitability. Include information on expected economies and synergies, cost comparisons to comparable services, and the added value both to investigators and to the NINDS mission.
• Applicability to Qualifying Projects: Describe how the services provided by the Cores will contribute to and enhance the funded specific aims of the qualifying research projects.
• Appropriateness of the Core PD/PI and personnel. Include information on expertise, training and history of service to users and/or colleagues.
• Activity Reports. Detail the exact format for annual quantitative reporting of Core usage at the level of Projects and Investigators. The format should be sufficient for the Steering Committee to ensure compliance with Center usage requirements, and to assess the ongoing value of Core services.
• Note that it is expected that the Cores will generate revenue via fee-for-service arrangements whenever possible, in order to optimize efficient resource usage and enhance resource sustainability. Fee-for-service arrangements must be explicitly described in the application.

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 PHS 398 Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 PHS 398 Application Guide.

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 PHS 398 Application Guide.

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

This initiative is not subject to intergovernmental review.

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

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

Applications must be 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, NIH. Applications that are incomplete will not be reviewed.

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

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

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

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

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?

Will the Center and each of the Cores enhance research output in ways that would not be practical for individual research projects? Do the Cores convincingly add value over comparable facilities and services, either on- or off-site?

Are the cores and their services specifically targeted to neuroscience research, and not general to biomedical science? Does the Center provide special synergies or influence the host research environment in tangible ways? Do the long term research goals of the qualifying users align with the NINDS mission, which is to reduce the burden of neurological disease through research on the normal and diseased nervous system?Are the services offered by the Cores within the scope of the funded aims of the identified qualifying projects?

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? ?

Is the Program Director(s)/Principal Investigator(s) well qualified to effectively administer the Center? Are each of the Core directors and personnel appropriately trained and suitably positioned for their respective roles? Are they able to devote adequate time and effort to Core activities? Do they have a history of performing services for their colleagues, outside the needs of their own research? Is the steering committee appropriate for effective oversight of the Center?

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?

Are features of the Center organization or its services unique? Are the technologies especially forward-ranging in their implementation? Do the Center and/or individual Cores have potential to serve as exemplars for outstanding research service?

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?

Do the Cores provide advanced techniques and services? Are they maximally appropriate for the anticipated research needs of the investigators? Are the facilities and equipment optimal? Are plans for Center administration, including procurement and personnel management, appropriate? Does the Dissemination and Access Plan ensure that facilities and services will be widely used, with easy and fair access to the appropriate users? Is the Project Prioritization Plan sufficient to ensure optimal allocation of Center resources? For each of the Cores, is the format for the annual Activity Report appropriate for ensuring compliance with Center usage guidelines, and for assessing the ongoing value of Core services?

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?

Is the host institution a premiere locus for cutting edge neuroscience research? Are the primary users at the top of their respective fields? Is there a large base of investigators, outside those holding the minimum qualifying projects, who will derive benefits from the Center? Has the host institution demonstrated tangible commitments in the support of the Center and/or in support of research towards the goals of the NINDS mission, which is to reduce the burden of neurological disease through research on the normal and diseased nervous system? .

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

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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

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. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center and 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 (NANDS) Council. The following will be considered in making funding decisions:

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

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Not Applicable

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

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

Edmund Talley, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email (strongly preferred): TalleyE@mail.nih.gov

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

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

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

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