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
Research Program Award (R35 Clinical Trial Optional)
Activity Code
R35 Outstanding Investigator Award
Announcement Type
Reissue of RFA-NS-17-020
Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-NS-18-032
Companion Funding Opportunity
None
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.853
Funding Opportunity Purpose
The purpose of the NINDS Research Program Award (RPA) is to provide longer-term support and increased flexibility to Program Directors (PDs) /Principal Investigators (PIs) whose records of research achievement demonstrate their ability to make major contributions to neuroscience.  RPAs will support the overall research programs of NINDS-funded investigators for up to 8 years, at a level commensurate with a PD/PI's recent NINDS support (Part 2, Section II)  This greater funding stability will provide eligible investigators at nearly all career stages increased freedom and flexibility, allowing them to be more adventurous in their research, take greater risks, embark upon research that breaks new ground, undertake research projects that require a longer timeframe, and/or extend previous discoveries in new directions.  Research supported through the RPA must be within the scope of the NINDS mission (http://www.ninds.nih.gov/about_ninds/mission.htm).  Research activities outside of the NINDS mission, or traditionally supported by another NIH Institute or Center will not be considered through this program. 

Other anticipated benefits of the RPA include:
  • A more stable funding environment, facilitating the pursuit of longer term research goals;
  • Flexible funding, enabling investigators to pursue research opportunities as they arise, not tied to specific aims;
  • Reduced time spent writing grant applications and managing multiple grant awards, thereby allowing investigators to spend more time conducting and overseeing research; and
  • More time for PDs/PIs to mentor junior scientists.
Eligibility to apply through this FOA is limited to investigators who currently have at least one active NINDS R01 or R01 equivalent grant (defined as R01, R37, R56, DP1 or DP2 awards) due to expire in FY18 or FY19.  Applicants must also have received R01, R00, or R01 equivalent grant support from NINDS in each of the past 5 years, with no more than one of those years in a no cost extension.  Investigators selected for R35 funding must relinquish their other NINDS research grants, with a limited number of exceptions (see Part 2, Section I).  NINDS will seek to ensure that RPA awards are diverse not only with respect to scientific approach and area of study, but also with respect to investigator background and career stage.

Key Dates

Posted Date
May 11, 2018
Open Date (Earliest Submission Date)
June 13, 2018
Letter of Intent Due Date(s)
June 13, 2018
Application Due Date(s)
July 13, 2018, by 5:00 PM local time of applicant organization. No late applications will be accepted for this Funding Opportunity Announcement.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)
Not Applicable.
Scientific Merit Review
November 2018
Advisory Council Review
January 2019
Earliest Start Date
April 2019
Expiration Date
July 14, 2018
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.
Table of Contents

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Overview
Most grant awards are limited to 2-5 years and are intended to support individual projects, rather than the overall research program of an investigator's laboratory or research group.  Because of these constraints, many PDs/PIs spend a considerable portion of their time writing grant applications rather than performing and overseeing research.  The NINDS RPA is a different approach to supporting investigators at nearly all career stages. An RPA will support all the NINDS-related research in an investigator's laboratory or research group for a sustained period of time.  The award is intended to increase funding stability, reduce the time investigators spend writing grant applications, and facilitate a more flexible research environment, thereby enabling more ambitious, creative and/or long-term research goals.

Investigators receiving an RPA must relinquish their other NINDS research grants, with a limited number of exceptions (see Part 2, Section I).  PDs/PIs can retain other non-overlapping grant support from other NIH ICs, provided they remain able to dedicate sufficient effort to the RPA (see below). Since the RPA is intended to support most, if not all, of the NINDS related research in an investigator's laboratory, the funding that PDs/PIs receive from leading or participating in NINDS multiple-PD/PI research grants, program project grants, and/or Center grants will also be incorporated into the RPA.

By replacing all or most of an investigator's NINDS funding, the research supported by an RPA should be the major focus of the PD/PI's laboratory or research group.  Therefore, the PD/PI must devote at least 6 person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) to the RPA throughout the duration of the award period.  Applications from PD/PIs committing less than 6 person months will not be accepted. When applicable, PDs/PIs will be expected to renegotiate their time and effort on other non-NINDS awards in order to accommodate the level of effort required by the RPA. 

It is important to note that though the RPA mechanism is not intended to support the expansion of an investigator's current level of NINDS funding, RPAs will be awarded for no less than $350K direct cost ( DC) . Barring this exception, only in very rare and extremely well-justified circumstances (e.g. an investigator is still within the growth phase of their careers) will awards exceed the investigator's 4 year NINDS funding average of awarded grants of the types subject to fold-in described below. Applicants should refer to Section II, Award Budget for detailed guidance on preparing their budget. When considering an RPA application, investigators should balance this funding limitation against the benefits of the RPA, which include:

  • Funding stability for up to eight years.  The initial budget period will be five years, with an additional three years granted contingent upon an administrative review (see Duration, below);

  • Support for an investigator's other currently funded NINDS research grants will in effect be extended through the RPA, without requiring submission of separate renewal applications;

  • Reduced administrative burden associated with writing multiple grant applications and managing multiple grant awards.

  • Increased flexibility to pursue new ideas and scientific opportunities as they arise during the course of research, since the award is not constrained by specific aims or predicated on completing specific, pre-defined research objectives;

It is anticipated that the RPA will be highly competitive. To prevent a lapse in funding, a PD/PI may submit a competitive renewal R01 application and an RPA application in parallel.  Should both applications be meritorious and considered for funding, the PD/PI will be permitted to accept only one of the awards.

Since an RPA is intended to be the primary source of support for an investigator's NINDS research, it is expected that it will replace most of the NINDS funding of the PD/PI's laboratory.  Institutions will be required to relinquish their financial interests in current NINDS-funded research grants where the applicant investigator is listed as the PD/PI (e.g. research project grants (RPGs), P01s, P50 and other Center awards) except for the following which would not be subject to consolidation into the R35 and the PD/PI would remain eligible to apply for:

  • Contracts;

  • SBIR/STTR grants or cooperative agreements;

  • Conference grants;

  • Grants or cooperative agreements that exclusively support research resources (e.g. P30, R24 or U24 awards);

  • Grants or cooperative agreements supporting training, diversity, or workforce development;

  • Grants or cooperative agreements supporting clinical trials submitted in response to NINDS clinical trials FOAs;

  • Grants or cooperative agreements submitted in response to the NINDS IGNITE, CREATE, or Translational Neural Devices Programs;

  • Grants or cooperative agreements submitted in response to BRAIN Initiative FOAs

In addition to those listed above, the PD/PI will remain eligible to apply for the additional sources of NINDS funding listed below; however, applicants should contact NINDS with questions or for further clarification regarding excepted programs.

  • Administrative Supplements;

  • Grants submitted in response to selected targeted research programs.  Eligible FOAs to be determined by NINDS in consultation with the NANDS Council. 

Though RPA awardees are encouraged to continue existing collaborations on NINDS grants as part of multi-PD/PI project teams, support for these or future collaborative activities must be supported through the R35 award.  Moreover, although RPA investigators will be permitted to accept a limited amount of support from other NINDS-funded investigators as a co-investigator or consultant, the level of support should not significantly exceed the level of subcontracted support at the time the R35 award is made.  R35 awardees are strongly encouraged to contact NINDS staff prior to agreeing to participate in activities not funded by the R35 award.

Duration:  The initial budget period of the RPA will be five years.  The award will be extended for three additional years contingent upon an administrative review by NINDS staff and approval of the NANDS Council.  This review will assess whether the investigator's research program is progressing appropriately and will continue to do so.  In this review, NINDS staff and the NANDS Council will take into account the fact that the RPA is intended to support projects that may involve higher risk and longer-term research.  NINDS anticipates that most RPA awards will be extended; however, if the year five administrative review determines that a research program is not progressing adequately, the investigator will be encouraged to apply for other competitive research project funding from the NIH and the level of RPA funding will be reduced.  If the investigator chooses to accept another NINDS grant award, he/she will be required to relinquish the remaining time and funds from the RPA.  In a limited number of exceptionally well-justified circumstances, the PD/PI may be permitted to request an increase in funds following successful completion of the administrative review. 

Renewals:  Although NINDS is currently planning to continue this program, the decision to do so will depend on funds available, and a preliminary analysis of the program's effectiveness.  If the program is continued, renewal RPA applications will be permitted through future R35 FOAs.

Eligibility:  The RPA is intended to provide a more stable funding environment to PDs/PIs with track records of productive, high-quality, and high-impact research, enabling them to operate their research programs more flexibly, unrestrained by specific project aims. It is important to note, however, that the RPA is not intended only for investigators with long track records of research.  Accomplished PDs/PIs who have made significant scientific contributions after one cycle of grant support are particularly encouraged to apply.  Eligibility to apply through this FOA is limited to investigators who currently have at least one active NINDS R01 or R01 equivalent grant (defined as R01, R37, R56, DP1 or DP2 awards) due to expire in FY18 or FY19.  Applicants must also have received R01, R00, or R01 equivalent grant support from NINDS in each of the past 5 years (that is, FY14-18 or FY13-17, with no more than one of those years in a no cost extension.  NINDS will seek to ensure that RPA awards are diverse not only with respect to scientific approach and area of study, but also with respect to investigator background and career stage. Research not supported through an NINDS RPA:

  • Research outside of the NINDS mission, or traditionally supported by another NIH Institute or Center

  • Activities supported by another NIH Institute or Center, federal or state agency, or private foundation;

  • Clinical trials designed to answer specific questions about the safety, tolerability, efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions

PDs/PIs are encouraged to contact NINDS Scientific/Research staff prior to submission of an RPA application to discuss whether their application is relevant to the NINDS mission and does not overlap with grants from other NIH ICs or independent funding entities.
 

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

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

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Clinical Trial?
Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?
Funds Available and Anticipated Number of Awards

NINDS intends to commit $20 million in FY 2019 to fund up to30 awards. NINDS will seek to ensure that RPA awards are diverse not only with respect to scientific approach and area of study, but also with respect to investigator background and career stage.

Award Budget
Applicants may request up to a maximum of $750,000 direct costs per year; however, the requested RPA budget must be commensurate with the investigator's recent level of NINDS support. That level of support must be calculated using the average direct cost total for the 4 most recent years (i.e. 2014 - 2017 or 2015 - 2018, whichever is greater) from all awarded NINDS research grants of the type that will be folded into the R35 award; it should not include funding that is exempt from R35 fold in (see Section 1, Overview). Calculations should use awarded direct costs (including administrative cuts), and in the case of MPI/MPD awards or multi-component grants/cooperative agreements, should only include the amount of the total award that is attributable to the applicant PI/PD. Moreover, in the case of multi-component grants/cooperative agreements, the budget should not incorporate funds attributable to cores, as these funds will not be folded into the RPA. Please note that pending support should not be considered when developing an RPA budget, even if such applications should get funded between the R35 submission and award. Although the RPA mechanism is not intended to support the expansion of an investigator's current level of NINDS funding, RPAs will be awarded for no less than $350K DC. Barring this exception, only in very rare and extremely well-justified circumstances (e.g. an investigator is still within the growth phase of their careers) will awards exceed the most recent 4 year funded average of NINDS grants subject to be folded in. Applications submitted with budgets of more than 20% over the 4 year average described above will be considered non-compliant to this FOA and will be withdrawn prior to review. PDs/PIs are encouraged to discuss their proposed budgets / projects with NINDS program staff prior to submission and should provide detailed evidence supporting their proposed request in the budget justification section (e.g. table calculating 4 year average of direct costs, including grant numbers with awarded direct costs for each year; for example see https://www.ninds.nih.gov/Funding/About-Funding/Research-Program-Award-R35). Year one of the R35 award will be offset by any funds disbursed in the same FY from awards that will be folded into the RPA.
Award Project Period
The maximum project period is 8 years.
 
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations
Higher Education Institutions
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
Governments
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
Other
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 
Required Registrations
Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Only single PD/PI applications are allowed, applications with multiple PD(s)/PI(s) will not be accepted. Eligible investigators at nearly all career stages, as well as those from underrepresented racial and ethnic groups and individuals with disabilities are encouraged to apply. Applications that do not meet eligibility requirements will not be reviewed.

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

Eligibility to apply to this FOA is limited to PDs/PIs who meet all the following criteria:
Are currently PD/PI on at least one active NINDS R01 or R01 equivalent grant (defined as R01, R37, R56, DP1 or DP2 awards) due to expire in FY18 or FY19;
Have received R01, R00, or R01 equivalent grant support from NINDS in each of the past 5 years (i.e. FY13-17 or FY14-18), with no more than one of those years in a no cost extension

2. Cost Sharing

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

3. Additional Information on Eligibility

 

 
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. To prevent a lapse in funding, a PD/PI may submit a competitive renewal R01 application and an RPA application in parallel. Should both applications be meritorious and considered for funding, the PD/PI will be permitted to accept only one of the awards.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
 
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD/PI
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity
 
The letter of intent should be sent to:
 
David Owens, Ph.D.
Telephone: 301-496-9248
Fax: 301-402-4370
Email: david.owens@nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Include a publication list from the previous 5 years in the Bibliography & References Cited section that separates research articles from review articles and commentaries
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.

Biographical Sketch:  The RPA is intended for investigators at nearly all career stages with track records of research achievement, consistent productivity, and significant scientific impact commensurate with their career stage.  Eligible investigators who are earlier in their career are encouraged to apply.  The PD/PI should address these considerations as well as the other RPA-specific elements of the Investigator Review Criterion, including the PD/PI's record of professional service, including successful mentoring of undergraduate, graduate, and/or medical students, postdoctoral or clinical fellows, or junior faculty and training of individuals from diverse, underrepresented populations. In the "Additional Information" section,  , applicants should include: 1) specific details demonstrating their commitment to mentorship (e.g. numbers/ types of trainees/faculty mentored with special attention to diverse trainees) and 2) specific details of their committee (e.g. NIH review, Advisory Council), journal review, and institutional service.

The R35 application should include standard biosketches for any subcontracted independent investigators.

Current & Pending Support:  Use the SF424 R&R Current and Pending Support instructions and attach this information to the Senior/Key Personnel Form.  List NINDS grants first, followed by other NIH grants, followed by other sources of support.

Provide a list of all current (FY18) and pending (FY19) support (including subcontracted support) for the PD/PI (even if they receive no salary support from the project(s)) for ongoing projects and pending applications. This information should include project number and title, start and end dates, role on grant, the total award amount for the most recent award period (including direct and indirect costs) as well as the number of calendar-months per year to be devoted to the project by the senior/key person, regardless of source of support. Concurrent submission of an application to other organizations that are not components of NIH or the Public Health Service will not prejudice the review.
 

 
All instructions in the SF424 (R&R) Application Guide must be followed.
While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 8 years of support. PDs/PIs should provide in the budget justification, detailed evidence supporting their proposed request (e.g. table calculating 4 year average of direct costs, including grant numbers with awarded direct costs for each year; for example see https://www.ninds.nih.gov/Funding/About-Funding/Research-Program-Award-R35).  Calculations should use awarded direct costs (including administrative cuts), and in the case of MPI/MPD awards or multi-component grants/cooperative agreements, should only include the amount of the total award that is attributable to the applicant PD/PI.  Moreover, in the case of multi-component grants/cooperative agreements, the budget should not incorporate funds attributable to cores, as these funds will not be folded into the RPA.  Applicants must commit at least 6 person months (i.e., the equivalent of 50% effort on for a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) throughout the duration of the RPA period. Applications from PD/PIs committing less than 6 person months will not be accepted.
 
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims:  Specific Aims should not be submitted. 

Research Strategy:   Upload the Research Strategy as a single attachment containing the following information:
1) Background regarding the area(s) of research proposed and key gaps in our understanding or challenges that need to be addressed.  Describe in broad terms the scientific question (s) that you will address and why it is important.
 
2) Description of leveraging of your recent research achievements.  This description should describe progress during the previous five years and should include evidence and examples of your conduct of rigorous research and transparent reporting in order to explain how you will leverage the contributions (e.g., novel ideas, accomplishments, experience, sustained productivity, etc.) made by your research group into the new approaches proposed in your research program.  Discuss the reasons and likelihood that the proposed research program will continue to be important and generate significant new discoveries. Do not repeat material covered in the Biosketch. 
 
3) Overview of proposed research program. Describe the overall vision, conceptual framework and general strategies for furthering and sustaining the proposed research program for the next eight years.  Identify the key questions or challenges you plan to address and the general approaches and tools that might be used to address them. Discuss the importance of the research question, and how the research, if successful, would affect current understanding of the problem being addressed and/or advance the field of study. Describe how the stable funding provided through the RPA will impact your research program and how the work proposed is distinct from that supported by other funding sources.  Include in your overview a description of how your goals will leverage your previous contributions, your existing program, and/or the current state of the science.  Include plans for transparent reporting, resource/data sharing , and consideration of sex and other biological variables in the research program
 
The proposed research can be either a continuation of your previous or current work or involve a new line of investigation.  If the planned research program diverges significantly from your past/current work, explain your rationale for the changes and describe your ability to undertake this new direction. A detailed experimental plan is not expected, and preliminary data should be included only if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which you have not yet published. Although the proposed direction of the research program will be considered in review, if new opportunities or directions arise during the course of the research, you will have the flexibility to change course and pursue them. Whether the program is an extension of current work or a new line of investigation, reviewers will consider how the proposed RPA research program and resultant impact on the field will benefit from the flexibility, level of effort and the longer-term funding offered by the RPA.

Letters of Support:  The application must include a letter from the institution's Authorized Organizational Official (AOR) indicating that they are aware of and accept the condition that other NINDS research awards must be relinquished as a condition of receiving a RPA (as described in Part 2, Section I), and providing a statement that if chosen to receive an award, the PD/PI must devote at least 6 person months (i.e., the equivalent of 50% effort on for a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) to the RFA throughout the duration of the award period.
 
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
  • All applications, regardless of the amount of direct costs requested for any one year, should includea Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.
It is anticipated that the terms of award will include, but not be limited to, the following:

A permanent change of PD/PI will not be allowed under the RPA. A temporary change may be allowed with prior approval under circumstances such as sabbatical leave, medical conditions, disability, or personal or family situations.

Transfer of a RPA to a foreign institution will not be allowed. Addition of a foreign component, including a significant new foreign collaboration requires prior approval.

It is expected that the RPA will replace current NINDS funding of the laboratory. Institutions will be required to relinquish their interests in current NINDS-funded research grants where the applicant investigator is listed as the PD/PI (e.g. RPGs, P01s, P50s) or proportional interest in awards where the applicant is one of a multiple PI team (MPI), with the exceptions of those indicated below. The initial budget period of the RPA and timing of the award will be negotiated so that a smooth transition of support takes place. Exceptions include:
  • Contracts;
  • SBIR/STTR grants or cooperative agreements;
  • Conference grants;
  • Grants or cooperative agreements that exclusively support research resources (e.g. P30, R24 or U24 awards);
  • Grants or cooperative agreements supporting training, diversity, or workforce development;
  • Grants or cooperative agreements supporting clinical trials submitted in response to NINDS clinical trials required FOAs;
  • Grants or cooperative agreements submitted in response to the NINDS IGNITE, CREATE, or Translational Neural Devices Program;
  • Grants or cooperative agreements submitted in response to BRAIN Initiative FOAs

It is expected that the PD/PI will renegotiate effort on other grants, if necessary, to permit required effort on the RPA. Note that a change in effort of more than 25% may require programmatic approval from other NIH ICs. A temporary reduction in effort may be approved under circumstances such as medical conditions, disability, or personal or family situations.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.


In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.


For this particular announcement, note the following:

An RPA is intended to support most of the NINDS-related research in an investigator's laboratory or research group for a sustained period of time, facilitating increased funding stability, reduced administrative burden, and a more flexible research environment enabling more ambitious, creative and/or long-term research.  RPA applicants are expected to provide an overview of their proposed research program, the scientific questions or challenges they intend to address and a general description of approaches and tools that might be used to address them.  A detailed experimental plan is not expected, and preliminary data should be included only if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which the PD/PI has not yet published.

Accordingly, reviewers will emphasize the following:
  • Evidence of important previous contributions made by the PD/PI commensurate with the investigator's career stage, particularly within the past 5 years
  • Potential for the PD/PI's research impact to continue at the same high level over the course of the RPA
  • Suitability of the R35 mechanism to advance the investigator's research program
Overall Impact
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).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit but will assign only a single overall impact score. 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 research program address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the research program? If the overall goals of the research program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will obtaining answers to the scientific questions posed change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Does the proposed research program address a problem that is sufficiently comprehensive and substantial to be appropriate for long-term pursuit? Is the proposed research program adequately broad and ambitious?  Will achievement of the proposed goals significantly affect the field of study? 

In addition, for applications involv ing clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)
Are the PD/PI, collaborators, and other researchers well suited to the project? If the PD/PI is in the early stages of an independent career, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

Specific to this FOA: Does the PD/PI have a track record of productivity and of having substantial impact in the proposed field of study appropriate for the applicant?s stage of career? Has the PD/PI shown evidence of being creative and adaptable, able to recognize new opportunities and explore new areas of scientific inquiry, and open to the use of new systems and strategies, as appropriate? What is the potential for the PD/PI's research productivity and influence to continue at the same high caliber? Does the PD/PI have a record of conducting rigorous, reproducible, and transparent research? Has the PD/PI proposed an appropriate commitment of time and effort for the proposed work? Does the PD/PI have a record of professional service, including successful mentoring of undergraduate, graduate, or medical students, postdoctoral or clinical fellows, or junior faculty?  Does the PD/PI have a record of training individuals from diverse, underrepresented populations?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating 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?

Specific to this FOA:  Does the PD/PI have a track record of creativity and innovation? Will the increased stability and flexibility of the RPA mechanism enable continued high innovation or more innovative and adventurous approaches to the scientific issues described in the application?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?


 
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the overall goals of the research program? Has the investigator presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Has the investigator presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA:Is the proposed research program suited to the use of the RPA mechanism?  Does the PD/PI provide strong evidence that the proposed work is distinct from that supported by other non-NINDS funding sources?  Does the PD/PI provide strong evidence that the research program will evolve appropriately as the work is performed?  Will the funding stability and flexibility of the RPA allow the PD/PI to pursue highly impactful, longer-term research that may be more difficult to pursue through other grant mechanisms? Is there a sound basis for the proposed level of effort?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

f multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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 score, but will not give separate scores for these items.

Study Timeline 

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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 Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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 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)  Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 Scientific Review Branch, 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.

The review will be convened by the Scientific Review Branch, NINDS. 

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score. 
  • Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke 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.
  • Programmatic diversity (e.g. career stage, race/ethnicity, gender)
  • Note that lower funding priority may be given to applicants with significant unrestricted research support

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

It is anticipated that the terms of award will include, but not be limited to, the following:

  • Relinquishment and/or deobligation of funds from NINDS grants awarded to the PI as described in Part 2, Section I and prorated proportional financial deobligation of the PI's contribution to MPI grants according to the initial distribution of committed effort.
  • Carryover of an unobligated balance for budgets greater than 25% from one budget period to another budget period will require Grants Management Officer prior approval.
  • The initial no-cost extension can be done by the grantee in eRA Commons. Any subsequent no-cost extension will require Grants Management Officer approval.
  • Change of PD/PI will not be allowed.
  • Change of grantee institution (with NIH approval) will be allowable if the receiving institution agrees to all of the required terms.
  • It is expected that the PD/PI will renegotiate effort on non-NINDS NIH grants, if necessary, to permit a minimum of 6 person months to be devoted to the RPA.
  • The initial budget period of the RPA will be five years. The award may be extended for three additional years contingent upon an administrative review by NINDS staff and approval of the NANDS Council.


Six months prior to the end of the -05 budget period, the following should be submitted concurrently with the year four RPPR in order to request the three additional years of funding: 1. A letter co-signed by the Business Official and Principal Investigator requesting an additional three years of support; and 2. A one to two page description of the overall research accomplishments during the previous 4.5 years that justifies continuation of the research program for the final three years.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 


ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain ?applicable clinical trials? on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).


Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). 

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award
Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
a)  Under Section 6.2 B.1 What are the major goals of the project?  Note that the goals of the program of research supported by the RPA are broader than the specific aims of a single project and should be appropriately described.  In addition to the scientific goals, describe the goals of enhanced mentoring of trainees and other research personnel that this award facilitates.  If the goals of the RPA have changed, complete section B.1.a. Provide a rationale for the changes in the context of the originally proposed research program and further contributions to the field, and an explanation of how the research continues to fit within NINDS mission interests.

b)  Under Section B.2, in addition to the instructions, emphasize how the work continues to be innovative and of high impact.

c)  Under section D.2.c. additional information, indicate if there have been changes in Other Support.  In addition to the revised Other Support page, include an explanation of the relationship of the new awards to the activities supported by the RPA.
 
A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
 
GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267
Scientific/Research Contact(s)
David Owens, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9248
Email: OwensD@ninds.nih.gov
Peer Review Contact(s)
Ernie Lyons, Ph.D
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email:LyoneE@ninds.nih.gov
 
Financial/Grants Management Contact(s)
Tijuanna Decoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
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 Part 75.
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NIH... Turning Discovery Into Health®


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